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Wyeth Study To Evaluate a 13-valent Pneumococcal Conjugate Vaccine in Infants

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ClinicalTrials.gov Identifier: NCT00464945
Recruitment Status : Completed
First Posted : April 24, 2007
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: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition Pneumococcal Vaccines
Intervention Biological: 13-valent Pneumococcal Conjugate Vaccine
Enrollment 269
Recruitment Details Participants were recruited in Poland from June 2007 to August 2007.
Pre-assignment Details Participants were enrolled into the study according to inclusion/exclusion criteria without a screening period.
Arm/Group Title 13vPnC Manufacturing 13vPnC Pilot
Hide Arm/Group Description Participants received one single 0.5mL manufacturing scale dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined diphtheria, tetanus, and acellular pertussis inactivated poliovirus, and hemophilus influenza type b vaccine (DTaP-IPV-Hib) and hepatitis B virus vaccine (HBV) at 2 months (infant series, dose 1). Participants received one single 0.5mL manufacturing scale dose of 13vPnC coadministered with DTaP-IPV-Hib at 3 and 4 months (infant series, dose 2 and 3). Participants received one single 0.5mL manufacturing scale dose of 13vPnC coadministered with measles, mumps, and rubella vaccine (MMR) and 12 months of age (toddler dose). Participants received one single 0.5mL pilot scale dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined diphtheria, tetanus, and acellular pertussis inactivated poliovirus, and hemophilus influenza type b vaccine (DTaP-IPV-Hib) and hepatitis B virus vaccine (HBV) at 2 months (infant series, dose 1). Participants received one single 0.5mL pilot scale dose of 13vPnC coadministered with DTaP-IPV-Hib at 3 and 4 months (infant series, dose 2 and 3). Participants received one single 0.5mL pilot scale dose of 13vPnC coadministered with measles, mumps, and rubella vaccine (MMR) and 12 months of age (toddler dose).
Period Title: Infant Series
Started 135 134
Vaccinated Dose 1 134 134
Vaccinated Dose 2 132 133
Vaccinated Dose 3 132 133
Completed 131 133
Not Completed 4 1
Reason Not Completed
Withdrawal by parent/guardian request             2             1
Protocol Violation             1             0
Lost to Follow-up             1             0
Period Title: After Infant Series
Started 131 133
Completed 131 131
Not Completed 0 2
Reason Not Completed
Withdrawal by Subject             0             2
Period Title: Toddler Dose
Started 131 131
Completed 131 130
Not Completed 0 1
Reason Not Completed
Lost to Follow-up             0             1
Arm/Group Title 13vPnC Manufacturing 13vPnC Pilot Total
Hide Arm/Group Description Participants received one single 0.5mL manufacturing scale dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined diphtheria, tetanus, and acellular pertussis inactivated poliovirus, and hemophilus influenza type b vaccine (DTaP-IPV-Hib) and hepatitis B virus vaccine (HBV) at 2 months (infant series, dose 1). Participants received one single 0.5mL manufacturing scale dose of 13vPnC coadministered with DTaP-IPV-Hib at 3 and 4 months (infant series, dose 2 and 3). Participants received one single 0.5mL manufacturing scale dose of 13vPnC coadministered with measles, mumps, and rubella vaccine (MMR) and 12 months of age (toddler dose). Participants received one single 0.5mL pilot scale dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined diphtheria, tetanus, and acellular pertussis inactivated poliovirus, and hemophilus influenza type b vaccine (DTaP-IPV-Hib) and hepatitis B virus vaccine (HBV) at 2 months (infant series, dose 1). Participants received one single 0.5mL pilot scale dose of 13vPnC coadministered with DTaP-IPV-Hib at 3 and 4 months (infant series, dose 2 and 3). Participants received one single 0.5mL pilot scale dose of 13vPnC coadministered with measles, mumps, and rubella vaccine (MMR) and 12 months of age (toddler dose). Total of all reporting groups
Overall Number of Baseline Participants 135 134 269
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Months
Number Analyzed 135 participants 134 participants 269 participants
2.1  (0.6) 2.1  (0.5) 2.1  (0.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 135 participants 134 participants 269 participants
Female
65
  48.1%
67
  50.0%
132
  49.1%
Male
70
  51.9%
67
  50.0%
137
  50.9%
1.Primary Outcome
Title Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Manufacturing Scale Group Relative to 13vPnC Pilot Scale Group After the 3-Dose Infant Series
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.
Time Frame One month after 3-dose infant series (5 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.
Arm/Group Title 13vPnC Manufacturing 13vPnC Pilot
Hide Arm/Group Description:
Participants received one single 0.5mL manufacturing scale dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined diphtheria, tetanus, and acellular pertussis inactivated poliovirus, and hemophilus influenza type b vaccine (DTaP-IPV-Hib) and hepatitis B virus vaccine (HBV) at 2 months (infant series, dose 1). Participants received one single 0.5mL manufacturing scale dose of 13vPnC coadministered with DTaP-IPV-Hib at 3 and 4 months (infant series, dose 2 and 3). Participants received one single 0.5mL manufacturing scale dose of 13vPnC coadministered with measles, mumps, and rubella vaccine (MMR) and 12 months of age (toddler dose).
Participants received one single 0.5mL pilot scale dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined diphtheria, tetanus, and acellular pertussis inactivated poliovirus, and hemophilus influenza type b vaccine (DTaP-IPV-Hib) and hepatitis B virus vaccine (HBV) at 2 months (infant series, dose 1). Participants received one single 0.5mL pilot scale dose of 13vPnC coadministered with DTaP-IPV-Hib at 3 and 4 months (infant series, dose 2 and 3). Participants received one single 0.5mL pilot scale dose of 13vPnC coadministered with measles, mumps, and rubella vaccine (MMR) and 12 months of age (toddler dose).
Overall Number of Participants Analyzed 128 131
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Common Serotypes-Serotype 4
97.7
(93.3 to 99.5)
96.9
(92.4 to 99.2)
Common Serotypes-Serotype 6B
77.3
(69.1 to 84.3)
74.0
(65.7 to 81.3)
Common Serotypes-Serotype 9V
98.4
(94.5 to 99.8)
96.2
(91.3 to 98.7)
Common Serotypes-Serotype 14
92.9
(87.0 to 96.7)
94.5
(89.1 to 97.8)
Common Serotypes-Serotype 18C
96.1
(91.1 to 98.7)
93.1
(87.4 to 96.8)
Common Serotypes-Serotype 19F
98.4
(94.4 to 99.8)
97.7
(93.5 to 99.5)
Common Serotypes-Serotype 23F
82.8
(75.1 to 88.9)
81.7
(74.0 to 87.9)
Additional Serotypes-Serotype 1
93.0
(87.1 to 96.7)
90.8
(84.5 to 95.2)
Additional Serotypes-Serotype 3
93.7
(88.0 to 97.2)
95.4
(90.3 to 98.3)
Additional Serotypes-Serotype 5
90.6
(84.2 to 95.1)
88.5
(81.8 to 93.4)
Additional Serotypes-Serotype 6A
85.2
(77.8 to 90.8)
86.3
(79.2 to 91.6)
Additional Serotypes-Serotype 7F
100.0
(97.2 to 100.0)
100.0
(97.2 to 100.0)
Additional Serotypes-Serotype 19A
99.2
(95.7 to 100.0)
99.2
(95.8 to 100.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 13vPnC Manufacturing, 13vPnC Pilot
Comments For serotype 4 the difference in percentages between the two groups (13vPnC Manufacturing - 13vPnC Pilot) was calculated
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference
Estimated Value 0.7
Confidence Interval 95%
-3.9 to 5.6
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 13vPnC Manufacturing, 13vPnC Pilot
Comments For serotype 6B the difference in percentages between the two groups (13vPnC Manufacturing - 13vPnC Pilot) was calculated
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference
Estimated Value 3.3
Confidence Interval 95%
-7.3 to 13.8
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 13vPnC Manufacturing, 13vPnC Pilot
Comments For serotype 9V the difference in percentages between the two groups (13vPnC Manufacturing - 13vPnC Pilot) was calculated
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference
Estimated Value 2.3
Confidence Interval 95%
-2.1 to 7.3
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection 13vPnC Manufacturing, 13vPnC Pilot
Comments For serotype 14 the difference in percentages between the two groups (13vPnC Manufacturing - 13vPnC Pilot) was calculated
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference
Estimated Value -1.6
Confidence Interval 95%
-8.2 to 4.7
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection 13vPnC Manufacturing, 13vPnC Pilot
Comments For serotype 18C the difference in percentages between the two groups (13vPnC Manufacturing - 13vPnC Pilot) was calculated
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference
Estimated Value 3.0
Confidence Interval 95%
-2.8 to 9.2
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection 13vPnC Manufacturing, 13vPnC Pilot
Comments For serotype 19F the difference in percentages between the two groups (13vPnC Manufacturing - 13vPnC Pilot) was calculated
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference
Estimated Value 0.7
Confidence Interval 95%
-3.5 to 5.1
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection 13vPnC Manufacturing, 13vPnC Pilot
Comments For serotype 23F the difference in percentages between the two groups (13vPnC Manufacturing - 13vPnC Pilot) was calculated
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference
Estimated Value 1.1
Confidence Interval 95%
-8.4 to 10.6
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection 13vPnC Manufacturing, 13vPnC Pilot
Comments For serotype 1 the difference in percentages between the two groups (13vPnC Manufacturing - 13vPnC Pilot) was calculated
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference
Estimated Value 2.1
Confidence Interval 95%
-4.8 to 9.2
Estimation Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection 13vPnC Manufacturing, 13vPnC Pilot
Comments For serotype 3 the difference in percentages between the two groups (13vPnC Manufacturing - 13vPnC Pilot) was calculated
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference
Estimated Value -1.7
Confidence Interval 95%
-7.9 to 4.2
Estimation Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection 13vPnC Manufacturing, 13vPnC Pilot
Comments For serotype 5 the difference in percentages between the two groups (13vPnC Manufacturing - 13vPnC Pilot) was calculated
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference
Estimated Value 2.1
Confidence Interval 95%
-5.6 to 9.9
Estimation Comments [Not Specified]
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection 13vPnC Manufacturing, 13vPnC Pilot
Comments For serotype 6A the difference in percentages between the two groups (13vPnC Manufacturing - 13vPnC Pilot) was calculated
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference
Estimated Value -1.1
Confidence Interval 95%
-9.9 to 7.6
Estimation Comments [Not Specified]
Show Statistical Analysis 12 Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection 13vPnC Manufacturing, 13vPnC Pilot
Comments For serotype 7F the difference in percentages between the two groups (13vPnC Manufacturing - 13vPnC Pilot) 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%
-3.0 to 2.8
Estimation Comments [Not Specified]
Show Statistical Analysis 13 Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection 13vPnC Manufacturing, 13vPnC Pilot
Comments For serotype 19A the difference in percentages between the two groups (13vPnC Manufacturing - 13vPnC Pilot) 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%
-3.6 to 3.5
Estimation Comments [Not Specified]
2.Primary Outcome
Title Percentage of Participants Reporting Pre-Specified Local Reactions
Hide Description Local reactions were reported using an electronic diary. 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 (> 7.0 cm). Participants may be represented in more than 1 category.
Time Frame During the 4-day period 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 reporting yes for at least 1 day or no for all days.
Arm/Group Title 13vPnC Manufacturing Dose 1 13vPnC Pilot Dose 1 13vPnC Manufacturing Dose 2 13vPnC Pilot Dose 2 13vPnC Manufacturing Dose 3 13vPnC Pilot Dose 3 13vPnC Manufacturing Toddler Dose 13vPnC Pilot Toddler Dose
Hide Arm/Group Description:
Participants received one single 0.5mL manufacturing scale dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined diphtheria, tetanus, and acellular pertussis inactivated poliovirus, and hemophilus influenza type b vaccine (DTaP-IPV-Hib) and hepatitis B virus vaccine (HBV) at 2 months (infant series, dose 1).
Participants received one single 0.5mL pilot scale dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined diphtheria, tetanus, and acellular pertussis inactivated poliovirus, and hemophilus influenza type b vaccine (DTaP-IPV-Hib) and hepatitis B virus vaccine (HBV) at 2 months (infant series, dose 1).
Participants received one single 0.5mL manufacturing scale dose of 13vPnC coadministered with DTaP-IPV-Hib at 3 and 4 months (infant series, dose 2 and 3).
Participants received one single 0.5mL pilot scale dose of 13vPnC coadministered with DTaP-IPV-Hib at 3 and 4 months (infant series, dose 2 and 3).
Participants received one single 0.5mL manufacturing scale dose of 13vPnC coadministered with DTaP-IPV-Hib at 3 and 4 months (infant series, dose 2 and 3).
Participants received one single 0.5mL pilot scale dose of 13vPnC coadministered with DTaP-IPV-Hib at 3 and 4 months (infant series, dose 2 and 3).
Participants received one single 0.5mL manufacturing scale dose of 13vPnC coadministered with measles, mumps, and rubella vaccine (MMR) and 12 months of age (toddler dose).
Participants received one single 0.5mL pilot scale dose of 13vPnC coadministered with measles, mumps, and rubella vaccine (MMR) and 12 months of age (toddler dose).
Overall Number of Participants Analyzed 134 134 132 133 132 133 131 131
Measure Type: Number
Unit of Measure: percentage of participants
Tenderness-Any (n=133,130,128,128,124,119,115,117) 18.8 20.0 20.3 17.2 15.3 12.6 24.3 29.1
Tenderness-Sig (n=131,129,128,128,124,119,112,114) 0.8 3.9 1.6 3.1 1.6 0.0 1.8 3.5
Swelling-Any (n=132,130,129,129,126,122,113,115) 25.0 20.0 30.2 27.1 29.4 30.3 22.1 26.1
Swelling-Mild (n=132,130,129,129,126,121,113,115) 22.7 17.7 29.5 25.6 27.0 25.6 22.1 25.2
Swelling-Mod (n=132,129,128,128,124,120,113,114) 6.1 7.0 8.6 8.6 8.9 13.3 8.8 8.8
Swelling-Severe(n=131,129,128,128,124,119,112,113) 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
Redness-Any (n=132,131,129,131,125,123,115,116) 28.8 24.4 37.2 33.6 40.0 34.1 37.4 42.2
Redness-Mild (n=132,131,129,131,125,123,115,115) 28.8 22.9 36.4 33.6 38.4 33.3 33.9 36.5
Redness-Mod (n=131,129,128,128,124,119,113,114) 0.0 1.6 3.1 1.6 5.6 3.4 10.6 12.3
Redness-Severe(n=131,129,128,128,124,119,112,113) 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.9
3.Primary Outcome
Title Percentage of Participants Reporting Pre-Specified Systemic Events (Infant Series)
Hide Description Systemic events (fever ≥ 38 degrees Celsius [C] but ≤ 39 C, fever >39 C but ≤ 40 C, fever > 40 C, decreased appetite, irritability, increased sleep, decreased sleep, use of medication (Meds)to prevent symptoms (sx), and use of medication to treat symptoms) were collected using an electronic diary. Participants may be represented in more than 1 category.
Time Frame During the 4-day period after each dose
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The safety population included all participants (268) who received at least 1 dose of vaccine; (n) = number of participants reporting yes for at least 1 day or no for all days.
Arm/Group Title 13vPnC Manufacturing Dose 1 13vPnC Pilot Dose 1 13vPnC Manufacturing Dose 2 13vPnC Pilot Dose 2 13vPnC Manufacturing Dose 3 13vPnC Pilot Dose 3
Hide Arm/Group Description:
Participants received one single 0.5mL manufacturing scale dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined diphtheria, tetanus, and acellular pertussis inactivated poliovirus, and hemophilus influenza type b vaccine (DTaP-IPV-Hib) and hepatitis B virus vaccine (HBV) at 2 months (infant series, dose 1).
Participants received one single 0.5mL pilot scale dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined diphtheria, tetanus, and acellular pertussis inactivated poliovirus, and hemophilus influenza type b vaccine (DTaP-IPV-Hib) and hepatitis B virus vaccine (HBV) at 2 months (infant series, dose 1).
Participants received one single 0.5mL manufacturing scale dose of 13vPnC coadministered with DTaP-IPV-Hib at 3 and 4 months (infant series, dose 2 and 3).
Participants received one single 0.5mL pilot scale dose of 13vPnC coadministered with DTaP-IPV-Hib at 3 and 4 months (infant series, dose 2 and 3).
Participants received one single 0.5mL manufacturing scale dose of 13vPnC coadministered with DTaP-IPV-Hib at 3 and 4 months (infant series, dose 2 and 3).
Participants received one single 0.5mL pilot scale dose of 13vPnC coadministered with DTaP-IPV-Hib at 3 and 4 months (infant series, dose 2 and 3).
Overall Number of Participants Analyzed 134 134 132 133 132 133
Measure Type: Number
Unit of Measure: percentage of participants
Fever ≥38°C but ≤39°C (n=132,130,129,130,124,121) 18.2 19.2 16.3 20.0 11.3 17.4
Fever >39°C but ≤40°C (n=131,129,128,128,124,119) 0.8 0.8 0.8 1.6 0.0 3.4
Fever >40°C (n=131,129,128,128,124,119) 0.0 0.0 0.0 0.0 0.0 0.0
Decreased appetite (n=133,129,129,128,125,121) 20.3 24.0 14.7 15.6 16.8 19.0
Irritability (n=134,131,130,131,127,123) 50.0 51.9 53.8 49.6 41.7 37.4
Increased sleep (n=132,129,128,129124,121) 41.7 39.5 25.0 29.5 20.2 30.6
Decreased sleep (n=132,130,129,129,124,123) 27.3 32.3 24.0 20.9 18.5 19.5
Meds to treat sx (n=132,130,128,128,124,123) 12.9 17.7 13.3 14.1 8.9 14.6
Meds to prevent sx (n=132,130,128,129124,121) 12.9 9.2 11.7 10.1 10.5 8.3
4.Primary Outcome
Title Percentage of Participants Reporting Pre-Specified Systemic Events (Toddler Series)
Hide Description Systemic events (fever ≥ 38 degrees Celsius [C] but ≤ 39 C, fever >39 C but ≤ 40 C, fever > 40 C), decreased appetite, irritability, increased sleep, decreased sleep, use of medication to prevent symptoms, and use of medication to treat symptoms) were collected using an electronic diary. Participants may be represented in more than 1 category.
Time Frame During the 4-day period after toddler 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 reporting yes for at least 1 day or no for all days.
Arm/Group Title 13vPnC Manufacturing 13vPnC Pilot
Hide Arm/Group Description:
Participants received one single 0.5mL manufacturing scale dose of 13vPnC coadministered with measles, mumps, and rubella vaccine (MMR) and 12 months of age (toddler dose).
Participants received one single 0.5mL pilot scale dose of 13vPnC coadministered with measles, mumps, and rubella vaccine (MMR) and 12 months of age (toddler dose).
Overall Number of Participants Analyzed 131 131
Measure Type: Number
Unit of Measure: percentage of participants
Fever ≥38°C but ≤39°C (n=114,114) 14.0 13.2
Fever >39°C but ≤40°C (n=112,113) 0.9 0.9
Fever >40°C (n=112,113) 0.0 0.0
Decreased appetite (n=115,117) 20.9 23.1
Irritability (n=119,123) 40.3 44.7
Increased sleep (n=114,119) 18.4 16.8
Decreased sleep (n=116,117) 13.8 13.7
Medication to treat symptoms (n=113,115) 17.7 17.4
Medication to prevent symptoms (n=114,114) 12.3 12.3
5.Primary Outcome
Title Geometric Mean Antibody Concentration in 13vPnC Manufacturing Scale Group Relative to 13vPnC Pilot Scale Group After the 3-Dose Infant Series
Hide Description Antibody concentration/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.
Time Frame One month after 3-dose infant series (5 months of age)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Evaluable immunogenicity (per protocol) population were participants who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations.
Arm/Group Title 13vPnC Manufacturing 13vPnC Pilot
Hide Arm/Group Description:
Participants received one single 0.5mL manufacturing scale dose of 13vPnC coadministered with Infanrix hexa at 2, 3, 4 months (infant series) and 12 months of age (toddler dose).
Participants received one single 0.5mL pilot scale dose of 13vPnC coadministered with Infanrix hexa at 2, 3, 4 months (infant series) and 12 months of age (toddler dose).
Overall Number of Participants Analyzed 128 131
Geometric Mean (95% Confidence Interval)
Unit of Measure: μg/mL
Common Serotypes-Serotype 4
2.09
(1.81 to 2.40)
1.55
(1.34 to 1.79)
Common Serotypes - Serotype 6B
0.80
(0.65 to 0.98)
0.83
(0.66 to 1.06)
Common Serotypes - Serotype 9V
1.28
(1.13 to 1.43)
1.21
(1.08 to 1.37)
Common Serotypes - Serotype 14
2.15
(1.77 to 2.61)
2.30
(1.91 to 2.77)
Common Serotypes - Serotype 18C
1.60
(1.38 to 1.87)
1.51
(1.31 to 1.75)
Common Serotypes - Serotype 19F
1.60
(1.40 to 1.83)
1.64
(1.44 to 1.86)
Common Serotypes - Serotype 23F
0.82
(0.69 to 0.98)
0.92
(0.77 to 1.10)
Additional Serotypes - Serotype 1
1.42
(1.21 to 1.66)
1.29
(1.10 to 1.51)
Additional Serotypes - Serotype 3
1.20
(1.05 to 1.38)
1.21
(1.06 to 1.37)
Additional Serotypes - Serotype 5
0.96
(0.84 to 1.09)
1.00
(0.87 to 1.16)
Additional Serotypes - Serotype 6A
0.87
(0.74 to 1.03)
1.05
(0.89 to 1.25)
Additional Serotypes - Serotype 7F
2.00
(1.77 to 2.25)
2.14
(1.89 to 2.42)
Additional Serotypes - Serotype 19A
2.19
(1.91 to 2.50)
2.31
(2.05 to 2.61)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 13vPnC Manufacturing, 13vPnC Pilot
Comments For serotype 4 the GMC ratio was calculated
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 1.35
Confidence Interval 95%
1.10 to 1.65
Estimation Comments [Not Specified]
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Statistical Analysis Overview Comparison Group Selection 13vPnC Manufacturing, 13vPnC Pilot
Comments For serotype 6B the GMC ratio 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%
0.70 to 1.31
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 13vPnC Manufacturing, 13vPnC Pilot
Comments For serotype 9V the GMC ratio was calculated
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 1.05
Confidence Interval 95%
0.89 to 1.24
Estimation Comments [Not Specified]
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Statistical Analysis Overview Comparison Group Selection 13vPnC Manufacturing, 13vPnC Pilot
Comments For serotype 14 the GMC ratio was calculated
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 0.93
Confidence Interval 95%
0.71 to 1.22
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection 13vPnC Manufacturing, 13vPnC Pilot
Comments For serotype 18C the GMC ratio was calculated
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 1.06
Confidence Interval 95%
0.86 to 1.30
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection 13vPnC Manufacturing, 13vPnC Pilot
Comments For serotype 19F the GMC ratio was calculated
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 0.98
Confidence Interval 95%
0.81 to 1.17
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection 13vPnC Manufacturing, 13vPnC Pilot
Comments For serotype 23F the GMC ratio was calculated
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 0.90
Confidence Interval 95%
0.70 to 1.15
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection 13vPnC Manufacturing, 13vPnC Pilot
Comments For serotype 1 the GMC ratio was calculated
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 1.10
Confidence Interval 95%
0.88 to 1.37
Estimation Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection 13vPnC Manufacturing, 13vPnC Pilot
Comments For serotype 3 the GMC ratio was calculated
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 1.00
Confidence Interval 95%
0.83 to 1.20
Estimation Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection 13vPnC Manufacturing, 13vPnC Pilot
Comments For serotype 5 the GMC ratio was calculated
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 0.95
Confidence Interval 95%
0.79 to 1.16
Estimation Comments [Not Specified]
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection 13vPnC Manufacturing, 13vPnC Pilot
Comments For serotype 6A the GMC ratio was calculated
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 0.83
Confidence Interval 95%
0.66 to 1.05
Estimation Comments [Not Specified]
Show Statistical Analysis 12 Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection 13vPnC Manufacturing, 13vPnC Pilot
Comments For serotype 7F the GMC ratio was calculated
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 0.93
Confidence Interval 95%
0.79 to 1.11
Estimation Comments [Not Specified]
Show Statistical Analysis 13 Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection 13vPnC Manufacturing, 13vPnC Pilot
Comments For serotype 19A the GMC ratio was calculated
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 0.95
Confidence Interval 95%
0.79 to 1.13
Estimation Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 13vPnC Manufacturing Infant Series 13vPnC Pilot Infant Series 13vPnC Manufacturing Post-Infant Series 13vPnC Pilot Post-Infant Series 13vPnC Manufacturing Toddler Series 13vPnC Pilot Toddler Series
Hide Arm/Group Description Participants received one single 0.5mL manufacturing scale dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined diphtheria, tetanus, and acellular pertussis inactivated poliovirus, and hemophilus influenza type b vaccine (DTaP-IPV-Hib) and hepatitis B virus vaccine (HBV) at 2 months (infant series, dose 1). Participants received one single 0.5mL manufacturing scale dose of 13vPnC coadministered with DTaP-IPV-Hib at 3 and 4 months (infant series, dose 2 and 3). Participants received one single 0.5mL pilot scale dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined diphtheria, tetanus, and acellular pertussis inactivated poliovirus, and hemophilus influenza type b vaccine (DTaP-IPV-Hib) and hepatitis B virus vaccine (HBV) at 2 months (infant series, dose 1). Participants received one single 0.5mL pilot scale dose of 13vPnC coadministered with DTaP-IPV-Hib at 3 and 4 months (infant series, dose 2 and 3). Participants received one single 0.5mL manufacturing scale dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined diphtheria, tetanus, and acellular pertussis inactivated poliovirus, and hemophilus influenza type b vaccine (DTaP-IPV-Hib) and hepatitis B virus vaccine (HBV) at 2 months (infant series, dose 1). Participants received one single 0.5mL manufacturing scale dose of 13vPnC coadministered with DTaP-IPV-Hib at 3 and 4 months (infant series, dose 2 and 3). Assessment done at 5 months of age, 1 month after infant series. Participants received one single 0.5mL pilot scale dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined diphtheria, tetanus, and acellular pertussis inactivated poliovirus, and hemophilus influenza type b vaccine (DTaP-IPV-Hib) and hepatitis B virus vaccine (HBV) at 2 months (infant series, dose 1). Participants received one single 0.5mL pilot scale dose of 13vPnC coadministered with DTaP-IPV-Hib at 3 and 4 months (infant series, dose 2 and 3). Assessment done at 5 months of age, 1 month after infant series. Participants received one single 0.5mL manufacturing scale dose of 13vPnC coadministered with measles, mumps, and rubella vaccine (MMR) and 12 months of age (toddler dose). Participants received one single 0.5mL pilot scale dose of 13vPnC coadministered with measles, mumps, and rubella vaccine (MMR) and 12 months of age (toddler dose).
All-Cause Mortality
13vPnC Manufacturing Infant Series 13vPnC Pilot Infant Series 13vPnC Manufacturing Post-Infant Series 13vPnC Pilot Post-Infant Series 13vPnC Manufacturing Toddler Series 13vPnC Pilot Toddler Series
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 Manufacturing Infant Series 13vPnC Pilot Infant Series 13vPnC Manufacturing Post-Infant Series 13vPnC Pilot Post-Infant Series 13vPnC Manufacturing Toddler Series 13vPnC Pilot Toddler Series
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   4/134 (2.99%)   2/134 (1.49%)   10/134 (7.46%)   11/134 (8.21%)   0/131 (0.00%)   1/131 (0.76%) 
Eye disorders             
Conjunctivitis *  0/134 (0.00%)  0/134 (0.00%)  0/134 (0.00%)  1/134 (0.75%)  0/131 (0.00%)  0/131 (0.00%) 
Gastrointestinal disorders             
Diarrhoea *  0/134 (0.00%)  1/134 (0.75%)  2/134 (1.49%)  1/134 (0.75%)  0/131 (0.00%)  0/131 (0.00%) 
Gastroesophageal reflux disease *  0/134 (0.00%)  0/134 (0.00%)  0/134 (0.00%)  1/134 (0.75%)  0/131 (0.00%)  0/131 (0.00%) 
General disorders             
Pyrexia *  0/134 (0.00%)  0/134 (0.00%)  1/134 (0.75%)  0/134 (0.00%)  0/131 (0.00%)  0/131 (0.00%) 
Infections and infestations             
Bronchitis *  1/134 (0.75%)  0/134 (0.00%)  1/134 (0.75%)  2/134 (1.49%)  0/131 (0.00%)  0/131 (0.00%) 
Bronchopneumonia *  0/134 (0.00%)  0/134 (0.00%)  1/134 (0.75%)  0/134 (0.00%)  0/131 (0.00%)  0/131 (0.00%) 
Enterocolitis infectious *  0/134 (0.00%)  0/134 (0.00%)  0/134 (0.00%)  1/134 (0.75%)  0/131 (0.00%)  0/131 (0.00%) 
Gastroenteritis *  0/134 (0.00%)  0/134 (0.00%)  3/134 (2.24%)  4/134 (2.99%)  0/131 (0.00%)  1/131 (0.76%) 
Infectious mononucleosis *  0/134 (0.00%)  0/134 (0.00%)  1/134 (0.75%)  0/134 (0.00%)  0/131 (0.00%)  0/131 (0.00%) 
Laryngitis *  1/134 (0.75%)  0/134 (0.00%)  2/134 (1.49%)  1/134 (0.75%)  0/131 (0.00%)  0/131 (0.00%) 
Nasopharyngitis *  0/134 (0.00%)  0/134 (0.00%)  0/134 (0.00%)  1/134 (0.75%)  0/131 (0.00%)  0/131 (0.00%) 
Otitis media *  0/134 (0.00%)  0/134 (0.00%)  0/134 (0.00%)  1/134 (0.75%)  0/131 (0.00%)  0/131 (0.00%) 
Pharyngitis *  0/134 (0.00%)  0/134 (0.00%)  0/134 (0.00%)  1/134 (0.75%)  0/131 (0.00%)  0/131 (0.00%) 
Pneumonia *  1/134 (0.75%)  0/134 (0.00%)  2/134 (1.49%)  3/134 (2.24%)  0/131 (0.00%)  0/131 (0.00%) 
Pneumonia primary atypical *  0/134 (0.00%)  0/134 (0.00%)  0/134 (0.00%)  1/134 (0.75%)  0/131 (0.00%)  0/131 (0.00%) 
Respiratory tract infection *  1/134 (0.75%)  0/134 (0.00%)  0/134 (0.00%)  0/134 (0.00%)  0/131 (0.00%)  0/131 (0.00%) 
Rotavirus infection *  0/134 (0.00%)  0/134 (0.00%)  1/134 (0.75%)  0/134 (0.00%)  0/131 (0.00%)  0/131 (0.00%) 
Sepsis *  1/134 (0.75%)  0/134 (0.00%)  0/134 (0.00%)  0/134 (0.00%)  0/131 (0.00%)  0/131 (0.00%) 
Upper respiratory tract infection *  0/134 (0.00%)  1/134 (0.75%)  1/134 (0.75%)  2/134 (1.49%)  0/131 (0.00%)  0/131 (0.00%) 
Metabolism and nutrition disorders             
Dehydration *  0/134 (0.00%)  0/134 (0.00%)  0/134 (0.00%)  1/134 (0.75%)  0/131 (0.00%)  0/131 (0.00%) 
Psychiatric disorders             
Crying *  0/134 (0.00%)  1/134 (0.75%)  0/134 (0.00%)  0/134 (0.00%)  0/131 (0.00%)  0/131 (0.00%) 
Respiratory, thoracic and mediastinal disorders             
Asthma *  0/134 (0.00%)  0/134 (0.00%)  2/134 (1.49%)  0/134 (0.00%)  0/131 (0.00%)  0/131 (0.00%) 
Bronchospasm *  1/134 (0.75%)  0/134 (0.00%)  0/134 (0.00%)  0/134 (0.00%)  0/131 (0.00%)  0/131 (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 Manufacturing Infant Series 13vPnC Pilot Infant Series 13vPnC Manufacturing Post-Infant Series 13vPnC Pilot Post-Infant Series 13vPnC Manufacturing Toddler Series 13vPnC Pilot Toddler Series
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   70/134 (52.24%)   68/134 (50.75%)   3/134 (2.24%)   7/134 (5.22%)   48/131 (36.64%)   55/131 (41.98%) 
Blood and lymphatic system disorders             
Anaemia *  2/134 (1.49%)  2/134 (1.49%)  0/134 (0.00%)  2/134 (1.49%)  0/131 (0.00%)  0/131 (0.00%) 
Iron deficiency anaemia *  0/134 (0.00%)  1/134 (0.75%)  0/134 (0.00%)  0/134 (0.00%)  0/131 (0.00%)  0/131 (0.00%) 
Lymphadenitis *  0/134 (0.00%)  1/134 (0.75%)  0/134 (0.00%)  0/134 (0.00%)  0/131 (0.00%)  1/131 (0.76%) 
Congenital, familial and genetic disorders             
Hip dysplasia *  1/134 (0.75%)  1/134 (0.75%)  0/134 (0.00%)  0/134 (0.00%)  0/131 (0.00%)  0/131 (0.00%) 
Atrial septal defect *  0/134 (0.00%)  1/134 (0.75%)  0/134 (0.00%)  0/134 (0.00%)  0/131 (0.00%)  0/131 (0.00%) 
Dacryostenosis congenital *  1/134 (0.75%)  0/134 (0.00%)  0/134 (0.00%)  0/134 (0.00%)  0/131 (0.00%)  0/131 (0.00%) 
Hydrocele *  1/134 (0.75%)  0/134 (0.00%)  0/134 (0.00%)  0/134 (0.00%)  0/131 (0.00%)  0/131 (0.00%) 
Plagiocephaly *  1/134 (0.75%)  0/134 (0.00%)  0/134 (0.00%)  0/134 (0.00%)  0/131 (0.00%)  0/131 (0.00%) 
Eye disorders             
Conjunctivitis *  5/134 (3.73%)  4/134 (2.99%)  0/134 (0.00%)  0/134 (0.00%)  1/131 (0.76%)  0/131 (0.00%) 
Dacryostenosis acquired *  0/134 (0.00%)  1/134 (0.75%)  0/134 (0.00%)  0/134 (0.00%)  0/131 (0.00%)  0/131 (0.00%) 
Eyelid oedema *  0/134 (0.00%)  1/134 (0.75%)  0/134 (0.00%)  0/134 (0.00%)  0/131 (0.00%)  0/131 (0.00%) 
Gastrointestinal disorders             
Diarrhoea *  4/134 (2.99%)  3/134 (2.24%)  0/134 (0.00%)  0/134 (0.00%)  3/131 (2.29%)  1/131 (0.76%) 
Dyspepsia *  1/134 (0.75%)  4/134 (2.99%)  0/134 (0.00%)  0/134 (0.00%)  0/131 (0.00%)  0/131 (0.00%) 
Constipation *  1/134 (0.75%)  2/134 (1.49%)  0/134 (0.00%)  0/134 (0.00%)  0/131 (0.00%)  0/131 (0.00%) 
Abdominal pain *  1/134 (0.75%)  0/134 (0.00%)  0/134 (0.00%)  0/134 (0.00%)  0/131 (0.00%)  0/131 (0.00%) 
Enlarged uvula *  1/134 (0.75%)  0/134 (0.00%)  0/134 (0.00%)  0/134 (0.00%)  0/131 (0.00%)  0/131 (0.00%) 
Frequent bowel movements *  1/134 (0.75%)  0/134 (0.00%)  0/134 (0.00%)  0/134 (0.00%)  0/131 (0.00%)  0/131 (0.00%) 
Infantile colic *  1/134 (0.75%)  0/134 (0.00%)  0/134 (0.00%)  0/134 (0.00%)  0/131 (0.00%)  0/131 (0.00%) 
Infrequent bowel movements *  0/134 (0.00%)  1/134 (0.75%)  0/134 (0.00%)  0/134 (0.00%)  0/131 (0.00%)  0/131 (0.00%) 
Teething *  1/134 (0.75%)  0/134 (0.00%)  0/134 (0.00%)  0/134 (0.00%)  0/131 (0.00%)  0/131 (0.00%) 
Gastrooesophageal reflux disease *  0/134 (0.00%)  0/134 (0.00%)  1/134 (0.75%)  1/134 (0.75%)  0/131 (0.00%)  0/131 (0.00%) 
Vomiting *  0/134 (0.00%)  0/134 (0.00%)  0/134 (0.00%)  0/134 (0.00%)  0/131 (0.00%)  1/131 (0.76%) 
General disorders             
Pyrexia *  2/134 (1.49%)  0/134 (0.00%)  0/134 (0.00%)  0/134 (0.00%)  2/131 (1.53%)  0/131 (0.00%) 
Irritability *  0/134 (0.00%)  1/134 (0.75%)  0/134 (0.00%)  0/134 (0.00%)  0/131 (0.00%)  0/131 (0.00%) 
Malaise *  0/134 (0.00%)  1/134 (0.75%)  0/134 (0.00%)  0/134 (0.00%)  0/131 (0.00%)  0/131 (0.00%) 
Fever ≥38°C but ≤39°C  2 [1]  24/132 (18.18%)  25/130 (19.23%)  0/134 (0.00%)  0/134 (0.00%)  16/114 (14.04%)  15/114 (13.16%) 
Fever ≥38°C but ≤39°C  2 [2]  21/129 (16.28%)  26/130 (20.00%)  0/134 (0.00%)  0/134 (0.00%)  0/131 (0.00%)  0/131 (0.00%) 
Fever ≥38°C but ≤39°C  2 [3]  14/124 (11.29%)  21/121 (17.36%)  0/134 (0.00%)  0/134 (0.00%)  0/131 (0.00%)  0/131 (0.00%) 
Fever >39°C but ≤40°C  2 [1]  1/131 (0.76%)  1/129 (0.78%)  0/134 (0.00%)  0/134 (0.00%)  1/112 (0.89%)  1/113 (0.88%) 
Fever >39°C but ≤40°C  2 [2]  1/128 (0.78%)  2/128 (1.56%)  0/134 (0.00%)  0/134 (0.00%)  0/131 (0.00%)  0/131 (0.00%) 
Fever >39°C but ≤40°C  2 [3]  0/124 (0.00%)  4/119 (3.36%)  0/134 (0.00%)  0/134 (0.00%)  0/131 (0.00%)  0/131 (0.00%) 
Fever >40°C  2 [1]  0/131 (0.00%)  0/129 (0.00%)  0/134 (0.00%)  0/134 (0.00%)  0/112 (0.00%)  0/113 (0.00%) 
Fever >40°C  2 [2]  0/128 (0.00%)  0/128 (0.00%)  0/134 (0.00%)  0/134 (0.00%)  0/131 (0.00%)  0/131 (0.00%) 
Fever >40°C  2 [3]  0/124 (0.00%)  0/119 (0.00%)  0/134 (0.00%)  0/134 (0.00%)  0/131 (0.00%)  0/131 (0.00%) 
Decreased appetite  2 [1]  27/133 (20.30%)  31/129 (24.03%)  0/134 (0.00%)  0/134 (0.00%)  24/115 (20.87%)  27/117 (23.08%) 
Decreased appetite  2 [2]  19/129 (14.73%)  20/128 (15.63%)  0/134 (0.00%)  0/134 (0.00%)  0/131 (0.00%)  0/131 (0.00%) 
Decreased appetite  2 [3]  21/125 (16.80%)  23/121 (19.01%)  0/134 (0.00%)  0/134 (0.00%)  0/131 (0.00%)  0/131 (0.00%) 
Irritability  2 [1]  67/134 (50.00%)  68/131 (51.91%)  0/134 (0.00%)  0/134 (0.00%)  48/119 (40.34%)  55/123 (44.72%) 
Irritability  2 [2]  70/130 (53.85%)  65/131 (49.62%)  0/134 (0.00%)  0/134 (0.00%)  0/131 (0.00%)  0/131 (0.00%) 
Irritability  2 [3]  53/127 (41.73%)  46/123 (37.40%)  0/134 (0.00%)  0/134 (0.00%)  0/131 (0.00%)  0/131 (0.00%) 
Increased sleep  2 [1]  55/132 (41.67%)  51/129 (39.53%)  0/134 (0.00%)  0/134 (0.00%)  21/114 (18.42%)  20/119 (16.81%) 
Increased sleep  2 [2]  32/128 (25.00%)  38/129 (29.46%)  0/134 (0.00%)  0/134 (0.00%)  0/131 (0.00%)  0/131 (0.00%) 
Increased sleep  2 [3]  25/124 (20.16%)  37/121 (30.58%)  0/134 (0.00%)  0/134 (0.00%)  0/131 (0.00%)  0/131 (0.00%) 
Decreased sleep  2 [1]  36/132 (27.27%)  42/130 (32.31%)  0/134 (0.00%)  0/134 (0.00%)  16/116 (13.79%)  16/117 (13.68%) 
Decreased sleep  2 [2]  31/129 (24.03%)  27/129 (20.93%)  0/134 (0.00%)  0/134 (0.00%)  0/131 (0.00%)  0/131 (0.00%) 
Decreased sleep  2 [3]  23/124 (18.55%)  24/123 (19.51%)  0/134 (0.00%)  0/134 (0.00%)  0/131 (0.00%)  0/131 (0.00%) 
Immune system disorders             
Food allergy *  0/134 (0.00%)  0/134 (0.00%)  0/134 (0.00%)  1/134 (0.75%)  0/131 (0.00%)  0/131 (0.00%) 
Milk allergy *  0/134 (0.00%)  0/134 (0.00%)  1/134 (0.75%)  0/134 (0.00%)  0/131 (0.00%)  0/131 (0.00%) 
Infections and infestations             
Rhinitis *  12/134 (8.96%)  10/134 (7.46%)  0/134 (0.00%)  0/134 (0.00%)  1/131 (0.76%)  2/131 (1.53%) 
Pharyngitis *  9/134 (6.72%)  10/134 (7.46%)  0/134 (0.00%)  0/134 (0.00%)  5/131 (3.82%)  5/131 (3.82%) 
Upper respiratory tract infection *  8/134 (5.97%)  11/134 (8.21%)  0/134 (0.00%)  0/134 (0.00%)  2/131 (1.53%)  1/131 (0.76%) 
Nasopharyngitis *  8/134 (5.97%)  9/134 (6.72%)  0/134 (0.00%)  0/134 (0.00%)  1/131 (0.76%)  2/131 (1.53%) 
Bronchitis *  5/134 (3.73%)  7/134 (5.22%)  0/134 (0.00%)  0/134 (0.00%)  1/131 (0.76%)  2/131 (1.53%) 
Candidiasis *  2/134 (1.49%)  1/134 (0.75%)  0/134 (0.00%)  0/134 (0.00%)  0/131 (0.00%)  0/131 (0.00%) 
Ear infection *  2/134 (1.49%)  1/134 (0.75%)  0/134 (0.00%)  0/134 (0.00%)  0/131 (0.00%)  0/131 (0.00%) 
Exanthema subitum *  2/134 (1.49%)  1/134 (0.75%)  0/134 (0.00%)  0/134 (0.00%)  0/131 (0.00%)  1/131 (0.76%) 
Viral infection *  2/134 (1.49%)  1/134 (0.75%)  0/134 (0.00%)  0/134 (0.00%)  1/131 (0.76%)  3/131 (2.29%) 
Bronchopneumonia *  1/134 (0.75%)  1/134 (0.75%)  0/134 (0.00%)  0/134 (0.00%)  0/131 (0.00%)  0/131 (0.00%) 
Gastrointestinal infection *  1/134 (0.75%)  0/134 (0.00%)  0/134 (0.00%)  0/134 (0.00%)  0/131 (0.00%)  0/131 (0.00%) 
Lower respiratory tract infection *  1/134 (0.75%)  0/134 (0.00%)  0/134 (0.00%)  0/134 (0.00%)  0/131 (0.00%)  0/131 (0.00%) 
Oral candidiasis *  0/134 (0.00%)  1/134 (0.75%)  0/134 (0.00%)  0/134 (0.00%)  0/131 (0.00%)  0/131 (0.00%) 
Tonsillitis *  1/134 (0.75%)  0/134 (0.00%)  0/134 (0.00%)  0/134 (0.00%)  0/131 (0.00%)  0/131 (0.00%) 
Gastroenteritis *  0/134 (0.00%)  0/134 (0.00%)  0/134 (0.00%)  0/134 (0.00%)  2/131 (1.53%)  2/131 (1.53%) 
Laryngitis *  0/134 (0.00%)  0/134 (0.00%)  0/134 (0.00%)  0/134 (0.00%)  2/131 (1.53%)  0/131 (0.00%) 
Urinary tract infection *  0/134 (0.00%)  0/134 (0.00%)  0/134 (0.00%)  0/134 (0.00%)  1/131 (0.76%)  1/131 (0.76%) 
Otitis media acute *  0/134 (0.00%)  0/134 (0.00%)  0/134 (0.00%)  0/134 (0.00%)  0/131 (0.00%)  1/131 (0.76%) 
Respiratory tract infection *  0/134 (0.00%)  0/134 (0.00%)  0/134 (0.00%)  0/134 (0.00%)  1/131 (0.76%)  0/131 (0.00%) 
Injury, poisoning and procedural complications             
Corneal abrasion *  1/134 (0.75%)  0/134 (0.00%)  0/134 (0.00%)  0/134 (0.00%)  0/131 (0.00%)  0/131 (0.00%) 
Musculoskeletal and connective tissue disorders             
Rickets *  1/134 (0.75%)  1/134 (0.75%)  0/134 (0.00%)  0/134 (0.00%)  0/131 (0.00%)  0/131 (0.00%) 
Posture abnormal *  1/134 (0.75%)  0/134 (0.00%)  0/134 (0.00%)  0/134 (0.00%)  0/131 (0.00%)  0/131 (0.00%) 
Nervous system disorders             
Hypertonia *  0/134 (0.00%)  1/134 (0.75%)  0/134 (0.00%)  0/134 (0.00%)  0/131 (0.00%)  0/131 (0.00%) 
Hypotonia *  0/134 (0.00%)  0/134 (0.00%)  0/134 (0.00%)  1/134 (0.75%)  0/131 (0.00%)  0/131 (0.00%) 
Poor quality sleep *  0/134 (0.00%)  0/134 (0.00%)  0/134 (0.00%)  0/134 (0.00%)  0/131 (0.00%)  1/131 (0.76%) 
Psychiatric disorders             
Crying *  0/134 (0.00%)  1/134 (0.75%)  0/134 (0.00%)  0/134 (0.00%)  0/131 (0.00%)  0/131 (0.00%) 
Psychomotor retardation *  0/134 (0.00%)  1/134 (0.75%)  0/134 (0.00%)  0/134 (0.00%)  0/131 (0.00%)  0/131 (0.00%) 
Reproductive system and breast disorders             
Posthitis *  0/134 (0.00%)  1/134 (0.75%)  0/134 (0.00%)  0/134 (0.00%)  0/131 (0.00%)  0/131 (0.00%) 
Respiratory, thoracic and mediastinal disorders             
Rhinorrhoea *  2/134 (1.49%)  0/134 (0.00%)  0/134 (0.00%)  0/134 (0.00%)  0/131 (0.00%)  0/131 (0.00%) 
Asthma *  0/134 (0.00%)  1/134 (0.75%)  0/134 (0.00%)  0/134 (0.00%)  0/131 (0.00%)  0/131 (0.00%) 
Cough *  0/134 (0.00%)  1/134 (0.75%)  0/134 (0.00%)  0/134 (0.00%)  0/131 (0.00%)  1/131 (0.76%) 
Dysphonia *  0/134 (0.00%)  1/134 (0.75%)  0/134 (0.00%)  0/134 (0.00%)  0/131 (0.00%)  0/131 (0.00%) 
Skin and subcutaneous tissue disorders             
Rash *  2/134 (1.49%)  2/134 (1.49%)  0/134 (0.00%)  0/134 (0.00%)  0/131 (0.00%)  0/131 (0.00%) 
Dermatitis atopic *  1/134 (0.75%)  2/134 (1.49%)  1/134 (0.75%)  0/134 (0.00%)  1/131 (0.76%)  1/131 (0.76%) 
Dermatitis *  1/134 (0.75%)  0/134 (0.00%)  0/134 (0.00%)  0/134 (0.00%)  0/131 (0.00%)  1/131 (0.76%) 
Eczema *  0/134 (0.00%)  1/134 (0.75%)  0/134 (0.00%)  0/134 (0.00%)  0/131 (0.00%)  0/131 (0.00%) 
Dermatitis allergic *  0/134 (0.00%)  0/134 (0.00%)  0/134 (0.00%)  2/134 (1.49%)  1/131 (0.76%)  0/131 (0.00%) 
Tenderness (Any)  1 [1]  25/133 (18.80%)  26/130 (20.00%)  0/134 (0.00%)  0/134 (0.00%)  28/115 (24.35%)  34/117 (29.06%) 
Tenderness (Any)  1 [2]  26/128 (20.31%)  22/128 (17.19%)  0/134 (0.00%)  0/134 (0.00%)  0/131 (0.00%)  0/131 (0.00%) 
Tenderness (Any)  1 [3]  19/124 (15.32%)  15/119 (12.61%)  0/134 (0.00%)  0/134 (0.00%)  0/131 (0.00%)  0/131 (0.00%) 
Tenderness (Significant)  1 [1]  1/131 (0.76%)  5/129 (3.88%)  0/134 (0.00%)  0/134 (0.00%)  2/112 (1.79%)  4/114 (3.51%) 
Tenderness (Significant)  1 [2]  2/128 (1.56%)  4/128 (3.13%)  0/134 (0.00%)  0/134 (0.00%)  0/131 (0.00%)  0/131 (0.00%) 
Tenderness (Significant)  1 [3]  2/124 (1.61%)  0/119 (0.00%)  0/134 (0.00%)  0/134 (0.00%)  0/131 (0.00%)  0/131 (0.00%) 
Induration (Any)  1 [1]  33/132 (25.00%)  26/130 (20.00%)  0/134 (0.00%)  0/134 (0.00%)  25/113 (22.12%)  30/115 (26.09%) 
Induration (Any)  1 [2]  39/129 (30.23%)  35/129 (27.13%)  0/134 (0.00%)  0/134 (0.00%)  0/131 (0.00%)  0/131 (0.00%) 
Induration (Any)  1 [4]  37/126 (29.37%)  37/122 (30.33%)  0/134 (0.00%)  0/134 (0.00%)  0/131 (0.00%)  0/131 (0.00%) 
Induration (Mild)  1 [1]  30/132 (22.73%)  23/130 (17.69%)  0/134 (0.00%)  0/134 (0.00%)  25/113 (22.12%)  29/115 (25.22%) 
Induration (Mild)  1 [2]  38/129 (29.46%)  33/129 (25.58%)  0/134 (0.00%)  0/134 (0.00%)  0/131 (0.00%)  0/131 (0.00%) 
Induration(Mild)  1 [3]  34/126 (26.98%)  31/121 (25.62%)  0/134 (0.00%)  0/134 (0.00%)  0/131 (0.00%)  0/131 (0.00%) 
Induration (Moderate)  1 [1]  8/132 (6.06%)  9/129 (6.98%)  0/134 (0.00%)  0/134 (0.00%)  10/113 (8.85%)  10/114 (8.77%) 
Induration (Moderate)  1 [2]  11/128 (8.59%)  11/128 (8.59%)  0/134 (0.00%)  0/134 (0.00%)  0/131 (0.00%)  0/131 (0.00%) 
Induration (Moderate)  1 [3]  11/124 (8.87%)  16/120 (13.33%)  0/134 (0.00%)  0/134 (0.00%)  0/131 (0.00%)  0/131 (0.00%) 
Induration (Severe)  1 [1]  0/131 (0.00%)  0/129 (0.00%)  0/134 (0.00%)  0/134 (0.00%)  0/112 (0.00%)  0/113 (0.00%) 
Induration (Severe)  1 [2]  0/128 (0.00%)  0/128 (0.00%)  0/134 (0.00%)  0/134 (0.00%)  0/131 (0.00%)  0/131 (0.00%) 
Induration (Severe)  1 [3]  0/124 (0.00%)  0/119 (0.00%)  0/134 (0.00%)  0/134 (0.00%)  0/131 (0.00%)  0/131 (0.00%) 
Erythema (Any)  1 [1]  38/132 (28.79%)  32/131 (24.43%)  0/134 (0.00%)  0/134 (0.00%)  43/115 (37.39%)  49/116 (42.24%) 
Erythema (Any)  1 [2]  48/129 (37.21%)  44/131 (33.59%)  0/134 (0.00%)  0/134 (0.00%)  0/131 (0.00%)  0/131 (0.00%) 
Erythema (Any)  1 [3]  50/125 (40.00%)  42/123 (34.15%)  0/134 (0.00%)  0/134 (0.00%)  0/131 (0.00%)  0/131 (0.00%) 
Erythema (Mild)  1 [1]  38/132 (28.79%)  30/131 (22.90%)  0/134 (0.00%)  0/134 (0.00%)  39/115 (33.91%)  42/115 (36.52%) 
Erythema (Mild)  1 [2]  47/129 (36.43%)  44/131 (33.59%)  0/134 (0.00%)  0/134 (0.00%)  0/131 (0.00%)  0/131 (0.00%) 
Erythema (Mild)  1 [3]  48/125 (38.40%)  41/123 (33.33%)  0/134 (0.00%)  0/134 (0.00%)  0/131 (0.00%)  0/131 (0.00%) 
Erythema (Moderate)  1 [1]  0/131 (0.00%)  2/129 (1.55%)  0/134 (0.00%)  0/134 (0.00%)  12/113 (10.62%)  14/114 (12.28%) 
Erythema (Moderate)  1 [2]  4/128 (3.13%)  2/128 (1.56%)  0/134 (0.00%)  0/134 (0.00%)  0/131 (0.00%)  0/131 (0.00%) 
Erythema (Moderate)  1 [3]  7/124 (5.65%)  4/119 (3.36%)  0/134 (0.00%)  0/134 (0.00%)  0/131 (0.00%)  0/131 (0.00%) 
Erythema (Severe)  1 [1]  0/131 (0.00%)  0/129 (0.00%)  0/134 (0.00%)  0/134 (0.00%)  0/112 (0.00%)  1/113 (0.88%) 
Erythema (Severe)  1 [2]  0/128 (0.00%)  0/128 (0.00%)  0/134 (0.00%)  0/134 (0.00%)  0/131 (0.00%)  0/131 (0.00%) 
Erythema (Severe)  1 [3]  0/124 (0.00%)  0/119 (0.00%)  0/134 (0.00%)  0/134 (0.00%)  0/131 (0.00%)  0/131 (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]
Dose 1 Infant Series and Toddler Dose
[2]
Dose 2 Infant Series
[3]
Dose 3 Infant Series
[4]
Dose 3 Infant Serie
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The PIs agreed to allow the sponsor 60 days to review and require changes to presentations or publications but only to protect confidential information and intellectual property, and for the sponsor to file a patent application, as applicable. The PIs also agreed for data to be presented first as a joint, multi-center publication.
Results Point of Contact
Name/Title: U. S. Contact Center
Organization: Wyeth
Responsible Party: Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier: NCT00464945     History of Changes
Other Study ID Numbers: 6096A1-3000
First Submitted: April 23, 2007
First Posted: April 24, 2007
Results First Submitted: March 26, 2010
Results First Posted: August 15, 2012
Last Update Posted: August 15, 2012