Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

13vPnC Multidose Vial Safety, Tolerability and Immunogenicity Study in Healthy Infants.

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: NCT01964716
Recruitment Status : Completed
First Posted : October 17, 2013
Results First Posted : March 13, 2015
Last Update Posted : March 13, 2015
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Pneumococcal Vaccines
Intervention Biological: 13-valent pneumococcal conjugate vaccine
Enrollment 500
Recruitment Details  
Pre-assignment Details Total number of participants screened were 526, out of which 500 were enrolled in the study. The study was conducted in Gambia which started on 09 January 2014 and completed on 01 September 2014.
Arm/Group Title 13vPnC Multi-dose Vial (MDV) 13vPnC Single-Dose Syringe (SDS)
Hide Arm/Group Description Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) with 2-phenoxyethanol (2-PE) in MDV intramuscularly at 8, 12 and 16 weeks of age. Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) without 2-phenoxyethanol (2-PE) in SDS intramuscularly at 8, 12 and 16 weeks of age.
Period Title: Overall Study
Started 250 250
Vaccinated Dose 1 250 250
Vaccinated Dose 2 249 248
Vaccinated Dose 3 247 244
Completed 245 244
Not Completed 5 6
Reason Not Completed
Withdrawal by Subject             2             3
Lost to Follow-up             1             2
No longer met eligibility criteria             1             1
Death             1             0
Arm/Group Title 13vPnC Multi-dose Vial (MDV) 13vPnC Single-Dose Syringe (SDS) Total
Hide Arm/Group Description Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) with 2-phenoxyethanol (2-PE) in MDV intramuscularly at 8, 12 and 16 weeks of age. Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) without 2-phenoxyethanol (2-PE) in SDS intramuscularly at 8, 12 and 16 weeks of age. Total of all reporting groups
Overall Number of Baseline Participants 250 250 500
Hide Baseline Analysis Population Description
Safety population included all participants who received at least 1 dose of investigational product.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Days
Number Analyzed 250 participants 250 participants 500 participants
57.3  (8.6) 56.9  (8.8) 57.1  (8.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 250 participants 250 participants 500 participants
Female
129
  51.6%
130
  52.0%
259
  51.8%
Male
121
  48.4%
120
  48.0%
241
  48.2%
1.Primary Outcome
Title Percentage of Participants Achieving a Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Concentration Greater Than or Equal To (>=) 0.35 Microgram Per Milliliter (mcg/mL) 1 Month After the Infant Series for Each Vaccine Group
Hide Description Percentage of participants achieving predefined antibody threshold >=0.35 mcg/mL along with the corresponding 95% confidence interval (CI) for the 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F 9V, 14, 18C, 19A, 19F and 23F) are presented. Exact 2-sided confidence interval (Clopper and Pearson) based on the observed proportion of participants. Here "n"= participants with valid and determinate IgG concentration to the given serotype.
Time Frame 1 month after the infant series
Hide Outcome Measure Data
Hide Analysis Population Description
Evaluable immunogenicity population: eligible participants who received vaccine (as randomized) at all 3 doses, had blood drawn within protocol-specified time frames, had at least 1 valid and determinate assay result for proposed analysis, had no major protocol violations.
Arm/Group Title 13vPnC Multi-dose Vial (MDV) 13vPnC Single-Dose Syringe (SDS)
Hide Arm/Group Description:
Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) with 2-phenoxyethanol (2-PE) in MDV intramuscularly at 8, 12 and 16 weeks of age.
Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) without 2-phenoxyethanol (2-PE) in SDS intramuscularly at 8, 12 and 16 weeks of age.
Overall Number of Participants Analyzed 245 244
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Serotype 1 (n=245,244)
99.2
(97.1 to 99.9)
100.0
(98.5 to 100.0)
Serotype 3 (n=245,243)
98.8
(96.5 to 99.7)
99.6
(97.7 to 100.0)
Serotype 4 (n=245,244)
99.6
(97.7 to 100.0)
99.6
(97.7 to 100.0)
Serotype 5 (n=245,244)
95.9
(92.6 to 98.0)
97.1
(94.2 to 98.8)
Serotype 6A (n=243,244)
96.3
(93.1 to 98.3)
97.5
(94.7 to 99.1)
Serotype 6B (n=245,244)
95.1
(91.6 to 97.4)
95.1
(91.6 to 97.4)
Serotype 7F (n=245,244)
99.6
(97.7 to 100.0)
100.0
(98.5 to 100.0)
Serotype 9V (n=245,244)
98.0
(95.3 to 99.3)
98.4
(95.9 to 99.6)
Serotype 14 (n=245,244)
97.6
(94.7 to 99.1)
98.4
(95.9 to 99.6)
Serotype 18C (n=245,244)
99.2
(97.1 to 99.9)
98.0
(95.3 to 99.3)
Serotype 19A (n=245,244)
99.6
(97.7 to 100.0)
98.8
(96.4 to 99.7)
Serotype 19F (n=245,244)
96.7
(93.7 to 98.6)
97.1
(94.2 to 98.8)
Serotype 23F (n=245,244)
95.9
(92.6 to 98.0)
95.9
(92.6 to 98.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 13vPnC Multi-dose Vial (MDV), 13vPnC Single-Dose Syringe (SDS)
Comments Serotype 1: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority for a given antibody was demonstrated if the lower bound of the 2-sided, 97.5% confidence interval, computed using the Chan and Zhang procedure, for the difference in proportions (13vPnC MDV - 13vPnC SDS) was greater than -0.10.
Method of Estimation Estimation Parameter percent difference
Estimated Value -0.8
Confidence Interval (2-Sided) 97.5%
-3.4 to 1.2
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 13vPnC Multi-dose Vial (MDV), 13vPnC Single-Dose Syringe (SDS)
Comments Serotype 3: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority for a given antibody was demonstrated if the lower bound of the 2-sided, 97.5% confidence interval, computed using the Chan and Zhang procedure, for the difference in proportions (13vPnC MDV - 13vPnC SDS) was greater than -0.10.
Method of Estimation Estimation Parameter percent difference
Estimated Value -0.8
Confidence Interval (2-Sided) 97.5%
-3.7 to 1.6
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 13vPnC Multi-dose Vial (MDV), 13vPnC Single-Dose Syringe (SDS)
Comments Serotype 4: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority for a given antibody was demonstrated if the lower bound of the 2-sided, 97.5% confidence interval, computed using the Chan and Zhang procedure, for the difference in proportions (13vPnC MDV - 13vPnC SDS) was greater than -0.10.
Method of Estimation Estimation Parameter percent difference
Estimated Value 0.0
Confidence Interval (2-Sided) 97.5%
-2.3 to 2.4
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection 13vPnC Multi-dose Vial (MDV), 13vPnC Single-Dose Syringe (SDS)
Comments Serotype 5: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority for a given antibody was demonstrated if the lower bound of the 2-sided, 97.5% confidence interval, computed using the Chan and Zhang procedure, for the difference in proportions (13vPnC MDV - 13vPnC SDS) was greater than -0.10.
Method of Estimation Estimation Parameter percent difference
Estimated Value -1.2
Confidence Interval (2-Sided) 97.5%
-5.4 to 2.8
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection 13vPnC Multi-dose Vial (MDV), 13vPnC Single-Dose Syringe (SDS)
Comments Serotype 6A: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority for a given antibody was demonstrated if the lower bound of the 2-sided, 97.5% confidence interval, computed using the Chan and Zhang procedure, for the difference in proportions (13vPnC MDV - 13vPnC SDS) was greater than -0.10.
Method of Estimation Estimation Parameter percent difference
Estimated Value -1.2
Confidence Interval (2-Sided) 97.5%
-5.3 to 2.6
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection 13vPnC Multi-dose Vial (MDV), 13vPnC Single-Dose Syringe (SDS)
Comments Serotype 6B: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority for a given antibody was demonstrated if the lower bound of the 2-sided, 97.5% confidence interval, computed using the Chan and Zhang procedure, for the difference in proportions (13vPnC MDV - 13vPnC SDS) was greater than -0.10.
Method of Estimation Estimation Parameter percent difference
Estimated Value 0.0
Confidence Interval (2-Sided) 97.5%
-4.7 to 4.7
Estimation Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection 13vPnC Multi-dose Vial (MDV), 13vPnC Single-Dose Syringe (SDS)
Comments Serotype 7F: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority for a given antibody was demonstrated if the lower bound of the 2-sided, 97.5% confidence interval, computed using the Chan and Zhang procedure, for the difference in proportions (13vPnC MDV - 13vPnC SDS) was greater than -0.10.
Method of Estimation Estimation Parameter percent difference
Estimated Value -0.4
Confidence Interval (2-Sided) 97.5%
-2.7 to 1.6
Estimation Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection 13vPnC Multi-dose Vial (MDV), 13vPnC Single-Dose Syringe (SDS)
Comments Serotype 9V: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority for a given antibody was demonstrated if the lower bound of the 2-sided, 97.5% confidence interval, computed using the Chan and Zhang procedure, for the difference in proportions (13vPnC MDV - 13vPnC SDS) was greater than -0.10.
Method of Estimation Estimation Parameter percent difference
Estimated Value -0.4
Confidence Interval (2-Sided) 97.5%
-3.8 to 2.8
Estimation Comments [Not Specified]
Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection 13vPnC Multi-dose Vial (MDV), 13vPnC Single-Dose Syringe (SDS)
Comments Serotype 14: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority for a given antibody was demonstrated if the lower bound of the 2-sided, 97.5% confidence interval, computed using the Chan and Zhang procedure, for the difference in proportions (13vPnC MDV - 13vPnC SDS) was greater than -0.10.
Method of Estimation Estimation Parameter percent difference
Estimated Value -0.8
Confidence Interval (2-Sided) 97.5%
-4.3 to 2.5
Estimation Comments [Not Specified]
Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection 13vPnC Multi-dose Vial (MDV), 13vPnC Single-Dose Syringe (SDS)
Comments Serotype 18C: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority for a given antibody was demonstrated if the lower bound of the 2-sided, 97.5% confidence interval, computed using the Chan and Zhang procedure, for the difference in proportions (13vPnC MDV - 13vPnC SDS) was greater than -0.10.
Method of Estimation Estimation Parameter percent difference
Estimated Value 1.2
Confidence Interval (2-Sided) 97.5%
-1.6 to 4.5
Estimation Comments [Not Specified]
Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection 13vPnC Multi-dose Vial (MDV), 13vPnC Single-Dose Syringe (SDS)
Comments Serotype 19A: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority for a given antibody was demonstrated if the lower bound of the 2-sided, 97.5% confidence interval, computed using the Chan and Zhang procedure, for the difference in proportions (13vPnC MDV - 13vPnC SDS) was greater than -0.10.
Method of Estimation Estimation Parameter percent difference
Estimated Value 0.8
Confidence Interval (2-Sided) 97.5%
-1.6 to 3.6
Estimation Comments [Not Specified]
Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection 13vPnC Multi-dose Vial (MDV), 13vPnC Single-Dose Syringe (SDS)
Comments Serotype 19F: Exact 2-sided confidence interval (based on Chan & Zhang) for the difference in proportions, 13vPnC multidose vial (MDV) - 13vPnC single-dose syringe (SDS), expressed as a percentage was analyzed.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter percentage difference
Estimated Value -0.4
Confidence Interval (2-Sided) 97.5%
-4.4 to 3.5
Estimation Comments [Not Specified]
Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection 13vPnC Multi-dose Vial (MDV), 13vPnC Single-Dose Syringe (SDS)
Comments Serotype 23F: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority for a given antibody was demonstrated if the lower bound of the 2-sided, 97.5% confidence interval, computed using the Chan and Zhang procedure, for the difference in proportions (13vPnC MDV - 13vPnC SDS) was greater than -0.10.
Method of Estimation Estimation Parameter percent difference
Estimated Value 0.0
Confidence Interval (2-Sided) 97.5%
-4.3 to 4.4
Estimation Comments [Not Specified]
2.Primary Outcome
Title Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series for Each Vaccine Group
Hide Description Antibody GMC for the 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F 9V, 14, 18C, 19A, 19F and 23F) are presented. GMC (13vPnC) and corresponding 2-sided 95% CI were evaluated. Geometric means (GMs) were calculated using all participants with available data for the specified blood draw. CIs were back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations. Here "n"= participants with valid and determinate IgG concentration to the given serotype.
Time Frame 1 month after the infant series
Hide Outcome Measure Data
Hide Analysis Population Description
Evaluable immunogenicity population: eligible participants who received vaccine (as randomized) at all 3 doses, had blood drawn within protocol-specified time frames, had at least 1 valid and determinate assay result for proposed analysis, had no major protocol violations.
Arm/Group Title 13vPnC Multi-dose Vial (MDV) 13vPnC Single-Dose Syringe (SDS)
Hide Arm/Group Description:
Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) with 2-phenoxyethanol (2-PE) in MDV intramuscularly at 8, 12 and 16 weeks of age.
Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) without 2-phenoxyethanol (2-PE) in SDS intramuscularly at 8, 12 and 16 weeks of age.
Overall Number of Participants Analyzed 245 244
Geometric Mean (95% Confidence Interval)
Unit of Measure: microgram per milliliter (mcg/mL)
Serotype 1 (n=245,244)
4.59
(4.11 to 5.12)
4.45
(4.01 to 4.93)
Serotype 3 (n=245,243)
1.38
(1.29 to 1.49)
1.74
(1.62 to 1.87)
Serotype 4 (n=245,244)
5.30
(4.84 to 5.81)
5.28
(4.76 to 5.85)
Serotype 5 (n=245,244)
2.00
(1.79 to 2.22)
1.98
(1.79 to 2.20)
Serotype 6A (n=243,244)
2.25
(2.02 to 2.50)
2.19
(1.96 to 2.44)
Serotype 6B (n=245,244)
3.42
(2.91 to 4.02)
3.24
(2.77 to 3.78)
Serotype 7F (n=245,244)
3.92
(3.59 to 4.27)
4.18
(3.83 to 4.55)
Serotype 9V (n=245,244)
2.83
(2.56 to 3.13)
2.75
(2.49 to 3.04)
Serotype 14 (n=245,244)
4.78
(4.06 to 5.63)
4.96
(4.27 to 5.77)
Serotype 18C (n=245,244)
3.47
(3.17 to 3.79)
2.72
(2.46 to 3.00)
Serotype 19A (n=245,244)
6.49
(5.70 to 7.38)
6.44
(5.66 to 7.32)
Serotype 19F (n=245,244)
5.19
(4.59 to 5.86)
5.00
(4.43 to 5.63)
Serotype 23F (n=245,244)
2.61
(2.30 to 2.97)
2.17
(1.92 to 2.46)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 13vPnC Multi-dose Vial (MDV), 13vPnC Single-Dose Syringe (SDS)
Comments Serotype 1: Ratio of GMCs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale; CIs for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority for a given antibody serotype was declared if lower bound of the 2-sided, 97.5% confidence interval for the geometric mean concentration ratio (GMC MDV /GMC SDS) was greater than 0.5 (2-fold criterion).
Method of Estimation Estimation Parameter GMC Ratio
Estimated Value 1.03
Confidence Interval (2-Sided) 97.5%
0.87 to 1.22
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 13vPnC Multi-dose Vial (MDV), 13vPnC Single-Dose Syringe (SDS)
Comments Serotype 3: Ratio of GMCs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale; CIs for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority for a given antibody serotype was declared if lower bound of the 2-sided, 97.5% confidence interval for the geometric mean concentration ratio (GMC MDV /GMC SDS) was greater than 0.5 (2-fold criterion).
Method of Estimation Estimation Parameter GMC Ratio
Estimated Value 0.79
Confidence Interval (2-Sided) 97.5%
0.71 to 0.90
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 13vPnC Multi-dose Vial (MDV), 13vPnC Single-Dose Syringe (SDS)
Comments Serotype 4: Ratio of GMCs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale; CIs for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority for a given antibody serotype was declared if lower bound of the 2-sided, 97.5% confidence interval for the geometric mean concentration ratio (GMC MDV /GMC SDS) was greater than 0.5 (2-fold criterion).
Method of Estimation Estimation Parameter GMC Ratio
Estimated Value 1.00
Confidence Interval (2-Sided) 97.5%
0.86 to 1.18
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection 13vPnC Multi-dose Vial (MDV), 13vPnC Single-Dose Syringe (SDS)
Comments Serotype 5: Ratio of GMCs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale; CIs for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority for a given antibody serotype was declared if lower bound of the 2-sided, 97.5% confidence interval for the geometric mean concentration ratio (GMC MDV /GMC SDS) was greater than 0.5 (2-fold criterion).
Method of Estimation Estimation Parameter GMC Ratio
Estimated Value 1.01
Confidence Interval (2-Sided) 97.5%
0.85 to 1.19
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection 13vPnC Multi-dose Vial (MDV), 13vPnC Single-Dose Syringe (SDS)
Comments Serotype 6A: Ratio of GMCs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale; CIs for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority for a given antibody serotype was declared if lower bound of the 2-sided, 97.5% confidence interval for the geometric mean concentration ratio (GMC MDV /GMC SDS) was greater than 0.5 (2-fold criterion).
Method of Estimation Estimation Parameter GMC Ratio
Estimated Value 1.03
Confidence Interval (2-Sided) 97.5%
0.86 to 1.22
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection 13vPnC Multi-dose Vial (MDV), 13vPnC Single-Dose Syringe (SDS)
Comments Serotype 6B: Ratio of GMCs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale; CIs for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority for a given antibody serotype was declared if lower bound of the 2-sided, 97.5% confidence interval for the geometric mean concentration ratio (GMC MDV /GMC SDS) was greater than 0.5 (2-fold criterion).
Method of Estimation Estimation Parameter GMC Ratio
Estimated Value 1.06
Confidence Interval (2-Sided) 97.5%
0.82 to 1.36
Estimation Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection 13vPnC Multi-dose Vial (MDV), 13vPnC Single-Dose Syringe (SDS)
Comments Serotype 7F: Ratio of GMCs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale; CIs for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority for a given antibody serotype was declared if lower bound of the 2-sided, 97.5% confidence interval for the geometric mean concentration ratio (GMC MDV /GMC SDS) was greater than 0.5 (2-fold criterion).
Method of Estimation Estimation Parameter GMC Ratio
Estimated Value 0.94
Confidence Interval (2-Sided) 97.5%
0.82 to 1.08
Estimation Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection 13vPnC Multi-dose Vial (MDV), 13vPnC Single-Dose Syringe (SDS)
Comments Serotype 9V: Ratio of GMCs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale; CIs for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority for a given antibody serotype was declared if lower bound of the 2-sided, 97.5% confidence interval for the geometric mean concentration ratio (GMC MDV /GMC SDS) was greater than 0.5 (2-fold criterion).
Method of Estimation Estimation Parameter GMC Ratio
Estimated Value 1.03
Confidence Interval (2-Sided) 97.5%
0.87 to 1.21
Estimation Comments [Not Specified]
Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection 13vPnC Multi-dose Vial (MDV), 13vPnC Single-Dose Syringe (SDS)
Comments Serotype 14: Ratio of GMCs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale; CIs for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority for a given antibody serotype was declared if lower bound of the 2-sided, 97.5% confidence interval for the geometric mean concentration ratio (GMC MDV /GMC SDS) was greater than 0.5 (2-fold criterion).
Method of Estimation Estimation Parameter GMC Ratio
Estimated Value 0.96
Confidence Interval (2-Sided) 97.5%
0.75 to 1.24
Estimation Comments [Not Specified]
Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection 13vPnC Multi-dose Vial (MDV), 13vPnC Single-Dose Syringe (SDS)
Comments Serotype 18C: Ratio of GMCs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale; CIs for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority for a given antibody serotype was declared if lower bound of the 2-sided, 97.5% confidence interval for the geometric mean concentration ratio (GMC MDV /GMC SDS) was greater than 0.5 (2-fold criterion).
Method of Estimation Estimation Parameter GMC Ratio
Estimated Value 1.28
Confidence Interval (2-Sided) 97.5%
1.09 to 1.49
Estimation Comments [Not Specified]
Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection 13vPnC Multi-dose Vial (MDV), 13vPnC Single-Dose Syringe (SDS)
Comments Serotype 19A: Ratio of GMCs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale; CIs for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority for a given antibody serotype was declared if lower bound of the 2-sided, 97.5% confidence interval for the geometric mean concentration ratio (GMC MDV /GMC SDS) was greater than 0.5 (2-fold criterion).
Method of Estimation Estimation Parameter GMC Ratio
Estimated Value 1.01
Confidence Interval (2-Sided) 97.5%
0.82 to 1.24
Estimation Comments [Not Specified]
Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection 13vPnC Multi-dose Vial (MDV), 13vPnC Single-Dose Syringe (SDS)
Comments Serotype 19F: Ratio of GMCs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale; CIs for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority for a given antibody serotype was declared if lower bound of the 2-sided, 97.5% confidence interval for the geometric mean concentration ratio (GMC MDV /GMC SDS) was greater than 0.5 (2-fold criterion).
Method of Estimation Estimation Parameter GMC Ratio
Estimated Value 1.04
Confidence Interval (2-Sided) 97.5%
0.85 to 1.26
Estimation Comments [Not Specified]
Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection 13vPnC Multi-dose Vial (MDV), 13vPnC Single-Dose Syringe (SDS)
Comments Serotype 23F: Ratio of GMCs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale; CIs for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority for a given antibody serotype was declared if lower bound of the 2-sided, 97.5% confidence interval for the geometric mean concentration ratio (GMC MDV /GMC SDS) was greater than 0.5 (2-fold criterion).
Method of Estimation Estimation Parameter GMC Ratio
Estimated Value 1.20
Confidence Interval (2-Sided) 97.5%
0.98 to 1.48
Estimation Comments [Not Specified]
3.Primary Outcome
Title Number of Participants Reporting Local Reaction Within 5 Days After Dose 1 in MDV and SDS Group
Hide Description Local reactions were reported within 5 days (day 2 to day 6) using an electronic diary. Tenderness was scaled as Any (tenderness present); Mild (hurt if gently touched; Moderate (hurt if gently touched with crying); Severe (caused limitation of limb movement). Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.1 to 7.0 cm); Severe (greater than [>] 7.0 cm). Participants may be represented in more than 1 category.
Time Frame Within 5 days after Dose 1(Day 2 to Day 6) of the infant series
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included participants who received at least 1 dose of study vaccine. 'N' (number of participants analyzed) included participants whose response was "Yes" for any day or "No" for all days.
Arm/Group Title 13vPnC Multi-dose Vial (MDV) 13vPnC Single-Dose Syringe (SDS)
Hide Arm/Group Description:
Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) with 2-phenoxyethanol (2-PE) in MDV intramuscularly at 8, 12 and 16 weeks of age.
Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) without 2-phenoxyethanol (2-PE) in SDS intramuscularly at 8, 12 and 16 weeks of age.
Overall Number of Participants Analyzed 248 250
Measure Type: Number
Unit of Measure: participants
Redness: Any 1 0
Redness: Mild 1 0
Redness: Moderate 0 0
Redness: Severe 0 0
Swelling: Any 1 0
Swelling: Mild 1 0
Swelling: Moderate 0 0
Swelling: Severe 0 0
Tenderness: Any 42 47
Tenderness: Mild 32 37
Tenderness: Moderate 13 14
Tenderness: Severe 0 0
4.Primary Outcome
Title Number of Participants Reporting Local Reaction Within 5 Days After Dose 2 in MDV and SDS Group
Hide Description Local reactions were reported within 5 days (day 2 to day 6) using an electronic diary. Tenderness was scaled as Any (tenderness present); Mild (hurt if gently touched; Moderate (hurt if gently touched with crying); Severe (caused limitation of limb movement). Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.1 to 7.0 cm); Severe (greater than [>] 7.0 cm). Participants may be represented in more than 1 category.
Time Frame Within 5 days after Dose 2 (Day 2 to Day 6) of the infant series
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included participants who received at least 1 dose of study vaccine. 'N' (number of participants analyzed) included participants whose response was "Yes" for any day or "No" for all days and 'n' = participants whose response was "Yes" for any day or "No" for all days for specified local reaction.
Arm/Group Title 13vPnC Multi-dose Vial (MDV) 13vPnC Single-Dose Syringe (SDS)
Hide Arm/Group Description:
Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) with 2-phenoxyethanol (2-PE) in MDV intramuscularly at 8, 12 and 16 weeks of age.
Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) without 2-phenoxyethanol (2-PE) in SDS intramuscularly at 8, 12 and 16 weeks of age.
Overall Number of Participants Analyzed 248 247
Measure Type: Number
Unit of Measure: participants
Redness: Any (n=247, 247) 2 0
Redness: Mild (n=247, 247) 2 0
Redness: Moderate (n=247, 247) 0 0
Redness: Severe (n=247, 247) 0 0
Swelling: Any (n=247, 247) 2 0
Swelling: Mild (n=247, 247) 2 0
Swelling: Moderate (n=247, 247) 1 0
Swelling: Severe (n=247, 247) 0 0
Tenderness: Any (n=248, 247) 34 32
Tenderness: Mild (n=248, 247) 27 28
Tenderness: Moderate (n=247, 247) 7 5
Tenderness: Severe (n=247, 247) 0 0
5.Primary Outcome
Title Number of Participants Reporting Local Reaction Within 5 Days After Dose 3 in MDV and SDS Group
Hide Description Local reactions were reported within 5 days (day 2 to day 6) using an electronic diary. Tenderness was scaled as Any (tenderness present); Mild (hurt if gently touched; Moderate (hurt if gently touched with crying); Severe (caused limitation of limb movement). Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.1 to 7.0 cm); Severe (greater than [>] 7.0 cm). Participants may be represented in more than 1 category.
Time Frame Within 5 days after Dose 3 (Day 2 to Day 6) of the infant series
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included participants who received at least 1 dose of study vaccine. 'N' (number of participants analyzed) included participants whose response was "Yes" for any day or "No" for all days.
Arm/Group Title 13vPnC Multi-dose Vial (MDV) 13vPnC Single-Dose Syringe (SDS)
Hide Arm/Group Description:
Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) with 2-phenoxyethanol (2-PE) in MDV intramuscularly at 8, 12 and 16 weeks of age.
Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) without 2-phenoxyethanol (2-PE) in SDS intramuscularly at 8, 12 and 16 weeks of age.
Overall Number of Participants Analyzed 246 241
Measure Type: Number
Unit of Measure: participants
Redness: Any 0 0
Redness: Mild 0 0
Redness: Moderate 0 0
Redness: Severe 0 0
Swelling: Any 0 0
Swelling: Mild 0 0
Swelling: Moderate 0 0
Swelling: Severe 0 0
Tenderness: Any 37 35
Tenderness: Mild 30 32
Tenderness: Moderate 9 4
Tenderness: Severe 0 0
6.Primary Outcome
Title Number of Participants Reporting Systemic Events Within 5 Days After Dose 1 in MDV and SDS Group
Hide Description Systemic events (any fever greater than or equal to [>=] 38.0 degrees Celsius [C], decreased appetite was scaled as; Moderate (decreased oral intake); Severe (refusal to feed). Irritability scaled as; Mild (easily consolable); Moderate (requiring increased attention); Severe (Inconsolable, crying that cannot be comforted). Increased sleep was scale as; mild (increased or prolonged sleeping bouts); Moderate (slightly subdued interfering with daily activity); Severe (Disabling not interested in usual daily activity) and use of antipyretic medication were reported using an electronic diary. Participants may be represented in more than 1 category.
Time Frame Within 5 days after Dose 1 (Day 2 to Day 6) of infant series
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included participants who received at least 1 dose of study vaccine. 'N' (number of participants analyzed) included participants whose response was "Yes" for any day or "No" for all days. 'n' included participants whose response was "Yes" for any day or "No" for all days for specified systemic event.
Arm/Group Title 13vPnC Multi-dose Vial (MDV) 13vPnC Single-Dose Syringe (SDS)
Hide Arm/Group Description:
Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) with 2-phenoxyethanol (2-PE) in MDV intramuscularly at 8, 12 and 16 weeks of age.
Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) without 2-phenoxyethanol (2-PE) in SDS intramuscularly at 8, 12 and 16 weeks of age.
Overall Number of Participants Analyzed 249 250
Measure Type: Number
Unit of Measure: participants
Fever: >=38.0 degree C (n=248, 250) 9 7
Fever: >=38.0 but <=39.0 degrees C (n=248, 250) 9 7
Fever: >39.0 but <=40.0 degrees C (n=248, 250) 0 0
Fever: >40.0 degrees C (n=248, 250) 0 0
Decreased appetite: Any (n=248, 250) 17 26
Decreased appetite: Moderate (n=248, 250) 17 26
Decreased appetite: Severe (n=248, 250) 0 0
Irritability: Any (n=249, 250) 103 93
Irritability: Mild (n=249, 250) 86 77
Irritability: Moderate (n=248, 250) 19 17
Irritability: Severe (n=248, 250) 0 0
Increased sleep: Any (n=248, 250) 16 14
Increased sleep: Mild (n=248, 250) 11 10
Increased sleep: Moderate (n=248, 250) 6 4
Increased sleep: Severe (n=248, 250) 0 0
Use of antipyretic medication (n=248, 250) 55 58
7.Primary Outcome
Title Number of Participants Reporting Systemic Events Within 5 Days After Dose 2 in MDV and SDS Group
Hide Description Systemic events (any fever greater than or equal to [>=] 38.0 degrees Celsius [C], decreased appetite was scaled as; Moderate (decreased oral intake); Severe (refusal to feed). Irritability scaled as; Mild (easily consolable); Moderate (requiring increased attention); Severe (Inconsolable, crying that cannot be comforted). Increased sleep was scale as; mild (increased or prolonged sleeping bouts); Moderate (slightly subdued interfering with daily activity); Severe (Disabling not interested in usual daily activity) and use of antipyretic medication were reported using an electronic diary. Participants may be represented in more than 1 category.
Time Frame Within 5 days after Dose 2 (Day 2 to Day 6) of infant series
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included participants who received at least 1 dose of study vaccine. 'N' (number of participants analyzed) included participants whose response was "Yes" for any day or "No" for all days. 'n' included participants whose response was "Yes" for any day or "No" for all days for specified systemic event.
Arm/Group Title 13vPnC Multi-dose Vial (MDV) 13vPnC Single-Dose Syringe (SDS)
Hide Arm/Group Description:
Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) with 2-phenoxyethanol (2-PE) in MDV intramuscularly at 8, 12 and 16 weeks of age.
Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) without 2-phenoxyethanol (2-PE) in SDS intramuscularly at 8, 12 and 16 weeks of age.
Overall Number of Participants Analyzed 248 247
Measure Type: Number
Unit of Measure: participants
Fever: >=38.0 degree C (n=247, 247) 7 7
Fever: >=38.0 but <=39.0 degrees C (n=247, 247) 7 7
Fever: >39.0 but <=40.0 degrees C (n=247, 247) 1 0
Fever: >40.0 degrees C (n=247, 247) 0 0
Decreased appetite: Any(n=247, 247) 28 18
Decreased appetite: Moderate (n=247, 247) 28 18
Decreased appetite: Severe (n=247, 247) 0 0
Irritability: Any (n=248, 247) 93 83
Irritability: Mild (n=248, 247) 75 67
Irritability: Moderate (n=247, 247) 23 17
Irritability: Severe (n=247, 247) 0 3
Increased sleep: Any (n=247, 247) 24 14
Increased sleep: Mild (n=247, 247) 20 12
Increased sleep: Moderate (n=247, 247) 4 1
Increased sleep: Severe (n=247, 247) 0 1
Use of antipyretic medication (n=248, 247) 46 43
8.Primary Outcome
Title Number of Participants Reporting Systemic Events Within 5 Days After Dose 3 in MDV and SDS Group
Hide Description Systemic events (any fever greater than or equal to [>=] 38.0 degrees Celsius [C], decreased appetite was scaled as; Moderate (decreased oral intake); Severe (refusal to feed). Irritability scaled as; Mild (easily consolable); Moderate (requiring increased attention); Severe (Inconsolable, crying that cannot be comforted). Increased sleep was scale as; mild (increased or prolonged sleeping bouts); Moderate (slightly subdued interfering with daily activity); Severe (Disabling not interested in usual daily activity) and use of antipyretic medication were reported using an electronic diary. Participants may be represented in more than 1 category.
Time Frame Within 5 days after Dose 3 (Day 2 to Day 6) of infant series
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included participants who received at least 1 dose of study vaccine. 'N' (number of participants analyzed) included participants whose response was "Yes" for any day or "No" for all days. 'n' included participants whose response was "Yes" for any day or "No" for all days for specified systemic event.
Arm/Group Title 13vPnC Multi-dose Vial (MDV) 13vPnC Single-Dose Syringe (SDS)
Hide Arm/Group Description:
Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) with 2-phenoxyethanol (2-PE) in MDV intramuscularly at 8, 12 and 16 weeks of age.
Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) without 2-phenoxyethanol (2-PE) in SDS intramuscularly at 8, 12 and 16 weeks of age.
Overall Number of Participants Analyzed 246 243
Measure Type: Number
Unit of Measure: participants
Fever: >=38.0 degree C (n=246, 241) 3 8
Fever: >=38.0 but <=39.0 degrees C (n=246, 241) 3 7
Fever: >39.0 but <=40.0 degrees C (n=246, 241) 0 1
Fever: >40.0 degrees C (n=246, 241) 0 0
Decreased appetite: Any (n=246, 242) 24 20
Decreased appetite: Moderate (n=246, 242) 24 19
Decreased appetite: Severe (n=246, 241) 0 1
Irritability: Any (n=246, 243) 83 92
Irritability: Mild (n=246, 242) 71 74
Irritability: Moderate (n=246, 242) 15 18
Irritability: Severe (n=246, 241) 1 5
Increased sleep: Any (n=246, 241) 12 12
Increased sleep: Mild (n=246, 241) 10 11
Increased sleep: Moderate (n=246, 241) 2 1
Increased sleep: Severe (n=246, 241) 1 0
Use of antipyretic medication (n=246, 241) 34 36
9.Primary Outcome
Title Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) in the Infant Series
Hide Description An AE was any untoward medical occurrence in a participants who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 to 42 days after last dose that were absent before treatment or that worsened relative to pretreatment state
Time Frame Dose 1 up to 28 to 42 days after dose 3
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who received at least 1 dose of study vaccine.
Arm/Group Title 13vPnC Multi-dose Vial (MDV) 13vPnC Single-Dose Syringe (SDS)
Hide Arm/Group Description:
Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) with 2-phenoxyethanol (2-PE) in MDV intramuscularly at 8, 12 and 16 weeks of age.
Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) without 2-phenoxyethanol (2-PE) in SDS intramuscularly at 8, 12 and 16 weeks of age.
Overall Number of Participants Analyzed 250 250
Measure Type: Number
Unit of Measure: participants
AEs 123 127
SAEs 1 0
10.Primary Outcome
Title Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Prior to Dose 1
Hide Description An AE was any untoward medical occurrence in a participants who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Adverse events were also reported in participants who provided consent but were not randomized in this study. The data of these participants has been reported under 'Screened Only' arm.
Time Frame Informed consent up to Dose 1
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population: participants who received at least 1 dose of study vaccine. Here "N"= participants evaluable for this outcome measure.
Arm/Group Title 13vPnC Multi-dose Vial (MDV) 13vPnC Single-Dose Syringe (SDS) Screened Only
Hide Arm/Group Description:
Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) with 2-phenoxyethanol (2-PE) in MDV intramuscularly at 8, 12 and 16 weeks of age.
Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) without 2-phenoxyethanol (2-PE) in SDS intramuscularly at 8, 12 and 16 weeks of age.
Participants who were screened for this study but were not randomized, assessed between signing of informed consent form and before randomization.
Overall Number of Participants Analyzed 250 250 26
Measure Type: Number
Unit of Measure: participants
AEs 2 0 9
SAEs 0 0 0
11.Secondary Outcome
Title Percentage of Participants Achieving a Serotype-Specific Opsonophagocytic Activity (OPA) Titer >= Lower Limit of Quantitation (LLOQ) 1 Month After Infant Series
Hide Description Percentage of participants achieving OPA Titer >= lower limit of quantitation (LLOQ) along with 95% CI for the 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F 9V, 14, 18C, 19A, 19F and 23F) are presented. The LLOQ in titers for each serotype was: Pn001, 18; Pn003, 12; Pn004, 21; Pn005, 29; Pn06A, 37; Pn06B, 43, Pn7F, 210; Pn09V, 345; Pn014, 35; Pn18C, 31; Pn19A, 18; Pn19F, 48; and Pn23F, 13. Exact 2-sided confidence interval (Clopper and Pearson) based on the observed proportion of participants. Here "n"= Number of participants with an antibody titer ≥ LLOQ for the given serotype.
Time Frame 1 month after the infant series
Hide Outcome Measure Data
Hide Analysis Population Description
Evaluable immunogenicity population:participants who received vaccine (randomized) at all 3 doses, had blood drawn within protocol-specified time frames, had at least 1 valid and determinate assay result for proposed analysis, had no major protocol violations. OPA analysis was performed in a subset of randomly selected participants from each group.
Arm/Group Title 13vPnC Multi-dose Vial (MDV) 13vPnC Single-Dose Syringe (SDS)
Hide Arm/Group Description:
Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) with 2-phenoxyethanol (2-PE) in MDV intramuscularly at 8, 12 and 16 weeks of age.
Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) without 2-phenoxyethanol (2-PE) in SDS intramuscularly at 8, 12 and 16 weeks of age.
Overall Number of Participants Analyzed 160 160
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Serotype 1 (n=159,160)
71.7
(64.0 to 78.5)
79.4
(72.3 to 85.4)
Serotype 3 (n=160,160)
98.8
(95.6 to 99.8)
100.0
(97.7 to 100.0)
Serotype 4 (n=159,159)
100.0
(97.7 to 100.0)
100.0
(97.7 to 100.0)
Serotype 5 (n=160,159)
83.1
(76.4 to 88.6)
85.5
(79.1 to 90.6)
Serotype 6A (n=160,160)
99.4
(96.6 to 100.0)
99.4
(96.6 to 100.0)
Serotype 6B (n=156,155)
96.8
(92.7 to 99.0)
96.8
(92.6 to 98.9)
Serotype 7F (n=159,160)
100.0
(97.7 to 100.0)
100.0
(97.7 to 100.0)
Serotype 9V (n=158,160)
79.7
(72.6 to 85.7)
75.0
(67.6 to 81.5)
Serotype 14 (n=157,160)
81.5
(74.6 to 87.3)
89.4
(83.5 to 93.7)
Serotype 18C (n=159,160)
99.4
(96.5 to 100.0)
99.4
(96.6 to 100.0)
Serotype 19A (n=160,160)
95.6
(91.2 to 98.2)
97.5
(93.7 to 99.3)
Serotype 19F (n=158,159)
93.7
(88.7 to 96.9)
94.3
(89.5 to 97.4)
Serotype 23F (n=159,160)
96.2
(92.0 to 98.6)
97.5
(93.7 to 99.3)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 13vPnC Multi-dose Vial (MDV), 13vPnC Single-Dose Syringe (SDS)
Comments Serotype 1: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter percent difference
Estimated Value -7.7
Confidence Interval (2-Sided) 95%
-17.2 to 1.9
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 13vPnC Multi-dose Vial (MDV), 13vPnC Single-Dose Syringe (SDS)
Comments Serotype 3: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter percent difference
Estimated Value -1.2
Confidence Interval (2-Sided) 95%
-4.4 to 1.1
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 13vPnC Multi-dose Vial (MDV), 13vPnC Single-Dose Syringe (SDS)
Comments Serotype 4: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter percent difference
Estimated Value 0.0
Confidence Interval (2-Sided) 95%
-2.3 to 2.3
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection 13vPnC Multi-dose Vial (MDV), 13vPnC Single-Dose Syringe (SDS)
Comments Serotype 5: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter percent difference
Estimated Value -2.4
Confidence Interval (2-Sided) 95%
-10.6 to 5.7
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection 13vPnC Multi-dose Vial (MDV), 13vPnC Single-Dose Syringe (SDS)
Comments Serotype 6A: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter percent difference
Estimated Value 0.0
Confidence Interval (2-Sided) 95%
-2.9 to 2.8
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection 13vPnC Multi-dose Vial (MDV), 13vPnC Single-Dose Syringe (SDS)
Comments Serotype 6B: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter percent difference
Estimated Value 0.0
Confidence Interval (2-Sided) 95%
-4.5 to 4.6
Estimation Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection 13vPnC Multi-dose Vial (MDV), 13vPnC Single-Dose Syringe (SDS)
Comments Serotype 7F: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter percent difference
Estimated Value 0.0
Confidence Interval (2-Sided) 95%
-2.3 to 2.3
Estimation Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection 13vPnC Multi-dose Vial (MDV), 13vPnC Single-Dose Syringe (SDS)
Comments Serotype 9V: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter percent difference
Estimated Value 4.7
Confidence Interval (2-Sided) 95%
-4.5 to 14.1
Estimation Comments [Not Specified]
Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection 13vPnC Multi-dose Vial (MDV), 13vPnC Single-Dose Syringe (SDS)
Comments Serotype 14: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter percent difference
Estimated Value -7.8
Confidence Interval (2-Sided) 95%
-15.8 to -0.0
Estimation Comments [Not Specified]
Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection 13vPnC Multi-dose Vial (MDV), 13vPnC Single-Dose Syringe (SDS)
Comments Serotype 18C: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter percent difference
Estimated Value -0.0
Confidence Interval (2-Sided) 95%
-2.9 to 2.9
Estimation Comments [Not Specified]
Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection 13vPnC Multi-dose Vial (MDV), 13vPnC Single-Dose Syringe (SDS)
Comments Serotype 19A: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter percent difference
Estimated Value -1.9
Confidence Interval (2-Sided) 95%
-6.6 to 2.4
Estimation Comments [Not Specified]
Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection 13vPnC Multi-dose Vial (MDV), 13vPnC Single-Dose Syringe (SDS)
Comments Serotype 19F: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter percent difference
Estimated Value -0.7
Confidence Interval (2-Sided) 95%
-6.3 to 4.9
Estimation Comments [Not Specified]
Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection 13vPnC Multi-dose Vial (MDV), 13vPnC Single-Dose Syringe (SDS)
Comments Serotype 23F: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter percent difference
Estimated Value -1.3
Confidence Interval (2-Sided) 95%
-5.8 to 3.0
Estimation Comments [Not Specified]
12.Secondary Outcome
Title Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After the Infant Series
Hide Description Antibody geometric mean titers as measured by OPA assay for the 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F 9V, 14, 18C, 19A, 19F and 23F) are presented. GMTs were calculated using all participants with available data for the specified blood draw. CIs were back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the titers. Here "n"= participants evaluable =specified category.
Time Frame 1 month after the infant series
Hide Outcome Measure Data
Hide Analysis Population Description
Evaluable immunogenicity population:participants who received vaccine (randomized) at all 3 doses, had blood drawn within protocol-specified time frames, had at least 1 valid and determinate assay result for proposed analysis, had no major protocol violations. OPA analysis was performed in a subset of randomly selected participants from each group.
Arm/Group Title 13vPnC Multi-dose Vial (MDV) 13vPnC Single-Dose Syringe (SDS)
Hide Arm/Group Description:
Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) with 2-phenoxyethanol (2-PE) in MDV intramuscularly at 8, 12 and 16 weeks of age.
Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) without 2-phenoxyethanol (2-PE) in SDS intramuscularly at 8, 12 and 16 weeks of age.
Overall Number of Participants Analyzed 160 160
Geometric Mean (95% Confidence Interval)
Unit of Measure: titer
Serotype 1 (n=159,160)
48
(39.0 to 58.0)
52
(43.2 to 62.6)
Serotype 3 (n=160,160)
97
(87.3 to 108.8)
122
(110.1 to 135.7)
Serotype 4 (n=159,159)
1666
(1412.3 to 1966.3)
1492
(1285.2 to 1732.3)
Serotype 5 (n=160,159)
79
(67.7 to 92.4)
80
(69.1 to 92.6)
Serotype 6A (n=160,160)
1690
(1460.5 to 1955.9)
1968
(1698.5 to 2279.3)
Serotype 6B (n=156,155)
1990
(1611.7 to 2456.9)
2014
(1639.1 to 2475.4)
Serotype 7F (n=159,160)
2891
(2565.4 to 3258.5)
3450
(3014.7 to 3947.9)
Serotype 9V (n=158,160)
709
(600.5 to 836.2)
706
(597.0 to 835.3)
Serotype 14 (n=157,160)
567
(415.4 to 773.5)
786
(607.8 to 1015.3)
Serotype 18C (n=159,160)
2792
(2387.5 to 3264.8)
1605
(1352.0 to 1904.4)
Serotype 19A (n=160,160)
305
(256.2 to 362.9)
329
(284.8 to 379.8)
Serotype 19F (n=158,159)
430
(357.6 to 517.1)
470
(391.4 to 565.3)
Serotype 23F (n=159,160)
918
(729.0 to 1156.4)
998
(810.6 to 1229.6)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 13vPnC Multi-dose Vial (MDV), 13vPnC Single-Dose Syringe (SDS)
Comments Serotype 1: Ratio of GMTs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter GMT Ratio
Estimated Value 0.9
Confidence Interval (2-Sided) 95%
0.70 to 1.20
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 13vPnC Multi-dose Vial (MDV), 13vPnC Single-Dose Syringe (SDS)
Comments Serotype 3: Ratio of GMTs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter GMT Ratio
Estimated Value 0.8
Confidence Interval (2-Sided) 95%
0.69 to 0.93
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 13vPnC Multi-dose Vial (MDV), 13vPnC Single-Dose Syringe (SDS)
Comments Serotype 4: Ratio of GMTs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter GMT Ratio
Estimated Value 1.1
Confidence Interval (2-Sided) 95%
0.89 to 1.39
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection 13vPnC Multi-dose Vial (MDV), 13vPnC Single-Dose Syringe (SDS)
Comments Serotype 5: Ratio of GMTs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter GMT Ratio
Estimated Value 1.0
Confidence Interval (2-Sided) 95%
0.80 to 1.22
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection 13vPnC Multi-dose Vial (MDV), 13vPnC Single-Dose Syringe (SDS)
Comments Serotype 6A: Ratio of GMTs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter GMT Ratio
Estimated Value 0.9
Confidence Interval (2-Sided) 95%
0.70 to 1.06
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection 13vPnC Multi-dose Vial (MDV), 13vPnC Single-Dose Syringe (SDS)
Comments Serotype 6B: Ratio of GMTs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter GMT Ratio
Estimated Value 1.0
Confidence Interval (2-Sided) 95%
0.74 to 1.33
Estimation Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection 13vPnC Multi-dose Vial (MDV), 13vPnC Single-Dose Syringe (SDS)
Comments Serotype 7F: Ratio of GMTs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter GMT Ratio
Estimated Value 0.8
Confidence Interval (2-Sided) 95%
0.70 to 1.00
Estimation Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection 13vPnC Multi-dose Vial (MDV), 13vPnC Single-Dose Syringe (SDS)
Comments Serotype 9V: Ratio of GMTs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter GMT Ratio
Estimated Value 1.0
Confidence Interval (2-Sided) 95%
0.79 to 1.27
Estimation Comments [Not Specified]
Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection 13vPnC Multi-dose Vial (MDV), 13vPnC Single-Dose Syringe (SDS)
Comments Serotype 14: Ratio of GMTs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter GMT Ratio
Estimated Value 0.7
Confidence Interval (2-Sided) 95%
0.48 to 1.08
Estimation Comments [Not Specified]
Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection 13vPnC Multi-dose Vial (MDV), 13vPnC Single-Dose Syringe (SDS)
Comments Serotype 18C: Ratio of GMTs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter GMT Ratio
Estimated Value 1.7
Confidence Interval (2-Sided) 95%
1.38 to 2.19
Estimation Comments [Not Specified]
Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection 13vPnC Multi-dose Vial (MDV), 13vPnC Single-Dose Syringe (SDS)
Comments Serotype 19A: Ratio of GMTs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter GMT Ratio
Estimated Value 0.9
Confidence Interval (2-Sided) 95%
0.74 to 1.16
Estimation Comments [Not Specified]
Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection 13vPnC Multi-dose Vial (MDV), 13vPnC Single-Dose Syringe (SDS)
Comments Serotype 19F: Ratio of GMTs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter GMT Ratio
Estimated Value 0.9
Confidence Interval (2-Sided) 95%
0.71 to 1.18
Estimation Comments [Not Specified]
Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection 13vPnC Multi-dose Vial (MDV), 13vPnC Single-Dose Syringe (SDS)
Comments Serotype 23F: Ratio of GMTs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter GMT Ratio
Estimated Value 0.9
Confidence Interval (2-Sided) 95%
0.67 to 1.25
Estimation Comments [Not Specified]
Time Frame Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
Adverse Event Reporting Description SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
 
Arm/Group Title 13vPnC MDV: Informed Consent to Dose 1 13vPnC SDS: Informed Consent to Dose 1 13vPnC MDV: After Dose 1 13vPnC SDS: After Dose 1 13vPnC MDV: After Dose 2 13vPnC SDS: After Dose 2 13vPnC MDV: After Dose 3 13vPnC SDS: After Dose 3 Screened Only
Hide Arm/Group Description Participants who were randomized to receive 13vPnC (PF-06414256) MDV at 8, 12, and 16 weeks of age, assessed between signing of informed consent and before Dose 1. Participants who were randomized to receive 13vPnC (PF-05208760) SDS at 8, 12, and 16 weeks of age, assessed between signing of informed consent and before Dose 1. Participants who received single 0.5 mL dose of 13vPnC (PF-06414256) using MDV intramuscularly into the anterolateral thigh muscle of the left leg at 8 weeks of age, assessed after Dose 1 and before Dose 2. Participants who received single 0.5 mL dose of 13vPnC (PF-05208760) using SDS intramuscularly into the anterolateral thigh muscle of the left leg at 8 weeks of age, assessed after Dose 1 and before Dose 2. Participants who received two 0.5 mL doses of 13vPnC (PF-06414256) using MDV intramuscularly into the anterolateral thigh muscle of the left leg 8, 12 weeks of age, assessed after Dose 2 and before Dose 3. Participants who received two 0.5 mL doses of 13vPnC (PF-05208760) using SDS intramuscularly into the anterolateral thigh muscle of the left leg 8, 12 weeks of age, assessed after Dose 2 and before Dose 3. Participants who received all three 0.5mL doses of 13vPnC (PF-06414256) using MDV intramuscularly into the anterolateral thigh muscle of the left leg at 8 weeks of age, assessed after Dose 3 and up to blood draw at 4 weeks. Participants who received all three 0.5mL doses of 13vPnC (PF-05208760) using SDS intramuscularly into the anterolateral thigh muscle of the left leg at 8 weeks of age, assessed after Dose 3 and up to blood draw at 4 weeks. Participants who were screened for this study but were not randomized, assessed between signing of informed consent form and before randomization.
All-Cause Mortality
13vPnC MDV: Informed Consent to Dose 1 13vPnC SDS: Informed Consent to Dose 1 13vPnC MDV: After Dose 1 13vPnC SDS: After Dose 1 13vPnC MDV: After Dose 2 13vPnC SDS: After Dose 2 13vPnC MDV: After Dose 3 13vPnC SDS: After Dose 3 Screened Only
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--      --/--      --/--      --/--      --/--      --/--    
Hide Serious Adverse Events
13vPnC MDV: Informed Consent to Dose 1 13vPnC SDS: Informed Consent to Dose 1 13vPnC MDV: After Dose 1 13vPnC SDS: After Dose 1 13vPnC MDV: After Dose 2 13vPnC SDS: After Dose 2 13vPnC MDV: After Dose 3 13vPnC SDS: After Dose 3 Screened Only
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/250 (0.00%)      0/250 (0.00%)      0/250 (0.00%)      0/250 (0.00%)      0/249 (0.00%)      0/248 (0.00%)      1/247 (0.40%)      0/244 (0.00%)      0/26 (0.00%)    
General disorders                   
Sudden infant death syndrome * 1  0/250 (0.00%)  0/250 (0.00%)  0/250 (0.00%)  0/250 (0.00%)  0/249 (0.00%)  0/248 (0.00%)  1/247 (0.40%)  0/244 (0.00%)  0/26 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 17.1
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
13vPnC MDV: Informed Consent to Dose 1 13vPnC SDS: Informed Consent to Dose 1 13vPnC MDV: After Dose 1 13vPnC SDS: After Dose 1 13vPnC MDV: After Dose 2 13vPnC SDS: After Dose 2 13vPnC MDV: After Dose 3 13vPnC SDS: After Dose 3 Screened Only
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/250 (0.80%)      0/250 (0.00%)      113/250 (45.20%)      107/250 (42.80%)      114/249 (45.78%)      99/248 (39.92%)      97/247 (39.27%)      102/244 (41.80%)      9/26 (34.62%)    
Congenital, familial and genetic disorders                   
Heart disease congenital * 1  0/250 (0.00%)  0/250 (0.00%)  0/250 (0.00%)  0/250 (0.00%)  0/249 (0.00%)  0/248 (0.00%)  0/247 (0.00%)  0/244 (0.00%)  1/26 (3.85%) 
Gastrointestinal disorders                   
Vomiting * 1  0/250 (0.00%)  0/250 (0.00%)  3/250 (1.20%)  1/250 (0.40%)  0/249 (0.00%)  1/248 (0.40%)  1/247 (0.40%)  0/244 (0.00%)  0/26 (0.00%) 
Abdominal pain * 1  0/250 (0.00%)  0/250 (0.00%)  1/250 (0.40%)  0/250 (0.00%)  1/249 (0.40%)  0/248 (0.00%)  1/247 (0.40%)  0/244 (0.00%)  0/26 (0.00%) 
General disorders                   
Pyrexia * 1  0/250 (0.00%)  0/250 (0.00%)  0/250 (0.00%)  2/250 (0.80%)  0/249 (0.00%)  0/248 (0.00%)  1/247 (0.40%)  1/244 (0.41%)  0/26 (0.00%) 
Vaccination site swelling * 1  0/250 (0.00%)  0/250 (0.00%)  0/250 (0.00%)  1/250 (0.40%)  0/249 (0.00%)  0/248 (0.00%)  0/247 (0.00%)  0/244 (0.00%)  0/26 (0.00%) 
Ulcer * 1  0/250 (0.00%)  0/250 (0.00%)  0/250 (0.00%)  0/250 (0.00%)  0/249 (0.00%)  1/248 (0.40%)  0/247 (0.00%)  0/244 (0.00%)  0/26 (0.00%) 
Fever: >=38.0 degree C  3  0/0  0/0  9/248 (3.63%)  7/250 (2.80%)  7/247 (2.83%)  7/247 (2.83%)  3/246 (1.22%)  8/241 (3.32%)  0/26 (0.00%) 
Fever: >=38.0 but <=39.0 degrees C  3  0/0  0/0  9/248 (3.63%)  7/250 (2.80%)  7/247 (2.83%)  7/247 (2.83%)  3/246 (1.22%)  7/241 (2.90%)  0/26 (0.00%) 
Fever: >39.0 but <=40.0 degrees C  3  0/0  0/0  0/248 (0.00%)  0/250 (0.00%)  1/247 (0.40%)  0/247 (0.00%)  0/246 (0.00%)  1/241 (0.41%)  0/26 (0.00%) 
Fever: >40.0 degrees C  3  0/0  0/0  0/248 (0.00%)  0/250 (0.00%)  0/247 (0.00%)  0/247 (0.00%)  0/246 (0.00%)  0/241 (0.00%)  0/26 (0.00%) 
Decreased appetite: Any  3  0/0  0/0  17/248 (6.85%)  26/250 (10.40%)  28/247 (11.34%)  18/247 (7.29%)  24/246 (9.76%)  20/242 (8.26%)  0/26 (0.00%) 
Decreased appetite: Moderate  3  0/0  0/0  17/248 (6.85%)  26/250 (10.40%)  28/247 (11.34%)  18/247 (7.29%)  24/246 (9.76%)  19/242 (7.85%)  0/26 (0.00%) 
Decreased appetite: Severe  3  0/0  0/0  0/248 (0.00%)  0/250 (0.00%)  0/247 (0.00%)  0/247 (0.00%)  0/246 (0.00%)  1/241 (0.41%)  0/26 (0.00%) 
Irritability: Any  3  0/0  0/0  103/249 (41.37%)  93/250 (37.20%)  93/248 (37.50%)  83/247 (33.60%)  83/246 (33.74%)  92/243 (37.86%)  0/26 (0.00%) 
Irritability: Mild  3  0/0  0/0  86/249 (34.54%)  77/250 (30.80%)  75/248 (30.24%)  67/247 (27.13%)  71/246 (28.86%)  74/242 (30.58%)  0/26 (0.00%) 
Irritability: Moderate  3  0/0  0/0  19/248 (7.66%)  17/250 (6.80%)  23/247 (9.31%)  17/247 (6.88%)  15/246 (6.10%)  18/242 (7.44%)  0/26 (0.00%) 
Irritability: Severe  3  0/0  0/0  0/248 (0.00%)  0/250 (0.00%)  0/247 (0.00%)  3/247 (1.21%)  1/246 (0.41%)  5/241 (2.07%)  0/26 (0.00%) 
Increased sleep: Any  3  0/0  0/0  16/248 (6.45%)  14/250 (5.60%)  24/247 (9.72%)  14/247 (5.67%)  12/246 (4.88%)  12/241 (4.98%)  0/26 (0.00%) 
Increased sleep: Mild  3  0/0  0/0  11/248 (4.44%)  10/250 (4.00%)  20/247 (8.10%)  12/247 (4.86%)  10/246 (4.07%)  11/241 (4.56%)  0/26 (0.00%) 
Increased sleep: Moderate  3  0/0  0/0  6/248 (2.42%)  4/250 (1.60%)  4/247 (1.62%)  1/247 (0.40%)  2/246 (0.81%)  1/241 (0.41%)  0/26 (0.00%) 
Increased sleep: Severe  3  0/0  0/0  0/248 (0.00%)  0/250 (0.00%)  0/247 (0.00%)  1/247 (0.40%)  1/246 (0.41%)  0/241 (0.00%)  0/26 (0.00%) 
Infections and infestations                   
Bronchopneumonia * 1  0/250 (0.00%)  0/250 (0.00%)  0/250 (0.00%)  0/250 (0.00%)  0/249 (0.00%)  1/248 (0.40%)  1/247 (0.40%)  4/244 (1.64%)  2/26 (7.69%) 
Conjunctivitis * 1  0/250 (0.00%)  0/250 (0.00%)  3/250 (1.20%)  3/250 (1.20%)  3/249 (1.20%)  1/248 (0.40%)  4/247 (1.62%)  3/244 (1.23%)  1/26 (3.85%) 
Upper respiratory tract infection * 1  1/250 (0.40%)  0/250 (0.00%)  27/250 (10.80%)  17/250 (6.80%)  17/249 (6.83%)  10/248 (4.03%)  19/247 (7.69%)  25/244 (10.25%)  0/26 (0.00%) 
Viral diarrhoea * 1  0/250 (0.00%)  0/250 (0.00%)  6/250 (2.40%)  10/250 (4.00%)  8/249 (3.21%)  10/248 (4.03%)  5/247 (2.02%)  10/244 (4.10%)  0/26 (0.00%) 
Tinea capitis * 1  0/250 (0.00%)  0/250 (0.00%)  4/250 (1.60%)  3/250 (1.20%)  3/249 (1.20%)  1/248 (0.40%)  2/247 (0.81%)  1/244 (0.41%)  0/26 (0.00%) 
Viral infection * 1  0/250 (0.00%)  0/250 (0.00%)  3/250 (1.20%)  1/250 (0.40%)  1/249 (0.40%)  3/248 (1.21%)  0/247 (0.00%)  4/244 (1.64%)  0/26 (0.00%) 
Otitis media * 1  0/250 (0.00%)  0/250 (0.00%)  1/250 (0.40%)  2/250 (0.80%)  2/249 (0.80%)  1/248 (0.40%)  3/247 (1.21%)  2/244 (0.82%)  0/26 (0.00%) 
Breast abscess * 1  0/250 (0.00%)  0/250 (0.00%)  1/250 (0.40%)  0/250 (0.00%)  1/249 (0.40%)  0/248 (0.00%)  0/247 (0.00%)  0/244 (0.00%)  0/26 (0.00%)  0
Dysentery * 1  0/250 (0.00%)  0/250 (0.00%)  0/250 (0.00%)  1/250 (0.40%)  0/249 (0.00%)  0/248 (0.00%)  0/247 (0.00%)  0/244 (0.00%)  0/26 (0.00%) 
Gastroenteritis * 1  0/250 (0.00%)  0/250 (0.00%)  0/250 (0.00%)  1/250 (0.40%)  1/249 (0.40%)  0/248 (0.00%)  0/247 (0.00%)  1/244 (0.41%)  0/26 (0.00%) 
Injection site abscess * 1  0/250 (0.00%)  0/250 (0.00%)  1/250 (0.40%)  0/250 (0.00%)  1/249 (0.40%)  0/248 (0.00%)  0/247 (0.00%)  0/244 (0.00%)  0/26 (0.00%) 
Oral candidiasis * 1  0/250 (0.00%)  0/250 (0.00%)  1/250 (0.40%)  0/250 (0.00%)  0/249 (0.00%)  0/248 (0.00%)  1/247 (0.40%)  0/244 (0.00%)  0/26 (0.00%) 
Otitis media acute * 1  0/250 (0.00%)  0/250 (0.00%)  1/250 (0.40%)  0/250 (0.00%)  1/249 (0.40%)  0/248 (0.00%)  0/247 (0.00%)  0/244 (0.00%)  0/26 (0.00%) 
Respiratory tract infection * 1  0/250 (0.00%)  0/250 (0.00%)  1/250 (0.40%)  0/250 (0.00%)  1/249 (0.40%)  3/248 (1.21%)  6/247 (2.43%)  3/244 (1.23%)  0/26 (0.00%) 
Tinea infection * 1  0/250 (0.00%)  0/250 (0.00%)  0/250 (0.00%)  1/250 (0.40%)  0/249 (0.00%)  0/248 (0.00%)  1/247 (0.40%)  0/244 (0.00%)  0/26 (0.00%) 
Tinea versicolour * 1  0/250 (0.00%)  0/250 (0.00%)  0/250 (0.00%)  1/250 (0.40%)  0/249 (0.00%)  0/248 (0.00%)  0/247 (0.00%)  0/244 (0.00%)  0/26 (0.00%) 
Rash pustular * 1  0/250 (0.00%)  0/250 (0.00%)  0/250 (0.00%)  0/250 (0.00%)  1/249 (0.40%)  0/248 (0.00%)  0/247 (0.00%)  0/244 (0.00%)  0/26 (0.00%) 
Tinea faciei * 1  0/250 (0.00%)  0/250 (0.00%)  0/250 (0.00%)  0/250 (0.00%)  1/249 (0.40%)  0/248 (0.00%)  0/247 (0.00%)  0/244 (0.00%)  0/26 (0.00%) 
Furuncle * 1  0/250 (0.00%)  0/250 (0.00%)  0/250 (0.00%)  0/250 (0.00%)  0/249 (0.00%)  0/248 (0.00%)  3/247 (1.21%)  0/244 (0.00%)  0/26 (0.00%) 
Impetigo * 1  0/250 (0.00%)  0/250 (0.00%)  0/250 (0.00%)  0/250 (0.00%)  0/249 (0.00%)  0/248 (0.00%)  2/247 (0.81%)  1/244 (0.41%)  0/26 (0.00%) 
Gastroenteritis viral * 1  0/250 (0.00%)  0/250 (0.00%)  0/250 (0.00%)  0/250 (0.00%)  0/249 (0.00%)  0/248 (0.00%)  1/247 (0.40%)  1/244 (0.41%)  0/26 (0.00%) 
Pneumonia * 1  0/250 (0.00%)  0/250 (0.00%)  0/250 (0.00%)  0/250 (0.00%)  0/249 (0.00%)  0/248 (0.00%)  0/247 (0.00%)  2/244 (0.82%)  0/26 (0.00%) 
Atypical pneumonia * 1  0/250 (0.00%)  0/250 (0.00%)  0/250 (0.00%)  0/250 (0.00%)  0/249 (0.00%)  0/248 (0.00%)  1/247 (0.40%)  0/244 (0.00%)  0/26 (0.00%)  0
Chest wall abscess * 1  0/250 (0.00%)  0/250 (0.00%)  0/250 (0.00%)  0/250 (0.00%)  0/249 (0.00%)  0/248 (0.00%)  1/247 (0.40%)  0/244 (0.00%)  0/26 (0.00%) 
Varicella * 1  0/250 (0.00%)  0/250 (0.00%)  0/250 (0.00%)  0/250 (0.00%)  0/249 (0.00%)  0/248 (0.00%)  1/247 (0.40%)  0/244 (0.00%)  0/26 (0.00%) 
Urinary tract infection * 1  0/250 (0.00%)  0/250 (0.00%)  0/250 (0.00%)  0/250 (0.00%)  0/249 (0.00%)  0/248 (0.00%)  0/247 (0.00%)  0/244 (0.00%)  1/26 (3.85%) 
Injury, poisoning and procedural complications                   
Burns first degree * 1  0/250 (0.00%)  0/250 (0.00%)  0/250 (0.00%)  0/250 (0.00%)  0/249 (0.00%)  0/248 (0.00%)  0/247 (0.00%)  1/244 (0.41%)  0/26 (0.00%) 
Contusion * 1  0/250 (0.00%)  0/250 (0.00%)  0/250 (0.00%)  1/250 (0.40%)  0/249 (0.00%)  0/248 (0.00%)  0/247 (0.00%)  0/244 (0.00%)  0/26 (0.00%) 
Fall * 1  0/250 (0.00%)  0/250 (0.00%)  0/250 (0.00%)  1/250 (0.40%)  0/249 (0.00%)  0/248 (0.00%)  0/247 (0.00%)  0/244 (0.00%)  0/26 (0.00%) 
Metabolism and nutrition disorders                   
Failure to thrive * 1  0/250 (0.00%)  0/250 (0.00%)  0/250 (0.00%)  0/250 (0.00%)  0/249 (0.00%)  0/248 (0.00%)  0/247 (0.00%)  1/244 (0.41%)  3/26 (11.54%) 
Musculoskeletal and connective tissue disorders                   
Musculoskeletal pain * 1  0/250 (0.00%)  0/250 (0.00%)  0/250 (0.00%)  0/250 (0.00%)  0/249 (0.00%)  0/248 (0.00%)  1/247 (0.40%)  0/244 (0.00%)  0/26 (0.00%) 
Growth retardation * 1  0/250 (0.00%)  0/250 (0.00%)  0/250 (0.00%)  0/250 (0.00%)  0/249 (0.00%)  0/248 (0.00%)  0/247 (0.00%)  0/244 (0.00%)  1/26 (3.85%) 
Pregnancy, puerperium and perinatal conditions                   
Umbilical granuloma * 1  0/250 (0.00%)  0/250 (0.00%)  2/250 (0.80%)  0/250 (0.00%)  0/249 (0.00%)  0/248 (0.00%)  0/247 (0.00%)  0/244 (0.00%)  0/26 (0.00%) 
Respiratory, thoracic and mediastinal disorders                   
Cough * 1  0/250 (0.00%)  0/250 (0.00%)  2/250 (0.80%)  2/250 (0.80%)  0/249 (0.00%)  0/248 (0.00%)  0/247 (0.00%)  0/244 (0.00%)  0/26 (0.00%) 
Bronchial hyperreactivity * 1  0/250 (0.00%)  0/250 (0.00%)  0/250 (0.00%)  0/250 (0.00%)  1/249 (0.40%)  0/248 (0.00%)  0/247 (0.00%)  0/244 (0.00%)  0/26 (0.00%) 
Skin and subcutaneous tissue disorders                   
Dermatitis * 1  1/250 (0.40%)  0/250 (0.00%)  8/250 (3.20%)  12/250 (4.80%)  5/249 (2.01%)  7/248 (2.82%)  2/247 (0.81%)  6/244 (2.46%)  0/26 (0.00%) 
Dermatitis diaper * 1  0/250 (0.00%)  0/250 (0.00%)  1/250 (0.40%)  0/250 (0.00%)  0/249 (0.00%)  0/248 (0.00%)  1/247 (0.40%)  2/244 (0.82%)  0/26 (0.00%) 
Eczema * 1  0/250 (0.00%)  0/250 (0.00%)  1/250 (0.40%)  0/250 (0.00%)  1/249 (0.40%)  1/248 (0.40%)  0/247 (0.00%)  0/244 (0.00%)  0/26 (0.00%) 
Dermatitis atopic * 1  0/250 (0.00%)  0/250 (0.00%)  0/250 (0.00%)  0/250 (0.00%)  0/249 (0.00%)  1/248 (0.40%)  0/247 (0.00%)  0/244 (0.00%)  0/26 (0.00%) 
Rash papular * 1  0/250 (0.00%)  0/250 (0.00%)  0/250 (0.00%)  0/250 (0.00%)  0/249 (0.00%)  1/248 (0.40%)  0/247 (0.00%)  0/244 (0.00%)  0/26 (0.00%) 
Skin ulcer * 1  0/250 (0.00%)  0/250 (0.00%)  0/250 (0.00%)  0/250 (0.00%)  0/249 (0.00%)  0/248 (0.00%)  0/247 (0.00%)  1/244 (0.41%)  0/26 (0.00%) 
Redness: Any  2  0/0  0/0  1/248 (0.40%)  0/250 (0.00%)  2/247 (0.81%)  0/247 (0.00%)  0/246 (0.00%)  0/241 (0.00%)  0/26 (0.00%) 
Redness: Mild  2  0/0  0/0  1/248 (0.40%)  0/250 (0.00%)  2/247 (0.81%)  0/247 (0.00%)  0/246 (0.00%)  0/241 (0.00%)  0/26 (0.00%) 
Redness: Moderate  2  0/0  0/0  0/248 (0.00%)  0/250 (0.00%)  0/247 (0.00%)  0/247 (0.00%)  0/246 (0.00%)  0/241 (0.00%)  0/26 (0.00%) 
Redness: Severe  2  0/0  0/0  0/248 (0.00%)  0/250 (0.00%)  0/247 (0.00%)  0/247 (0.00%)  0/246 (0.00%)  0/241 (0.00%)  0/26 (0.00%) 
Swelling: Any  2  0/0  0/0  1/248 (0.40%)  0/250 (0.00%)  2/247 (0.81%)  0/247 (0.00%)  0/246 (0.00%)  0/241 (0.00%)  0/26 (0.00%) 
Swelling: Mild  2  0/0  0/0  1/248 (0.40%)  0/250 (0.00%)  2/247 (0.81%)  0/247 (0.00%)  0/246 (0.00%)  0/241 (0.00%)  0/26 (0.00%) 
Swelling: Moderate  2  0/0  0/0  0/248 (0.00%)  0/250 (0.00%)  1/247 (0.40%)  0/247 (0.00%)  0/246 (0.00%)  0/241 (0.00%)  0/26 (0.00%) 
Swelling: Severe  2  0/0  0/0  0/248 (0.00%)  0/250 (0.00%)  0/247 (0.00%)  0/247 (0.00%)  0/246 (0.00%)  0/241 (0.00%)  0/26 (0.00%) 
Tenderness: Any  2  0/0  0/0  42/248 (16.94%)  47/250 (18.80%)  34/248 (13.71%)  32/247 (12.96%)  37/246 (15.04%)  35/241 (14.52%)  0/26 (0.00%) 
Tenderness: Mild  2  0/0  0/0  32/248 (12.90%)  37/250 (14.80%)  27/248 (10.89%)  28/247 (11.34%)  30/246 (12.20%)  32/241 (13.28%)  0/26 (0.00%) 
Tenderness: Moderate  2  0/0  0/0  13/248 (5.24%)  14/250 (5.60%)  7/247 (2.83%)  5/247 (2.02%)  9/246 (3.66%)  4/241 (1.66%)  0/26 (0.00%) 
Tenderness: Severe  2  0/0  0/0  0/248 (0.00%)  0/250 (0.00%)  0/247 (0.00%)  0/247 (0.00%)  0/246 (0.00%)  0/241 (0.00%)  0/26 (0.00%) 
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 17.1
2
Term from vocabulary, Local Reactions
3
Term from vocabulary, Systemic Events
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
EMail: ClinicalTrials.gov_Inquiries@pfizer.com
Layout table for additonal information
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01964716    
Other Study ID Numbers: B4671001
2012-000482-21 ( EudraCT Number )
First Submitted: September 9, 2013
First Posted: October 17, 2013
Results First Submitted: February 27, 2015
Results First Posted: March 13, 2015
Last Update Posted: March 13, 2015