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Study Evaluating A 13-Valent Pneumococcal Conjugate Vaccine Administered To Infants In Korea

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00689351
Recruitment Status : Completed
First Posted : June 3, 2008
Results First Posted : January 11, 2011
Last Update Posted : June 28, 2011
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Care Provider, Investigator);   Primary Purpose: Prevention
Condition Pneumococcal Vaccine
Interventions Biological: 13-valent pneumococcal conjugate vaccine
Biological: 7-valent pneumococcal conjugate vaccine
Enrollment 180
Recruitment Details  
Pre-assignment Details  
Arm/Group Title 13vPnC 7vPnC
Hide Arm/Group Description 13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose). 7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
Period Title: Infant Series of Dosing
Started 91 89
Vaccinated Dose 1 88 89
Vaccinated Dose 2 86 88
Vaccinated Dose 3 85 88
Completed 85 88
Not Completed 6 1
Reason Not Completed
Parent/legal guardian request             5             0
Adverse Event             1             0
Lost to Follow-up             0             1
Period Title: After Infant Series
Started 85 88
Completed 84 88
Not Completed 1 0
Reason Not Completed
Parent/legal guardian request             1             0
Period Title: Toddler Dose
Started 84 88
Completed 84 88
Not Completed 0 0
Arm/Group Title 13vPnC 7vPnC Total
Hide Arm/Group Description 13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose). 7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose). Total of all reporting groups
Overall Number of Baseline Participants 91 89 180
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Months
Number Analyzed 91 participants 89 participants 180 participants
2.1  (0.3) 2.1  (0.2) 2.1  (0.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 91 participants 89 participants 180 participants
Female
45
  49.5%
39
  43.8%
84
  46.7%
Male
46
  50.5%
50
  56.2%
96
  53.3%
1.Primary Outcome
Title Percentage of Participants Achieving a Serotype-specific Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (≥) 0.35 Micrograms Per Milliliter (Mcg/mL) Measured 1 Month After the Infant Series
Hide Description Percentage of participants achieving predefined antibody threshold ≥0.35 Mcg/mL along with the corresponding 95 percent (%) confidence interval (CI) was calculated 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).
Time Frame 1 month after the infant series (7 months of age)
Hide Outcome Measure Data
Hide Analysis Population Description
Evaluable Infant Immunogenicity population: participants who were 41 to 99 days of age (inclusive) on the day of the first vaccination, who had treatments as randomized (all expected doses) and at least 1 valid and determinate assay result for proposed analysis.
Arm/Group Title 13vPnC 7vPnC
Hide Arm/Group Description:
13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
Overall Number of Participants Analyzed 91 89
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Serotype 4
100.0
(95.7 to 100.0)
100.0
(95.8 to 100.0)
Serotype 6B
98.8
(93.5 to 100.0)
100.0
(95.8 to 100.0)
Serotype 9V
100.0
(95.7 to 100.0)
100.0
(95.8 to 100.0)
Serotype 14
100.0
(95.7 to 100.0)
100.0
(95.7 to 100.0)
Serotype 18C
100.0
(95.7 to 100.0)
100.0
(95.8 to 100.0)
Serotype 19F
97.6
(91.6 to 99.7)
98.8
(93.6 to 100.0)
Serotype 23F
98.8
(93.5 to 100.0)
98.8
(93.6 to 100.0)
Serotype 1
100.0
(95.7 to 100.0)
2.4
(0.3 to 8.2)
Serotype 3
100.0
(95.7 to 100.0)
2.4
(0.3 to 8.2)
Serotype 5
100.0
(95.7 to 100.0)
57.5
(45.9 to 68.5)
Serotype 6A
97.6
(91.6 to 99.7)
72.3
(61.4 to 81.6)
Serotype 7F
100.0
(95.7 to 100.0)
4.8
(1.3 to 11.7)
Serotype 19A
100.0
(95.7 to 100.0)
100.0
(95.6 to 100.0)
2.Secondary Outcome
Title Percentage of Participants Achieving a Serotype-specific IgG Antibody Level ≥0.35 Mcg/mL Measured 1 Month After the Toddler Dose
Hide Description Percentage of participants achieving predefined antibody threshold ≥0.35Mcg/mL along with the corresponding 95% CI was calculated 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). Exact 2-sided CI was based on the observed percentage of participants.
Time Frame 1 month after the toddler dose (13 months of age)
Hide Outcome Measure Data
Hide Analysis Population Description
Evaluable Toddler Immunogenicity population:41-99 days old inclusive on day of first vaccination, 365-395 days old inclusive at toddler dose, had all treatments as randomized, blood drawn within specified timeframes, at least 1 valid and determinate assay result for proposed analysis, and no major protocol violations
Arm/Group Title 13vPnC 7vPnC
Hide Arm/Group Description:
13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
Overall Number of Participants Analyzed 91 89
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Serotype 4
100.0
(95.5 to 100.0)
100.0
(95.7 to 100.0)
Serotype 6B
100.0
(95.5 to 100.0)
100.0
(95.7 to 100.0)
Serotype 9V
100.0
(95.5 to 100.0)
100.0
(95.7 to 100.0)
Serotype 14
98.7
(93.1 to 100.0)
100.0
(95.7 to 100.0)
Serotype 18C
100.0
(95.5 to 100.0)
100.0
(95.7 to 100.0)
Serotype 19F
100.0
(95.5 to 100.0)
100.0
(95.7 to 100.0)
Serotype 23F
100.0
(95.5 to 100.0)
100.0
(95.7 to 100.0)
Serotype 1
100.0
(95.5 to 100.0)
1.3
(0.0 to 6.9)
Serotype 3
100.0
(95.5 to 100.0)
12.0
(5.9 to 21.0)
Serotype 5
100.0
(95.5 to 100.0)
92.4
(84.2 to 97.2)
Serotype 6A
98.8
(93.2 to 100.0)
100.0
(95.7 to 100.0)
Serotype 7F
100.0
(95.4 to 100.0)
23.6
(13.2 to 37.0)
Serotype 19A
100.0
(95.5 to 100.0)
98.8
(93.5 to 100.0)
3.Other Pre-specified Outcome
Title Geometric Mean Concentration (GMC) of Serotype-specific IgG Antibody 1 Month After the Infant Series
Hide Description Antibody GMC along with corresponding 2-sided 95% CI 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. Geometric mean concentrations (GMCs) were calculated using all participants with available data for the specified blood draw.
Time Frame 1 month after the infant series (7 months of age)
Hide Outcome Measure Data
Hide Analysis Population Description
Evaluable Infant Immunogenicity Population
Arm/Group Title 13vPnC 7vPnC
Hide Arm/Group Description:
13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
Overall Number of Participants Analyzed 91 89
Geometric Mean (95% Confidence Interval)
Unit of Measure: Mcg/mL
Serotype 4
5.40
(4.62 to 6.30)
6.97
(5.94 to 8.18)
Serotype 6B
5.71
(4.64 to 7.03)
4.88
(3.96 to 6.01)
Serotype 9V
3.33
(2.90 to 3.83)
3.78
(3.31 to 4.33)
Serotype 14
14.83
(12.38 to 17.77)
16.29
(13.36 to 19.85)
Serotype 18C
4.57
(3.98 to 5.24)
4.73
(4.09 to 5.47)
Serotype 19F
3.88
(3.18 to 4.72)
4.20
(3.55 to 4.96)
Serotype 23F
4.29
(3.56 to 5.16)
4.11
(3.40 to 4.98)
Serotype 1
7.44
(6.25 to 8.85)
0.02
(0.02 to 0.03)
Serotype 3
1.60
(1.35 to 1.89)
0.04
(0.03 to 0.05)
Serotype 5
5.06
(4.37 to 5.85)
0.39
(0.30 to 0.49)
Serotype 6A
5.73
(4.64 to 7.07)
0.64
(0.49 to 0.82)
Serotype 7F
6.97
(6.07 to 8.00)
0.04
(0.03 to 0.05)
Serotype 19A
5.94
(5.13 to 6.89)
2.65
(2.29 to 3.06)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments Serotype 4: Ratio of geometric means (13vPnC, 7vPnC)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Student t distribution
Comments Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.
Method of Estimation Estimation Parameter Ratio of geometric means
Estimated Value 0.77
Confidence Interval (2-Sided) 95%
0.62 to 0.97
Estimation Comments CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments Serotype 6B: Ratio of geometric means (13vPnC, 7vPnC)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Student t distribution
Comments Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.
Method of Estimation Estimation Parameter Ratio of geometric means
Estimated Value 1.17
Confidence Interval (2-Sided) 95%
0.87 to 1.57
Estimation Comments CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments Serotype 9V: Ratio of geometric means (13vPnC, 7vPnC)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Student t distribution
Comments Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.
Method of Estimation Estimation Parameter Ratio of geometric means
Estimated Value 0.88
Confidence Interval (2-Sided) 95%
0.73 to 1.07
Estimation Comments CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments Serotype 14: Ratio of geometric means (13vPnC, 7vPnC)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Student t distribution
Comments Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.
Method of Estimation Estimation Parameter Ratio of geometric means
Estimated Value 0.91
Confidence Interval (2-Sided) 95%
0.70 to 1.19
Estimation Comments CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments Serotype 18C: Ratio of geometric means (13vPnC, 7vPnC)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Student t distribution
Comments Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.
Method of Estimation Estimation Parameter Ratio of geometric means
Estimated Value 0.97
Confidence Interval (2-Sided) 95%
0.79 to 1.18
Estimation Comments CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments Serotype 19F: Ratio of geometric means (13vPnC, 7vPnC)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Student t distribution
Comments Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.
Method of Estimation Estimation Parameter Ratio of geometric means
Estimated Value 0.92
Confidence Interval (2-Sided) 95%
0.71 to 1.19
Estimation Comments CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments Serotype 23F: Ratio of geometric means (13vPnC, 7vPnC)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Student t distribution
Comments Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.
Method of Estimation Estimation Parameter Ratio of geometric means
Estimated Value 1.04
Confidence Interval (2-Sided) 95%
0.80 to 1.36
Estimation Comments CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments Serotype 1: Ratio of geometric means (13vPnC, 7vPnC)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Student t distribution
Comments Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.
Method of Estimation Estimation Parameter Ratio of geometric means
Estimated Value 329.44
Confidence Interval (2-Sided) 95%
242.98 to 446.67
Estimation Comments CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).
Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments Serotype 3: Ratio of geometric means (13vPnC, 7vPnC)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Student t distribution
Comments Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.
Method of Estimation Estimation Parameter Ratio of geometric means
Estimated Value 40.79
Confidence Interval (2-Sided) 95%
30.27 to 54.97
Estimation Comments CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).
Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments Serotype 5: Ratio of geometric means (13vPnC, 7vPnC)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Student t distribution
Comments Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.
Method of Estimation Estimation Parameter Ratio of geometric means
Estimated Value 13.12
Confidence Interval (2-Sided) 95%
9.92 to 17.34
Estimation Comments CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).
Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments Serotype 6A: Ratio of geometric means (13vPnC, 7vPnC)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Student t distribution
Comments Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.
Method of Estimation Estimation Parameter Ratio of geometric means
Estimated Value 9.01
Confidence Interval (2-Sided) 95%
6.46 to 12.56
Estimation Comments CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).
Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments Serotype 7F: Ratio of geometric means (13vPnC, 7vPnC)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Student t distribution
Comments Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.
Method of Estimation Estimation Parameter Ratio of geometric means
Estimated Value 165.90
Confidence Interval (2-Sided) 95%
122.95 to 223.85
Estimation Comments CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).
Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments Serotype 19A: Ratio of geometric means (13vPnC, 7vPnC)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Student t distribution
Comments Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.
Method of Estimation Estimation Parameter Ratio of geometric means
Estimated Value 2.24
Confidence Interval (2-Sided) 95%
1.83 to 2.75
Estimation Comments CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).
4.Other Pre-specified Outcome
Title Geometric Mean Concentration (GMC) of Serotype-specific IgG Antibody 1 Month After the Toddler Dose
Hide Description Antibody GMC along with corresponding 2-sided 95% CI 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. Geometric mean concentrations (GMCs) were calculated using all participants with available data for the specified blood draw.
Time Frame 1 month after the Toddler Dose (13 months of age)
Hide Outcome Measure Data
Hide Analysis Population Description
Evaluable Toddler Immunogenicity Population
Arm/Group Title 13vPnC 7vPnC
Hide Arm/Group Description:
13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
Overall Number of Participants Analyzed 91 89
Geometric Mean (95% Confidence Interval)
Unit of Measure: Mcg/mL
Serotype 4
6.46
(5.29 to 7.90)
8.25
(6.88 to 9.89)
Serotype 6B
16.81
(14.36 to 19.68)
15.14
(11.91 to 19.25)
Serotype 9V
4.59
(3.91 to 5.38)
4.83
(4.12 to 5.67)
Serotype 14
11.51
(9.59 to 13.80)
15.64
(13.07 to 18.72)
Serotype 18C
6.86
(5.67 to 8.29)
7.44
(6.27 to 8.83)
Serotype 19F
7.75
(6.30 to 9.53)
5.35
(4.52 to 6.33)
Serotype 23F
10.95
(8.77 to 13.66)
10.44
(8.60 to 12.68)
Serotype 1
9.29
(7.65 to 11.28)
0.04
(0.03 to 0.05)
Serotype 3
1.65
(1.40 to 1.95)
0.10
(0.08 to 0.13)
Serotype 5
8.92
(7.62 to 10.45)
1.31
(1.09 to 1.56)
Serotype 6A
13.58
(11.28 to 16.36)
3.33
(2.67 to 4.14)
Serotype 7F
11.17
(9.33 to 13.37)
0.10
(0.07 to 0.14)
Serotype 19A
10.12
(8.55 to 11.98)
2.38
(2.04 to 2.78)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments Serotype 4: Ratio of geometric means (13vPnC, 7vPnC)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Student t distribution
Comments Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.
Method of Estimation Estimation Parameter Ratio of geometric means
Estimated Value 0.78
Confidence Interval (2-Sided) 95%
0.60 to 1.02
Estimation Comments CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments Serotype 6B: Ratio of geometric means (13vPnC, 7vPnC)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Student t distribution
Comments Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.
Method of Estimation Estimation Parameter Ratio of geometric means
Estimated Value 1.11
Confidence Interval (2-Sided) 95%
0.83 to 1.48
Estimation Comments CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments Serotype 9V: Ratio of geometric means (13vPnC, 7vPnC)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Student t distribution
Comments Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.
Method of Estimation Estimation Parameter Ratio of geometric means
Estimated Value 0.95
Confidence Interval (2-Sided) 95%
0.76 to 1.19
Estimation Comments CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments Serotype 14: Ratio of geometric means (13vPnC, 7vPnC)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Student t distribution
Comments Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.
Method of Estimation Estimation Parameter Ratio of geometric means
Estimated Value 0.74
Confidence Interval (2-Sided) 95%
0.57 to 0.95
Estimation Comments CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments Serotype 18C: Ratio of geometric means (13vPnC, 7vPnC)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Student t distribution
Comments Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.
Method of Estimation Estimation Parameter Ratio of geometric means
Estimated Value 0.92
Confidence Interval (2-Sided) 95%
0.72 to 1.19
Estimation Comments CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments Serotype 19F: Ratio of geometric means (13vPnC, 7vPnC)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Student t distribution
Comments Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.
Method of Estimation Estimation Parameter Ratio of geometric means
Estimated Value 1.45
Confidence Interval (2-Sided) 95%
1.11 to 1.88
Estimation Comments CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments Serotype 23F: Ratio of geometric means (13vPnC, 7vPnC)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Student t distribution
Comments Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.
Method of Estimation Estimation Parameter Ratio of geometric means
Estimated Value 1.05
Confidence Interval (2-Sided) 95%
0.78 to 1.40
Estimation Comments CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments Serotype 1: Ratio of geometric means (13vPnC, 7vPnC)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Student t distribution
Comments Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.
Method of Estimation Estimation Parameter Ratio of geometric means
Estimated Value 234.33
Confidence Interval (2-Sided) 95%
176.33 to 311.41
Estimation Comments CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).
Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments Serotype 3: Ratio of geometric means (13vPnC, 7vPnC)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Student t distribution
Comments Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.
Method of Estimation Estimation Parameter Ratio of geometric means
Estimated Value 16.63
Confidence Interval (2-Sided) 95%
12.19 to 22.69
Estimation Comments CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).
Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments Serotype 5: Ratio of geometric means (13vPnC, 7vPnC)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Student t distribution
Comments Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.
Method of Estimation Estimation Parameter Ratio of geometric means
Estimated Value 6.84
Confidence Interval (2-Sided) 95%
5.39 to 8.67
Estimation Comments CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).
Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments Serotype 6A: Ratio of geometric means (13vPnC, 7vPnC)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Student t distribution
Comments Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.
Method of Estimation Estimation Parameter Ratio of geometric means
Estimated Value 4.08
Confidence Interval (2-Sided) 95%
3.07 to 5.43
Estimation Comments CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).
Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments Serotype 7F: Ratio of geometric means (13vPnC, 7vPnC)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Student t distribution
Comments Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.
Method of Estimation Estimation Parameter Ratio of geometric means
Estimated Value 110.92
Confidence Interval (2-Sided) 95%
77.09 to 159.59
Estimation Comments CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).
Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments Serotype 19A: Ratio of geometric means (13vPnC, 7vPnC)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Student t distribution
Comments Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.
Method of Estimation Estimation Parameter Ratio of geometric means
Estimated Value 4.25
Confidence Interval (2-Sided) 95%
3.39 to 5.33
Estimation Comments CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).
5.Other Pre-specified Outcome
Title Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 1 (2 Months of Age)
Hide Description Pre-specified local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (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 (2.5 to 7.0 cm); Severe (greater than [>] 7.0 cm). Participants may be represented in more than 1 category.
Time Frame Within 4 days after dose 1 (2 months of age)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population: All participants who received at least 1 dose of the study vaccine; N=number of participants reporting yes for at least 1 day or no for all days; n=number of participants reporting the specific characteristic.
Arm/Group Title 13vPnC 7vPnC
Hide Arm/Group Description:
13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
Overall Number of Participants Analyzed 75 79
Measure Type: Number
Unit of Measure: percentage of participants
Tenderness: Any (n=23,26) 31.9 34.2
Tenderness: Significant (n=6,2) 8.8 2.8
Swelling: Any (n=14,18) 19.7 24.7
Swelling: Mild (n=8,18) 11.6 24.7
Swelling: Moderate (n=7,4) 10.1 5.7
Redness: Any (n=27,22) 37.5 29.3
Redness: Mild (n=23,19) 32.9 25.3
Redness: Moderate (n=4,3) 5.8 4.3
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments Comparison between treatments for any tenderness.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.862
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments Comparison between treatments for significant tenderness.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.157
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments Comparison between treatments for any swelling.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.550
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments Comparison between treatments for mild swelling.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.052
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments Comparison between treatments for moderate swelling.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.366
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments Comparison between treatments for any redness.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.301
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments Comparison between treatments for mild redness.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.362
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments Comparison between treatments for moderate redness.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.718
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
6.Other Pre-specified Outcome
Title Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 2 (4 Months of Age)
Hide Description Pre-specified local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling or redness present); Mild (0.5 cm to 2.0 cm); Moderate (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 dose 2 (4 months of age)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety; N=number of participants reporting yes for at least 1 day or no for all days; n=number of participants reporting the specific characteristic.
Arm/Group Title 13vPnC 7vPnC
Hide Arm/Group Description:
13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
Overall Number of Participants Analyzed 62 68
Measure Type: Number
Unit of Measure: percentage of participants
Tenderness: Any (n=23,24) 38.3 37.5
Tenderness: Significant (n=0,3) 0.0 5.0
Swelling: Any (n=22,18) 35.5 28.6
Swelling: Mild (n=18,15) 29.5 24.6
Swelling: Moderate (n=4,4) 7.1 6.6
Redness: Any (n=20,25) 32.8 38.5
Redness: Mild (n=18,24) 29.5 36.9
Redness: Moderate (n=4,3) 7.1 5.1
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments Comparison between treatments for any tenderness.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.99
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments Comparison between treatments for significant tenderness.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.245
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments Comparison between treatments for any swelling.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.447
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments Comparison between treatments for mild swelling.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.684
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments Comparison between treatments for moderate swelling.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.99
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments Comparison between treatments for any redness.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.578
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments Comparison between treatments for mild redness.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.451
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments Comparison between treatments for moderate redness.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.712
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
7.Other Pre-specified Outcome
Title Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 3 (6 Months of Age)
Hide Description Pre-specified local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling or redness present); Mild (0.5 cm to 2.0 cm); Moderate (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 dose 3 (6 months of age)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety; N=number of participants reporting yes for at least 1 day or no for all days; n=number of participants reporting the specific characteristic.
Arm/Group Title 13vPnC 7vPnC
Hide Arm/Group Description:
13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
Overall Number of Participants Analyzed 66 64
Measure Type: Number
Unit of Measure: percentage of participants
Tenderness: Any (n=15,16) 23.4 27.1
Tenderness: Significant (n=0,1) 0.0 1.9
Swelling: Any (n=18,14) 27.7 23.3
Swelling: Mild (n=13,13) 21.0 22.0
Swelling: Moderate (n=7,4) 11.3 7.0
Redness: Any (n=19,16) 30.2 26.2
Redness: Mild (n=12,15) 20.0 25.0
Redness: Moderate (n=7,3) 11.5 5.6
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments Comparison between treatments for any tenderness.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.681
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments Comparison between treatments for significant tenderness.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.482
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments Comparison between treatments for any swelling.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.683
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments Comparison between treatments for mild swelling.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.99
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments Comparison between treatments for moderate swelling.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.533
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments Comparison between treatments for any redness.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.692
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments Comparison between treatments for mild redness.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.662
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments Comparison between treatments for moderate redness.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.331
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
8.Other Pre-specified Outcome
Title Percentage of Participants Reporting Pre-specified Local Reactions: Toddler Dose (12 Months of Age)
Hide Description Pre-specified local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling or redness present); Mild (0.5 cm to 2.0 cm); Moderate (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 toddler dose (12 months of age)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety; N=number of participants reporting yes for at least 1 day or no for all days; n=number of participants reporting the specific characteristic.
Arm/Group Title 13vPnC 7vPnC
Hide Arm/Group Description:
13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
Overall Number of Participants Analyzed 57 57
Measure Type: Number
Unit of Measure: percentage of participants
Tenderness: Any (n=19,14) 33.9 25.9
Tenderness: Significant (n=3,1) 5.9 2.0
Swelling: Any (n=11,10) 22.4 18.9
Swelling: Mild (n=4,7) 8.2 13.5
Swelling: Moderate (n=9,4) 18.4 7.8
Swelling: Severe (n=1,0) 2.0 0.0
Redness: Any (n=15,12) 28.8 22.2
Redness: Mild (n=9,10) 17.6 18.5
Redness: Moderate (n=8,3) 16.0 6.0
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments Comparison between treatments for any tenderness.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.409
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments Comparison between treatments for significant tenderness.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.617
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments Comparison between treatments for any swelling.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.807
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments Comparison between treatments for mild swelling.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.527
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments Comparison between treatments for moderate swelling.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.144
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments Comparison between treatments for severe swelling.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.495
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments Comparison between treatments for any redness.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.506
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments Comparison between treatments for mild redness.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.99
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments Comparison between treatments for moderate redness.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.200
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
9.Other Pre-specified Outcome
Title Percentage of Participants Reporting Pre-specified Systemic Events: Infant Series Dose 1 (2 Months of Age)
Hide Description Pre-specified systemic events (any fever ≥ 38 degrees Celsius [C], decreased appetite, irritability, increased sleep, and decreased sleep) were reported using an electronic diary. Participants may be represented in more than 1 category.
Time Frame Within 4 days after dose 1 (2 months of age)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety; N=number of participants reporting yes for at least 1 day or no for all days; n=number of participants reporting the event.
Arm/Group Title 13vPnC 7vPnC
Hide Arm/Group Description:
13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
Overall Number of Participants Analyzed 83 86
Measure Type: Number
Unit of Measure: percentage of participants
Fever ≥38 degrees C but ≤39 degrees C (n=11,9) 15.9 12.5
Decreased appetite (n=23,22) 32.4 28.9
Irritability (n=38,56) 49.4 70.9
Increased sleep (n=37,30) 49.3 39.0
Decreased sleep (n=28,38) 37.8 50.0
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments Comparison between treatments for fever ≥38 degrees C but but less than or equal to (≤)39 degrees C.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.633
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments Comparison between treatments for decreased appetite.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.721
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments Comparison between treatments for irritability.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.009
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments Comparison between treatments for increased sleep.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.253
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments Comparison between treatments for decreased sleep.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.143
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
10.Other Pre-specified Outcome
Title Percentage of Participants Reporting Pre-specified Systemic Events: Infant Series Dose 2 (4 Months of Age)
Hide Description Pre-specified systemic events (any fever ≥ 38 degrees Celsius [C], decreased appetite, irritability, increased sleep, and decreased sleep) were reported using an electronic diary. Participants may be represented in more than 1 category.
Time Frame Within 4 days after dose 2 (4 months of age)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety; N=number of participants reporting yes for at least 1 day or no for all days; n=number of participants reporting the event.
Arm/Group Title 13vPnC 7vPnC
Hide Arm/Group Description:
13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
Overall Number of Participants Analyzed 64 72
Measure Type: Number
Unit of Measure: percentage of participants
Fever ≥38 degrees C but ≤39 degrees C (n=6,8) 10.9 13.1
Decreased appetite (n=16,28) 27.1 44.4
Irritability (n=25,36) 40.3 53.7
Increased sleep (n=17,16) 28.8 26.2
Decreased sleep (n=18,27) 30.0 40.9
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments Comparison between treatments for fever ≥38 degrees C but ≤39 degrees C.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.781
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments Comparison between treatments for decreased appetite.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.060
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments Comparison between treatments for irritability.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.159
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments Comparison between treatments for increased sleep.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.839
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments Comparison between treatments for decreased sleep.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.264
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
11.Other Pre-specified Outcome
Title Percentage of Participants Reporting Pre-specified Systemic Events: Infant Series Dose 3 (6 Months of Age)
Hide Description Pre-specified systemic events (any fever ≥ 38 degrees Celsius [C], decreased appetite, irritability, increased sleep, and decreased sleep) were reported using an electronic diary. Participants may be represented in more than 1 category.
Time Frame Within 4 days after dose 3 (6 months of age)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety; N=number of participants reporting yes for at least 1 day or no for all days; n=number of participants reporting the event.
Arm/Group Title 13vPnC 7vPnC
Hide Arm/Group Description:
13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
Overall Number of Participants Analyzed 65 64
Measure Type: Number
Unit of Measure: percentage of participants
Fever ≥38 degrees C but ≤39 degrees C (n=8,5) 13.6 9.3
Fever >39 degrees C but ≤40 degrees C (n=0,1) 0.0 2.0
Decreased appetite (n=14,16) 23.0 28.1
Irritability (n=13,25) 21.0 41.7
Increased sleep (n=18,12) 29.5 21.1
Decreased sleep (n=10,17) 16.4 29.3
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments Comparison between treatments for fever ≥38 degrees C but ≤39 degrees C.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.563
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments Comparison between treatments for fever >39 degrees C but ≤40 degrees C.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.468
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments Comparison between treatments for decreased appetite.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.535
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments Comparison between treatments for irritability.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.019
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments Comparison between treatments for increased sleep.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.398
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments Comparison between treatments for decreased sleep.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.125
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
12.Other Pre-specified Outcome
Title Percentage of Participants Reporting Pre-specified Systemic Events: Toddler Dose (12 Months of Age)
Hide Description Pre-specified systemic events (any fever ≥ 38 degrees Celsius [C], decreased appetite, irritability, increased sleep, and decreased sleep) were reported using an electronic diary. Participants may be represented in more than 1 category.
Time Frame Within 4 days after toddler dose (12 months of age)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety; N=number of participants reporting yes for at least 1 day or no for all days; n=number of participants reporting the event.
Arm/Group Title 13vPnC 7vPnC
Hide Arm/Group Description:
13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
Overall Number of Participants Analyzed 64 65
Measure Type: Number
Unit of Measure: percentage of participants
Fever ≥38 degrees C but ≤39 degrees C (n=7,10) 13.7 19.6
Fever >39 degrees C but ≤40 degrees C (n=1,0) 2.0 0.0
Decreased appetite (n=13,15) 22.8 27.8
Irritability (n=18,21) 30.5 37.5
Increased sleep (n=11,8) 21.2 15.4
Decreased sleep (n=11,20) 20.4 34.5
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments Comparison between treatments for fever ≥38 degrees C but ≤39 degrees C.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.596
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments Comparison between treatments for fever >39 degrees C but ≤40 degrees C.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.99
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments Comparison between treatments for decreased appetite.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.663
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments Comparison between treatments for irritability.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.439
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments Comparison between treatments for increased sleep.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.613
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments Comparison between treatments for decreased sleep.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.138
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Time Frame Baseline through 1 Month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=2 months of age; Dose 2=4 months of age; Dose 3=6 months of age; Toddler Dose=12 months of age.
Adverse Event Reporting Description Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
 
Arm/Group Title Infant Series 13vPnC Infant Series 7vPnC After the Infant Series 13vPnC After the Infant Series 7vPnC Toddler Dose 13vPnC Toddler Dose 7vPnC
Hide Arm/Group Description 13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series). 7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series). 13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series); assessment 1 month after the infant series (7 months of age). 7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series); assessment 1 month after the infant series (7 months of age). 13-valent pneumococcal conjugate vaccine (13vPnC) 0.5mL dose administered IM at 12 months of age (toddler dose). 7-valent pneumococcal conjugate vaccine (7vPnC ) 0.5mL dose administered IM at 12 months of age (toddler dose).
All-Cause Mortality
Infant Series 13vPnC Infant Series 7vPnC After the Infant Series 13vPnC After the Infant Series 7vPnC Toddler Dose 13vPnC Toddler Dose 7vPnC
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/--   --/-- 
Hide Serious Adverse Events
Infant Series 13vPnC Infant Series 7vPnC After the Infant Series 13vPnC After the Infant Series 7vPnC Toddler Dose 13vPnC Toddler Dose 7vPnC
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   8/88 (9.09%)   9/89 (10.11%)   9/88 (10.23%)   12/89 (13.48%)   3/84 (3.57%)   3/88 (3.41%) 
Gastrointestinal disorders             
Diarrhoea * 1  0/88 (0.00%)  1/89 (1.12%)  0/88 (0.00%)  0/89 (0.00%)  0/84 (0.00%)  0/88 (0.00%) 
Inguinal hernia * 1  0/88 (0.00%)  0/89 (0.00%)  1/88 (1.14%)  0/89 (0.00%)  0/84 (0.00%)  0/88 (0.00%) 
General disorders             
Soft tissue inflammation * 1  0/88 (0.00%)  0/89 (0.00%)  0/88 (0.00%)  0/89 (0.00%)  0/84 (0.00%)  1/88 (1.14%) 
Hepatobiliary disorders             
Hepatitis * 1  0/88 (0.00%)  0/89 (0.00%)  0/88 (0.00%)  1/89 (1.12%)  0/84 (0.00%)  0/88 (0.00%) 
Infections and infestations             
Bronchiolitis * 1  2/88 (2.27%)  4/89 (4.49%)  1/88 (1.14%)  1/89 (1.12%)  0/84 (0.00%)  0/88 (0.00%) 
Pneumonia * 1  3/88 (3.41%)  1/89 (1.12%)  1/88 (1.14%)  1/89 (1.12%)  1/84 (1.19%)  1/88 (1.14%) 
Urinary tract infection * 1  0/88 (0.00%)  2/89 (2.25%)  0/88 (0.00%)  1/89 (1.12%)  0/84 (0.00%)  0/88 (0.00%) 
Bronchitis * 1  1/88 (1.14%)  0/89 (0.00%)  1/88 (1.14%)  1/89 (1.12%)  1/84 (1.19%)  1/88 (1.14%) 
Bronchopneumonia * 1  0/88 (0.00%)  1/89 (1.12%)  0/88 (0.00%)  1/89 (1.12%)  0/84 (0.00%)  0/88 (0.00%) 
Gastroenteritis * 1  1/88 (1.14%)  0/89 (0.00%)  3/88 (3.41%)  2/89 (2.25%)  1/84 (1.19%)  0/88 (0.00%) 
Kawasaki's disease * 1  1/88 (1.14%)  0/89 (0.00%)  0/88 (0.00%)  0/89 (0.00%)  0/84 (0.00%)  0/88 (0.00%) 
Otitis media acute * 1  0/88 (0.00%)  0/89 (0.00%)  1/88 (1.14%)  3/89 (3.37%)  0/84 (0.00%)  0/88 (0.00%) 
Herpangina * 1  0/88 (0.00%)  0/89 (0.00%)  1/88 (1.14%)  1/89 (1.12%)  0/84 (0.00%)  0/88 (0.00%) 
Adenovirus infection * 1  0/88 (0.00%)  0/89 (0.00%)  0/88 (0.00%)  1/89 (1.12%)  0/84 (0.00%)  0/88 (0.00%) 
Bacterial infection * 1  0/88 (0.00%)  0/89 (0.00%)  0/88 (0.00%)  1/89 (1.12%)  0/84 (0.00%)  0/88 (0.00%) 
Exanthema subitum * 1  0/88 (0.00%)  0/89 (0.00%)  1/88 (1.14%)  0/89 (0.00%)  0/84 (0.00%)  0/88 (0.00%) 
Gastroenteritis rotavirus * 1  0/88 (0.00%)  0/89 (0.00%)  0/88 (0.00%)  1/89 (1.12%)  0/84 (0.00%)  0/88 (0.00%) 
Hand-foot-and-mouth disease * 1  0/88 (0.00%)  0/89 (0.00%)  1/88 (1.14%)  0/89 (0.00%)  0/84 (0.00%)  0/88 (0.00%) 
Influenza * 1  0/88 (0.00%)  0/89 (0.00%)  0/88 (0.00%)  1/89 (1.12%)  0/84 (0.00%)  0/88 (0.00%) 
Rhinitis * 1  0/88 (0.00%)  0/89 (0.00%)  0/88 (0.00%)  1/89 (1.12%)  0/84 (0.00%)  0/88 (0.00%) 
Tonsillitis * 1  0/88 (0.00%)  0/89 (0.00%)  0/88 (0.00%)  1/89 (1.12%)  0/84 (0.00%)  0/88 (0.00%) 
Pharyngitis * 1  0/88 (0.00%)  0/89 (0.00%)  0/88 (0.00%)  0/89 (0.00%)  0/84 (0.00%)  1/88 (1.14%) 
Metabolism and nutrition disorders             
Dehydration * 1  1/88 (1.14%)  0/89 (0.00%)  0/88 (0.00%)  0/89 (0.00%)  0/84 (0.00%)  0/88 (0.00%) 
Nervous system disorders             
Convulsion * 1  0/88 (0.00%)  1/89 (1.12%)  0/88 (0.00%)  0/89 (0.00%)  0/84 (0.00%)  0/88 (0.00%) 
Renal and urinary disorders             
Nephrolithiasis * 1  0/88 (0.00%)  0/89 (0.00%)  0/88 (0.00%)  1/89 (1.12%)  0/84 (0.00%)  0/88 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (Unspecified)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Infant Series 13vPnC Infant Series 7vPnC After the Infant Series 13vPnC After the Infant Series 7vPnC Toddler Dose 13vPnC Toddler Dose 7vPnC
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   78/88 (88.64%)   75/89 (84.27%)   18/88 (20.45%)   19/89 (21.35%)   28/84 (33.33%)   36/88 (40.91%) 
Blood and lymphatic system disorders             
Iron deficiency anaemia * 1  0/88 (0.00%)  0/89 (0.00%)  1/88 (1.14%)  4/89 (4.49%)  0/84 (0.00%)  0/88 (0.00%) 
Cardiac disorders             
Supraventricular tachycardia * 1  0/88 (0.00%)  1/89 (1.12%)  0/88 (0.00%)  0/89 (0.00%)  0/84 (0.00%)  0/88 (0.00%) 
Congenital, familial and genetic disorders             
Hydrocele * 1  0/88 (0.00%)  0/89 (0.00%)  1/88 (1.14%)  0/89 (0.00%)  0/84 (0.00%)  0/88 (0.00%) 
Ear and labyrinth disorders             
Middle ear effusion * 1  1/88 (1.14%)  0/89 (0.00%)  0/88 (0.00%)  0/89 (0.00%)  0/84 (0.00%)  0/88 (0.00%) 
Otorrhoea * 1  0/88 (0.00%)  1/89 (1.12%)  0/88 (0.00%)  0/89 (0.00%)  0/84 (0.00%)  0/88 (0.00%) 
Eye disorders             
Conjunctivitis * 1  4/88 (4.55%)  2/89 (2.25%)  0/88 (0.00%)  0/89 (0.00%)  1/84 (1.19%)  0/88 (0.00%) 
Dacryostenosis acquired * 1  2/88 (2.27%)  0/89 (0.00%)  0/88 (0.00%)  0/89 (0.00%)  0/84 (0.00%)  0/88 (0.00%) 
Blepharitis * 1  0/88 (0.00%)  1/89 (1.12%)  0/88 (0.00%)  0/89 (0.00%)  0/84 (0.00%)  0/88 (0.00%) 
Entropion * 1  0/88 (0.00%)  1/89 (1.12%)  0/88 (0.00%)  0/89 (0.00%)  0/84 (0.00%)  0/88 (0.00%) 
Eye discharge * 1  0/88 (0.00%)  1/89 (1.12%)  0/88 (0.00%)  0/89 (0.00%)  0/84 (0.00%)  0/88 (0.00%) 
Gastrointestinal disorders             
Diarrhoea * 1  10/88 (11.36%)  10/89 (11.24%)  3/88 (3.41%)  0/89 (0.00%)  1/84 (1.19%)  1/88 (1.14%) 
Vomiting * 1  2/88 (2.27%)  3/89 (3.37%)  0/88 (0.00%)  1/89 (1.12%)  0/84 (0.00%)  0/88 (0.00%) 
Constipation * 1  0/88 (0.00%)  1/89 (1.12%)  0/88 (0.00%)  0/89 (0.00%)  0/84 (0.00%)  1/88 (1.14%) 
Gastrooesophageal reflux disease * 1  1/88 (1.14%)  0/89 (0.00%)  0/88 (0.00%)  0/89 (0.00%)  0/84 (0.00%)  0/88 (0.00%) 
Intussusception * 1  1/88 (1.14%)  0/89 (0.00%)  0/88 (0.00%)  0/89 (0.00%)  0/84 (0.00%)  0/88 (0.00%) 
Regurgitation * 1  0/88 (0.00%)  1/89 (1.12%)  0/88 (0.00%)  0/89 (0.00%)  0/84 (0.00%)  0/88 (0.00%) 
Anal fissure * 1  0/88 (0.00%)  0/89 (0.00%)  0/88 (0.00%)  1/89 (1.12%)  0/84 (0.00%)  0/88 (0.00%) 
General disorders             
Pyrexia * 1  8/88 (9.09%)  4/89 (4.49%)  0/88 (0.00%)  1/89 (1.12%)  3/84 (3.57%)  2/88 (2.27%) 
Injection site erythema * 1  1/88 (1.14%)  0/89 (0.00%)  0/88 (0.00%)  0/89 (0.00%)  0/84 (0.00%)  0/88 (0.00%) 
Injection site induration * 1  1/88 (1.14%)  0/89 (0.00%)  0/88 (0.00%)  0/89 (0.00%)  0/84 (0.00%)  0/88 (0.00%) 
Irritability * 1  0/88 (0.00%)  1/89 (1.12%)  0/88 (0.00%)  0/89 (0.00%)  0/84 (0.00%)  0/88 (0.00%) 
Fever ≥ 38 degrees C but ≤ 39 degrees C  3 [1]  11/69 (15.94%)  9/72 (12.50%)  0/0  0/0  7/51 (13.73%)  10/51 (19.61%) 
Fever ≥ 38 degrees C but ≤ 39 degrees C  3 [2]  6/55 (10.91%)  8/61 (13.11%)  0/0  0/0  0/0  0/0 
Fever ≥ 38 degrees C but ≤ 39 degrees C  3 [3]  8/59 (13.56%)  5/54 (9.26%)  0/0  0/0  0/0  0/0 
Fever > 39 degrees C but ≤ 40 degrees C  3 [4]  0/67 (0.00%)  0/70 (0.00%)  0/0  0/0  1/50 (2.00%)  0/49 (0.00%) 
Fever > 39 degrees C but ≤ 40 degrees C  3 [5]  0/55 (0.00%)  0/58 (0.00%)  0/0  0/0  0/0  0/0 
Fever > 39 degrees C but ≤ 40 degrees C  3 [6]  0/58 (0.00%)  1/51 (1.96%)  0/0  0/0  0/0  0/0 
Fever > 40 degrees C  3 [7]  0/67 (0.00%)  0/70 (0.00%)  0/0  0/0  0/49 (0.00%)  0/49 (0.00%) 
Fever > 40 degrees C  3 [8]  0/55 (0.00%)  0/58 (0.00%)  0/0  0/0  0/0  0/0 
Fever > 40 degrees C  3 [9]  0/58 (0.00%)  0/51 (0.00%)  0/0  0/0  0/0  0/0 
Decreased appetite  3 [10]  23/71 (32.39%)  22/76 (28.95%)  0/0  0/0  13/57 (22.81%)  15/54 (27.78%) 
Decreased appetite  3 [11]  16/59 (27.12%)  28/63 (44.44%)  0/0  0/0  0/0  0/0 
Decreased appetite  3 [12]  14/61 (22.95%)  16/57 (28.07%)  0/0  0/0  0/0  0/0 
Irritability  3 [13]  38/77 (49.35%)  56/79 (70.89%)  0/0  0/0  18/59 (30.51%)  21/56 (37.50%) 
Irritability  3 [14]  25/62 (40.32%)  36/67 (53.73%)  0/0  0/0  0/0  0/0 
Irritability  3 [15]  13/62 (20.97%)  25/60 (41.67%)  0/0  0/0  0/0  0/0 
Increased sleep  3 [16]  37/75 (49.33%)  30/77 (38.96%)  0/0  0/0  11/52 (21.15%)  8/52 (15.38%) 
Increased sleep  3 [17]  17/59 (28.81%)  16/61 (26.23%)  0/0  0/0  0/0  0/0 
Increased sleep  3 [18]  18/61 (29.51%)  12/57 (21.05%)  0/0  0/0  0/0  0/0 
Decreased sleep  3 [19]  28/74 (37.84%)  38/76 (50.00%)  0/0  0/0  11/54 (20.37%)  20/58 (34.48%) 
Decreased sleep  3 [20]  18/60 (30.00%)  27/66 (40.91%)  0/0  0/0  0/0  0/0 
Decreased sleep  3 [21]  10/61 (16.39%)  17/58 (29.31%)  0/0  0/0  0/0  0/0 
Immune system disorders             
Atopy * 1  1/88 (1.14%)  0/89 (0.00%)  0/88 (0.00%)  0/89 (0.00%)  0/84 (0.00%)  0/88 (0.00%) 
Infections and infestations             
Upper respiratory tract infection * 1  24/88 (27.27%)  30/89 (33.71%)  3/88 (3.41%)  4/89 (4.49%)  7/84 (8.33%)  10/88 (11.36%) 
Bronchiolitis * 1  17/88 (19.32%)  9/89 (10.11%)  0/88 (0.00%)  0/89 (0.00%)  1/84 (1.19%)  0/88 (0.00%) 
Nasopharyngitis * 1  11/88 (12.50%)  17/89 (19.10%)  3/88 (3.41%)  0/89 (0.00%)  3/84 (3.57%)  9/88 (10.23%) 
Bronchitis * 1  10/88 (11.36%)  10/89 (11.24%)  2/88 (2.27%)  1/89 (1.12%)  1/84 (1.19%)  2/88 (2.27%) 
Gastroenteritis * 1  12/88 (13.64%)  7/89 (7.87%)  0/88 (0.00%)  0/89 (0.00%)  4/84 (4.76%)  2/88 (2.27%) 
Otitis media acute * 1  9/88 (10.23%)  5/89 (5.62%)  0/88 (0.00%)  1/89 (1.12%)  0/84 (0.00%)  4/88 (4.55%) 
Pharyngotonsillitis * 1  4/88 (4.55%)  1/89 (1.12%)  1/88 (1.14%)  1/89 (1.12%)  1/84 (1.19%)  3/88 (3.41%) 
Acute tonsillitis * 1  1/88 (1.14%)  2/89 (2.25%)  0/88 (0.00%)  0/89 (0.00%)  0/84 (0.00%)  1/88 (1.14%) 
Otitis media * 1  1/88 (1.14%)  2/89 (2.25%)  0/88 (0.00%)  0/89 (0.00%)  1/84 (1.19%)  0/88 (0.00%) 
Pharyngitis * 1  1/88 (1.14%)  1/89 (1.12%)  0/88 (0.00%)  0/89 (0.00%)  1/84 (1.19%)  2/88 (2.27%) 
Pneumonia * 1  2/88 (2.27%)  0/89 (0.00%)  0/88 (0.00%)  0/89 (0.00%)  0/84 (0.00%)  1/88 (1.14%) 
Varicella * 1  2/88 (2.27%)  0/89 (0.00%)  1/88 (1.14%)  0/89 (0.00%)  0/84 (0.00%)  0/88 (0.00%) 
Acute sinusitis * 1  0/88 (0.00%)  1/89 (1.12%)  0/88 (0.00%)  0/89 (0.00%)  0/84 (0.00%)  0/88 (0.00%) 
Bronchopneumonia * 1  1/88 (1.14%)  0/89 (0.00%)  0/88 (0.00%)  0/89 (0.00%)  0/84 (0.00%)  0/88 (0.00%) 
Candidiasis * 1  1/88 (1.14%)  0/89 (0.00%)  0/88 (0.00%)  0/89 (0.00%)  0/84 (0.00%)  0/88 (0.00%) 
Croup infectious * 1  1/88 (1.14%)  0/89 (0.00%)  0/88 (0.00%)  0/89 (0.00%)  0/84 (0.00%)  0/88 (0.00%) 
Diarrhoea infectious * 1  1/88 (1.14%)  0/89 (0.00%)  0/88 (0.00%)  0/89 (0.00%)  0/84 (0.00%)  0/88 (0.00%) 
Herpangina * 1  0/88 (0.00%)  1/89 (1.12%)  0/88 (0.00%)  1/89 (1.12%)  1/84 (1.19%)  2/88 (2.27%) 
Hordeolum * 1  1/88 (1.14%)  0/89 (0.00%)  0/88 (0.00%)  0/89 (0.00%)  0/84 (0.00%)  0/88 (0.00%) 
Oral candidiasis * 1  1/88 (1.14%)  0/89 (0.00%)  1/88 (1.14%)  0/89 (0.00%)  1/84 (1.19%)  1/88 (1.14%) 
Rhinitis * 1  0/88 (0.00%)  1/89 (1.12%)  0/88 (0.00%)  0/89 (0.00%)  1/84 (1.19%)  0/88 (0.00%) 
Sinusitis * 1  0/88 (0.00%)  1/89 (1.12%)  0/88 (0.00%)  0/89 (0.00%)  0/84 (0.00%)  0/88 (0.00%) 
Urinary tract infection * 1  0/88 (0.00%)  1/89 (1.12%)  0/88 (0.00%)  0/89 (0.00%)  0/84 (0.00%)  0/88 (0.00%) 
Viral diarrhoea * 1  1/88 (1.14%)  0/89 (0.00%)  0/88 (0.00%)  0/89 (0.00%)  0/84 (0.00%)  0/88 (0.00%) 
Viral rash * 1  0/88 (0.00%)  0/89 (0.00%)  0/88 (0.00%)  0/89 (0.00%)  1/84 (1.19%)  2/88 (2.27%) 
Laryngitis * 1  0/88 (0.00%)  0/89 (0.00%)  0/88 (0.00%)  0/89 (0.00%)  1/84 (1.19%)  0/88 (0.00%) 
Periorbital cellulit * 1  0/88 (0.00%)  0/89 (0.00%)  0/88 (0.00%)  0/89 (0.00%)  1/84 (1.19%)  0/88 (0.00%) 
Injury, poisoning and procedural complications             
Concussion * 1  0/88 (0.00%)  1/89 (1.12%)  0/88 (0.00%)  0/89 (0.00%)  0/84 (0.00%)  0/88 (0.00%) 
Joint dislocation * 1  0/88 (0.00%)  1/89 (1.12%)  0/88 (0.00%)  0/89 (0.00%)  0/84 (0.00%)  0/88 (0.00%) 
Joint sprain * 1  0/88 (0.00%)  1/89 (1.12%)  0/88 (0.00%)  0/89 (0.00%)  0/84 (0.00%)  0/88 (0.00%) 
Mouth injury * 1  0/88 (0.00%)  0/89 (0.00%)  0/88 (0.00%)  1/89 (1.12%)  0/84 (0.00%)  0/88 (0.00%) 
Investigations             
Urine output decreased * 1  1/88 (1.14%)  0/89 (0.00%)  0/88 (0.00%)  0/89 (0.00%)  0/84 (0.00%)  0/88 (0.00%) 
Weight decreased * 1  0/88 (0.00%)  1/89 (1.12%)  0/88 (0.00%)  0/89 (0.00%)  0/84 (0.00%)  0/88 (0.00%) 
Alanine aminotransferase increased * 1  0/88 (0.00%)  0/89 (0.00%)  1/88 (1.14%)  0/89 (0.00%)  0/84 (0.00%)  0/88 (0.00%) 
Aspartate aminotransferase increased * 1  0/88 (0.00%)  0/89 (0.00%)  1/88 (1.14%)  0/89 (0.00%)  0/84 (0.00%)  0/88 (0.00%) 
Metabolism and nutrition disorders             
Hypophagia * 1  1/88 (1.14%)  0/89 (0.00%)  0/88 (0.00%)  0/89 (0.00%)  0/84 (0.00%)  0/88 (0.00%) 
Psychiatric disorders             
Insomnia * 1  1/88 (1.14%)  0/89 (0.00%)  0/88 (0.00%)  0/89 (0.00%)  0/84 (0.00%)  0/88 (0.00%) 
Reproductive system and breast disorders             
Perineal fistula * 1  0/88 (0.00%)  1/89 (1.12%)  0/88 (0.00%)  0/89 (0.00%)  0/84 (0.00%)  0/88 (0.00%) 
Respiratory, thoracic and mediastinal disorders             
Rhinorrhoea * 1  16/88 (18.18%)  16/89 (17.98%)  1/88 (1.14%)  2/89 (2.25%)  5/84 (5.95%)  0/88 (0.00%) 
Cough * 1  11/88 (12.50%)  17/89 (19.10%)  2/88 (2.27%)  0/89 (0.00%)  2/84 (2.38%)  1/88 (1.14%) 
Productive cough * 1  3/88 (3.41%)  2/89 (2.25%)  0/88 (0.00%)  0/89 (0.00%)  0/84 (0.00%)  0/88 (0.00%) 
Nasal congestion * 1  2/88 (2.27%)  1/89 (1.12%)  0/88 (0.00%)  0/89 (0.00%)  0/84 (0.00%)  0/88 (0.00%) 
Dyspnoea * 1  1/88 (1.14%)  0/89 (0.00%)  0/88 (0.00%)  0/89 (0.00%)  0/84 (0.00%)  0/88 (0.00%) 
Grunting * 1  1/88 (1.14%)  0/89 (0.00%)  0/88 (0.00%)  0/89 (0.00%)  0/84 (0.00%)  0/88 (0.00%) 
Wheezing * 1  0/88 (0.00%)  1/89 (1.12%)  0/88 (0.00%)  0/89 (0.00%)  1/84 (1.19%)  0/88 (0.00%) 
Asthma * 1  0/88 (0.00%)  0/89 (0.00%)  0/88 (0.00%)  0/89 (0.00%)  1/84 (1.19%)  0/88 (0.00%) 
Upper airway obstruction * 1  0/88 (0.00%)  0/89 (0.00%)  0/88 (0.00%)  0/89 (0.00%)  1/84 (1.19%)  0/88 (0.00%) 
Skin and subcutaneous tissue disorders             
Dermatitis atopic * 1  8/88 (9.09%)  8/89 (8.99%)  2/88 (2.27%)  4/89 (4.49%)  0/84 (0.00%)  0/88 (0.00%) 
Eczema * 1  7/88 (7.95%)  3/89 (3.37%)  0/88 (0.00%)  0/89 (0.00%)  0/84 (0.00%)  0/88 (0.00%) 
Dermatitis diaper * 1  4/88 (4.55%)  2/89 (2.25%)  0/88 (0.00%)  0/89 (0.00%)  0/84 (0.00%)  0/88 (0.00%) 
Rash * 1  1/88 (1.14%)  6/89 (6.74%)  2/88 (2.27%)  0/89 (0.00%)  0/84 (0.00%)  1/88 (1.14%) 
Dermatitis * 1  2/88 (2.27%)  3/89 (3.37%)  0/88 (0.00%)  0/89 (0.00%)  0/84 (0.00%)  0/88 (0.00%) 
Urticaria * 1  0/88 (0.00%)  3/89 (3.37%)  0/88 (0.00%)  1/89 (1.12%)  0/84 (0.00%)  0/88 (0.00%) 
Heat rash * 1  2/88 (2.27%)  0/89 (0.00%)  0/88 (0.00%)  0/89 (0.00%)  0/84 (0.00%)  1/88 (1.14%) 
Rash papular * 1  1/88 (1.14%)  1/89 (1.12%)  0/88 (0.00%)  0/89 (0.00%)  0/84 (0.00%)  0/88 (0.00%) 
Skin erosion * 1  1/88 (1.14%)  1/89 (1.12%)  0/88 (0.00%)  0/89 (0.00%)  0/84 (0.00%)  0/88 (0.00%) 
Dermal cyst * 1  1/88 (1.14%)  0/89 (0.00%)  0/88 (0.00%)  0/89 (0.00%)  0/84 (0.00%)  0/88 (0.00%) 
Dermatitis allergic * 1  0/88 (0.00%)  1/89 (1.12%)  0/88 (0.00%)  0/89 (0.00%)  0/84 (0.00%)  0/88 (0.00%) 
Eczema infantile * 1  0/88 (0.00%)  1/89 (1.12%)  0/88 (0.00%)  0/89 (0.00%)  0/84 (0.00%)  0/88 (0.00%) 
Intertrigo * 1  1/88 (1.14%)  0/89 (0.00%)  0/88 (0.00%)  0/89 (0.00%)  0/84 (0.00%)  0/88 (0.00%) 
Rash erythematous * 1  1/88 (1.14%)  0/89 (0.00%)  0/88 (0.00%)  0/89 (0.00%)  0/84 (0.00%)  0/88 (0.00%) 
Rash vesicular * 1  1/88 (1.14%)  0/89 (0.00%)  0/88 (0.00%)  0/89 (0.00%)  0/84 (0.00%)  0/88 (0.00%) 
Tenderness (any)  2 [22]  23/72 (31.94%)  26/76 (34.21%)  0/0  0/0  19/56 (33.93%)  14/54 (25.93%) 
Tenderness (any)  2 [23]  23/60 (38.33%)  24/64 (37.50%)  0/0  0/0  0/0  0/0 
Tenderness (any)  2 [24]  15/64 (23.44%)  16/59 (27.12%)  0/0  0/0  0/0  0/0 
Tenderness (significant)  2 [25]  6/68 (8.82%)  2/72 (2.78%)  0/0  0/0  3/51 (5.88%)  1/50 (2.00%) 
Tenderness (significant)  2 [26]  0/55 (0.00%)  3/60 (5.00%)  0/0  0/0  0/0  0/0 
Tenderness (significant)  2 [27]  0/58 (0.00%)  1/54 (1.85%)  0/0  0/0  0/0  0/0 
Swelling (any)  2 [28]  14/71 (19.72%)  18/73 (24.66%)  0/0  0/0  11/49 (22.45%)  10/53 (18.87%) 
Swelling (any)  2 [29]  22/62 (35.48%)  18/63 (28.57%)  0/0  0/0  0/0  0/0 
Swelling (any) * 2 [30]  18/65 (27.69%)  14/60 (23.33%)  0/0  0/0  0/0  0/0 
Swelling (mild)  2 [31]  8/69 (11.59%)  18/73 (24.66%)  0/0  0/0  4/49 (8.16%)  7/52 (13.46%) 
Swelling (mild)  2 [32]  18/61 (29.51%)  15/61 (24.59%)  0/0  0/0  0/0  0/0 
Swelling (mild)  2 [33]  13/62 (20.97%)  13/59 (22.03%)  0/0  0/0  0/0  0/0 
Swelling (moderate)  2 [34]  7/69 (10.14%)  4/70 (5.71%)  0/0  0/0  9/49 (18.37%)  4/51 (7.84%) 
Swelling (moderate)  2 [35]  4/56 (7.14%)  4/61 (6.56%)  0/0  0/0  0/0  0/0 
Swelling (moderate)  2 [36]  7/62 (11.29%)  4/57 (7.02%)  0/0  0/0  0/0  0/0 
Swelling (severe)  2 [37]  0/67 (0.00%)  0/70 (0.00%)  0/0  0/0  1/49 (2.04%)  0/50 (0.00%) 
Swelling (severe)  2 [38]  0/55 (0.00%)  0/59 (0.00%)  0/0  0/0  0/0  0/0 
Swelling (severe)  2 [39]  0/58 (0.00%)  0/53 (0.00%)  0/0  0/0  0/0  0/0 
Redness (any)  2 [40]  27/72 (37.50%)  22/75 (29.33%)  0/0  0/0  15/52 (28.85%)  12/54 (22.22%) 
Redness (any)  2 [41]  20/61 (32.79%)  25/65 (38.46%)  0/0  0/0  0/0  0/0 
Redness (any)  2 [42]  19/63 (30.16%)  16/61 (26.23%)  0/0  0/0  0/0  0/0 
Redness (mild)  2 [43]  23/70 (32.86%)  19/75 (25.33%)  0/0  0/0  9/51 (17.65%)  10/54 (18.52%) 
Redness (mild)  2 [44]  18/61 (29.51%)  24/65 (36.92%)  0/0  0/0  0/0  0/0 
Redness (mild)  2 [45]  12/60 (20.00%)  15/60 (25.00%)  0/0  0/0  0/0  0/0 
Redness (moderate)  2 [46]  4/69 (5.80%)  3/70 (4.29%)  0/0  0/0  8/50 (16.00%)  3/50 (6.00%) 
Redness (moderate)  2 [47]  4/56 (7.14%)  3/59 (5.08%)  0/0  0/0  0/0  0/0 
Redness (moderate)  2 [48]  7/61 (11.48%)  3/54 (5.56%)  0/0  0/0  0/0  0/0 
Redness (severe)  2 [49]  0/67 (0.00%)  0/70 (0.00%)  0/0  0/0  0/49 (0.00%)  0/50 (0.00%) 
Redness (severe)  2 [50]  0/55 (0.00%)  0/59 (0.00%)  0/0  0/0  0/0  0/0 
Redness (severe)  2 [51]  0/58 (0.00%)  0/53 (0.00%)  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 (Unspecified)
2
Term from vocabulary, Local reactions
3
Term from vocabulary, Systemic Events
[1]
Infant Series Dose 1 and Toddler Dose; Fever 38 degrees C but 39 degrees C
[2]
Infant Series Dose 2; Fever 38 degrees C but 39 degrees C
[3]
Infant Series Dose 3; Fever 38 degrees C but 39 degrees C
[4]
Infant Series Dose 1 and Toddler Dose; Fever > 39 degrees C but 40 degrees C
[5]
Infant Series Dose 2; Fever > 39 degrees C but 40 degrees C
[6]
Infant Series Dose 3; Fever > 39 degrees C but 40 degrees C
[7]
Infant Series Dose 1 and Toddler Dose; Fever > 40 degrees C
[8]
Infant Series Dose 2; Fever > 40 degrees C
[9]
Infant Series Dose 3; Fever > 40 degrees 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)=present at site of vaccination
[24]
Infant Series Dose 3; tenderness (any)=present at site of vaccination
[25]
Infant Series Dose 1 and Toddler Dose; Tenderness (significant)=present and interfered with limb movement
[26]
Infant Series Dose 2; Tenderness (significant)=present and interfered with limb movement
[27]
Infant Series Dose 3; Tenderness (significant)=present and interfered with limb movement
[28]
Infant Series Dose 1 and Toddler Dose; Swelling (any)=present at site of vaccination
[29]
Infant Series Dose 2; Swelling (any)=present at site of vaccination
[30]
Infant Series Dose 3; Swelling (any)=present at site of vaccination
[31]
Infant Series Dose 1 and Toddler Dose; Swelling (mild)=0.5 to 2.0 cm
[32]
Infant Series Dose 2; Swelling (mild)=0.5 to 2.0 cm
[33]
Infant Series Dose 3; Swelling (mild)=0.5 to 2.0 cm
[34]
Infant Series Dose 1 and Toddler Dose; Swelling (moderate)=2.5 to 7.0 cm
[35]
Infant Series Dose 2; Swelling (moderate)=2.5 to 7.0 cm
[36]
Infant Series Dose 3; Swelling (moderate)=2.5 to 7.0 cm
[37]
Infant Series Dose 1 and Toddler Dose; Swelling (severe) >7.0 cm
[38]
Infant Series Dose 2; Swelling (severe) >7.0 cm
[39]
Infant Series Dose 3; Swelling (severe) >7.0 cm
[40]
Infant Series Dose 1 and Toddler Dose; Redness (any)=present at site of vaccination.
[41]
Infant Series Dose 2; Redness (any)=present at site of vaccination
[42]
Infant Series Dose 3; Redness (any)=present at site of vaccination
[43]
Infant Series Dose 1 and Toddler Dose; Redness (mild)=0.5 to 2.0 cm
[44]
Infant Series Dose 2; Redness (mild)=0.5 to 2.0 cm
[45]
Infant Series Dose 3; Redness (mild)=0.5 to 2.0 cm
[46]
Infant Series Dose 1 and Toddler Dose; Redness (moderate)=2.5 to 7.0 cm
[47]
Infant Series Dose 2; Redness (moderate)=2.5 to 7.0 cm
[48]
Infant Series Dose 3; Redness (moderate)=2.5 to 7.0 cm
[49]
Infant Series Dose 1 and Toddler Dose; Redness (severe) >7.0 cm
[50]
Infant Series Dose 2; Redness (severe) >7.0 cm
[51]
Infant Series Dose 3; Redness (severe) >7.0 cm
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Pfizer Clinical Trials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
EMail: ClinicalTrials.gov_Inquires@Pfizer.com
Layout table for additonal information
Responsible Party: Director, Clinical Trial Disclosure Group, Wyeth, Inc
ClinicalTrials.gov Identifier: NCT00689351    
Other Study ID Numbers: 6096A1-010
B1851001
First Submitted: May 29, 2008
First Posted: June 3, 2008
Results First Submitted: December 10, 2010
Results First Posted: January 11, 2011
Last Update Posted: June 28, 2011