Trial Outcomes & Findings for Wyeth Study To Evaluate a 13-valent Pneumococcal Conjugate Vaccine in Infants (NCT NCT00464945)
NCT ID: NCT00464945
Last Updated: 2012-08-15
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
269 participants
Primary outcome timeframe
One month after 3-dose infant series (5 months of age)
Results posted on
2012-08-15
Participant Flow
Participants were recruited in Poland from June 2007 to August 2007.
Participants were enrolled into the study according to inclusion/exclusion criteria without a screening period.
Participant milestones
| Measure |
13vPnC Manufacturing
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).
|
13vPnC Pilot
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).
|
|---|---|---|
|
Infant Series
STARTED
|
135
|
134
|
|
Infant Series
Vaccinated Dose 1
|
134
|
134
|
|
Infant Series
Vaccinated Dose 2
|
132
|
133
|
|
Infant Series
Vaccinated Dose 3
|
132
|
133
|
|
Infant Series
COMPLETED
|
131
|
133
|
|
Infant Series
NOT COMPLETED
|
4
|
1
|
|
After Infant Series
STARTED
|
131
|
133
|
|
After Infant Series
COMPLETED
|
131
|
131
|
|
After Infant Series
NOT COMPLETED
|
0
|
2
|
|
Toddler Dose
STARTED
|
131
|
131
|
|
Toddler Dose
COMPLETED
|
131
|
130
|
|
Toddler Dose
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
13vPnC Manufacturing
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).
|
13vPnC Pilot
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).
|
|---|---|---|
|
Infant Series
Withdrawal by parent/guardian request
|
2
|
1
|
|
Infant Series
Protocol Violation
|
1
|
0
|
|
Infant Series
Lost to Follow-up
|
1
|
0
|
|
After Infant Series
Withdrawal by Subject
|
0
|
2
|
|
Toddler Dose
Lost to Follow-up
|
0
|
1
|
Baseline Characteristics
Wyeth Study To Evaluate a 13-valent Pneumococcal Conjugate Vaccine in Infants
Baseline characteristics by cohort
| Measure |
13vPnC Manufacturing
n=135 Participants
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).
|
13vPnC Pilot
n=134 Participants
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
n=269 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
2.1 months
STANDARD_DEVIATION 0.6 • n=5 Participants
|
2.1 months
STANDARD_DEVIATION 0.5 • n=7 Participants
|
2.1 months
STANDARD_DEVIATION 0.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
65 Participants
n=5 Participants
|
67 Participants
n=7 Participants
|
132 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
70 Participants
n=5 Participants
|
67 Participants
n=7 Participants
|
137 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: One month after 3-dose infant series (5 months of age)Population: 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.
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.
Outcome measures
| Measure |
13vPnC Manufacturing
n=128 Participants
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).
|
13vPnC Pilot
n=131 Participants
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).
|
13vPnC Manufacturing Dose 2
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).
|
13vPnC Pilot Dose 2
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).
|
13vPnC Manufacturing Dose 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).
|
13vPnC Pilot Dose 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).
|
13vPnC Manufacturing Toddler Dose
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).
|
13vPnC Pilot 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).
|
|---|---|---|---|---|---|---|---|---|
|
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
Common Serotypes-Serotype 4
|
97.7 percentage of participants
Interval 93.3 to 99.5
|
96.9 percentage of participants
Interval 92.4 to 99.2
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
Common Serotypes-Serotype 6B
|
77.3 percentage of participants
Interval 69.1 to 84.3
|
74.0 percentage of participants
Interval 65.7 to 81.3
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
Common Serotypes-Serotype 9V
|
98.4 percentage of participants
Interval 94.5 to 99.8
|
96.2 percentage of participants
Interval 91.3 to 98.7
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
Common Serotypes-Serotype 14
|
92.9 percentage of participants
Interval 87.0 to 96.7
|
94.5 percentage of participants
Interval 89.1 to 97.8
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
Common Serotypes-Serotype 18C
|
96.1 percentage of participants
Interval 91.1 to 98.7
|
93.1 percentage of participants
Interval 87.4 to 96.8
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
Common Serotypes-Serotype 19F
|
98.4 percentage of participants
Interval 94.4 to 99.8
|
97.7 percentage of participants
Interval 93.5 to 99.5
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
Common Serotypes-Serotype 23F
|
82.8 percentage of participants
Interval 75.1 to 88.9
|
81.7 percentage of participants
Interval 74.0 to 87.9
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
Additional Serotypes-Serotype 1
|
93.0 percentage of participants
Interval 87.1 to 96.7
|
90.8 percentage of participants
Interval 84.5 to 95.2
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
Additional Serotypes-Serotype 3
|
93.7 percentage of participants
Interval 88.0 to 97.2
|
95.4 percentage of participants
Interval 90.3 to 98.3
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
Additional Serotypes-Serotype 5
|
90.6 percentage of participants
Interval 84.2 to 95.1
|
88.5 percentage of participants
Interval 81.8 to 93.4
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
Additional Serotypes-Serotype 6A
|
85.2 percentage of participants
Interval 77.8 to 90.8
|
86.3 percentage of participants
Interval 79.2 to 91.6
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
Additional Serotypes-Serotype 7F
|
100.0 percentage of participants
Interval 97.2 to 100.0
|
100.0 percentage of participants
Interval 97.2 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
Additional Serotypes-Serotype 19A
|
99.2 percentage of participants
Interval 95.7 to 100.0
|
99.2 percentage of participants
Interval 95.8 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: During the 4-day period after each dosePopulation: 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.
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.
Outcome measures
| Measure |
13vPnC Manufacturing
n=134 Participants
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).
|
13vPnC Pilot
n=134 Participants
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).
|
13vPnC Manufacturing Dose 2
n=132 Participants
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).
|
13vPnC Pilot Dose 2
n=133 Participants
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).
|
13vPnC Manufacturing Dose 3
n=132 Participants
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).
|
13vPnC Pilot Dose 3
n=133 Participants
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).
|
13vPnC Manufacturing Toddler Dose
n=131 Participants
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).
|
13vPnC Pilot Toddler Dose
n=131 Participants
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).
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Reporting Pre-Specified Local Reactions
Tenderness-Any (n=133,130,128,128,124,119,115,117)
|
18.8 percentage of participants
|
20.0 percentage of participants
|
20.3 percentage of participants
|
17.2 percentage of participants
|
15.3 percentage of participants
|
12.6 percentage of participants
|
24.3 percentage of participants
|
29.1 percentage of participants
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions
Tenderness-Sig (n=131,129,128,128,124,119,112,114)
|
0.8 percentage of participants
|
3.9 percentage of participants
|
1.6 percentage of participants
|
3.1 percentage of participants
|
1.6 percentage of participants
|
0.0 percentage of participants
|
1.8 percentage of participants
|
3.5 percentage of participants
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions
Swelling-Any (n=132,130,129,129,126,122,113,115)
|
25.0 percentage of participants
|
20.0 percentage of participants
|
30.2 percentage of participants
|
27.1 percentage of participants
|
29.4 percentage of participants
|
30.3 percentage of participants
|
22.1 percentage of participants
|
26.1 percentage of participants
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions
Swelling-Mild (n=132,130,129,129,126,121,113,115)
|
22.7 percentage of participants
|
17.7 percentage of participants
|
29.5 percentage of participants
|
25.6 percentage of participants
|
27.0 percentage of participants
|
25.6 percentage of participants
|
22.1 percentage of participants
|
25.2 percentage of participants
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions
Swelling-Mod (n=132,129,128,128,124,120,113,114)
|
6.1 percentage of participants
|
7.0 percentage of participants
|
8.6 percentage of participants
|
8.6 percentage of participants
|
8.9 percentage of participants
|
13.3 percentage of participants
|
8.8 percentage of participants
|
8.8 percentage of participants
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions
Swelling-Severe(n=131,129,128,128,124,119,112,113)
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions
Redness-Any (n=132,131,129,131,125,123,115,116)
|
28.8 percentage of participants
|
24.4 percentage of participants
|
37.2 percentage of participants
|
33.6 percentage of participants
|
40.0 percentage of participants
|
34.1 percentage of participants
|
37.4 percentage of participants
|
42.2 percentage of participants
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions
Redness-Mild (n=132,131,129,131,125,123,115,115)
|
28.8 percentage of participants
|
22.9 percentage of participants
|
36.4 percentage of participants
|
33.6 percentage of participants
|
38.4 percentage of participants
|
33.3 percentage of participants
|
33.9 percentage of participants
|
36.5 percentage of participants
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions
Redness-Mod (n=131,129,128,128,124,119,113,114)
|
0.0 percentage of participants
|
1.6 percentage of participants
|
3.1 percentage of participants
|
1.6 percentage of participants
|
5.6 percentage of participants
|
3.4 percentage of participants
|
10.6 percentage of participants
|
12.3 percentage of participants
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions
Redness-Severe(n=131,129,128,128,124,119,112,113)
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.9 percentage of participants
|
PRIMARY outcome
Timeframe: During the 4-day period after each dosePopulation: 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.
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.
Outcome measures
| Measure |
13vPnC Manufacturing
n=134 Participants
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).
|
13vPnC Pilot
n=134 Participants
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).
|
13vPnC Manufacturing Dose 2
n=132 Participants
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).
|
13vPnC Pilot Dose 2
n=133 Participants
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).
|
13vPnC Manufacturing Dose 3
n=132 Participants
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).
|
13vPnC Pilot Dose 3
n=133 Participants
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).
|
13vPnC Manufacturing Toddler Dose
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).
|
13vPnC Pilot 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).
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Reporting Pre-Specified Systemic Events (Infant Series)
Meds to treat sx (n=132,130,128,128,124,123)
|
12.9 percentage of participants
|
17.7 percentage of participants
|
13.3 percentage of participants
|
14.1 percentage of participants
|
8.9 percentage of participants
|
14.6 percentage of participants
|
—
|
—
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events (Infant Series)
Fever ≥38°C but ≤39°C (n=132,130,129,130,124,121)
|
18.2 percentage of participants
|
19.2 percentage of participants
|
16.3 percentage of participants
|
20.0 percentage of participants
|
11.3 percentage of participants
|
17.4 percentage of participants
|
—
|
—
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events (Infant Series)
Fever >39°C but ≤40°C (n=131,129,128,128,124,119)
|
0.8 percentage of participants
|
0.8 percentage of participants
|
0.8 percentage of participants
|
1.6 percentage of participants
|
0.0 percentage of participants
|
3.4 percentage of participants
|
—
|
—
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events (Infant Series)
Fever >40°C (n=131,129,128,128,124,119)
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
—
|
—
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events (Infant Series)
Decreased appetite (n=133,129,129,128,125,121)
|
20.3 percentage of participants
|
24.0 percentage of participants
|
14.7 percentage of participants
|
15.6 percentage of participants
|
16.8 percentage of participants
|
19.0 percentage of participants
|
—
|
—
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events (Infant Series)
Irritability (n=134,131,130,131,127,123)
|
50.0 percentage of participants
|
51.9 percentage of participants
|
53.8 percentage of participants
|
49.6 percentage of participants
|
41.7 percentage of participants
|
37.4 percentage of participants
|
—
|
—
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events (Infant Series)
Increased sleep (n=132,129,128,129124,121)
|
41.7 percentage of participants
|
39.5 percentage of participants
|
25.0 percentage of participants
|
29.5 percentage of participants
|
20.2 percentage of participants
|
30.6 percentage of participants
|
—
|
—
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events (Infant Series)
Decreased sleep (n=132,130,129,129,124,123)
|
27.3 percentage of participants
|
32.3 percentage of participants
|
24.0 percentage of participants
|
20.9 percentage of participants
|
18.5 percentage of participants
|
19.5 percentage of participants
|
—
|
—
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events (Infant Series)
Meds to prevent sx (n=132,130,128,129124,121)
|
12.9 percentage of participants
|
9.2 percentage of participants
|
11.7 percentage of participants
|
10.1 percentage of participants
|
10.5 percentage of participants
|
8.3 percentage of participants
|
—
|
—
|
PRIMARY outcome
Timeframe: During the 4-day period after toddler dosePopulation: 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.
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.
Outcome measures
| Measure |
13vPnC Manufacturing
n=131 Participants
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).
|
13vPnC Pilot
n=131 Participants
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).
|
13vPnC Manufacturing Dose 2
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).
|
13vPnC Pilot Dose 2
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).
|
13vPnC Manufacturing Dose 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).
|
13vPnC Pilot Dose 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).
|
13vPnC Manufacturing Toddler Dose
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).
|
13vPnC Pilot 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).
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Reporting Pre-Specified Systemic Events (Toddler Series)
Fever ≥38°C but ≤39°C (n=114,114)
|
14.0 percentage of participants
|
13.2 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events (Toddler Series)
Fever >39°C but ≤40°C (n=112,113)
|
0.9 percentage of participants
|
0.9 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events (Toddler Series)
Fever >40°C (n=112,113)
|
0.0 percentage of participants
|
0.0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events (Toddler Series)
Decreased appetite (n=115,117)
|
20.9 percentage of participants
|
23.1 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events (Toddler Series)
Irritability (n=119,123)
|
40.3 percentage of participants
|
44.7 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events (Toddler Series)
Increased sleep (n=114,119)
|
18.4 percentage of participants
|
16.8 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events (Toddler Series)
Decreased sleep (n=116,117)
|
13.8 percentage of participants
|
13.7 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events (Toddler Series)
Medication to treat symptoms (n=113,115)
|
17.7 percentage of participants
|
17.4 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events (Toddler Series)
Medication to prevent symptoms (n=114,114)
|
12.3 percentage of participants
|
12.3 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: One month after 3-dose infant series (5 months of age)Population: 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.
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.
Outcome measures
| Measure |
13vPnC Manufacturing
n=128 Participants
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).
|
13vPnC Pilot
n=131 Participants
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).
|
13vPnC Manufacturing Dose 2
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).
|
13vPnC Pilot Dose 2
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).
|
13vPnC Manufacturing Dose 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).
|
13vPnC Pilot Dose 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).
|
13vPnC Manufacturing Toddler Dose
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).
|
13vPnC Pilot 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).
|
|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Antibody Concentration in 13vPnC Manufacturing Scale Group Relative to 13vPnC Pilot Scale Group After the 3-Dose Infant Series
Common Serotypes-Serotype 4
|
2.09 μg/mL
Interval 1.81 to 2.4
|
1.55 μg/mL
Interval 1.34 to 1.79
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Antibody Concentration in 13vPnC Manufacturing Scale Group Relative to 13vPnC Pilot Scale Group After the 3-Dose Infant Series
Common Serotypes - Serotype 6B
|
0.80 μg/mL
Interval 0.65 to 0.98
|
0.83 μg/mL
Interval 0.66 to 1.06
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Antibody Concentration in 13vPnC Manufacturing Scale Group Relative to 13vPnC Pilot Scale Group After the 3-Dose Infant Series
Common Serotypes - Serotype 9V
|
1.28 μg/mL
Interval 1.13 to 1.43
|
1.21 μg/mL
Interval 1.08 to 1.37
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Antibody Concentration in 13vPnC Manufacturing Scale Group Relative to 13vPnC Pilot Scale Group After the 3-Dose Infant Series
Common Serotypes - Serotype 14
|
2.15 μg/mL
Interval 1.77 to 2.61
|
2.30 μg/mL
Interval 1.91 to 2.77
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Antibody Concentration in 13vPnC Manufacturing Scale Group Relative to 13vPnC Pilot Scale Group After the 3-Dose Infant Series
Common Serotypes - Serotype 18C
|
1.60 μg/mL
Interval 1.38 to 1.87
|
1.51 μg/mL
Interval 1.31 to 1.75
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Antibody Concentration in 13vPnC Manufacturing Scale Group Relative to 13vPnC Pilot Scale Group After the 3-Dose Infant Series
Common Serotypes - Serotype 19F
|
1.60 μg/mL
Interval 1.4 to 1.83
|
1.64 μg/mL
Interval 1.44 to 1.86
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Antibody Concentration in 13vPnC Manufacturing Scale Group Relative to 13vPnC Pilot Scale Group After the 3-Dose Infant Series
Common Serotypes - Serotype 23F
|
0.82 μg/mL
Interval 0.69 to 0.98
|
0.92 μg/mL
Interval 0.77 to 1.1
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Antibody Concentration in 13vPnC Manufacturing Scale Group Relative to 13vPnC Pilot Scale Group After the 3-Dose Infant Series
Additional Serotypes - Serotype 1
|
1.42 μg/mL
Interval 1.21 to 1.66
|
1.29 μg/mL
Interval 1.1 to 1.51
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Antibody Concentration in 13vPnC Manufacturing Scale Group Relative to 13vPnC Pilot Scale Group After the 3-Dose Infant Series
Additional Serotypes - Serotype 3
|
1.20 μg/mL
Interval 1.05 to 1.38
|
1.21 μg/mL
Interval 1.06 to 1.37
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Antibody Concentration in 13vPnC Manufacturing Scale Group Relative to 13vPnC Pilot Scale Group After the 3-Dose Infant Series
Additional Serotypes - Serotype 5
|
0.96 μg/mL
Interval 0.84 to 1.09
|
1.00 μg/mL
Interval 0.87 to 1.16
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Antibody Concentration in 13vPnC Manufacturing Scale Group Relative to 13vPnC Pilot Scale Group After the 3-Dose Infant Series
Additional Serotypes - Serotype 6A
|
0.87 μg/mL
Interval 0.74 to 1.03
|
1.05 μg/mL
Interval 0.89 to 1.25
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Antibody Concentration in 13vPnC Manufacturing Scale Group Relative to 13vPnC Pilot Scale Group After the 3-Dose Infant Series
Additional Serotypes - Serotype 7F
|
2.00 μg/mL
Interval 1.77 to 2.25
|
2.14 μg/mL
Interval 1.89 to 2.42
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Antibody Concentration in 13vPnC Manufacturing Scale Group Relative to 13vPnC Pilot Scale Group After the 3-Dose Infant Series
Additional Serotypes - Serotype 19A
|
2.19 μg/mL
Interval 1.91 to 2.5
|
2.31 μg/mL
Interval 2.05 to 2.61
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
13vPnC Manufacturing Infant Series
Serious events: 4 serious events
Other events: 70 other events
Deaths: 0 deaths
13vPnC Pilot Infant Series
Serious events: 2 serious events
Other events: 68 other events
Deaths: 0 deaths
13vPnC Manufacturing Post-Infant Series
Serious events: 10 serious events
Other events: 3 other events
Deaths: 0 deaths
13vPnC Pilot Post-Infant Series
Serious events: 11 serious events
Other events: 7 other events
Deaths: 0 deaths
13vPnC Manufacturing Toddler Series
Serious events: 0 serious events
Other events: 48 other events
Deaths: 0 deaths
13vPnC Pilot Toddler Series
Serious events: 1 serious events
Other events: 55 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
13vPnC Manufacturing Infant Series
n=134 participants at risk
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).
|
13vPnC Pilot Infant Series
n=134 participants at risk
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).
|
13vPnC Manufacturing Post-Infant Series
n=134 participants at risk
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.
|
13vPnC Pilot Post-Infant Series
n=134 participants at risk
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.
|
13vPnC Manufacturing Toddler Series
n=131 participants at risk
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).
|
13vPnC Pilot Toddler Series
n=131 participants at risk
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).
|
|---|---|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/134
|
0.00%
0/134
|
1.5%
2/134
|
0.00%
0/134
|
0.00%
0/131
|
0.00%
0/131
|
|
Infections and infestations
Bronchitis
|
0.75%
1/134
|
0.00%
0/134
|
0.75%
1/134
|
1.5%
2/134
|
0.00%
0/131
|
0.00%
0/131
|
|
Infections and infestations
Bronchopneumonia
|
0.00%
0/134
|
0.00%
0/134
|
0.75%
1/134
|
0.00%
0/134
|
0.00%
0/131
|
0.00%
0/131
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.75%
1/134
|
0.00%
0/134
|
0.00%
0/134
|
0.00%
0/134
|
0.00%
0/131
|
0.00%
0/131
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/134
|
0.00%
0/134
|
0.00%
0/134
|
0.75%
1/134
|
0.00%
0/131
|
0.00%
0/131
|
|
Psychiatric disorders
Crying
|
0.00%
0/134
|
0.75%
1/134
|
0.00%
0/134
|
0.00%
0/134
|
0.00%
0/131
|
0.00%
0/131
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/134
|
0.00%
0/134
|
0.00%
0/134
|
0.75%
1/134
|
0.00%
0/131
|
0.00%
0/131
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/134
|
0.75%
1/134
|
1.5%
2/134
|
0.75%
1/134
|
0.00%
0/131
|
0.00%
0/131
|
|
Infections and infestations
Enterocolitis infectious
|
0.00%
0/134
|
0.00%
0/134
|
0.00%
0/134
|
0.75%
1/134
|
0.00%
0/131
|
0.00%
0/131
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/134
|
0.00%
0/134
|
2.2%
3/134
|
3.0%
4/134
|
0.00%
0/131
|
0.76%
1/131
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
0.00%
0/134
|
0.00%
0/134
|
0.00%
0/134
|
0.75%
1/134
|
0.00%
0/131
|
0.00%
0/131
|
|
Infections and infestations
Infectious mononucleosis
|
0.00%
0/134
|
0.00%
0/134
|
0.75%
1/134
|
0.00%
0/134
|
0.00%
0/131
|
0.00%
0/131
|
|
Infections and infestations
Laryngitis
|
0.75%
1/134
|
0.00%
0/134
|
1.5%
2/134
|
0.75%
1/134
|
0.00%
0/131
|
0.00%
0/131
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/134
|
0.00%
0/134
|
0.00%
0/134
|
0.75%
1/134
|
0.00%
0/131
|
0.00%
0/131
|
|
Infections and infestations
Otitis media
|
0.00%
0/134
|
0.00%
0/134
|
0.00%
0/134
|
0.75%
1/134
|
0.00%
0/131
|
0.00%
0/131
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/134
|
0.00%
0/134
|
0.00%
0/134
|
0.75%
1/134
|
0.00%
0/131
|
0.00%
0/131
|
|
Infections and infestations
Pneumonia
|
0.75%
1/134
|
0.00%
0/134
|
1.5%
2/134
|
2.2%
3/134
|
0.00%
0/131
|
0.00%
0/131
|
|
Infections and infestations
Pneumonia primary atypical
|
0.00%
0/134
|
0.00%
0/134
|
0.00%
0/134
|
0.75%
1/134
|
0.00%
0/131
|
0.00%
0/131
|
|
General disorders
Pyrexia
|
0.00%
0/134
|
0.00%
0/134
|
0.75%
1/134
|
0.00%
0/134
|
0.00%
0/131
|
0.00%
0/131
|
|
Infections and infestations
Respiratory tract infection
|
0.75%
1/134
|
0.00%
0/134
|
0.00%
0/134
|
0.00%
0/134
|
0.00%
0/131
|
0.00%
0/131
|
|
Infections and infestations
Rotavirus infection
|
0.00%
0/134
|
0.00%
0/134
|
0.75%
1/134
|
0.00%
0/134
|
0.00%
0/131
|
0.00%
0/131
|
|
Infections and infestations
Sepsis
|
0.75%
1/134
|
0.00%
0/134
|
0.00%
0/134
|
0.00%
0/134
|
0.00%
0/131
|
0.00%
0/131
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/134
|
0.75%
1/134
|
0.75%
1/134
|
1.5%
2/134
|
0.00%
0/131
|
0.00%
0/131
|
Other adverse events
| Measure |
13vPnC Manufacturing Infant Series
n=134 participants at risk
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).
|
13vPnC Pilot Infant Series
n=134 participants at risk
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).
|
13vPnC Manufacturing Post-Infant Series
n=134 participants at risk
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.
|
13vPnC Pilot Post-Infant Series
n=134 participants at risk
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.
|
13vPnC Manufacturing Toddler Series
n=131 participants at risk
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).
|
13vPnC Pilot Toddler Series
n=131 participants at risk
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).
|
|---|---|---|---|---|---|---|
|
Psychiatric disorders
Psychomotor retardation
|
0.00%
0/134
|
0.75%
1/134
|
0.00%
0/134
|
0.00%
0/134
|
0.00%
0/131
|
0.00%
0/131
|
|
Reproductive system and breast disorders
Posthitis
|
0.00%
0/134
|
0.75%
1/134
|
0.00%
0/134
|
0.00%
0/134
|
0.00%
0/131
|
0.00%
0/131
|
|
General disorders
Decreased appetite
|
20.3%
27/133
|
24.0%
31/129
|
0.00%
0/134
|
0.00%
0/134
|
20.9%
24/115
|
23.1%
27/117
|
|
General disorders
Irritability
|
0.00%
0/134
|
0.75%
1/134
|
0.00%
0/134
|
0.00%
0/134
|
0.00%
0/131
|
0.00%
0/131
|
|
General disorders
Increased sleep
|
20.2%
25/124
|
30.6%
37/121
|
0.00%
0/134
|
0.00%
0/134
|
0.00%
0/131
|
0.00%
0/131
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
1.5%
2/134
|
0.00%
0/134
|
0.00%
0/134
|
0.00%
0/134
|
0.00%
0/131
|
0.00%
0/131
|
|
General disorders
Decreased sleep
|
18.5%
23/124
|
19.5%
24/123
|
0.00%
0/134
|
0.00%
0/134
|
0.00%
0/131
|
0.00%
0/131
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/134
|
0.75%
1/134
|
0.00%
0/134
|
0.00%
0/134
|
0.00%
0/131
|
0.00%
0/131
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/134
|
0.75%
1/134
|
0.00%
0/134
|
0.00%
0/134
|
0.00%
0/131
|
0.76%
1/131
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/134
|
0.75%
1/134
|
0.00%
0/134
|
0.00%
0/134
|
0.00%
0/131
|
0.00%
0/131
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.5%
2/134
|
1.5%
2/134
|
0.00%
0/134
|
0.00%
0/134
|
0.00%
0/131
|
0.00%
0/131
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
0.75%
1/134
|
1.5%
2/134
|
0.75%
1/134
|
0.00%
0/134
|
0.76%
1/131
|
0.76%
1/131
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.75%
1/134
|
0.00%
0/134
|
0.00%
0/134
|
0.00%
0/134
|
0.00%
0/131
|
0.76%
1/131
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/134
|
0.75%
1/134
|
0.00%
0/134
|
0.00%
0/134
|
0.00%
0/131
|
0.00%
0/131
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/134
|
0.00%
0/134
|
0.00%
0/134
|
1.5%
2/134
|
0.76%
1/131
|
0.00%
0/131
|
|
Skin and subcutaneous tissue disorders
Tenderness (Any)
|
15.3%
19/124
|
12.6%
15/119
|
0.00%
0/134
|
0.00%
0/134
|
0.00%
0/131
|
0.00%
0/131
|
|
Skin and subcutaneous tissue disorders
Tenderness (Significant)
|
1.6%
2/124
|
0.00%
0/119
|
0.00%
0/134
|
0.00%
0/134
|
0.00%
0/131
|
0.00%
0/131
|
|
Skin and subcutaneous tissue disorders
Induration (Any)
|
29.4%
37/126
|
30.3%
37/122
|
0.00%
0/134
|
0.00%
0/134
|
0.00%
0/131
|
0.00%
0/131
|
|
Skin and subcutaneous tissue disorders
Induration (Mild)
|
29.5%
38/129
|
25.6%
33/129
|
0.00%
0/134
|
0.00%
0/134
|
0.00%
0/131
|
0.00%
0/131
|
|
Skin and subcutaneous tissue disorders
Induration(Mild)
|
27.0%
34/126
|
25.6%
31/121
|
0.00%
0/134
|
0.00%
0/134
|
0.00%
0/131
|
0.00%
0/131
|
|
Skin and subcutaneous tissue disorders
Induration (Moderate)
|
8.9%
11/124
|
13.3%
16/120
|
0.00%
0/134
|
0.00%
0/134
|
0.00%
0/131
|
0.00%
0/131
|
|
Skin and subcutaneous tissue disorders
Induration (Severe)
|
0.00%
0/124
|
0.00%
0/119
|
0.00%
0/134
|
0.00%
0/134
|
0.00%
0/131
|
0.00%
0/131
|
|
Skin and subcutaneous tissue disorders
Erythema (Any)
|
40.0%
50/125
|
34.1%
42/123
|
0.00%
0/134
|
0.00%
0/134
|
0.00%
0/131
|
0.00%
0/131
|
|
Skin and subcutaneous tissue disorders
Erythema (Mild)
|
38.4%
48/125
|
33.3%
41/123
|
0.00%
0/134
|
0.00%
0/134
|
0.00%
0/131
|
0.00%
0/131
|
|
Skin and subcutaneous tissue disorders
Erythema (Moderate)
|
5.6%
7/124
|
3.4%
4/119
|
0.00%
0/134
|
0.00%
0/134
|
0.00%
0/131
|
0.00%
0/131
|
|
Skin and subcutaneous tissue disorders
Erythema (Severe)
|
0.00%
0/124
|
0.00%
0/119
|
0.00%
0/134
|
0.00%
0/134
|
0.00%
0/131
|
0.00%
0/131
|
|
General disorders
Fever ≥38°C but ≤39°C
|
11.3%
14/124
|
17.4%
21/121
|
0.00%
0/134
|
0.00%
0/134
|
0.00%
0/131
|
0.00%
0/131
|
|
General disorders
Fever >39°C but ≤40°C
|
0.00%
0/124
|
3.4%
4/119
|
0.00%
0/134
|
0.00%
0/134
|
0.00%
0/131
|
0.00%
0/131
|
|
General disorders
Fever >40°C
|
0.00%
0/124
|
0.00%
0/119
|
0.00%
0/134
|
0.00%
0/134
|
0.00%
0/131
|
0.00%
0/131
|
|
Blood and lymphatic system disorders
Anaemia
|
1.5%
2/134
|
1.5%
2/134
|
0.00%
0/134
|
1.5%
2/134
|
0.00%
0/131
|
0.00%
0/131
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/134
|
0.75%
1/134
|
0.00%
0/134
|
0.00%
0/134
|
0.00%
0/131
|
0.00%
0/131
|
|
Blood and lymphatic system disorders
Lymphadenitis
|
0.00%
0/134
|
0.75%
1/134
|
0.00%
0/134
|
0.00%
0/134
|
0.00%
0/131
|
0.76%
1/131
|
|
Congenital, familial and genetic disorders
Hip dysplasia
|
0.75%
1/134
|
0.75%
1/134
|
0.00%
0/134
|
0.00%
0/134
|
0.00%
0/131
|
0.00%
0/131
|
|
Congenital, familial and genetic disorders
Atrial septal defect
|
0.00%
0/134
|
0.75%
1/134
|
0.00%
0/134
|
0.00%
0/134
|
0.00%
0/131
|
0.00%
0/131
|
|
Congenital, familial and genetic disorders
Dacryostenosis congenital
|
0.75%
1/134
|
0.00%
0/134
|
0.00%
0/134
|
0.00%
0/134
|
0.00%
0/131
|
0.00%
0/131
|
|
Congenital, familial and genetic disorders
Hydrocele
|
0.75%
1/134
|
0.00%
0/134
|
0.00%
0/134
|
0.00%
0/134
|
0.00%
0/131
|
0.00%
0/131
|
|
Congenital, familial and genetic disorders
Plagiocephaly
|
0.75%
1/134
|
0.00%
0/134
|
0.00%
0/134
|
0.00%
0/134
|
0.00%
0/131
|
0.00%
0/131
|
|
Eye disorders
Conjunctivitis
|
3.7%
5/134
|
3.0%
4/134
|
0.00%
0/134
|
0.00%
0/134
|
0.76%
1/131
|
0.00%
0/131
|
|
Eye disorders
Dacryostenosis acquired
|
0.00%
0/134
|
0.75%
1/134
|
0.00%
0/134
|
0.00%
0/134
|
0.00%
0/131
|
0.00%
0/131
|
|
Eye disorders
Eyelid oedema
|
0.00%
0/134
|
0.75%
1/134
|
0.00%
0/134
|
0.00%
0/134
|
0.00%
0/131
|
0.00%
0/131
|
|
Gastrointestinal disorders
Diarrhoea
|
3.0%
4/134
|
2.2%
3/134
|
0.00%
0/134
|
0.00%
0/134
|
2.3%
3/131
|
0.76%
1/131
|
|
Gastrointestinal disorders
Dyspepsia
|
0.75%
1/134
|
3.0%
4/134
|
0.00%
0/134
|
0.00%
0/134
|
0.00%
0/131
|
0.00%
0/131
|
|
Gastrointestinal disorders
Constipation
|
0.75%
1/134
|
1.5%
2/134
|
0.00%
0/134
|
0.00%
0/134
|
0.00%
0/131
|
0.00%
0/131
|
|
Gastrointestinal disorders
Abdominal pain
|
0.75%
1/134
|
0.00%
0/134
|
0.00%
0/134
|
0.00%
0/134
|
0.00%
0/131
|
0.00%
0/131
|
|
Gastrointestinal disorders
Enlarged uvula
|
0.75%
1/134
|
0.00%
0/134
|
0.00%
0/134
|
0.00%
0/134
|
0.00%
0/131
|
0.00%
0/131
|
|
Gastrointestinal disorders
Frequent bowel movements
|
0.75%
1/134
|
0.00%
0/134
|
0.00%
0/134
|
0.00%
0/134
|
0.00%
0/131
|
0.00%
0/131
|
|
Gastrointestinal disorders
Infantile colic
|
0.75%
1/134
|
0.00%
0/134
|
0.00%
0/134
|
0.00%
0/134
|
0.00%
0/131
|
0.00%
0/131
|
|
Gastrointestinal disorders
Infrequent bowel movements
|
0.00%
0/134
|
0.75%
1/134
|
0.00%
0/134
|
0.00%
0/134
|
0.00%
0/131
|
0.00%
0/131
|
|
Gastrointestinal disorders
Teething
|
0.75%
1/134
|
0.00%
0/134
|
0.00%
0/134
|
0.00%
0/134
|
0.00%
0/131
|
0.00%
0/131
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/134
|
0.00%
0/134
|
0.75%
1/134
|
0.75%
1/134
|
0.00%
0/131
|
0.00%
0/131
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/134
|
0.00%
0/134
|
0.00%
0/134
|
0.00%
0/134
|
0.00%
0/131
|
0.76%
1/131
|
|
General disorders
Pyrexia
|
1.5%
2/134
|
0.00%
0/134
|
0.00%
0/134
|
0.00%
0/134
|
1.5%
2/131
|
0.00%
0/131
|
|
General disorders
Malaise
|
0.00%
0/134
|
0.75%
1/134
|
0.00%
0/134
|
0.00%
0/134
|
0.00%
0/131
|
0.00%
0/131
|
|
Immune system disorders
Food allergy
|
0.00%
0/134
|
0.00%
0/134
|
0.00%
0/134
|
0.75%
1/134
|
0.00%
0/131
|
0.00%
0/131
|
|
Immune system disorders
Milk allergy
|
0.00%
0/134
|
0.00%
0/134
|
0.75%
1/134
|
0.00%
0/134
|
0.00%
0/131
|
0.00%
0/131
|
|
Infections and infestations
Rhinitis
|
9.0%
12/134
|
7.5%
10/134
|
0.00%
0/134
|
0.00%
0/134
|
0.76%
1/131
|
1.5%
2/131
|
|
Infections and infestations
Pharyngitis
|
6.7%
9/134
|
7.5%
10/134
|
0.00%
0/134
|
0.00%
0/134
|
3.8%
5/131
|
3.8%
5/131
|
|
Infections and infestations
Upper respiratory tract infection
|
6.0%
8/134
|
8.2%
11/134
|
0.00%
0/134
|
0.00%
0/134
|
1.5%
2/131
|
0.76%
1/131
|
|
Infections and infestations
Nasopharyngitis
|
6.0%
8/134
|
6.7%
9/134
|
0.00%
0/134
|
0.00%
0/134
|
0.76%
1/131
|
1.5%
2/131
|
|
Infections and infestations
Bronchitis
|
3.7%
5/134
|
5.2%
7/134
|
0.00%
0/134
|
0.00%
0/134
|
0.76%
1/131
|
1.5%
2/131
|
|
Infections and infestations
Candidiasis
|
1.5%
2/134
|
0.75%
1/134
|
0.00%
0/134
|
0.00%
0/134
|
0.00%
0/131
|
0.00%
0/131
|
|
Infections and infestations
Ear infection
|
1.5%
2/134
|
0.75%
1/134
|
0.00%
0/134
|
0.00%
0/134
|
0.00%
0/131
|
0.00%
0/131
|
|
Infections and infestations
Exanthema subitum
|
1.5%
2/134
|
0.75%
1/134
|
0.00%
0/134
|
0.00%
0/134
|
0.00%
0/131
|
0.76%
1/131
|
|
Infections and infestations
Viral infection
|
1.5%
2/134
|
0.75%
1/134
|
0.00%
0/134
|
0.00%
0/134
|
0.76%
1/131
|
2.3%
3/131
|
|
Infections and infestations
Bronchopneumonia
|
0.75%
1/134
|
0.75%
1/134
|
0.00%
0/134
|
0.00%
0/134
|
0.00%
0/131
|
0.00%
0/131
|
|
Infections and infestations
Gastrointestinal infection
|
0.75%
1/134
|
0.00%
0/134
|
0.00%
0/134
|
0.00%
0/134
|
0.00%
0/131
|
0.00%
0/131
|
|
Infections and infestations
Lower respiratory tract infection
|
0.75%
1/134
|
0.00%
0/134
|
0.00%
0/134
|
0.00%
0/134
|
0.00%
0/131
|
0.00%
0/131
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/134
|
0.75%
1/134
|
0.00%
0/134
|
0.00%
0/134
|
0.00%
0/131
|
0.00%
0/131
|
|
Infections and infestations
Tonsillitis
|
0.75%
1/134
|
0.00%
0/134
|
0.00%
0/134
|
0.00%
0/134
|
0.00%
0/131
|
0.00%
0/131
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/134
|
0.00%
0/134
|
0.00%
0/134
|
0.00%
0/134
|
1.5%
2/131
|
1.5%
2/131
|
|
Infections and infestations
Laryngitis
|
0.00%
0/134
|
0.00%
0/134
|
0.00%
0/134
|
0.00%
0/134
|
1.5%
2/131
|
0.00%
0/131
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/134
|
0.00%
0/134
|
0.00%
0/134
|
0.00%
0/134
|
0.76%
1/131
|
0.76%
1/131
|
|
Infections and infestations
Otitis media acute
|
0.00%
0/134
|
0.00%
0/134
|
0.00%
0/134
|
0.00%
0/134
|
0.00%
0/131
|
0.76%
1/131
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/134
|
0.00%
0/134
|
0.00%
0/134
|
0.00%
0/134
|
0.76%
1/131
|
0.00%
0/131
|
|
Injury, poisoning and procedural complications
Corneal abrasion
|
0.75%
1/134
|
0.00%
0/134
|
0.00%
0/134
|
0.00%
0/134
|
0.00%
0/131
|
0.00%
0/131
|
|
Musculoskeletal and connective tissue disorders
Rickets
|
0.75%
1/134
|
0.75%
1/134
|
0.00%
0/134
|
0.00%
0/134
|
0.00%
0/131
|
0.00%
0/131
|
|
Musculoskeletal and connective tissue disorders
Posture abnormal
|
0.75%
1/134
|
0.00%
0/134
|
0.00%
0/134
|
0.00%
0/134
|
0.00%
0/131
|
0.00%
0/131
|
|
Nervous system disorders
Hypertonia
|
0.00%
0/134
|
0.75%
1/134
|
0.00%
0/134
|
0.00%
0/134
|
0.00%
0/131
|
0.00%
0/131
|
|
Nervous system disorders
Hypotonia
|
0.00%
0/134
|
0.00%
0/134
|
0.00%
0/134
|
0.75%
1/134
|
0.00%
0/131
|
0.00%
0/131
|
|
Nervous system disorders
Poor quality sleep
|
0.00%
0/134
|
0.00%
0/134
|
0.00%
0/134
|
0.00%
0/134
|
0.00%
0/131
|
0.76%
1/131
|
|
Psychiatric disorders
Crying
|
0.00%
0/134
|
0.75%
1/134
|
0.00%
0/134
|
0.00%
0/134
|
0.00%
0/131
|
0.00%
0/131
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER