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Trial record 1 of 1 for:    NCT00366548
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Study to Evaluate a 13-valent Pneumococcal Conjugate Vaccine in Infants

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ClinicalTrials.gov Identifier: NCT00366548
Recruitment Status : Completed
First Posted : August 21, 2006
Results First Posted : August 15, 2012
Last Update Posted : August 15, 2012
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: Double;   Primary Purpose: Prevention
Condition Vaccines, Pneumococcal
Interventions Biological: 13 valent pneumococcal conjugate vaccine with Polysorbate 80
Biological: 13 valent pneumococcal conjugate vaccine without Polysorbate 80
Enrollment 500
Recruitment Details Participants were recruited in Poland from November 2006 to December 2006.
Pre-assignment Details Participants were enrolled into the study according to inclusion/exclusion criteria without a screening period.
Arm/Group Title 13vPnC With (+) Polysorbate 80 13vPnC Without (-) Polysorbate 80
Hide Arm/Group Description Participants received one single 0.5mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) with (+) P80 coadministered with combination vaccine containing diphtheria, tetanus, acellular pertussis, inactivated poliovirus, and conjugated Hib antigens (Pentaxim) and hepatitis B recombinant vaccine adsorbed (Engerix-B) at approximately 2 months of age, Pentaxim at approximately 3 months and 4 months of age (infant series), and combined vaccine containing attenuated measles, mumps, and rubella viruses (Priorix) at 12 months of age (toddler dose). Participants received one single 0.5mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) without (-) P80 coadministered with combination vaccine containing diphtheria, tetanus, acellular pertussis, inactivated poliovirus, and conjugated Hib antigens (Pentaxim) and hepatitis B recombinant vaccine adsorbed (Engerix-B) at approximately 2 months of age, Pentaxim at approximately 3 months and 4 months of age (infant series), and combined vaccine containing attenuated measles, mumps, and rubella viruses (Priorix) at 12 months of age (toddler dose).
Period Title: Infant Series
Started 250 250
Vaccinated Dose 1 250 250
Vaccinated Dose 2 246 249
Vaccinated Dose 3 246 247
Completed 246 245
Not Completed 4 5
Reason Not Completed
Adverse Event             1             3
Protocol Violation             0             1
Withdrawal by Subject             3             1
Period Title: After Infant Series
Started 246 245
Completed 240 244
Not Completed 6 1
Reason Not Completed
Withdrawal by Subject             3             1
Adverse Event             2             0
Lost to Follow-up             1             0
Period Title: Toddler Dose
Started 240 244
Completed 240 244
Not Completed 0 0
Arm/Group Title 13vPnC With (+) Polysorbate 80 13vPnC Without (-) Polysorbate 80 Total
Hide Arm/Group Description Participants received one single 0.5mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) with (+) P80 coadministered with combination vaccine containing diphtheria, tetanus, acellular pertussis, inactivated poliovirus, and conjugated Hib antigens (Pentaxim) and hepatitis B recombinant vaccine adsorbed (Engerix-B) at approximately 2 months of age, Pentaxim at approximately 3 months and 4 months of age (infant series), and combined vaccine containing attenuated measles, mumps, and rubella viruses (Priorix) at 12 months of age (toddler dose). Participants received one single 0.5mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) without (-) P80 coadministered with combination vaccine containing diphtheria, tetanus, acellular pertussis, inactivated poliovirus, and conjugated Hib antigens (Pentaxim) and hepatitis B recombinant vaccine adsorbed (Engerix-B) at approximately 2 months of age, Pentaxim at approximately 3 months and 4 months of age (infant series), and combined vaccine containing attenuated measles, mumps, and rubella viruses (Priorix) at 12 months of age (toddler dose). Total of all reporting groups
Overall Number of Baseline Participants 250 250 500
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Months
Number Analyzed 250 participants 250 participants 500 participants
2.1  (0.5) 2.1  (0.5) 2.1  (0.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 250 participants 250 participants 500 participants
Female
122
  48.8%
122
  48.8%
244
  48.8%
Male
128
  51.2%
128
  51.2%
256
  51.2%
1.Primary Outcome
Title Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC+P80 Group Relative to 13vPnC-80 Group After the Infant Series
Hide Description Percentages of participants achieving World Health Organization (WHO) predefined antibody threshold ≥0.35μg/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 3-dose infant series (at 5 months of age)
Hide Outcome Measure Data
Hide Analysis Population Description
Evaluable immunogenicity population 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 serotype.
Arm/Group Title 13vPnC + Polysorbate 80 After the Infant Series 13vPnC - Polysorbate 80 After the Infant Series
Hide Arm/Group Description:
Participants received one single 0.5mL dose of 13vPnC + P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 and 4 months age (infant doses), and Priorix at 12 months of age (toddler dose).
Participants received one single 0.5mL dose of 13vPnC - P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 and 4 months age (infant doses), and Priorix at 12 months of age (toddler dose).
Overall Number of Participants Analyzed 238 238
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Common Serotypes - Serotype 4 (n=222,224)
93.3
(89.3 to 96.1)
94.1
(90.3 to 96.7)
Common Serotypes - Serotype 6B (n=145,158)
60.9
(54.4 to 67.2)
66.4
(60.0 to 72.4)
Common Serotypes - Serotype 9V (n=231,232)
97.1
(94.0 to 98.8)
97.5
(94.6 to 99.1)
Common Serotypes - Serotype 14 (n=225,232)
94.5
(90.8 to 97.1)
97.5
(94.6 to 99.1)
Common Serotypes - Serotype 18C (n=233,233)
97.9
(95.2 to 99.3)
97.9
(95.2 to 99.3)
Common Serotypes - Serotype 19F (n=228,234)
95.8
(92.4 to 98.0)
98.3
(95.8 to 99.5)
Common Serotypes - Serotype 23F (n=205,220)
86.1
(81.1 to 90.3)
92.4
(88.3 to 95.5)
Additional Serotypes - Serotype 1 (n=228,220)
95.8
(92.4 to 98.0)
92.4
(88.3 to 95.5)
Additional Serotypes - Serotype 3 (n=233,236)
97.9
(95.2 to 99.3)
99.2
(97.0 to 99.9)
Additional Serotypes - Serotype 5 (n=224,220)
94.1
(90.3 to 96.7)
92.4
(88.3 to 95.5)
Additional Serotypes - Serotype 6A (n=206,205)
86.6
(81.6 to 90.6)
86.1
(81.1 to 90.3)
Additional Serotypes - Serotype 7F (n=235,237)
98.7
(96.4 to 99.7)
99.6
(97.7 to 100.0)
Additional Serotypes - Serotype 19A (n=235,238)
98.7
(96.4 to 99.7)
100.0
(98.5 to 100.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 13vPnC + Polysorbate 80 After the Infant Series, 13vPnC - Polysorbate 80 After the Infant Series
Comments For serotype 4 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups > -10%.
Method of Estimation Estimation Parameter Difference
Estimated Value -0.8
Confidence Interval 95%
-5.4 to 3.7
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 13vPnC + Polysorbate 80 After the Infant Series, 13vPnC - Polysorbate 80 After the Infant Series
Comments For serotype 6B the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups > -10%.
Method of Estimation Estimation Parameter Difference
Estimated Value -5.5
Confidence Interval 95%
-14.2 to 3.3
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 13vPnC + Polysorbate 80 After the Infant Series, 13vPnC - Polysorbate 80 After the Infant Series
Comments For serotype 9V the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups > -10%.
Method of Estimation Estimation Parameter Difference
Estimated Value -0.4
Confidence Interval 95%
-3.7 to 2.8
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection 13vPnC + Polysorbate 80 After the Infant Series, 13vPnC - Polysorbate 80 After the Infant Series
Comments For serotype 14 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups > -10%.
Method of Estimation Estimation Parameter Difference
Estimated Value -2.9
Confidence Interval 95%
-6.9 to 0.7
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection 13vPnC + Polysorbate 80 After the Infant Series, 13vPnC - Polysorbate 80 After the Infant Series
Comments For serotype 18C the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups > -10%.
Method of Estimation Estimation Parameter Difference
Estimated Value 0.0
Confidence Interval 95%
-3.0 to 3.0
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection 13vPnC + Polysorbate 80 After the Infant Series, 13vPnC - Polysorbate 80 After the Infant Series
Comments For serotype 19F the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups > -10%.
Method of Estimation Estimation Parameter Difference
Estimated Value -2.5
Confidence Interval 95%
-6.1 to 0.6
Estimation Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection 13vPnC + Polysorbate 80 After the Infant Series, 13vPnC - Polysorbate 80 After the Infant Series
Comments For serotype 23F the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups > -10%.
Method of Estimation Estimation Parameter Difference
Estimated Value -6.3
Confidence Interval 95%
-12.1 to -0.7
Estimation Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection 13vPnC + Polysorbate 80 After the Infant Series, 13vPnC - Polysorbate 80 After the Infant Series
Comments For serotype 1 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups > -10%.
Method of Estimation Estimation Parameter Difference
Estimated Value 3.4
Confidence Interval 95%
-0.9 to 7.9
Estimation Comments [Not Specified]
Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection 13vPnC - Polysorbate 80 After the Infant Series
Comments For serotype 3 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups > -10%.
Method of Estimation Estimation Parameter Difference
Estimated Value -1.3
Confidence Interval 95%
-4.1 to 1.1
Estimation Comments [Not Specified]
Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection 13vPnC + Polysorbate 80 After the Infant Series, 13vPnC - Polysorbate 80 After the Infant Series
Comments For serotype 5 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups > -10%.
Method of Estimation Estimation Parameter Difference
Estimated Value 1.7
Confidence Interval 95%
-3.0 to 6.4
Estimation Comments [Not Specified]
Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection 13vPnC + Polysorbate 80 After the Infant Series, 13vPnC - Polysorbate 80 After the Infant Series
Comments For serotype 6A the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups > -10%.
Method of Estimation Estimation Parameter Difference
Estimated Value 0.4
Confidence Interval 95%
-5.8 to 6.7
Estimation Comments [Not Specified]
Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection 13vPnC + Polysorbate 80 After the Infant Series, 13vPnC - Polysorbate 80 After the Infant Series
Comments For serotype 7F the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups > -10%.
Method of Estimation Estimation Parameter Difference
Estimated Value -0.8
Confidence Interval 95%
-3.2 to 1.2
Estimation Comments [Not Specified]
Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection 13vPnC + Polysorbate 80 After the Infant Series, 13vPnC - Polysorbate 80 After the Infant Series
Comments For serotype 19A the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups > -10%.
Method of Estimation Estimation Parameter Difference
Estimated Value -1.3
Confidence Interval 95%
-3.6 to 0.3
Estimation Comments [Not Specified]
2.Primary Outcome
Title Geometric Mean Antibody Concentration (GMC) in 13vPnC+P80 Group Relative to 13vPnC-P80 Group After the 3-Dose Infant Series
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.
Time Frame One month after 3-dose infant series (at 5 months of age)
Hide Outcome Measure Data
Hide Analysis Population Description
Evaluable immunogenicity population had valid and determinate assay results, and had no other major protocol violations, (n) = number of participants with a determinate antibody concentration for the specified serotype.
Arm/Group Title 13vPnC + Polysorbate 80 After the Infant Series 13vPnC - Polysorbate 80 After the Infant Series
Hide Arm/Group Description:
Participants received one single 0.5mL dose of 13vPnC + P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 and 4 months age (infant doses), and Priorix at 12 months of age (toddler dose).
Participants received one single 0.5mL dose of 13vPnC - P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 and 4 months age (infant doses), and Priorix at 12 months of age (toddler dose).
Overall Number of Participants Analyzed 238 238
Geometric Mean (95% Confidence Interval)
Unit of Measure: μg/mL
Common Serotypes - Serotype 4
1.47
(1.30 to 1.65)
1.53
(1.36 to 1.72)
Common Serotypes - Serotype 6B
0.51
(0.44 to 0.60)
0.57
(0.48 to 0.68)
Common Serotypes - Serotype 9V
1.46
(1.34 to 1.60)
1.51
(1.38 to 1.65)
Common Serotypes - Serotype 14
2.37
(2.06 to 2.73)
2.48
(2.20 to 2.80)
Common Serotypes - Serotype 18C
1.84
(1.67 to 2.03)
1.87
(1.71 to 2.04)
Common Serotypes - Serotype 19F
1.46
(1.30 to 1.65)
1.75
(1.60 to 1.91)
Common Serotypes - Serotype 23F
0.93
(0.83 to 1.05)
1.11
(1.00 to 1.24)
Additional Serotypes - Serotype 1
1.39
(1.26 to 1.55)
1.48
(1.32 to 1.66)
Additional Serotypes - Serotype 3
1.50
(1.38 to 1.63)
1.62
(1.49 to 1.75)
Additional Serotypes - Serotype 5
1.26
(1.13 to 1.40)
1.30
(1.16 to 1.44)
Additional Serotypes - Serotype 6A
0.99
(0.88 to 1.12)
1.04
(0.92 to 1.17)
Additional Serotypes - Serotype 7F
1.98
(1.81 to 2.15)
1.89
(1.73 to 2.06)
Additional Serotypes - Serotype 19A
2.68
(2.44 to 2.95)
2.94
(2.69 to 3.21)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 13vPnC + Polysorbate 80 After the Infant Series, 13vPnC - Polysorbate 80 After the Infant Series
Comments For serotype 4 the GMC ratio (13vPnC/7vPnC) was calculated
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) > 0.5 (2-fold criterion).
Method of Estimation Estimation Parameter Difference
Estimated Value 0.96
Confidence Interval 95%
0.81 to 1.13
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 13vPnC + Polysorbate 80 After the Infant Series, 13vPnC - Polysorbate 80 After the Infant Series
Comments For serotype 6B the GMC ratio (13vPnC/7vPnC) was calculated
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) > 0.5 (2-fold criterion).
Method of Estimation Estimation Parameter Difference
Estimated Value 0.90
Confidence Interval 95%
0.72 to 1.14
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 13vPnC + Polysorbate 80 After the Infant Series, 13vPnC - Polysorbate 80 After the Infant Series
Comments For serotype 9V the GMC ratio (13vPnC/7vPnC) was calculated
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) > 0.5 (2-fold criterion).
Method of Estimation Estimation Parameter Difference
Estimated Value 0.97
Confidence Interval 95%
0.85 to 1.10
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection 13vPnC + Polysorbate 80 After the Infant Series
Comments For serotype 14 the GMC ratio (13vPnC/7vPnC) was calculated
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) > 0.5 (2-fold criterion).
Method of Estimation Estimation Parameter Difference
Estimated Value 0.96
Confidence Interval 95%
0.79 to 1.15
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection 13vPnC + Polysorbate 80 After the Infant Series, 13vPnC - Polysorbate 80 After the Infant Series
Comments For serotype 18C the GMC ratio (13vPnC/7vPnC) was calculated
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) > 0.5 (2-fold criterion).
Method of Estimation Estimation Parameter Difference
Estimated Value 0.98
Confidence Interval 95%
0.86 to 1.13
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection 13vPnC + Polysorbate 80 After the Infant Series, 13vPnC - Polysorbate 80 After the Infant Series
Comments For serotype 19F the GMC ratio (13vPnC/7vPnC) was calculated
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) > 0.5 (2-fold criterion).
Method of Estimation Estimation Parameter Difference
Estimated Value 0.84
Confidence Interval 95%
0.72 to 0.97
Estimation Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection 13vPnC + Polysorbate 80 After the Infant Series, 13vPnC - Polysorbate 80 After the Infant Series
Comments For serotype 23F the GMC ratio (13vPnC/7vPnC) was calculated
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) > 0.5 (2-fold criterion).
Method of Estimation Estimation Parameter Difference
Estimated Value 0.84
Confidence Interval 95%
0.71 to 0.98
Estimation Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection 13vPnC + Polysorbate 80 After the Infant Series, 13vPnC - Polysorbate 80 After the Infant Series
Comments For serotype 1 the GMC ratio (13vPnC/7vPnC) was calculated
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) > 0.5 (2-fold criterion).
Method of Estimation Estimation Parameter Difference
Estimated Value 0.94
Confidence Interval 95%
0.81 to 1.10
Estimation Comments [Not Specified]
Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection 13vPnC + Polysorbate 80 After the Infant Series, 13vPnC - Polysorbate 80 After the Infant Series
Comments For serotype 3 the GMC ratio (13vPnC/7vPnC) was calculated
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) > 0.5 (2-fold criterion).
Method of Estimation Estimation Parameter Difference
Estimated Value 0.93
Confidence Interval 95%
0.83 to 1.04
Estimation Comments [Not Specified]
Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection 13vPnC + Polysorbate 80 After the Infant Series, 13vPnC - Polysorbate 80 After the Infant Series
Comments For serotype 5 the GMC ratio (13vPnC/7vPnC) was calculated
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) > 0.5 (2-fold criterion).
Method of Estimation Estimation Parameter Difference
Estimated Value 0.97
Confidence Interval 95%
0.83 to 1.13
Estimation Comments [Not Specified]
Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection 13vPnC + Polysorbate 80 After the Infant Series, 13vPnC - Polysorbate 80 After the Infant Series
Comments For serotype 6A the GMC ratio (13vPnC/7vPnC) was calculated
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) > 0.5 (2-fold criterion).
Method of Estimation Estimation Parameter Difference
Estimated Value 0.96
Confidence Interval 95%
0.81 to 1.13
Estimation Comments [Not Specified]
Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection 13vPnC + Polysorbate 80 After the Infant Series, 13vPnC - Polysorbate 80 After the Infant Series
Comments For serotype 7F the GMC ratio (13vPnC/7vPnC) was calculated
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) > 0.5 (2-fold criterion).
Method of Estimation Estimation Parameter Difference
Estimated Value 1.05
Confidence Interval 95%
0.93 to 1.18
Estimation Comments [Not Specified]
Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection 13vPnC + Polysorbate 80 After the Infant Series, 13vPnC - Polysorbate 80 After the Infant Series
Comments For serotype 19A the GMC ratio (13vPnC/7vPnC) was calculated
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) > 0.5 (2-fold criterion).
Method of Estimation Estimation Parameter Difference
Estimated Value 0.91
Confidence Interval 95%
0.80 to 1.04
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Percentage of Participants Achieving Antibody Level ≥ 0.35 μg/mL in the 13vPnC Group 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 the toddler dose (at 13 months of age)
Hide Outcome Measure Data
Hide Analysis Population Description
Evaluable immunogenicity population 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 serotype.
Arm/Group Title 13vPnC + Polysorbate 80 After Toddler Dose 13vPnC - Polysorbate 80 After Toddler Dose
Hide Arm/Group Description:
Participants received one single 0.5mL dose of 13vPnC + P80 coadministered with Pentaxim and Engerix-B at approximately 2 months of age, Pentaxim at approximately 3 months and 4 months of age (infant doses), and Priorix at 12 months of age (toddler dose).
Participants received one single 0.5mL dose of 13vPnC - P80 coadministered with Pentaxim and Engerix-B at the 2 month visit, Pentaxim at the 3 and 4 month visits, and Priorix at 12 months of age (toddler dose).
Overall Number of Participants Analyzed 227 238
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Common Serotypes - Serotype 4 (n=226,238)
99.6
(97.6 to 100.0)
99.6
(97.7 to 100.0)
Common Serotypes - Serotype 6B (n=225,237)
99.6
(97.5 to 100.0)
99.2
(97.0 to 99.9)
Common Serotypes - Serotype 9V (n=226,238)
99.6
(97.6 to 100.0)
100.0
(98.5 to 100.0)
Common Serotypes - Serotype 14 (n=226,238)
99.6
(97.6 to 100.0)
99.6
(97.7 to 100.0)
Common Serotypes - Serotype 18C (n=226,238)
100.0
(98.4 to 100.0)
99.6
(97.7 to 100.0)
Common Serotypes - Serotype 19F (n=226,237)
99.1
(96.8 to 99.9)
98.7
(96.3 to 99.7)
Common Serotypes - Serotype 23F (n=226,238)
98.7
(96.2 to 99.7)
99.6
(97.7 to 100.0)
Additional Serotypes - Serotype 1 (n=226,238)
100.0
(98.4 to 100.0)
99.2
(97.0 to 99.9)
Additional Serotypes - Serotype 3 (n=223,236)
95.1
(91.3 to 97.5)
94.5
(90.8 to 97.0)
Additional Serotypes - Serotype 5 (n=226,238)
99.6
(97.6 to 100.0)
100.0
(98.5 to 100.0)
Additional Serotypes - Serotype 6A (n=226,237)
99.6
(97.6 to 100.0)
100.0
(98.5 to 100.0)
Additional Serotypes - Serotype 7F (n=226,238)
100.0
(98.4 to 100.0)
100.0
(98.5 to 100.0)
Additional Serotypes - Serotype 19A (n=226,238)
100.0
(98.4 to 100.0)
100.0
(98.5 to 100.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 13vPnC + Polysorbate 80 After Toddler Dose, 13vPnC - Polysorbate 80 After Toddler Dose
Comments For serotype 4 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups > -10%.
Method of Estimation Estimation Parameter Difference
Estimated Value -0.0
Confidence Interval 95%
-2.1 to 1.9
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 13vPnC + Polysorbate 80 After Toddler Dose, 13vPnC - Polysorbate 80 After Toddler Dose
Comments For serotype 6B the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups > -10%.
Method of Estimation Estimation Parameter Difference
Estimated Value 0.4
Confidence Interval 95%
-1.7 to 2.6
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 13vPnC + Polysorbate 80 After Toddler Dose, 13vPnC - Polysorbate 80 After Toddler Dose
Comments For serotype 9V the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups > -10%.
Method of Estimation Estimation Parameter Difference
Estimated Value -0.4
Confidence Interval 95%
-2.4 to 1.1
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection 13vPnC + Polysorbate 80 After Toddler Dose, 13vPnC - Polysorbate 80 After Toddler Dose
Comments For serotype 14 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups > -10%.
Method of Estimation Estimation Parameter Difference
Estimated Value -0.0
Confidence Interval 95%
-2.1 to 1.9
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection 13vPnC + Polysorbate 80 After Toddler Dose, 13vPnC - Polysorbate 80 After Toddler Dose
Comments For serotype 18C the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups > -10%.
Method of Estimation Estimation Parameter Difference
Estimated Value 0.4
Confidence Interval 95%
-1.2 to 2.3
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection 13vPnC + Polysorbate 80 After Toddler Dose, 13vPnC - Polysorbate 80 After Toddler Dose
Comments For serotype 19F the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups > -10%.
Method of Estimation Estimation Parameter Difference
Estimated Value 0.4
Confidence Interval 95%
-2.0 to 2.9
Estimation Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection 13vPnC + Polysorbate 80 After Toddler Dose, 13vPnC - Polysorbate 80 After Toddler Dose
Comments For serotype 23F the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups > -10%.
Method of Estimation Estimation Parameter Difference
Estimated Value -0.9
Confidence Interval 95%
-3.4 to 1.1
Estimation Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection 13vPnC + Polysorbate 80 After Toddler Dose, 13vPnC - Polysorbate 80 After Toddler Dose
Comments For serotype 1 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups > -10%.
Method of Estimation Estimation Parameter Difference
Estimated Value 0.8
Confidence Interval 95%
-0.8 to 3.0
Estimation Comments [Not Specified]
Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection 13vPnC + Polysorbate 80 After Toddler Dose, 13vPnC - Polysorbate 80 After Toddler Dose
Comments For serotype 3 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups > -10%.
Method of Estimation Estimation Parameter Difference
Estimated Value 0.6
Confidence Interval 95%
-3.7 to 4.9
Estimation Comments [Not Specified]
Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection 13vPnC + Polysorbate 80 After Toddler Dose, 13vPnC - Polysorbate 80 After Toddler Dose
Comments For serotype 5 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups > -10%.
Method of Estimation Estimation Parameter Difference
Estimated Value -0.4
Confidence Interval 95%
-2.4 to 1.1
Estimation Comments [Not Specified]
Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection 13vPnC + Polysorbate 80 After Toddler Dose, 13vPnC - Polysorbate 80 After Toddler Dose
Comments For serotype 6A the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups > -10%.
Method of Estimation Estimation Parameter Difference
Estimated Value -0.4
Confidence Interval 95%
-2.4 to 1.2
Estimation Comments [Not Specified]
Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection 13vPnC + Polysorbate 80 After Toddler Dose, 13vPnC - Polysorbate 80 After Toddler Dose
Comments For serotype 7F the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups > -10%.
Method of Estimation Estimation Parameter Difference
Estimated Value 0.0
Confidence Interval 95%
-1.7 to 1.6
Estimation Comments [Not Specified]
Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection 13vPnC + Polysorbate 80 After Toddler Dose, 13vPnC - Polysorbate 80 After Toddler Dose
Comments For serotype 19A the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups > -10%.
Method of Estimation Estimation Parameter Difference
Estimated Value 0.0
Confidence Interval 95%
-1.7 to 1.6
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Geometric Mean Antibody Concentration (GMC) in 13vPnC Group Relative 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.
Time Frame one month after the toddler dose (at 13 months of age)
Hide Outcome Measure Data
Hide Analysis Population Description
Evaluable immunogenicity population had valid and determinate assay results, and had no other major protocol violations, (n) = number of participants with a determinate IgG antibody concentration for the specified serotype.
Arm/Group Title 13vPnC + Polysorbate 80 After Toddler Dose 13vPnC - Polysorbate 80 After Toddler Dose
Hide Arm/Group Description:
Participants received one single 0.5mL dose of 13vPnC + P80 coadministered with Pentaxim and Engerix-B at approximately 2 months of age, Pentaxim at approximately 3 months and 4 months of age (infant doses), and Priorix at 12 months of age (toddler dose).
Participants received one single 0.5mL dose of 13vPnC - P80 coadministered with Pentaxim and Engerix-B at the 2 month visit, Pentaxim at the 3 and 4 month visits, and Priorix at 12 months of age (toddler dose).
Overall Number of Participants Analyzed 227 238
Geometric Mean (95% Confidence Interval)
Unit of Measure: μg/mL
Common Serotypes - Serotype 4 (n=226,238)
5.25
(4.65 to 5.92)
5.38
(4.78 to 6.07)
Common Serotypes - Serotype 6B (n=221,228)
9.89
(8.70 to 11.23)
10.65
(9.40 to 12.06)
Common Serotypes - Serotype 9V (n=226,238)
3.01
(2.73 to 3.31)
3.10
(2.80 to 3.42)
Common Serotypes - Serotype 14 (n=224,238)
11.72
(10.26 to 13.40)
11.95
(10.42 to 13.71)
Common Serotypes - Serotype 18C (n=226,238)
3.40
(3.06 to 3.78)
3.10
(2.79 to 3.45)
Common Serotypes - Serotype 19F (n=223,236)
9.63
(8.45 to 10.97)
10.27
(8.99 to 11.73)
Common Serotypes - Serotype 23F (n=223,236)
3.88
(3.44 to 4.38)
4.15
(3.73 to 4.62)
Additional Serotypes - Serotype 1 (n=226,238)
6.03
(5.36 to 6.78)
6.11
(5.43 to 6.87)
Additional Serotypes - Serotype 3 (n=213,226)
1.09
(0.99 to 1.20)
1.16
(1.05 to 1.29)
Additional Serotypes - Serotype 5 (n=225,234)
3.80
(3.41 to 4.23)
3.98
(3.59 to 4.41)
Additional Serotypes - Serotype 6A (n=224,236)
7.48
(6.66 to 8.40)
8.19
(7.38 to 9.09)
Additional Serotypes - Serotype 7F (n=226,238)
5.36
(4.89 to 5.88)
4.95
(4.50 to 5.44)
Additional Serotypes - Serotype 19A (n=224,236)
13.20
(11.88 to 14.67)
13.02
(11.88 to 14.27)
5.Other Pre-specified Outcome
Title Percent 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 (>7.0 cm). Participants may be represented in more than 1 category.
Time Frame Within 4-days after each dose
Hide Outcome Measure Data
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 + P80 Dose 1 Infant Series 13vPnC - P 80 Dose 1 Infant Series 13vPnC + P80 Dose 2 Infant Series 13vPnC - P80 Dose 2 Infant Series 13vPnC + P80 Dose 3 Infant Series 13vPnC - P80 Dose 3 Infant Series 13vPnC + P80 Toddler Dose 13vPnC - P80 Toddler Dose
Hide Arm/Group Description:
Participants received one single 0.5mL dose of 13vPnC + P80 coadministered with Pentaxim and Engerix-B at 2 months of age(infant series, Dose 1).
Participants received one single 0.5mL dose of 13vPnC - P80 coadministered with Pentaxim and Engerix-B at 2 months of age (infant series, Dose 1).
Participants received one single 0.5mL dose of 13vPnC + P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 months age (infant series, Dose 2).
Participants received one single 0.5mL dose of 13vPnC - P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 months age (infant series, Dose 2).
Participants received one single 0.5mL dose of 13vPnC + P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 and 4 months age (infant series, Dose 3).
Participants received one single 0.5mL dose of 13vPnC - P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 and 4 months age (infant series, Dose 3).
Participants received one single 0.5mL dose of 13vPnC + P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 and 4 months age (infant series), and Priorix at 12 months of age (toddler dose).
Participants received one single 0.5mL dose of 13vPnC - P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 and 4 months age (infant series), and Priorix at 12 months of age (toddler dose).
Overall Number of Participants Analyzed 250 250 246 249 246 247 240 244
Measure Type: Number
Unit of Measure: Percentage of Participants
Tenderness-Any (n=238,237,228,229,210,216,178,188) 27.7 32.9 26.8 32.8 24.8 23.1 42.1 43.1
Tenderness-Sig (n=235,233,220,221,203,211,160,165) 2.1 4.3 0.9 0.5 1.5 1.9 2.5 1.2
Swelling-Any (n=236,239,228,228,210,225,174,181) 22.9 30.5 25.0 36.4 36.7 38.2 29.9 34.8
Swelling-Mild (n=236,236,227,226,209,221,169,178) 18.2 24.2 20.3 31.9 32.5 33.5 26.6 29.8
Swelling-Mod (n=236,236,224,224,208,217,164,171) 11.9 14.4 11.2 14.3 13.9 17.5 12.2 19.9
Swelling-Severe(n=235,233,220,221,203,211,159,164) 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
Redness-Any (n=238,238,232,231,216,226,178,200) 29.8 39.5 38.8 48.5 46.8 50.0 42.1 52.0
Redness-Mild (n=238,235,232,230,215,226,176,194) 28.2 35.7 38.4 47.0 46.5 46.9 35.8 46.4
Redness-Mod (n=235,232,220,222,206,211,164,173) 2.1 4.3 1.4 3.2 3.9 9.0 12.8 19.7
Redness-Severe (n=235,231,220,221,203,211,159,164) 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.6
6.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 Within 4-days after each dose
Hide Outcome Measure Data
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 + P80 Dose 1 Infant Series 13vPnC - P 80 Dose 1 Infant Series 13vPnC + P80 Dose 2 Infant Series 13vPnC - P80 Dose 2 Infant Series 13vPnC + P80 Dose 3 Infant Series 13vPnC - P80 Dose 3 Infant Series 13vPnC + P80 Toddler Dose 13vPnC - P80 Toddler Dose
Hide Arm/Group Description:
Participants received one single 0.5mL dose of 13vPnC + P80 coadministered with Pentaxim and Engerix-B at 2 months of age(infant series, Dose 1).
Participants received one single 0.5mL dose of 13vPnC - P80 coadministered with Pentaxim and Engerix-B at 2 months of age (infant series, Dose 1).
Participants received one single 0.5mL dose of 13vPnC + P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 months age (infant series, Dose 2).
Participants received one single 0.5mL dose of 13vPnC - P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 months age (infant series, Dose 2).
Participants received one single 0.5mL dose of 13vPnC + P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 and 4 months age (infant series, Dose 3).
Participants received one single 0.5mL dose of 13vPnC - P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 and 4 months age (infant series, Dose 3).
Participants received one single 0.5mL dose of 13vPnC + P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 and 4 months age (infant doses), and Priorix at 12 months of age (toddler dose).
Participants received one single 0.5mL dose of 13vPnC - P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 and 4 months age (infant doses), and Priorix at 12 months of age (toddler dose).
Overall Number of Participants Analyzed 250 250 246 249 246 247 240 244
Measure Type: Number
Unit of Measure: Percentage of Participants
Fv ≥38°C, ≤39°C(n=236,235,224,229,208,218,170,172) 14.0 16.2 18.3 17.0 19.7 20.6 22.9 18.0
Fv >39°C, ≤40°C(n=235,233,221,221,203,211,162,164) 0.4 0.4 0.9 0.5 1.0 0.9 2.5 1.8
Fv >40°C (n=235,233,221,221,203,211,160,164) 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
Decr appetite (n=237,237,221,224,210,222,172,183) 21.5 22.4 16.3 24.1 21.4 20.7 26.2 29.0
Irritability (n=240,239,232,232,215,226,184,198) 55.0 55.2 51.7 53.9 45.6 50.0 49.5 56.1
Incr sleep (n=242,242,231,229,209,221,174,182) 46.3 52.5 35.9 39.3 25.8 27.6 19.0 30.8
Decr sleep (n=238,236,227,227,209,217,170,180) 35.7 29.7 24.7 26.4 25.4 24.4 19.4 25.6
Meds-treat sx (n=236,235,222,226,205,218,172,168) 14.0 16.6 15.3 16.8 15.1 14.7 21.5 15.5
Meds-prevent sx(n=235,234,220,223,205,217,171,171) 14.5 15.8 16.4 15.2 15.1 10.6 18.7 15.2
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 13vPnC + P80 Infant Series 13vPnC - P 80 Infant Series 13vPnC + P80 Post-Infant Series 13vPnC - P80 Post-Infant Series 13vPnC + P80 Toddler Dose 13vPnC - P80 Toddler Dose 13vPnC + P80 6-Month Follow-up 13vPnC - P80 6-Month Follow-up
Hide Arm/Group Description Participants received one single 0.5mL dose of 13vPnC + P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 and 4 months age (infant doses), and Priorix at 12 months of age (toddler dose). Participants received one single 0.5mL dose of 13vPnC - P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 and 4 months age (infant doses), and Priorix at 12 months of age (toddler dose). Participants received one single 0.5mL dose of 13vPnC + P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 and 4 months age (infant doses), and Priorix at 12 months of age (toddler dose). Participants received one single 0.5mL dose of 13vPnC - P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 and 4 months age (infant doses), and Priorix at 12 months of age (toddler dose). Participants received one single 0.5mL dose of 13vPnC + P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 and 4 months age (infant doses), and Priorix at 12 months of age (toddler dose). Participants received one single 0.5mL dose of 13vPnC - P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 and 4 months age (infant doses), and Priorix at 12 months of age (toddler dose). Participants received one single 0.5mL dose of 13vPnC + P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 and 4 months age (infant doses), and Priorix at 12 months of age (toddler dose). Participants received one single 0.5mL dose of 13vPnC - P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 and 4 months age (infant doses), and Priorix at 12 months of age (toddler dose).
All-Cause Mortality
13vPnC + P80 Infant Series 13vPnC - P 80 Infant Series 13vPnC + P80 Post-Infant Series 13vPnC - P80 Post-Infant Series 13vPnC + P80 Toddler Dose 13vPnC - P80 Toddler Dose 13vPnC + P80 6-Month Follow-up 13vPnC - P80 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 + P80 Infant Series 13vPnC - P 80 Infant Series 13vPnC + P80 Post-Infant Series 13vPnC - P80 Post-Infant Series 13vPnC + P80 Toddler Dose 13vPnC - P80 Toddler Dose 13vPnC + P80 6-Month Follow-up 13vPnC - P80 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   15/249 (6.02%)   21/250 (8.40%)   24/249 (9.64%)   16/250 (6.40%)   3/239 (1.26%)   2/244 (0.82%)   13/249 (5.22%)   14/250 (5.60%) 
Blood and lymphatic system disorders                 
Anaemia *  0/249 (0.00%)  1/250 (0.40%)  0/249 (0.00%)  0/250 (0.00%)  0/239 (0.00%)  0/244 (0.00%)  1/249 (0.40%)  0/250 (0.00%) 
Leukocytosis *  0/249 (0.00%)  0/250 (0.00%)  1/249 (0.40%)  0/250 (0.00%)  0/239 (0.00%)  0/244 (0.00%)  0/249 (0.00%)  0/250 (0.00%) 
Splenomegaly *  0/249 (0.00%)  0/250 (0.00%)  1/249 (0.40%)  0/250 (0.00%)  0/239 (0.00%)  0/244 (0.00%)  0/249 (0.00%)  0/250 (0.00%) 
Gastrointestinal disorders                 
Diarrhoea *  2/249 (0.80%)  2/250 (0.80%)  4/249 (1.61%)  3/250 (1.20%)  1/239 (0.42%)  0/244 (0.00%)  3/249 (1.20%)  4/250 (1.60%) 
Dyspepsia *  0/249 (0.00%)  0/250 (0.00%)  1/249 (0.40%)  0/250 (0.00%)  0/239 (0.00%)  0/244 (0.00%)  0/249 (0.00%)  0/250 (0.00%) 
Gastritis *  0/249 (0.00%)  0/250 (0.00%)  0/249 (0.00%)  0/250 (0.00%)  0/239 (0.00%)  1/244 (0.41%)  0/249 (0.00%)  0/250 (0.00%) 
Gastrooesophageal reflux disease *  1/249 (0.40%)  0/250 (0.00%)  0/249 (0.00%)  0/250 (0.00%)  0/239 (0.00%)  0/244 (0.00%)  0/249 (0.00%)  0/250 (0.00%) 
Inguinal hernia, obstructive *  0/249 (0.00%)  0/250 (0.00%)  0/249 (0.00%)  1/250 (0.40%)  0/239 (0.00%)  0/244 (0.00%)  0/249 (0.00%)  0/250 (0.00%) 
Vomiting *  0/249 (0.00%)  1/250 (0.40%)  0/249 (0.00%)  0/250 (0.00%)  0/239 (0.00%)  0/244 (0.00%)  0/249 (0.00%)  0/250 (0.00%) 
General disorders                 
Fibrosis *  0/249 (0.00%)  0/250 (0.00%)  0/249 (0.00%)  0/250 (0.00%)  1/239 (0.42%)  0/244 (0.00%)  0/249 (0.00%)  0/250 (0.00%) 
Pyrexia *  0/249 (0.00%)  0/250 (0.00%)  0/249 (0.00%)  1/250 (0.40%)  0/239 (0.00%)  0/244 (0.00%)  0/249 (0.00%)  0/250 (0.00%) 
Hepatobiliary disorders                 
Hepatitis *  0/249 (0.00%)  0/250 (0.00%)  1/249 (0.40%)  0/250 (0.00%)  0/239 (0.00%)  0/244 (0.00%)  0/249 (0.00%)  0/250 (0.00%) 
Immune system disorders                 
Alloimmunisation *  0/249 (0.00%)  0/250 (0.00%)  1/249 (0.40%)  0/250 (0.00%)  0/239 (0.00%)  0/244 (0.00%)  0/249 (0.00%)  0/250 (0.00%) 
Hypersensitivity *  1/249 (0.40%)  0/250 (0.00%)  0/249 (0.00%)  0/250 (0.00%)  0/239 (0.00%)  0/244 (0.00%)  0/249 (0.00%)  0/250 (0.00%) 
Infections and infestations                 
Bronchitis *  4/249 (1.61%)  9/250 (3.60%)  5/249 (2.01%)  1/250 (0.40%)  0/239 (0.00%)  1/244 (0.41%)  1/249 (0.40%)  2/250 (0.80%) 
Bronchopneumonia *  0/249 (0.00%)  3/250 (1.20%)  0/249 (0.00%)  0/250 (0.00%)  0/239 (0.00%)  0/244 (0.00%)  1/249 (0.40%)  0/250 (0.00%) 
Gastroenteritis *  2/249 (0.80%)  1/250 (0.40%)  4/249 (1.61%)  3/250 (1.20%)  0/239 (0.00%)  0/244 (0.00%)  0/249 (0.00%)  1/250 (0.40%) 
Gastroenteritis rotavirus *  0/249 (0.00%)  0/250 (0.00%)  0/249 (0.00%)  0/250 (0.00%)  0/239 (0.00%)  0/244 (0.00%)  0/249 (0.00%)  1/250 (0.40%) 
Infectious mononucleosis *  0/249 (0.00%)  0/250 (0.00%)  1/249 (0.40%)  0/250 (0.00%)  0/239 (0.00%)  0/244 (0.00%)  0/249 (0.00%)  0/250 (0.00%) 
Laryngitis *  1/249 (0.40%)  0/250 (0.00%)  1/249 (0.40%)  2/250 (0.80%)  1/239 (0.42%)  0/244 (0.00%)  3/249 (1.20%)  0/250 (0.00%) 
Meningitis meningococcal *  0/249 (0.00%)  1/250 (0.40%)  0/249 (0.00%)  0/250 (0.00%)  0/239 (0.00%)  0/244 (0.00%)  0/249 (0.00%)  0/250 (0.00%) 
Meningococcal sepsis *  0/249 (0.00%)  1/250 (0.40%)  0/249 (0.00%)  0/250 (0.00%)  0/239 (0.00%)  0/244 (0.00%)  0/249 (0.00%)  0/250 (0.00%) 
Nasopharyngitis *  0/249 (0.00%)  0/250 (0.00%)  1/249 (0.40%)  1/250 (0.40%)  0/239 (0.00%)  0/244 (0.00%)  0/249 (0.00%)  0/250 (0.00%) 
Otitis media *  0/249 (0.00%)  0/250 (0.00%)  1/249 (0.40%)  0/250 (0.00%)  0/239 (0.00%)  0/244 (0.00%)  0/249 (0.00%)  0/250 (0.00%) 
Pharyngitis *  0/249 (0.00%)  0/250 (0.00%)  2/249 (0.80%)  1/250 (0.40%)  0/239 (0.00%)  0/244 (0.00%)  2/249 (0.80%)  0/250 (0.00%) 
Pneumonia *  8/249 (3.21%)  3/250 (1.20%)  6/249 (2.41%)  1/250 (0.40%)  0/239 (0.00%)  0/244 (0.00%)  3/249 (1.20%)  3/250 (1.20%) 
Pneumonia primary atypical *  0/249 (0.00%)  1/250 (0.40%)  0/249 (0.00%)  1/250 (0.40%)  0/239 (0.00%)  0/244 (0.00%)  0/249 (0.00%)  0/250 (0.00%) 
Respiratory tract infection *  1/249 (0.40%)  1/250 (0.40%)  0/249 (0.00%)  1/250 (0.40%)  0/239 (0.00%)  0/244 (0.00%)  0/249 (0.00%)  0/250 (0.00%) 
Rhinitis *  0/249 (0.00%)  2/250 (0.80%)  0/249 (0.00%)  0/250 (0.00%)  0/239 (0.00%)  0/244 (0.00%)  0/249 (0.00%)  0/250 (0.00%) 
Sepsis *  0/249 (0.00%)  0/250 (0.00%)  0/249 (0.00%)  0/250 (0.00%)  0/239 (0.00%)  0/244 (0.00%)  1/249 (0.40%)  0/250 (0.00%) 
Staphylococcal bacteraemia *  0/249 (0.00%)  0/250 (0.00%)  1/249 (0.40%)  0/250 (0.00%)  0/239 (0.00%)  0/244 (0.00%)  0/249 (0.00%)  0/250 (0.00%) 
Urinary tract infection *  0/249 (0.00%)  1/250 (0.40%)  1/249 (0.40%)  2/250 (0.80%)  0/239 (0.00%)  0/244 (0.00%)  0/249 (0.00%)  1/250 (0.40%) 
Viral infection *  0/249 (0.00%)  0/250 (0.00%)  2/249 (0.80%)  0/250 (0.00%)  0/239 (0.00%)  0/244 (0.00%)  0/249 (0.00%)  0/250 (0.00%) 
Injury, poisoning and procedural complications                 
Head injury *  0/249 (0.00%)  0/250 (0.00%)  2/249 (0.80%)  0/250 (0.00%)  0/239 (0.00%)  0/244 (0.00%)  1/249 (0.40%)  0/250 (0.00%) 
Limbic traumatic amputation *  0/249 (0.00%)  0/250 (0.00%)  0/249 (0.00%)  1/250 (0.40%)  0/239 (0.00%)  0/244 (0.00%)  0/249 (0.00%)  0/250 (0.00%) 
Radius fracture *  0/249 (0.00%)  0/250 (0.00%)  0/249 (0.00%)  0/250 (0.00%)  0/239 (0.00%)  0/244 (0.00%)  1/249 (0.40%)  0/250 (0.00%) 
Thermal burn *  0/249 (0.00%)  0/250 (0.00%)  1/249 (0.40%)  0/250 (0.00%)  0/239 (0.00%)  0/244 (0.00%)  0/249 (0.00%)  0/250 (0.00%) 
Investigations                 
Ultrasound kidney abnormal *  0/249 (0.00%)  0/250 (0.00%)  0/249 (0.00%)  1/250 (0.40%)  0/239 (0.00%)  0/244 (0.00%)  0/249 (0.00%)  0/250 (0.00%) 
Metabolism and nutrition disorders                 
Dehydration *  0/249 (0.00%)  0/250 (0.00%)  1/249 (0.40%)  0/250 (0.00%)  0/239 (0.00%)  0/244 (0.00%)  0/249 (0.00%)  0/250 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)                 
Renal neoplasm *  0/249 (0.00%)  0/250 (0.00%)  0/249 (0.00%)  0/250 (0.00%)  0/239 (0.00%)  0/244 (0.00%)  1/249 (0.40%)  0/250 (0.00%) 
Nervous system disorders                 
Balance disorder *  0/249 (0.00%)  0/250 (0.00%)  0/249 (0.00%)  0/250 (0.00%)  0/239 (0.00%)  0/244 (0.00%)  0/249 (0.00%)  1/250 (0.40%) 
Febrile convulsion *  0/249 (0.00%)  0/250 (0.00%)  1/249 (0.40%)  0/250 (0.00%)  0/239 (0.00%)  0/244 (0.00%)  0/249 (0.00%)  0/250 (0.00%) 
Hydrocephalus *  0/249 (0.00%)  1/250 (0.40%)  0/249 (0.00%)  0/250 (0.00%)  0/239 (0.00%)  0/244 (0.00%)  0/249 (0.00%)  1/250 (0.40%) 
Psychiatric disorders                 
Breath holding *  0/249 (0.00%)  0/250 (0.00%)  1/249 (0.40%)  0/250 (0.00%)  0/239 (0.00%)  0/244 (0.00%)  0/249 (0.00%)  0/250 (0.00%) 
Renal and urinary disorders                 
Calculus urinary *  0/249 (0.00%)  0/250 (0.00%)  0/249 (0.00%)  0/250 (0.00%)  0/239 (0.00%)  0/244 (0.00%)  0/249 (0.00%)  1/250 (0.40%) 
Hydronephrosis *  0/249 (0.00%)  1/250 (0.40%)  0/249 (0.00%)  0/250 (0.00%)  0/239 (0.00%)  0/244 (0.00%)  0/249 (0.00%)  0/250 (0.00%) 
Hypercalciuria *  0/249 (0.00%)  0/250 (0.00%)  0/249 (0.00%)  1/250 (0.40%)  0/239 (0.00%)  0/244 (0.00%)  0/249 (0.00%)  0/250 (0.00%) 
Renal tubular disorder *  0/249 (0.00%)  0/250 (0.00%)  0/249 (0.00%)  1/250 (0.40%)  0/239 (0.00%)  0/244 (0.00%)  0/249 (0.00%)  1/250 (0.40%) 
Respiratory, thoracic and mediastinal disorders                 
Bronchospasm *  0/249 (0.00%)  0/250 (0.00%)  0/249 (0.00%)  1/250 (0.40%)  0/239 (0.00%)  0/244 (0.00%)  0/249 (0.00%)  0/250 (0.00%) 
Pneumonia aspiration *  1/249 (0.40%)  1/250 (0.40%)  0/249 (0.00%)  0/250 (0.00%)  0/239 (0.00%)  0/244 (0.00%)  0/249 (0.00%)  0/250 (0.00%) 
Sleep apnoea syndrome *  0/249 (0.00%)  1/250 (0.40%)  0/249 (0.00%)  0/250 (0.00%)  0/239 (0.00%)  0/244 (0.00%)  0/249 (0.00%)  0/250 (0.00%) 
Skin and subcutaneous tissue disorders                 
Urticaria *  1/249 (0.40%)  0/250 (0.00%)  0/249 (0.00%)  1/250 (0.40%)  0/239 (0.00%)  0/244 (0.00%)  0/249 (0.00%)  0/250 (0.00%) 
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
13vPnC + P80 Infant Series 13vPnC - P 80 Infant Series 13vPnC + P80 Post-Infant Series 13vPnC - P80 Post-Infant Series 13vPnC + P80 Toddler Dose 13vPnC - P80 Toddler Dose 13vPnC + P80 6-Month Follow-up 13vPnC - P80 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   132/249 (53.01%)   132/250 (52.80%)   15/249 (6.02%)   9/250 (3.60%)   91/239 (38.08%)   111/244 (45.49%)   0/249 (0.00%)   1/250 (0.40%) 
Blood and lymphatic system disorders                 
Anaemia *  2/249 (0.80%)  2/250 (0.80%)  0/249 (0.00%)  0/250 (0.00%)  0/239 (0.00%)  0/244 (0.00%)  0/249 (0.00%)  0/250 (0.00%) 
Iron deficiency anaemia *  0/249 (0.00%)  1/250 (0.40%)  0/249 (0.00%)  0/250 (0.00%)  0/239 (0.00%)  0/244 (0.00%)  0/249 (0.00%)  0/250 (0.00%) 
Cardiac disorders                 
Aortic valve incompetence *  0/249 (0.00%)  0/250 (0.00%)  0/249 (0.00%)  1/250 (0.40%)  0/239 (0.00%)  0/244 (0.00%)  0/249 (0.00%)  0/250 (0.00%) 
Tricuspid valve incompetence *  0/249 (0.00%)  0/250 (0.00%)  0/249 (0.00%)  1/250 (0.40%)  0/239 (0.00%)  0/244 (0.00%)  0/249 (0.00%)  0/250 (0.00%) 
Congenital, familial and genetic disorders                 
Craniotabes *  0/249 (0.00%)  1/250 (0.40%)  0/249 (0.00%)  0/250 (0.00%)  0/239 (0.00%)  0/244 (0.00%)  0/249 (0.00%)  0/250 (0.00%) 
Dacryostenosis congenital *  0/249 (0.00%)  1/250 (0.40%)  0/249 (0.00%)  0/250 (0.00%)  0/239 (0.00%)  0/244 (0.00%)  0/249 (0.00%)  0/250 (0.00%) 
Brachycephaly *  0/249 (0.00%)  0/250 (0.00%)  0/249 (0.00%)  1/250 (0.40%)  0/239 (0.00%)  0/244 (0.00%)  0/249 (0.00%)  0/250 (0.00%) 
Cryptorchism *  0/249 (0.00%)  0/250 (0.00%)  1/249 (0.40%)  0/250 (0.00%)  0/239 (0.00%)  1/244 (0.41%)  0/249 (0.00%)  0/250 (0.00%) 
Ventricular septal defect *  0/249 (0.00%)  0/250 (0.00%)  0/249 (0.00%)  1/250 (0.40%)  0/239 (0.00%)  0/244 (0.00%)  0/249 (0.00%)  0/250 (0.00%) 
Eye disorders                 
Conjunctivitis *  5/249 (2.01%)  2/250 (0.80%)  1/249 (0.40%)  0/250 (0.00%)  0/239 (0.00%)  3/244 (1.23%)  0/249 (0.00%)  0/250 (0.00%) 
Gastrointestinal disorders                 
Diarrhoea *  5/249 (2.01%)  11/250 (4.40%)  0/249 (0.00%)  0/250 (0.00%)  4/239 (1.67%)  5/244 (2.05%)  0/249 (0.00%)  0/250 (0.00%) 
Vomiting *  2/249 (0.80%)  3/250 (1.20%)  0/249 (0.00%)  0/250 (0.00%)  1/239 (0.42%)  0/244 (0.00%)  0/249 (0.00%)  0/250 (0.00%) 
Abdominal pain *  1/249 (0.40%)  2/250 (0.80%)  0/249 (0.00%)  0/250 (0.00%)  0/239 (0.00%)  0/244 (0.00%)  0/249 (0.00%)  0/250 (0.00%) 
Haematochezia *  1/249 (0.40%)  1/250 (0.40%)  0/249 (0.00%)  0/250 (0.00%)  0/239 (0.00%)  0/244 (0.00%)  0/249 (0.00%)  0/250 (0.00%) 
Abdominal distension *  1/249 (0.40%)  0/250 (0.00%)  0/249 (0.00%)  0/250 (0.00%)  0/239 (0.00%)  0/244 (0.00%)  0/249 (0.00%)  0/250 (0.00%) 
Aphthous stomatitis *  0/249 (0.00%)  1/250 (0.40%)  0/249 (0.00%)  0/250 (0.00%)  0/239 (0.00%)  0/244 (0.00%)  0/249 (0.00%)  0/250 (0.00%) 
Constipation *  0/249 (0.00%)  1/250 (0.40%)  0/249 (0.00%)  0/250 (0.00%)  0/239 (0.00%)  0/244 (0.00%)  0/249 (0.00%)  0/250 (0.00%) 
Dyspepsia *  1/249 (0.40%)  0/250 (0.00%)  0/249 (0.00%)  0/250 (0.00%)  1/239 (0.42%)  0/244 (0.00%)  0/249 (0.00%)  0/250 (0.00%) 
Infantile colic *  1/249 (0.40%)  0/250 (0.00%)  0/249 (0.00%)  0/250 (0.00%)  0/239 (0.00%)  0/244 (0.00%)  0/249 (0.00%)  0/250 (0.00%) 
Umbilical hernia *  1/249 (0.40%)  0/250 (0.00%)  0/249 (0.00%)  0/250 (0.00%)  0/239 (0.00%)  0/244 (0.00%)  0/249 (0.00%)  0/250 (0.00%) 
Gastrooesophageal reflux disease *  0/249 (0.00%)  0/250 (0.00%)  2/249 (0.80%)  0/250 (0.00%)  0/239 (0.00%)  0/244 (0.00%)  0/249 (0.00%)  0/250 (0.00%) 
Stomatitis *  0/249 (0.00%)  0/250 (0.00%)  0/249 (0.00%)  0/250 (0.00%)  1/239 (0.42%)  0/244 (0.00%)  0/249 (0.00%)  0/250 (0.00%) 
General disorders                 
Pyrexia *  5/249 (2.01%)  4/250 (1.60%)  0/249 (0.00%)  0/250 (0.00%)  1/239 (0.42%)  1/244 (0.41%)  0/249 (0.00%)  0/250 (0.00%) 
Irritability *  1/249 (0.40%)  1/250 (0.40%)  0/249 (0.00%)  0/250 (0.00%)  0/239 (0.00%)  0/244 (0.00%)  0/249 (0.00%)  0/250 (0.00%) 
Injection site induration *  1/249 (0.40%)  0/250 (0.00%)  0/249 (0.00%)  0/250 (0.00%)  0/239 (0.00%)  0/244 (0.00%)  0/249 (0.00%)  0/250 (0.00%) 
Injection site nodule *  1/249 (0.40%)  0/250 (0.00%)  0/249 (0.00%)  0/250 (0.00%)  0/239 (0.00%)  0/244 (0.00%)  0/249 (0.00%)  0/250 (0.00%) 
Injection site swelling *  0/249 (0.00%)  1/250 (0.40%)  0/249 (0.00%)  0/250 (0.00%)  0/239 (0.00%)  0/244 (0.00%)  0/249 (0.00%)  0/250 (0.00%) 
Fever ≥38°C but ≤39°C  2 [1]  33/236 (13.98%)  38/235 (16.17%)  0/0  0/0  39/170 (22.94%)  31/172 (18.02%)  0/0  0/0 
Fever ≥38°C but ≤39°C  2 [2]  41/224 (18.30%)  39/229 (17.03%)  0/0  0/0  0/0  0/0  0/0  0/0 
Fever ≥38°C but ≤39°C  2 [3]  41/208 (19.71%)  45/218 (20.64%)  0/0  0/0  0/0  0/0  0/0  0/0 
Fever >39°C but ≤40°C  2 [4]  1/235 (0.43%)  1/233 (0.43%)  0/0  0/0  4/162 (2.47%)  3/164 (1.83%)  0/0  0/0 
Fever >39°C but ≤40°C  2 [5]  2/221 (0.90%)  1/221 (0.45%)  0/0  0/0  0/0  0/0  0/0  0/0 
Fever >39°C but ≤40°C  2 [6]  2/203 (0.99%)  2/211 (0.95%)  0/0  0/0  0/0  0/0  0/0  0/0 
Fever >40°C  2 [7]  0/235 (0.00%)  0/233 (0.00%)  0/0  0/0  0/160 (0.00%)  0/164 (0.00%)  0/0  0/0 
Fever >40°C  2 [8]  0/221 (0.00%)  0/221 (0.00%)  0/0  0/0  0/0  0/0  0/0  0/0 
Fever >40°C  2 [9]  0/203 (0.00%)  0/211 (0.00%)  0/0  0/0  0/0  0/0  0/0  0/0 
Decreased appetite  2 [10]  51/237 (21.52%)  53/237 (22.36%)  0/0  0/0  45/172 (26.16%)  53/183 (28.96%)  0/0  0/0 
Decreased appetite  2 [11]  36/221 (16.29%)  54/224 (24.11%)  0/0  0/0  0/0  0/0  0/0  0/0 
Decreased appetite  2 [12]  45/210 (21.43%)  46/222 (20.72%)  0/0  0/0  0/0  0/0  0/0  0/0 
Decreased sleep  2 [13]  85/238 (35.71%)  70/236 (29.66%)  0/0  0/0  33/170 (19.41%)  46/180 (25.56%)  0/0  0/0 
Decreased sleep  2 [14]  56/227 (24.67%)  60/227 (26.43%)  0/0  0/0  0/0  0/0  0/0  0/0 
Decreased sleep  2 [15]  53/209 (25.36%)  53/217 (24.42%)  0/0  0/0  0/0  0/0  0/0  0/0 
Increased sleep  2 [16]  112/242 (46.28%)  127/242 (52.48%)  0/0  0/0  33/174 (18.97%)  56/182 (30.77%)  0/0  0/0 
Increased sleep  2 [17]  83/231 (35.93%)  90/229 (39.30%)  0/0  0/0  0/0  0/0  0/0  0/0 
Increased sleep  2 [18]  54/209 (25.84%)  61/221 (27.60%)  0/0  0/0  0/0  0/0  0/0  0/0 
Irritability  2 [19]  132/240 (55.00%)  132/239 (55.23%)  0/0  0/0  91/184 (49.46%)  111/198 (56.06%)  0/0  0/0 
Irritability  2 [20]  120/232 (51.72%)  125/232 (53.88%)  0/0  0/0  0/0  0/0  0/0  0/0 
Irritability  2 [21]  98/215 (45.58%)  113/226 (50.00%)  0/0  0/0  0/0  0/0  0/0  0/0 
Immune system disorders                 
Food allergy *  0/249 (0.00%)  3/250 (1.20%)  0/249 (0.00%)  0/250 (0.00%)  0/239 (0.00%)  1/244 (0.41%)  0/249 (0.00%)  0/250 (0.00%) 
Infections and infestations                 
Bronchitis *  23/249 (9.24%)  19/250 (7.60%)  0/249 (0.00%)  0/250 (0.00%)  3/239 (1.26%)  6/244 (2.46%)  0/249 (0.00%)  0/250 (0.00%) 
Rhinitis *  19/249 (7.63%)  21/250 (8.40%)  3/249 (1.20%)  1/250 (0.40%)  8/239 (3.35%)  10/244 (4.10%)  0/249 (0.00%)  0/250 (0.00%) 
Pharyngitis *  17/249 (6.83%)  15/250 (6.00%)  0/249 (0.00%)  0/250 (0.00%)  10/239 (4.18%)  19/244 (7.79%)  0/249 (0.00%)  0/250 (0.00%) 
Upper respiratory tract infection *  17/249 (6.83%)  13/250 (5.20%)  0/249 (0.00%)  0/250 (0.00%)  9/239 (3.77%)  17/244 (6.97%)  0/249 (0.00%)  0/250 (0.00%) 
Nasopharyngitis *  13/249 (5.22%)  13/250 (5.20%)  1/249 (0.40%)  0/250 (0.00%)  4/239 (1.67%)  10/244 (4.10%)  0/249 (0.00%)  0/250 (0.00%) 
Respiratory tract infection *  8/249 (3.21%)  6/250 (2.40%)  0/249 (0.00%)  0/250 (0.00%)  2/239 (0.84%)  1/244 (0.41%)  0/249 (0.00%)  0/250 (0.00%) 
Urinary tract infection *  7/249 (2.81%)  1/250 (0.40%)  0/249 (0.00%)  0/250 (0.00%)  1/239 (0.42%)  0/244 (0.00%)  0/249 (0.00%)  0/250 (0.00%) 
Bronchopneumonia *  2/249 (0.80%)  3/250 (1.20%)  0/249 (0.00%)  0/250 (0.00%)  0/239 (0.00%)  0/244 (0.00%)  0/249 (0.00%)  0/250 (0.00%) 
Pneumonia *  3/249 (1.20%)  2/250 (0.80%)  0/249 (0.00%)  0/250 (0.00%)  2/239 (0.84%)  0/244 (0.00%)  0/249 (0.00%)  0/250 (0.00%) 
Viral infection *  2/249 (0.80%)  3/250 (1.20%)  0/249 (0.00%)  0/250 (0.00%)  1/239 (0.42%)  1/244 (0.41%)  0/249 (0.00%)  0/250 (0.00%) 
Ear infection *  2/249 (0.80%)  2/250 (0.80%)  0/249 (0.00%)  0/250 (0.00%)  0/239 (0.00%)  0/244 (0.00%)  0/249 (0.00%)  0/250 (0.00%) 
Gastroenteritis *  3/249 (1.20%)  1/250 (0.40%)  0/249 (0.00%)  0/250 (0.00%)  3/239 (1.26%)  1/244 (0.41%)  0/249 (0.00%)  0/250 (0.00%) 
Laryngitis *  2/249 (0.80%)  1/250 (0.40%)  0/249 (0.00%)  0/250 (0.00%)  1/239 (0.42%)  4/244 (1.64%)  0/249 (0.00%)  0/250 (0.00%) 
Otitis media *  2/249 (0.80%)  1/250 (0.40%)  0/249 (0.00%)  0/250 (0.00%)  1/239 (0.42%)  2/244 (0.82%)  0/249 (0.00%)  0/250 (0.00%) 
Exanthema subitum *  1/249 (0.40%)  1/250 (0.40%)  0/249 (0.00%)  0/250 (0.00%)  0/239 (0.00%)  5/244 (2.05%)  0/249 (0.00%)  0/250 (0.00%) 
Viral upper respiratory tract infection *  1/249 (0.40%)  1/250 (0.40%)  0/249 (0.00%)  0/250 (0.00%)  0/239 (0.00%)  0/244 (0.00%)  0/249 (0.00%)  0/250 (0.00%) 
Candidiasis *  1/249 (0.40%)  0/250 (0.00%)  0/249 (0.00%)  0/250 (0.00%)  0/239 (0.00%)  0/244 (0.00%)  0/249 (0.00%)  0/250 (0.00%) 
Conjunctivitis infective *  0/249 (0.00%)  1/250 (0.40%)  0/249 (0.00%)  0/250 (0.00%)  0/239 (0.00%)  0/244 (0.00%)  0/249 (0.00%)  0/250 (0.00%) 
Gastroenteritis staphylococcal *  1/249 (0.40%)  0/250 (0.00%)  0/249 (0.00%)  0/250 (0.00%)  0/239 (0.00%)  0/244 (0.00%)  0/249 (0.00%)  0/250 (0.00%) 
Oral candidiasis *  1/249 (0.40%)  0/250 (0.00%)  0/249 (0.00%)  0/250 (0.00%)  0/239 (0.00%)  0/244 (0.00%)  0/249 (0.00%)  0/250 (0.00%) 
Perianal abscess *  1/249 (0.40%)  0/250 (0.00%)  0/249 (0.00%)  0/250 (0.00%)  0/239 (0.00%)  0/244 (0.00%)  0/249 (0.00%)  0/250 (0.00%) 
Pneumonia primary atypical *  0/249 (0.00%)  1/250 (0.40%)  0/249 (0.00%)  0/250 (0.00%)  0/239 (0.00%)  0/244 (0.00%)  0/249 (0.00%)  0/250 (0.00%) 
Tinea cruris *  1/249 (0.40%)  0/250 (0.00%)  0/249 (0.00%)  0/250 (0.00%)  0/239 (0.00%)  0/244 (0.00%)  0/249 (0.00%)  0/250 (0.00%) 
Tonsillitis *  1/249 (0.40%)  0/250 (0.00%)  0/249 (0.00%)  0/250 (0.00%)  1/239 (0.42%)  1/244 (0.41%)  0/249 (0.00%)  0/250 (0.00%) 
Varicella *  1/249 (0.40%)  0/250 (0.00%)  0/249 (0.00%)  0/250 (0.00%)  1/239 (0.42%)  1/244 (0.41%)  0/249 (0.00%)  0/250 (0.00%) 
Viral diarrhoea *  0/249 (0.00%)  1/250 (0.40%)  0/249 (0.00%)  0/250 (0.00%)  0/239 (0.00%)  0/244 (0.00%)  0/249 (0.00%)  0/250 (0.00%) 
Viral rash *  1/249 (0.40%)  0/250 (0.00%)  0/249 (0.00%)  0/250 (0.00%)  0/239 (0.00%)  0/244 (0.00%)  0/249 (0.00%)  0/250 (0.00%) 
Hordeolum *  0/249 (0.00%)  0/250 (0.00%)  0/249 (0.00%)  1/250 (0.40%)  0/239 (0.00%)  0/244 (0.00%)  0/249 (0.00%)  0/250 (0.00%) 
Acute tonsillitis *  0/249 (0.00%)  0/250 (0.00%)  0/249 (0.00%)  0/250 (0.00%)  0/239 (0.00%)  2/244 (0.82%)  0/249 (0.00%)  0/250 (0.00%) 
Influenza *  0/249 (0.00%)  0/250 (0.00%)  0/249 (0.00%)  0/250 (0.00%)  1/239 (0.42%)  0/244 (0.00%)  0/249 (0.00%)  0/250 (0.00%) 
Investigations                 
Cardiac murmur functional *  1/249 (0.40%)  2/250 (0.80%)  0/249 (0.00%)  0/250 (0.00%)  0/239 (0.00%)  0/244 (0.00%)  0/249 (0.00%)  0/250 (0.00%) 
Cardiac murmur *  0/249 (0.00%)  0/250 (0.00%)  0/249 (0.00%)  1/250 (0.40%)  0/239 (0.00%)  0/244 (0.00%)  0/249 (0.00%)  0/250 (0.00%) 
Metabolism and nutrition disorders                 
Weight gain poor *  0/249 (0.00%)  0/250 (0.00%)  0/249 (0.00%)  1/250 (0.40%)  0/239 (0.00%)  0/244 (0.00%)  0/249 (0.00%)  0/250 (0.00%) 
Nervous system disorders                 
Hypertonia *  1/249 (0.40%)  3/250 (1.20%)  0/249 (0.00%)  0/250 (0.00%)  0/239 (0.00%)  0/244 (0.00%)  0/249 (0.00%)  0/250 (0.00%) 
Hypotonia *  2/249 (0.80%)  0/250 (0.00%)  0/249 (0.00%)  0/250 (0.00%)  0/239 (0.00%)  0/244 (0.00%)  0/249 (0.00%)  0/250 (0.00%) 
Psychiatric disorders                 
Decreased activity *  1/249 (0.40%)  0/250 (0.00%)  0/249 (0.00%)  0/250 (0.00%)  0/239 (0.00%)  0/244 (0.00%)  0/249 (0.00%)  0/250 (0.00%) 
Insomnia *  0/249 (0.00%)  1/250 (0.40%)  0/249 (0.00%)  0/250 (0.00%)  0/239 (0.00%)  0/244 (0.00%)  0/249 (0.00%)  0/250 (0.00%) 
Respiratory, thoracic and mediastinal disorders                 
Cough *  2/249 (0.80%)  0/250 (0.00%)  0/249 (0.00%)  0/250 (0.00%)  0/239 (0.00%)  0/244 (0.00%)  0/249 (0.00%)  0/250 (0.00%) 
Interstitial lung disease *  1/249 (0.40%)  0/250 (0.00%)  0/249 (0.00%)  0/250 (0.00%)  0/239 (0.00%)  0/244 (0.00%)  0/249 (0.00%)  0/250 (0.00%) 
Pharyngolaryngeal pain *  1/249 (0.40%)  0/250 (0.00%)  0/249 (0.00%)  0/250 (0.00%)  0/239 (0.00%)  0/244 (0.00%)  0/249 (0.00%)  0/250 (0.00%) 
Rhinitis allergic *  1/249 (0.40%)  0/250 (0.00%)  1/249 (0.40%)  1/250 (0.40%)  0/239 (0.00%)  0/244 (0.00%)  0/249 (0.00%)  0/250 (0.00%) 
Skin and subcutaneous tissue disorders                 
Dermatitis atopic *  14/249 (5.62%)  7/250 (2.80%)  3/249 (1.20%)  1/250 (0.40%)  2/239 (0.84%)  1/244 (0.41%)  0/249 (0.00%)  1/250 (0.40%) 
Dermatitis allergic *  3/249 (1.20%)  8/250 (3.20%)  1/249 (0.40%)  2/250 (0.80%)  0/239 (0.00%)  1/244 (0.41%)  0/249 (0.00%)  0/250 (0.00%) 
Rash *  5/249 (2.01%)  1/250 (0.40%)  1/249 (0.40%)  0/250 (0.00%)  0/239 (0.00%)  0/244 (0.00%)  0/249 (0.00%)  0/250 (0.00%) 
Dermatitis *  1/249 (0.40%)  1/250 (0.40%)  0/249 (0.00%)  0/250 (0.00%)  0/239 (0.00%)  0/244 (0.00%)  0/249 (0.00%)  0/250 (0.00%) 
Dermatitis diaper *  1/249 (0.40%)  1/250 (0.40%)  1/249 (0.40%)  0/250 (0.00%)  0/239 (0.00%)  0/244 (0.00%)  0/249 (0.00%)  0/250 (0.00%) 
Heat rash *  2/249 (0.80%)  0/250 (0.00%)  0/249 (0.00%)  0/250 (0.00%)  0/239 (0.00%)  0/244 (0.00%)  0/249 (0.00%)  0/250 (0.00%) 
Dermatitis contact *  0/249 (0.00%)  1/250 (0.40%)  0/249 (0.00%)  0/250 (0.00%)  0/239 (0.00%)  0/244 (0.00%)  0/249 (0.00%)  0/250 (0.00%) 
Hyperhidrosis *  1/249 (0.40%)  0/250 (0.00%)  0/249 (0.00%)  0/250 (0.00%)  0/239 (0.00%)  0/244 (0.00%)  0/249 (0.00%)  0/250 (0.00%) 
Seborrhoeic dermatitis *  1/249 (0.40%)  0/250 (0.00%)  0/249 (0.00%)  0/250 (0.00%)  0/239 (0.00%)  0/244 (0.00%)  0/249 (0.00%)  0/250 (0.00%) 
Skin inflammation *  0/249 (0.00%)  1/250 (0.40%)  0/249 (0.00%)  0/250 (0.00%)  0/239 (0.00%)  0/244 (0.00%)  0/249 (0.00%)  0/250 (0.00%) 
Urticaria *  0/249 (0.00%)  1/250 (0.40%)  0/249 (0.00%)  0/250 (0.00%)  0/239 (0.00%)  0/244 (0.00%)  0/249 (0.00%)  0/250 (0.00%) 
Tenderness (Any)  1 [22]  45/181 (24.86%)  59/181 (32.60%)  0/0  0/0  75/178 (42.13%)  81/188 (43.09%)  0/0  0/0 
Tenderness (any)  1 [23]  43/176 (24.43%)  63/176 (35.80%)  0/0  0/0  0/0  0/0  0/0  0/0 
Tenderness (any)  1 [24]  41/167 (24.55%)  38/170 (22.35%)  0/0  0/0  0/0  0/0  0/0  0/0 
Tenderness (significant)  1 [25]  4/179 (2.23%)  8/178 (4.49%)  0/0  0/0  4/160 (2.50%)  2/165 (1.21%)  0/0  0/0 
Tenderness (significant)  1 [26]  1/172 (0.58%)  1/170 (0.59%)  0/0  0/0  0/0  0/0  0/0  0/0 
Tenderness (significant)  1 [27]  2/163 (1.23%)  2/165 (1.21%)  0/0  0/0  0/0  0/0  0/0  0/0 
Induration (Any)  1 [28]  39/179 (21.79%)  55/183 (30.05%)  0/0  0/0  52/174 (29.89%)  63/181 (34.81%)  0/0  0/0 
Induration (Any)  1 [29]  46/178 (25.84%)  62/175 (35.43%)  0/0  0/0  0/0  0/0  0/0  0/0 
Induration (Any)  1 [30]  59/165 (35.76%)  67/175 (38.29%)  0/0  0/0  0/0  0/0  0/0  0/0 
Induration (mild)  1 [31]  33/179 (18.44%)  41/180 (22.78%)  0/0  0/0  45/169 (26.63%)  53/178 (29.78%)  0/0  0/0 
Induration (mild)  1 [32]  37/177 (20.90%)  54/173 (31.21%)  0/0  0/0  0/0  0/0  0/0  0/0 
Induration (mild)  1 [33]  51/165 (30.91%)  56/171 (32.75%)  0/0  0/0  0/0  0/0  0/0  0/0 
Induration (moderate)  1 [34]  18/179 (10.06%)  28/182 (15.38%)  0/0  0/0  20/164 (12.20%)  34/171 (19.88%)  0/0  0/0 
Induration (moderate)  1 [35]  22/175 (12.57%)  24/172 (13.95%)  0/0  0/0  0/0  0/0  0/0  0/0 
Induration (moderate)  1 [36]  23/164 (14.02%)  30/169 (17.75%)  0/0  0/0  0/0  0/0  0/0  0/0 
Induration (severe)  1 [37]  0/179 (0.00%)  0/179 (0.00%)  0/0  0/0  0/159 (0.00%)  0/164 (0.00%)  0/0  0/0 
Induration (severe)  1 [38]  0/172 (0.00%)  0/170 (0.00%)  0/0  0/0  0/0  0/0  0/0  0/0 
Induration (severe)  1 [39]  0/163 (0.00%)  0/165 (0.00%)  0/0  0/0  0/0  0/0  0/0  0/0 
Erythema (Any)  1 [40]  58/181 (32.04%)  73/183 (39.89%)  0/0  0/0  75/178 (42.13%)  104/200 (52.00%)  0/0  0/0 
Erythema (Any)  1 [41]  68/180 (37.78%)  86/178 (48.31%)  0/0  0/0  0/0  0/0  0/0  0/0 
Erythema (Any)  1 [42]  78/169 (46.15%)  89/177 (50.28%)  0/0  0/0  0/0  0/0  0/0  0/0 
Erythema (Mild)  1 [43]  56/181 (30.94%)  63/180 (35.00%)  0/0  0/0  63/176 (35.80%)  90/194 (46.39%)  0/0  0/0 
Erythema (Mild)  1 [44]  68/180 (37.78%)  82/177 (46.33%)  0/0  0/0  0/0  0/0  0/0  0/0 
Erythema (Mild)  1 [45]  78/169 (46.15%)  82/177 (46.33%)  0/0  0/0  0/0  0/0  0/0  0/0 
Erythema (Moderate)  1 [46]  3/179 (1.68%)  10/178 (5.62%)  0/0  0/0  21/164 (12.80%)  34/173 (19.65%)  0/0  0/0 
Erythema (Moderate)  1 [47]  2/172 (1.16%)  6/171 (3.51%)  0/0  0/0  0/0  0/0  0/0  0/0 
Erythema (Moderate)  1 [48]  5/164 (3.05%)  16/165 (9.70%)  0/0  0/0  0/0  0/0  0/0  0/0 
Erythema (Severe)  1 [49]  0/179 (0.00%)  0/177 (0.00%)  0/0  0/0  0/159 (0.00%)  1/164 (0.61%)  0/0  0/0 
Erythema (Severe)  1 [50]  0/172 (0.00%)  0/170 (0.00%)  0/0  0/0  0/0  0/0  0/0  0/0 
Erythema (Severe)  1 [51]  0/163 (0.00%)  0/165 (0.00%)  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, Local Reactions
2
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; Decreased sleep
[14]
Infant Series Dose 2; Decreased sleep
[15]
Infant Series Dose 3; Decreased sleep
[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; Irritability
[20]
Infant Series Dose 2; Irritability
[21]
Infant Series Dose 3; Irritability
[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: NCT00366548    
Other Study ID Numbers: 6096A1-009
First Submitted: August 17, 2006
First Posted: August 21, 2006
Results First Submitted: March 26, 2010
Results First Posted: August 15, 2012
Last Update Posted: August 15, 2012