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Trial record 1 of 1 for:    V114-029
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Safety, Tolerability, and Immunogenicity of V114 in Healthy Infants (V114-029) (PNEU-PED)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03893448
Recruitment Status : Completed
First Posted : March 28, 2019
Results First Posted : March 25, 2022
Last Update Posted : March 25, 2022
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme LLC

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Prevention
Conditions Pneumococcal Infections
Pneumococcal Vaccines
Interventions Biological: V114
Biological: Prevnar 13™
Biological: RotaTeq™
Biological: Pentacel™
Biological: RECOMBIVAX HB™
Biological: VAQTA™
Biological: MMR II™
Biological: VARIVAX™
Biological: HIBERIX™
Enrollment 1720
Recruitment Details This study recruited healthy infants approximately 2 months (42 to 90 days, inclusive) of age, without a history of invasive pneumococcal disease or prior administration of any pneumococcal vaccine.
Pre-assignment Details 1720 participants were randomized in a 1:1 ratio to receive a 4-dose regimen of either V114 or Prevnar 13™. One participant randomized to the Prevnar 13™ arm was inadvertently treated with Prevnar 13™ and V114.
Arm/Group Title V114 Prevnar 13™
Hide Arm/Group Description Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 from 42-90 days of age inclusive (Vaccination 1), Month 4 from 4 months of age to 1 day prior to 5 months of age (Vaccination 2), Month 6 from 6 months of age to 1 day prior to 7 months of age (Vaccination 3) and Months 12-15 from 12 months of age to 1 day prior to 16 months of age (Vaccination 4). Participants concomitantly received other licensed paediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 4, and Month 6; VAQTA™, HIBERIX™, M-M-R™ II, VARIVAX™ on Months 12-15. Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 from 42-90 days of age inclusive (Vaccination 1), Month 4 from 4 months of age to 1 day prior to 5 months of age (Vaccination 2), Month 6 from 6 months of age to 1 day prior to 7 months of age (Vaccination 3) and Months 12-15 from 12 months of age to 1 day prior to 16 months of age (Vaccination 4). Participants concomitantly received other licensed paediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 4, and Month 6; VAQTA™, HIBERIX™, M-M-R™ II, VARIVAX™ on Months 12-15.
Period Title: Overall Study
Started 860 860
Treated 858 856
Completed 758 734
Not Completed 102 126
Reason Not Completed
Withdrawal by Parent/Guardian             59             85
Physician Decision             8             14
Lost to Follow-up             34             27
Death             1             0
Arm/Group Title V114 Prevnar 13™ Total
Hide Arm/Group Description Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 from 42-90 days of age inclusive (Vaccination 1), Month 4 from 4 months of age to 1 day prior to 5 months of age (Vaccination 2), Month 6 from 6 months of age to 1 day prior to 7 months of age (Vaccination 3) and Months 12-15 from 12 months of age to 1 day prior to 16 months of age (Vaccination 4). Participants concomitantly received other licensed paediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 4, and Month 6; VAQTA™, HIBERIX™, M-M-R™ II, VARIVAX™ on Months 12-15. Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 between 42-90 days of age inclusive (Vaccination 1), Month 4 from 4 months of age to 1 day prior to 5 months of age (Vaccination 2), Month 6 from 6 months of age to 1 day prior to 7 months of age (Vaccination 3) and Months 12-15 from 12 months of age to 1 day prior to 16 months of age (Vaccination 4). Participants concomitantly received other licensed paediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 4, and Month 6; VAQTA™, HIBERIX™, M-M-R™ II, VARIVAX™ on Months 12-15. Total of all reporting groups
Overall Number of Baseline Participants 860 860 1720
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Weeks
Number Analyzed 860 participants 860 participants 1720 participants
8.4  (1.2) 8.4  (1.3) 8.4  (1.2)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 860 participants 860 participants 1720 participants
In utero 0 0 0
Preterm newborn infants (gestational age < 37 weeks) 0 0 0
Newborns (0-27 days) 0 0 0
Infants and toddlers (28 days-23 months) 860 860 1720
Children (2-11 years) 0 0 0
Adolescents (12-17 years) 0 0 0
Adults (18-64 years) 0 0 0
From 65-84 years 0 0 0
85 years and over 0 0 0
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 860 participants 860 participants 1720 participants
Female
397
  46.2%
428
  49.8%
825
  48.0%
Male
463
  53.8%
432
  50.2%
895
  52.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 860 participants 860 participants 1720 participants
Hispanic or Latino
207
  24.1%
204
  23.7%
411
  23.9%
Not Hispanic or Latino
640
  74.4%
645
  75.0%
1285
  74.7%
Unknown or Not Reported
13
   1.5%
11
   1.3%
24
   1.4%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 860 participants 860 participants 1720 participants
American Indian or Alaska Native
6
   0.7%
13
   1.5%
19
   1.1%
Asian
223
  25.9%
227
  26.4%
450
  26.2%
Native Hawaiian or Other Pacific Islander
6
   0.7%
4
   0.5%
10
   0.6%
Black or African American
52
   6.0%
53
   6.2%
105
   6.1%
White
474
  55.1%
483
  56.2%
957
  55.6%
More than one race
98
  11.4%
80
   9.3%
178
  10.3%
Unknown or Not Reported
1
   0.1%
0
   0.0%
1
   0.1%
1.Primary Outcome
Title Percentage of Participants With Solicited Injection-Site Adverse Events (AEs) in V114 Versus Prevnar 13™
Hide Description An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited injection-site AEs consisted of swelling, redness, pain or tenderness, and hard lump.
Time Frame Up to 14 days after each vaccination with either V114 or Prevnar 13™
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of either V114 or Prevnar 13™. One participant in the Prevnar 13™ group inadvertently received both V114 and Prevnar 13™ and was excluded from the analysis population.
Arm/Group Title V114 Prevnar 13™
Hide Arm/Group Description:
Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 from 42-90 days of age inclusive (Vaccination 1), Month 4 from 4 months of age to 1 day prior to 5 months of age (Vaccination 2), Month 6 from 6 months of age to 1 day prior to 7 months of age (Vaccination 3) and Months 12-15 from 12 months of age to 1 day prior to 16 months of age (Vaccination 4). Participants concomitantly received other licensed paediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 4, and Month 6; VAQTA™, HIBERIX™, M-M-R™ II, VARIVAX™ on Months 12-15.
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 from 42-90 days of age inclusive (Vaccination 1), Month 4 from 4 months of age to 1 day prior to 5 months of age (Vaccination 2), Month 6 from 6 months of age to 1 day prior to 7 months of age (Vaccination 3) and Months 12-15 from 12 months of age to 1 day prior to 16 months of age (Vaccination 4). Participants concomitantly received other licensed paediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 4, and Month 6; VAQTA™, HIBERIX™, M-M-R™ II, VARIVAX™ on Months 12-15.
Overall Number of Participants Analyzed 858 855
Measure Type: Number
Unit of Measure: Percentage of participants
Solicited injection site AEs 69.0 69.2
Injection site erythema (redness) 33.7 38.5
Injection site induration (hard lump) 26.3 26.8
Injection site pain (pain) 49.8 46.9
Injection site swelling (swelling) 26.3 24.0
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection V114, Prevnar 13™
Comments Injection site erythema Estimated difference, CI, and p-value are calculated based on the Miettinen & Nurminen method
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value = 0.039
Comments [Not Specified]
Method Miettinen & Nurminen
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage Point Difference
Estimated Value -4.8
Confidence Interval (2-Sided) 95%
-9.3 to -0.2
Estimation Comments V114-Prevnar 13™
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection V114, Prevnar 13™
Comments Injection site induration Estimated difference, CI, and p-value are calculated based on the Miettinen & Nurminen method
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value = 0.836
Comments [Not Specified]
Method Miettinen & Nurminen
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage Point Difference
Estimated Value -0.4
Confidence Interval (2-Sided) 95%
-4.6 to 3.7
Estimation Comments V114-Prevnar 13™
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection V114, Prevnar 13™
Comments Injection site pain Estimated difference, CI, and p-value are calculated based on the Miettinen & Nurminen method
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value = 0.235
Comments [Not Specified]
Method Miettinen & Nurminen
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage Point Difference
Estimated Value 2.9
Confidence Interval (2-Sided) 95%
-1.9 to 7.6
Estimation Comments V114-Prevnar 13™
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection V114, Prevnar 13™
Comments Injection site swelling Estimated difference, CI, and p-value are calculated based on the Miettinen & Nurminen method
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value = 0.260
Comments [Not Specified]
Method Miettinen & Nurminen
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage Point Difference
Estimated Value 2.4
Confidence Interval (2-Sided) 95%
-1.7 to 6.5
Estimation Comments V114-Prevnar 13™
2.Primary Outcome
Title Percentage of Participants With Solicited Systemic AEs
Hide Description An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited systemic AEs consisted of irritability, drowsiness, appetite lost, and hives or welts.
Time Frame Up to 14 days after each vaccination with either V114 or Prevnar 13™
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of either V114 or Prevnar 13™. One participant in the Prevnar 13™ group inadvertently received both V114 and Prevnar 13™ and was excluded from the analysis population.
Arm/Group Title V114 Prevnar 13™
Hide Arm/Group Description:
Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 from 42-90 days of age inclusive (Vaccination 1), Month 4 from 4 months of age to 1 day prior to 5 months of age (Vaccination 2), Month 6 from 6 months of age to 1 day prior to 7 months of age (Vaccination 3) and Months 12-15 from 12 months of age to 1 day prior to 16 months of age (Vaccination 4). Participants concomitantly received other licensed paediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 4, and Month 6; VAQTA™, HIBERIX™, M-M-R™ II, VARIVAX™ on Months 12-15.
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 from 42-90 days of age inclusive (Vaccination 1), Month 4 from 4 months of age to 1 day prior to 5 months of age (Vaccination 2), Month 6 from 6 months of age to 1 day prior to 7 months of age (Vaccination 3) and Months 12-15 from 12 months of age to 1 day prior to 16 months of age (Vaccination 4). Participants concomitantly received other licensed paediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 4, and Month 6; VAQTA™, HIBERIX™, M-M-R™ II, VARIVAX™ on Months 12-15.
Overall Number of Participants Analyzed 858 855
Measure Type: Number
Unit of Measure: Percentage of participants
Solicited systemic adverse events 84.4 84.8
Decreased appetite 34.3 36.0
Irritability 76.5 75.4
Somnolence (drowsiness) 59.0 62.0
Urticaria (hives) 6.5 6.5
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection V114, Prevnar 13™
Comments Decreased appetite Estimated difference, CI, and p-value are calculated based on the Miettinen & Nurminen method
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value = 0.446
Comments [Not Specified]
Method Miettinen & Nurminen
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage Point Difference
Estimated Value -1.8
Confidence Interval (2-Sided) 95%
-6.3 to 2.8
Estimation Comments V114-Prevnar 13™
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection V114, Prevnar 13™
Comments Irritability Estimated difference, CI, and p-value are calculated based on the Miettinen & Nurminen method
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value = 0.622
Comments [Not Specified]
Method Miettinen & Nurminen
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage Point Difference
Estimated Value 1.0
Confidence Interval (2-Sided) 95%
-3.0 to 5.1
Estimation Comments V114-Prevnar 13™
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection V114, Prevnar 13™
Comments Somnolence (drowsiness) Estimated difference, CI, and p-value are calculated based on the Miettinen & Nurminen method
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value = 0.202
Comments [Not Specified]
Method Miettinen & Nurminen
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage Point Difference
Estimated Value -3.0
Confidence Interval (2-Sided) 95%
-7.6 to 1.6
Estimation Comments V114-Prevnar 13™
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection V114, Prevnar 13™
Comments Urticaria (Hives) Estimated difference, CI, and p-value are calculated based on the Miettinen & Nurminen method
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value = 0.985
Comments [Not Specified]
Method Miettinen & Nurminen
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage Point Difference
Estimated Value 0.0
Confidence Interval (2-Sided) 95%
-2.4 to 2.3
Estimation Comments V114-Prevnar 13™
3.Primary Outcome
Title Percentage of Participants With Vaccine-Related Serious Adverse Events (SAEs)
Hide Description An SAE is any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires inpatient hospitalization or prolongs existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an other important medical event. Any SAEs that are at least possibly related to vaccination are summarized.
Time Frame From Day 1 up to 6 months after Vaccination 4 (up to 21 months)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of either V114 or Prevnar 13™. One participant in the Prevnar 13™ group inadvertently received both V114 and Prevnar 13™ and was excluded from the analysis population.
Arm/Group Title V114 Prevnar 13™
Hide Arm/Group Description:
Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 from 42-90 days of age inclusive (Vaccination 1), Month 4 from 4 months of age to 1 day prior to 5 months of age (Vaccination 2), Month 6 from 6 months of age to 1 day prior to 7 months of age (Vaccination 3) and Months 12-15 from 12 months of age to 1 day prior to 16 months of age (Vaccination 4). Participants concomitantly received other licensed paediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 4, and Month 6; VAQTA™, HIBERIX™, M-M-R™ II, VARIVAX™ on Months 12-15.
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 from 42-90 days of age inclusive (Vaccination 1), Month 4 from 4 months of age to 1 day prior to 5 months of age (Vaccination 2), Month 6 from 6 months of age to 1 day prior to 7 months of age (Vaccination 3) and Months 12-15 from 12 months of age to 1 day prior to 16 months of age (Vaccination 4). Participants concomitantly received other licensed paediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 4, and Month 6; VAQTA™, HIBERIX™, M-M-R™ II, VARIVAX™ on Months 12-15.
Overall Number of Participants Analyzed 858 855
Measure Type: Number
Unit of Measure: Percentage of participants
0.0 0.0
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection V114, Prevnar 13™
Comments Estimated difference, CI, and p-value are calculated based on the Miettinen & Nurminen method
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage Point Difference
Estimated Value 0.0
Confidence Interval (2-Sided) 95%
-0.4 to 0.4
Estimation Comments V114-Prevnar 13™
4.Primary Outcome
Title Percentage of Participants With Anti-Pneumococcal Polysaccharide (Anti-PnP) Immunoglobulin G (IgG) Antibody (Ab) ≥0.35 ug/mL One Month After Vaccination 3
Hide Description Anti-PnP serotype-specific IgG response rates for the 15 serotypes contained in V114 were measured with pneumococcal electrochemiluminescence (PnECL). The percentage of participants with IgG Ab ≥0.35 ug/mL are reported for each serotype.
Time Frame One month after Vaccination 3 (Month 7)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who did not have protocol deviations that could have substantially affected the results of the immunogenicity analysis and who had sufficient blood volume to perform the analysis.
Arm/Group Title V114 Prevnar 13™
Hide Arm/Group Description:
Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 from 42-90 days of age inclusive (Vaccination 1), Month 4 from 4 months of age to 1 day prior to 5 months of age (Vaccination 2), Month 6 from 6 months of age to 1 day prior to 7 months of age (Vaccination 3) and Months 12-15 from 12 months of age to 1 day prior to 16 months of age (Vaccination 4). Participants concomitantly received other licensed paediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 4, and Month 6; VAQTA™, HIBERIX™, M-M-R™ II, VARIVAX™ on Months 12-15.
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 from 42-90 days of age inclusive (Vaccination 1), Month 4 from 4 months of age to 1 day prior to 5 months of age (Vaccination 2), Month 6 from 6 months of age to 1 day prior to 7 months of age (Vaccination 3) and Months 12-15 from 12 months of age to 1 day prior to 16 months of age (Vaccination 4). Participants concomitantly received other licensed paediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 4, and Month 6; VAQTA™, HIBERIX™, M-M-R™ II, VARIVAX™ on Months 12-15.
Overall Number of Participants Analyzed 858 856
Measure Type: Number
Unit of Measure: Percentage of participants
Serotype 1 Number Analyzed 702 participants 665 participants
95.7 99.1
Serotype 3 Number Analyzed 699 participants 662 participants
94.7 79.2
Serotype 4 Number Analyzed 699 participants 663 participants
96.4 98.6
Serotype 5 Number Analyzed 702 participants 664 participants
95.3 97.4
Serotype 6A Number Analyzed 702 participants 663 participants
93.7 98.6
Serotype 6B Number Analyzed 699 participants 662 participants
88.6 92.0
Serotype 7F Number Analyzed 701 participants 665 participants
99.0 99.8
Serotype 9V Number Analyzed 700 participants 661 participants
97.1 98.2
Serotype 14 Number Analyzed 700 participants 661 participants
97.9 97.9
Serotype 18C Number Analyzed 700 participants 662 participants
97.4 98.3
Serotype 19A Number Analyzed 702 participants 665 participants
97.9 99.7
Serotype 19F Number Analyzed 700 participants 663 participants
99.0 100.0
Serotype 23F Number Analyzed 698 participants 661 participants
91.5 91.8
Serotype 22F Number Analyzed 701 participants 661 participants
98.6 91.8
Serotype 33F Number Analyzed 702 participants 661 participants
87.3 91.8
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection V114, Prevnar 13™
Comments Serotype 1 Estimated difference, CI, and p-value are calculated based on the Miettinen & Nurminen method
Type of Statistical Test Non-Inferiority
Comments A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevnar 13™) being >-10 percentage points (1-sided p-value <0.025).
Statistical Test of Hypothesis P-Value < 0.001
Comments p-value is 1-sided
Method Miettinen & Nurminen
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage Point Difference
Estimated Value -3.4
Confidence Interval (2-Sided) 95%
-5.2 to -1.8
Estimation Comments V114-Prevnar 13™
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection V114, Prevnar 13™
Comments Serotype 3 Estimated difference, CI, and p-value are calculated based on the Miettinen & Nurminen method
Type of Statistical Test Non-Inferiority
Comments A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevnar 13™) being >-10 percentage points (1-sided p-value <0.025).
Statistical Test of Hypothesis P-Value < 0.001
Comments p-value is 1-sided
Method Miettinen & Nurminen
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage Point Difference
Estimated Value 15.6
Confidence Interval (2-Sided) 95%
12.1 to 19.2
Estimation Comments V114-Prevnar 13™
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection V114, Prevnar 13™
Comments Serotype 4 Estimated difference, CI, and p-value are calculated based on the Miettinen & Nurminen method
Type of Statistical Test Non-Inferiority
Comments A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevnar 13™) being >-10 percentage points (1-sided p-value <0.025).
Statistical Test of Hypothesis P-Value < 0.001
Comments p-value is 1-sided
Method Miettinen & Nurminen
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage Point Difference
Estimated Value -2.2
Confidence Interval (2-Sided) 95%
-4.0 to -0.6
Estimation Comments V114-Prevnar 13™
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection V114, Prevnar 13™
Comments Serotype 5 Estimated difference, CI, and p-value are calculated based on the Miettinen & Nurminen method
Type of Statistical Test Non-Inferiority
Comments A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevnar 13™) being >-10 percentage points (1-sided p-value <0.025).
Statistical Test of Hypothesis P-Value < 0.001
Comments p-value is 1-sided
Method Miettinen & Nurminen
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage Point Difference
Estimated Value -2.1
Confidence Interval (2-Sided) 95%
-4.2 to -0.2
Estimation Comments V114-Prevnar 13™
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection V114, Prevnar 13™
Comments Serotype 6A Estimated difference, CI, and p-value are calculated based on the Miettinen & Nurminen method
Type of Statistical Test Non-Inferiority
Comments A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevnar 13™) being >-10 percentage points (1-sided p-value <0.025).
Statistical Test of Hypothesis P-Value < 0.001
Comments p-value is 1-sided
Method Miettinen & Nurminen
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage Point Difference
Estimated Value -4.9
Confidence Interval (2-Sided) 95%
-7.1 to -3.0
Estimation Comments V114-Prevnar 13™
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection V114, Prevnar 13™
Comments Serotype 6B Estimated difference, CI, and p-value are calculated based on the Miettinen & Nurminen method
Type of Statistical Test Non-Inferiority
Comments A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevnar 13™) being >-10 percentage points (1-sided p-value <0.025).
Statistical Test of Hypothesis P-Value < 0.001
Comments p-value is 1-sided
Method Miettinen & Nurminen
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage Point Difference
Estimated Value -3.4
Confidence Interval (2-Sided) 95%
-6.6 to -0.3
Estimation Comments V114-Prevnar 13™
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection V114, Prevnar 13™
Comments Serotype 7F Estimated difference, CI, and p-value are calculated based on the Miettinen & Nurminen method
Type of Statistical Test Non-Inferiority
Comments A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevnar 13™) being >-10 percentage points (1-sided p-value <0.025).
Statistical Test of Hypothesis P-Value < 0.001
Comments p-value is 1-sided
Method Miettinen & Nurminen
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage Point Difference
Estimated Value -0.8
Confidence Interval (2-Sided) 95%
-1.9 to -0.1
Estimation Comments V114-Prevnar 13™
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection V114, Prevnar 13™
Comments Serotype 9V Estimated difference, CI, and p-value are calculated based on the Miettinen & Nurminen method
Type of Statistical Test Non-Inferiority
Comments A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevnar 13™) being >-10 percentage points (1-sided p-value <0.025).
Statistical Test of Hypothesis P-Value < 0.001
Comments p-value is 1-sided
Method Miettinen & Nurminen
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage Point Difference
Estimated Value -1.0
Confidence Interval (2-Sided) 95%
-2.8 to 0.6
Estimation Comments V114-Prevnar 13™
Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection V114, Prevnar 13™
Comments Serotype 14 Estimated difference, CI, and p-value are calculated based on the Miettinen & Nurminen method
Type of Statistical Test Non-Inferiority
Comments A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevnar 13™) being >-10 percentage points (1-sided p-value <0.025).
Statistical Test of Hypothesis P-Value < 0.001
Comments p-value is 1-sided
Method Miettinen & Nurminen
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage Point Difference
Estimated Value 0.0
Confidence Interval (2-Sided) 95%
-1.6 to 1.6
Estimation Comments V114-Prevnar 13™
Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection V114, Prevnar 13™
Comments Serotype 18C Estimated difference, CI, and p-value are calculated based on the Miettinen & Nurminen method
Type of Statistical Test Non-Inferiority
Comments A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevnar 13™) being >-10 percentage points (1-sided p-value <0.025).
Statistical Test of Hypothesis P-Value < 0.001
Comments p-value is 1-sided
Method Miettinen & Nurminen
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage Point Difference
Estimated Value -0.9
Confidence Interval (2-Sided) 95%
-2.6 to 0.7
Estimation Comments V114-Prevnar 13™
Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection V114, Prevnar 13™
Comments Serotype 19A Estimated difference, CI, and p-value are calculated based on the Miettinen & Nurminen method
Type of Statistical Test Non-Inferiority
Comments A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevnar 13™) being >-10 percentage points (1-sided p-value <0.025).
Statistical Test of Hypothesis P-Value < 0.001
Comments p-value is 1-sided
Method Miettinen & Nurminen
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage Point Difference
Estimated Value -1.8
Confidence Interval (2-Sided) 95%
-3.2 to -0.8
Estimation Comments V114-Prevnar 13™
Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection V114, Prevnar 13™
Comments Serotype 19F Estimated difference, CI, and p-value are calculated based on the Miettinen & Nurminen method
Type of Statistical Test Non-Inferiority
Comments A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevnar 13™) being >-10 percentage points (1-sided p-value <0.025).
Statistical Test of Hypothesis P-Value < 0.001
Comments p-value is 1-sided
Method Miettinen & Nurminen
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage Point Difference
Estimated Value -1.0
Confidence Interval (2-Sided) 95%
-2.1 to -0.4
Estimation Comments V114-Prevnar 13™
Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection V114, Prevnar 13™
Comments Serotype 23F Estimated difference, CI, and p-value are calculated based on the Miettinen & Nurminen method
Type of Statistical Test Non-Inferiority
Comments A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevnar 13™) being >-10 percentage points (1-sided p-value <0.025).
Statistical Test of Hypothesis P-Value < 0.001
Comments p-value is 1-sided
Method Miettinen & Nurminen
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage Point Difference
Estimated Value -0.3
Confidence Interval (2-Sided) 95%
-3.2 to 2.7
Estimation Comments V114-Prevnar 13™
Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection V114, Prevnar 13™
Comments Serotype 22F This analysis represents the difference between response rate to Serotype 22F in recipients of V114 and lowest response (Serotype 23F at 91.8) in recipients of Prevnar 13™ for shared serotypes, excluding serotype 3. Estimated difference, CI, and p-value are calculated based on the Miettinen & Nurminen method
Type of Statistical Test Non-Inferiority
Comments A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevnar 13™) being >-10 percentage points (1-sided p-value <0.025).
Statistical Test of Hypothesis P-Value < 0.001
Comments p-value is 1-sided
Method Miettinen & Nurminen
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage Point Difference
Estimated Value 6.7
Confidence Interval (2-Sided) 95%
4.6 to 9.2
Estimation Comments V114-Prevnar 13™
Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection V114, Prevnar 13™
Comments Serotype 33F This analysis represents the difference between response rate to Serotype 33F in recipients of V114 and lowest response (Serotype 23F at 91.8) in recipients of Prevnar 13™ for shared serotypes, excluding serotype 3. Estimated difference, CI, and p-value are calculated based on the Miettinen & Nurminen method
Type of Statistical Test Non-Inferiority
Comments A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevnar 13™) being >-10 percentage points (1-sided p-value <0.025).
Statistical Test of Hypothesis P-Value < 0.001
Comments p-value is 1-sided
Method Miettinen & Nurminen
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage Point Difference
Estimated Value -4.5
Confidence Interval (2-Sided) 95%
-7.8 to -1.3
Estimation Comments V114-Prevnar 13™
5.Primary Outcome
Title Geometric Mean Concentration (GMC) of Anti-PnP IgG Ab One Month After Vaccination 3
Hide Description The GMC of anti-PnP IgG Ab were measured with PnECL one month after vaccination 3 and reported for the 15 serotypes contained in V114. IgG GMCs were compared to the lowest in recipients of Prevnar 13™ excluding serotype 3 for the 2 serotypes unique to V114, and compared to the same serotypes for the 13 shared serotypes.
Time Frame One month after Vaccination 3 (Month 7)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who did not have protocol deviations that could have substantially affected the results of the immunogenicity analysis and who had sufficient blood volume to perform the analysis.
Arm/Group Title V114 Prevnar 13™
Hide Arm/Group Description:
Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 from 42-90 days of age inclusive (Vaccination 1), Month 4 from 4 months of age to 1 day prior to 5 months of age (Vaccination 2), Month 6 from 6 months of age to 1 day prior to 7 months of age (Vaccination 3) and Months 12-15 from 12 months of age to 1 day prior to 16 months of age (Vaccination 4). Participants concomitantly received other licensed paediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 4, and Month 6; VAQTA™, HIBERIX™, M-M-R™ II, VARIVAX™ on Months 12-15.
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 from 42-90 days of age inclusive (Vaccination 1), Month 4 from 4 months of age to 1 day prior to 5 months of age (Vaccination 2), Month 6 from 6 months of age to 1 day prior to 7 months of age (Vaccination 3) and Months 12-15 from 12 months of age to 1 day prior to 16 months of age (Vaccination 4). Participants concomitantly received other licensed paediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 4, and Month 6; VAQTA™, HIBERIX™, M-M-R™ II, VARIVAX™ on Months 12-15.
Overall Number of Participants Analyzed 858 856
Geometric Mean (95% Confidence Interval)
Unit of Measure: ug/mL
Serotype 1 Number Analyzed 702 participants 665 participants
1.21
(1.15 to 1.27)
1.89
(1.79 to 2.00)
Serotype 3 Number Analyzed 699 participants 662 participants
1.08
(1.03 to 1.14)
0.62
(0.59 to 0.66)
Serotype 4 Number Analyzed 699 participants 663 participants
1.29
(1.22 to 1.36)
1.35
(1.28 to 1.43)
Serotype 5 Number Analyzed 702 participants 664 participants
1.63
(1.52 to 1.74)
2.25
(2.09 to 2.41)
Serotype 6A Number Analyzed 702 participants 663 participants
1.55
(1.44 to 1.66)
2.95
(2.76 to 3.15)
Serotype 6B Number Analyzed 699 participants 662 participants
1.60
(1.45 to 1.76)
1.97
(1.80 to 2.16)
Serotype 7F Number Analyzed 701 participants 665 participants
2.48
(2.35 to 2.61)
3.23
(3.06 to 3.40)
Serotype 9V Number Analyzed 700 participants 661 participants
1.73
(1.63 to 1.83)
1.89
(1.77 to 2.01)
Serotype 14 Number Analyzed 700 participants 661 participants
4.78
(4.44 to 5.16)
6.80
(6.30 to 7.33)
Serotype 18C Number Analyzed 700 participants 662 participants
1.53
(1.44 to 1.61)
2.00
(1.88 to 2.13)
Serotype 19A Number Analyzed 702 participants 665 participants
1.63
(1.54 to 1.73)
2.29
(2.16 to 2.44)
Serotype 19F Number Analyzed 700 participants 663 participants
2.01
(1.91 to 2.11)
2.72
(2.59 to 2.86)
Serotype 23F Number Analyzed 698 participants 661 participants
1.31
(1.22 to 1.41)
1.47
(1.36 to 1.59)
Serotype 22F Number Analyzed 701 participants 660 participants
4.91
(4.58 to 5.26)
0.05
(0.05 to 0.06)
Serotype 33F Number Analyzed 702 participants 664 participants
1.67
(1.51 to 1.85)
0.06
(0.05 to 0.06)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection V114, Prevnar 13™
Comments Serotype 1 GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.
Type of Statistical Test Non-Inferiority
Comments A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being >0.5 (1-sided p-value <0.025).
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method t-test, 1 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter GMC Ratio (V114 / Prevnar 13™)
Estimated Value 0.64
Confidence Interval (2-Sided) 95%
0.59 to 0.69
Estimation Comments V114/Prevnar 13™
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection V114, Prevnar 13™
Comments Serotype 3 GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.
Type of Statistical Test Non-Inferiority
Comments A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being >0.5 (1-sided p-value <0.025).
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method t-test, 1 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter GMC Ratio (V114 / Prevnar 13™)
Estimated Value 1.73
Confidence Interval (2-Sided) 95%
1.61 to 1.87
Estimation Comments V114/Prevnar 13™
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection V114, Prevnar 13™
Comments Serotype 4 GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.
Type of Statistical Test Non-Inferiority
Comments A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being >0.5 (1-sided p-value <0.025).
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method t-test, 1 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter GMC Ratio (V114 / Prevnar 13™)
Estimated Value 0.95
Confidence Interval (2-Sided) 95%
0.88 to 1.03
Estimation Comments V114/Prevnar 13™
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection V114, Prevnar 13™
Comments Serotype 5 GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.
Type of Statistical Test Non-Inferiority
Comments A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being >0.5 (1-sided p-value <0.025).
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method t-test, 1 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter GMC Ratio (V114 / Prevnar 13™)
Estimated Value 0.72
Confidence Interval (2-Sided) 95%
0.66 to 0.80
Estimation Comments V114/Prevnar 13™
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection V114, Prevnar 13™
Comments Serotype 6A GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.
Type of Statistical Test Non-Inferiority
Comments A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being >0.5 (1-sided p-value <0.025).
Statistical Test of Hypothesis P-Value = 0.167
Comments [Not Specified]
Method t-test, 1 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter GMC Ratio (V114 / Prevnar 13™)
Estimated Value 0.52
Confidence Interval (2-Sided) 95%
0.48 to 0.58
Estimation Comments V114/Prevnar 13™
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection V114, Prevnar 13™
Comments Serotype 6B GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.
Type of Statistical Test Non-Inferiority
Comments A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being >0.5 (1-sided p-value <0.025).
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method t-test, 1 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter GMC Ratio (V114 / Prevnar 13™)
Estimated Value 0.81
Confidence Interval (2-Sided) 95%
0.71 to 0.93
Estimation Comments V114/Prevnar 13™
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection V114, Prevnar 13™
Comments Serotype 7F GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.
Type of Statistical Test Non-Inferiority
Comments A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being >0.5 (1-sided p-value <0.025).
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method t-test, 1 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter GMC Ratio (V114 / Prevnar 13™)
Estimated Value 0.77
Confidence Interval (2-Sided) 95%
0.71 to 0.83
Estimation Comments V114/Prevnar 13™
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection V114, Prevnar 13™
Comments Serotype 9V GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.
Type of Statistical Test Non-Inferiority
Comments A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being >0.5 (1-sided p-value <0.025).
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method t-test, 1 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter GMC Ratio (V114 / Prevnar 13™)
Estimated Value 0.91
Confidence Interval (2-Sided) 95%
0.84 to 1.00
Estimation Comments V114/Prevnar 13™
Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection V114, Prevnar 13™
Comments Serotype 14 GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.
Type of Statistical Test Non-Inferiority
Comments A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being >0.5 (1-sided p-value <0.025).
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method t-test, 1 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter GMC Ratio (V114 / Prevnar 13™)
Estimated Value 0.70
Confidence Interval (2-Sided) 95%
0.63 to 0.78
Estimation Comments V114/Prevnar 13™
Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection V114, Prevnar 13™
Comments Serotype 18C GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.
Type of Statistical Test Non-Inferiority
Comments A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being >0.5 (1-sided p-value <0.025).
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method t-test, 1 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter GMC Ratio (V114 / Prevnar 13™)
Estimated Value 0.76
Confidence Interval (2-Sided) 95%
0.70 to 0.83
Estimation Comments V114/Prevnar 13™
Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection V114, Prevnar 13™
Comments Serotype 19A GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.
Type of Statistical Test Non-Inferiority
Comments A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being >0.5 (1-sided p-value <0.025).
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method t-test, 1 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter GMC Ratio (V114 / Prevnar 13™)
Estimated Value 0.71
Confidence Interval (2-Sided) 95%
0.65 to 0.77
Estimation Comments V114/Prevnar 13™
Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection V114, Prevnar 13™
Comments Serotype 19F GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.
Type of Statistical Test Non-Inferiority
Comments A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being >0.5 (1-sided p-value <0.025).
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method t-test, 1 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter GMC Ratio (V114 / Prevnar 13™)
Estimated Value 0.74
Confidence Interval (2-Sided) 95%
0.69 to 0.79
Estimation Comments V114/Prevnar 13™
Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection V114, Prevnar 13™
Comments Serotype 23F GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.
Type of Statistical Test Non-Inferiority
Comments A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being >0.5 (1-sided p-value <0.025).
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method t-test, 1 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter GMC Ratio (V114 / Prevnar 13™)
Estimated Value 0.89
Confidence Interval (2-Sided) 95%
0.80 to 0.99
Estimation Comments V114/Prevnar 13™
Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection V114, Prevnar 13™
Comments Serotype 22F IgG GMC for Serotype 22F in recipients of V114 was compared to lowest IgG GMC (Serotype 4 at 1.35 ug/mL) for shared serotype in recipients of Prevnar 13™, excluding serotype 3. GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.
Type of Statistical Test Non-Inferiority
Comments A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being >0.5 (1-sided p-value <0.025).
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method t-test, 1 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter GMC Ratio (V114 / Prevnar 13™)
Estimated Value 3.64
Confidence Interval (2-Sided) 95%
3.33 to 3.98
Estimation Comments V114/Prevnar 13™
Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection V114, Prevnar 13™
Comments Serotype 33F IgG GMC for Serotype 33F in recipients of V114 was compared to lowest IgG GMC (Serotype 4 at 1.35 ug/mL) for shared serotype in recipients of Prevnar 13™, excluding serotype 3. GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.
Type of Statistical Test Non-Inferiority
Comments A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being >0.5 (1-sided p-value <0.025).
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method t-test, 1 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter GMC Ratio (V114 / Prevnar 13™)
Estimated Value 1.24
Confidence Interval (2-Sided) 95%
1.10 to 1.39
Estimation Comments V114/Prevnar 13™
6.Primary Outcome
Title GMC of Anti-PnP IgG Ab One Month After Vaccination 4
Hide Description The GMC of anti-PnP IgG Ab were measured with PnECL one month after vaccination 4 and reported for the 15 serotypes contained in V114. IgG GMCs were compared to the lowest in recipients of Prevnar 13™ excluding serotype 3 for the 2 serotypes unique to V114, and compared to the same serotypes for the 13 shared serotypes.
Time Frame One month after Vaccination 4 (Month 13 to Month 16)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who did not have protocol deviations that could have substantially affected the results of the immunogenicity analysis and who had sufficient blood volume to perform the analysis.
Arm/Group Title V114 Prevnar 13™
Hide Arm/Group Description:
Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 from 42-90 days of age inclusive (Vaccination 1), Month 4 from 4 months of age to 1 day prior to 5 months of age (Vaccination 2), Month 6 from 6 months of age to 1 day prior to 7 months of age (Vaccination 3) and Months 12-15 from 12 months of age to 1 day prior to 16 months of age (Vaccination 4). Participants concomitantly received other licensed paediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 4, and Month 6; VAQTA™, HIBERIX™, M-M-R™ II, VARIVAX™ on Months 12-15.
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 from 42-90 days of age inclusive (Vaccination 1), Month 4 from 4 months of age to 1 day prior to 5 months of age (Vaccination 2), Month 6 from 6 months of age to 1 day prior to 7 months of age (Vaccination 3) and Months 12-15 from 12 months of age to 1 day prior to 16 months of age (Vaccination 4). Participants concomitantly received other licensed paediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 4, and Month 6; VAQTA™, HIBERIX™, M-M-R™ II, VARIVAX™ on Months 12-15.
Overall Number of Participants Analyzed 858 856
Geometric Mean (95% Confidence Interval)
Unit of Measure: ug/mL
Serotype 1 Number Analyzed 715 participants 685 participants
1.35
(1.27 to 1.42)
2.03
(1.92 to 2.14)
Serotype 3 Number Analyzed 712 participants 686 participants
0.96
(0.91 to 1.01)
0.71
(0.67 to 0.75)
Serotype 4 Number Analyzed 713 participants 682 participants
1.23
(1.16 to 1.31)
1.60
(1.51 to 1.71)
Serotype 5 Number Analyzed 713 participants 682 participants
2.49
(2.34 to 2.64)
3.95
(3.71 to 4.20)
Serotype 6A Number Analyzed 713 participants 682 participants
3.70
(3.46 to 3.97)
6.21
(5.83 to 6.62)
Serotype 6B Number Analyzed 712 participants 682 participants
4.76
(4.43 to 5.10)
6.43
(6.02 to 6.88)
Serotype 7F Number Analyzed 714 participants 686 participants
3.42
(3.22 to 3.64)
4.85
(4.56 to 5.16)
Serotype 9V Number Analyzed 716 participants 686 participants
2.40
(2.27 to 2.55)
3.29
(3.10 to 3.49)
Serotype 14 Number Analyzed 716 participants 685 participants
5.61
(5.21 to 6.04)
6.95
(6.51 to 7.43)
Serotype 18C Number Analyzed 713 participants 684 participants
2.62
(2.46 to 2.78)
3.08
(2.88 to 3.29)
Serotype 19A Number Analyzed 715 participants 685 participants
4.10
(3.88 to 4.33)
5.53
(5.21 to 5.87)
Serotype 19F Number Analyzed 715 participants 685 participants
3.55
(3.37 to 3.75)
4.47
(4.23 to 4.73)
Serotype 23F Number Analyzed 713 participants 683 participants
2.04
(1.91 to 2.18)
3.32
(3.08 to 3.58)
Serotype 22F Number Analyzed 714 participants 682 participants
7.52
(7.09 to 7.98)
0.11
(0.10 to 0.12)
Serotype 33F Number Analyzed 714 participants 677 participants
4.15
(3.89 to 4.42)
0.09
(0.09 to 0.10)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection V114, Prevnar 13™
Comments Serotype 1 GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.
Type of Statistical Test Non-Inferiority
Comments A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being >0.5 (1-sided p-value <0.025).
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method t-test, 1 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter GMC Ratio (V114 / Prevnar 13™)
Estimated Value 0.66
Confidence Interval (2-Sided) 95%
0.62 to 0.72
Estimation Comments V114/Prevnar 13™
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection V114, Prevnar 13™
Comments Serotype 3 GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.
Type of Statistical Test Non-Inferiority
Comments A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being >0.5 (1-sided p-value <0.025).
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method t-test, 1 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter GMC Ratio (V114 / Prevnar 13™)
Estimated Value 1.35
Confidence Interval (2-Sided) 95%
1.25 to 1.46
Estimation Comments V114/Prevnar 13™
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection V114, Prevnar 13™
Comments Serotype 4 GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.
Type of Statistical Test Non-Inferiority
Comments A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being >0.5 (1-sided p-value <0.025).
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method t-test, 1 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter GMC Ratio (V114 / Prevnar 13™)
Estimated Value 0.77
Confidence Interval (2-Sided) 95%
0.71 to 0.84
Estimation Comments V114/Prevnar 13™
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection V114, Prevnar 13™
Comments Serotype 5 GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.
Type of Statistical Test Non-Inferiority
Comments A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being >0.5 (1-sided p-value <0.025).
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method t-test, 1 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter GMC Ratio (V114 / Prevnar 13™)
Estimated Value 0.63
Confidence Interval (2-Sided) 95%
0.58 to 0.69
Estimation Comments V114/Prevnar 13™
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection V114, Prevnar 13™
Comments Serotype 6A GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.
Type of Statistical Test Non-Inferiority
Comments A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being >0.5 (1-sided p-value <0.025).
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method t-test, 1 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter GMC Ratio (V114 / Prevnar 13™)
Estimated Value 0.60
Confidence Interval (2-Sided) 95%
0.54 to 0.65
Estimation Comments V114/Prevnar 13™
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection V114, Prevnar 13™
Comments Serotype 6B GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.
Type of Statistical Test Non-Inferiority
Comments A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being >0.5 (1-sided p-value <0.025).
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method t-test, 1 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter GMC Ratio (V114 / Prevnar 13™)
Estimated Value 0.74
Confidence Interval (2-Sided) 95%
0.67 to 0.81
Estimation Comments V114/Prevnar 13™
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection V114, Prevnar 13™
Comments Serotype 7F GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.
Type of Statistical Test Non-Inferiority
Comments A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being >0.5 (1-sided p-value <0.025).
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method t-test, 1 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter GMC Ratio (V114 / Prevnar 13™)
Estimated Value 0.70
Confidence Interval (2-Sided) 95%
0.65 to 0.77
Estimation Comments V114/Prevnar 13™
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection V114, Prevnar 13™
Comments Serotype 9V GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.
Type of Statistical Test Non-Inferiority
Comments A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being >0.5 (1-sided p-value <0.025).
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method t-test, 1 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter GMC Ratio (V114 / Prevnar 13™)
Estimated Value 0.73
Confidence Interval (2-Sided) 95%
0.67 to 0.80
Estimation Comments V114/Prevnar 13™
Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection V114, Prevnar 13™
Comments Serotype 14 GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.
Type of Statistical Test Non-Inferiority
Comments A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being >0.5 (1-sided p-value <0.025).
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method t-test, 1 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter GMC Ratio (V114 / Prevnar 13™)
Estimated Value 0.81
Confidence Interval (2-Sided) 95%
0.73 to 0.89
Estimation Comments V114/Prevnar 13™
Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection V114, Prevnar 13™
Comments Serotype 18C GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.
Type of Statistical Test Non-Inferiority
Comments A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being >0.5 (1-sided p-value <0.025).
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method t-test, 1 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter GMC Ratio (V114 / Prevnar 13™)
Estimated Value 0.85
Confidence Interval (2-Sided) 95%
0.78 to 0.93
Estimation Comments V114/Prevnar 13™
Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection V114, Prevnar 13™
Comments Serotype 19A GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.
Type of Statistical Test Non-Inferiority
Comments A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being >0.5 (1-sided p-value <0.025).
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method t-test, 1 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter GMC Ratio (V114 / Prevnar 13™)
Estimated Value 0.74
Confidence Interval (2-Sided) 95%
0.68 to 0.80
Estimation Comments V114/Prevnar 13™
Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection V114, Prevnar 13™
Comments Serotype 19F GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.
Type of Statistical Test Non-Inferiority
Comments A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being >0.5 (1-sided p-value <0.025).
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method t-test, 1 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter GMC Ratio (V114 / Prevnar 13™)
Estimated Value 0.79
Confidence Interval (2-Sided) 95%
0.74 to 0.86
Estimation Comments V114/Prevnar 13™
Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection V114, Prevnar 13™
Comments Serotype 23F GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.
Type of Statistical Test Non-Inferiority
Comments A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being >0.5 (1-sided p-value <0.025).
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method t-test, 1 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter GMC Ratio (V114 / Prevnar 13™)
Estimated Value 0.61
Confidence Interval (2-Sided) 95%
0.56 to 0.68
Estimation Comments V114/Prevnar 13™
Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection V114, Prevnar 13™
Comments Serotype 22F IgG GMC for Serotype 22F in recipients of V114 was compared to the lowest IgG GMC (Serotype 4 at 1.60 ug/mL) for shared serotype in recipients of Prevnar 13™, excluding serotype 3. GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.
Type of Statistical Test Non-Inferiority
Comments A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being >0.5 (1-sided p-value <0.025).
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method t-test, 1 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter GMC Ratio (V114 / Prevnar 13™)
Estimated Value 4.69
Confidence Interval (2-Sided) 95%
4.30 to 5.11
Estimation Comments V114/Prevnar 13™
Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection V114, Prevnar 13™
Comments Serotype 33F IgG GMC for Serotype 33F in recipients of V114 was compared to the lowest IgG GMC (Serotype 4 at 1.60 ug/mL) for shared serotype in recipients of Prevnar 13™, excluding serotype 3. GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.
Type of Statistical Test Non-Inferiority
Comments A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being >0.5 (1-sided p-value <0.025).
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method t-test, 1 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter GMC Ratio (V114 / Prevnar 13™)
Estimated Value 2.59
Confidence Interval (2-Sided) 95%
2.36 to 2.83
Estimation Comments V114/Prevnar 13™
7.Secondary Outcome
Title Percentage of Participants Meeting Response Rate Criteria for Pentacel™-Specific (Anti-Diptheria Toxoid, Tetanus Toxoid, and Pertussis Antigens) Immunoglobulin G (IgG) Antibody (Ab) Geometric Mean Concentration (GMC) One Month After Vaccination 3
Hide Description Antibody responses to diphtheria toxoid, tetanus toxoid, and pertussis antigens were measured using Luminex Assay. The percentage of participants meeting specific criteria are summarized for each serotype. The serotype-specific response rate criteria are as follows: diphtheria toxoid: % ≥0.1 IU/mL; tetanus toxoid: % ≥0.1 IU/mL; pertussis toxin (PT): % ≥ 5 EU/mL; pertussis filamentous hemagglutinin (FHA): % ≥5 EU/mL; pertussis fimbrae types 2/3 (FIM 2/3): % ≥20 EU/mL; pertussis pertactin (PRN): % ≥5 EU/mL; poliovirus 1: % neutralizing antibody (NAb) ≥1:8 dilution; poliovirus 2: % NAb ≥1:8 dilution, poliovirus 3: % NAb ≥1:8 dilution; and Haemophilus influenzae Type B polyribosylribitol phosphate (Hib-PRP): % ≥0.15 ug/mL.
Time Frame One month after Vaccination 3 (Month 7)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who did not have protocol deviations that could have substantially affected the results of the immunogenicity analysis and who had sufficient blood volume to perform the analysis.
Arm/Group Title V114 Prevnar 13™
Hide Arm/Group Description:
Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 from 42-90 days of age inclusive (Vaccination 1), Month 4 from 4 months of age to 1 day prior to 5 months of age (Vaccination 2), Month 6 from 6 months of age to 1 day prior to 7 months of age (Vaccination 3) and Months 12-15 from 12 months of age to 1 day prior to 16 months of age (Vaccination 4). Participants concomitantly received other licensed paediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 4, and Month 6; VAQTA™, HIBERIX™, M-M-R™ II, VARIVAX™ on Months 12-15.
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 from 42-90 days of age inclusive (Vaccination 1), Month 4 from 4 months of age to 1 day prior to 5 months of age (Vaccination 2), Month 6 from 6 months of age to 1 day prior to 7 months of age (Vaccination 3) and Months 12-15 from 12 months of age to 1 day prior to 16 months of age (Vaccination 4). Participants concomitantly received other licensed paediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 4, and Month 6; VAQTA™, HIBERIX™, M-M-R™ II, VARIVAX™ on Months 12-15.
Overall Number of Participants Analyzed 858 856
Measure Type: Number
Unit of Measure: Percentage of participants
Diphtheria toxoid Number Analyzed 703 participants 666 participants
96.9 97.6
Tetanus toxoid Number Analyzed 703 participants 666 participants
100.0 99.8
Pertussis toxin Number Analyzed 703 participants 666 participants
99.0 98.5
Pertussis filamentous hemagglutinin Number Analyzed 703 participants 666 participants
99.1 99.4
Pertussis fimbrae types 2/3 Number Analyzed 703 participants 666 participants
63.7 61.7
Pertussis pertactin Number Analyzed 703 participants 666 participants
67.3 65.5
Poliovirus 1 Number Analyzed 662 participants 619 participants
99.8 99.8
Poliovirus 2 Number Analyzed 648 participants 614 participants
100.0 100.0
Poliovirus 3 Number Analyzed 650 participants 607 participants
100.0 100.0
Hib-PRP Number Analyzed 648 participants 615 participants
92.1 93.5
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection V114, Prevnar 13™
Comments Diphtheria toxoid % ≥0.1 IU/mL Estimated difference, CI, and p-value are based on the Miettinen & Nurminen method.
Type of Statistical Test Non-Inferiority
Comments A conclusion of non-inferiority of Pentacel™ administered concomitantly with V114 to Pentacel™ administered concomitantly with Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevnar 13™) being greater than -10% (1-sided p-value <0.025).
Statistical Test of Hypothesis P-Value < 0.001
Comments p-value is 1-sided
Method Miettinen & Nurminen
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage Point Difference
Estimated Value -0.7
Confidence Interval (2-Sided) 95%
-2.6 to 1.1
Estimation Comments V114-Prevnar 13™
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection V114, Prevnar 13™
Comments Tetanus toxoid: % ≥0.1 IU/mL Estimated difference, CI, and p-value are based on the Miettinen & Nurminen method.
Type of Statistical Test Non-Inferiority
Comments A conclusion of non-inferiority of Pentacel™ administered concomitantly with V114 to Pentacel™ administered concomitantly with Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevnar 13™) being greater than -5% (1-sided p-value <0.025).
Statistical Test of Hypothesis P-Value < 0.001
Comments p-value is 1-sided
Method Miettinen & Nurminen
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage Point Difference
Estimated Value 0.2
Confidence Interval (2-Sided) 95%
-0.4 to 0.8
Estimation Comments V114-Prevnar 13™
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection V114, Prevnar 13™
Comments Pertussis toxin (PT): % ≥ 5 EU/mL Estimated difference, CI, and p-value are based on the Miettinen & Nurminen method.
Type of Statistical Test Non-Inferiority
Comments A conclusion of non-inferiority of Pentacel™ administered concomitantly with V114 to Pentacel™ administered concomitantly with Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevnar 13™) being greater than -10% (1-sided p-value <0.025).
Statistical Test of Hypothesis P-Value < 0.001
Comments p-value is 1-sided
Method Miettinen & Nurminen
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage Point Difference
Estimated Value 0.5
Confidence Interval (2-Sided) 95%
-0.7 to 1.9
Estimation Comments V114-Prevnar 13™
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection V114, Prevnar 13™
Comments Pertussis filamentous hemagglutinin (FHA): % ≥5 EU/mL Estimated difference, CI, and p-value are based on the Miettinen & Nurminen method.
Type of Statistical Test Non-Inferiority
Comments A conclusion of non-inferiority of Pentacel™ administered concomitantly with V114 to Pentacel™ administered concomitantly with Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevnar 13™) being greater than -10% (1-sided p-value <0.025).
Statistical Test of Hypothesis P-Value < 0.001
Comments p-value is 1-sided
Method Miettinen & Nurminen
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage Point Difference
Estimated Value -0.3
Confidence Interval (2-Sided) 95%
-1.3 to 0.8
Estimation Comments V114-Prevnar 13™
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection V114, Prevnar 13™
Comments Pertussis fimbrae types 2/3 (FIM 2/3): % ≥20 EU/mL Estimated difference, CI, and p-value are based on the Miettinen & Nurminen method.
Type of Statistical Test Non-Inferiority
Comments A conclusion of non-inferiority of Pentacel™ administered concomitantly with V114 to Pentacel™ administered concomitantly with Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevnar 13™) being greater than -10% (1-sided p-value <0.025).
Statistical Test of Hypothesis P-Value < 0.001
Comments p-value is 1-sided
Method Miettinen & Nurminen
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage Point Difference
Estimated Value 2.0
Confidence Interval (2-Sided) 95%
-3.1 to 7.1
Estimation Comments V114-Prevnar 13™
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection V114, Prevnar 13™
Comments Pertussis pertactin (PRN): % ≥5 EU/mL Estimated difference, CI, and p-value are based on the Miettinen & Nurminen method.
Type of Statistical Test Non-Inferiority
Comments A conclusion of non-inferiority of Pentacel™ administered concomitantly with V114 to Pentacel™ administered concomitantly with Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevnar 13™) being greater than -10% (1-sided p-value <0.025).
Statistical Test of Hypothesis P-Value < 0.001
Comments p-value is 1-sided
Method Miettinen & Nurminen
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage Point Difference
Estimated Value 1.8
Confidence Interval (2-Sided) 95%
-3.2 to 6.8
Estimation Comments V114-Prevnar 13™
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection V114, Prevnar 13™
Comments Poliovirus 1: % NAb ≥1:8 dilution Estimated difference, CI, and p-value are based on the Miettinen & Nurminen method.
Type of Statistical Test Non-Inferiority
Comments A conclusion of non-inferiority of Pentacel™ administered concomitantly with V114 to Pentacel™ administered concomitantly with Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevnar 13™) being greater than -5% (1-sided p-value <0.025).
Statistical Test of Hypothesis P-Value < 0.001
Comments p-value is 1-sided
Method Miettinen & Nurminen
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage Point Difference
Estimated Value 0.0
Confidence Interval (2-Sided) 95%
-0.7 to 0.8
Estimation Comments V114-Prevnar 13™
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection V114, Prevnar 13™
Comments Poliovirus 2: % NAb ≥1:8 dilution Estimated difference, CI, and p-value are based on the Miettinen & Nurminen method.
Type of Statistical Test Non-Inferiority
Comments A conclusion of non-inferiority of Pentacel™ administered concomitantly with V114 to Pentacel™ administered concomitantly with Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevnar 13™) being greater than -5% (1-sided p-value <0.025).
Statistical Test of Hypothesis P-Value < 0.001
Comments p-value is 1-sided
Method Miettinen & Nurminen
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage Point Difference
Estimated Value 0.0
Confidence Interval (2-Sided) 95%
-0.6 to 0.6
Estimation Comments V114-Prevnar 13™
Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection V114, Prevnar 13™
Comments Poliovirus 3: % NAb ≥1:8 dilution Estimated difference, CI, and p-value are based on the Miettinen & Nurminen method.
Type of Statistical Test Non-Inferiority
Comments A conclusion of non-inferiority of Pentacel™ administered concomitantly with V114 to Pentacel™ administered concomitantly with Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevnar 13™) being greater than -5% (1-sided p-value <0.025).
Statistical Test of Hypothesis P-Value < 0.001
Comments p-value is 1-sided
Method Miettinen & Nurminen
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage Point Difference
Estimated Value 0.0
Confidence Interval (2-Sided) 95%
-0.6 to 0.6
Estimation Comments V114-Prevnar 13™
Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection V114, Prevnar 13™
Comments Haemophilus influenzae Type B polyribosylribitol phosphate (Hib-PRP): % ≥0.15 ug/mL Estimated difference, CI, and p-value are based on the Miettinen & Nurminen method.
Type of Statistical Test Non-Inferiority
Comments A conclusion of non-inferiority of Pentacel™ administered concomitantly with V114 to Pentacel™ administered concomitantly with Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevnar 13™) being greater than -10% (1-sided p-value <0.025).
Statistical Test of Hypothesis P-Value < 0.001
Comments p-value is 1-sided
Method Miettinen & Nurminen
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage Point Difference
Estimated Value -1.4
Confidence Interval (2-Sided) 95%
-4.3 to 1.5
Estimation Comments V114-Prevnar 13™
8.Secondary Outcome
Title Pertussis Antigen Immunoglobulin G (IgG) Antibody (Ab) Geometric Mean Concentration (GMC) One Month After Vaccination 3
Hide Description Pertussis antibody GMCs were measured using Luminex Assay.
Time Frame One month after Vaccination 3 (Month 7)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who did not have protocol deviations that could have substantially affected the results of the immunogenicity analysis and who had sufficient blood volume to perform the analysis.
Arm/Group Title V114 Prevnar 13™
Hide Arm/Group Description:
Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 from 42-90 days of age inclusive (Vaccination 1), Month 4 from 4 months of age to 1 day prior to 5 months of age (Vaccination 2), Month 6 from 6 months of age to 1 day prior to 7 months of age (Vaccination 3) and Months 12-15 from 12 months of age to 1 day prior to 16 months of age (Vaccination 4). Participants concomitantly received other licensed paediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 4, and Month 6; VAQTA™, HIBERIX™, M-M-R™ II, VARIVAX™ on Months 12-15.
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 from 42-90 days of age inclusive (Vaccination 1), Month 4 from 4 months of age to 1 day prior to 5 months of age (Vaccination 2), Month 6 from 6 months of age to 1 day prior to 7 months of age (Vaccination 3) and Months 12-15 from 12 months of age to 1 day prior to 16 months of age (Vaccination 4). Participants concomitantly received other licensed paediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 4, and Month 6; VAQTA™, HIBERIX™, M-M-R™ II, VARIVAX™ on Months 12-15.
Overall Number of Participants Analyzed 858 856
Geometric Mean (95% Confidence Interval)
Unit of Measure: ug/mL
Pertussis - PT Number Analyzed 703 participants 666 participants
43.73 [1] 
(NA to NA)
44.35 [2] 
(NA to NA)
Pertussis - FHA Number Analyzed 703 participants 666 participants
67.51 [2] 
(NA to NA)
69.18 [2] 
(NA to NA)
Pertussis - FIM 2/3 Number Analyzed 703 participants 666 participants
39.79 [2] 
(NA to NA)
36.87 [2] 
(NA to NA)
Pertussis - PRN Number Analyzed 703 participants 666 participants
13.16 [2] 
(NA to NA)
13.17 [2] 
(NA to NA)
[1]
Within-group confidence intervals (CIs) were not calculated, per protocol.
[2]
Within-group CIs were not calculated, per protocol.
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection V114, Prevnar 13™
Comments Pertussis - PT GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.
Type of Statistical Test Non-Inferiority
Comments A conclusion of non-inferiority of Pentacel™ administered concomitantly with V114 to Pentacel™ administered concomitantly with Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being >0.67 (1-sided p-value <0.025).
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method t-test, 1 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter GMC Ratio (V114 / Prevnar 13™)
Estimated Value 0.99
Confidence Interval (2-Sided) 95%
0.89 to 1.09
Estimation Comments V114/Prevnar 13™
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection V114, Prevnar 13™
Comments Pertussis - FHA GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.
Type of Statistical Test Non-Inferiority
Comments A conclusion of non-inferiority of Pentacel™ administered concomitantly with V114 to Pentacel™ administered concomitantly with Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being >0.67 (1-sided p-value <0.025).
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method t-test, 1 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter GMC Ratio (V114 / Prevnar 13™)
Estimated Value 0.98
Confidence Interval (2-Sided) 95%
0.87 to 1.09
Estimation Comments V114/Prevnar 13™
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection V114, Prevnar 13™
Comments Pertussis - FIM 2/3 GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.
Type of Statistical Test Non-Inferiority
Comments A conclusion of non-inferiority of Pentacel™ administered concomitantly with V114 to Pentacel™ administered concomitantly with Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being >0.67 (1-sided p-value <0.025).
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method t-test, 1 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter GMC Ratio (V114 / Prevnar 13™)
Estimated Value 1.08
Confidence Interval (2-Sided) 95%
0.91 to 1.28
Estimation Comments V114/Prevnar 13™
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection V114, Prevnar 13™
Comments Pertussis - PRN GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.
Type of Statistical Test Non-Inferiority
Comments A conclusion of non-inferiority of Pentacel™ administered concomitantly with V114 to Pentacel™ administered concomitantly with Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being >0.67 (1-sided p-value <0.025).
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method t-test, 1 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter GMC Ratio (V114 / Prevnar 13™)
Estimated Value 1.00
Confidence Interval (2-Sided) 95%
0.84 to 1.19
Estimation Comments V114/Prevnar 13™
9.Secondary Outcome
Title Hepatitis A Antibody Response Rate One Month After Vaccination 4
Hide Description Antibody response rates to hepatitis A were measured with hepatitis A virus enzyme immunoassay (HAV EIA). The percentage of participants with hepatitis A antigen ≥10 mIU/mL are reported.
Time Frame One month after Vaccination 4 (Month 13 to Month 16)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who did not have protocol deviations that could have substantially affected the results of the immunogenicity analysis, who had sufficient blood volume to perform the analysis, and who had available HAV EIA data.
Arm/Group Title V114 Prevnar 13™
Hide Arm/Group Description:
Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 from 42-90 days of age inclusive (Vaccination 1), Month 4 from 4 months of age to 1 day prior to 5 months of age (Vaccination 2), Month 6 from 6 months of age to 1 day prior to 7 months of age (Vaccination 3) and Months 12-15 from 12 months of age to 1 day prior to 16 months of age (Vaccination 4). Participants concomitantly received other licensed paediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 4, and Month 6; VAQTA™, HIBERIX™, M-M-R™ II, VARIVAX™ on Months 12-15.
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 from 42-90 days of age inclusive (Vaccination 1), Month 4 from 4 months of age to 1 day prior to 5 months of age (Vaccination 2), Month 6 from 6 months of age to 1 day prior to 7 months of age (Vaccination 3) and Months 12-15 from 12 months of age to 1 day prior to 16 months of age (Vaccination 4). Participants concomitantly received other licensed paediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 4, and Month 6; VAQTA™, HIBERIX™, M-M-R™ II, VARIVAX™ on Months 12-15.
Overall Number of Participants Analyzed 649 626
Measure Type: Number
Unit of Measure: Percentage of participants
97.4 97.1
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection V114, Prevnar 13™
Comments Estimated difference, CI, and p-value are based on the Miettinen & Nurminen method.
Type of Statistical Test Non-Inferiority
Comments A conclusion of non-inferiority of VAQTA™ administered concomitantly with V114 to VAQTA™ administered concomitantly with Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevnar 13™) being greater than -10% (1-sided p-value <0.025).
Statistical Test of Hypothesis P-Value < 0.001
Comments p value is 1-sided
Method Miettinen & Nurminen
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage Point Difference
Estimated Value 0.3
Confidence Interval (2-Sided) 95%
-1.6 to 2.2
Estimation Comments V114-Prevnar 13™
10.Secondary Outcome
Title Measles, Mumps, and Rubella Antibody Response Rate One Month After Vaccination 4
Hide Description Antibody responses to measles were measured with the bulk measles IgG enzyme immunoassay (EIA). Antibody responses to mumps were measured with enzyme-linked immunosorbent assay (ELISA). Antibody responses to rubella were measured with Bulk Rubella IgG EIA. The percentage of participants with measles antigen ≥255 mIU/ML; mumps antigen ≥10 mumps Ab units/mL; and rubella antigen ≥10 IU/mL, are reported.
Time Frame One month after Vaccination 4 (Month 13 to Month 16)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who did not have protocol deviations that could have substantially affected the results of the immunogenicity analysis and who had sufficient blood volume to perform the analysis.
Arm/Group Title V114 Prevnar 13™
Hide Arm/Group Description:
Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 from 42-90 days of age inclusive (Vaccination 1), Month 4 from 4 months of age to 1 day prior to 5 months of age (Vaccination 2), Month 6 from 6 months of age to 1 day prior to 7 months of age (Vaccination 3) and Months 12-15 from 12 months of age to 1 day prior to 16 months of age (Vaccination 4). Participants concomitantly received other licensed paediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 4, and Month 6; VAQTA™, HIBERIX™, M-M-R™ II, VARIVAX™ on Months 12-15.
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 from 42-90 days of age inclusive (Vaccination 1), Month 4 from 4 months of age to 1 day prior to 5 months of age (Vaccination 2), Month 6 from 6 months of age to 1 day prior to 7 months of age (Vaccination 3) and Months 12-15 from 12 months of age to 1 day prior to 16 months of age (Vaccination 4). Participants concomitantly received other licensed paediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 4, and Month 6; VAQTA™, HIBERIX™, M-M-R™ II, VARIVAX™ on Months 12-15.
Overall Number of Participants Analyzed 858 856
Measure Type: Number
Unit of Measure: Percentage of participants
Measles antigen ≥255 mIU/ML Number Analyzed 670 participants 648 participants
98.1 98.3
Mumps antigen ≥10 mumps Ab units/mL Number Analyzed 670 participants 648 participants
95.8 97.5
Rubella antigen ≥10 IU/mL Number Analyzed 670 participants 648 participants
98.1 98.9
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection V114, Prevnar 13™
Comments Measles antigen ≥255 mIU/mL Estimated difference, CI, and p-value are based on the Miettinen & Nurminen method.
Type of Statistical Test Non-Inferiority
Comments A conclusion of non-inferiority of M-M-R™ II administered concomitantly with V114 to M-M-R™ II administered concomitantly with Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevnar 13™) being greater than -5% (1-sided p-value <0.025).
Statistical Test of Hypothesis P-Value < 0.001
Comments p-value is 1-sided
Method Miettinen & Nurminen
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage Point Difference
Estimated Value -0.2
Confidence Interval (2-Sided) 95%
-1.8 to 1.3
Estimation Comments V114-Prevnar 13™
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection V114, Prevnar 13™
Comments Mumps antigen ≥10 mumps Ab units/mL Estimated difference, CI, and p-value are based on the Miettinen & Nurminen method.
Type of Statistical Test Non-Inferiority
Comments A conclusion of non-inferiority of M-M-R™ II administered concomitantly with V114 to M-M-R™ II administered concomitantly with Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevnar 13™) being greater than -5% (1-sided p-value <0.025).
Statistical Test of Hypothesis P-Value < 0.001
Comments p-value is 1-sided
Method Miettinen & Nurminen
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage Point Difference
Estimated Value -1.7
Confidence Interval (2-Sided) 95%
-3.8 to 0.2
Estimation Comments V114-Prevnar 13™
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection V114, Prevnar 13™
Comments Rubella antigen ≥10 IU/mL Estimated difference, CI, and p-value are based on the Miettinen & Nurminen method.
Type of Statistical Test Non-Inferiority
Comments A conclusion of non-inferiority of M-M-R™ II administered concomitantly with V114 to M-M-R™ II administered concomitantly with Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevnar 13™) being greater than -5% (1-sided p-value <0.025).
Statistical Test of Hypothesis P-Value < 0.001
Comments p-value is 1-sided
Method Miettinen & Nurminen
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage Point Difference
Estimated Value -0.9
Confidence Interval (2-Sided) 95%
-2.3 to 0.5
Estimation Comments V114-Prevnar 13™
11.Secondary Outcome
Title Varicella-Zoster Virus (VZV) Antibody Response Rate One Month After Vaccination 4
Hide Description Antibody responses to varicella-zoster virus were measured with glycoprotein enzyme-linked immunosorbent assay (gpELISA). The percentage of participants with VZV antigen ≥5 gpELISA units/mL are reported.
Time Frame One month after Vaccination 4 (Month 13 to Month 16)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who did not have protocol deviations that could have substantially affected the results of the immunogenicity analysis, who had sufficient blood volume to perform the analysis, and who had available VZV gpELISA data.
Arm/Group Title V114 Prevnar 13™
Hide Arm/Group Description:
Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 from 42-90 days of age inclusive (Vaccination 1), Month 4 from 4 months of age to 1 day prior to 5 months of age (Vaccination 2), Month 6 from 6 months of age to 1 day prior to 7 months of age (Vaccination 3) and Months 12-15 from 12 months of age to 1 day prior to 16 months of age (Vaccination 4). Participants concomitantly received other licensed paediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 4, and Month 6; VAQTA™, HIBERIX™, M-M-R™ II, VARIVAX™ on Months 12-15.
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 from 42-90 days of age inclusive (Vaccination 1), Month 4 from 4 months of age to 1 day prior to 5 months of age (Vaccination 2), Month 6 from 6 months of age to 1 day prior to 7 months of age (Vaccination 3) and Months 12-15 from 12 months of age to 1 day prior to 16 months of age (Vaccination 4). Participants concomitantly received other licensed paediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 4, and Month 6; VAQTA™, HIBERIX™, M-M-R™ II, VARIVAX™ on Months 12-15.
Overall Number of Participants Analyzed 715 685
Measure Type: Number
Unit of Measure: Percentage of participants
96.4 97.7
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection V114, Prevnar 13™
Comments Estimated difference, CI, and p-value are based on the Miettinen & Nurminen method.
Type of Statistical Test Non-Inferiority
Comments A conclusion of non-inferiority of VARIVAX™ administered concomitantly with V114 to VARIVAX™ administered concomitantly with Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevnar 13™) being greater than -10% (1-sided p-value <0.025).
Statistical Test of Hypothesis P-Value < 0.001
Comments p-value is 1-sided
Method Miettinen & Nurminen
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage Point Difference
Estimated Value -1.3
Confidence Interval (2-Sided) 95%
-3.2 to 0.5
Estimation Comments V114-Prevnar 13™
12.Secondary Outcome
Title Haemophilus Influenzae Type B Antibody Response Rate One Month After Vaccination 4
Hide Description Antibody responses to Haemophilus influenzae Type B polyribosylribitol phosphate (Hib PRP) were measured with ELISA. The percentage of participants with anti-HiB PRP antigen ≥0.15 ug/mL are reported.
Time Frame One month after Vaccination 4 (Month 13 to Month 16)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who did not have protocol deviations that could have substantially affected the results of the immunogenicity, who had sufficient blood volume to perform the analysis, and who had available Hib PRP ELISA data.
Arm/Group Title V114 Prevnar 13™
Hide Arm/Group Description:
Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 from 42-90 days of age inclusive (Vaccination 1), Month 4 from 4 months of age to 1 day prior to 5 months of age (Vaccination 2), Month 6 from 6 months of age to 1 day prior to 7 months of age (Vaccination 3) and Months 12-15 from 12 months of age to 1 day prior to 16 months of age (Vaccination 4). Participants concomitantly received other licensed paediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 4, and Month 6; VAQTA™, HIBERIX™, M-M-R™ II, VARIVAX™ on Months 12-15.
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 from 42-90 days of age inclusive (Vaccination 1), Month 4 from 4 months of age to 1 day prior to 5 months of age (Vaccination 2), Month 6 from 6 months of age to 1 day prior to 7 months of age (Vaccination 3) and Months 12-15 from 12 months of age to 1 day prior to 16 months of age (Vaccination 4). Participants concomitantly received other licensed paediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 4, and Month 6; VAQTA™, HIBERIX™, M-M-R™ II, VARIVAX™ on Months 12-15.
Overall Number of Participants Analyzed 650 626
Measure Type: Number
Unit of Measure: Percentage of participants
98.9 100.0
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection V114, Prevnar 13™
Comments Estimated difference, CI, and p-value are based on the Miettinen & Nurminen method.
Type of Statistical Test Non-Inferiority
Comments A conclusion of non-inferiority of HIBERIX™ administered concomitantly with V114 to HIBERIX™ administered concomitantly with Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevnar 13™) being greater than -10% (1-sided p-value <0.025).
Statistical Test of Hypothesis P-Value < 0.001
Comments p-value is 1-sided
Method Miettinen & Nurminen
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage Point Difference
Estimated Value -1.1
Confidence Interval (2-Sided) 95%
-2.2 to -0.5
Estimation Comments V114-Prevnar 13™
13.Secondary Outcome
Title Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype-Specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) One Month After Vaccination 3 for 2 Unique V114 Seroptypes
Hide Description Serotype-specific anti-PnP IgG GMCs for the 2 unique V114 serotypes were measured with PnECL. The GMCs for each serotype are reported.
Time Frame One month after Vaccination 3 (Month 7)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who did not have protocol deviations that could have substantially affected the results of the immunogenicity analysis and who had sufficient blood volume to perform the analysis.
Arm/Group Title V114 Prevnar 13™
Hide Arm/Group Description:
Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 from 42-90 days of age inclusive (Vaccination 1), Month 4 from 4 months of age to 1 day prior to 5 months of age (Vaccination 2), Month 6 from 6 months of age to 1 day prior to 7 months of age (Vaccination 3) and Months 12-15 from 12 months of age to 1 day prior to 16 months of age (Vaccination 4). Participants concomitantly received other licensed paediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 4, and Month 6; VAQTA™, HIBERIX™, M-M-R™ II, VARIVAX™ on Months 12-15.
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 from 42-90 days of age inclusive (Vaccination 1), Month 4 from 4 months of age to 1 day prior to 5 months of age (Vaccination 2), Month 6 from 6 months of age to 1 day prior to 7 months of age (Vaccination 3) and Months 12-15 from 12 months of age to 1 day prior to 16 months of age (Vaccination 4). Participants concomitantly received other licensed paediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 4, and Month 6; VAQTA™, HIBERIX™, M-M-R™ II, VARIVAX™ on Months 12-15.
Overall Number of Participants Analyzed 858 856
Geometric Mean (95% Confidence Interval)
Unit of Measure: ug/mL
22F Number Analyzed 701 participants 660 participants
4.91
(4.58 to 5.26)
0.05
(0.05 to 0.06)
33F Number Analyzed 702 participants 664 participants
1.67
(1.51 to 1.85)
0.06
(0.05 to 0.06)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection V114, Prevnar 13™
Comments Serotype 22F GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method t-test, 1 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter GMC Ratio (V114 / Prevnar 13™)
Estimated Value 92.03
Confidence Interval (2-Sided) 95%
83.47 to 101.47
Estimation Comments V114/Prevnar 13™
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection V114, Prevnar 13™
Comments Serotype 33F GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method t-test, 1 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter GMC Ratio (V114 / Prevnar 13™)
Estimated Value 29.50
Confidence Interval (2-Sided) 95%
26.16 to 33.26
Estimation Comments V114/Prevnar 13™
14.Secondary Outcome
Title Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype-Specific Immunoglobulin G (IgG) Response Rates One Month After Vaccination 3 for 2 Unique V114 Seroptypes
Hide Description Serotype-specific anti-PnP IgG response rates for the 2 unique V114 serotypes were measured with PnECL. The percentage of participants with IgG Ab ≥0.35 ug/mL are reported for each serotype.
Time Frame One month after Vaccination 3 (Month 7)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who did not have protocol deviations that could have substantially affected the results of the immunogenicity analysis and who had sufficient blood volume to perform the analysis.
Arm/Group Title V114 Prevnar 13™
Hide Arm/Group Description:
Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 from 42-90 days of age inclusive (Vaccination 1), Month 4 from 4 months of age to 1 day prior to 5 months of age (Vaccination 2), Month 6 from 6 months of age to 1 day prior to 7 months of age (Vaccination 3) and Months 12-15 from 12 months of age to 1 day prior to 16 months of age (Vaccination 4). Participants concomitantly received other licensed paediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 4, and Month 6; VAQTA™, HIBERIX™, M-M-R™ II, VARIVAX™ on Months 12-15.
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 from 42-90 days of age inclusive (Vaccination 1), Month 4 from 4 months of age to 1 day prior to 5 months of age (Vaccination 2), Month 6 from 6 months of age to 1 day prior to 7 months of age (Vaccination 3) and Months 12-15 from 12 months of age to 1 day prior to 16 months of age (Vaccination 4). Participants concomitantly received other licensed paediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 4, and Month 6; VAQTA™, HIBERIX™, M-M-R™ II, VARIVAX™ on Months 12-15.
Overall Number of Participants Analyzed 858 856
Measure Type: Number
Unit of Measure: Percentage of participants
Serotype 22F Number Analyzed 701 participants 660 participants
98.6 3.5
Serotype 33F Number Analyzed 702 participants 664 participants
87.3 2.1
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection V114, Prevnar 13™
Comments Serotype 22F Estimated difference, CI, and p-value are based on the Miettinen & Nurminen method.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments p-value is 1-sided
Method Miettinen & Nurminen
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage Point Difference
Estimated Value 95.1
Confidence Interval (2-Sided) 95%
93.1 to 96.5
Estimation Comments V114-Prevnar 13™
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection V114, Prevnar 13™
Comments Serotype 33F Estimated difference, CI, and p-value are based on the Miettinen & Nurminen method.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments p-value is 1-sided
Method Miettinen & Nurminen
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage Point Difference
Estimated Value 85.2
Confidence Interval (2-Sided) 95%
82.3 to 87.7
Estimation Comments V114-Prevnar 13™
15.Secondary Outcome
Title Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype-Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMC) One Month After Vaccination 4 for 2 Unique V114 Seroptypes
Hide Description Serotype-specific anti-PnP GMCs were measured with PnECL. The GMC for each serotype is reported.
Time Frame One month after Vaccination 4 (Month 13 to Month 16)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who did not have protocol deviations that could have substantially affected the results of the immunogenicity analysis and who had sufficient blood volume to perform the analysis.
Arm/Group Title V114 Prevnar 13™
Hide Arm/Group Description:
Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 from 42-90 days of age inclusive (Vaccination 1), Month 4 from 4 months of age to 1 day prior to 5 months of age (Vaccination 2), Month 6 from 6 months of age to 1 day prior to 7 months of age (Vaccination 3) and Months 12-15 from 12 months of age to 1 day prior to 16 months of age (Vaccination 4). Participants concomitantly received other licensed paediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 4, and Month 6; VAQTA™, HIBERIX™, M-M-R™ II, VARIVAX™ on Months 12-15.
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 from 42-90 days of age inclusive (Vaccination 1), Month 4 from 4 months of age to 1 day prior to 5 months of age (Vaccination 2), Month 6 from 6 months of age to 1 day prior to 7 months of age (Vaccination 3) and Months 12-15 from 12 months of age to 1 day prior to 16 months of age (Vaccination 4). Participants concomitantly received other licensed paediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 4, and Month 6; VAQTA™, HIBERIX™, M-M-R™ II, VARIVAX™ on Months 12-15.
Overall Number of Participants Analyzed 858 856
Geometric Mean (95% Confidence Interval)
Unit of Measure: ug/mL
22F Number Analyzed 714 participants 682 participants
7.52
(7.09 to 7.98)
0.11
(0.10 to 0.12)
33F Number Analyzed 714 participants 677 participants
4.15
(3.89 to 4.42)
0.09
(0.09 to 0.10)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection V114, Prevnar 13™
Comments Serotype 22F GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method t-test, 1 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter GMC Ratio (V114 / Prevnar 13™)
Estimated Value 68.80
Confidence Interval (2-Sided) 95%
63.10 to 75.02
Estimation Comments V114/Prevnar 13™
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection V114, Prevnar 13™
Comments Serotype 33F GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method t-test, 1 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter GMC Ratio (V114 / Prevnar 13™)
Estimated Value 44.91
Confidence Interval (2-Sided) 95%
41.04 to 49.14
Estimation Comments V114/Prevnar 13™
16.Secondary Outcome
Title Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) One Month After Vaccination 3
Hide Description Serotype-specific anti-PnP OPA GMTs were measured with multiplex opsonophagocytic assay (MOPA). The GMTs for each serotype are summarized.
Time Frame One month after Vaccination 3 (Month 7)
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Hide Analysis Population Description
Due to the large serum volume required for MOPA, the analysis population for OPA testing was performed on a subset of participants, which included the first 20% of all participants with sufficient serum volume at 30 days post-dose 3.
Arm/Group Title V114 Prevnar 13™
Hide Arm/Group Description:
Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 from 42-90 days of age inclusive (Vaccination 1), Month 4 from 4 months of age to 1 day prior to 5 months of age (Vaccination 2), Month 6 from 6 months of age to 1 day prior to 7 months of age (Vaccination 3) and Months 12-15 from 12 months of age to 1 day prior to 16 months of age (Vaccination 4). Participants concomitantly received other licensed paediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 4, and Month 6; VAQTA™, HIBERIX™, M-M-R™ II, VARIVAX™ on Months 12-15.
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 from 42-90 days of age inclusive (Vaccination 1), Month 4 from 4 months of age to 1 day prior to 5 months of age (Vaccination 2), Month 6 from 6 months of age to 1 day prior to 7 months of age (Vaccination 3) and Months 12-15 from 12 months of age to 1 day prior to 16 months of age (Vaccination 4). Participants concomitantly received other licensed paediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 4, and Month 6; VAQTA™, HIBERIX™, M-M-R™ II, VARIVAX™ on Months 12-15.
Overall Number of Participants Analyzed 176 168
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
Serotype 1 Number Analyzed 170 participants 162 participants
56.9
(46.1 to 70.3)
78.3
(61.5 to 99.5)
Serotype 3 Number Analyzed 169 participants 158 participants
284.7
(253.5 to 319.8)
210.6
(188.2 to 235.7)
Serotype 4 Number Analyzed 169 participants 159 participants
1304.8
(1139.6 to 1494.0)
1566.7
(1381.8 to 1776.4)
Serotype 5 Number Analyzed 171 participants 162 participants
387.4
(315.0 to 476.3)
510.8
(415.9 to 627.2)
Serotype 6A Number Analyzed 171 participants 159 participants
2072.1
(1787.5 to 2401.9)
2743.4
(2368.1 to 3178.2)
Serotype 6B Number Analyzed 169 participants 160 participants
1932.5
(1612.1 to 2316.6)
1963.7
(1604.9 to 2402.8)
Serotype 7F Number Analyzed 170 participants 158 participants
4973.2
(4277.6 to 5781.8)
7335.1
(6181.8 to 8703.5)
Serotype 9V Number Analyzed 168 participants 162 participants
1217.3
(1040.2 to 1424.6)
1534.1
(1305.5 to 1802.8)
Serotype 14 Number Analyzed 167 participants 160 participants
2400.7
(1980.8 to 2909.6)
1853.1
(1511.2 to 2272.5)
Serotype 18C Number Analyzed 171 participants 162 participants
1171.2
(1022.7 to 1341.4)
1330.2
(1158.3 to 1527.5)
Serotype 19A Number Analyzed 171 participants 162 participants
841.3
(716.0 to 988.6)
1400.7
(1205.5 to 1627.4)
Serotype 19F Number Analyzed 171 participants 162 participants
703.9
(614.2 to 806.6)
850.6
(744.5 to 971.9)
Serotype 23F Number Analyzed 167 participants 158 participants
2078.9
(1779.2 to 2428.9)
3668.8
(3069.2 to 4385.6)
Serotype 22F Number Analyzed 170 participants 155 participants
1849.3
(1606.9 to 2128.2)
9.1
(7.9 to 10.4)
Serotype 33F Number Analyzed 170 participants 155 participants
8262.6
(6585.3 to 10367.1)
119.6
(83.2 to 171.8)
17.Secondary Outcome
Title Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype-Specific Opsonophagocytic Activity (OPA) Response Rates One Month After Vaccination 3
Hide Description Serotype-specific anti-PnP OPA GMTs were measured with MOPA. The percentage of participants meeting ≥0.35 ug/mL are reported for each serotype.
Time Frame One month after Vaccination 3 (Month 7)
Hide Outcome Measure Data
Hide Analysis Population Description
Due to the large serum volume required for MOPA, the analysis population for OPA testing was performed on a subset of participants, which included the first 20% of all participants with sufficient serum volume at 30 days post-dose 3.
Arm/Group Title V114 Prevnar 13™
Hide Arm/Group Description:
Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 from 42-90 days of age inclusive (Vaccination 1), Month 4 from 4 months of age to 1 day prior to 5 months of age (Vaccination 2), Month 6 from 6 months of age to 1 day prior to 7 months of age (Vaccination 3) and Months 12-15 from 12 months of age to 1 day prior to 16 months of age (Vaccination 4). Participants concomitantly received other licensed paediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 4, and Month 6; VAQTA™, HIBERIX™, M-M-R™ II, VARIVAX™ on Months 12-15.
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 from 42-90 days of age inclusive (Vaccination 1), Month 4 from 4 months of age to 1 day prior to 5 months of age (Vaccination 2), Month 6 from 6 months of age to 1 day prior to 7 months of age (Vaccination 3) and Months 12-15 from 12 months of age to 1 day prior to 16 months of age (Vaccination 4). Participants concomitantly received other licensed paediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 4, and Month 6; VAQTA™, HIBERIX™, M-M-R™ II, VARIVAX™ on Months 12-15.
Overall Number of Participants Analyzed 176 168
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
Serotype 1 Number Analyzed 170 participants 162 participants
86.5
(80.4 to 91.2)
87.7
(81.6 to 92.3)
Serotype 3 Number Analyzed 169 participants 158 participants
100.0
(97.8 to 100.00)
100.0
(97.7 to 100.0)
Serotype 4 Number Analyzed 169 participants 159 participants
99.4
(96.7 to 100.0)
100.0
(97.7 to 100.0)
Serotype 5 Number Analyzed 171 participants 162 participants
96.5
(92.5 to 98.7)
98.1
(94.7 to 99.6)
Serotype 6A Number Analyzed 171 participants 159 participants
97.1
(93.3 to 99.0)
98.1
(94.6 to 99.6)
Serotype 6B Number Analyzed 169 participants 160 participants
98.2
(94.9 to 99.6)
98.1
(94.6 to 99.6)
Serotype 7F Number Analyzed 170 participants 158 participants
100.0
(97.9 to 100.0)
100.0
(97.7 to 100.0)
Serotype 9V Number Analyzed 168 participants 162 participants
98.2
(94.9 to 99.6)
97.5
(93.8 to 99.3)
Serotype 14 Number Analyzed 167 participants 160 participants
98.8
(95.7 to 99.9)
98.8
(95.6 to 99.8)
Serotype 18C Number Analyzed 171 participants 162 participants
98.8
(95.8 to 99.9)
99.4
(96.6 to 100.00)
Serotype 19A Number Analyzed 171 participants 162 participants
98.2
(95.0 to 99.6)
99.4
(96.6 to 100.0)
Serotype 19F Number Analyzed 171 participants 162 participants
95.9
(91.7 to 98.3)
98.8
(95.6 to 99.9)
Serotype 23F Number Analyzed 167 participants 158 participants
99.4
(96.7 to 100.0)
100.0
(97.7 to 100.0)
Serotype 22F Number Analyzed 170 participants 155 participants
99.4
(96.8 to 100.0)
5.8
(2.7 to 10.7)
Serotype 33F Number Analyzed 170 participants 155 participants
98.8
(95.8 to 99.9)
56.8
(48.6 to 64.7)
18.Secondary Outcome
Title Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype 3-Specific Immunoglobulin G (IgG) Response Rate One Month After Vaccination 3
Hide Description Serotype 3-specific anti-PnP IgG response rates were measured with PnECL. The percentage of participants with IgG Ab ≥0.35 ug/mL are reported for Serotype 3.
Time Frame One month after Vaccination 3 (Month 7)
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Hide Analysis Population Description
All randomized participants who did not have protocol deviations that could have substantially affected the results of the immunogenicity analysis, who had sufficient blood volume to perform the analysis, and who had available serotype 3-specific IgG data.
Arm/Group Title V114 Prevnar 13™
Hide Arm/Group Description:
Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 from 42-90 days of age inclusive (Vaccination 1), Month 4 from 4 months of age to 1 day prior to 5 months of age (Vaccination 2), Month 6 from 6 months of age to 1 day prior to 7 months of age (Vaccination 3) and Months 12-15 from 12 months of age to 1 day prior to 16 months of age (Vaccination 4). Participants concomitantly received other licensed paediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 4, and Month 6; VAQTA™, HIBERIX™, M-M-R™ II, VARIVAX™ on Months 12-15.
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 from 42-90 days of age inclusive (Vaccination 1), Month 4 from 4 months of age to 1 day prior to 5 months of age (Vaccination 2), Month 6 from 6 months of age to 1 day prior to 7 months of age (Vaccination 3) and Months 12-15 from 12 months of age to 1 day prior to 16 months of age (Vaccination 4). Participants concomitantly received other licensed paediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 4, and Month 6; VAQTA™, HIBERIX™, M-M-R™ II, VARIVAX™ on Months 12-15.
Overall Number of Participants Analyzed 699 662
Measure Type: Number
Unit of Measure: Percentage of participants
94.7 79.2
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection V114, Prevnar 13™
Comments Estimated difference, CI, and p-value are based on the Miettinen & Nurminen method
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments p-value is 1-sided
Method Miettinen & Nurminen
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage Point Difference
Estimated Value 15.6
Confidence Interval (2-Sided) 95%
12.1 to 19.2
Estimation Comments V114-Prevnar 13™
19.Secondary Outcome
Title Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype 3-Specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) One Month After Vaccination 3
Hide Description Serotype 3-specific anti-PnP GMC was measured with PnECL.
Time Frame One month after Vaccination 3 (Month 7)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who did not have protocol deviations that could have substantially affected the results of the immunogenicity analysis, who had sufficient blood volume to perform the analysis, and who had available serotype 3-specific IgG data.
Arm/Group Title V114 Prevnar 13™
Hide Arm/Group Description:
Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 from 42-90 days of age inclusive (Vaccination 1), Month 4 from 4 months of age to 1 day prior to 5 months of age (Vaccination 2), Month 6 from 6 months of age to 1 day prior to 7 months of age (Vaccination 3) and Months 12-15 from 12 months of age to 1 day prior to 16 months of age (Vaccination 4). Participants concomitantly received other licensed paediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 4, and Month 6; VAQTA™, HIBERIX™, M-M-R™ II, VARIVAX™ on Months 12-15.
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 from 42-90 days of age inclusive (Vaccination 1), Month 4 from 4 months of age to 1 day prior to 5 months of age (Vaccination 2), Month 6 from 6 months of age to 1 day prior to 7 months of age (Vaccination 3) and Months 12-15 from 12 months of age to 1 day prior to 16 months of age (Vaccination 4). Participants concomitantly received other licensed paediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 4, and Month 6; VAQTA™, HIBERIX™, M-M-R™ II, VARIVAX™ on Months 12-15.
Overall Number of Participants Analyzed 699 662
Geometric Mean (95% Confidence Interval)
Unit of Measure: ug/mL
1.08
(1.03 to 1.14)
0.62
(0.59 to 0.66)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection V114, Prevnar 13™
Comments GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method t-test, 1 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter GMC Ratio (V114 / Prevnar 13™)
Estimated Value 1.73
Confidence Interval (2-Sided) 95%
1.61 to 1.87
Estimation Comments V114/Prevnar 13™
20.Secondary Outcome
Title Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype 3-Specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) One Month After Vaccination 4
Hide Description Serotype 3-specific anti-PnP GMC were measured with PnECL.
Time Frame One month after Vaccination 4 (Month 13 to Month 16)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who did not have protocol deviations that could have substantially affected the results of the immunogenicity analysis who had sufficient blood volume to perform the analysis, and who had available serotype 3-specific IgG data.
Arm/Group Title V114 Prevnar 13™
Hide Arm/Group Description:
Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 from 42-90 days of age inclusive (Vaccination 1), Month 4 from 4 months of age to 1 day prior to 5 months of age (Vaccination 2), Month 6 from 6 months of age to 1 day prior to 7 months of age (Vaccination 3) and Months 12-15 from 12 months of age to 1 day prior to 16 months of age (Vaccination 4). Participants concomitantly received other licensed paediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 4, and Month 6; VAQTA™, HIBERIX™, M-M-R™ II, VARIVAX™ on Months 12-15.
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 from 42-90 days of age inclusive (Vaccination 1), Month 4 from 4 months of age to 1 day prior to 5 months of age (Vaccination 2), Month 6 from 6 months of age to 1 day prior to 7 months of age (Vaccination 3) and Months 12-15 from 12 months of age to 1 day prior to 16 months of age (Vaccination 4). Participants concomitantly received other licensed paediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 4, and Month 6; VAQTA™, HIBERIX™, M-M-R™ II, VARIVAX™ on Months 12-15.
Overall Number of Participants Analyzed 712 686
Geometric Mean (95% Confidence Interval)
Unit of Measure: ug/mL
0.96
(0.91 to 1.01)
0.71
(0.67 to 0.75)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection V114, Prevnar 13™
Comments GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method t-test, 1 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter GMC Ratio (V114 / Prevnar 13™)
Estimated Value 1.35
Confidence Interval (2-Sided) 95%
1.25 to 1.46
Estimation Comments V114/Prevnar 13™
Time Frame Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
Adverse Event Reporting Description All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
 
Arm/Group Title V114 Prevnar 13™ Cross-treated Participants
Hide Arm/Group Description Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 from 42-90 days of age inclusive (Vaccination 1), Month 4 from 4 months of age to 1 day prior to 5 months of age (Vaccination 2), Month 6 from 6 months of age to 1 day prior to 7 months of age (Vaccination 3) and Months 12-15 from 12 months of age to 1 day prior to 16 months of age (Vaccination 4). Participants concomitantly received other licensed paediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 4, and Month 6; VAQTA™, HIBERIX™, M-M-R™ II, VARIVAX™ on Months 12-15. Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 between 42-90 days of age inclusive (Vaccination 1), Month 4 from 4 months of age to 1 day prior to 5 months of age (Vaccination 2), Month 6 from 6 months of age to 1 day prior to 7 months of age (Vaccination 3) and Months 12-15 from 12 months of age to 1 day prior to 16 months of age (Vaccination 4). Participants concomitantly received other licensed paediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 4, and Month 6; VAQTA™, HIBERIX™, M-M-R™ II, VARIVAX™ on Months 12-15. One participant assigned to the Prevnar 13™ arm who inadvertently received both V114 and Prevnar 13™. The participant received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 between 42-90 days of age inclusive (Vaccination 1), Month 4 from 4 months of age to 1 day prior to 5 months of age (Vaccination 2), Month 6 from 6 months of age to 1 day prior to 7 months of age (Vaccination 3) and a single 0.5 mL IM injection of V114 Months 12-15 from 12 months of age to 1 day prior to 16 months of age (Vaccination 4). The participant concomitantly received other licensed paediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 4, and Month 6; VAQTA™, HIBERIX™, M-M-R™ II, VARIVAX™ on Months 12-15.
All-Cause Mortality
V114 Prevnar 13™ Cross-treated Participants
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/860 (0.12%)      1/859 (0.12%)      0/1 (0.00%)    
Hide Serious Adverse Events
V114 Prevnar 13™ Cross-treated Participants
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   88/858 (10.26%)      81/855 (9.47%)      1/1 (100.00%)    
Blood and lymphatic system disorders       
Iron deficiency anaemia  1  1/858 (0.12%)  1 0/855 (0.00%)  0 0/1 (0.00%)  0
Congenital, familial and genetic disorders       
Heart disease congenital  1  1/858 (0.12%)  1 0/855 (0.00%)  0 0/1 (0.00%)  0
Gastrointestinal disorders       
Diarrhoea  1  2/858 (0.23%)  2 1/855 (0.12%)  1 0/1 (0.00%)  0
Enteritis  1  0/858 (0.00%)  0 1/855 (0.12%)  1 0/1 (0.00%)  0
Flatulence  1  0/858 (0.00%)  0 1/855 (0.12%)  1 0/1 (0.00%)  0
Gastritis  1  1/858 (0.12%)  1 1/855 (0.12%)  1 0/1 (0.00%)  0
Gastrooesophageal reflux disease  1  0/858 (0.00%)  0 1/855 (0.12%)  1 0/1 (0.00%)  0
Haematochezia  1  1/858 (0.12%)  1 0/855 (0.00%)  0 0/1 (0.00%)  0
Inguinal hernia  1  1/858 (0.12%)  1 0/855 (0.00%)  0 0/1 (0.00%)  0
General disorders       
Pyrexia  1  2/858 (0.23%)  2 3/855 (0.35%)  3 0/1 (0.00%)  0
Immune system disorders       
Anaphylactic reaction  1  2/858 (0.23%)  2 0/855 (0.00%)  0 0/1 (0.00%)  0
Infections and infestations       
Abscess limb  1  1/858 (0.12%)  1 1/855 (0.12%)  1 0/1 (0.00%)  0
Bacteraemia  1  2/858 (0.23%)  2 1/855 (0.12%)  1 0/1 (0.00%)  0
Bronchiolitis  1  11/858 (1.28%)  12 6/855 (0.70%)  6 1/1 (100.00%)  1
Bronchitis  1  5/858 (0.58%)  5 2/855 (0.23%)  2 0/1 (0.00%)  0
Bronchitis viral  1  1/858 (0.12%)  1 0/855 (0.00%)  0 0/1 (0.00%)  0
COVID-19  1  2/858 (0.23%)  2 1/855 (0.12%)  1 0/1 (0.00%)  0
Croup infectious  1  2/858 (0.23%)  2 1/855 (0.12%)  1 0/1 (0.00%)  0
Cystitis  1  1/858 (0.12%)  1 0/855 (0.00%)  0 0/1 (0.00%)  0
Dengue fever  1  1/858 (0.12%)  1 1/855 (0.12%)  1 0/1 (0.00%)  0
Diarrhoea infectious  1  1/858 (0.12%)  1 1/855 (0.12%)  1 0/1 (0.00%)  0
Enterovirus infection  1  1/858 (0.12%)  1 0/855 (0.00%)  0 0/1 (0.00%)  0
Escherichia urinary tract infection  1  1/858 (0.12%)  1 1/855 (0.12%)  1 0/1 (0.00%)  0
Exanthema subitum  1  3/858 (0.35%)  3 3/855 (0.35%)  3 0/1 (0.00%)  0
Gastroenteritis  1  7/858 (0.82%)  7 11/855 (1.29%)  13 0/1 (0.00%)  0
Gastroenteritis bacterial  1  0/858 (0.00%)  0 1/855 (0.12%)  1 0/1 (0.00%)  0
Gastroenteritis viral  1  6/858 (0.70%)  6 2/855 (0.23%)  2 0/1 (0.00%)  0
Hand-foot-and-mouth disease  1  0/858 (0.00%)  0 1/855 (0.12%)  1 0/1 (0.00%)  0
Herpangina  1  1/858 (0.12%)  1 0/855 (0.00%)  0 0/1 (0.00%)  0
Influenza  1  2/858 (0.23%)  2 1/855 (0.12%)  1 0/1 (0.00%)  0
Nasopharyngitis  1  1/858 (0.12%)  1 1/855 (0.12%)  1 0/1 (0.00%)  0
Oral herpes  1  0/858 (0.00%)  0 1/855 (0.12%)  1 0/1 (0.00%)  0
Oral viral infection  1  0/858 (0.00%)  0 1/855 (0.12%)  1 0/1 (0.00%)  0
Otitis media  1  1/858 (0.12%)  1 0/855 (0.00%)  0 0/1 (0.00%)  0
Periorbital cellulitis  1  1/858 (0.12%)  1 0/855 (0.00%)  0 0/1 (0.00%)  0
Pharyngitis  1  2/858 (0.23%)  2 0/855 (0.00%)  0 0/1 (0.00%)  0
Pneumonia  1  5/858 (0.58%)  5