Trial Outcomes & Findings for Study Evaluating 13-valent Pneumococcal Conjugate Vaccine Catch-Up Regimens in Older Infants and Children (NCT NCT00452452)
NCT ID: NCT00452452
Last Updated: 2012-08-15
Results Overview
Percentages of participants achieving World Health Organization (WHO) predefined antibody threshold ≥0.35μg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
355 participants
Primary outcome timeframe
28 to 42 days after vaccination 3 for Group 1 (13 to <17 months of age), after vaccination 2 for Group 2 (14 to <26 months of age), and after vaccination 1 for Group 3 (26 to <73 months of age).
Results posted on
2012-08-15
Participant Flow
Participants were recruited in Poland from July 2007 to September 2007.
Participants were enrolled into the study according to inclusion/exclusion criteria without a screening period.
Participant milestones
| Measure |
13vPnC 7 to <12 Months of Age
Participants 7 to less than (\<) 12 months of age with 0 prior doses of 7-valent pneumococcal conjugate vaccine (Prevnar) received a total of 3 single intramuscular (IM) 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC); the first two at least 28 days apart (infant series) and the third single IM 0.5 mL dose of 13vPnC at 12 to 16 months of age (toddler dose), at least 46 days after last infant dose.
|
13vPnC 12 to <24 Months of Age
Participants 12 to \< 24 months of age with 0 prior dose of 7-valent pneumococcal conjugate vaccine (Prevnar) received a total of 2 single IM 0.5 mL doses of 13vPnC at least 56 days apart.
|
13vPnC 24 to < 72 Months of Age
Participants 24 to \< 72 months of age with 0 prior doses of 7-valent pneumococcal conjugate vaccine (Prevnar) received a single IM 0.5 mL dose of 13vPnC.
|
|---|---|---|---|
|
Overall Study
STARTED
|
90
|
112
|
153
|
|
Overall Study
Vaccinated Dose 1
|
90
|
112
|
152
|
|
Overall Study
Vaccinated Dose 2
|
90
|
112
|
0
|
|
Overall Study
Vaccinated Dose 3
|
89
|
0
|
0
|
|
Overall Study
COMPLETED
|
88
|
112
|
152
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
1
|
Reasons for withdrawal
| Measure |
13vPnC 7 to <12 Months of Age
Participants 7 to less than (\<) 12 months of age with 0 prior doses of 7-valent pneumococcal conjugate vaccine (Prevnar) received a total of 3 single intramuscular (IM) 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC); the first two at least 28 days apart (infant series) and the third single IM 0.5 mL dose of 13vPnC at 12 to 16 months of age (toddler dose), at least 46 days after last infant dose.
|
13vPnC 12 to <24 Months of Age
Participants 12 to \< 24 months of age with 0 prior dose of 7-valent pneumococcal conjugate vaccine (Prevnar) received a total of 2 single IM 0.5 mL doses of 13vPnC at least 56 days apart.
|
13vPnC 24 to < 72 Months of Age
Participants 24 to \< 72 months of age with 0 prior doses of 7-valent pneumococcal conjugate vaccine (Prevnar) received a single IM 0.5 mL dose of 13vPnC.
|
|---|---|---|---|
|
Overall Study
Protocol Violation
|
0
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
0
|
Baseline Characteristics
Study Evaluating 13-valent Pneumococcal Conjugate Vaccine Catch-Up Regimens in Older Infants and Children
Baseline characteristics by cohort
| Measure |
13vPnC 7 to <12 Months of Age
n=90 Participants
Participants 7 to less than (\<) 12 months of age with 0 prior doses of 7-valent pneumococcal conjugate vaccine (Prevnar) received a total of 3 single intramuscular (IM) 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC); the first two at least 28 days apart (infant series) and the third single IM 0.5 mL dose of 13vPnC at 12 to 16 months of age (toddler dose), at least 46 days after last infant dose.
|
13vPnC 12 to <24 Months of Age
n=112 Participants
Participants 12 to \< 24 months of age with 0 prior dose of 7-valent pneumococcal conjugate vaccine (Prevnar) received a total of 2 single IM 0.5 mL doses of 13vPnC at least 56 days apart.
|
13vPnC 24 to < 72 Months of Age
n=153 Participants
Participants 24 to \< 72 months of age with 0 prior doses of 7-valent pneumococcal conjugate vaccine (Prevnar) received a single IM 0.5 mL dose of 13vPnC.
|
Total
n=355 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age Continuous
|
8.7 months
STANDARD_DEVIATION 1.6 • n=5 Participants
|
17.6 months
STANDARD_DEVIATION 3.5 • n=7 Participants
|
42.0 months
STANDARD_DEVIATION 13.1 • n=5 Participants
|
25.9 months
STANDARD_DEVIATION 17.0 • n=4 Participants
|
|
Sex: Female, Male
Female
|
47 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
74 Participants
n=5 Participants
|
179 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
43 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
79 Participants
n=5 Participants
|
176 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 28 to 42 days after vaccination 3 for Group 1 (13 to <17 months of age), after vaccination 2 for Group 2 (14 to <26 months of age), and after vaccination 1 for Group 3 (26 to <73 months of age).Population: Evaluable immunogenicity (per protocol) population who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations; (n) = number of participants with a determinate immunoglobulin G (IgG) antibody concentration to the given serotype.
Percentages of participants achieving World Health Organization (WHO) predefined antibody threshold ≥0.35μg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.
Outcome measures
| Measure |
13vPnC Group 3 - Dose 1
n=152 Participants
Participants 24 to \< 72 months of age with 0 prior doses of Prevnar received a single IM 0.5 mL dose of 13vPnC (infant series).
|
13vPnC Group 1 - Dose 2
Participants 7 to less than (\<) 12 months of age received a second single intramuscular (IM) 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) at least 28 days after the first (infant series).
|
13vPnC Group 2 - Dose 2
Participants 12 to \< 24 months of age received a second single IM 0.5 mL doses of 13vPnC at least 56 days from the first (infant series).
|
13vPnC Group 1 - Dose 3
Participants received a third single IM 0.5 mL dose of 13vPnC at 12 to 16 months of age (toddler dose), at least 46 days after last infant dose.
|
13vPnC Group 1 - Dose 1
n=84 Participants
Participants 7 to less than (\<) 12 months of age with 0 prior doses of Prevnar received a single intramuscular (IM) 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC)(infant series).
|
13vPnC Group 2 - Dose 1
n=110 Participants
Participants 12 to \< 24 months of age with 0 prior doses of Prevnar received a single IM 0.5 mL doses of 13vPnC (infant series).
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving Antibody Level ≥0.35μg/mL After Vaccination
Common Serotypes - Serotype 4 (n= 84,110,151)
|
99.3 percentage of participants
Interval 96.4 to 100.0
|
—
|
—
|
—
|
100.0 percentage of participants
Interval 95.7 to 100.0
|
100.0 percentage of participants
Interval 96.7 to 100.0
|
|
Percentage of Participants Achieving Antibody Level ≥0.35μg/mL After Vaccination
Common Serotypes - Serotype 6B (n=83,110,150)
|
99.3 percentage of participants
Interval 96.3 to 100.0
|
—
|
—
|
—
|
98.8 percentage of participants
Interval 93.5 to 100.0
|
100.0 percentage of participants
Interval 96.7 to 100.0
|
|
Percentage of Participants Achieving Antibody Level ≥0.35μg/mL After Vaccination
Common Serotypes - Serotype 9V (n= 83,104,148)
|
98.6 percentage of participants
Interval 95.2 to 99.8
|
—
|
—
|
—
|
98.8 percentage of participants
Interval 93.5 to 100.0
|
99.0 percentage of participants
Interval 94.8 to 100.0
|
|
Percentage of Participants Achieving Antibody Level ≥0.35μg/mL After Vaccination
Common Serotypes - Serotype 14 (n= 84,108,135)
|
88.1 percentage of participants
Interval 81.5 to 93.1
|
—
|
—
|
—
|
100.0 percentage of participants
Interval 95.7 to 100.0
|
100.0 percentage of participants
Interval 96.6 to 100.0
|
|
Percentage of Participants Achieving Antibody Level ≥0.35μg/mL After Vaccination
Common Serotypes - Serotype 18C (n= 83,109,151)
|
98.7 percentage of participants
Interval 95.3 to 99.8
|
—
|
—
|
—
|
100.0 percentage of participants
Interval 95.7 to 100.0
|
100.0 percentage of participants
Interval 96.7 to 100.0
|
|
Percentage of Participants Achieving Antibody Level ≥0.35μg/mL After Vaccination
Common Serotypes - Serotype 19F (n=84,110,147)
|
98.0 percentage of participants
Interval 94.2 to 99.6
|
—
|
—
|
—
|
97.6 percentage of participants
Interval 91.7 to 99.7
|
100.0 percentage of participants
Interval 96.7 to 100.0
|
|
Percentage of Participants Achieving Antibody Level ≥0.35μg/mL After Vaccination
Common Serotypes - Serotype 23F (n= 84,110,151)
|
93.4 percentage of participants
Interval 88.2 to 96.8
|
—
|
—
|
—
|
98.8 percentage of participants
Interval 93.5 to 100.0
|
92.7 percentage of participants
Interval 86.2 to 96.8
|
|
Percentage of Participants Achieving Antibody Level ≥0.35μg/mL After Vaccination
Additional Serotypes - Serotype 1 (n= 83,108,149)
|
96.6 percentage of participants
Interval 92.3 to 98.9
|
—
|
—
|
—
|
100.0 percentage of participants
Interval 95.7 to 100.0
|
100.0 percentage of participants
Interval 96.6 to 100.0
|
|
Percentage of Participants Achieving Antibody Level ≥0.35μg/mL After Vaccination
Additional Serotypes - Serotype 3 (n= 83,108,149)
|
97.3 percentage of participants
Interval 93.3 to 99.3
|
—
|
—
|
—
|
98.8 percentage of participants
Interval 93.5 to 100.0
|
100.0 percentage of participants
Interval 96.6 to 100.0
|
|
Percentage of Participants Achieving Antibody Level ≥0.35μg/mL After Vaccination
Additional Serotypes - Serotype 5 (n= 84,107,152)
|
98.7 percentage of participants
Interval 95.3 to 99.8
|
—
|
—
|
—
|
97.6 percentage of participants
Interval 91.7 to 99.7
|
99.1 percentage of participants
Interval 94.9 to 100.0
|
|
Percentage of Participants Achieving Antibody Level ≥0.35μg/mL After Vaccination
Additional Serotypes - Serotype 6A (n= 84,110,150)
|
100.0 percentage of participants
Interval 97.6 to 100.0
|
—
|
—
|
—
|
100.0 percentage of participants
Interval 95.7 to 100.0
|
98.2 percentage of participants
Interval 93.6 to 99.8
|
|
Percentage of Participants Achieving Antibody Level ≥0.35μg/mL After Vaccination
Additional Serotypes - Serotype 7F (n= 84,108,142)
|
99.3 percentage of participants
Interval 96.1 to 100.0
|
—
|
—
|
—
|
100.0 percentage of participants
Interval 95.7 to 100.0
|
100.0 percentage of participants
Interval 96.6 to 100.0
|
|
Percentage of Participants Achieving Antibody Level ≥0.35μg/mL After Vaccination
Additional Serotypes - Serotype 19A (n=84,110,150
|
100.0 percentage of participants
Interval 97.6 to 100.0
|
—
|
—
|
—
|
100.0 percentage of participants
Interval 95.7 to 100.0
|
100.0 percentage of participants
Interval 96.7 to 100.0
|
PRIMARY outcome
Timeframe: 28 to 42 days after vaccination 3 for Group 1 (13 to <17 months of age), after vaccination 2 for Group 2 (14 to <26 months of age), and after vaccination 1 for Group 3 (26 to <73 months of age).Population: The evaluable immunogenicity (per protocol) population was the primary analysis population consisting of eligible subjects who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations.
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 Group 3 - Dose 1
n=152 Participants
Participants 24 to \< 72 months of age with 0 prior doses of Prevnar received a single IM 0.5 mL dose of 13vPnC (infant series).
|
13vPnC Group 1 - Dose 2
Participants 7 to less than (\<) 12 months of age received a second single intramuscular (IM) 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) at least 28 days after the first (infant series).
|
13vPnC Group 2 - Dose 2
Participants 12 to \< 24 months of age received a second single IM 0.5 mL doses of 13vPnC at least 56 days from the first (infant series).
|
13vPnC Group 1 - Dose 3
Participants received a third single IM 0.5 mL dose of 13vPnC at 12 to 16 months of age (toddler dose), at least 46 days after last infant dose.
|
13vPnC Group 1 - Dose 1
n=84 Participants
Participants 7 to less than (\<) 12 months of age with 0 prior doses of Prevnar received a single intramuscular (IM) 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC)(infant series).
|
13vPnC Group 2 - Dose 1
n=110 Participants
Participants 12 to \< 24 months of age with 0 prior doses of Prevnar received a single IM 0.5 mL doses of 13vPnC (infant series).
|
|---|---|---|---|---|---|---|
|
Geometric Mean Antibody Concentration (GMC) After Vaccination in 13vPnC Groups
Common Serotypes - Serotype 4
|
3.37 μg/mL
Interval 2.95 to 3.85
|
—
|
—
|
—
|
3.63 μg/mL
Interval 3.11 to 4.23
|
4.28 μg/mL
Interval 3.78 to 4.86
|
|
Geometric Mean Antibody Concentration (GMC) After Vaccination in 13vPnC Groups
Common Serotypes - Serotype 6B
|
3.41 μg/mL
Interval 2.8 to 4.16
|
—
|
—
|
—
|
4.77 μg/mL
Interval 3.9 to 5.84
|
3.38 μg/mL
Interval 2.81 to 4.06
|
|
Geometric Mean Antibody Concentration (GMC) After Vaccination in 13vPnC Groups
Common Serotypes - Serotype 9V
|
2.67 μg/mL
Interval 2.32 to 3.07
|
—
|
—
|
—
|
2.56 μg/mL
Interval 2.21 to 2.96
|
3.08 μg/mL
Interval 2.69 to 3.53
|
|
Geometric Mean Antibody Concentration (GMC) After Vaccination in 13vPnC Groups
Common Serotypes - Serotype 14
|
2.24 μg/mL
Interval 1.71 to 2.93
|
—
|
—
|
—
|
8.04 μg/mL
Interval 6.95 to 9.3
|
6.45 μg/mL
Interval 5.48 to 7.59
|
|
Geometric Mean Antibody Concentration (GMC) After Vaccination in 13vPnC Groups
Common Serotypes - Serotype 18C
|
2.56 μg/mL
Interval 2.17 to 3.03
|
—
|
—
|
—
|
2.77 μg/mL
Interval 2.39 to 3.23
|
3.71 μg/mL
Interval 3.29 to 4.19
|
|
Geometric Mean Antibody Concentration (GMC) After Vaccination in 13vPnC Groups
Common Serotypes - Serotype 19F
|
2.53 μg/mL
Interval 2.14 to 2.99
|
—
|
—
|
—
|
2.88 μg/mL
Interval 2.35 to 3.54
|
3.07 μg/mL
Interval 2.68 to 3.51
|
|
Geometric Mean Antibody Concentration (GMC) After Vaccination in 13vPnC Groups
Common Serotypes - Serotype 23F
|
1.55 μg/mL
Interval 1.31 to 1.85
|
—
|
—
|
—
|
2.16 μg/mL
Interval 1.82 to 2.55
|
1.98 μg/mL
Interval 1.64 to 2.39
|
|
Geometric Mean Antibody Concentration (GMC) After Vaccination in 13vPnC Groups
Additional Serotypes - Serotype 1
|
1.78 μg/mL
Interval 1.52 to 2.08
|
—
|
—
|
—
|
2.88 μg/mL
Interval 2.44 to 3.39
|
2.74 μg/mL
Interval 2.37 to 3.16
|
|
Geometric Mean Antibody Concentration (GMC) After Vaccination in 13vPnC Groups
Additional Serotypes - Serotype 3
|
1.42 μg/mL
Interval 1.23 to 1.64
|
—
|
—
|
—
|
1.94 μg/mL
Interval 1.68 to 2.24
|
1.86 μg/mL
Interval 1.6 to 2.15
|
|
Geometric Mean Antibody Concentration (GMC) After Vaccination in 13vPnC Groups
Additional Serotypes - Serotype 5
|
2.33 μg/mL
Interval 2.05 to 2.64
|
—
|
—
|
—
|
2.85 μg/mL
Interval 2.34 to 3.46
|
2.16 μg/mL
Interval 1.89 to 2.47
|
|
Geometric Mean Antibody Concentration (GMC) After Vaccination in 13vPnC Groups
Additional Serotypes - Serotype 6A
|
2.96 μg/mL
Interval 2.52 to 3.47
|
—
|
—
|
—
|
3.72 μg/mL
Interval 3.12 to 4.45
|
2.62 μg/mL
Interval 2.25 to 3.06
|
|
Geometric Mean Antibody Concentration (GMC) After Vaccination in 13vPnC Groups
Additional Serotypes - Serotype 7F
|
4.92 μg/mL
Interval 4.26 to 5.68
|
—
|
—
|
—
|
5.30 μg/mL
Interval 4.54 to 6.18
|
5.99 μg/mL
Interval 5.4 to 6.65
|
|
Geometric Mean Antibody Concentration (GMC) After Vaccination in 13vPnC Groups
Additional Serotypes - Serotype 19A
|
6.03 μg/mL
Interval 5.22 to 6.97
|
—
|
—
|
—
|
4.77 μg/mL
Interval 4.28 to 5.33
|
4.94 μg/mL
Interval 4.31 to 5.65
|
SECONDARY outcome
Timeframe: During the 4-day period after each dosePopulation: The safety population included all participants who received at least 1 dose of vaccine.
Local reactions were collected using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling or redness present); Mild (0.5 centimeters \[cm\] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (\>7.0 cm). Participants may be represented in more than 1 category.
Outcome measures
| Measure |
13vPnC Group 3 - Dose 1
n=152 Participants
Participants 24 to \< 72 months of age with 0 prior doses of Prevnar received a single IM 0.5 mL dose of 13vPnC (infant series).
|
13vPnC Group 1 - Dose 2
n=90 Participants
Participants 7 to less than (\<) 12 months of age received a second single intramuscular (IM) 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) at least 28 days after the first (infant series).
|
13vPnC Group 2 - Dose 2
n=112 Participants
Participants 12 to \< 24 months of age received a second single IM 0.5 mL doses of 13vPnC at least 56 days from the first (infant series).
|
13vPnC Group 1 - Dose 3
n=89 Participants
Participants received a third single IM 0.5 mL dose of 13vPnC at 12 to 16 months of age (toddler dose), at least 46 days after last infant dose.
|
13vPnC Group 1 - Dose 1
n=90 Participants
Participants 7 to less than (\<) 12 months of age with 0 prior doses of Prevnar received a single intramuscular (IM) 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC)(infant series).
|
13vPnC Group 2 - Dose 1
n=112 Participants
Participants 12 to \< 24 months of age with 0 prior doses of Prevnar received a single IM 0.5 mL doses of 13vPnC (infant series).
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Reporting Pre-Specified Local Reactions
Redness - Severe
|
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
Swelling - Mild
|
28.2 percentage of participants
|
28.7 percentage of participants
|
36.2 percentage of participants
|
20.5 percentage of participants
|
32.6 percentage of participants
|
36.7 percentage of participants
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions
Tenderness - Any
|
42.3 percentage of participants
|
15.1 percentage of participants
|
43.7 percentage of participants
|
15.2 percentage of participants
|
15.1 percentage of participants
|
33.3 percentage of participants
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions
Tenderness - Significant
|
4.1 percentage of participants
|
3.5 percentage of participants
|
4.1 percentage of participants
|
6.4 percentage of participants
|
1.2 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions
Swelling - Any
|
36.9 percentage of participants
|
32.2 percentage of participants
|
41.0 percentage of participants
|
25.0 percentage of participants
|
36.0 percentage of participants
|
44.5 percentage of participants
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions
Swelling - Moderate
|
20.3 percentage of participants
|
14.0 percentage of participants
|
12.1 percentage of participants
|
11.3 percentage of participants
|
11.6 percentage of participants
|
24.8 percentage of participants
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions
Swelling - Severe
|
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
|
50.0 percentage of participants
|
46.0 percentage of participants
|
54.7 percentage of participants
|
37.8 percentage of participants
|
48.8 percentage of participants
|
70.0 percentage of participants
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions
Redness - Mild
|
37.4 percentage of participants
|
40.2 percentage of participants
|
44.7 percentage of participants
|
31.3 percentage of participants
|
41.9 percentage of participants
|
55.5 percentage of participants
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions
Redness - Moderate
|
25.7 percentage of participants
|
9.3 percentage of participants
|
25.5 percentage of participants
|
12.5 percentage of participants
|
16.3 percentage of participants
|
38.2 percentage of participants
|
SECONDARY outcome
Timeframe: During the 4-day period after each dosePopulation: The safety population included all subjects who received at least 1 dose of vaccine.
Systemic events (fever ≥ 37.5 degrees Celsius \[C\], fever ≥ 38 C but ≤ 39 C, fever \>39 C but ≤ 40 C, fever \> 40 C, decreased appetite, irritability, increased sleep, decreased sleep, hives, use of medication to treat symptoms, and use of medication to prevent symptoms) were reported using an electronic diary. Participants may be represented in more than 1 category.
Outcome measures
| Measure |
13vPnC Group 3 - Dose 1
n=152 Participants
Participants 24 to \< 72 months of age with 0 prior doses of Prevnar received a single IM 0.5 mL dose of 13vPnC (infant series).
|
13vPnC Group 1 - Dose 2
n=90 Participants
Participants 7 to less than (\<) 12 months of age received a second single intramuscular (IM) 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) at least 28 days after the first (infant series).
|
13vPnC Group 2 - Dose 2
n=112 Participants
Participants 12 to \< 24 months of age received a second single IM 0.5 mL doses of 13vPnC at least 56 days from the first (infant series).
|
13vPnC Group 1 - Dose 3
n=89 Participants
Participants received a third single IM 0.5 mL dose of 13vPnC at 12 to 16 months of age (toddler dose), at least 46 days after last infant dose.
|
13vPnC Group 1 - Dose 1
n=90 Participants
Participants 7 to less than (\<) 12 months of age with 0 prior doses of Prevnar received a single intramuscular (IM) 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC)(infant series).
|
13vPnC Group 2 - Dose 1
n=112 Participants
Participants 12 to \< 24 months of age with 0 prior doses of Prevnar received a single IM 0.5 mL doses of 13vPnC (infant series).
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Reporting Pre-Specified Systemic Events
Fever >39°C but ≤40°C
|
0.7 percentage of participants
|
2.3 percentage of participants
|
0.0 percentage of participants
|
1.3 percentage of participants
|
1.2 percentage of participants
|
0.9 percentage of participants
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events
Fever >40°C
|
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
Fever ≥38°C but ≤39°C
|
0.7 percentage of participants
|
8.1 percentage of participants
|
5.1 percentage of participants
|
5.1 percentage of participants
|
3.4 percentage of participants
|
3.7 percentage of participants
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events
Decreased appetite
|
16.3 percentage of participants
|
17.2 percentage of participants
|
25.5 percentage of participants
|
17.5 percentage of participants
|
19.5 percentage of participants
|
22.2 percentage of participants
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events
Irritability
|
14.3 percentage of participants
|
34.5 percentage of participants
|
34.0 percentage of participants
|
24.7 percentage of participants
|
24.1 percentage of participants
|
30.6 percentage of participants
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events
Increased sleep
|
11.6 percentage of participants
|
9.3 percentage of participants
|
10.1 percentage of participants
|
2.6 percentage of participants
|
9.2 percentage of participants
|
13.0 percentage of participants
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events
Decreased sleep
|
6.8 percentage of participants
|
18.4 percentage of participants
|
20.4 percentage of participants
|
15.0 percentage of participants
|
24.1 percentage of participants
|
19.4 percentage of participants
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events
Use of antipyretic medication to treat symptoms
|
2.7 percentage of participants
|
9.3 percentage of participants
|
13.3 percentage of participants
|
7.6 percentage of participants
|
9.2 percentage of participants
|
10.1 percentage of participants
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events
Use of antipyretic medication to prevent symptoms
|
4.8 percentage of participants
|
4.7 percentage of participants
|
14.3 percentage of participants
|
5.1 percentage of participants
|
8.0 percentage of participants
|
13.8 percentage of participants
|
Adverse Events
13vPnC 7 to <12 Months of Age
Serious events: 5 serious events
Other events: 55 other events
Deaths: 0 deaths
13vPnC 12 to <24 Months of Age
Serious events: 2 serious events
Other events: 77 other events
Deaths: 0 deaths
13vPnC 24 to < 72 Months of Age
Serious events: 2 serious events
Other events: 74 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
13vPnC 7 to <12 Months of Age
n=90 participants at risk
Participants 7 to less than (\<) 12 months of age with 0 prior doses of 7-valent pneumococcal conjugate vaccine (Prevnar) received a total of 3 single intramuscular (IM) 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC); the first two at least 28 days apart (infant series) and the third single IM 0.5 mL dose of 13vPnC at 12 to 16 months of age (toddler dose), at least 46 days after last infant dose.
|
13vPnC 12 to <24 Months of Age
n=112 participants at risk
Participants 12 to \< 24 months of age with 0 prior dose of 7-valent pneumococcal conjugate vaccine (Prevnar) received a total of 2 single IM 0.5 mL doses of 13vPnC at least 56 days apart.
|
13vPnC 24 to < 72 Months of Age
n=152 participants at risk
Participants 24 to \< 72 months of age with 0 prior doses of 7-valent pneumococcal conjugate vaccine (Prevnar) received a single IM 0.5 mL dose of 13vPnC.
|
|---|---|---|---|
|
General disorders
Diarrhoea
|
1.1%
1/90
|
0.00%
0/112
|
0.00%
0/152
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/90
|
0.00%
0/112
|
0.66%
1/152
|
|
Infections and infestations
Exanthema subitum
|
1.1%
1/90
|
0.00%
0/112
|
0.00%
0/152
|
|
Nervous system disorders
Febrile convulsion
|
1.1%
1/90
|
0.00%
0/112
|
0.00%
0/152
|
|
Infections and infestations
Gastrointestinal infection
|
1.1%
1/90
|
0.00%
0/112
|
0.00%
0/152
|
|
Infections and infestations
Otitis media
|
0.00%
0/90
|
0.89%
1/112
|
0.00%
0/152
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/90
|
0.89%
1/112
|
0.66%
1/152
|
|
Infections and infestations
Pneumonia
|
1.1%
1/90
|
0.00%
0/112
|
0.00%
0/152
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/90
|
0.89%
1/112
|
0.00%
0/152
|
|
Injury, poisoning and procedural complications
Thermal burn
|
1.1%
1/90
|
0.00%
0/112
|
0.00%
0/152
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/90
|
0.89%
1/112
|
0.00%
0/152
|
Other adverse events
| Measure |
13vPnC 7 to <12 Months of Age
n=90 participants at risk
Participants 7 to less than (\<) 12 months of age with 0 prior doses of 7-valent pneumococcal conjugate vaccine (Prevnar) received a total of 3 single intramuscular (IM) 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC); the first two at least 28 days apart (infant series) and the third single IM 0.5 mL dose of 13vPnC at 12 to 16 months of age (toddler dose), at least 46 days after last infant dose.
|
13vPnC 12 to <24 Months of Age
n=112 participants at risk
Participants 12 to \< 24 months of age with 0 prior dose of 7-valent pneumococcal conjugate vaccine (Prevnar) received a total of 2 single IM 0.5 mL doses of 13vPnC at least 56 days apart.
|
13vPnC 24 to < 72 Months of Age
n=152 participants at risk
Participants 24 to \< 72 months of age with 0 prior doses of 7-valent pneumococcal conjugate vaccine (Prevnar) received a single IM 0.5 mL dose of 13vPnC.
|
|---|---|---|---|
|
Eye disorders
Chalazion
|
0.00%
0/90
|
0.89%
1/112
|
0.00%
0/152
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/90
|
0.89%
1/112
|
0.00%
0/152
|
|
Gastrointestinal disorders
Diarrhoea
|
6.7%
6/90
|
7.1%
8/112
|
0.66%
1/152
|
|
Gastrointestinal disorders
Dyspepsia
|
2.2%
2/90
|
1.8%
2/112
|
0.66%
1/152
|
|
Gastrointestinal disorders
Teething
|
1.1%
1/90
|
0.00%
0/112
|
0.00%
0/152
|
|
Gastrointestinal disorders
Vomiting
|
1.1%
1/90
|
0.89%
1/112
|
0.66%
1/152
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/90
|
1.8%
2/112
|
0.00%
0/152
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/90
|
0.00%
0/112
|
0.66%
1/152
|
|
General disorders
Pyrexia
|
4.4%
4/90
|
1.8%
2/112
|
0.66%
1/152
|
|
General disorders
Injection site nodule
|
1.1%
1/90
|
0.00%
0/112
|
0.00%
0/152
|
|
General disorders
Injection site erythema
|
0.00%
0/90
|
0.89%
1/112
|
0.00%
0/152
|
|
General disorders
Injection site pain
|
0.00%
0/90
|
0.89%
1/112
|
0.00%
0/152
|
|
Immune system disorders
Allergy to animal
|
0.00%
0/90
|
0.00%
0/112
|
0.66%
1/152
|
|
Immune system disorders
Allergy to arthropod sting
|
0.00%
0/90
|
0.00%
0/112
|
0.66%
1/152
|
|
Infections and infestations
Pharyngitis
|
13.3%
12/90
|
11.6%
13/112
|
3.3%
5/152
|
|
Infections and infestations
Nasopharyngitis
|
12.2%
11/90
|
10.7%
12/112
|
3.3%
5/152
|
|
Infections and infestations
Upper respiratory tract infection
|
8.9%
8/90
|
14.3%
16/112
|
2.6%
4/152
|
|
Infections and infestations
Bronchitis
|
6.7%
6/90
|
8.0%
9/112
|
0.66%
1/152
|
|
Infections and infestations
Respiratory tract infection
|
6.7%
6/90
|
0.00%
0/112
|
0.66%
1/152
|
|
Infections and infestations
Rhinitis
|
6.7%
6/90
|
8.0%
9/112
|
2.6%
4/152
|
|
Infections and infestations
Exanthema subitum
|
4.4%
4/90
|
1.8%
2/112
|
0.00%
0/152
|
|
Infections and infestations
Viral infection
|
4.4%
4/90
|
1.8%
2/112
|
0.00%
0/152
|
|
Infections and infestations
Otitis media
|
1.1%
1/90
|
0.89%
1/112
|
0.00%
0/152
|
|
Infections and infestations
Acute tonsillitis
|
1.1%
1/90
|
0.00%
0/112
|
0.66%
1/152
|
|
Infections and infestations
Ear infection
|
1.1%
1/90
|
0.00%
0/112
|
0.00%
0/152
|
|
Infections and infestations
Gastroenteritis
|
1.1%
1/90
|
3.6%
4/112
|
1.3%
2/152
|
|
Infections and infestations
Pneumonia
|
1.1%
1/90
|
0.89%
1/112
|
0.00%
0/152
|
|
Infections and infestations
Tonsillitis
|
1.1%
1/90
|
0.00%
0/112
|
0.66%
1/152
|
|
Infections and infestations
Laryngitis
|
0.00%
0/90
|
3.6%
4/112
|
0.66%
1/152
|
|
Infections and infestations
Varicella
|
0.00%
0/90
|
0.89%
1/112
|
0.00%
0/152
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/90
|
0.00%
0/112
|
0.66%
1/152
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.00%
0/90
|
0.00%
0/112
|
0.66%
1/152
|
|
Investigations
Urological examination abnormal
|
0.00%
0/90
|
0.89%
1/112
|
0.00%
0/152
|
|
Nervous system disorders
Syncope
|
0.00%
0/90
|
0.00%
0/112
|
0.66%
1/152
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
1.1%
1/90
|
0.00%
0/112
|
0.00%
0/152
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
1.1%
1/90
|
1.8%
2/112
|
0.66%
1/152
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/90
|
0.89%
1/112
|
0.00%
0/152
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/90
|
0.00%
0/112
|
0.66%
1/152
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
2.2%
2/90
|
0.89%
1/112
|
0.00%
0/152
|
|
Skin and subcutaneous tissue disorders
Dermatitis diaper
|
2.2%
2/90
|
0.89%
1/112
|
0.00%
0/152
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.1%
1/90
|
0.89%
1/112
|
0.66%
1/152
|
|
Skin and subcutaneous tissue disorders
Heat rash
|
0.00%
0/90
|
0.00%
0/112
|
1.3%
2/152
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/90
|
0.00%
0/112
|
0.66%
1/152
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
0.00%
0/90
|
0.00%
0/112
|
0.66%
1/152
|
|
Skin and subcutaneous tissue disorders
Tenderness (any)
|
15.2%
12/79
|
—
0/0
|
—
0/0
|
|
Skin and subcutaneous tissue disorders
Tenderness (significant)
|
6.4%
5/78
|
—
0/0
|
—
0/0
|
|
Skin and subcutaneous tissue disorders
Induration (Any)
|
25.0%
20/80
|
—
0/0
|
—
0/0
|
|
Skin and subcutaneous tissue disorders
Induration (mild)
|
20.5%
16/78
|
—
0/0
|
—
0/0
|
|
Skin and subcutaneous tissue disorders
Induration (moderate)
|
11.2%
9/80
|
—
0/0
|
—
0/0
|
|
Skin and subcutaneous tissue disorders
Induration (severe)
|
0.00%
0/78
|
—
0/0
|
—
0/0
|
|
Skin and subcutaneous tissue disorders
Erythema (any)
|
37.8%
31/82
|
—
0/0
|
—
0/0
|
|
Skin and subcutaneous tissue disorders
Erythema (Mild)
|
31.2%
25/80
|
—
0/0
|
—
0/0
|
|
Skin and subcutaneous tissue disorders
Erythema (Moderate)
|
12.5%
10/80
|
—
0/0
|
—
0/0
|
|
Skin and subcutaneous tissue disorders
Erythema (Severe)
|
0.00%
0/78
|
—
0/0
|
—
0/0
|
|
General disorders
Fever ≥38°C but ≤39°C
|
5.1%
4/78
|
—
0/0
|
—
0/0
|
|
General disorders
Fever >39°C but ≤40°C
|
1.3%
1/79
|
—
0/0
|
—
0/0
|
|
General disorders
Fever >40°C
|
0.00%
0/78
|
—
0/0
|
—
0/0
|
|
General disorders
Decreased appetite
|
17.5%
14/80
|
—
0/0
|
—
0/0
|
|
General disorders
Irritability
|
24.7%
20/81
|
—
0/0
|
—
0/0
|
|
General disorders
Increased sleep
|
2.6%
2/78
|
—
0/0
|
—
0/0
|
|
General disorders
Decreased sleep
|
15.0%
12/80
|
—
0/0
|
—
0/0
|
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