Trial Outcomes & Findings for A Study To Assess The Safety And Effectiveness Of Prevenar In Chinese Children Who Have Not Previously Received A Vaccine Against Pneumococcal Bacteria (NCT NCT01193582)
NCT ID: NCT01193582
Last Updated: 2013-11-20
Results Overview
Serotype-specific Pneumococcal Immunoglobulin G (IgG) antibody geometric mean concentration (GMC) after 1 month of last dose for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) are presented. GMC and corresponding 2-sided 95% confidence intervals (CI) were evaluated. Geometric means (GMs) were calculated using all participants with available data for the specified blood draw.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
505 participants
Primary outcome timeframe
1 month after last dose in each group
Results posted on
2013-11-20
Participant Flow
This report presents results following completion of all vaccinations, including data from the 12-month follow-up. This study was conducted at one site in China.
Participants were enrolled into 1 of 4 groups based on inclusion/exclusion criteria without a screening period.
Participant milestones
| Measure |
Group 1
Participants 121 to \<212 days of age and received 4 doses of Prevenar.
|
Group 2
Participants 212 days to \<12 months of age (before the first birthday) and received 3 doses of Prevenar.
|
Group 3
Participants 12 to \<24 months of age (before the second birthday) and received 2 doses of Prevenar
|
Group 4
Participants 24 to \<72 months of age (before the sixth birthday) and received 1 dose of Prevenar
|
|---|---|---|---|---|
|
Vaccination Series
STARTED
|
100
|
101
|
125
|
180
|
|
Vaccination Series
Vaccinated Dose 1
|
100
|
100
|
125
|
180
|
|
Vaccination Series
Vaccinated Dose 2
|
92
|
91
|
118
|
0
|
|
Vaccination Series
Vaccinated Dose 3
|
90
|
89
|
0
|
0
|
|
Vaccination Series
Vaccinated Dose 4
|
90
|
0
|
0
|
0
|
|
Vaccination Series
COMPLETED
|
89
|
88
|
117
|
177
|
|
Vaccination Series
NOT COMPLETED
|
11
|
13
|
8
|
3
|
|
12 Month Follow-up
STARTED
|
89
|
88
|
117
|
177
|
|
12 Month Follow-up
COMPLETED
|
83
|
88
|
113
|
166
|
|
12 Month Follow-up
NOT COMPLETED
|
6
|
0
|
4
|
11
|
Reasons for withdrawal
| Measure |
Group 1
Participants 121 to \<212 days of age and received 4 doses of Prevenar.
|
Group 2
Participants 212 days to \<12 months of age (before the first birthday) and received 3 doses of Prevenar.
|
Group 3
Participants 12 to \<24 months of age (before the second birthday) and received 2 doses of Prevenar
|
Group 4
Participants 24 to \<72 months of age (before the sixth birthday) and received 1 dose of Prevenar
|
|---|---|---|---|---|
|
Vaccination Series
Withdrawal by Subject
|
11
|
13
|
8
|
3
|
|
12 Month Follow-up
Death
|
0
|
0
|
1
|
0
|
|
12 Month Follow-up
Withdrawal by Subject
|
6
|
0
|
3
|
11
|
Baseline Characteristics
A Study To Assess The Safety And Effectiveness Of Prevenar In Chinese Children Who Have Not Previously Received A Vaccine Against Pneumococcal Bacteria
Baseline characteristics by cohort
| Measure |
Group 1
n=88 Participants
Participants 121 to \<212 days of age and received 4 doses of Prevenar.
|
Group 2
n=87 Participants
Participants 212 days to \<12 months of age (before the first birthday) and received 3 doses of Prevenar.
|
Group 3
n=115 Participants
Participants 12 to \<24 months of age (before the second birthday) and received 2 doses of Prevenar
|
Group 4
n=177 Participants
Participants 24 to \<72 months of age (before the sixth birthday) and received 1 dose of Prevenar
|
Total
n=467 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age Continuous
|
5.3 Months
STANDARD_DEVIATION 0.9 • n=5 Participants
|
9.8 Months
STANDARD_DEVIATION 1.4 • n=7 Participants
|
17.5 Months
STANDARD_DEVIATION 4.2 • n=5 Participants
|
44.5 Months
STANDARD_DEVIATION 13.0 • n=4 Participants
|
24.0 Months
STANDARD_DEVIATION 18.5 • n=21 Participants
|
|
Sex: Female, Male
Female
|
50 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
93 Participants
n=4 Participants
|
244 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
38 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
84 Participants
n=4 Participants
|
223 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 1 month after last dose in each groupPopulation: Evaluable immunogenicity population consisted of eligible participants in the age range who had received all the assigned vaccination(s), had blood drawn within required time frames, had at least 1 valid and determinate assay result for the proposed analysis, had received no prohibited vaccines, and had no other major protocol violations.
Serotype-specific Pneumococcal Immunoglobulin G (IgG) antibody geometric mean concentration (GMC) after 1 month of last dose for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) are presented. GMC and corresponding 2-sided 95% confidence intervals (CI) were evaluated. Geometric means (GMs) were calculated using all participants with available data for the specified blood draw.
Outcome measures
| Measure |
Group 1
n=100 Participants
Participants 121 to \<212 days of age and received 4 doses of Prevenar.
|
Group 2
n=101 Participants
Participants 212 days to \<12 months of age (before the first birthday) and received 3 doses of Prevenar.
|
Group 3
n=125 Participants
Participants 12 to \<24 months of age (before the second birthday) and received 2 doses of Prevenar
|
Group 4
n=180 Participants
Participants 24 to \<72 months of age (before the sixth birthday) and received 1 dose of Prevenar.
|
|---|---|---|---|---|
|
Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in Prevenar
Serotype 4 (n= 88, 87, 115, 177)
|
6.90 μg/mL
Interval 5.61 to 8.48
|
7.16 μg/mL
Interval 6.09 to 8.42
|
7.53 μg/mL
Interval 6.7 to 8.46
|
9.45 μg/mL
Interval 8.38 to 10.65
|
|
Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in Prevenar
Serotype 19F (n= 87, 87, 115, 177)
|
4.05 μg/mL
Interval 3.07 to 5.36
|
4.02 μg/mL
Interval 3.05 to 5.31
|
4.03 μg/mL
Interval 3.26 to 4.98
|
4.53 μg/mL
Interval 3.73 to 5.49
|
|
Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in Prevenar
Serotype 23F (n= 88, 87, 115, 177)
|
4.75 μg/mL
Interval 3.77 to 5.99
|
3.95 μg/mL
Interval 3.19 to 4.89
|
4.18 μg/mL
Interval 3.51 to 4.96
|
5.64 μg/mL
Interval 4.84 to 6.57
|
|
Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in Prevenar
Serotype 6B (n= 88, 87, 114, 177)
|
8.01 μg/mL
Interval 6.24 to 10.3
|
5.79 μg/mL
Interval 4.64 to 7.23
|
4.81 μg/mL
Interval 3.89 to 5.96
|
6.36 μg/mL
Interval 5.32 to 7.59
|
|
Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in Prevenar
Serotype 9V (n= 88, 87, 115, 177)
|
4.11 μg/mL
Interval 3.4 to 4.96
|
4.64 μg/mL
Interval 3.93 to 5.47
|
4.67 μg/mL
Interval 4.18 to 5.21
|
6.14 μg/mL
Interval 5.42 to 6.95
|
|
Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in Prevenar
Serotype 14 (n= 88, 87, 115, 177)
|
12.75 μg/mL
Interval 10.32 to 15.76
|
13.02 μg/mL
Interval 10.89 to 15.57
|
11.98 μg/mL
Interval 10.51 to 13.65
|
9.86 μg/mL
Interval 8.03 to 12.1
|
|
Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in Prevenar
Serotype 18C (n= 88, 87, 115, 177)
|
4.65 μg/mL
Interval 3.81 to 5.69
|
4.65 μg/mL
Interval 3.86 to 5.61
|
5.40 μg/mL
Interval 4.78 to 6.1
|
7.39 μg/mL
Interval 6.41 to 8.51
|
PRIMARY outcome
Timeframe: BaselinePopulation: Evaluable immunogenicity population consisted of eligible participants in the age range who had received all the assigned vaccination(s), had blood drawn within required time frames, had at least 1 valid and determinate assay result for the proposed analysis, had received no prohibited vaccines, and had no other major protocol violations.
Serotype-specific Pneumococcal IgG antibody GMC at baseline for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) are presented. GMC and corresponding 2-sided 95% CI were evaluated. GMs were calculated using all participants with available data for the specified blood draw.
Outcome measures
| Measure |
Group 1
n=100 Participants
Participants 121 to \<212 days of age and received 4 doses of Prevenar.
|
Group 2
n=101 Participants
Participants 212 days to \<12 months of age (before the first birthday) and received 3 doses of Prevenar.
|
Group 3
n=125 Participants
Participants 12 to \<24 months of age (before the second birthday) and received 2 doses of Prevenar
|
Group 4
n=180 Participants
Participants 24 to \<72 months of age (before the sixth birthday) and received 1 dose of Prevenar.
|
|---|---|---|---|---|
|
Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in Prevenar at Baseline in Each Group
Serotype 4 (n= 88, 87, 115, 172)
|
0.01 μg/mL
Interval 0.01 to 0.02
|
0.01 μg/mL
Interval 0.01 to 0.02
|
0.02 μg/mL
Interval 0.01 to 0.02
|
0.06 μg/mL
Interval 0.05 to 0.08
|
|
Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in Prevenar at Baseline in Each Group
Serotype 6B (n= 86, 64, 100, 177)
|
0.12 μg/mL
Interval 0.1 to 0.15
|
0.16 μg/mL
Interval 0.12 to 0.22
|
0.27 μg/mL
Interval 0.21 to 0.35
|
1.30 μg/mL
Interval 1.08 to 1.55
|
|
Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in Prevenar at Baseline in Each Group
Serotype 9V (n= 88, 84, 113, 177)
|
0.10 μg/mL
Interval 0.08 to 0.12
|
0.10 μg/mL
Interval 0.08 to 0.13
|
0.17 μg/mL
Interval 0.13 to 0.21
|
0.66 μg/mL
Interval 0.56 to 0.77
|
|
Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in Prevenar at Baseline in Each Group
Serotype 14 (n= 88, 87, 115, 177)
|
0.16 μg/mL
Interval 0.12 to 0.22
|
0.04 μg/mL
Interval 0.03 to 0.05
|
0.03 μg/mL
Interval 0.02 to 0.04
|
0.36 μg/mL
Interval 0.26 to 0.5
|
|
Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in Prevenar at Baseline in Each Group
Serotype 18C (n= 88, 87, 114, 172)
|
0.04 μg/mL
Interval 0.03 to 0.06
|
0.02 μg/mL
Interval 0.01 to 0.02
|
0.02 μg/mL
Interval 0.02 to 0.03
|
0.12 μg/mL
Interval 0.1 to 0.16
|
|
Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in Prevenar at Baseline in Each Group
Serotype 19F (n= 88, 85, 115, 169)
|
0.11 μg/mL
Interval 0.09 to 0.14
|
0.09 μg/mL
Interval 0.07 to 0.12
|
0.13 μg/mL
Interval 0.1 to 0.17
|
0.71 μg/mL
Interval 0.57 to 0.89
|
|
Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in Prevenar at Baseline in Each Group
Serotype 23F (n= 85, 75, 102, 174)
|
0.07 μg/mL
Interval 0.06 to 0.09
|
0.08 μg/mL
Interval 0.06 to 0.11
|
0.17 μg/mL
Interval 0.12 to 0.23
|
0.88 μg/mL
Interval 0.74 to 1.04
|
SECONDARY outcome
Timeframe: 1 month after third dose of Prevenar in Group 1Population: Evaluable immunogenicity population consisted of eligible participants in the age range who had received all the assigned vaccination(s), had blood drawn within required time frames, had at least 1 valid and determinate assay result for the proposed analysis, had received no prohibited vaccines, and had no other major protocol violations.
Serotype-specific Pneumococcal IgG antibody GMC one month after the third dose in Group 1 for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) are presented. GMC and corresponding 2-sided 95% CI were evaluated. GMs were calculated using all participants with available data for the specified blood draw.
Outcome measures
| Measure |
Group 1
n=100 Participants
Participants 121 to \<212 days of age and received 4 doses of Prevenar.
|
Group 2
Participants 212 days to \<12 months of age (before the first birthday) and received 3 doses of Prevenar.
|
Group 3
Participants 12 to \<24 months of age (before the second birthday) and received 2 doses of Prevenar
|
Group 4
Participants 24 to \<72 months of age (before the sixth birthday) and received 1 dose of Prevenar.
|
|---|---|---|---|---|
|
Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in Prevenar at 1 Month After the Third Dose in Group 1
Serotype 4 (n= 88)
|
6.38 μg/mL
Interval 5.56 to 7.33
|
—
|
—
|
—
|
|
Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in Prevenar at 1 Month After the Third Dose in Group 1
Serotype 6B (n= 87)
|
2.88 μg/mL
Interval 2.33 to 3.56
|
—
|
—
|
—
|
|
Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in Prevenar at 1 Month After the Third Dose in Group 1
Serotype 9V (n= 88)
|
4.18 μg/mL
Interval 3.51 to 4.98
|
—
|
—
|
—
|
|
Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in Prevenar at 1 Month After the Third Dose in Group 1
Serotype 14 (n= 88)
|
11.16 μg/mL
Interval 9.12 to 13.66
|
—
|
—
|
—
|
|
Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in Prevenar at 1 Month After the Third Dose in Group 1
Serotype 18C (n= 88)
|
4.60 μg/mL
Interval 3.8 to 5.57
|
—
|
—
|
—
|
|
Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in Prevenar at 1 Month After the Third Dose in Group 1
Serotype 19F (n= 88)
|
3.60 μg/mL
Interval 2.75 to 4.72
|
—
|
—
|
—
|
|
Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in Prevenar at 1 Month After the Third Dose in Group 1
Serotype 23F (n= 88)
|
2.45 μg/mL
Interval 1.97 to 3.04
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-vaccination to 1 month after third dose of Prevenar in Group 1Population: Evaluable immunogenicity population consisted of eligible participants in the age range who had received all the assigned vaccination(s), had blood drawn within required time frames, had at least 1 valid and determinate assay result for the proposed analysis, had received no prohibited vaccines, and had no other major protocol violations.
GMFRs for the 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) from pre-vaccination to post-vaccination were computed using the logarithmically transformed assay results. CIs for GMFR are back transformations of a CI based on the Student t-distribution for the mean logarithm of the titers.
Outcome measures
| Measure |
Group 1
n=100 Participants
Participants 121 to \<212 days of age and received 4 doses of Prevenar.
|
Group 2
Participants 212 days to \<12 months of age (before the first birthday) and received 3 doses of Prevenar.
|
Group 3
Participants 12 to \<24 months of age (before the second birthday) and received 2 doses of Prevenar
|
Group 4
Participants 24 to \<72 months of age (before the sixth birthday) and received 1 dose of Prevenar.
|
|---|---|---|---|---|
|
Geometric Mean Fold Rise (GMFR) of Anti-Pneumococcal Antibody Levels to the 7 Pneumococcal Serotypes Contained in Prevenar Above Vaccination Baseline Values in Group 1.
Serotype 18C (n= 88)
|
106.74 Fold rise
Interval 76.83 to 148.31
|
—
|
—
|
—
|
|
Geometric Mean Fold Rise (GMFR) of Anti-Pneumococcal Antibody Levels to the 7 Pneumococcal Serotypes Contained in Prevenar Above Vaccination Baseline Values in Group 1.
Serotype 19F (n= 88)
|
32.52 Fold rise
Interval 23.39 to 45.21
|
—
|
—
|
—
|
|
Geometric Mean Fold Rise (GMFR) of Anti-Pneumococcal Antibody Levels to the 7 Pneumococcal Serotypes Contained in Prevenar Above Vaccination Baseline Values in Group 1.
Serotype 4 (n= 88)
|
453.17 Fold rise
Interval 344.56 to 596.01
|
—
|
—
|
—
|
|
Geometric Mean Fold Rise (GMFR) of Anti-Pneumococcal Antibody Levels to the 7 Pneumococcal Serotypes Contained in Prevenar Above Vaccination Baseline Values in Group 1.
Serotype 6B (n= 85)
|
23.10 Fold rise
Interval 18.15 to 29.4
|
—
|
—
|
—
|
|
Geometric Mean Fold Rise (GMFR) of Anti-Pneumococcal Antibody Levels to the 7 Pneumococcal Serotypes Contained in Prevenar Above Vaccination Baseline Values in Group 1.
Serotype 9V (n= 88)
|
43.38 Fold rise
Interval 33.42 to 56.32
|
—
|
—
|
—
|
|
Geometric Mean Fold Rise (GMFR) of Anti-Pneumococcal Antibody Levels to the 7 Pneumococcal Serotypes Contained in Prevenar Above Vaccination Baseline Values in Group 1.
Serotype 14 (n= 88)
|
69.90 Fold rise
Interval 45.95 to 106.35
|
—
|
—
|
—
|
|
Geometric Mean Fold Rise (GMFR) of Anti-Pneumococcal Antibody Levels to the 7 Pneumococcal Serotypes Contained in Prevenar Above Vaccination Baseline Values in Group 1.
Serotype 23F (n= 85)
|
34.01 Fold rise
Interval 24.98 to 46.32
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 1 month after second dose of Prevenar in Group 2Population: Evaluable immunogenicity population consisted of eligible participants in the age range who had received all the assigned vaccination(s), had blood drawn within required time frames, had at least 1 valid and determinate assay result for the proposed analysis, had received no prohibited vaccines, and had no other major protocol violations.
Serotype-specific Pneumococcal IgG antibody GMC 1 month after the second dose in Group 2 for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) are presented. GMC and corresponding 2-sided 95% CI were evaluated. GMs were calculated using all participants with available data for the specified blood draw.
Outcome measures
| Measure |
Group 1
n=101 Participants
Participants 121 to \<212 days of age and received 4 doses of Prevenar.
|
Group 2
Participants 212 days to \<12 months of age (before the first birthday) and received 3 doses of Prevenar.
|
Group 3
Participants 12 to \<24 months of age (before the second birthday) and received 2 doses of Prevenar
|
Group 4
Participants 24 to \<72 months of age (before the sixth birthday) and received 1 dose of Prevenar.
|
|---|---|---|---|---|
|
Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in Prevenar at 1 Month After the Second Dose in Group 2
Serotype 4 (n= 87)
|
8.46 μg/mL
Interval 7.36 to 9.72
|
—
|
—
|
—
|
|
Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in Prevenar at 1 Month After the Second Dose in Group 2
Serotype 18C (n= 87)
|
4.93 μg/mL
Interval 4.0 to 6.08
|
—
|
—
|
—
|
|
Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in Prevenar at 1 Month After the Second Dose in Group 2
Serotype 19F (n= 87)
|
3.03 μg/mL
Interval 2.27 to 4.04
|
—
|
—
|
—
|
|
Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in Prevenar at 1 Month After the Second Dose in Group 2
Serotype 6B (n= 85)
|
2.67 μg/mL
Interval 2.06 to 3.46
|
—
|
—
|
—
|
|
Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in Prevenar at 1 Month After the Second Dose in Group 2
Serotype 9V (n= 87)
|
4.71 μg/mL
Interval 3.91 to 5.66
|
—
|
—
|
—
|
|
Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in Prevenar at 1 Month After the Second Dose in Group 2
Serotype 14 (n= 87)
|
8.05 μg/mL
Interval 6.71 to 9.68
|
—
|
—
|
—
|
|
Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in Prevenar at 1 Month After the Second Dose in Group 2
Serotype 23F (n= 87)
|
2.66 μg/mL
Interval 2.1 to 3.37
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-vaccination to 1 month after second dose of Prevenar in Group 2Population: Evaluable immunogenicity population consisted of eligible participants in the age range who had received all the assigned vaccination(s), had blood drawn within required time frames, had at least 1 valid and determinate assay result for the proposed analysis, had received no prohibited vaccines, and had no other major protocol violations.
GMFRs for the 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) from pre-vaccination to post-vaccination were computed using the logarithmically transformed assay results. CIs for GMFR are back transformations of a CI based on the Student t-distribution for the mean logarithm of the titers.
Outcome measures
| Measure |
Group 1
n=101 Participants
Participants 121 to \<212 days of age and received 4 doses of Prevenar.
|
Group 2
Participants 212 days to \<12 months of age (before the first birthday) and received 3 doses of Prevenar.
|
Group 3
Participants 12 to \<24 months of age (before the second birthday) and received 2 doses of Prevenar
|
Group 4
Participants 24 to \<72 months of age (before the sixth birthday) and received 1 dose of Prevenar.
|
|---|---|---|---|---|
|
GMFR of Anti-Pneumococcal Antibody Levels to the 7 Pneumococcal Serotypes Contained in Prevenar Above Vaccination Baseline Values in Group 2.
Serotype 23F (n= 75)
|
30.77 Fold rise
Interval 21.3 to 44.45
|
—
|
—
|
—
|
|
GMFR of Anti-Pneumococcal Antibody Levels to the 7 Pneumococcal Serotypes Contained in Prevenar Above Vaccination Baseline Values in Group 2.
Serotype 4 (n= 87)
|
705.95 Fold rise
Interval 540.5 to 922.05
|
—
|
—
|
—
|
|
GMFR of Anti-Pneumococcal Antibody Levels to the 7 Pneumococcal Serotypes Contained in Prevenar Above Vaccination Baseline Values in Group 2.
Serotype 6B (n= 63)
|
16.64 Fold rise
Interval 11.17 to 24.79
|
—
|
—
|
—
|
|
GMFR of Anti-Pneumococcal Antibody Levels to the 7 Pneumococcal Serotypes Contained in Prevenar Above Vaccination Baseline Values in Group 2.
Serotype 9V (n= 84)
|
44.72 Fold rise
Interval 34.22 to 58.44
|
—
|
—
|
—
|
|
GMFR of Anti-Pneumococcal Antibody Levels to the 7 Pneumococcal Serotypes Contained in Prevenar Above Vaccination Baseline Values in Group 2.
Serotype 14 (n= 87)
|
217.21 Fold rise
Interval 152.52 to 309.33
|
—
|
—
|
—
|
|
GMFR of Anti-Pneumococcal Antibody Levels to the 7 Pneumococcal Serotypes Contained in Prevenar Above Vaccination Baseline Values in Group 2.
Serotype 18C (n= 87)
|
317.90 Fold rise
Interval 219.65 to 460.1
|
—
|
—
|
—
|
|
GMFR of Anti-Pneumococcal Antibody Levels to the 7 Pneumococcal Serotypes Contained in Prevenar Above Vaccination Baseline Values in Group 2.
Serotype 19F (n= 85)
|
33.66 Fold rise
Interval 24.28 to 46.65
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 1 month after first dose of Prevenar in Group 3Population: Evaluable immunogenicity population consisted of eligible participants in the age range who had received all the assigned vaccination(s), had blood drawn within required time frames, had at least 1 valid and determinate assay result for the proposed analysis, had received no prohibited vaccines, and had no other major protocol violations.
Serotype-specific Pneumococcal IgG antibody GMC one month after the first dose in Group 3 for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) are presented. GMC and corresponding 2-sided 95% CI were evaluated. GMs were calculated using all participants with available data for the specified blood draw.
Outcome measures
| Measure |
Group 1
n=125 Participants
Participants 121 to \<212 days of age and received 4 doses of Prevenar.
|
Group 2
Participants 212 days to \<12 months of age (before the first birthday) and received 3 doses of Prevenar.
|
Group 3
Participants 12 to \<24 months of age (before the second birthday) and received 2 doses of Prevenar
|
Group 4
Participants 24 to \<72 months of age (before the sixth birthday) and received 1 dose of Prevenar.
|
|---|---|---|---|---|
|
Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in Prevenar at 1 Month After the First Dose in Group 3
Serotype 4 (n= 115)
|
8.44 μg/mL
Interval 7.25 to 9.81
|
—
|
—
|
—
|
|
Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in Prevenar at 1 Month After the First Dose in Group 3
Serotype 23F (n= 115)
|
2.83 μg/mL
Interval 2.26 to 3.53
|
—
|
—
|
—
|
|
Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in Prevenar at 1 Month After the First Dose in Group 3
Serotype 6B (n= 113)
|
1.92 μg/mL
Interval 1.51 to 2.42
|
—
|
—
|
—
|
|
Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in Prevenar at 1 Month After the First Dose in Group 3
Serotype 9V (n= 115)
|
4.77 μg/mL
Interval 4.09 to 5.56
|
—
|
—
|
—
|
|
Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in Prevenar at 1 Month After the First Dose in Group 3
Serotype 14 (n= 115)
|
3.37 μg/mL
Interval 2.74 to 4.16
|
—
|
—
|
—
|
|
Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in Prevenar at 1 Month After the First Dose in Group 3
Serotype 18C (n= 115)
|
5.72 μg/mL
Interval 4.82 to 6.77
|
—
|
—
|
—
|
|
Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in Prevenar at 1 Month After the First Dose in Group 3
Serotype 19F (n= 113)
|
1.96 μg/mL
Interval 1.55 to 2.49
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-vaccination to 1 month after first dose of Prevenar in Group 3Population: Evaluable immunogenicity population consisted of eligible participants in the age range who had received all the assigned vaccination(s), had blood drawn within required time frames, had at least 1 valid and determinate assay result for the proposed analysis, had received no prohibited vaccines, and had no other major protocol violations.
GMFRs for the 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) from pre-vaccination to post-vaccination were computed using the logarithmically transformed assay results. CIs for GMFR are back transformations of a CI based on the Student t-distribution for the mean logarithm of the titers.
Outcome measures
| Measure |
Group 1
n=125 Participants
Participants 121 to \<212 days of age and received 4 doses of Prevenar.
|
Group 2
Participants 212 days to \<12 months of age (before the first birthday) and received 3 doses of Prevenar.
|
Group 3
Participants 12 to \<24 months of age (before the second birthday) and received 2 doses of Prevenar
|
Group 4
Participants 24 to \<72 months of age (before the sixth birthday) and received 1 dose of Prevenar.
|
|---|---|---|---|---|
|
GMFR of Anti-Pneumococcal Antibody Levels to the 7 Pneumococcal Serotypes Contained in Prevenar Above Vaccination Baseline Values in Group 3.
Serotype 4 (n= 115)
|
476.49 Fold rise
Interval 363.31 to 624.93
|
—
|
—
|
—
|
|
GMFR of Anti-Pneumococcal Antibody Levels to the 7 Pneumococcal Serotypes Contained in Prevenar Above Vaccination Baseline Values in Group 3.
Serotype 6B (n= 99)
|
7.06 Fold rise
Interval 5.5 to 9.05
|
—
|
—
|
—
|
|
GMFR of Anti-Pneumococcal Antibody Levels to the 7 Pneumococcal Serotypes Contained in Prevenar Above Vaccination Baseline Values in Group 3.
Serotype 9V (n= 113)
|
28.11 Fold rise
Interval 22.18 to 35.63
|
—
|
—
|
—
|
|
GMFR of Anti-Pneumococcal Antibody Levels to the 7 Pneumococcal Serotypes Contained in Prevenar Above Vaccination Baseline Values in Group 3.
Serotype 14 (n= 115)
|
108.18 Fold rise
Interval 78.76 to 148.6
|
—
|
—
|
—
|
|
GMFR of Anti-Pneumococcal Antibody Levels to the 7 Pneumococcal Serotypes Contained in Prevenar Above Vaccination Baseline Values in Group 3.
Serotype 18C (n= 114)
|
236.39 Fold rise
Interval 182.65 to 305.93
|
—
|
—
|
—
|
|
GMFR of Anti-Pneumococcal Antibody Levels to the 7 Pneumococcal Serotypes Contained in Prevenar Above Vaccination Baseline Values in Group 3.
Serotype 19F (n= 113)
|
15.13 Fold rise
Interval 11.02 to 20.77
|
—
|
—
|
—
|
|
GMFR of Anti-Pneumococcal Antibody Levels to the 7 Pneumococcal Serotypes Contained in Prevenar Above Vaccination Baseline Values in Group 3.
Serotype 23F (n= 102)
|
17.64 Fold rise
Interval 13.43 to 23.17
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 12 months after the last dosePopulation: Evaluable immunogenicity population consisted subjects who had received all , assigned vaccination(s), had blood drawn within required time frame for 12 month follow-up blood draw visit, had at least 1 valid and determinate assay result, had received no prohibited vaccines, and had no major protocol violations.
Serotype-specific Pneumococcal IgG antibody GMC 12 months after the last dose for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) are presented. GMC and corresponding 2-sided 95% CI were evaluated. GMs were calculated using all participants with available data for the specified blood draw.
Outcome measures
| Measure |
Group 1
n=89 Participants
Participants 121 to \<212 days of age and received 4 doses of Prevenar.
|
Group 2
n=88 Participants
Participants 212 days to \<12 months of age (before the first birthday) and received 3 doses of Prevenar.
|
Group 3
n=117 Participants
Participants 12 to \<24 months of age (before the second birthday) and received 2 doses of Prevenar
|
Group 4
n=177 Participants
Participants 24 to \<72 months of age (before the sixth birthday) and received 1 dose of Prevenar.
|
|---|---|---|---|---|
|
Antibody Concentrations Against the 7 Pneumococcal Serotypes Contained in Prevenar at 12 Months After the Last Dose.
Serotype 6B (n= 81, 78, 109, 161)
|
3.22 μg/mL
Interval 2.41 to 4.29
|
2.31 μg/mL
Interval 1.77 to 3.03
|
2.38 μg/mL
Interval 1.89 to 3.0
|
4.20 μg/mL
Interval 3.49 to 5.04
|
|
Antibody Concentrations Against the 7 Pneumococcal Serotypes Contained in Prevenar at 12 Months After the Last Dose.
Serotype 9V (n= 81, 79, 111, 162)
|
1.26 μg/mL
Interval 1.0 to 1.59
|
0.98 μg/mL
Interval 0.79 to 1.21
|
1.44 μg/mL
Interval 1.2 to 1.71
|
2.23 μg/mL
Interval 1.94 to 2.56
|
|
Antibody Concentrations Against the 7 Pneumococcal Serotypes Contained in Prevenar at 12 Months After the Last Dose.
Serotype 19F (n= 80, 76, 109, 156)
|
1.25 μg/mL
Interval 0.95 to 1.64
|
1.29 μg/mL
Interval 0.85 to 1.95
|
1.39 μg/mL
Interval 1.03 to 1.88
|
2.85 μg/mL
Interval 2.28 to 3.56
|
|
Antibody Concentrations Against the 7 Pneumococcal Serotypes Contained in Prevenar at 12 Months After the Last Dose.
Serotype 23F (n= 81, 78, 110, 162)
|
1.38 μg/mL
Interval 1.07 to 1.77
|
1.20 μg/mL
Interval 0.91 to 1.59
|
1.79 μg/mL
Interval 1.45 to 2.21
|
2.49 μg/mL
Interval 2.13 to 2.92
|
|
Antibody Concentrations Against the 7 Pneumococcal Serotypes Contained in Prevenar at 12 Months After the Last Dose.
Serotype 4 (n= 81, 79, 111, 162)
|
0.78 μg/mL
Interval 0.62 to 0.98
|
0.65 μg/mL
Interval 0.52 to 0.82
|
0.96 μg/mL
Interval 0.8 to 1.14
|
1.27 μg/mL
Interval 1.11 to 1.45
|
|
Antibody Concentrations Against the 7 Pneumococcal Serotypes Contained in Prevenar at 12 Months After the Last Dose.
Serotype 14 (n= 81, 79, 111, 162)
|
1.84 μg/mL
Interval 1.4 to 2.41
|
2.18 μg/mL
Interval 1.62 to 2.94
|
2.61 μg/mL
Interval 2.09 to 3.27
|
5.19 μg/mL
Interval 4.25 to 6.33
|
|
Antibody Concentrations Against the 7 Pneumococcal Serotypes Contained in Prevenar at 12 Months After the Last Dose.
Serotype 18C (n= 81, 79, 111, 162)
|
0.87 μg/mL
Interval 0.69 to 1.1
|
0.71 μg/mL
Interval 0.59 to 0.85
|
0.98 μg/mL
Interval 0.84 to 1.15
|
1.46 μg/mL
Interval 1.24 to 1.72
|
SECONDARY outcome
Timeframe: Pre-vaccination to 12 months after the last dosePopulation: Evaluable immunogenicity population consisted subjects who had received all , assigned vaccination(s), had blood drawn within required time frame for 12 month follow-up blood draw visit, had at least 1 valid and determinate assay result, had received no prohibited vaccines, and had no major protocol violations.
GMFRs for the 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) from pre-vaccination to 12- month follow-up were computed using the logarithmically transformed assay results. CIs for GMFR are back transformations of a CI based on the Student t-distribution for the mean logarithm of the titers.
Outcome measures
| Measure |
Group 1
n=89 Participants
Participants 121 to \<212 days of age and received 4 doses of Prevenar.
|
Group 2
n=88 Participants
Participants 212 days to \<12 months of age (before the first birthday) and received 3 doses of Prevenar.
|
Group 3
n=117 Participants
Participants 12 to \<24 months of age (before the second birthday) and received 2 doses of Prevenar
|
Group 4
n=177 Participants
Participants 24 to \<72 months of age (before the sixth birthday) and received 1 dose of Prevenar.
|
|---|---|---|---|---|
|
GMFR of Anti-Pneumococcal Antibody Levels to the 7 Pneumococcal Serotypes Contained in Prevenar Above Vaccination Baseline Values at 12 Months After the Last Dose.
Serotype 4 (n= 81, 79, 111, 157)
|
52.86 Fold rise
Interval 37.61 to 74.31
|
50.54 Fold rise
Interval 37.47 to 68.18
|
52.19 Fold rise
Interval 39.75 to 68.53
|
21.01 Fold rise
Interval 17.04 to 25.91
|
|
GMFR of Anti-Pneumococcal Antibody Levels to the 7 Pneumococcal Serotypes Contained in Prevenar Above Vaccination Baseline Values at 12 Months After the Last Dose.
Serotype 14 (n= 81, 79, 111, 162)
|
10.19 Fold rise
Interval 6.84 to 15.19
|
55.55 Fold rise
Interval 37.23 to 82.87
|
88.27 Fold rise
Interval 63.53 to 122.63
|
15.67 Fold rise
Interval 11.43 to 21.47
|
|
GMFR of Anti-Pneumococcal Antibody Levels to the 7 Pneumococcal Serotypes Contained in Prevenar Above Vaccination Baseline Values at 12 Months After the Last Dose.
Serotype 19F (n= 80, 74, 109, 150)
|
10.06 Fold rise
Interval 6.85 to 14.77
|
12.62 Fold rise
Interval 8.67 to 18.39
|
11.15 Fold rise
Interval 7.87 to 15.8
|
4.19 Fold rise
Interval 3.19 to 5.51
|
|
GMFR of Anti-Pneumococcal Antibody Levels to the 7 Pneumococcal Serotypes Contained in Prevenar Above Vaccination Baseline Values at 12 Months After the Last Dose.
Serotype 23F (n= 79, 67, 97, 159)
|
18.80 Fold rise
Interval 13.26 to 26.66
|
13.50 Fold rise
Interval 9.56 to 19.04
|
11.39 Fold rise
Interval 8.31 to 15.61
|
2.86 Fold rise
Interval 2.39 to 3.42
|
|
GMFR of Anti-Pneumococcal Antibody Levels to the 7 Pneumococcal Serotypes Contained in Prevenar Above Vaccination Baseline Values at 12 Months After the Last Dose.
Serotype 6B (n= 79, 58, 95, 161)
|
25.52 Fold rise
Interval 18.57 to 35.07
|
15.58 Fold rise
Interval 10.18 to 23.83
|
7.99 Fold rise
Interval 5.98 to 10.67
|
3.16 Fold rise
Interval 2.7 to 3.7
|
|
GMFR of Anti-Pneumococcal Antibody Levels to the 7 Pneumococcal Serotypes Contained in Prevenar Above Vaccination Baseline Values at 12 Months After the Last Dose.
Serotype 9V (n= 81, 76, 109, 162)
|
12.73 Fold rise
Interval 9.41 to 17.24
|
8.97 Fold rise
Interval 6.84 to 11.77
|
8.40 Fold rise
Interval 6.55 to 10.77
|
3.35 Fold rise
Interval 2.93 to 3.83
|
|
GMFR of Anti-Pneumococcal Antibody Levels to the 7 Pneumococcal Serotypes Contained in Prevenar Above Vaccination Baseline Values at 12 Months After the Last Dose.
Serotype 18C (n= 81, 79, 110, 158)
|
19.75 Fold rise
Interval 14.0 to 27.87
|
45.07 Fold rise
Interval 33.12 to 61.33
|
41.14 Fold rise
Interval 32.18 to 52.59
|
11.43 Fold rise
Interval 9.38 to 13.92
|
Adverse Events
Group 1
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Group 2
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Group 3
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Group 4
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group 1
n=100 participants at risk
Participants 121 to \<212 days of age and received 4 doses of Prevenar.
|
Group 2
n=100 participants at risk
Participants 212 days to \<12 months of age (before the first birthday) and received 3 doses of Prevenar.
|
Group 3
n=125 participants at risk
Participants 12 to \<24 months of age (before the second birthday) and received 2 doses of Prevenar
|
Group 4
n=180 participants at risk
Participants 24 to \<72 months of age (before the sixth birthday) and received 1 dose of Prevenar
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Enteritis
|
1.0%
1/100 • Baseline through 12 months following last dose of Prevenar
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/100 • Baseline through 12 months following last dose of Prevenar
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/125 • Baseline through 12 months following last dose of Prevenar
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/180 • Baseline through 12 months following last dose of Prevenar
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Gastroenteritis shigella
|
0.00%
0/100 • Baseline through 12 months following last dose of Prevenar
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/100 • Baseline through 12 months following last dose of Prevenar
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.80%
1/125 • Baseline through 12 months following last dose of Prevenar
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/180 • Baseline through 12 months following last dose of Prevenar
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/100 • Baseline through 12 months following last dose of Prevenar
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/100 • Baseline through 12 months following last dose of Prevenar
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.80%
1/125 • Baseline through 12 months following last dose of Prevenar
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/180 • Baseline through 12 months following last dose of Prevenar
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Vascular disorders
Circulatory collapse
|
0.00%
0/100 • Baseline through 12 months following last dose of Prevenar
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/100 • Baseline through 12 months following last dose of Prevenar
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.80%
1/125 • Baseline through 12 months following last dose of Prevenar
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/180 • Baseline through 12 months following last dose of Prevenar
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
Other adverse events
| Measure |
Group 1
n=100 participants at risk
Participants 121 to \<212 days of age and received 4 doses of Prevenar.
|
Group 2
n=100 participants at risk
Participants 212 days to \<12 months of age (before the first birthday) and received 3 doses of Prevenar.
|
Group 3
n=125 participants at risk
Participants 12 to \<24 months of age (before the second birthday) and received 2 doses of Prevenar
|
Group 4
n=180 participants at risk
Participants 24 to \<72 months of age (before the sixth birthday) and received 1 dose of Prevenar
|
|---|---|---|---|---|
|
General disorders
Pyrexia
|
2.0%
2/100 • Baseline through 12 months following last dose of Prevenar
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
4.0%
4/100 • Baseline through 12 months following last dose of Prevenar
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.80%
1/125 • Baseline through 12 months following last dose of Prevenar
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.56%
1/180 • Baseline through 12 months following last dose of Prevenar
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Hypersensitivity
|
0.00%
0/100 • Baseline through 12 months following last dose of Prevenar
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/100 • Baseline through 12 months following last dose of Prevenar
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.80%
1/125 • Baseline through 12 months following last dose of Prevenar
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/180 • Baseline through 12 months following last dose of Prevenar
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Dermatitis Allergic
|
0.00%
0/100 • Baseline through 12 months following last dose of Prevenar
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/100 • Baseline through 12 months following last dose of Prevenar
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.80%
1/125 • Baseline through 12 months following last dose of Prevenar
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/180 • Baseline through 12 months following last dose of Prevenar
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
1.0%
1/100 • Baseline through 12 months following last dose of Prevenar
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/100 • Baseline through 12 months following last dose of Prevenar
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/125 • Baseline through 12 months following last dose of Prevenar
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/180 • Baseline through 12 months following last dose of Prevenar
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER