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Trial record 1 of 1 for:    NCT00474539
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Study Evaluating a 13-Valent Pneumococcal Conjugate Vaccine in Healthy Infants

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ClinicalTrials.gov Identifier: NCT00474539
Recruitment Status : Completed
First Posted : May 17, 2007
Results First Posted : March 5, 2013
Last Update Posted : March 5, 2013
Sponsor:
Information provided by (Responsible Party):
Wyeth is now a wholly owned subsidiary of Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition Vaccines, Pneumococcal
Interventions Biological: 13-valent pneumococcal conjugate vaccine
Biological: 7-valent pneumococcal conjugate vaccine
Enrollment 449
Recruitment Details Participants were recruited in Spain from 4 July 2007 to 23 July 2007.
Pre-assignment Details Participants were enrolled into the study according to the inclusion/exclusion criteria without a screening period.
Arm/Group Title 13vPnC 7vPnC
Hide Arm/Group Description Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with meningococcal C-tetanus toxoid conjugate vaccine (NeisVac-C) and combined diphtheria-tetanus-acellular pertussis (DTPa), hepatitis B, inactivated poliovirus, and hemophilus influenza type b (Hib) vaccine (Infanrix hexa) at the 2- and 4-month visits (infant series Dose 2) and one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at the 6-month visit (infant series dose 3). Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and combined DTPa, inactivated poliovirus, and hemophilus influenza type b (Hib) vaccine (Infanrix IPV + Hib) at the 15-month visit (toddler dose). Measles, mumps, and rubella vaccine (MMR) was administered without study vaccine at the 12-month visit. Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with meningococcal C-tetanus toxoid conjugate vaccine (NeisVac-C) and combined diphtheria-tetanus-acellular pertussis (DTPa), hepatitis B, inactivated poliovirus, and hemophilus influenza type b (Hib) vaccine (Infanrix hexa) at the 2- and 4-month visits (infant series Dose 2) and one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at the 6-month visit (infant series dose 3). Participants received one single 0.5 mL dose of 7vPnC coadministered with NeisVac-C and combined DTPa, inactivated poliovirus, and hemophilus influenza type b (Hib) vaccine (Infanrix IPV + Hib) at the 15-month visit (toddler dose). Measles, mumps, and rubella vaccine (MMR) was administered without study vaccine at the 12-month visit.
Period Title: Infant Series
Started 223 [1] 226 [1]
Vaccinated Dose 1 218 226
Vaccinated Dose 2 217 222
Vaccinated Dose 3 214 221
Completed 213 220
Not Completed 10 6
Reason Not Completed
Withdrawal by Subject             3             4
Randomization error             5             0
Lost to Follow-up             2             1
Protocol Violation             0             1
[1]
One participant was randomized to 7vPnC, but received 13vPnC.
Period Title: After Infant Series
Started 213 220
Completed 209 220
Not Completed 4 0
Reason Not Completed
Lost to Follow-up             3             0
Withdrawal by Subject             1             0
Period Title: Toddler Dose
Started 209 220
Completed 208 220
Not Completed 1 0
Reason Not Completed
Protocol Violation             1             0
Arm/Group Title 13vPnC 7vPnC Total
Hide Arm/Group Description Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with meningococcal C-tetanus toxoid conjugate vaccine (NeisVac-C) and combined diphtheria-tetanus-acellular pertussis (DTPa), hepatitis B, inactivated poliovirus, and hemophilus influenza type b (Hib) vaccine (Infanrix hexa) at the 2- and 4-month visits (infant series Dose 2) and one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at the 6-month visit (infant series dose 3). Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and combined DTPa, inactivated poliovirus, and hemophilus influenza type b (Hib) vaccine (Infanrix IPV + Hib) at the 15-month visit (toddler dose). Measles, mumps, and rubella vaccine (MMR) was administered without study vaccine at the 12-month visit. Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with meningococcal C-tetanus toxoid conjugate vaccine (NeisVac-C) and combined diphtheria-tetanus-acellular pertussis (DTPa), hepatitis B, inactivated poliovirus, and hemophilus influenza type b (Hib) vaccine (Infanrix hexa) at the 2- and 4-month visits (infant series Dose 2) and one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at the 6-month visit (infant series dose 3). Participants received one single 0.5 mL dose of 7vPnC coadministered with NeisVac-C and combined DTPa, inactivated poliovirus, and hemophilus influenza type b (Hib) vaccine (Infanrix IPV + Hib) at the 15-month visit (toddler dose). Measles, mumps, and rubella vaccine (MMR) was administered without study vaccine at the 12-month visit. Total of all reporting groups
Overall Number of Baseline Participants 219 225 444
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Months
Number Analyzed 219 participants 225 participants 444 participants
2.1  (0.4) 2.0  (0.4) 2.1  (0.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 219 participants 225 participants 444 participants
Female
104
  47.5%
116
  51.6%
220
  49.5%
Male
115
  52.5%
109
  48.4%
224
  50.5%
1.Primary Outcome
Title Percentage of Participants Achieving a Serum Bactericidal Assay (SBA) Titer ≥ 1:8 in 13vPnC Group Relative to 7vPnC Group After the 2-dose NeisVac-C Infant Series
Hide Description Percentage of participants achieving a meningococcal C SBA serum antibody titer greater than or equal to (≥) 1:8 along with the corresponding 95% confidence interval (CI) are presented.
Time Frame One month after infant series dose (at 5 months of age)
Hide Outcome Measure Data
Hide Analysis Population Description
Evaluable immunogenicity (per protocol) population consisting of eligible participants who adhered to protocol requirements, had valid and determinate assay results, and had no other major protocol violations; (n)= number of participants with a determinate immunoglobulin G (IgG) antibody concentration to the given concomitant vaccine component.
Arm/Group Title 13vPnC After Infant Series Dose 2 7vPnC After Infant Series Dose 2
Hide Arm/Group Description:
Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Infanrix hexa at the 2- and 4-month visits (infant series Dose 2).
Participants received one single 0.5 mL dose of 7vPnC coadministered with NeisVac-C and Infanrix hexa at the 2- and 4-month visits (infant series Dose 2).
Overall Number of Participants Analyzed 206 218
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
98.5
(95.8 to 99.7)
99.1
(96.7 to 99.9)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 13vPnC After Infant Series Dose 2, 7vPnC After Infant Series Dose 2
Comments For Meningococcal C the difference in percentages between the two groups (13vPnC - 7vPnC) at >=1:8 titer was calculated
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority for immune response induced by NeisVac-C was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) greater than (>) -10%.
Method of Estimation Estimation Parameter Difference
Estimated Value -0.5
Confidence Interval 95%
-3.3 to 2.0
Estimation Comments [Not Specified]
2.Primary Outcome
Title Geometric Mean Titers (GMT) for Meningococcal C Antibodies in as Measured by Serum Bactericidal Assay (SBA) 13vPnC Group Relative to 7vPnC Group After the 2-dose NeisVac-C Infant Series and the Toddler Dose
Hide Description [Not Specified]
Time Frame One month after infant series dose 2 (at 5 months of age) and one month after toddler dose (at 16 months of age)
Hide Outcome Measure Data
Hide Analysis Population Description
The evaluable 2-dose immunogenicity (per protocol) population was the primary analysis population consisting of eligible subjects who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations.
Arm/Group Title 13vPnC After Infant Series Dose 2 7vPnC After Infant Series Dose 2 13vPnC After Toddler Dose 7vPnC After Toddler Dose
Hide Arm/Group Description:
Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Infanrix hexa at the 2- and 4-month visits (infant series Dose 2).
Participants received one single 0.5 mL dose of 7vPnC coadministered with NeisVac-C and Infanrix hexa at the 2- and 4-month visits (infant series Dose 2)
Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Infanrix IPV + Hib at the 15-month visit (toddler dose). MMR was administered without study vaccine at the 12-month visit.
Participants received one single 0.5 mL dose of 7vPnC coadministered with NeisVac-C and Infanrix IPV + Hib at the 15-month visit (toddler dose). MMR was administered without study vaccine at the 12-month visit.
Overall Number of Participants Analyzed 206 218 164 172
Geometric Mean (95% Confidence Interval)
Unit of Measure: titer
654.55
(557.75 to 768.16)
757.04
(648.45 to 883.81)
2573.06
(2176.29 to 3042.16)
2098.12
(1779.65 to 2473.58)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 13vPnC After Infant Series Dose 2, 7vPnC After Infant Series Dose 2
Comments For Meningococcal C the GMT ratio (13vPnC/7vPnC) was calculated
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority for or immune response induced by NeisVac-C was declared if the lower bound of the 2-sided, 95% CI for the GMT ratio (13vPnC group/7vPnC group) was >0.5 (2-fold criterion).
Method of Estimation Estimation Parameter Ratio
Estimated Value 0.86
Confidence Interval 95%
0.69 to 1.08
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 13vPnC After Toddler Dose, 7vPnC After Toddler Dose
Comments For Meningococcal C the GMT ratio (13vPnC/7vPnC) was calculated
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority for or immune response induced by NeisVac-C was declared if the lower bound of the 2-sided, 95% CI for the GMT ratio (13vPnC group/7vPnC group) was >0.5 (2-fold criterion).
Method of Estimation Estimation Parameter Ratio
Estimated Value 1.23
Confidence Interval 95%
0.97 to 1.55
Estimation Comments [Not Specified]
3.Primary Outcome
Title Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria and Tetanus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and After the Toddler Dose
Hide Description Predefined antibody levels for Diphtheria (0.01 or 0.1 International units [IU]/mL) and Tetanus (0.01 or 0.1 [IU]/mL).
Time Frame One month after infant series dose 3 (at 7 months of age) and one month after the toddler dose (at 16 months of age)
Hide Outcome Measure Data
Hide Analysis Population Description
The evaluable 3-dose immunogenicity (per protocol) population was the primary analysis population consisting of eligible subjects who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations.
Arm/Group Title 13vPnC After Infant Series Dose 3 7vPnC After Infant Series Dose 3 13vPnC After Toddler Dose 7vPnC After Toddler Dose
Hide Arm/Group Description:
Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at the 6-month visit (infant series dose 3).
Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at the 6-month visit (infant series dose 3).
Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Infanrix IPV + Hib at the 15-month visit (toddler dose).
Participants received one single 0.5 mL dose of 7vPnC coadministered with NeisVac-C and Infanrix IPV + Hib at the 15-month visit (toddler dose).
Overall Number of Participants Analyzed 197 212 164 172
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Diphtheria ≥0.10 IU/mL
98.5
(95.6 to 99.7)
99.1
(96.6 to 99.9)
100.0
(97.8 to 100.0)
100.0
(97.9 to 100.0)
Diphtheria ≥0.01 IU/mL
100.0
(98.1 to 100.0)
100.0
(98.3 to 100.0)
100.0
(97.8 to 100.0)
100.0
(97.9 to 100.0)
Tetanus ≥0.10 IU/mL
96.6
(92.6 to 98.7)
96.7
(93.0 to 98.8)
100.0
(97.8 to 100.0)
100.0
(97.9 to 100.0)
Tetanus ≥0.01 IU/mL
100.0
(97.9 to 100.0)
100.0
(98.0 to 100.0)
100.0
(97.8 to 100.0)
100.0
(97.9 to 100.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 13vPnC After Infant Series Dose 3, 7vPnC After Infant Series Dose 3
Comments For diphtheria the difference in percentage between the two groups (13vPnC - 7vPnC) at >=0.10 IU/mL threshold was calculated
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) > -10%.
Method of Estimation Estimation Parameter Difference
Estimated Value -0.6
Confidence Interval 95%
-3.5 to 2.0
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 13vPnC After Infant Series Dose 3, 7vPnC After Infant Series Dose 3
Comments For diphtheria the difference in percentage between the two groups (13vPnC - 7vPnC) at >=0.01 IU/mL threshold was calculated
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) > -10%.
Method of Estimation Estimation Parameter Difference
Estimated Value 0.0
Confidence Interval 95%
-1.9 to 1.7
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 13vPnC After Infant Series Dose 3, 7vPnC After Infant Series Dose 3
Comments For tetanus the difference in percentage between the two groups (13vPnC - 7vPnC) at >=0.10 IU/mL threshold was calculated
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) > -10%.
Method of Estimation Estimation Parameter Difference
Estimated Value -0.2
Confidence Interval 95%
-4.4 to 4.0
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection 13vPnC After Infant Series Dose 3, 7vPnC After Infant Series Dose 3
Comments For tetanus the difference in percentage between the two groups (13vPnC - 7vPnC) at >=0.01 IU/mL threshold was calculated
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) > -10%.
Method of Estimation Estimation Parameter Difference
Estimated Value 0.0
Confidence Interval 95%
-2.1 to 2.0
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection 13vPnC After Toddler Dose, 7vPnC After Toddler Dose
Comments For diphtheria the difference in percentage between the two groups (13vPnC - 7vPnC) at >=0.10 IU/mL threshold was calculated
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) > -10%.
Method of Estimation Estimation Parameter Ratio
Estimated Value 0.0
Confidence Interval 95%
-2.2 to 2.2
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection 13vPnC After Toddler Dose, 7vPnC After Toddler Dose
Comments For diphtheria the difference in percentage between the two groups (13vPnC - 7vPnC) at >=0.01 IU/mL threshold was calculated
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) > -10%.
Method of Estimation Estimation Parameter Ratio
Estimated Value 0.0
Confidence Interval 95%
-2.2 to 2.2
Estimation Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection 13vPnC After Toddler Dose, 7vPnC After Toddler Dose
Comments For tetanus the difference in percentage between the two groups (13vPnC - 7vPnC) at >=0.10 IU/mL threshold was calculated
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) > -10%.
Method of Estimation Estimation Parameter Ratio
Estimated Value 0.0
Confidence Interval 95%
-2.3 to 2.2
Estimation Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection 13vPnC After Toddler Dose, 7vPnC After Toddler Dose
Comments For tetanus the difference in percentage between the two groups (13vPnC - 7vPnC) at >=0.01 IU/mL threshold was calculated
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) > -10%.
Method of Estimation Estimation Parameter Ratio
Estimated Value 0.0
Confidence Interval 95%
-2.3 to 2.2
Estimation Comments [Not Specified]
4.Primary Outcome
Title Geometric Mean Antibody Concentrations (GMC) for Diphtheria and Tetanus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and After the Toddler Dose
Hide Description [Not Specified]
Time Frame One month after infant series dose 3 (at 7 months of age) and one month after the toddler dose (at 16 months of age)
Hide Outcome Measure Data
Hide Analysis Population Description
The evaluable 3-dose immunogenicity (per protocol) population was the primary analysis population consisting of eligible subjects who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations.
Arm/Group Title 13vPnC After Infant Series Dose 3 7vPnC After Infant Series Dose 3 13vPnC After Toddler Dose 7vPnC After Toddler Dose
Hide Arm/Group Description:
Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at the 6-month visit (infant series dose 3).
Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at the 6-month visit (infant series dose 3).
Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Infanrix IPV + Hib at the 15-month visit (toddler dose).
SParticipants received one single 0.5 mL dose of 7vPnC coadministered with NeisVac-C and Infanrix IPV + Hib at the 15-month visit (toddler dose).
Overall Number of Participants Analyzed 197 212 164 172
Geometric Mean (95% Confidence Interval)
Unit of Measure: IU/mL
Diphtheria
0.79
(0.69 to 0.90)
0.92
(0.81 to 1.04)
3.00
(2.63 to 3.41)
3.23
(2.88 to 3.63)
Tetanus
1.10
(0.94 to 1.27)
1.20
(1.04 to 1.39)
3.29
(2.83 to 3.83)
3.28
(2.83 to 3.79)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 13vPnC After Infant Series Dose 3, 7vPnC After Infant Series Dose 3
Comments For diphtheria toxoid the GMC ratio (13vPnC/7vPnC) was calculated
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was >0.5 (2-fold criterion).
Method of Estimation Estimation Parameter Ratio
Estimated Value 0.86
Confidence Interval 95%
0.72 to 1.03
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 13vPnC After Infant Series Dose 3, 7vPnC After Infant Series Dose 3
Comments For tetanus the GMC ratio (13vPnC/7vPnC) was calculated
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was >0.5 (2-fold criterion).
Method of Estimation Estimation Parameter Ratio
Estimated Value 0.91
Confidence Interval 95%
0.74 to 1.12
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 13vPnC After Toddler Dose, 7vPnC After Toddler Dose
Comments For diphtheria toxoid the GMC ratio (13vPnC/7vPnC) was calculated
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was >0.5 (2-fold criterion).
Method of Estimation Estimation Parameter Ratio
Estimated Value 0.93
Confidence Interval 95%
0.78 to 1.10
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection 13vPnC After Toddler Dose, 7vPnC After Toddler Dose
Comments For tetanus the GMC ratio (13vPnC/7vPnC) was calculated
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was >0.5 (2-fold criterion).
Method of Estimation Estimation Parameter Ratio
Estimated Value 1.00
Confidence Interval 95%
0.81 to 1.24
Estimation Comments [Not Specified]
5.Primary Outcome
Title Percentage of Participants Achieving Antibody Level ≥ 0.35μg/mL in 13vPnC Group After the Second and the Third Dose of a 3-Dose Infant Series and After the Toddler Dose
Hide Description Percentages of participants achieving World Health Organization (WHO) predefined antibody threshold ≥ 0.35 μg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.
Time Frame One month after infant series dose 2 (at 5 months of age) and dose 3 (at 7 months of age) and one month after the toddler dose (at 16 months of age)
Hide Outcome Measure Data
Hide Analysis Population Description
The evaluable immunogenicity (per protocol) population was the primary analysis population consisting of eligible subjects who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations.
Arm/Group Title 13vPnC After Infant Series Dose 2 13vPnC After Infant Series Dose 3 13vPnC After Toddler Dose
Hide Arm/Group Description:
Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Infanrix hexa at the 2- and 4-month visits (infant series Dose 2).
Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at the 6-month visit (infant series dose 3).
Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Infanrix IPV + Hib at the 15-month visit (toddler dose).
Overall Number of Participants Analyzed 206 197 212
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Common Serotypes - Serotype 4
92.5
(87.9 to 95.7)
98.5
(95.7 to 99.7)
100.0
(97.7 to 100.0)
Common Serotypes - Serotype 6B
27.9
(21.8 to 34.7)
94.9
(90.9 to 97.5)
100.0
(97.7 to 100.0)
Common Serotypes - Serotype 9V
89.9
(84.8 to 93.7)
97.0
(93.5 to 98.9)
99.3
(96.3 to 100.0)
Common Serotypes - Serotype 14
91.0
(86.1 to 94.6)
97.0
(93.6 to 98.9)
99.4
(96.6 to 100.0)
Common Serotypes - Serotype 18C
88.9
(83.7 to 92.9)
99.0
(96.4 to 99.9)
98.8
(95.6 to 99.8)
Common Serotypes - Serotype 19F
100.0
(98.2 to 100.0)
99.0
(96.4 to 99.9)
98.7
(95.5 to 99.8)
Common Serotypes - Serotype 23F
55.8
(48.6 to 62.8)
93.0
(88.5 to 96.1)
98.1
(94.7 to 99.6)
Additional Serotypes - Serotype 1
96.0
(92.2 to 98.2)
98.5
(95.7 to 99.7)
98.8
(95.6 to 99.8)
Additional Serotypes - Serotype 3
73.8
(67.1 to 79.9)
86.2
(80.5 to 90.7)
93.6
(88.6 to 96.9)
Additional Serotypes - Serotype 5
86.4
(80.8 to 90.8)
96.0
(92.2 to 98.2)
100.0
(97.6 to 100.0)
Additional Serotypes - Serotype 6A
80.8
(74.6 to 86.0)
99.0
(96.4 to 99.9)
99.4
(96.5 to 100.0)
Additional Serotypes - Serotype 7F
94.5
(90.3 to 97.2)
100.0
(98.2 to 100.0)
99.4
(96.5 to 100.0)
Additional Serotypes - Serotype 19A
92.9
(88.4 to 96.1)
99.5
(97.2 to 100.0)
100.0
(97.5 to 100.0)
6.Primary Outcome
Title Geometric Mean Antibody Concentration (GMC) in 13vPnC Group After the Second and the Third Dose of a 3-Dose Infant Series and After the Toddler Dose
Hide Description GMC as measured by enzyme-linked immunosorbent assay (ELISA) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. GMCs (13vPnC) were calculated for each pneumococcal serotype and timepoint, and 2-sided, 95% CI were constructed.
Time Frame One month after infant series dose 2 (at 5 months of age) and dose 3 (at 7 months of age) and one month after the toddler dose (at 16 months of age)
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Hide Analysis Population Description
The evaluable immunogenicity (per protocol) population was the primary analysis population consisting of eligible subjects who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations.
Arm/Group Title 13vPnC After Infant Series Dose 2 13vPnC After Infant Series Dose 3 13vPnC After Toddler Dose
Hide Arm/Group Description:
Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Infanrix hexa at the 2- and 4-month visits (infant series Dose 2).
Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at the 6-month visit (infant series dose 3).
Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Infanrix IPV + Hib at the 15-month visit (toddler dose).
Overall Number of Participants Analyzed 206 197 212
Geometric Mean (95% Confidence Interval)
Unit of Measure: μg/mL
Common Serotypes - Serotype 4
1.55
(1.35 to 1.78)
2.32
(2.08 to 2.60)
3.88
(3.42 to 4.40)
Common Serotypes - Serotype 6B
0.21
(0.18 to 0.25)
2.59
(2.20 to 3.05)
12.25
(10.78 to 13.92)
Common Serotypes - Serotype 9V
1.15
(1.01 to 1.32)
1.51
(1.35 to 1.68)
2.67
(2.34 to 3.05)
Common Serotypes - Serotype 14
1.94
(1.64 to 2.29)
4.51
(3.89 to 5.22)
9.82
(8.54 to 11.30)
Common Serotypes - Serotype 18C
1.30
(1.11 to 1.51)
1.86
(1.68 to 2.07)
2.29
(2.01 to 2.61)
Common Serotypes - Serotype 19F
2.98
(2.60 to 3.41)
2.46
(2.21 to 2.74)
6.11
(5.21 to 7.16)
Common Serotypes - Serotype 23F
0.40
(0.34 to 0.48)
1.67
(1.44 to 1.94)
3.96
(3.43 to 4.59)
Additional Serotypes - Serotype 1
1.87
(1.61 to 2.16)
2.95
(2.61 to 3.33)
4.60
(3.94 to 5.37)
Additional Serotypes - Serotype 3
0.54
(0.48 to 0.61)
0.85
(0.76 to 0.95)
1.04
(0.91 to 1.19)
Additional Serotypes - Serotype 5
0.88
(0.77 to 1.00)
1.83
(1.62 to 2.06)
3.69
(3.26 to 4.18)
Additional Serotypes - Serotype 6A
0.81
(0.70 to 0.95)
3.08
(2.76 to 3.44)
7.71
(6.75 to 8.80)
Additional Serotypes - Serotype 7F
1.51
(1.33 to 1.71)
3.41
(3.11 to 3.74)
5.66
(4.90 to 6.53)
Additional Serotypes - Serotype 19A
1.52
(1.31 to 1.76)
2.50
(2.27 to 2.75)
10.21
(8.92 to 11.68)
7.Secondary Outcome
Title Percentage of Participants Achieving a Serum Bactericidal Assay (SBA) Titer ≥ 1:8 in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose
Hide Description Percentage of participants achieving a meningococcal C SBA serum antibody titer ≥ 1:8 along with the corresponding 95% confidence interval (CI) are presented.
Time Frame One month after toddler dose (at 16 months of age)
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Hide Analysis Population Description
Evaluable immunogenicity (per protocol) population consisting of eligible participants who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations; (n)= number of participants with a determinate IgG antibody concentration to the given concomitant vaccine component.
Arm/Group Title 13vPnC After Toddler Dose 7vPnC After Toddler Dose
Hide Arm/Group Description:
Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with meningococcal C-tetanus toxoid conjugate vaccine (NeisVac-C) and combined diphtheria-tetanus-acellular pertussis (DTPa), hepatitis B, inactivated poliovirus, and hemophilus influenza type b (Hib) vaccine (Infanrix hexa) at the 2- and 4-month visits (infant series Dose 2) and one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at the 6-month visit (infant series dose 3). Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and combined DTPa, inactivated poliovirus, and hemophilus influenza type b (Hib) vaccine (Infanrix IPV + Hib) at the 15-month visit (toddler dose). Measles, mumps, and rubella vaccine (MMR) was administered without study vaccine at the 12-month visit.
Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with meningococcal C-tetanus toxoid conjugate vaccine (NeisVac-C) and combined diphtheria-tetanus-acellular pertussis (DTPa), hepatitis B, inactivated poliovirus, and hemophilus influenza type b (Hib) vaccine (Infanrix hexa) at the 2- and 4-month visits (infant series Dose 2) and one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at the 6-month visit (infant series dose 3). Participants received one single 0.5 mL dose of 7vPnC coadministered with NeisVac-C and combined DTPa, inactivated poliovirus, and hemophilus influenza type b (Hib) vaccine (Infanrix IPV + Hib) at the 15-month visit (toddler dose). Measles, mumps, and rubella vaccine (MMR) was administered without study vaccine at the 12-month visit.
Overall Number of Participants Analyzed 164 172
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
100.0
(97.8 to 100.0)
99.4
(96.80 to 100.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 13vPnC After Toddler Dose, 7vPnC After Toddler Dose
Comments For Meningococcal C the difference in percentages between the two groups (13vPnC - 7vPnC) at ≥ 1:8 titer was calculated.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority for immune response induced by NeisVac-C was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) > -10%.
Method of Estimation Estimation Parameter Difference
Estimated Value 0.6
Confidence Interval 95%
-1.7 to 3.2
Estimation Comments [Not Specified]
8.Other Pre-specified Outcome
Title Percentage of Participants Reporting Pre-Specified Local Reactions
Hide Description Local reactions were collected using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (Sig)(present and interfered with limb movement). Swelling and redness were scaled as Any (swelling or redness present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (Mod) (2.5 to 7.0 cm); Severe (Sev) (>7.0 cm). Participants may be represented in more than 1 category.
Time Frame During the 4-day period after each dose
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Hide Analysis Population Description
The safety population included all participants who received at least 1 dose of vaccine, (n) = number of participants reporting yes for at least 1 day or no for all days.
Arm/Group Title 13vPnC Dose 1 7vPnC Dose 1 13vPnC Dose 2 7vPnC Dose 2 13vPnC Dose 3 7vPnC Dose 3 13vPnC Toddler Dose 7vPnC Toddler Dose
Hide Arm/Group Description:
Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Infanrix hexa at the 2-month visit.
Participants received one single 0.5 mL dose of 7vPnC coadministered with NeisVac-C and Infanrix hexa at the 2-month visit.
Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Infanrix hexa at the 4-month visit.
Participants received one single 0.5 mL dose of 7vPnC coadministered with NeisVac-C and Infanrix hexa at the 4-month visit.
Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa and at the 6-month visit.
Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa and at the 6-month visit.
Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Infanrix-IPV+Hib at the 15-month visit.
Participants received one single 0.5 mL dose of 7vPnC coadministered with with NeisVac-C and Infanrix-IPV+Hib at the 15-month visit.
Overall Number of Participants Analyzed 218 226 217 222 214 221 209 220
Measure Type: Number
Unit of Measure: percentage of participants
Tenderness-Any (n=199,205,182,180,170,175,164,172) 21.1 18.5 21.4 16.1 10.6 14.3 28.7 26.7
Tenderness-Sig (n=199,200,177,177,167,169,154,160) 3.0 4.0 1.1 4.0 1.2 1.2 2.6 3.8
Swelling-Any (n=196,200,182,177,171,170,169,168) 13.3 14.5 22.0 14.7 23.4 20.0 26.6 18.5
Swelling-Mild (n=196,200,182,177,171,170,166,168) 12.2 13.0 20.3 13.0 20.5 17.1 22.9 16.0
Swelling-Mod (n=196,196,177,175,166,168,156,163) 2.6 2.0 2.3 2.3 6.6 6.0 9.0 5.5
Swelling-Sev (n=196,196,177,175,166,168,152,156) 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
Redness-Any (n=197,199,181,180,172,172,170,169) 15.2 15.1 23.8 20.0 26.7 22.7 30.0 23.1
Redness-Mild (n=197,198,180,180,172,171,167,165) 14.7 14.1 22.2 19.4 24.4 21.1 28.1 21.2
Redness-Mod (n=196,197,178,175,166,169,157,163) 0.5 1.0 2.2 1.1 3.6 3.6 9.6 6.7
Redness-Sev (n=196,196,177,175,166,168,152,156) 0.0 0.0 0.0 0.0 0.6 0.0 0.0 0.0
9.Other Pre-specified Outcome
Title Percentage of Participants Reporting Pre-Specified Systemic Events
Hide Description Systemic events (fever [Fv] ≥ 37.5 degrees Celsius [C], fever ≥ 38 C but ≤ 39 C, fever >39 C but ≤ 40 C, fever > 40 C, decreased (Decr) appetite, irritability, increased (Incr) sleep, decreased sleep, hives, use of medication (Meds) to treat symptoms (Sx), and use of medication to prevent symptoms were reported using an electronic diary. Participants may be represented in more than 1 category.
Time Frame During the 4-day period after each dose
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Hide Analysis Population Description
The safety population included all subjects who received at least 1 dose of vaccine, (n) = number of participants reporting yes for at least 1 day or no for all days.
Arm/Group Title 13vPnC Dose 1 7vPnC Dose 1 13vPnC Dose 2 7vPnC Dose 2 13vPnC Dose 3 7vPnC Dose 3 13vPnC Toddler Dose 7vPnC Toddler Dose
Hide Arm/Group Description:
Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Infanrix hexa at the 2-month visit.
Participants received one single 0.5 mL dose of 7vPnC coadministered with NeisVac-C and Infanrix hexa at the 2-month visit.
Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Infanrix hexa at the 4-month visit.
Participants received one single 0.5 mL dose of 7vPnC coadministered with NeisVac-C and Infanrix hexa at the 4-month visit.
Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa and at the 6-month visit.
Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa and at the 6-month visit.
Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Infanrix-IPV+Hib at the 15-month visit.
Participants received one single 0.5 mL dose of 7vPnC coadministered with with NeisVac-C and Infanrix-IPV+Hib at the 15-month visit.
Overall Number of Participants Analyzed 218 226 217 222 214 221 209 220
Measure Type: Number
Unit of Measure: percentage of participants
Fv ≥38°C, ≤39°C(n=201,204,181,189,172,176,156,169) 22.9 19.6 32.6 41.8 20.9 29.0 31.4 34.3
Fv >39°C, ≤40°C(n=196,196,177,176,166,168,154,156) 1.0 0.5 1.7 1.1 3.6 3.0 4.5 2.6
Fv >40°C (n=196,197,177,175,166,168,152,156) 0.0 0.5 0.0 0.0 0.0 0.0 0.7 0.0
Decr appetite (n=204,207,189,191,178,178,163,178) 31.4 35.7 46.6 44.0 37.1 36.0 31.9 41.0
Irritability (n=202,211,192,190,179,188,171,179) 46.5 49.8 57.3 60.0 43.0 39.4 41.5 53.6
Incr sleep (n=204,206,189,187,175,174,162,165) 38.7 39.3 39.2 36.4 21.1 27.0 16.7 24.8
Decr sleep (n=196,204,183,187,175,178,162,166) 19.4 27.5 27.3 27.8 22.9 25.3 19.8 18.7
Meds-treat sx (n=205,209,193,197,175,189,165,177) 41.0 44.5 54.4 57.9 39.4 42.9 50.3 46.9
Meds-prevent sx(n=201,210,194,196,177,185,168,177) 41.3 45.7 47.9 49.5 44.6 40.5 43.5 41.8
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 13vPnC Infant Series 7vPnC Infant Series 13vPnC Post-Infant Series 7vPnC Post-Infant Series 13vPnC Toddler Series 7vPnC Toddler Series 13vPnC 6-Month Follow-up 7vPnC 6-Month Follow-up
Hide Arm/Group Description Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Infanrix hexa at the 2- and 4-month visits. Adverse events were collected from dose 1 to approximately one month after dose 3. Participants received one single 0.5 mL dose of 7vPnC coadministered with NeisVac-C and Infanrix hexa at the 2- and 4-month visits. Adverse events were collected from dose 1 to approximately one month after dose 3. Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at the 6-month visit. Adverse events were collected from approximately one month after dose 3 to toddler dose. Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at the 6-month visit. Adverse events were collected from approximately one month after dose 3 to toddler dose. Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Infanrix-IPV+Hib at the 15-month visit. Adverse events were collected for approximately one month after toddler dose. Participants received one single 0.5 mL dose of 7vPnC coadministered with with NeisVac-C and Infanrix-IPV+Hib at the 15-month visit. Adverse events were collected for approximately one month after toddler dose. Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Infanrix hexa at the 2- and 4-month visits (infant series Dose 2) and one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at the 6-month visit (infant series dose 3). Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Infanrix IPV + Hib at the 15-month visit (toddler dose). MMR was administered without study vaccine at the 12-month visit. Adverse events were collected for approximately six months after last visit Participants received one single 0.5 mL dose of 7vPnC coadministered with NeisVac-C and Infanrix hexa at the 2- and 4-month visits (infant series Dose 2) and one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at the 6-month visit (infant series dose 3). Participants received one single 0.5 mL dose of 7vPnC coadministered with NeisVac-C and Infanrix IPV + Hib at the 15-month visit (toddler dose). MMR was administered without study vaccine at the 12-month visit. Adverse events were collected for approximately six months after last visit
All-Cause Mortality
13vPnC Infant Series 7vPnC Infant Series 13vPnC Post-Infant Series 7vPnC Post-Infant Series 13vPnC Toddler Series 7vPnC Toddler Series 13vPnC 6-Month Follow-up 7vPnC 6-Month Follow-up
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 Infant Series 7vPnC Infant Series 13vPnC Post-Infant Series 7vPnC Post-Infant Series 13vPnC Toddler Series 7vPnC Toddler Series 13vPnC 6-Month Follow-up 7vPnC 6-Month Follow-up
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   6/218 (2.75%)   8/226 (3.54%)   9/218 (4.13%)   6/226 (2.65%)   1/218 (0.46%)   0/226 (0.00%)   4/218 (1.83%)   9/226 (3.98%) 
Gastrointestinal disorders                 
Aphthous stomatitis * 1  0/218 (0.00%)  0/226 (0.00%)  0/218 (0.00%)  0/226 (0.00%)  0/218 (0.00%)  0/226 (0.00%)  0/218 (0.00%)  1/226 (0.44%) 
Coleliac disease * 1  0/218 (0.00%)  0/226 (0.00%)  0/218 (0.00%)  0/226 (0.00%)  0/218 (0.00%)  0/226 (0.00%)  0/218 (0.00%)  1/226 (0.44%) 
Diarrhoea * 1  0/218 (0.00%)  0/226 (0.00%)  1/218 (0.46%)  0/226 (0.00%)  0/218 (0.00%)  0/226 (0.00%)  0/218 (0.00%)  1/226 (0.44%) 
Gastrooesophageal reflux disease * 1  0/218 (0.00%)  1/226 (0.44%)  0/218 (0.00%)  0/226 (0.00%)  0/218 (0.00%)  0/226 (0.00%)  0/218 (0.00%)  0/226 (0.00%) 
Inguinal hernia * 1  0/218 (0.00%)  0/226 (0.00%)  0/218 (0.00%)  1/226 (0.44%)  0/218 (0.00%)  0/226 (0.00%)  0/218 (0.00%)  0/226 (0.00%) 
Intussusception * 1  0/218 (0.00%)  0/226 (0.00%)  0/218 (0.00%)  0/226 (0.00%)  0/218 (0.00%)  0/226 (0.00%)  0/218 (0.00%)  1/226 (0.44%) 
General disorders                 
Pyrexia * 1  1/218 (0.46%)  1/226 (0.44%)  1/218 (0.46%)  0/226 (0.00%)  1/218 (0.46%)  0/226 (0.00%)  0/218 (0.00%)  0/226 (0.00%) 
Infections and infestations                 
Bacteriuria * 1  0/218 (0.00%)  0/226 (0.00%)  0/218 (0.00%)  1/226 (0.44%)  0/218 (0.00%)  0/226 (0.00%)  0/218 (0.00%)  0/226 (0.00%) 
Bronchiolitis * 1  1/218 (0.46%)  2/226 (0.88%)  2/218 (0.92%)  0/226 (0.00%)  0/218 (0.00%)  0/226 (0.00%)  0/218 (0.00%)  0/226 (0.00%) 
Bronchitis * 1  0/218 (0.00%)  0/226 (0.00%)  1/218 (0.46%)  0/226 (0.00%)  0/218 (0.00%)  0/226 (0.00%)  0/218 (0.00%)  0/226 (0.00%) 
Enterocolitis viral * 1  0/218 (0.00%)  0/226 (0.00%)  1/218 (0.46%)  0/226 (0.00%)  0/218 (0.00%)  0/226 (0.00%)  0/218 (0.00%)  0/226 (0.00%) 
Escherichia urinary tract infection * 1  1/218 (0.46%)  0/226 (0.00%)  0/218 (0.00%)  0/226 (0.00%)  0/218 (0.00%)  0/226 (0.00%)  0/218 (0.00%)  0/226 (0.00%) 
Gastroenteritis * 1  1/218 (0.46%)  1/226 (0.44%)  0/218 (0.00%)  1/226 (0.44%)  0/218 (0.00%)  0/226 (0.00%)  0/218 (0.00%)  2/226 (0.88%) 
Gastroenteritis rotavirus * 1  0/218 (0.00%)  0/226 (0.00%)  0/218 (0.00%)  1/226 (0.44%)  0/218 (0.00%)  0/226 (0.00%)  0/218 (0.00%)  0/226 (0.00%) 
Influenza * 1  0/218 (0.00%)  0/226 (0.00%)  0/218 (0.00%)  0/226 (0.00%)  0/218 (0.00%)  0/226 (0.00%)  1/218 (0.46%)  0/226 (0.00%) 
Orchitis * 1  1/218 (0.46%)  0/226 (0.00%)  0/218 (0.00%)  0/226 (0.00%)  0/218 (0.00%)  0/226 (0.00%)  0/218 (0.00%)  0/226 (0.00%) 
Otitis media * 1  0/218 (0.00%)  0/226 (0.00%)  0/218 (0.00%)  0/226 (0.00%)  0/218 (0.00%)  0/226 (0.00%)  0/218 (0.00%)  1/226 (0.44%) 
Pharyngotonsillitis * 1  0/218 (0.00%)  0/226 (0.00%)  0/218 (0.00%)  0/226 (0.00%)  0/218 (0.00%)  0/226 (0.00%)  0/218 (0.00%)  1/226 (0.44%) 
Pneumonia * 1  1/218 (0.46%)  0/226 (0.00%)  1/218 (0.46%)  1/226 (0.44%)  0/218 (0.00%)  0/226 (0.00%)  2/218 (0.92%)  0/226 (0.00%) 
Pyelonephritis * 1  0/218 (0.00%)  1/226 (0.44%)  0/218 (0.00%)  0/226 (0.00%)  0/218 (0.00%)  0/226 (0.00%)  0/218 (0.00%)  0/226 (0.00%) 
Respiratory syncytial virus bronchiolitis * 1  0/218 (0.00%)  0/226 (0.00%)  1/218 (0.46%)  0/226 (0.00%)  0/218 (0.00%)  0/226 (0.00%)  1/218 (0.46%)  1/226 (0.44%) 
Tonsillitis * 1  0/218 (0.00%)  0/226 (0.00%)  0/218 (0.00%)  0/226 (0.00%)  0/218 (0.00%)  0/226 (0.00%)  0/218 (0.00%)  1/226 (0.44%) 
Urinary tract infection * 1  1/218 (0.46%)  1/226 (0.44%)  1/218 (0.46%)  1/226 (0.44%)  0/218 (0.00%)  0/226 (0.00%)  0/218 (0.00%)  0/226 (0.00%) 
Viral infection * 1  0/218 (0.00%)  1/226 (0.44%)  0/218 (0.00%)  0/226 (0.00%)  0/218 (0.00%)  0/226 (0.00%)  0/218 (0.00%)  0/226 (0.00%) 
Injury, poisoning and procedural complications                 
Femur fracture * 1  0/218 (0.00%)  0/226 (0.00%)  0/218 (0.00%)  0/226 (0.00%)  0/218 (0.00%)  0/226 (0.00%)  0/218 (0.00%)  1/226 (0.44%) 
Joint dislocation * 1  0/218 (0.00%)  0/226 (0.00%)  1/218 (0.46%)  0/226 (0.00%)  0/218 (0.00%)  0/226 (0.00%)  0/218 (0.00%)  0/226 (0.00%) 
Metabolism and nutrition disorders                 
Metabolic acidosis * 1  0/218 (0.00%)  0/226 (0.00%)  0/218 (0.00%)  0/226 (0.00%)  0/218 (0.00%)  0/226 (0.00%)  0/218 (0.00%)  1/226 (0.44%) 
Nervous system disorders                 
Convulsion * 1  0/218 (0.00%)  0/226 (0.00%)  1/218 (0.46%)  0/226 (0.00%)  1/218 (0.46%)  0/226 (0.00%)  0/218 (0.00%)  0/226 (0.00%) 
Febrile convulsion * 1  0/218 (0.00%)  0/226 (0.00%)  1/218 (0.46%)  0/226 (0.00%)  0/218 (0.00%)  0/226 (0.00%)  0/218 (0.00%)  0/226 (0.00%) 
Respiratory, thoracic and mediastinal disorders                 
Asthma * 1  0/218 (0.00%)  0/226 (0.00%)  1/218 (0.46%)  0/226 (0.00%)  0/218 (0.00%)  0/226 (0.00%)  0/218 (0.00%)  0/226 (0.00%) 
Bronchospams * 1  0/218 (0.00%)  0/226 (0.00%)  0/218 (0.00%)  0/226 (0.00%)  0/218 (0.00%)  0/226 (0.00%)  1/218 (0.46%)  0/226 (0.00%) 
Increased bronchial secretion * 1  0/218 (0.00%)  0/226 (0.00%)  0/218 (0.00%)  0/226 (0.00%)  0/218 (0.00%)  0/226 (0.00%)  0/218 (0.00%)  1/226 (0.44%) 
Wheezing * 1  1/218 (0.46%)  0/226 (0.00%)  0/218 (0.00%)  0/226 (0.00%)  0/218 (0.00%)  0/226 (0.00%)  0/218 (0.00%)  0/226 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
13vPnC Infant Series 7vPnC Infant Series 13vPnC Post-Infant Series 7vPnC Post-Infant Series 13vPnC Toddler Series 7vPnC Toddler Series 13vPnC 6-Month Follow-up 7vPnC 6-Month Follow-up
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   204/218 (93.58%)   211/225 (93.78%)   6/218 (2.75%)   13/225 (5.78%)   171/209 (81.82%)   179/218 (82.11%)   4/218 (1.83%)   2/224 (0.89%) 
Blood and lymphatic system disorders                 
Lymphadenitis * 1  0/218 (0.00%)  0/225 (0.00%)  0/218 (0.00%)  0/225 (0.00%)  0/209 (0.00%)  1/218 (0.46%)  0/218 (0.00%)  0/224 (0.00%) 
Congenital, familial and genetic disorders                 
Phimosis * 1  0/218 (0.00%)  0/225 (0.00%)  0/218 (0.00%)  1/225 (0.44%)  0/209 (0.00%)  0/218 (0.00%)  0/218 (0.00%)  0/224 (0.00%) 
Thalassaemia beta * 1  0/218 (0.00%)  0/225 (0.00%)  0/218 (0.00%)  0/225 (0.00%)  0/209 (0.00%)  0/218 (0.00%)  1/218 (0.46%)  0/224 (0.00%) 
Ear and labyrinth disorders                 
Ear pain * 1  0/218 (0.00%)  0/225 (0.00%)  0/218 (0.00%)  0/225 (0.00%)  1/209 (0.48%)  0/218 (0.00%)  0/218 (0.00%)  0/224 (0.00%) 
Eye disorders                 
Conjunctivitis * 1  3/218 (1.38%)  11/225 (4.89%)  0/218 (0.00%)  0/225 (0.00%)  0/209 (0.00%)  1/218 (0.46%)  0/218 (0.00%)  0/224 (0.00%) 
Conjunctivitis allergic * 1  0/218 (0.00%)  1/225 (0.44%)  0/218 (0.00%)  0/225 (0.00%)  0/209 (0.00%)  0/218 (0.00%)  0/218 (0.00%)  0/224 (0.00%) 
Dacryostenosis acquired * 1  1/218 (0.46%)  0/225 (0.00%)  0/218 (0.00%)  0/225 (0.00%)  0/209 (0.00%)  0/218 (0.00%)  0/218 (0.00%)  0/224 (0.00%) 
Gastrointestinal disorders                 
Diarrhoea * 1  8/218 (3.67%)  9/225 (4.00%)  0/218 (0.00%)  1/225 (0.44%)  2/209 (0.96%)  3/218 (1.38%)  0/218 (0.00%)  0/224 (0.00%) 
Vomiting * 1  3/218 (1.38%)  4/225 (1.78%)  0/218 (0.00%)  0/225 (0.00%)  0/209 (0.00%)  0/218 (0.00%)  0/218 (0.00%)  0/224 (0.00%) 
Gastrointestinal inflammation * 1  3/218 (1.38%)  2/225 (0.89%)  0/218 (0.00%)  0/225 (0.00%)  0/209 (0.00%)  0/218 (0.00%)  0/218 (0.00%)  0/224 (0.00%) 
Constipation * 1  0/218 (0.00%)  2/225 (0.89%)  0/218 (0.00%)  0/225 (0.00%)  0/209 (0.00%)  0/218 (0.00%)  0/218 (0.00%)  0/224 (0.00%) 
Enteritis * 1  1/218 (0.46%)  1/225 (0.44%)  0/218 (0.00%)  0/225 (0.00%)  0/209 (0.00%)  0/218 (0.00%)  0/218 (0.00%)  0/224 (0.00%) 
Abnormal faeces * 1  1/218 (0.46%)  0/225 (0.00%)  0/218 (0.00%)  0/225 (0.00%)  0/209 (0.00%)  0/218 (0.00%)  0/218 (0.00%)  0/224 (0.00%) 
Infantile colic * 1  0/218 (0.00%)  1/225 (0.44%)  0/218 (0.00%)  0/225 (0.00%)  0/209 (0.00%)  0/218 (0.00%)  0/218 (0.00%)  0/224 (0.00%) 
Aphthous stomatitis * 1  0/218 (0.00%)  0/225 (0.00%)  0/218 (0.00%)  0/225 (0.00%)  0/209 (0.00%)  1/218 (0.46%)  0/218 (0.00%)  0/224 (0.00%) 
Stomatitis * 1  0/218 (0.00%)  0/225 (0.00%)  0/218 (0.00%)  0/225 (0.00%)  0/209 (0.00%)  1/218 (0.46%)  0/218 (0.00%)  0/224 (0.00%) 
General disorders                 
Pyrexia * 1  6/218 (2.75%)  9/225 (4.00%)  0/218 (0.00%)  0/225 (0.00%)  5/209 (2.39%)  2/218 (0.92%)  0/218 (0.00%)  0/224 (0.00%) 
Irritability * 1  2/218 (0.92%)  0/225 (0.00%)  0/218 (0.00%)  0/225 (0.00%)  0/209 (0.00%)  0/218 (0.00%)  0/218 (0.00%)  0/224 (0.00%) 
Developmental delay * 1  0/218 (0.00%)  0/225 (0.00%)  0/218 (0.00%)  1/225 (0.44%)  0/209 (0.00%)  0/218 (0.00%)  0/218 (0.00%)  0/224 (0.00%) 
Fever ≥38°C but ≤39°C  3 [1]  201/218 (92.20%)  204/225 (90.67%)  0/0  0/0  156/209 (74.64%)  169/218 (77.52%)  0/0  0/0 
Fever ≥38°C but ≤39°C  3 [2]  181/218 (83.03%)  189/225 (84.00%)  0/0  0/0  0/0  0/0  0/0  0/0 
Fever ≥38°C but ≤39°C  3 [3]  172/218 (78.90%)  176/225 (78.22%)  0/0  0/0  0/0  0/0  0/0  0/0 
Fever >39°C but ≤40°C  3 [4]  196/218 (89.91%)  196/225 (87.11%)  0/0  0/0  154/209 (73.68%)  156/218 (71.56%)  0/0  0/0 
Fever >39°C but ≤40°C  3 [5]  177/218 (81.19%)  176/225 (78.22%)  0/0  0/0  0/0  0/0  0/0  0/0 
Fever >39°C but ≤40°C  3 [6]  166/218 (76.15%)  168/225 (74.67%)  0/0  0/0  0/0  0/0  0/0  0/0 
Fever >40°C  3 [7]  196/218 (89.91%)  197/225 (87.56%)  0/0  0/0  152/209 (72.73%)  156/218 (71.56%)  0/0  0/0 
Fever >40°C  3 [8]  177/218 (81.19%)  175/225 (77.78%)  0/0  0/0  0/0  0/0  0/0  0/0 
Fever >40°C  3 [9]  166/218 (76.15%)  168/225 (74.67%)  0/0  0/0  0/0  0/0  0/0  0/0 
Decreased appetite  3 [10]  204/218 (93.58%)  207/225 (92.00%)  0/0  0/0  163/209 (77.99%)  178/218 (81.65%)  0/0  0/0 
Decreased appetite  3 [11]  189/218 (86.70%)  191/225 (84.89%)  0/0  0/0  0/0  0/0  0/0  0/0 
Decreased appetite  3 [12]  178/218 (81.65%)  178/225 (79.11%)  0/0  0/0  0/0  0/0  0/0  0/0 
Irritability  3 [13]  202/218 (92.66%)  211/225 (93.78%)  0/0  0/0  171/209 (81.82%)  179/218 (82.11%)  0/0  0/0 
Irritability  3 [14]  192/218 (88.07%)  190/225 (84.44%)  0/0  0/0  0/0  0/0  0/0  0/0 
Irritability  3 [15]  179/218 (82.11%)  188/225 (83.56%)  0/0  0/0  0/0  0/0  0/0  0/0 
Increased sleep  3 [16]  204/218 (93.58%)  206/225 (91.56%)  0/0  0/0  162/209 (77.51%)  165/218 (75.69%)  0/0  0/0 
Increased sleep  3 [17]  189/218 (86.70%)  187/225 (83.11%)  0/0  0/0  0/0  0/0  0/0  0/0 
Increased sleep  3 [18]  175/218 (80.28%)  174/225 (77.33%)  0/0  0/0  0/0  0/0  0/0  0/0 
Decreased sleep  3 [19]  196/218 (89.91%)  204/225 (90.67%)  0/0  0/0  162/209 (77.51%)  166/218 (76.15%)  0/0  0/0 
Decreased sleep  3 [20]  183/218 (83.94%)  187/225 (83.11%)  0/0  0/0  0/0  0/0  0/0  0/0 
Decreased sleep  3 [21]  175/218 (80.28%)  178/225 (79.11%)  0/0  0/0  0/0  0/0  0/0  0/0 
Immune system disorders                 
Milk allergy * 1  1/218 (0.46%)  1/225 (0.44%)  0/218 (0.00%)  1/225 (0.44%)  0/209 (0.00%)  0/218 (0.00%)  0/218 (0.00%)  0/224 (0.00%) 
Food allergy * 1  0/218 (0.00%)  0/225 (0.00%)  1/218 (0.46%)  0/225 (0.00%)  0/209 (0.00%)  0/218 (0.00%)  1/218 (0.46%)  1/224 (0.45%) 
Infections and infestations                 
Nasopharyngitis * 1  21/218 (9.63%)  27/225 (12.00%)  0/218 (0.00%)  1/225 (0.44%)  9/209 (4.31%)  6/218 (2.75%)  0/218 (0.00%)  0/224 (0.00%) 
Upper respiratory tract infection * 1  23/218 (10.55%)  24/225 (10.67%)  1/218 (0.46%)  2/225 (0.89%)  5/209 (2.39%)  4/218 (1.83%)  0/218 (0.00%)  0/224 (0.00%) 
Gastroenteritis * 1  19/218 (8.72%)  15/225 (6.67%)  0/218 (0.00%)  0/225 (0.00%)  7/209 (3.35%)  3/218 (1.38%)  0/218 (0.00%)  0/224 (0.00%) 
Bronchiolitis * 1  12/218 (5.50%)  17/225 (7.56%)  0/218 (0.00%)  0/225 (0.00%)  1/209 (0.48%)  0/218 (0.00%)  0/218 (0.00%)  0/224 (0.00%) 
Respiratory tract infection * 1  9/218 (4.13%)  14/225 (6.22%)  0/218 (0.00%)  0/225 (0.00%)  0/209 (0.00%)  1/218 (0.46%)  0/218 (0.00%)  0/224 (0.00%) 
Bronchitis * 1  9/218 (4.13%)  13/225 (5.78%)  0/218 (0.00%)  1/225 (0.44%)  1/209 (0.48%)  1/218 (0.46%)  0/218 (0.00%)  0/224 (0.00%) 
Laryngitis * 1  5/218 (2.29%)  8/225 (3.56%)  0/218 (0.00%)  0/225 (0.00%)  1/209 (0.48%)  1/218 (0.46%)  0/218 (0.00%)  0/224 (0.00%) 
Otitis media * 1  3/218 (1.38%)  8/225 (3.56%)  0/218 (0.00%)  0/225 (0.00%)  0/209 (0.00%)  0/218 (0.00%)  0/218 (0.00%)  0/224 (0.00%) 
Rhinitis * 1  4/218 (1.83%)  7/225 (3.11%)  0/218 (0.00%)  0/225 (0.00%)  0/209 (0.00%)  0/218 (0.00%)  0/218 (0.00%)  0/224 (0.00%) 
Ear infection * 1  5/218 (2.29%)  5/225 (2.22%)  0/218 (0.00%)  1/225 (0.44%)  0/209 (0.00%)  5/218 (2.29%)  0/218 (0.00%)  0/224 (0.00%) 
Pharyngitis * 1  4/218 (1.83%)  2/225 (0.89%)  0/218 (0.00%)  0/225 (0.00%)  5/209 (2.39%)  3/218 (1.38%)  0/218 (0.00%)  0/224 (0.00%) 
Tonsillitis * 1  2/218 (0.92%)  3/225 (1.33%)  0/218 (0.00%)  0/225 (0.00%)  1/209 (0.48%)  4/218 (1.83%)  0/218 (0.00%)  0/224 (0.00%) 
Viral infection * 1  1/218 (0.46%)  4/225 (1.78%)  0/218 (0.00%)  0/225 (0.00%)  2/209 (0.96%)  0/218 (0.00%)  0/218 (0.00%)  0/224 (0.00%) 
Candidiasis * 1  1/218 (0.46%)  3/225 (1.33%)  0/218 (0.00%)  0/225 (0.00%)  0/209 (0.00%)  0/218 (0.00%)  0/218 (0.00%)  0/224 (0.00%) 
Otitis media acute * 1  1/218 (0.46%)  2/225 (0.89%)  0/218 (0.00%)  0/225 (0.00%)  2/209 (0.96%)  0/218 (0.00%)  0/218 (0.00%)  0/224 (0.00%) 
Varicella * 1  1/218 (0.46%)  2/225 (0.89%)  0/218 (0.00%)  1/225 (0.44%)  0/209 (0.00%)  0/218 (0.00%)  0/218 (0.00%)  0/224 (0.00%) 
Oral candidiasis * 1  1/218 (0.46%)  1/225 (0.44%)  0/218 (0.00%)  0/225 (0.00%)  0/209 (0.00%)  0/218 (0.00%)  0/218 (0.00%)  0/224 (0.00%) 
Urinary tract infection * 1  2/218 (0.92%)  0/225 (0.00%)  0/218 (0.00%)  0/225 (0.00%)  1/209 (0.48%)  1/218 (0.46%)  0/218 (0.00%)  0/224 (0.00%) 
Bronchopneumonia * 1  1/218 (0.46%)  0/225 (0.00%)  0/218 (0.00%)  0/225 (0.00%)  0/209 (0.00%)  0/218 (0.00%)  0/218 (0.00%)  0/224 (0.00%) 
Campylobacter gastroenteritis * 1  0/218 (0.00%)  1/225 (0.44%)  0/218 (0.00%)  0/225 (0.00%)  0/209 (0.00%)  0/218 (0.00%)  0/218 (0.00%)  0/224 (0.00%) 
Campylobacter intestinal infection * 1  1/218 (0.46%)  0/225 (0.00%)  0/218 (0.00%)  0/225 (0.00%)  0/209 (0.00%)  0/218 (0.00%)  0/218 (0.00%)  0/224 (0.00%) 
Croup infectious * 1  1/218 (0.46%)  0/225 (0.00%)  0/218 (0.00%)  0/225 (0.00%)  0/209 (0.00%)  0/218 (0.00%)  0/218 (0.00%)  0/224 (0.00%) 
Escherichia urinary tract infection * 1  1/218 (0.46%)  0/225 (0.00%)  0/218 (0.00%)  0/225 (0.00%)  0/209 (0.00%)  0/218 (0.00%)  0/218 (0.00%)  0/224 (0.00%) 
Exanthema subitum * 1  1/218 (0.46%)  0/225 (0.00%)  0/218 (0.00%)  0/225 (0.00%)  0/209 (0.00%)  0/218 (0.00%)  0/218 (0.00%)  0/224 (0.00%) 
Gastroenteritis rotavirus * 1  0/218 (0.00%)  1/225 (0.44%)  0/218 (0.00%)  0/225 (0.00%)  0/209 (0.00%)  0/218 (0.00%)  0/218 (0.00%)  0/224 (0.00%) 
Gastrointestinal infection * 1  0/218 (0.00%)  1/225 (0.44%)  0/218 (0.00%)  0/225 (0.00%)  0/209 (0.00%)  1/218 (0.46%)  0/218 (0.00%)  0/224 (0.00%) 
Herpangina * 1  1/218 (0.46%)  0/225 (0.00%)  0/218 (0.00%)  0/225 (0.00%)  0/209 (0.00%)  0/218 (0.00%)  1/218 (0.46%)  0/224 (0.00%) 
Paronychia * 1  0/218 (0.00%)  1/225 (0.44%)  0/218 (0.00%)  0/225 (0.00%)  0/209 (0.00%)  0/218 (0.00%)  0/218 (0.00%)  0/224 (0.00%) 
Pharyngotonsillitis * 1  0/218 (0.00%)  1/225 (0.44%)  0/218 (0.00%)  0/225 (0.00%)  1/209 (0.48%)  0/218 (0.00%)  0/218 (0.00%)  0/224 (0.00%) 
Pneumonia * 1  1/218 (0.46%)  0/225 (0.00%)  0/218 (0.00%)  0/225 (0.00%)  0/209 (0.00%)  1/218 (0.46%)  0/218 (0.00%)  0/224 (0.00%) 
Respiratory tract infection viral * 1  1/218 (0.46%)  0/225 (0.00%)  0/218 (0.00%)  0/225 (0.00%)  0/209 (0.00%)  0/218 (0.00%)  0/218 (0.00%)  0/224 (0.00%) 
Roseola * 1  1/218 (0.46%)  0/225 (0.00%)  0/218 (0.00%)  0/225 (0.00%)  0/209 (0.00%)  1/218 (0.46%)  0/218 (0.00%)  0/224 (0.00%) 
Viral skin infection * 1  0/218 (0.00%)  1/225 (0.44%)  0/218 (0.00%)  0/225 (0.00%)  0/209 (0.00%)  0/218 (0.00%)  0/218 (0.00%)  0/224 (0.00%) 
Viral upper respiratory tract infection * 1  1/218 (0.46%)  0/225 (0.00%)  0/218 (0.00%)  0/225 (0.00%)  0/209 (0.00%)  0/218 (0.00%)  0/218 (0.00%)  0/224 (0.00%) 
Acarodermatitis * 1  0/218 (0.00%)  0/225 (0.00%)  0/218 (0.00%)  1/225 (0.44%)  0/209 (0.00%)  0/218 (0.00%)  0/218 (0.00%)  0/224 (0.00%) 
Injection site abscess * 1  0/218 (0.00%)  0/225 (0.00%)  1/218 (0.46%)  0/225 (0.00%)  0/209 (0.00%)  0/218 (0.00%)  0/218 (0.00%)  0/224 (0.00%) 
Oral herpes * 1  0/218 (0.00%)  0/225 (0.00%)  0/218 (0.00%)  0/225 (0.00%)  1/209 (0.48%)  1/218 (0.46%)  0/218 (0.00%)  0/224 (0.00%) 
Fungal skin infection * 1  0/218 (0.00%)  0/225 (0.00%)  0/218 (0.00%)  0/225 (0.00%)  0/209 (0.00%)  1/218 (0.46%)  0/218 (0.00%)  0/224 (0.00%) 
Lice infestation * 1  0/218 (0.00%)  0/225 (0.00%)  0/218 (0.00%)  0/225 (0.00%)  1/209 (0.48%)  0/218 (0.00%)  0/218 (0.00%)  0/224 (0.00%) 
Viral rash * 1  0/218 (0.00%)  0/225 (0.00%)  0/218 (0.00%)  0/225 (0.00%)  1/209 (0.48%)  0/218 (0.00%)  0/218 (0.00%)  0/224 (0.00%) 
Injury, poisoning and procedural complications                 
Head injury * 1  1/218 (0.46%)  1/225 (0.44%)  0/218 (0.00%)  0/225 (0.00%)  0/209 (0.00%)  1/218 (0.46%)  0/218 (0.00%)  0/224 (0.00%) 
Burns third degree * 1  1/218 (0.46%)  0/225 (0.00%)  0/218 (0.00%)  0/225 (0.00%)  0/209 (0.00%)  0/218 (0.00%)  0/218 (0.00%)  0/224 (0.00%) 
Arthropod bite * 1  0/218 (0.00%)  0/225 (0.00%)  0/218 (0.00%)  0/225 (0.00%)  2/209 (0.96%)  0/218 (0.00%)  0/218 (0.00%)  0/224 (0.00%) 
Metabolism and nutrition disorders                 
Cow's milk intolerance * 1  1/218 (0.46%)  1/225 (0.44%)  0/218 (0.00%)  1/225 (0.44%)  0/209 (0.00%)  0/218 (0.00%)  0/218 (0.00%)  0/224 (0.00%) 
Anorexia * 1  1/218 (0.46%)  0/225 (0.00%)  0/218 (0.00%)  0/225 (0.00%)  1/209 (0.48%)  0/218 (0.00%)  0/218 (0.00%)  0/224 (0.00%) 
Failure to thrive * 1  1/218 (0.46%)  0/225 (0.00%)  0/218 (0.00%)  0/225 (0.00%)  0/209 (0.00%)  0/218 (0.00%)  0/218 (0.00%)  0/224 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)                 
Benign neoplasm * 1  1/218 (0.46%)  0/225 (0.00%)  0/218 (0.00%)  0/225 (0.00%)  0/209 (0.00%)  0/218 (0.00%)  0/218 (0.00%)  0/224 (0.00%) 
Nervous system disorders                 
Somnolence * 1  1/218 (0.46%)  0/225 (0.00%)  0/218 (0.00%)  0/225 (0.00%)  0/209 (0.00%)  0/218 (0.00%)  0/218 (0.00%)  0/224 (0.00%) 
Psychiatric disorders                 
Restlessness * 1  1/218 (0.46%)  0/225 (0.00%)  0/218 (0.00%)  0/225 (0.00%)  0/209 (0.00%)  0/218 (0.00%)  0/218 (0.00%)  0/224 (0.00%) 
Respiratory, thoracic and mediastinal disorders                 
Cough * 1  4/218 (1.83%)  2/225 (0.89%)  0/218 (0.00%)  0/225 (0.00%)  1/209 (0.48%)  0/218 (0.00%)  0/218 (0.00%)  0/224 (0.00%) 
Rhinorrhoea * 1  1/218 (0.46%)  5/225 (2.22%)  0/218 (0.00%)  0/225 (0.00%)  0/209 (0.00%)  0/218 (0.00%)  0/218 (0.00%)  0/224 (0.00%) 
Wheezing * 1  3/218 (1.38%)  3/225 (1.33%)  1/218 (0.46%)  0/225 (0.00%)  0/209 (0.00%)  0/218 (0.00%)  0/218 (0.00%)  0/224 (0.00%) 
Bronchial hyperreactivity * 1  1/218 (0.46%)  1/225 (0.44%)  0/218 (0.00%)  0/225 (0.00%)  0/209 (0.00%)  0/218 (0.00%)  0/218 (0.00%)  0/224 (0.00%) 
Asphyxia * 1  1/218 (0.46%)  0/225 (0.00%)  0/218 (0.00%)  0/225 (0.00%)  0/209 (0.00%)  0/218 (0.00%)  0/218 (0.00%)  0/224 (0.00%) 
Asthma * 1  1/218 (0.46%)  0/225 (0.00%)  1/218 (0.46%)  0/225 (0.00%)  0/209 (0.00%)  0/218 (0.00%)  0/218 (0.00%)  1/224 (0.45%) 
Bronchospasm * 1  1/218 (0.46%)  0/225 (0.00%)  0/218 (0.00%)  0/225 (0.00%)  0/209 (0.00%)  0/218 (0.00%)  0/218 (0.00%)  0/224 (0.00%) 
Throat irritation * 1  1/218 (0.46%)  0/225 (0.00%)  0/218 (0.00%)  0/225 (0.00%)  0/209 (0.00%)  0/218 (0.00%)  0/218 (0.00%)  0/224 (0.00%) 
Infantile asthma * 1  0/218 (0.00%)  0/225 (0.00%)  0/218 (0.00%)  0/225 (0.00%)  0/209 (0.00%)  0/218 (0.00%)  1/218 (0.46%)  0/224 (0.00%) 
Skin and subcutaneous tissue disorders                 
Dermatitis atopic * 1  3/218 (1.38%)  3/225 (1.33%)  1/218 (0.46%)  2/225 (0.89%)  0/209 (0.00%)  0/218 (0.00%)  0/218 (0.00%)  0/224 (0.00%) 
Rash * 1  0/218 (0.00%)  6/225 (2.67%)  0/218 (0.00%)  0/225 (0.00%)  1/209 (0.48%)  0/218 (0.00%)  0/218 (0.00%)  0/224 (0.00%) 
Dermatitis * 1  3/218 (1.38%)  0/225 (0.00%)  0/218 (0.00%)  0/225 (0.00%)  0/209 (0.00%)  1/218 (0.46%)  0/218 (0.00%)  0/224 (0.00%) 
Urticaria * 1  1/218 (0.46%)  2/225 (0.89%)  0/218 (0.00%)  0/225 (0.00%)  1/209 (0.48%)  1/218 (0.46%)  0/218 (0.00%)  0/224 (0.00%) 
Angioedema * 1  0/218 (0.00%)  1/225 (0.44%)  0/218 (0.00%)  0/225 (0.00%)  0/209 (0.00%)  0/218 (0.00%)  0/218 (0.00%)  0/224 (0.00%) 
Dermatitis diaper * 1  0/218 (0.00%)  0/225 (0.00%)  0/218 (0.00%)  0/225 (0.00%)  1/209 (0.48%)  0/218 (0.00%)  0/218 (0.00%)  0/224 (0.00%) 
Petechiae * 1  0/218 (0.00%)  0/225 (0.00%)  0/218 (0.00%)  0/225 (0.00%)  1/209 (0.48%)  0/218 (0.00%)  0/218 (0.00%)  0/224 (0.00%) 
Tenderness (any)  2 [22]  199/218 (91.28%)  205/225 (91.11%)  0/0  0/0  164/209 (78.47%)  172/218 (78.90%)  0/0  0/0 
Tenderness (any)  2 [23]  182/218 (83.49%)  180/225 (80.00%)  0/0  0/0  0/0  0/0  0/0  0/0 
Tenderness (any)  2 [24]  170/218 (77.98%)  175/225 (77.78%)  0/0  0/0  0/0  0/0  0/0  0/0 
Tenderness (significant)  2 [25]  199/218 (91.28%)  200/225 (88.89%)  0/0  0/0  154/209 (73.68%)  160/218 (73.39%)  0/0  0/0 
Tenderness (significant)  2 [26]  177/218 (81.19%)  177/225 (78.67%)  0/0  0/0  0/0  0/0  0/0  0/0 
Tenderness (significant)  2 [27]  167/218 (76.61%)  169/225 (75.11%)  0/0  0/0  0/0  0/0  0/0  0/0 
Induration (any)  2 [28]  196/218 (89.91%)  200/225 (88.89%)  0/0  0/0  169/209 (80.86%)  168/218 (77.06%)  0/0  0/0 
Induration (any)  2 [29]  182/218 (83.49%)  177/225 (78.67%)  0/0  0/0  0/0  0/0  0/0  0/0 
Induration (any)  2 [30]  171/218 (78.44%)  170/225 (75.56%)  0/0  0/0  0/0  0/0  0/0  0/0 
Induration (mild)  2 [31]  196/218 (89.91%)  200/225 (88.89%)  0/0  0/0  166/209 (79.43%)  163/218 (74.77%)  0/0  0/0 
Induration (mild)  2 [32]  182/218 (83.49%)  177/225 (78.67%)  0/0  0/0  0/0  0/0  0/0  0/0 
Induration (mild)  2 [33]  171/218 (78.44%)  170/225 (75.56%)  0/0  0/0  0/0  0/0  0/0  0/0 
Induration (moderate)  2 [34]  196/218 (89.91%)  196/225 (87.11%)  0/0  0/0  156/209 (74.64%)  163/218 (74.77%)  0/0  0/0 
Induration (moderate)  2 [35]  177/218 (81.19%)  175/225 (77.78%)  0/0  0/0  0/0  0/0  0/0  0/0 
Induration (moderate)  2 [36]  166/218 (76.15%)  168/225 (74.67%)  0/0  0/0  0/0  0/0  0/0  0/0 
Induration (severe)  2 [37]  196/218 (89.91%)  196/225 (87.11%)  0/0  0/0  152/209 (72.73%)  156/218 (71.56%)  0/0  0/0 
Induration (severe)  2 [38]  177/218 (81.19%)  175/225 (77.78%)  0/0  0/0  0/0  0/0  0/0  0/0 
Induration (severe)  2 [39]  166/218 (76.15%)  168/225 (74.67%)  0/0  0/0  0/0  0/0  0/0  0/0 
Erythema (any)  2 [40]  197/218 (90.37%)  199/225 (88.44%)  0/0  0/0  170/209 (81.34%)  169/218 (77.52%)  0/0  0/0 
Erythema (any)  2 [41]  181/218 (83.03%)  180/225 (80.00%)  0/0  0/0  0/0  0/0  0/0  0/0 
Erythema (any)  2 [42]  172/218 (78.90%)  172/225 (76.44%)  0/0  0/0  0/0  0/0  0/0  0/0 
Erythema (mild)  2 [43]  197/218 (90.37%)  198/225 (88.00%)  0/0  0/0  167/209 (79.90%)  165/218 (75.69%)  0/0  0/0 
Erythema (mild)  2 [44]  180/218 (82.57%)  180/225 (80.00%)  0/0  0/0  0/0  0/0  0/0  0/0 
Erythema (mild)  2 [45]  172/218 (78.90%)  171/225 (76.00%)  0/0  0/0  0/0  0/0  0/0  0/0 
Erythema (moderate)  2 [46]  196/218 (89.91%)  197/225 (87.56%)  0/0  0/0  157/209 (75.12%)  163/218 (74.77%)  0/0  0/0 
Erythema (moderate)  2 [47]  178/218 (81.65%)  175/225 (77.78%)  0/0  0/0  0/0  0/0  0/0  0/0 
Erythema (moderate)  2 [48]  166/218 (76.15%)  169/225 (75.11%)  0/0  0/0  0/0  0/0  0/0  0/0 
Erythema (severe)  2 [49]  196/218 (89.91%)  196/225 (87.11%)  0/0  0/0  152/209 (72.73%)  156/218 (71.56%)  0/0  0/0 
Erythema (severe)  2 [50]  177/218 (81.19%)  175/225 (77.78%)  0/0  0/0  0/0  0/0  0/0  0/0 
Erythema (severe)  2 [51]  166/218 (76.15%)  168/225 (74.67%)  0/0  0/0  0/0  0/0  0/0  0/0 
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA
2
Term from vocabulary, Local Reactions
3
Term from vocabulary, Systemic Events
[1]
Infant Series Dose 1 and Toddler Dose; Fever ≥38°C but ≤39°C
[2]
Infant Series Dose 2; Fever ≥38°C but ≤39°C
[3]
Infant Series Dose 3; Fever ≥38°C but ≤39°C
[4]
Infant Series Dose 1 and Toddler Dose; Fever >39°C but ≤40°C
[5]
Infant Series Dose 2; Fever >39°C but ≤40°C
[6]
Infant Series Dose 3; Fever >39°C but ≤40°C
[7]
Infant Series Dose 1 and Toddler Dose; Fever >40°C
[8]
Infant Series Dose 2; Fever >40°C
[9]
Infant Series Dose 3; Fever >40°C
[10]
Infant Series Dose 1 and Toddler Dose; Decreased appetite
[11]
Infant Series Dose 2; Decreased appetite
[12]
Infant Series Dose 3; Decreased appetite
[13]
Infant Series Dose 1 and Toddler Dose; Irritability
[14]
Infant Series Dose 2; Irritability
[15]
Infant Series Dose 3; Irritability
[16]
Infant Series Dose 1 and Toddler Dose; Increased sleep
[17]
Infant Series Dose 2; Increased sleep
[18]
Infant Series Dose 3; Increased sleep
[19]
Infant Series Dose 1 and Toddler Dose; Decreased sleep
[20]
Infant Series Dose 2; Decreased sleep
[21]
Infant Series Dose 3; Decreased sleep
[22]
Infant Series Dose 1 and Toddler Dose; Tenderness (any)=present at site of vaccination.
[23]
Infant Series Dose 2; Tenderness (any)
[24]
Infant Series Dose 3; Tenderness (any)
[25]
Infant Series Dose 1 and Toddler Dose; Tenderness (significant)=present and interfered with limb movement.
[26]
Infant Series Dose 2; Tenderness (significant)
[27]
Infant Series Dose 3; Tenderness (significant)
[28]
Infant Series Dose 1 and Toddler Dose;Induration (any)=present at site of vaccination.
[29]
Infant Series Dose 2; Induration (any)
[30]
Infant Series Dose 3; Induration (any)
[31]
Infant Series Dose 1 and Toddler Dose; Induration (mild)=0.5 centimeters (cm) to 2.0 cm.
[32]
Infant Series Dose 2; Induration (mild)
[33]
Infant Series Dose 3; Induration (mild)
[34]
Infant Series Dose 1 and Toddler Dose; Induration (moderate)=2.5 cm to 7.0 cm.
[35]
Infant Series Dose 2; Induration (moderate)
[36]
Infant Series Dose 3; Induration (moderate)
[37]
Infant Series Dose 1 and Toddler Dose; Induration (severe) >7.0 cm.
[38]
Infant Series Dose 2; Induration (severe)
[39]
Infant Series Dose 3; Induration (severe)
[40]
Infant Series Dose 1 and Toddler Dose; Erythema (any)=present at site of vaccination.
[41]
Infant Series Dose 2; Erythema (any)
[42]
Infant Series Dose 3; Erythema (any)
[43]
Infant Series Dose 1 and Toddler Dose; Erythema (mild)=0.5 centimeters (cm) to 2.0 cm.
[44]
Infant Series Dose 2; Erythema (mild)
[45]
Infant Series Dose 3; Erythema (mild)
[46]
Infant Series Dose 1 and Toddler Dose; Erythema (moderate)=2.5 cm to 7.0 cm.
[47]
Infant Series Dose 2; Erythema (moderate)
[48]
Infant Series Dose 3; Erythema (moderate)
[49]
Infant Series Dose 1 and Toddler Dose; Erythema (severe) >7.0 cm.
[50]
Infant Series Dose 2; Erythema (severe)
[51]
Infant Series Dose 3; Erythema (severe)
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.
The PIs agreed to allow the sponsor 60 days to review and require changes to presentations or publications but only to protect confidential information and intellectual property, and for the sponsor to file a patent application, as applicable. The PIs also agreed for data to be presented first as a joint, multi-center publication.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: U. S. Contact Center
Organization: Wyeth
EMail: clintrialresults@wyeth.com
Layout table for additonal information
Responsible Party: Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier: NCT00474539    
Other Study ID Numbers: 6096A1-3007
First Submitted: May 15, 2007
First Posted: May 17, 2007
Results First Submitted: March 26, 2010
Results First Posted: March 5, 2013
Last Update Posted: March 5, 2013