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Study Evaluating Pneumococcal Vaccine in Healthy Infants

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ClinicalTrials.gov Identifier: NCT00205803
Recruitment Status : Completed
First Posted : September 20, 2005
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
Conditions Healthy Subjects
Pneumococcal Infections
Interventions Biological: 13-Valent Pneumococcal Conjugate Vaccine (13vPnC)
Biological: 7-Valent Pneumococcal Conjugate Vaccine (7vPnC)
Enrollment 249
Recruitment Details Participants were recruited in the United States from September 2004 to September 2005.
Pre-assignment Details Participants were enrolled into the study according to the inclusion/exclusion criteria without a screening period.
Arm/Group Title 13vPnC 7vPnC
Hide Arm/Group Description Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 13vPnC coadministered with ActHIB at 12-15 months of age (toddler dose). Participants received one single 0.5mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with ActHIB and Pediarix at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 7vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).
Period Title: Infant Series
Started 122 127
Vaccinated Dose 1 121 126
Vaccinated Dose 2 115 122
Vaccinated Dose 3 110 118
Completed 104 116
Not Completed 18 11
Reason Not Completed
Lost to Follow-up             10             4
Withdrawal by Subject             2             5
Physician Decision             3             1
Protocol Violation             1             0
Lost Kaiser coverage             0             1
Non-compliant             1             0
Sponsor request             1             0
Period Title: After Infant Series
Started 104 116
Completed 86 103
Not Completed 18 13
Reason Not Completed
Adverse Event             1             1
Protocol Violation             1             1
Lost to Follow-up             2             1
Physician Decision             3             2
Withdrawal by Subject             1             4
Other             10             4
Period Title: Toddler Dose
Started 86 103
Completed 84 100
Not Completed 2 3
Reason Not Completed
Lost to Follow-up             2             3
Arm/Group Title 13vPnC 7vPnC Total
Hide Arm/Group Description Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 13vPnC coadministered with ActHIB at 12-15 months of age (toddler dose). Participants received one single 0.5mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with ActHIB and Pediarix at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 7vPnC coadministered with ActHIB at 12-15 months of age (toddler dose). Total of all reporting groups
Overall Number of Baseline Participants 121 126 247
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Weeks
Number Analyzed 121 participants 126 participants 247 participants
9.2  (1.4) 9.1  (1.2) 9.2  (1.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 121 participants 126 participants 247 participants
Female
58
  47.9%
59
  46.8%
117
  47.4%
Male
63
  52.1%
67
  53.2%
130
  52.6%
1.Primary Outcome
Title Percentage of Participants Reporting Pre-Specified Local Reactions
Hide Description Local reaction events were collected using a paper worksheet. Tenderness was scaled as Any (tenderness present); Significant (Sig.) (present and interfered with limb movement). Induration and erythema were scaled as Any (induration or erythema present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (Mod.)(2.5 to 7.0 cm); Severe (Sev.)(> 7.0 cm). Participants may be represented in more than 1 category.
Time Frame Within 15 days after each dose
Show Outcome Measure DataHide 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 with known values.
Arm/Group Title 13vPnC Dose 1 7vPnc Dose 1 13vPnC Dose 2 7vPnC Dose 2 13vPnC Dose 3 7vPnC Dose 3 13vPnC Toddler Dose 7vPnC Toddler Dose
Hide Arm/Group Description:
Participants received one single 0.5mL dose of 13vPnC coadministered with Pediarix and ActHIB at 2 months of age (infant series Dose 1).
Participants received one single 0.5mL dose of 7vPnC coadministered with Pediarix and ActHIB at 2 months of age (infant series Dose 1).
Participants received one single 0.5mL dose of 13vPnC coadministered with Pediarix and ActHIB at 4 months of age (infant series Dose 2).
Participants received one single 0.5mL dose of 7vPnC coadministered with Pediarix and ActHIB at 4 months of age (infant series Dose 2).
Participants received one single 0.5mL dose of 13vPnC coadministered with Pediarix and ActHIB at 6 months of age (infant series Dose 3).
Participants received one single 0.5mL dose of 7vPnC coadministered with Pediarix and ActHIB at 6 months of age (infant series Dose 3).
Participants received one single 0.5mL dose of 13vPnC coadministered with ActHIB at 12 to 15 months of age (toddler dose).
Participants received one single 0.5mL dose of 7vPnC coadministered with ActHIB at 12 to 15 months of age (toddler dose).
Overall Number of Participants Analyzed 121 126 115 122 110 118 86 103
Measure Type: Number
Unit of Measure: percentage of participants
Tenderness-Any (n=119,124,110,118,107,117,85,101) 34.5 43.5 28.2 36.4 24.3 25.6 22.4 29.7
Tenderness-Sig. (n=119,124,110,118,107,117,85,101) 8.4 5.6 1.8 8.5 4.7 6.0 2.4 4.0
Induration-Any (n=119,124,110,118,107,117,85,100) 21.8 19.4 16.4 19.5 16.8 18.8 18.8 17.0
Induration-Mild (n=119,123,110,117,107,116,85,100) 20.2 17.9 16.4 17.1 16.8 17.2 18.8 17.0
Induration-Mod. (n=119,123,110,117,107,116,85,100) 3.4 2.4 3.6 3.4 0.0 4.3 2.4 3.0
Induration-Sev. (n=119,123,110,117,107,116,85,100) 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
Erythema-Any (n=119,124,111,118,107,117, 85,100) 21.0 19.4 16.2 17.8 17.8 19.7 24.7 19.0
Erythema-Mild (n=119,124,110,117,106,116,85,99) 20.2 19.4 13.6 17.1 16.0 18.1 24.7 16.2
Erythema-Mod. (n=119,124,108,117,106,116,85,99) 2.5 0.0 2.8 0.0 0.9 2.6 3.5 5.1
Erythema-Severe (n=119,124,108,117,106,116,85,99) 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
2.Primary Outcome
Title Percentage of Participants Reporting Pre-Specified Systemic Events
Hide Description Systemic events (fever [Fv] ≥ 38 degrees Celsius [C] but ≤ 39 C, fever >39 C but ≤ 40 C, fever > 40 C, decreased (decr.) appetite, irritability, increased sleep, decreased sleep, use of medication (Med.)to prevent symptoms (sx), and use of medication to treat symptoms) were reported using a paper worksheet. Participants may be represented in more than 1 category.
Time Frame Within 15 days after each dose
Show Outcome Measure DataHide 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 with known values.
Arm/Group Title 13vPnC Dose 1 7vPnc Dose 1 13vPnC Dose 2 7vPnC Dose 2 13vPnC Dose 3 7vPnC Dose 3 13vPnC Toddler Dose 7vPnC Toddler Dose
Hide Arm/Group Description:
Participants received one single 0.5mL dose of 13vPnC coadministered with Pediarix and ActHIB at 2 months of age (infant series Dose 1).
Participants received one single 0.5mL dose of 7vPnC coadministered with Pediarix and ActHIB at 2 months of age (infant series Dose 1).
Participants received one single 0.5mL dose of 13vPnC coadministered with Pediarix and ActHIB at 4 months of age (infant series Dose 2).
Participants received one single 0.5mL dose of 7vPnC coadministered with Pediarix and ActHIB at 4 months of age (infant series Dose 2).
Participants received one single 0.5mL dose of 13vPnC coadministered with Pediarix and ActHIB at 6 months of age (infant series Dose 3).
Participants received one single 0.5mL dose of 7vPnC coadministered with Pediarix and ActHIB at 6 months of age (infant series Dose 3).
Participants received one single 0.5mL dose of 13vPnC coadministered with ActHIB at 12 to 15 months of age (toddler dose).
Participants received one single 0.5mL dose of 7vPnC coadministered with ActHIB at 12 to 15 months of age (toddler dose).
Overall Number of Participants Analyzed 121 126 115 122 110 118 86 103
Measure Type: Number
Unit of Measure: percentage of participants
Fv ≥38°C but≤39°C(n=114,121,102,114,100,113,78,94) 16.7 16.5 21.6 24.6 20.0 20.4 14.1 12.8
Fv >39°C but≤40°C(n=113,121,102,113,101,113,77,94) 2.7 0.8 3.9 3.5 2.0 0.9 2.6 0.0
Fv >40°C (n=113,121,102,113,100,113,76,94) 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
Decr. Appetite (n=118,124,110,118,107,117,85,101) 30.5 31.5 22.7 22.9 27.1 30.8 22.4 21.8
Decr. Sleep (n=118,124,110,118,107,117,84,101) 18.6 17.7 24.5 19.5 21.5 18.8 13.1 14.9
Increased Sleep (n=119,124,111,118,107,117,86,101) 56.3 54.0 42.3 46.6 34.6 41.0 27.9 43.6
Irritability (n=118,124,110,118,107,117,85,101) 66.9 71.0 62.7 56.8 51.4 53.8 38.8 47.5
Med.-Prevent Sx (n=95,101,86,96,83,93,85,102) 29.5 33.7 34.9 32.3 36.1 43.0 17.6 35.3
Med.-Treat Symptoms (n=94,101,86,96,84,94,85,101) 44.7 34.7 48.8 50.0 42.9 47.9 29.4 27.7
3.Primary Outcome
Title Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series
Hide Description Percentage 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. Exact 2-sided CI based on the observed proportion of participants.
Time Frame one month after 3-dose infant series (at 7 months of age)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Evaluable immunogenicity (per protocol) population consisting of eligible participants who adhered to protocol requirements, had valid and determinate assay results, and had no other major protocol violations; (n)=number of participants with a determinate postinfant series IgG antibody concentration to the given serotype.
Arm/Group Title 13vPnC 7vPnC
Hide Arm/Group Description:
Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 13vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).
Participants received one single 0.5mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with ActHIB and Pediarix at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 7vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).
Overall Number of Participants Analyzed 94 108
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Common Serotypes - Serotype 4 (n=94,107)
96.81
(90.96 to 99.34)
99.07
(94.90 to 99.98)
Common Serotypes - Serotype 6B (n=94,107)
88.30
(80.03 to 94.01)
88.79
(81.23 to 94.07)
Common Serotypes - Serotype 9V (n=94,108)
96.81
(90.96 to 99.34)
99.07
(94.95 to 99.98)
Common Serotypes - Serotype 14 (n=94,107)
97.87
(92.52 to 99.74)
97.20
(92.02 to 99.42)
Common Serotypes - Serotype 18C (n=94,106)
96.81
(90.96 to 99.34)
99.06
(94.86 to 99.98)
Common Serotypes - Serotype 19F (n=94,106)
97.87
(92.52 to 99.74)
97.17
(91.95 to 99.41)
Common Serotypes - Serotype 23F (n=94,108)
94.68
(88.02 to 98.25)
95.37
(89.53 to 98.48)
Additional Serotypes - Serotype 1 (n=94,108)
97.87
(92.52 to 99.74)
25.00
(17.17 to 34.25)
Additional Serotypes - Serotype 3 (n=94,107)
98.94
(94.21 to 99.97)
14.02
(8.06 to 22.07)
Additional Serotypes - Serotype 5 (n=93,107)
100.00
(96.11 to 100.00)
42.06
(32.58 to 51.99)
Additional Serotypes - Serotype 6A (n=93,106)
96.77
(90.86 to 99.33)
33.96
(25.04 to 43.80)
Additional Serotypes - Serotype 7F (n=94,105)
98.94
(94.21 to 99.97)
6.67
(2.72 to 13.25)
Additional Serotypes - Serotype 19A (n=94,107)
100.00
(96.15 to 100.00)
94.39
(88.19 to 97.91)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments For serotype 4 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference
Estimated Value -2.26
Confidence Interval (2-Sided) 95%
-8.08 to 2.33
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments For serotype 6B the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference
Estimated Value -0.49
Confidence Interval (2-Sided) 95%
-9.93 to 8.65
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments For serotype 9V the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference
Estimated Value -2.27
Confidence Interval (2-Sided) 95%
-8.07 to 2.26
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments For serotype 14 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference
Estimated Value 0.68
Confidence Interval 95%
-4.96 to 6.16
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments For serotype 18C the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference
Estimated Value -2.25
Confidence Interval 95%
-8.18 to 2.36
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments For serotype 19F the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference
Estimated Value 0.70
Confidence Interval 95%
-4.84 to 6.32
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments For serotype 23F the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference
Estimated Value -0.69
Confidence Interval 95%
-7.75 to 5.86
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments For serotype 1 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference
Estimated Value 72.87
Confidence Interval 95%
63.32 to 81.07
Estimation Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments For serotype 3 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference
Estimated Value 84.92
Confidence Interval 95%
76.73 to 91.05
Estimation Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments For serotype 5 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference
Estimated Value 57.94
Confidence Interval 95%
48.01 to 67.42
Estimation Comments [Not Specified]
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments For serotype 6A the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference
Estimated Value 62.81
Confidence Interval 95%
52.33 to 72.20
Estimation Comments [Not Specified]
Show Statistical Analysis 12 Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments For serotype 7F the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference
Estimated Value 92.27
Confidence Interval 95%
85.26 to 96.54
Estimation Comments [Not Specified]
Show Statistical Analysis 13 Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments For serotype 19A the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference
Estimated Value 5.61
Confidence Interval 95%
1.23 to 11.86
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose
Hide Description Percentages of participants achieving 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. Exact 2-sided CI based on the observed proportion of participants.
Time Frame One month after the toddler dose (at 13 to 16 months of age)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The All-Available Toddler Immunogenicity population consisted of eligible participants who had at least 1 valid and determinate assay result related to the proposed analysis; (n)=number of participants with a determinate posttoddler dose IgG antibody concentration to the given serotype.
Arm/Group Title 13vPnC 7vPnC
Hide Arm/Group Description:
Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 13vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).
Participants received one single 0.5mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with ActHIB and Pediarix at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 7vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).
Overall Number of Participants Analyzed 85 102
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Common Serotypes - Serotype 4 (n=78,94)
97.4
(91.0 to 99.7)
98.9
(94.2 to 100.0)
Common Serotypes - Serotype 6B (n=78,93)
100.0
(95.4 to 100.0)
100.0
(96.1 to 100.0)
Common Serotypes - Serotype 9V (n=78,94)
98.7
(93.1 to 100.0)
100.0
(96.2 to 100.0)
Common Serotypes - Serotype 14 (n=78,93)
100.0
(95.4 to 100.0)
100.0
(96.1 to 100.0)
Common Serotypes - Serotype 18C (n=78,94)
100.0
(95.4 to 100.0)
100.0
(96.2 to 100.0)
Common Serotypes - Serotype 19F (n=78,93)
100.0
(95.4 to 100.0)
100.0
(96.1 to 100.0)
Common Serotypes - Serotype 23F (n=78,93)
100.0
(95.4 to 100.0)
97.8
(92.4 to 99.7)
Additional Serotypes - Serotype 1 (n=78,91)
100.00
(95.4 to 100.00)
2.2
(0.3 to 7.7)
Additional Serotypes - Serotype 3 (n=78,92)
92.3
(84.0 to 97.1)
8.7
(3.8 to 16.4)
Additional Serotypes - Serotype 5 (n=78,78)
100.0
(95.4 to 100.0)
70.5
(59.1 to 80.3)
Additional Serotypes - Serotype 6A (n=78,92)
100.0
(95.4 to 100.0)
88.0
(79.6 to 93.9)
Additional Serotypes - Serotype 7F (n=78,85)
100.0
(95.4 to 100.0)
5.9
(1.9 to 13.2)
Additional Serotypes - Serotype 19A (n=78,93)
100.0
(95.4 to 100.0)
100.0
(96.1 to 100.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments For serotype 4 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference
Estimated Value -1.5
Confidence Interval 95%
-7.9 to 3.6
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments For serotype 6B the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference
Estimated Value 0.0
Confidence Interval 95%
-4.6 to 4.0
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments For serotype 9V the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference
Estimated Value -1.3
Confidence Interval 95%
-6.9 to 2.8
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments For serotype 14 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference
Estimated Value 0.0
Confidence Interval 95%
-4.6 to 4.0
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments For serotype 18C the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference
Estimated Value 0.0
Confidence Interval 95%
-4.7 to 3.9
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments For serotype 19F the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference
Estimated Value 0.0
Confidence Interval 95%
-4.6 to 4.0
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments For serotype 23F the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference
Estimated Value 2.2
Confidence Interval 95%
-2.6 to 7.7
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments For serotype 1 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference
Estimated Value 97.8
Confidence Interval 95%
92.3 to 99.7
Estimation Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments For serotype 3 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference
Estimated Value 83.6
Confidence Interval 95%
73.2 to 90.8
Estimation Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments For serotype 5 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference
Estimated Value 29.5
Confidence Interval 95%
19.7 to 40.9
Estimation Comments [Not Specified]
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments For serotype 6A the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference
Estimated Value 12.0
Confidence Interval 95%
5.9 to 20.4
Estimation Comments [Not Specified]
Show Statistical Analysis 12 Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments For serotype 7F the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference
Estimated Value 94.1
Confidence Interval 95%
86.8 to 98.1
Estimation Comments [Not Specified]
Show Statistical Analysis 13 Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments For serotype 19A the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference
Estimated Value 0.0
Confidence Interval 95%
-4.6 to 4.0
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Geometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series
Hide Description Antibody geometric mean concentration (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. GMC ratios (13vPnC/7vPnC) and corresponding 2-sided 95% CI were evaluated.
Time Frame One month after 3-dose infant series (at 7 months of age)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Evaluable immunogenicity (per protocol) population consisting of eligible participants who adhered to protocol requirements, had valid and determinate assay results, and had no other major protocol violations;(n)=number of participants with a determinate antibody concentration for the specified serotype.
Arm/Group Title 13vPnC 7vPnC
Hide Arm/Group Description:
Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 13vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).
Participants received one single 0.5mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with ActHIB and Pediarix at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 7vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).
Overall Number of Participants Analyzed 94 108
Geometric Mean (95% Confidence Interval)
Unit of Measure: μg/mL
Common Serotypes - Serotype 4 (n=94,107)
1.81
(1.54 to 2.13)
2.40
(2.01 to 2.87)
Common Serotypes - Serotype 6B (n=94,107)
2.74
(2.02 to 3.71)
2.86
(2.09 to 3.91)
Common Serotypes - Serotype 9V (n=94,108)
1.52
(1.29 to 1.78)
1.78
(1.55 to 2.05)
Common Serotypes - Serotype 14 (n=94,107)
4.24
(3.44 to 5.23)
5.19
(4.13 to 6.52)
Common Serotypes - Serotype 18C (n=94,106)
1.53
(1.30 to 1.80)
2.46
(2.08 to 2.91)
Common Serotypes - Serotype 19F (n=94,106)
2.21
(1.87 to 2.61)
2.58
(2.17 to 3.08)
Common Serotypes - Serotype 23F (n=94,108)
1.39
(1.15 to 1.67)
1.81
(1.51 to 2.19)
Additional Serotypes - Serotype 1 (n=94,108)
2.57
(2.14 to 3.08)
0.06
(0.05 to 0.09)
Additional Serotypes - Serotype 3 (n=94,107)
1.40
(1.20 to 1.62)
0.09
(0.07 to 0.11)
Additional Serotypes - Serotype 5 (n=93,107)
2.41
(2.07 to 2.80)
0.28
(0.22 to 0.34)
Additional Serotypes - Serotype 6A (n=93,106)
2.36
(1.89 to 2.94)
0.25
(0.20 to 0.30)
Additional Serotypes - Serotype 7F (n=94,105)
1.85
(1.62 to 2.11)
0.07
(0.06 to 0.08)
Additional Serotypes - Serotype 19A (n=94,107)
1.93
(1.64 to 2.27)
1.12
(0.96 to 1.32)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments For serotype 4 the GMC ratio (13vPnC/7vPnC) was calculated
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 0.76
Confidence Interval 95%
0.59 to 0.96
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments For serotype 6B the GMC ratio (13vPnC/7vPnC) was calculated
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 0.96
Confidence Interval 95%
0.62 to 1.48
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments For serotype 9V the GMC ratio (13vPnC/7vPnC) was calculated
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference
Estimated Value 0.85
Confidence Interval 95%
0.69 to 1.05
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments For serotype 14 the GMC ratio (13vPnC/7vPnC) was calculated
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 0.82
Confidence Interval 95%
0.60 to 1.11
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments For serotype 18C the GMC ratio (13vPnC/7vPnC) was calculated
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 0.62
Confidence Interval 95%
0.49 to 0.79
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments For serotype 19F the GMC ratio (13vPnC/7vPnC) was calculated
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 0.86
Confidence Interval 95%
0.67 to 1.09
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments For serotype 23F the GMC ratio (13vPnC/7vPnC) was calculated
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 0.77
Confidence Interval 95%
0.59 to 1.00
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments For serotype 1 the GMC ratio (13vPnC/7vPnC) was calculated
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 39.78
Confidence Interval 95%
27.47 to 57.63
Estimation Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments For serotype 3 the GMC ratio (13vPnC/7vPnC) was calculated
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 15.56
Confidence Interval 95%
11.63 to 20.81
Estimation Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments For serotype 5 the GMC ratio (13vPnC/7vPnC) was calculated
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 8.67
Confidence Interval 95%
6.65 to 11.29
Estimation Comments [Not Specified]
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments For serotype 6A the GMC ratio (13vPnC/7vPnC) was calculated
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 9.60
Confidence Interval 95%
7.07 to 13.04
Estimation Comments [Not Specified]
Show Statistical Analysis 12 Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments For serotype 7F the GMC ratio (13vPnC/7vPnC) was calculated
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 26.78
Confidence Interval 95%
20.97 to 34.22
Estimation Comments [Not Specified]
Show Statistical Analysis 13 Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments For serotype 19A the GMC ratio (13vPnC/7vPnC) was calculated
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 1.71
Confidence Interval 95%
1.36 to 2.16
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Geometric Mean Concentration in 13vPnC Group Relative to 7vPnC Group Before and After the Toddler Dose
Hide Description Antibody geometric mean concentration (GMC) as measured by ELISA with their corresponding 95% CI immediately before and after the toddler dose 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 Immediately before (12 to 15 months of age) and one month after the toddler dose (13 to 16 months of age)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All-Available Toddler Immunogenicity population consisted of eligible participants who had at least 1 valid and determinate assay result related to proposed analysis;(n)= number of participants with a determinate antibody concentration for the specified serotype.
Arm/Group Title 13vPnC Before Toddler Dose 7vPnC Before Toddler Dose 13vPnC After Toddler Dose 7vPnC After Toddler Dose
Hide Arm/Group Description:
Participants received one single 0.5mL dose of 13vPnC coadministered with ActHIB and Pediarix at 2, 4, 6 months (infant series).
Participants received one single 0.5mL dose of 7vPnC coadministered with ActHIB and Pediarix at 2, 4, 6 months (infant series).
Participants received one single 0.5mL dose of 13vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).
Participants received one single 0.5mL dose of 7vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).
Overall Number of Participants Analyzed 85 102 85 102
Geometric Mean (95% Confidence Interval)
Unit of Measure: μg/mL
Common Serotypes-Serotype 4 (n=83,100,78,94)
0.33
(0.28 to 0.40)
0.48
(0.41 to 0.56)
2.86
(2.31 to 3.55)
4.09
(3.34 to 5.00)
Common Serotypes-Serotype 6B (n=82,98,78,93)
0.84
(0.69 to 1.03)
0.95
(0.77 to 1.18)
11.03
(8.78 to 13.86)
11.85
(9.63 to 14.56)
Common Serotypes-Serotype 9V (n=83,100,78,94)
0.43
(0.37 to 0.51)
0.43
(0.37 to 0.50)
2.55
(2.15 to 3.02)
2.75
(2.37 to 3.18)
Common Serotypes-Serotype 14 (n=83,100,78,93)
1.59
(1.27 to 2.00)
2.00
(1.66 to 2.41)
7.68
(6.08 to 9.70)
10.24
(8.23 to 12.74)
Common Serotypes-Serotype 18C (n=83,100,78,94)
0.25
(0.22 to 0.30)
0.40
(0.34 to 0.46)
2.57
(2.08 to 3.18)
4.08
(3.42 to 4.87)
Common Serotypes-Serotype 19F (n=82,100,78,93)
0.81
(0.66 to 1.00)
0.60
(0.49 to 0.72)
6.34
(5.06 to 7.94)
3.97
(3.26 to 4.85)
Common Serotypes-Serotype 23F (n=83,100,78,93)
0.29
(0.24 to 0.36)
0.38
(0.31 to 0.47)
3.36
(2.70 to 4.18)
4.79
(3.86 to 5.94)
Additional Serotypes-Serotype 1 (n=83,90,78,91)
0.68
(0.56 to 0.82)
0.04
(0.03 to 0.04)
3.44
(2.79 to 4.23)
0.03
(0.03 to 0.04)
Additional Serotypes-Serotype 3 (n=83,98,78,92)
0.27
(0.23 to 0.32)
0.09
(0.07 to 0.12)
1.11
(0.94 to 1.33)
0.10
(0.08 to 0.12)
Additional Serotypes-Serotype 5 (n=83,92,78,78)
1.01
(0.87 to 1.18)
0.40
(0.31 to 0.50)
3.92
(3.27 to 4.69)
0.56
(0.45 to 0.70)
Additional Serotypes-Serotype 6A (n=82,96,78,92)
0.81
(0.68 to 0.96)
0.27
(0.22 to 0.33)
8.06
(6.60 to 9.85)
1.68
(1.27 to 2.21)
Additional Serotypes-Serotype 7F (n=83,91,78,85)
0.58
(0.50 to 0.67)
0.04
(0.03 to 0.05)
2.67
(2.26 to 3.16)
0.05
(0.04 to 0.06)
Additional Serotypes-Serotype19A (n=83,100,78,93)
0.85
(0.67 to 1.09)
0.64
(0.52 to 0.79)
5.60
(4.60 to 6.83)
2.82
(2.32 to 3.41)
7.Secondary Outcome
Title Percentage of Participants Achieving Predefined Antibody Levels for Haemophilus Influenzae Type b, Diphtheria Toxoid, Polio, Pertussis, Tetanus, and Hepatitis B in 13vPnC Group Relative to 7vPnC Group After the Infant Series
Hide Description Percentage of participants achieving predefined antibody threshold levels for Haemophilus Influenzae Type b (Hib) polyribosylribitol phosphate (PRP), Diphtheria Toxoid, Polio (Types 1, 2, and 3), Pertussis (filamentous hemagglutinin [FHA], Pertussis Toxoid, and Pertactin), Tetanus, and Hepatitis B with the corresponding 95% CI for each concomitant antigen are presented.
Time Frame One month after the infant series (7 months of age)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Evaluable immunogenicity (per protocol) population consisting of eligible participants who adhered to protocol requirements, had valid and determinate assay results, and had no other major protocol violations;(n)=number of participants with a determinate postinfant series antibody level to the given concomitant vaccine component.
Arm/Group Title 13vPnC 7vPnC
Hide Arm/Group Description:
Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 13vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).
Participants received one single 0.5mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with ActHIB and Pediarix at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 7vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).
Overall Number of Participants Analyzed 94 108
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
Hib (PRP) 0.15 μg/mL (n=84,87)
89.29
(80.63 to 94.98)
86.21
(77.15 to 92.66)
Hib (PRP) 1.0 μg/mL (n=84,87)
70.24
(59.27 to 79.73)
63.22
(52.20 to 73.31)
Diphtheria 0.01 IU/mL (n=38,48)
100.00
(90.75 to 100.00)
100.00
(92.60 to 100.00)
Diphtheria 0.1 IU/mL (n=38,48)
100.00
(90.75 to 100.00)
100.00
(92.60 to 100.00)
Tetanus 0.01 IU/mL (n=38,48)
100.00
(90.75 to 100.00)
100.00
(92.60 to 100.00)
Tetanus 0.1 IU/mL (n=38,48)
100.00
(90.75 to 100.00)
100.00
(92.60 to 100.00)
Polio Type 1 (antibody threshold ≥1:8) (n=61,64)
100.00
(94.13 to 100.00)
100.00
(94.40 to 100.00)
Polio Type 2 (antibody threshold ≥1:8) (n=61,64)
98.36
(91.20 to 99.96)
100.00
(9.40 to 100.00)
Polio Type 3 (antibody threshold ≥1:8) (n=61,63)
98.36
(91.20 to 99.96)
100.00
(94.31 to 100.00)
Hepatitis b 10 mIU/mL (n=38,48)
100.00
(90.75 to 100.00)
100.00
(92.60 to 100.00)
Pertussis - FHA 82.00 EU/MI (n=65,68)
93.85
(84.99 to 98.30)
95.59
(87.64 to 99.08)
Pertussis - Pertussis Toxoid 43.00 EU/mL (n=65,68)
89.23
(79.06 to 95.56)
95.59
(87.64 to 99.08)
Pertussis - Pertactin 18.00 EU/mL (n=65,68)
96.92
(89.32 to 99.63)
95.59
(87.64 to 99.08)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments For Haemophilus influenzae type b the difference in percentage between the two groups (13vPnC - 7vPnC) at 0.15 µg/mL threshold was calculated
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference
Estimated Value 3.08
Confidence Interval 95%
-7.22 to 13.73
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments For Haemophilus influenzae type b the difference in percentage between the two groups (13vPnC - 7vPnC) at 1.0 µg/mL threshold was calculated
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference
Estimated Value 7.02
Confidence Interval 95%
-7.28 to 21.14
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments For Diphtheria the difference in percentage between the two groups (13vPnC - 7vPnC) at 0.01 IU/mL and 0.1 IU/mL thresholds was calculated
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference
Estimated Value 0.00
Confidence Interval 95%
-9.38 to 7.73
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments For Tetanus the difference in percentage between the two groups (13vPnC - 7vPnC) at 0.01 IU/mL and 0.1 IU/mL thresholds was calculated
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference
Estimated Value 0.00
Confidence Interval 95%
-9.38 to 7.73
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments For Polio Type 1 the difference in percentage between the two groups (13vPnC - 7vPnC) at 1:8 threshold was calculated
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference
Estimated Value 0.00
Confidence Interval 95%
-5.97 to 5.68
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments For Polio Type 2 the difference in percentage between the two groups (13vPnC - 7vPnC) at 1:8 threshold was calculated
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference
Estimated Value -1.64
Confidence Interval 95%
-8.80 to 4.24
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments For Polio Type 3 the difference in percentage between the two groups (13vPnC - 7vPnC) at 1:8 threshold was calculated
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference
Estimated Value -1.64
Confidence Interval 95%
-8.80 to 4.21
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments For Hepatitis b the difference in percentage between the two groups (13vPnC - 7vPnC) at 10 mIU/mL threshold was calculated
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference
Estimated Value 0.00
Confidence Interval 95%
-9.38 to 7.73
Estimation Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments For Pertussis - FHA the difference in percentage between the two groups (13vPnC - 7vPnC) at 82.00 EU/MI threshold was calculated
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference
Estimated Value -1.74
Confidence Interval 95%
-11.00 to 6.99
Estimation Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments For Pertussis - PT the difference in percentage between the two groups (13vPnC - 7vPnC) at 43.00 EU/mL threshold was calculated
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference
Estimated Value -6.36
Confidence Interval 95%
-17.03 to 3.16
Estimation Comments [Not Specified]
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments For Pertussis - Pertactin the difference in percentage between the two groups (13vPnC - 7vPnC) at 18.00 EU/mL threshold was calculated
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference
Estimated Value 1.33
Confidence Interval 95%
-6.79 to 9.68
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Geometric Mean Antibody Concentration of Haemophilus Influenzae Type b in 13vPnC Group Relative to 7vPnC Group After the Infant Series
Hide Description [Not Specified]
Time Frame one month after the infant series (7 months of age)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Evaluable immunogenicity (per protocol) population consisting of eligible participants who adhered to protocol requirements, had valid and determinate assay results, and had no other major protocol violations; (N)= number of participants with a determinate antibody concentration for the specified concomitant vaccine component.
Arm/Group Title 13vPnC 7vPnC
Hide Arm/Group Description:
Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 13vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).
Participants received one single 0.5mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with ActHIB and Pediarix at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 7vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).
Overall Number of Participants Analyzed 84 87
Geometric Mean (95% Confidence Interval)
Unit of Measure: μg/mL
1.99
(1.34 to 2.97)
1.64
(1.09 to 2.47)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 1.21
Confidence Interval (2-Sided) 95%
0.69 to 2.14
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Geometric Mean Antibody Concentration of Hepatitis B in 13vPnC Group Relative to 7vPnC Group After the Infant Series
Hide Description GMCs of anti-hepatitis B surface antigen (HBsAg) using a Food and Drug Administration (FDA) approved in vitro diagnostic kit are presented.
Time Frame one month after the infant series (7 months of age)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Evaluable immunogenicity (per protocol) population consisting of eligible participants who adhered to protocol requirements, had valid and determinate assay results, and had no other major protocol violations; (N)=number of participants with a determinate antibody concentration for the specified concomitant vaccine component.
Arm/Group Title 13vPnC 7vPnC
Hide Arm/Group Description:
Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 13vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).
Participants received one single 0.5mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with ActHIB and Pediarix at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 7vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).
Overall Number of Participants Analyzed 38 48
Geometric Mean (95% Confidence Interval)
Unit of Measure: milli International Units (mIU)/mL
1257.74
(904.77 to 1748.42)
1300.01
(976.91 to 1729.99)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 0.97
Confidence Interval (2-Sided) 95%
0.63 to 1.48
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Geometric Mean Antibody Concentration Diphtheria Toxoid and Anti-Tetanus Toxoid in 13vPnC Group Relative to 7vPnC Group After the Infant Series
Hide Description [Not Specified]
Time Frame one month after the infant series (7 months of age)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Evaluable immunogenicity (per protocol) population consisting of eligible participants who adhered to protocol requirements, had valid and determinate assay results, and had no other major protocol violations; (N)=number of participants with a determinate antibody concentration for the specified concomitant vaccine component.
Arm/Group Title 13vPnC 7vPnC
Hide Arm/Group Description:
Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series).
Participants received one single 0.5mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with ActHIB and Pediarix at 2, 4, 6 months (infant series).
Overall Number of Participants Analyzed 38 48
Geometric Mean (95% Confidence Interval)
Unit of Measure: IU/mL
Diphtheria Toxoid
0.86
(0.65 to 1.14)
1.04
(0.80 to 1.34)
Anti-Tetanus Toxoid
0.93
(0.72 to 1.22)
0.97
(0.73 to 1.28)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 0.83
Confidence Interval (2-Sided) 95%
0.57 to 1.21
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Geometric Mean Antibody Concentration of Polio in 13vPnC Group Relative to 7vPnC Group After the Infant Series
Hide Description [Not Specified]
Time Frame one month after the infant series (7 months of age)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Evaluable immunogenicity (per protocol) population consisting of eligible participants who adhered to protocol requirements, had valid and determinate assay results, and had no other major protocol violations; (n)= number of participants with a postinfant series blood sample.
Arm/Group Title 13vPnC 7vPnC
Hide Arm/Group Description:
Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 13vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).
Participants received one single 0.5mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with ActHIB and Pediarix at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 7vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).
Overall Number of Participants Analyzed 94 108
Geometric Mean (95% Confidence Interval)
Unit of Measure: titer
Polio Type 1 (n=61,64)
483.72
(352.52 to 663.75)
479.79
(361.79 to 636.26)
Polio Type 2 (n=61,64)
368.26
(250.75 to 540.84)
403.45
(249.90 to 551.96)
Polio Type 3 (n=61,63)
914.01
(638.80 to 1307.80)
812.75
(577.32 to 1144.18)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments Polio Type 1
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 1.01
Confidence Interval (2-Sided) 95%
0.66 to 1.53
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments Polio Type 2
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 0.91
Confidence Interval (2-Sided) 95%
0.56 to 1.49
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments Polio Type 3
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 1.12
Confidence Interval (2-Sided) 95%
0.69 to 1.84
Estimation Comments [Not Specified]
12.Secondary Outcome
Title Geometric Mean Antibody Concentration of Pertussis Antigens in 13vPnC Group Relative to 7vPnC Group After the Infant Series
Hide Description [Not Specified]
Time Frame one month after the infant series (7 months of age)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Evaluable immunogenicity (per protocol) population consisting of eligible participants who adhered to protocol requirements, had valid and determinate assay results, and had no other major protocol violations; (N)= number of participants with a determinate antibody concentration for the specified concomitant vaccine component.
Arm/Group Title 13vPnC 7vPnC
Hide Arm/Group Description:
Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 13vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).
Participants received one single 0.5mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with ActHIB and Pediarix at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 7vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).
Overall Number of Participants Analyzed 65 68
Geometric Mean (95% Confidence Interval)
Unit of Measure: EU/mL
Pertussis - filamentous hemagglutinin (FHA)
207.85
(178.72 to 241.74)
225.12
(191.97 to 264.01)
Pertussis - pertussis toxoid (PT)
98.68
(82.89 to 117.49)
96.58
(86.45 to 107.89)
Pertussis - pertactin
141.23
(113.02 to 176.48)
135.51
(107.13 to 171.41)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments Pertussis - FHA
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 0.92
Confidence Interval (2-Sided) 95%
0.74 to 1.15
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments Pertussis - PT
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 1.02
Confidence Interval (2-Sided) 95%
0.83 to 1.25
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments Pertussis - Pertactin
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 1.04
Confidence Interval (2-Sided) 95%
0.76 to 1.44
Estimation Comments [Not Specified]
13.Secondary Outcome
Title Percentage of Participants Achieving Antibody Titer (OPA) ≥1:8 in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series
Hide Description Percentage of participants achieving functional antibody titer ≥1:8 as measured by opsonophagocytic activity assay (OPA) 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 infant series (7 months of age)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Evaluable immunogenicity (per protocol) population consisting of eligible participants who adhered to protocol requirements, had valid and determinate assay results, and had no other major protocol violations;(n)=number of participants with a determinate postinfant series antibody titer to the given serotype.
Arm/Group Title 13vPnC 7vPnC
Hide Arm/Group Description:
Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 13vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).
Participants received one single 0.5mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with ActHIB and Pediarix at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 7vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).
Overall Number of Participants Analyzed 94 108
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
Common Serotypes - Serotype 4 (n=30,33)
96.67
(82.78 to 99.92)
100.00
(89.42 to 100.00)
Common Serotypes - Serotype 6B (n=27,30)
92.59
(75.71 to 99.09)
93.33
(77.93 to 99.18)
Common Serotypes - Serotype 9V (n=27,27)
100.00
(87.23 to 100.00)
100.00
(87.23 to 100.00)
Common Serotypes - Serotype 14 (n=27,30)
100.00
(87.23 to 100.00)
100.00
(88.43 to 100.00)
Common Serotypes - Serotype 18C (n=27,30)
100.00
(87.23 to 100.00)
96.67
(82.78 to 99.92)
Common Serotypes - Serotype 19F (n=25,25)
84.00
(63.92 to 95.46)
80.00
(59.30 to 93.17)
Common Serotypes - Serotype 23F (n=27,26)
92.59
(75.71 to 99.09)
100.00
(86.77 to 100.00)
Additional Serotypes - Serotype 1 (n=30,32)
83.33
(65.28 to 94.36)
6.25
(0.77 to 20.81)
Additional Serotypes - Serotype 3 (n=25,29)
80.00
(59.30 to 93.17)
3.45
(0.09 to 17.76)
Additional Serotypes - Serotype 5 (n=30,33)
100.00
(88.43 to 100.00)
6.06
(0.74 to 20.23)
Additional Serotypes - Serotype 6A (n=25,29)
96.00
(79.65 to 99.90)
48.28
(29.45 to 67.47)
Additional Serotypes - Serotype 7F (n=22,24)
100.00
(84.56 to 100.00)
20.83
(7.13 to 42.15)
Additional Serotypes - Serotype 19A (n=22,24)
77.27
(54.63 to 92.18)
12.50
(2.66 to 32.36)
14.Secondary Outcome
Title Percentage of Participants Achieving Antibody Titer (OPA) ≥1:8 in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose
Hide Description Percentage of participants achieving functional antibody titer ≥1:8 as measured by opsonophagocytic activity assay (OPA) 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) were assessed. Results are reported for the serotypes with a determinate antibody titer.
Time Frame One month after the toddler dose (13 to 16 months of age)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All-available (per protocol) population consisting of eligible participants who had at least 1 valid and determinate assay result related to the proposed analysis; (n)= number of participants with determinant posttoddler dose antibody titer to the given serotype.
Arm/Group Title 13vPnC 7vPnC
Hide Arm/Group Description:
Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 13vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).
Participants received one single 0.5mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with ActHIB and Pediarix at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 7vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).
Overall Number of Participants Analyzed 85 102
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
Additional Serotypes - Serotype 6A (n=73,70)
100.00
(95.1 to 100.00)
90.0
(80.5 to 95.9)
Additional Serotypes - Serotype 19A (n=71,72)
100.00
(94.9 to 100.00)
51.4
(39.3 to 63.3)
15.Secondary Outcome
Title Geometric Mean Antibody Titer (OPA) in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose
Hide Description Antibody functionality/geometric mean titer (GMT) as measured by opsonophagocytic activity assay (OPA) 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) were assessed. Results are reported for the serotypes with a determinate antibody titer.
Time Frame One month after the Toddler Dose (13 to 16 months of age)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All-available (per protocol) population consisting of eligible participants who had at least 1 valid and determinate assay result related to the proposed analysis; (n)=number of participants with a determinant antibody titer for the specified serotype.
Arm/Group Title 13vPnC 7vPnC
Hide Arm/Group Description:
Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 13vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).
Participants received one single 0.5mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with ActHIB and Pediarix at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 7vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).
Overall Number of Participants Analyzed 85 102
Geometric Mean (95% Confidence Interval)
Unit of Measure: titer
Additional Serotypes - Serotype 6A (n=73,70)
2147.58
(1630.73 to 2828.23)
599.90
(375.83 to 957.54)
Additional Serotypes - Serotype 19A (n=71,72)
802.24
(633.92 to 1015.24)
36.62
(21.09 to 63.59)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 13vPnC Infant Series 7vPnC Infant Series 13vPnC Toddler Dose 7vPnC Toddler Dose 13vPnC 6-Month Follow-up 7vPnC 6-Month Follow-up
Hide Arm/Group Description Participants received one single 0.5mL dose of 13vPnC coadministered with ActHIB and Pediarix at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 7vPnC coadministered with ActHIB and Pediarix at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 13vPnC coadministered with ActHIB at 12 to 15 months of age (toddler dose). Participants received one single 0.5mL dose of 7vPnC coadministered with ActHIB at 12 to 15 months of age (toddler dose). Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 13vPnC coadministered with ActHIB at 12-15 months of age (toddler dose). Participants received one single 0.5mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with ActHIB and Pediarix at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 7vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).
All-Cause Mortality
13vPnC Infant Series 7vPnC Infant Series 13vPnC Toddler Dose 7vPnC Toddler Dose 13vPnC 6-Month Follow-up 7vPnC 6-Month Follow-up
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
13vPnC Infant Series 7vPnC Infant Series 13vPnC Toddler Dose 7vPnC Toddler Dose 13vPnC 6-Month Follow-up 7vPnC 6-Month Follow-up
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   9/120 (7.50%)   9/126 (7.14%)   1/86 (1.16%)   0/103 (0.00%)   4/86 (4.65%)   1/103 (0.97%) 
Blood and lymphatic system disorders             
Leukocytosis *  1/120 (0.83%)  0/126 (0.00%)  0/86 (0.00%)  0/103 (0.00%)  0/86 (0.00%)  0/103 (0.00%) 
Lymphadenitis *  1/120 (0.83%)  0/126 (0.00%)  0/86 (0.00%)  0/103 (0.00%)  0/86 (0.00%)  0/103 (0.00%) 
Congenital, familial and genetic disorders             
Chairi I malformation *  1/120 (0.83%)  0/126 (0.00%)  0/86 (0.00%)  0/103 (0.00%)  0/86 (0.00%)  0/103 (0.00%) 
Gastrointestinal disorders             
Gastroenteritis *  1/120 (0.83%)  1/126 (0.79%)  0/86 (0.00%)  0/103 (0.00%)  0/86 (0.00%)  0/103 (0.00%) 
Rotaviral diarrhea *  0/120 (0.00%)  1/126 (0.79%)  0/86 (0.00%)  0/103 (0.00%)  0/86 (0.00%)  0/103 (0.00%) 
Vomiting *  1/120 (0.83%)  0/126 (0.00%)  0/86 (0.00%)  0/103 (0.00%)  0/86 (0.00%)  0/103 (0.00%) 
General disorders             
Irritability *  1/120 (0.83%)  0/126 (0.00%)  0/86 (0.00%)  0/103 (0.00%)  0/86 (0.00%)  0/103 (0.00%) 
Infections and infestations             
Bilateral otitis media *  1/120 (0.83%)  0/126 (0.00%)  0/86 (0.00%)  0/103 (0.00%)  0/86 (0.00%)  0/103 (0.00%) 
Bronchiolitis *  3/120 (2.50%)  3/126 (2.38%)  0/86 (0.00%)  0/103 (0.00%)  1/86 (1.16%)  0/103 (0.00%) 
Bronchiolitis RSV *  1/120 (0.83%)  0/126 (0.00%)  0/86 (0.00%)  0/103 (0.00%)  0/86 (0.00%)  0/103 (0.00%) 
Cystitis *  1/120 (0.83%)  0/126 (0.00%)  0/86 (0.00%)  0/103 (0.00%)  0/86 (0.00%)  0/103 (0.00%) 
Febrile illness (fever) *  0/120 (0.00%)  1/126 (0.79%)  0/86 (0.00%)  0/103 (0.00%)  0/86 (0.00%)  0/103 (0.00%) 
Fever of unknown origin *  1/120 (0.83%)  0/126 (0.00%)  0/86 (0.00%)  0/103 (0.00%)  1/86 (1.16%)  0/103 (0.00%) 
Otitis media *  1/120 (0.83%)  0/126 (0.00%)  0/86 (0.00%)  0/103 (0.00%)  0/86 (0.00%)  0/103 (0.00%) 
Pneumococcal meningitis *  0/120 (0.00%)  1/126 (0.79%)  0/86 (0.00%)  0/103 (0.00%)  0/86 (0.00%)  0/103 (0.00%) 
Staphylococcal infection (hand) *  1/120 (0.83%)  0/126 (0.00%)  0/86 (0.00%)  0/103 (0.00%)  0/86 (0.00%)  0/103 (0.00%) 
Urinary tract infection *  0/120 (0.00%)  1/126 (0.79%)  0/86 (0.00%)  0/103 (0.00%)  0/86 (0.00%)  0/103 (0.00%) 
Viral URI *  0/120 (0.00%)  0/126 (0.00%)  0/86 (0.00%)  0/103 (0.00%)  1/86 (1.16%)  0/103 (0.00%) 
Viral conjunctivitis *  0/120 (0.00%)  0/126 (0.00%)  1/86 (1.16%)  0/103 (0.00%)  0/86 (0.00%)  0/103 (0.00%) 
Viral respiratory infection *  0/120 (0.00%)  0/126 (0.00%)  1/86 (1.16%)  0/103 (0.00%)  0/86 (0.00%)  0/103 (0.00%) 
Metabolism and nutrition disorders             
Dehydration *  2/120 (1.67%)  2/126 (1.59%)  0/86 (0.00%)  0/103 (0.00%)  0/86 (0.00%)  0/103 (0.00%) 
Hypoglycemia *  1/120 (0.83%)  0/126 (0.00%)  0/86 (0.00%)  0/103 (0.00%)  0/86 (0.00%)  0/103 (0.00%) 
Nervous system disorders             
Complex febrile seizure *  0/120 (0.00%)  0/126 (0.00%)  0/86 (0.00%)  0/103 (0.00%)  1/86 (1.16%)  0/103 (0.00%) 
Febrile seizure *  1/120 (0.83%)  0/126 (0.00%)  0/86 (0.00%)  0/103 (0.00%)  0/86 (0.00%)  0/103 (0.00%) 
Seizure *  0/120 (0.00%)  0/126 (0.00%)  0/86 (0.00%)  0/103 (0.00%)  1/86 (1.16%)  0/103 (0.00%) 
Sensory integration disorder *  1/120 (0.83%)  0/126 (0.00%)  0/86 (0.00%)  0/103 (0.00%)  0/86 (0.00%)  0/103 (0.00%) 
Tethered cord syndrome *  1/120 (0.83%)  0/126 (0.00%)  0/86 (0.00%)  0/103 (0.00%)  0/86 (0.00%)  0/103 (0.00%) 
Respiratory, thoracic and mediastinal disorders             
Asthma exacerbation *  0/120 (0.00%)  0/126 (0.00%)  0/86 (0.00%)  0/103 (0.00%)  1/86 (1.16%)  1/103 (0.97%) 
Pneumonia right middle lobe *  0/120 (0.00%)  1/126 (0.79%)  0/86 (0.00%)  0/103 (0.00%)  0/86 (0.00%)  0/103 (0.00%) 
RSV positive bronchiolitis *  0/120 (0.00%)  1/126 (0.79%)  0/86 (0.00%)  0/103 (0.00%)  1/86 (1.16%)  0/103 (0.00%) 
Right upper and left lower lobe pneumonia *  0/120 (0.00%)  1/126 (0.79%)  0/86 (0.00%)  0/103 (0.00%)  0/86 (0.00%)  0/103 (0.00%) 
Status asthmaticus *  0/120 (0.00%)  0/126 (0.00%)  1/86 (1.16%)  0/103 (0.00%)  2/86 (2.33%)  0/103 (0.00%) 
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
13vPnC Infant Series 7vPnC Infant Series 13vPnC Toddler Dose 7vPnC Toddler Dose 13vPnC 6-Month Follow-up 7vPnC 6-Month Follow-up
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   104/120 (86.67%)   110/126 (87.30%)   33/86 (38.37%)   51/103 (49.51%)   20/86 (23.26%)   33/103 (32.04%) 
Blood and lymphatic system disorders             
Leukocytosis *  1/120 (0.83%)  0/126 (0.00%)  0/86 (0.00%)  0/103 (0.00%)  0/86 (0.00%)  0/103 (0.00%) 
Anaemia *  0/120 (0.00%)  0/126 (0.00%)  1/86 (1.16%)  2/103 (1.94%)  0/86 (0.00%)  1/103 (0.97%) 
Congenital, familial and genetic disorders             
Plagiocephaly *  2/120 (1.67%)  3/126 (2.38%)  0/86 (0.00%)  0/103 (0.00%)  0/86 (0.00%)  0/103 (0.00%) 
Dacryostenosis congenital *  2/120 (1.67%)  1/126 (0.79%)  0/86 (0.00%)  0/103 (0.00%)  0/86 (0.00%)  0/103 (0.00%) 
Ankyloglossia congenital *  1/120 (0.83%)  0/126 (0.00%)  0/86 (0.00%)  0/103 (0.00%)  0/86 (0.00%)  0/103 (0.00%) 
Macrocephaly *  1/120 (0.83%)  0/126 (0.00%)  0/86 (0.00%)  0/103 (0.00%)  0/86 (0.00%)  0/103 (0.00%) 
Thalassaemia alpha *  0/120 (0.00%)  0/126 (0.00%)  0/86 (0.00%)  0/103 (0.00%)  0/86 (0.00%)  1/103 (0.97%) 
Ear and labyrinth disorders             
Ear pain *  1/120 (0.83%)  1/126 (0.79%)  0/86 (0.00%)  0/103 (0.00%)  0/86 (0.00%)  0/103 (0.00%) 
Cerumen impaction *  1/120 (0.83%)  0/126 (0.00%)  0/86 (0.00%)  0/103 (0.00%)  0/86 (0.00%)  0/103 (0.00%) 
Middle ear effusion *  0/120 (0.00%)  0/126 (0.00%)  1/86 (1.16%)  0/103 (0.00%)  0/86 (0.00%)  0/103 (0.00%) 
Otorrhoea *  0/120 (0.00%)  0/126 (0.00%)  0/86 (0.00%)  1/103 (0.97%)  0/86 (0.00%)  0/103 (0.00%) 
Eye disorders             
Conjunctivitis *  13/120 (10.83%)  16/126 (12.70%)  0/86 (0.00%)  1/103 (0.97%)  0/86 (0.00%)  4/103 (3.88%) 
Dacryostenosis acquired *  3/120 (2.50%)  2/126 (1.59%)  0/86 (0.00%)  0/103 (0.00%)  0/86 (0.00%)  0/103 (0.00%) 
Conjunctival haemorrhage *  1/120 (0.83%)  0/126 (0.00%)  0/86 (0.00%)  0/103 (0.00%)  0/86 (0.00%)  0/103 (0.00%) 
Eyelid ptosis *  1/120 (0.83%)  0/126 (0.00%)  0/86 (0.00%)  0/103 (0.00%)  0/86 (0.00%)  0/103 (0.00%) 
Strabismus *  0/120 (0.00%)  1/126 (0.79%)  0/86 (0.00%)  1/103 (0.97%)  0/86 (0.00%)  0/103 (0.00%) 
Scleral hyperaemia *  0/120 (0.00%)  0/126 (0.00%)  0/86 (0.00%)  1/103 (0.97%)  0/86 (0.00%)  0/103 (0.00%) 
Eye disorder *  1/120 (0.83%)  0/126 (0.00%)  0/86 (0.00%)  0/103 (0.00%)  0/86 (0.00%)  0/103 (0.00%) 
Gastrointestinal disorders             
Diarrhoea *  7/120 (5.83%)  17/126 (13.49%)  2/86 (2.33%)  6/103 (5.83%)  0/86 (0.00%)  2/103 (1.94%) 
Vomiting *  8/120 (6.67%)  10/126 (7.94%)  1/86 (1.16%)  6/103 (5.83%)  0/86 (0.00%)  1/103 (0.97%) 
Gastrooesophageal reflux disease *  2/120 (1.67%)  8/126 (6.35%)  0/86 (0.00%)  0/103 (0.00%)  0/86 (0.00%)  0/103 (0.00%) 
Constipation *  2/120 (1.67%)  4/126 (3.17%)  1/86 (1.16%)  0/103 (0.00%)  0/86 (0.00%)  0/103 (0.00%) 
Umbilical hernia *  4/120 (3.33%)  2/126 (1.59%)  0/86 (0.00%)  1/103 (0.97%)  0/86 (0.00%)  0/103 (0.00%) 
Teething *  2/120 (1.67%)  2/126 (1.59%)  0/86 (0.00%)  2/103 (1.94%)  1/86 (1.16%)  0/103 (0.00%) 
Abdominal pain *  0/120 (0.00%)  1/126 (0.79%)  0/86 (0.00%)  0/103 (0.00%)  0/86 (0.00%)  0/103 (0.00%) 
Abdominal pain upper *  0/120 (0.00%)  1/126 (0.79%)  0/86 (0.00%)  0/103 (0.00%)  0/86 (0.00%)  0/103 (0.00%) 
Glossodynia *  1/120 (0.83%)  0/126 (0.00%)  0/86 (0.00%)  0/103 (0.00%)  0/86 (0.00%)  0/103 (0.00%) 
Infantile spitting up *  0/120 (0.00%)  1/126 (0.79%)  0/86 (0.00%)  0/103 (0.00%)  0/86 (0.00%)  0/103 (0.00%) 
Mouth cyst *  0/120 (0.00%)  1/126 (0.79%)  0/86 (0.00%)  0/103 (0.00%)  0/86 (0.00%)  0/103 (0.00%) 
Oesophagitis *  0/120 (0.00%)  1/126 (0.79%)  0/86 (0.00%)  0/103 (0.00%)  0/86 (0.00%)  0/103 (0.00%) 
Dental caries *  0/120 (0.00%)  0/126 (0.00%)  0/86 (0.00%)  1/103 (0.97%)  0/86 (0.00%)  0/103 (0.00%) 
Enteritis *  0/120 (0.00%)  0/126 (0.00%)  0/86 (0.00%)  1/103 (0.97%)  0/86 (0.00%)  0/103 (0.00%) 
Stomatitis *  0/120 (0.00%)  0/126 (0.00%)  1/86 (1.16%)  0/103 (0.00%)  0/86 (0.00%)  0/103 (0.00%) 
General disorders             
Pyrexia *  10/120 (8.33%)  12/126 (9.52%)  1/86 (1.16%)  2/103 (1.94%)  1/86 (1.16%)  3/103 (2.91%) 
Irritability *  3/120 (2.50%)  6/126 (4.76%)  0/86 (0.00%)  0/103 (0.00%)  0/86 (0.00%)  0/103 (0.00%) 
Granuloma *  2/120 (1.67%)  0/126 (0.00%)  0/86 (0.00%)  0/103 (0.00%)  0/86 (0.00%)  0/103 (0.00%) 
Xerosis *  2/120 (1.67%)  0/126 (0.00%)  0/86 (0.00%)  0/103 (0.00%)  0/86 (0.00%)  0/103 (0.00%) 
Fever ≥38°C but≤39°C  2 [1]  19/114 (16.67%)  20/121 (16.53%)  11/78 (14.10%)  12/94 (12.77%)  0/0  0/0 
Fever ≥38°C but≤39°C  2 [2]  22/102 (21.57%)  28/114 (24.56%)  0/0  0/0  0/0  0/0 
Fever ≥38°C but≤39°C  2 [3]  20/100 (20.00%)  23/113 (20.35%)  0/0  0/0  0/0  0/0 
Fever >39°C but≤40°C  2 [4]  3/113 (2.65%)  1/121 (0.83%)  2/77 (2.60%)  0/94 (0.00%)  0/0  0/0 
Fever >39°C but≤40°C  2 [5]  4/102 (3.92%)  4/113 (3.54%)  0/0  0/0  0/0  0/0 
Fever >39°C but≤40°C  2 [6]  2/101 (1.98%)  1/113 (0.88%)  0/0  0/0  0/0  0/0 
Fever >40°C  2 [7]  0/113 (0.00%)  0/121 (0.00%)  0/76 (0.00%)  0/94 (0.00%)  0/0  0/0 
Fever >40°C  2 [8]  0/102 (0.00%)  0/113 (0.00%)  0/0  0/0  0/0  0/0 
Fever >40°C  2 [9]  0/100 (0.00%)  0/113 (0.00%)  0/0  0/0  0/0  0/0 
Decreased appetite  2 [10]  36/118 (30.51%)  39/124 (31.45%)  19/85 (22.35%)  22/101 (21.78%)  0/0  0/0 
Decreased appetite  2 [11]  25/110 (22.73%)  27/118 (22.88%)  0/0  0/0  0/0  0/0 
Decreased appetite  2 [12]  29/107 (27.10%)  36/117 (30.77%)  0/0  0/0  0/0  0/0 
Decreased sleep  2 [13]  22/118 (18.64%)  22/124 (17.74%)  11/84 (13.10%)  15/101 (14.85%)  0/0  0/0 
Decreased sleep  2 [14]  27/110 (24.55%)  23/118 (19.49%)  0/0  0/0  0/0  0/0 
Decreased sleep  2 [15]  23/107 (21.50%)  22/117 (18.80%)  0/0  0/0  0/0  0/0 
Increased sleep  2 [16]  67/119 (56.30%)  67/124 (54.03%)  24/86 (27.91%)  44/101 (43.56%)  0/0  0/0 
Increased sleep  2 [17]  47/111 (42.34%)  55/118 (46.61%)  0/0  0/0  0/0  0/0 
Increased sleep  2 [18]  37/107 (34.58%)  48/117 (41.03%)  0/0  0/0  0/0  0/0 
Irritability  2 [13]  79/118 (66.95%)  88/124 (70.97%)  33/85 (38.82%)  48/101 (47.52%)  0/0  0/0 
Irritability  2 [14]  69/110 (62.73%)  67/118 (56.78%)  0/0  0/0  0/0  0/0 
Irritability  2 [15]  55/107 (51.40%)  63/117 (53.85%)  0/0  0/0  0/0  0/0 
Immune system disorders             
Allergy to chemicals *  1/120 (0.83%)  0/126 (0.00%)  0/86 (0.00%)  0/103 (0.00%)  0/86 (0.00%)  0/103 (0.00%) 
Drug hypersensitivity *  1/120 (0.83%)  0/126 (0.00%)  0/86 (0.00%)  0/103 (0.00%)  0/86 (0.00%)  1/103 (0.97%) 
Hypersensitivity *  1/120 (0.83%)  0/126 (0.00%)  0/86 (0.00%)  0/103 (0.00%)  0/86 (0.00%)  0/103 (0.00%) 
Seasonal allergy *  1/120 (0.83%)  0/126 (0.00%)  0/86 (0.00%)  0/103 (0.00%)  0/86 (0.00%)  0/103 (0.00%) 
Food allergy *  0/120 (0.00%)  0/126 (0.00%)  0/86 (0.00%)  0/103 (0.00%)  1/86 (1.16%)  0/103 (0.00%) 
Cellulitis orbital *  0/120 (0.00%)  0/126 (0.00%)  0/86 (0.00%)  0/103 (0.00%)  0/86 (0.00%)  1/103 (0.97%) 
Infections and infestations             
Upper respiratory tract infection *  57/120 (47.50%)  65/126 (51.59%)  8/86 (9.30%)  10/103 (9.71%)  5/86 (5.81%)  12/103 (11.65%) 
Otitis media *  40/120 (33.33%)  37/126 (29.37%)  1/86 (1.16%)  10/103 (9.71%)  9/86 (10.47%)  14/103 (13.59%) 
Bronchiolitis *  13/120 (10.83%)  13/126 (10.32%)  0/86 (0.00%)  1/103 (0.97%)  0/86 (0.00%)  2/103 (1.94%) 
Otitis media acute *  7/120 (5.83%)  16/126 (12.70%)  1/86 (1.16%)  2/103 (1.94%)  2/86 (2.33%)  2/103 (1.94%) 
Viral infection *  9/120 (7.50%)  12/126 (9.52%)  1/86 (1.16%)  3/103 (2.91%)  1/86 (1.16%)  2/103 (1.94%) 
Candida nappy rash *  8/120 (6.67%)  7/126 (5.56%)  1/86 (1.16%)  0/103 (0.00%)  0/86 (0.00%)  0/103 (0.00%) 
Viral upper respiratory tract infection *  6/120 (5.00%)  8/126 (6.35%)  1/86 (1.16%)  0/103 (0.00%)  0/86 (0.00%)  1/103 (0.97%) 
Gastroenteritis *  7/120 (5.83%)  4/126 (3.17%)  0/86 (0.00%)  0/103 (0.00%)  2/86 (2.33%)  4/103 (3.88%) 
Oral candidiasis *  8/120 (6.67%)  2/126 (1.59%)  0/86 (0.00%)  0/103 (0.00%)  2/86 (2.33%)  0/103 (0.00%) 
Croup infectious *  3/120 (2.50%)  6/126 (4.76%)  3/86 (3.49%)  1/103 (0.97%)  1/86 (1.16%)  4/103 (3.88%) 
Nasopharyngitis *  4/120 (3.33%)  5/126 (3.97%)  1/86 (1.16%)  1/103 (0.97%)  0/86 (0.00%)  0/103 (0.00%) 
Pneumonia *  4/120 (3.33%)  5/126 (3.97%)  0/86 (0.00%)  0/103 (0.00%)  2/86 (2.33%)  2/103 (1.94%) 
Gastroenteritis viral *  4/120 (3.33%)  3/126 (2.38%)  0/86 (0.00%)  1/103 (0.97%)  0/86 (0.00%)  0/103 (0.00%) 
Viral pharyngitis *  3/120 (2.50%)  4/126 (3.17%)  1/86 (1.16%)  1/103 (0.97%)  0/86 (0.00%)  0/103 (0.00%) 
Candidiasis *  1/120 (0.83%)  5/126 (3.97%)  0/86 (0.00%)  0/103 (0.00%)  0/86 (0.00%)  0/103 (0.00%) 
Sinusitis *  2/120 (1.67%)  4/126 (3.17%)  1/86 (1.16%)  0/103 (0.00%)  1/86 (1.16%)  2/103 (1.94%) 
Bronchitis *  2/120 (1.67%)  3/126 (2.38%)  0/86 (0.00%)  0/103 (0.00%)  0/86 (0.00%)  2/103 (1.94%) 
Pharyngitis *  4/120 (3.33%)  1/126 (0.79%)  0/86 (0.00%)  1/103 (0.97%)  1/86 (1.16%)  2/103 (1.94%) 
Viral rash *  3/120 (2.50%)  2/126 (1.59%)  1/86 (1.16%)  2/103 (1.94%)  2/86 (2.33%)  0/103 (0.00%) 
Respiratory syncytial virus bronchiolitis *  2/120 (1.67%)  1/126 (0.79%)  0/86 (0.00%)  0/103 (0.00%)  0/86 (0.00%)  0/103 (0.00%) 
Skin candida *  1/120 (0.83%)  2/126 (1.59%)  0/86 (0.00%)  0/103 (0.00%)  0/86 (0.00%)  0/103 (0.00%) 
Acarodermatitis *  2/120 (1.67%)  0/126 (0.00%)  0/86 (0.00%)  0/103 (0.00%)  0/86 (0.00%)  0/103 (0.00%) 
Body tinea *  2/120 (1.67%)  0/126 (0.00%)  0/86 (0.00%)  1/103 (0.97%)  0/86 (0.00%)  0/103 (0.00%) 
Roseola *  2/120 (1.67%)  0/126 (0.00%)  0/86 (0.00%)  0/103 (0.00%)  0/86 (0.00%)  0/103 (0.00%) 
Tinea infection *  1/120 (0.83%)  1/126 (0.79%)  0/86 (0.00%)  0/103 (0.00%)  0/86 (0.00%)  0/103 (0.00%) 
Varicella *  1/120 (0.83%)  1/126 (0.79%)  0/86 (0.00%)  2/103 (1.94%)  0/86 (0.00%)  2/103 (1.94%) 
Acute tonsillitis *  1/120 (0.83%)  0/126 (0.00%)  0/86 (0.00%)  0/103 (0.00%)  0/86 (0.00%)  0/103 (0.00%) 
Dacryocystitis *  1/120 (0.83%)  0/126 (0.00%)  0/86 (0.00%)  0/103 (0.00%)  0/86 (0.00%)  0/103 (0.00%) 
Eczema infected *  1/120 (0.83%)  0/126 (0.00%)  0/86 (0.00%)  0/103 (0.00%)  0/86 (0.00%)  0/103 (0.00%) 
Erythema infectiosum *  0/120 (0.00%)  1/126 (0.79%)  0/86 (0.00%)  0/103 (0.00%)  0/86 (0.00%)  0/103 (0.00%) 
Exanthema subitum *  0/120 (0.00%)  1/126 (0.79%)  0/86 (0.00%)  0/103 (0.00%)  0/86 (0.00%)  0/103 (0.00%) 
Fungal skin infection *  0/120 (0.00%)  1/126 (0.79%)  0/86 (0.00%)  0/103 (0.00%)  0/86 (0.00%)  0/103 (0.00%) 
Herpangina *  1/120 (0.83%)  0/126 (0.00%)  0/86 (0.00%)  2/103 (1.94%)  0/86 (0.00%)  0/103 (0.00%) 
Infection *  1/120 (0.83%)  0/126 (0.00%)  0/86 (0.00%)  0/103 (0.00%)  0/86 (0.00%)  0/103 (0.00%) 
Localised infection *  1/120 (0.83%)  0/126 (0.00%)  0/86 (0.00%)  0/103 (0.00%)  0/86 (0.00%)  0/103 (0.00%) 
Nail infection *  1/120 (0.83%)  0/126 (0.00%)  0/86 (0.00%)  0/103 (0.00%)  0/86 (0.00%)  0/103 (0.00%) 
Paronychia *  1/120 (0.83%)  0/126 (0.00%)  0/86 (0.00%)  0/103 (0.00%)  1/86 (1.16%)  0/103 (0.00%) 
Pneumonia primary atypical *  1/120 (0.83%)  0/126 (0.00%)  0/86 (0.00%)  0/103 (0.00%)  0/86 (0.00%)  0/103 (0.00%) 
Rash pustular *  1/120 (0.83%)  0/126 (0.00%)  0/86 (0.00%)  0/103 (0.00%)  0/86 (0.00%)  0/103 (0.00%) 
Respiratory syncytial virus infection *  0/120 (0.00%)  1/126 (0.79%)  0/86 (0.00%)  0/103 (0.00%)  0/86 (0.00%)  0/103 (0.00%) 
Rhinitis *  0/120 (0.00%)  1/126 (0.79%)  0/86 (0.00%)  1/103 (0.97%)  4/86 (4.65%)  1/103 (0.97%) 
Staphylococcal infection *  1/120 (0.83%)  0/126 (0.00%)  0/86 (0.00%)  0/103 (0.00%)  0/86 (0.00%)  1/103 (0.97%) 
Tinea versicolour *  1/120 (0.83%)  0/126 (0.00%)  0/86 (0.00%)  0/103 (0.00%)  0/86 (0.00%)  0/103 (0.00%) 
Folliculitis *  0/120 (0.00%)  0/126 (0.00%)  0/86 (0.00%)  1/103 (0.97%)  0/86 (0.00%)  0/103 (0.00%) 
Influenza *  0/120 (0.00%)  0/126 (0.00%)  0/86 (0.00%)  1/103 (0.97%)  0/86 (0.00%)  0/103 (0.00%) 
Pharyngitis streptococcal *  0/120 (0.00%)  0/126 (0.00%)  1/86 (1.16%)  0/103 (0.00%)  1/86 (1.16%)  0/103 (0.00%) 
Tinea capitis *  0/120 (0.00%)  0/126 (0.00%)  0/86 (0.00%)  2/103 (1.94%)  0/86 (0.00%)  0/103 (0.00%) 
Tonsillitis *  0/120 (0.00%)  0/126 (0.00%)  1/86 (1.16%)  0/103 (0.00%)  0/86 (0.00%)  0/103 (0.00%) 
Conjunctivitis infective *  0/120 (0.00%)  0/126 (0.00%)  0/86 (0.00%)  0/103 (0.00%)  0/86 (0.00%)  1/103 (0.97%) 
Oral herpes *  0/120 (0.00%)  0/126 (0.00%)  0/86 (0.00%)  0/103 (0.00%)  1/86 (1.16%)  0/103 (0.00%) 
Rotavirus infection *  0/120 (0.00%)  0/126 (0.00%)  0/86 (0.00%)  0/103 (0.00%)  0/86 (0.00%)  1/103 (0.97%) 
Injury, poisoning and procedural complications             
Fall *  2/120 (1.67%)  0/126 (0.00%)  0/86 (0.00%)  0/103 (0.00%)  0/86 (0.00%)  0/103 (0.00%) 
Arthropod bite *  1/120 (0.83%)  0/126 (0.00%)  2/86 (2.33%)  2/103 (1.94%)  0/86 (0.00%)  0/103 (0.00%) 
Injury *  0/120 (0.00%)  1/126 (0.79%)  0/86 (0.00%)  1/103 (0.97%)  0/86 (0.00%)  1/103 (0.97%) 
Limb injury *  0/120 (0.00%)  1/126 (0.79%)  0/86 (0.00%)  0/103 (0.00%)  0/86 (0.00%)  0/103 (0.00%) 
Skin laceration *  1/120 (0.83%)  0/126 (0.00%)  0/86 (0.00%)  0/103 (0.00%)  0/86 (0.00%)  0/103 (0.00%) 
Traumatic brain injury *  1/120 (0.83%)  0/126 (0.00%)  0/86 (0.00%)  0/103 (0.00%)  0/86 (0.00%)  1/103 (0.97%) 
Arthropod sting *  0/120 (0.00%)  0/126 (0.00%)  0/86 (0.00%)  1/103 (0.97%)  0/86 (0.00%)  0/103 (0.00%) 
Burns second degree *  0/120 (0.00%)  0/126 (0.00%)  0/86 (0.00%)  1/103 (0.97%)  0/86 (0.00%)  0/103 (0.00%) 
Exposure to toxic agent *  0/120 (0.00%)  0/126 (0.00%)  0/86 (0.00%)  1/103 (0.97%)  0/86 (0.00%)  0/103 (0.00%) 
Back injury *  0/120 (0.00%)  0/126 (0.00%)  0/86 (0.00%)  0/103 (0.00%)  1/86 (1.16%)  0/103 (0.00%) 
Contusion *  0/120 (0.00%)  0/126 (0.00%)  0/86 (0.00%)  0/103 (0.00%)  0/86 (0.00%)  1/103 (0.97%) 
Investigations             
Cardiac murmur *  1/120 (0.83%)  1/126 (0.79%)  1/86 (1.16%)  0/103 (0.00%)  0/86 (0.00%)  0/103 (0.00%) 
Cardiac murmur functional *  0/120 (0.00%)  2/126 (1.59%)  0/86 (0.00%)  0/103 (0.00%)  0/86 (0.00%)  0/103 (0.00%) 
Metabolism and nutrition disorders             
Decreased appetite *  4/120 (3.33%)  3/126 (2.38%)  0/86 (0.00%)  0/103 (0.00%)  0/86 (0.00%)  0/103 (0.00%) 
Dehydration *  1/120 (0.83%)  2/126 (1.59%)  0/86 (0.00%)  0/103 (0.00%)  0/86 (0.00%)  2/103 (1.94%) 
Food intolerance *  2/120 (1.67%)  1/126 (0.79%)  0/86 (0.00%)  0/103 (0.00%)  0/86 (0.00%)  0/103 (0.00%) 
Anorexia *  0/120 (0.00%)  1/126 (0.79%)  0/86 (0.00%)  0/103 (0.00%)  0/86 (0.00%)  0/103 (0.00%) 
Failure to thrive *  1/120 (0.83%)  0/126 (0.00%)  0/86 (0.00%)  0/103 (0.00%)  0/86 (0.00%)  0/103 (0.00%) 
Hypervitaminosis a *  0/120 (0.00%)  1/126 (0.79%)  0/86 (0.00%)  0/103 (0.00%)  0/86 (0.00%)  0/103 (0.00%) 
Lactose intolerance *  0/120 (0.00%)  1/126 (0.79%)  0/86 (0.00%)  0/103 (0.00%)  0/86 (0.00%)  0/103 (0.00%) 
Weight gain poor *  0/120 (0.00%)  0/126 (0.00%)  1/86 (1.16%)  0/103 (0.00%)  0/86 (0.00%)  0/103 (0.00%) 
Musculoskeletal and connective tissue disorders             
Torticollis *  0/120 (0.00%)  2/126 (1.59%)  0/86 (0.00%)  0/103 (0.00%)  0/86 (0.00%)  0/103 (0.00%) 
Weight bearing difficulty *  0/120 (0.00%)  0/126 (0.00%)  0/86 (0.00%)  0/103 (0.00%)  0/86 (0.00%)  1/103 (0.97%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)             
Haemangioma *  1/120 (0.83%)  0/126 (0.00%)  0/86 (0.00%)  0/103 (0.00%)  0/86 (0.00%)  0/103 (0.00%) 
Melanocytic naevus *  0/120 (0.00%)  1/126 (0.79%)  0/86 (0.00%)  0/103 (0.00%)  0/86 (0.00%)  0/103 (0.00%) 
Nervous system disorders             
Hypersomnia *  1/120 (0.83%)  3/126 (2.38%)  0/86 (0.00%)  0/103 (0.00%)  0/86 (0.00%)  0/103 (0.00%) 
Hypertonia *  0/120 (0.00%)  1/126 (0.79%)  0/86 (0.00%)  0/103 (0.00%)  0/86 (0.00%)  0/103 (0.00%) 
Hypotonia *  1/120 (0.83%)  0/126 (0.00%)  0/86 (0.00%)  0/103 (0.00%)  0/86 (0.00%)  0/103 (0.00%) 
Somnolence *  1/120 (0.83%)  0/126 (0.00%)  0/86 (0.00%)  0/103 (0.00%)  0/86 (0.00%)  0/103 (0.00%) 
Speech disorder developmental *  0/120 (0.00%)  0/126 (0.00%)  0/86 (0.00%)  1/103 (0.97%)  0/86 (0.00%)  0/103 (0.00%) 
Febrile convulsion *  0/120 (0.00%)  0/126 (0.00%)  0/86 (0.00%)  0/103 (0.00%)  0/86 (0.00%)  1/103 (0.97%) 
Psychiatric disorders             
Insomnia *  2/120 (1.67%)  2/126 (1.59%)  0/86 (0.00%)  0/103 (0.00%)  0/86 (0.00%)  0/103 (0.00%) 
Renal and urinary disorders             
Vesicoureteric reflux *  0/120 (0.00%)  1/126 (0.79%)  0/86 (0.00%)  0/103 (0.00%)  0/86 (0.00%)  0/103 (0.00%) 
Haematuria *  0/120 (0.00%)  0/126 (0.00%)  0/86 (0.00%)  1/103 (0.97%)  0/86 (0.00%)  0/103 (0.00%) 
Penile adhesion *  0/120 (0.00%)  0/126 (0.00%)  1/86 (1.16%)  1/103 (0.97%)  0/86 (0.00%)  0/103 (0.00%) 
Reproductive system and breast disorders             
Penile blister *  0/120 (0.00%)  1/126 (0.79%)  0/86 (0.00%)  0/103 (0.00%)  0/86 (0.00%)  0/103 (0.00%) 
Vaginal discharge *  0/120 (0.00%)  1/126 (0.79%)  0/86 (0.00%)  0/103 (0.00%)  0/86 (0.00%)  0/103 (0.00%) 
Respiratory, thoracic and mediastinal disorders             
Cough *  9/120 (7.50%)  16/126 (12.70%)  1/86 (1.16%)  1/103 (0.97%)  1/86 (1.16%)  3/103 (2.91%) 
Nasal congestion *  8/120 (6.67%)  17/126 (13.49%)  1/86 (1.16%)  3/103 (2.91%)  0/86 (0.00%)  0/103 (0.00%) 
Rhinorrhoea *  11/120 (9.17%)  8/126 (6.35%)  3/86 (3.49%)  3/103 (2.91%)  0/86 (0.00%)  0/103 (0.00%) 
Wheezing *  5/120 (4.17%)  7/126 (5.56%)  1/86 (1.16%)  2/103 (1.94%)  0/86 (0.00%)  0/103 (0.00%) 
Asthma *  3/120 (2.50%)  2/126 (1.59%)  1/86 (1.16%)  0/103 (0.00%)  1/86 (1.16%)  2/103 (1.94%) 
Bronchial hyperreactivity *  3/120 (2.50%)  2/126 (1.59%)  0/86 (0.00%)  1/103 (0.97%)  0/86 (0.00%)  0/103 (0.00%) 
Rhinitis allergic *  2/120 (1.67%)  0/126 (0.00%)  0/86 (0.00%)  2/103 (1.94%)  0/86 (0.00%)  0/103 (0.00%) 
Tracheomalacia *  1/120 (0.83%)  1/126 (0.79%)  0/86 (0.00%)  0/103 (0.00%)  0/86 (0.00%)  0/103 (0.00%) 
Choking *  0/120 (0.00%)  1/126 (0.79%)  0/86 (0.00%)  0/103 (0.00%)  0/86 (0.00%)  0/103 (0.00%) 
Hypoxia *  1/120 (0.83%)  0/126 (0.00%)  0/86 (0.00%)  0/103 (0.00%)  0/86 (0.00%)  0/103 (0.00%) 
Macleod's syndrome *  0/120 (0.00%)  1/126 (0.79%)  0/86 (0.00%)  0/103 (0.00%)  0/86 (0.00%)  0/103 (0.00%) 
Sinus congestion *  0/120 (0.00%)  1/126 (0.79%)  0/86 (0.00%)  0/103 (0.00%)  0/86 (0.00%)  0/103 (0.00%) 
Sneezing *  0/120 (0.00%)  1/126 (0.79%)  0/86 (0.00%)  0/103 (0.00%)  0/86 (0.00%)  0/103 (0.00%) 
Skin and subcutaneous tissue disorders             
Dermatitis diaper *  7/120 (5.83%)  10/126 (7.94%)  1/86 (1.16%)  1/103 (0.97%)  0/86 (0.00%)  0/103 (0.00%) 
Eczema *  10/120 (8.33%)  6/126 (4.76%)  1/86 (1.16%)  0/103 (0.00%)  0/86 (0.00%)  0/103 (0.00%) 
Rash *  2/120 (1.67%)  7/126 (5.56%)  1/86 (1.16%)  3/103 (2.91%)  0/86 (0.00%)  0/103 (0.00%) 
Dry skin *  2/120 (1.67%)  4/126 (3.17%)  0/86 (0.00%)  0/103 (0.00%)  0/86 (0.00%)  0/103 (0.00%) 
Seborrhoeic dermatitis *  3/120 (2.50%)  2/126 (1.59%)  0/86 (0.00%)  0/103 (0.00%)  0/86 (0.00%)  0/103 (0.00%) 
Rash macular *  2/120 (1.67%)  1/126 (0.79%)  0/86 (0.00%)  0/103 (0.00%)  0/86 (0.00%)  0/103 (0.00%) 
Dermatitis atopic *  1/120 (0.83%)  1/126 (0.79%)  0/86 (0.00%)  0/103 (0.00%)  0/86 (0.00%)  0/103 (0.00%) 
Rash papular *  1/120 (0.83%)  1/126 (0.79%)  0/86 (0.00%)  0/103 (0.00%)  0/86 (0.00%)  0/103 (0.00%) 
Urticaria *  1/120 (0.83%)  1/126 (0.79%)  1/86 (1.16%)  0/103 (0.00%)  0/86 (0.00%)  1/103 (0.97%) 
Dermatitis contact *  1/120 (0.83%)  0/126 (0.00%)  0/86 (0.00%)  0/103 (0.00%)  0/86 (0.00%)  0/103 (0.00%) 
Erythema multiforme *  0/120 (0.00%)  1/126 (0.79%)  0/86 (0.00%)  0/103 (0.00%)  0/86 (0.00%)  0/103 (0.00%) 
Heat rash *  1/120 (0.83%)  0/126 (0.00%)  0/86 (0.00%)  0/103 (0.00%)  0/86 (0.00%)  0/103 (0.00%) 
Ingrowing nail *  1/120 (0.83%)  0/126 (0.00%)  0/86 (0.00%)  0/103 (0.00%)  0/86 (0.00%)  0/103 (0.00%) 
Petechiae *  1/120 (0.83%)  0/126 (0.00%)  0/86 (0.00%)  0/103 (0.00%)  0/86 (0.00%)  0/103 (0.00%) 
Rash erythematous *  0/120 (0.00%)  1/126 (0.79%)  0/86 (0.00%)  0/103 (0.00%)  0/86 (0.00%)  0/103 (0.00%) 
Rash maculo-papular *  0/120 (0.00%)  1/126 (0.79%)  0/86 (0.00%)  0/103 (0.00%)  0/86 (0.00%)  0/103 (0.00%) 
Skin irritation *  0/120 (0.00%)  1/126 (0.79%)  0/86 (0.00%)  0/103 (0.00%)  0/86 (0.00%)  0/103 (0.00%) 
Acne infantile *  0/120 (0.00%)  0/126 (0.00%)  0/86 (0.00%)  1/103 (0.97%)  0/86 (0.00%)  0/103 (0.00%) 
Dermatitis *  0/120 (0.00%)  0/126 (0.00%)  1/86 (1.16%)  0/103 (0.00%)  0/86 (0.00%)  1/103 (0.97%) 
Dermatitis allergic *  0/120 (0.00%)  0/126 (0.00%)  1/86 (1.16%)  0/103 (0.00%)  0/86 (0.00%)  0/103 (0.00%) 
Keratosis pilaris *  0/120 (0.00%)  0/126 (0.00%)  0/86 (0.00%)  1/103 (0.97%)  0/86 (0.00%)  0/103 (0.00%) 
Blister *  0/120 (0.00%)  0/126 (0.00%)  0/86 (0.00%)  0/103 (0.00%)  0/86 (0.00%)  1/103 (0.97%) 
Tenderness (Any)  1 [19]  41/119 (34.45%)  54/124 (43.55%)  19/85 (22.35%)  30/101 (29.70%)  0/0  0/0 
Tenderness (Any)  1 [20]  31/110 (28.18%)  43/118 (36.44%)  0/0  0/0  0/0  0/0 
Tenderness (Any)  1 [21]  26/107 (24.30%)  30/117 (25.64%)  0/0  0/0  0/0  0/0 
Tenderness (Significant)  1 [22]  10/119 (8.40%)  7/124 (5.65%)  2/85 (2.35%)  4/101 (3.96%)  0/0  0/0 
Tenderness (Significant)  1 [23]  2/110 (1.82%)  10/118 (8.47%)  0/0  0/0  0/0  0/0 
Tenderness (Significant)  1 [24]  5/107 (4.67%)  7/117 (5.98%)  0/0  0/0  0/0  0/0 
Induration (Any)  1 [25]  26/119 (21.85%)  24/124 (19.35%)  16/85 (18.82%)  17/100 (17.00%)  0/0  0/0 
Induration (Any)  1 [26]  18/110 (16.36%)  23/118 (19.49%)  0/0  0/0  0/0  0/0 
Induration (Any)  1 [27]  18/107 (16.82%)  22/117 (18.80%)  0/0  0/0  0/0  0/0 
Induration (Mild)  1 [28]  24/119 (20.17%)  22/123 (17.89%)  16/85 (18.82%)  17/100 (17.00%)  0/0  0/0 
Induration (Mild)  1 [29]  18/110 (16.36%)  20/117 (17.09%)  0/0  0/0  0/0  0/0 
Induration (Mild)  1 [30]  18/107 (16.82%)  20/116 (17.24%)  0/0  0/0  0/0  0/0 
Induration (Moderate)  1 [31]  4/119 (3.36%)  3/123 (2.44%)  2/85 (2.35%)  3/100 (3.00%)  0/0  0/0 
Induration (Moderate)  1 [32]  4/110 (3.64%)  4/117 (3.42%)  0/0  0/0  0/0  0/0 
Induration (Moderate)  1 [33]  0/107 (0.00%)  5/116 (4.31%)  0/0  0/0  0/0  0/0 
Induration (Severe)  1 [34]  0/119 (0.00%)  0/123 (0.00%)  0/85 (0.00%)  0/100 (0.00%)  0/0  0/0 
Induration (Severe)  1 [35]  0/110 (0.00%)  0/117 (0.00%)  0/0  0/0  0/0  0/0 
Induration (Severe)  1 [36]  0/107 (0.00%)  0/116 (0.00%)  0/0  0/0  0/0  0/0 
Erythema (Any)  1 [37]  25/119 (21.01%)  24/124 (19.35%)  21/85 (24.71%)  19/100 (19.00%)  0/0  0/0 
Erythema (Any)  1 [38]  18/111 (16.22%)  21/118 (17.80%)  0/0  0/0  0/0  0/0 
Erythema (Any)  1 [39]  19/107 (17.76%)  23/117 (19.66%)  0/0  0/0  0/0  0/0 
Erythema (Mild)  1 [40]  24/119 (20.17%)  24/124 (19.35%)  21/85 (24.71%)  16/99 (16.16%)  0/0  0/0 
Erythema (Mild)  1 [41]  15/110 (13.64%)  20/117 (17.09%)  0/0  0/0  0/0  0/0 
Erythema (Mild)  1 [42]  17/106 (16.04%)  21/116 (18.10%)  0/0  0/0  0/0  0/0 
Erythema (Moderate)  1 [43]  3/119 (2.52%)  0/124 (0.00%)  3/85 (3.53%)  5/99 (5.05%)  0/0  0/0 
Erythema (Moderate)  1 [44]  3/108 (2.78%)  0/117 (0.00%)  0/0  0/0  0/0  0/0 
Erythema (Moderate)  1 [45]  1/106 (0.94%)  3/116 (2.59%)  0/0  0/0  0/0  0/0 
Erythema (Severe)  1 [46]  0/119 (0.00%)  0/124 (0.00%)  0/85 (0.00%)  0/99 (0.00%)  0/0  0/0 
Erythema (Severe)  1 [47]  0/108 (0.00%)  0/117 (0.00%)  0/0  0/0  0/0  0/0 
Erythema (Severe)  1 [48]  0/106 (0.00%)  0/116 (0.00%)  0/0  0/0  0/0  0/0 
Social circumstances             
Corrective lens user *  0/120 (0.00%)  1/126 (0.79%)  0/86 (0.00%)  0/103 (0.00%)  0/86 (0.00%)  0/103 (0.00%) 
Exposure to communicable disease *  1/120 (0.83%)  0/126 (0.00%)  0/86 (0.00%)  0/103 (0.00%)  0/86 (0.00%)  0/103 (0.00%) 
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 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; Tenderness (any)=present at site of vaccination.
[20]
Infant Series Dose 2; Tenderness (any)
[21]
Infant Series Dose 3; Tenderness (any)
[22]
Infant Series Dose 1 and Toddler Dose; Tenderness (significant)=present and interfered with limb movement.
[23]
Infant Series Dose 2; Tenderness (significant)
[24]
Infant Series Dose 3; Tenderness (significant)
[25]
Infant Series Dose 1 and Toddler Dose; Induration (any)=present at site of vaccination.
[26]
Infant Series Dose 2; Induration (any)
[27]
Infant Series Dose 3; Induration (any)
[28]
Infant Series Dose 1 and Toddler Dose; Induration (mild)=0.5 centimeters (cm) to 2.0 cm.
[29]
Infant Series Dose 2; Induration (mild)
[30]
Infant Series Dose 3; Induration (mild)
[31]
Infant Series Dose 1 and Toddler Dose; Induration (moderate)=2.5 cm to 7.0 cm.
[32]
Infant Series Dose 2; Induration (moderate)
[33]
Infant Series Dose 3; Induration (moderate)
[34]
Infant Series Dose 1 and Toddler Dose; Induration (severe) >7.0 cm.
[35]
Infant Series Dose 2; Induration (severe)
[36]
Infant Series Dose 3; Induration (severe)
[37]
Infant Series Dose 1 and Toddler Dose; Erythema (any)=present at site of vaccination.
[38]
Infant Series Dose 2; Erythema (any)
[39]
Infant Series Dose 3; Erythema (any)
[40]
Infant Series Dose 1 and Toddler Dose; Erythema (mild)=0.5 cm to 2.0 cm.
[41]
Infant Series Dose 2; Erythema (mild)
[42]
Infant Series Dose 3; Erythema (mild)
[43]
Infant Series Dose 1 and Toddler Dose; Erythema (moderate)=2.5 cm to 7.0 cm.
[44]
Infant Series Dose 2; Erythema (moderate)
[45]
Infant Series Dose 3; Erythema (moderate)
[46]
Infant Series Dose 1 and Toddler Dose; Erythema (severe) >7.0 cm.
[47]
Infant Series Dose 2; Erythema (severe)
[48]
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.
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
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
Responsible Party: Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier: NCT00205803     History of Changes
Other Study ID Numbers: 6096A1-003
First Submitted: September 19, 2005
First Posted: September 20, 2005
Results First Submitted: March 26, 2010
Results First Posted: August 15, 2012
Last Update Posted: August 15, 2012