Trial Outcomes & Findings for Study Evaluating Prevnar Infant Long-term Immune Response Versus Prevnar Naive Cohort (NCT NCT00824850)
NCT ID: NCT00824850
Last Updated: 2011-11-11
Results Overview
Percentage of participants achieving predefined OPA antibody titer ≥1:8 for the 13 pneumococcal serotypes (7vPnC serotypes 4, 6B, 9V, 14, 18C, 19F, 23F and additional serotypes 1, 3, 5, 6A, 7F, and 19A) along with the exact, 2-sided 95% CIs based on the observed percentage of participants. The lowest titer that can be determined using the standard OPA assay is a titer of 1:8 limit of detection (LOD) and is the same for each serotype-specific OPA assay.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
75 participants
Primary outcome timeframe
Day 7 (Visit 4)
Results posted on
2011-11-11
Participant Flow
Participants were previously enrolled in Prevnar protocol D118-P8 (study duration 1995 to 1998) and were randomized to receive either 7-valent pneumococcal conjugate vaccine or meningococcal C conjugate vaccine in that study.
Participant milestones
| Measure |
7vPnC / 13vPnC
13vPnC administered as a single 0.5 mL dose IM. Participants had previously received 7vPnC in study D118-P8.
|
MnCC / 13vPnC
13vPnC administered as a single 0.5 mL dose IM. Participants had previously received MnCC in study D118-P8.
|
|---|---|---|
|
Overall Study
STARTED
|
38
|
37
|
|
Overall Study
Received Vaccination 13vPnC
|
38
|
36
|
|
Overall Study
COMPLETED
|
38
|
36
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
7vPnC / 13vPnC
13vPnC administered as a single 0.5 mL dose IM. Participants had previously received 7vPnC in study D118-P8.
|
MnCC / 13vPnC
13vPnC administered as a single 0.5 mL dose IM. Participants had previously received MnCC in study D118-P8.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Study Evaluating Prevnar Infant Long-term Immune Response Versus Prevnar Naive Cohort
Baseline characteristics by cohort
| Measure |
7vPnC / 13vPnC
n=38 Participants
13vPnC administered as a single 0.5 mL dose IM. Participants had previously received 7vPnC in study D118-P8.
|
MnCC / 13vPnC
n=37 Participants
13vPnC administered as a single 0.5 mL dose IM. Participants had previously received MnCC in study D118-P8.
|
Total
n=75 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
12.6 years
STANDARD_DEVIATION 1.1 • n=5 Participants
|
13.1 years
STANDARD_DEVIATION 0.9 • n=7 Participants
|
12.8 years
STANDARD_DEVIATION 1.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 28 (Visit 5)Population: Evaluable Immunogenicity population: eligible participants based on all inclusion and exclusion criteria, had a baseline blood sample collection performed (Visit 1), received 1 dose of 13vPnC, and had Visit 5 blood sample collection performed, and at least 1 valid and determinate assay result at Visit 1 and also at Visit 5.
Percentage of participants achieving predefined IgG antibody threshold ≥0.35 micrograms per milliliter (Mcg/mL) for the 13 pneumococcal serotypes (7vPnC serotypes 4, 6B, 9V, 14, 18C, 19F, 23F and additional serotypes 1, 3, 5, 6A, 7F, and 19A) along with the exact, 2-sided 95% confidence intervals (CIs) based on the observed percentage of participants.
Outcome measures
| Measure |
7vPnC / 13vPnC
n=38 Participants
13vPnC administered as a single 0.5 mL dose IM. Participants had previously received 7vPnC in study D118-P8.
|
MnCC / 13vPnC
n=35 Participants
13vPnC administered as a single 0.5 mL dose IM. Participants had previously received MnCC in study D118-P8.
|
|---|---|---|
|
Percentage of Participants Achieving a Pneumococcal IgG Antibody Concentration ≥0.35 Mcg/mL for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 5)
7vPnC serotype 4
|
100.0 observed percentage of participants
Interval 90.7 to 100.0
|
100.0 observed percentage of participants
Interval 90.0 to 100.0
|
|
Percentage of Participants Achieving a Pneumococcal IgG Antibody Concentration ≥0.35 Mcg/mL for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 5)
7vPnC serotype 19F
|
100.0 observed percentage of participants
Interval 90.7 to 100.0
|
100.0 observed percentage of participants
Interval 89.7 to 100.0
|
|
Percentage of Participants Achieving a Pneumococcal IgG Antibody Concentration ≥0.35 Mcg/mL for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 5)
7vPnC serotype 23F
|
100.0 observed percentage of participants
Interval 90.7 to 100.0
|
100.0 observed percentage of participants
Interval 90.0 to 100.0
|
|
Percentage of Participants Achieving a Pneumococcal IgG Antibody Concentration ≥0.35 Mcg/mL for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 5)
7vPnC serotype 6B
|
100.0 observed percentage of participants
Interval 90.7 to 100.0
|
100.0 observed percentage of participants
Interval 90.0 to 100.0
|
|
Percentage of Participants Achieving a Pneumococcal IgG Antibody Concentration ≥0.35 Mcg/mL for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 5)
7vPnC serotype 9V
|
100.0 observed percentage of participants
Interval 90.7 to 100.0
|
100.0 observed percentage of participants
Interval 90.0 to 100.0
|
|
Percentage of Participants Achieving a Pneumococcal IgG Antibody Concentration ≥0.35 Mcg/mL for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 5)
7vPnC serotype 14
|
100.0 observed percentage of participants
Interval 90.7 to 100.0
|
97.1 observed percentage of participants
Interval 85.1 to 99.9
|
|
Percentage of Participants Achieving a Pneumococcal IgG Antibody Concentration ≥0.35 Mcg/mL for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 5)
7vPnC serotype 18C
|
100.0 observed percentage of participants
Interval 90.7 to 100.0
|
100.0 observed percentage of participants
Interval 90.0 to 100.0
|
|
Percentage of Participants Achieving a Pneumococcal IgG Antibody Concentration ≥0.35 Mcg/mL for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 5)
Additional serotype 1
|
100.0 observed percentage of participants
Interval 90.7 to 100.0
|
100.0 observed percentage of participants
Interval 90.0 to 100.0
|
|
Percentage of Participants Achieving a Pneumococcal IgG Antibody Concentration ≥0.35 Mcg/mL for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 5)
Additional serotype 3
|
94.7 observed percentage of participants
Interval 82.3 to 99.4
|
97.0 observed percentage of participants
Interval 84.2 to 99.9
|
|
Percentage of Participants Achieving a Pneumococcal IgG Antibody Concentration ≥0.35 Mcg/mL for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 5)
Additional serotype 5
|
100.0 observed percentage of participants
Interval 90.7 to 100.0
|
100.0 observed percentage of participants
Interval 90.0 to 100.0
|
|
Percentage of Participants Achieving a Pneumococcal IgG Antibody Concentration ≥0.35 Mcg/mL for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 5)
Additional serotype 6A
|
100.0 observed percentage of participants
Interval 90.7 to 100.0
|
100.0 observed percentage of participants
Interval 90.0 to 100.0
|
|
Percentage of Participants Achieving a Pneumococcal IgG Antibody Concentration ≥0.35 Mcg/mL for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 5)
Additional serotype 7F
|
100.0 observed percentage of participants
Interval 90.7 to 100.0
|
100.0 observed percentage of participants
Interval 90.0 to 100.0
|
|
Percentage of Participants Achieving a Pneumococcal IgG Antibody Concentration ≥0.35 Mcg/mL for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 5)
Additional serotype 19A
|
100.0 observed percentage of participants
Interval 90.7 to 100.0
|
100.0 observed percentage of participants
Interval 90.0 to 100.0
|
PRIMARY outcome
Timeframe: Day 7 (Visit 4)Population: Evaluable Immunogenicity population; N=number of participants with a determinate IgG antibody concentration for the serotypes.
Percentage of participants achieving predefined IgG antibody threshold ≥0.35 Mcg/mL for the 13 pneumococcal serotypes (7vPnC serotypes 4, 6B, 9V, 14, 18C, 19F, 23F and additional serotypes 1, 3, 5, 6A, 7F, and 19A) along with the exact, 2-sided 95% CIs based on the observed percentage of participants.
Outcome measures
| Measure |
7vPnC / 13vPnC
n=38 Participants
13vPnC administered as a single 0.5 mL dose IM. Participants had previously received 7vPnC in study D118-P8.
|
MnCC / 13vPnC
n=35 Participants
13vPnC administered as a single 0.5 mL dose IM. Participants had previously received MnCC in study D118-P8.
|
|---|---|---|
|
Percentage of Participants Achieving a Pneumococcal IgG Antibody Concentration ≥0.35 Mcg/mL for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 4)
7vPnC serotype 4
|
94.7 observed percentage of participants
Interval 82.3 to 99.4
|
85.7 observed percentage of participants
Interval 69.7 to 95.2
|
|
Percentage of Participants Achieving a Pneumococcal IgG Antibody Concentration ≥0.35 Mcg/mL for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 4)
7vPnC serotype 6B
|
100.0 observed percentage of participants
Interval 90.7 to 100.0
|
100.0 observed percentage of participants
Interval 90.0 to 100.0
|
|
Percentage of Participants Achieving a Pneumococcal IgG Antibody Concentration ≥0.35 Mcg/mL for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 4)
7vPnC serotype 9V
|
100.0 observed percentage of participants
Interval 90.7 to 100.0
|
97.1 observed percentage of participants
Interval 85.1 to 99.9
|
|
Percentage of Participants Achieving a Pneumococcal IgG Antibody Concentration ≥0.35 Mcg/mL for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 4)
7vPnC serotype 14
|
100.0 observed percentage of participants
Interval 90.7 to 100.0
|
94.3 observed percentage of participants
Interval 80.8 to 99.3
|
|
Percentage of Participants Achieving a Pneumococcal IgG Antibody Concentration ≥0.35 Mcg/mL for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 4)
7vPnC serotype 18C
|
97.4 observed percentage of participants
Interval 86.2 to 99.9
|
94.3 observed percentage of participants
Interval 80.8 to 99.3
|
|
Percentage of Participants Achieving a Pneumococcal IgG Antibody Concentration ≥0.35 Mcg/mL for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 4)
7vPnC serotype 19F
|
100.0 observed percentage of participants
Interval 90.7 to 100.0
|
100.0 observed percentage of participants
Interval 89.7 to 100.0
|
|
Percentage of Participants Achieving a Pneumococcal IgG Antibody Concentration ≥0.35 Mcg/mL for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 4)
7vPnC serotype 23F
|
100.0 observed percentage of participants
Interval 90.7 to 100.0
|
100.0 observed percentage of participants
Interval 90.0 to 100.0
|
|
Percentage of Participants Achieving a Pneumococcal IgG Antibody Concentration ≥0.35 Mcg/mL for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 4)
Additional serotype 1
|
100.0 observed percentage of participants
Interval 90.7 to 100.0
|
97.1 observed percentage of participants
Interval 85.1 to 99.9
|
|
Percentage of Participants Achieving a Pneumococcal IgG Antibody Concentration ≥0.35 Mcg/mL for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 4)
Additional serotype 3
|
94.7 observed percentage of participants
Interval 82.3 to 99.4
|
87.9 observed percentage of participants
Interval 71.8 to 96.6
|
|
Percentage of Participants Achieving a Pneumococcal IgG Antibody Concentration ≥0.35 Mcg/mL for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 4)
Additional serotype 5
|
100.0 observed percentage of participants
Interval 90.7 to 100.0
|
100.0 observed percentage of participants
Interval 90.0 to 100.0
|
|
Percentage of Participants Achieving a Pneumococcal IgG Antibody Concentration ≥0.35 Mcg/mL for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 4)
Additional serotype 6A
|
100.0 observed percentage of participants
Interval 90.7 to 100.0
|
100.0 observed percentage of participants
Interval 90.0 to 100.0
|
|
Percentage of Participants Achieving a Pneumococcal IgG Antibody Concentration ≥0.35 Mcg/mL for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 4)
Additional serotype 7F
|
100.0 observed percentage of participants
Interval 90.7 to 100.0
|
100.0 observed percentage of participants
Interval 90.0 to 100.0
|
|
Percentage of Participants Achieving a Pneumococcal IgG Antibody Concentration ≥0.35 Mcg/mL for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 4)
Additional serotype 19A
|
100.0 observed percentage of participants
Interval 90.7 to 100.0
|
100.0 observed percentage of participants
Interval 90.0 to 100.0
|
PRIMARY outcome
Timeframe: Day 28 (Visit 5)Population: Evaluable Immunogenicity population; N=number of participants with a determinate OPA antibody titer to the serotypes.
Percentage of participants achieving predefined OPA antibody titer ≥ serotype-specific lower limit of quantification (LLOQ) using modified microcolony assays for the 13 pneumococcal serotypes (7vPnC serotypes 4, 6B, 9V, 14, 18C, 19F, 23F and additional serotypes 1, 3, 5, 6A, 7F, and 19A) along with the exact, 2-sided 95% CIs based on the observed percentage of participants. LLOQ for each serotype: 1=1:8, 3=1:12, 4=1:21, 5=1:29, 6A=1:37, 6B=1:43, 7F=1:210, 9V=1:345, 14=1:35, 18C=1:31, 19A=1:18, 19F=1:48, 23F=1:13.
Outcome measures
| Measure |
7vPnC / 13vPnC
n=38 Participants
13vPnC administered as a single 0.5 mL dose IM. Participants had previously received 7vPnC in study D118-P8.
|
MnCC / 13vPnC
n=35 Participants
13vPnC administered as a single 0.5 mL dose IM. Participants had previously received MnCC in study D118-P8.
|
|---|---|---|
|
Percentage of Participants Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥LLOQ for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 5)
7vPnC serotype 19F
|
97.4 observed percentage of participants
Interval 86.2 to 99.9
|
100.0 observed percentage of participants
Interval 89.7 to 100.0
|
|
Percentage of Participants Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥LLOQ for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 5)
Additional serotype 7F
|
100.0 observed percentage of participants
Interval 90.5 to 100.0
|
100.0 observed percentage of participants
Interval 90.0 to 100.0
|
|
Percentage of Participants Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥LLOQ for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 5)
Additional serotype 19A
|
97.4 observed percentage of participants
Interval 86.2 to 99.9
|
100.0 observed percentage of participants
Interval 90.0 to 100.0
|
|
Percentage of Participants Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥LLOQ for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 5)
7vPnC serotype 4
|
100.0 observed percentage of participants
Interval 90.3 to 100.0
|
100.0 observed percentage of participants
Interval 89.1 to 100.0
|
|
Percentage of Participants Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥LLOQ for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 5)
7vPnC serotype 6B
|
100.0 observed percentage of participants
Interval 90.5 to 100.0
|
100.0 observed percentage of participants
Interval 90.0 to 100.0
|
|
Percentage of Participants Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥LLOQ for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 5)
7vPnC serotype 9V
|
100.0 observed percentage of participants
Interval 90.7 to 100.0
|
100.0 observed percentage of participants
Interval 89.7 to 100.0
|
|
Percentage of Participants Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥LLOQ for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 5)
7vPnC serotype 14
|
100.0 observed percentage of participants
Interval 90.7 to 100.0
|
100.0 observed percentage of participants
Interval 89.7 to 100.0
|
|
Percentage of Participants Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥LLOQ for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 5)
7vPnC serotype 18C
|
100.0 observed percentage of participants
Interval 90.7 to 100.0
|
100.0 observed percentage of participants
Interval 90.0 to 100.0
|
|
Percentage of Participants Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥LLOQ for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 5)
7vPnC serotype 23F
|
100.0 observed percentage of participants
Interval 90.5 to 100.0
|
100.0 observed percentage of participants
Interval 90.0 to 100.0
|
|
Percentage of Participants Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥LLOQ for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 5)
Additional serotype 1
|
100.0 observed percentage of participants
Interval 90.7 to 100.0
|
97.1 observed percentage of participants
Interval 84.7 to 99.9
|
|
Percentage of Participants Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥LLOQ for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 5)
Additional serotype 3
|
100.0 observed percentage of participants
Interval 90.7 to 100.0
|
100.0 observed percentage of participants
Interval 90.0 to 100.0
|
|
Percentage of Participants Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥LLOQ for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 5)
Additional serotype 5
|
89.5 observed percentage of participants
Interval 75.2 to 97.1
|
88.6 observed percentage of participants
Interval 73.3 to 96.8
|
|
Percentage of Participants Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥LLOQ for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 5)
Additional serotype 6A
|
100.0 observed percentage of participants
Interval 90.7 to 100.0
|
100.0 observed percentage of participants
Interval 89.7 to 100.0
|
PRIMARY outcome
Timeframe: Day 7 (Visit 4)Population: Evaluable Immunogenicity population; N=number of participants with a determinate OPA antibody titer to the serotypes.
Percentage of participants achieving predefined OPA antibody titer ≥ serotype-specific lower limit of quantification (LLOQ) using modified microcolony assays for the 13 pneumococcal serotypes (7vPnC serotypes 4, 6B, 9V, 14, 18C, 19F, 23F and additional serotypes 1, 3, 5, 6A, 7F, and 19A) along with the exact, 2-sided 95% CIs based on the observed percentage of participants. LLOQ for each serotype: 1=1:8, 3=1:12, 4=1:21, 5=1:29, 6A=1:37, 6B=1:43, 7F=1:210, 9V=1:345, 14=1:35, 18C=1:31, 19A=1:18, 19F=1:48, 23F=1:13.
Outcome measures
| Measure |
7vPnC / 13vPnC
n=38 Participants
13vPnC administered as a single 0.5 mL dose IM. Participants had previously received 7vPnC in study D118-P8.
|
MnCC / 13vPnC
n=35 Participants
13vPnC administered as a single 0.5 mL dose IM. Participants had previously received MnCC in study D118-P8.
|
|---|---|---|
|
Percentage of Participants Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥LLOQ for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 4)
7vPnC serotype 4
|
97.4 observed percentage of participants
Interval 86.2 to 99.9
|
100.0 observed percentage of participants
Interval 89.7 to 100.0
|
|
Percentage of Participants Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥LLOQ for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 4)
7vPnC serotype 6B
|
100.0 observed percentage of participants
Interval 90.7 to 100.0
|
100.0 observed percentage of participants
Interval 89.4 to 100.0
|
|
Percentage of Participants Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥LLOQ for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 4)
7vPnC serotype 9V
|
100.0 observed percentage of participants
Interval 90.7 to 100.0
|
100.0 observed percentage of participants
Interval 89.7 to 100.0
|
|
Percentage of Participants Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥LLOQ for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 4)
7vPnC serotype 14
|
100.0 observed percentage of participants
Interval 90.5 to 100.0
|
100.0 observed percentage of participants
Interval 89.7 to 100.0
|
|
Percentage of Participants Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥LLOQ for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 4)
7vPnC serotype 18C
|
100.0 observed percentage of participants
Interval 90.5 to 100.0
|
100.0 observed percentage of participants
Interval 90.0 to 100.0
|
|
Percentage of Participants Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥LLOQ for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 4)
7vPnC serotype 19F
|
94.3 observed percentage of participants
Interval 80.8 to 99.3
|
97.1 observed percentage of participants
Interval 84.7 to 99.9
|
|
Percentage of Participants Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥LLOQ for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 4)
7vPnC serotype 23F
|
97.3 observed percentage of participants
Interval 85.8 to 99.9
|
94.3 observed percentage of participants
Interval 80.8 to 99.3
|
|
Percentage of Participants Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥LLOQ for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 4)
Additional serotype 1
|
100.0 observed percentage of participants
Interval 90.5 to 100.0
|
97.1 observed percentage of participants
Interval 85.1 to 99.9
|
|
Percentage of Participants Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥LLOQ for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 4)
Additional serotype 3
|
97.4 observed percentage of participants
Interval 86.2 to 99.9
|
100.0 observed percentage of participants
Interval 89.7 to 100.0
|
|
Percentage of Participants Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥LLOQ for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 4)
Additional serotype 5
|
89.5 observed percentage of participants
Interval 75.2 to 97.1
|
88.2 observed percentage of participants
Interval 72.5 to 96.7
|
|
Percentage of Participants Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥LLOQ for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 4)
Additional serotype 6A
|
100.0 observed percentage of participants
Interval 90.7 to 100.0
|
100.0 observed percentage of participants
Interval 90.0 to 100.0
|
|
Percentage of Participants Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥LLOQ for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 4)
Additional serotype 7F
|
100.0 observed percentage of participants
Interval 90.5 to 100.0
|
97.0 observed percentage of participants
Interval 84.2 to 99.9
|
|
Percentage of Participants Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥LLOQ for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 4)
Additional serotype 19A
|
97.4 observed percentage of participants
Interval 86.2 to 99.9
|
100.0 observed percentage of participants
Interval 90.0 to 100.0
|
PRIMARY outcome
Timeframe: Day 28 (Visit 5)Population: Evaluable Immunogenicity population; N=number of participants with a determinate OPA antibody titer to the serotypes.
Percentage of participants achieving predefined OPA antibody titer ≥1:8 for the 13 pneumococcal serotypes (7vPnC serotypes 4, 6B, 9V, 14, 18C, 19F, 23F and additional serotypes 1, 3, 5, 6A, 7F, and 19A) along with the exact, 2-sided 95% CIs based on the observed percentage of participants. The lowest titer that can be determined using the standard OPA assay is a titer of 1:8 limit of detection (LOD) and is the same for each serotype-specific OPA assay.
Outcome measures
| Measure |
7vPnC / 13vPnC
n=38 Participants
13vPnC administered as a single 0.5 mL dose IM. Participants had previously received 7vPnC in study D118-P8.
|
MnCC / 13vPnC
n=35 Participants
13vPnC administered as a single 0.5 mL dose IM. Participants had previously received MnCC in study D118-P8.
|
|---|---|---|
|
Percentage of Participants Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥1:8 for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 5)
7vPnC serotype 4
|
100.0 observed percentage of participants
Interval 90.3 to 100.0
|
100.0 observed percentage of participants
Interval 89.1 to 100.0
|
|
Percentage of Participants Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥1:8 for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 5)
7vPnC serotype 6B
|
100.0 observed percentage of participants
Interval 90.5 to 100.0
|
100.0 observed percentage of participants
Interval 90.0 to 100.0
|
|
Percentage of Participants Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥1:8 for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 5)
7vPnC serotype 9V
|
100.0 observed percentage of participants
Interval 90.7 to 100.0
|
100.0 observed percentage of participants
Interval 89.7 to 100.0
|
|
Percentage of Participants Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥1:8 for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 5)
7vPnC serotype 14
|
100.0 observed percentage of participants
Interval 90.7 to 100.0
|
100.0 observed percentage of participants
Interval 89.7 to 100.0
|
|
Percentage of Participants Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥1:8 for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 5)
7vPnC serotype 18C
|
100.0 observed percentage of participants
Interval 90.7 to 100.0
|
100.0 observed percentage of participants
Interval 90.0 to 100.0
|
|
Percentage of Participants Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥1:8 for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 5)
7vPnC serotype 19F
|
100.0 observed percentage of participants
Interval 90.7 to 100.0
|
100.0 observed percentage of participants
Interval 89.7 to 100.0
|
|
Percentage of Participants Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥1:8 for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 5)
7vPnC serotype 23F
|
100.0 observed percentage of participants
Interval 90.5 to 100.0
|
100.0 observed percentage of participants
Interval 90.0 to 100.0
|
|
Percentage of Participants Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥1:8 for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 5)
Additional serotype 1
|
100.0 observed percentage of participants
Interval 90.7 to 100.0
|
100.0 observed percentage of participants
Interval 89.7 to 100.0
|
|
Percentage of Participants Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥1:8 for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 5)
Additional serotype 3
|
100.0 observed percentage of participants
Interval 90.7 to 100.0
|
100.0 observed percentage of participants
Interval 90.0 to 100.0
|
|
Percentage of Participants Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥1:8 for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 5)
Additional serotype 5
|
97.4 observed percentage of participants
Interval 86.2 to 99.9
|
94.3 observed percentage of participants
Interval 80.8 to 99.3
|
|
Percentage of Participants Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥1:8 for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 5)
Additional serotype 6A
|
100.0 observed percentage of participants
Interval 90.7 to 100.0
|
100.0 observed percentage of participants
Interval 89.7 to 100.0
|
|
Percentage of Participants Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥1:8 for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 5)
Additional serotype 7F
|
100.0 observed percentage of participants
Interval 90.5 to 100.0
|
100.0 observed percentage of participants
Interval 90.0 to 100.0
|
|
Percentage of Participants Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥1:8 for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 5)
Additional serotype 19A
|
100.0 observed percentage of participants
Interval 90.7 to 100.0
|
100.0 observed percentage of participants
Interval 90.0 to 100.0
|
PRIMARY outcome
Timeframe: Day 7 (Visit 4)Population: Evaluable Immunogenicity population; N=number of participants with a determinate OPA antibody titer to the serotypes.
Percentage of participants achieving predefined OPA antibody titer ≥1:8 for the 13 pneumococcal serotypes (7vPnC serotypes 4, 6B, 9V, 14, 18C, 19F, 23F and additional serotypes 1, 3, 5, 6A, 7F, and 19A) along with the exact, 2-sided 95% CIs based on the observed percentage of participants. The lowest titer that can be determined using the standard OPA assay is a titer of 1:8 limit of detection (LOD) and is the same for each serotype-specific OPA assay.
Outcome measures
| Measure |
7vPnC / 13vPnC
n=38 Participants
13vPnC administered as a single 0.5 mL dose IM. Participants had previously received 7vPnC in study D118-P8.
|
MnCC / 13vPnC
n=35 Participants
13vPnC administered as a single 0.5 mL dose IM. Participants had previously received MnCC in study D118-P8.
|
|---|---|---|
|
Percentage of Participants Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥1:8 for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 4)
Additional serotype 7F
|
100.0 observed percentage of participants
Interval 90.5 to 100.0
|
100.0 observed percentage of participants
Interval 89.4 to 100.0
|
|
Percentage of Participants Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥1:8 for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 4)
7vPnC serotype 4
|
97.4 observed percentage of participants
Interval 86.2 to 99.9
|
100.0 observed percentage of participants
Interval 89.7 to 100.0
|
|
Percentage of Participants Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥1:8 for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 4)
7vPnC serotype 6B
|
100.0 observed percentage of participants
Interval 90.7 to 100.0
|
100.0 observed percentage of participants
Interval 89.4 to 100.0
|
|
Percentage of Participants Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥1:8 for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 4)
7vPnC serotype 9V
|
100.0 observed percentage of participants
Interval 90.7 to 100.0
|
100.0 observed percentage of participants
Interval 89.7 to 100.0
|
|
Percentage of Participants Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥1:8 for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 4)
7vPnC serotype 14
|
100.0 observed percentage of participants
Interval 90.5 to 100.0
|
100.0 observed percentage of participants
Interval 89.7 to 100.0
|
|
Percentage of Participants Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥1:8 for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 4)
7vPnC serotype 18C
|
100.0 observed percentage of participants
Interval 90.5 to 100.0
|
100.0 observed percentage of participants
Interval 90.0 to 100.0
|
|
Percentage of Participants Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥1:8 for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 4)
7vPnC serotype 19F
|
100.0 observed percentage of participants
Interval 90.0 to 100.0
|
100.0 observed percentage of participants
Interval 89.7 to 100.0
|
|
Percentage of Participants Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥1:8 for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 4)
7vPnC serotype 23F
|
97.3 observed percentage of participants
Interval 85.8 to 99.9
|
94.3 observed percentage of participants
Interval 80.8 to 99.3
|
|
Percentage of Participants Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥1:8 for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 4)
Additional serotype 1
|
100.0 observed percentage of participants
Interval 90.5 to 100.0
|
100.0 observed percentage of participants
Interval 90.0 to 100.0
|
|
Percentage of Participants Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥1:8 for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 4)
Additional serotype 19A
|
100.0 observed percentage of participants
Interval 90.7 to 100.0
|
100.0 observed percentage of participants
Interval 90.0 to 100.0
|
|
Percentage of Participants Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥1:8 for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 4)
Additional serotype 3
|
100.0 observed percentage of participants
Interval 90.7 to 100.0
|
100.0 observed percentage of participants
Interval 89.7 to 100.0
|
|
Percentage of Participants Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥1:8 for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 4)
Additional serotype 5
|
97.4 observed percentage of participants
Interval 86.2 to 99.9
|
94.1 observed percentage of participants
Interval 80.3 to 99.3
|
|
Percentage of Participants Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥1:8 for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 4)
Additional serotype 6A
|
100.0 observed percentage of participants
Interval 90.7 to 100.0
|
100.0 observed percentage of participants
Interval 90.0 to 100.0
|
SECONDARY outcome
Timeframe: Baseline (Visit 1), Day 28 (Visit 5)Population: Evaluable Immunogenicity population. GMCs calculated using all participants with available data at both the prevaccination and postvaccination blood draws.
Pneumococcal IgG GMCs measured as Mcg/mL for the 13 pneumococcal serotypes (7vPnC serotypes 4, 6B, 9V, 14, 18C, 19F, 23F and additional serotypes 1, 3, 5, 6A, 7F, and 19A). The 2-sided, 95% CIs for the GMCs were constructed by back transformation of the CIs for the mean of the logarithmically transformed assay results computed using the Student t distribution.
Outcome measures
| Measure |
7vPnC / 13vPnC
n=38 Participants
13vPnC administered as a single 0.5 mL dose IM. Participants had previously received 7vPnC in study D118-P8.
|
MnCC / 13vPnC
n=38 Participants
13vPnC administered as a single 0.5 mL dose IM. Participants had previously received MnCC in study D118-P8.
|
|---|---|---|
|
Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5
7vPnC serotype 9V
|
1.54 Mcg/mL
Interval 1.19 to 2.0
|
8.62 Mcg/mL
Interval 6.55 to 11.34
|
|
Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5
7vPnC serotype 14
|
0.58 Mcg/mL
Interval 0.39 to 0.86
|
41.45 Mcg/mL
Interval 27.72 to 61.97
|
|
Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5
7vPnC serotype 18C
|
0.75 Mcg/mL
Interval 0.48 to 1.18
|
5.93 Mcg/mL
Interval 4.34 to 8.11
|
|
Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5
7vPnC serotype 19F
|
2.94 Mcg/mL
Interval 2.08 to 4.15
|
13.41 Mcg/mL
Interval 8.89 to 20.23
|
|
Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5
7vPnC serotype 23F
|
2.51 Mcg/mL
Interval 1.92 to 3.27
|
17.20 Mcg/mL
Interval 12.44 to 23.77
|
|
Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5
Additional serotype 3
|
1.30 Mcg/mL
Interval 0.83 to 2.04
|
2.19 Mcg/mL
Interval 1.6 to 2.99
|
|
Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5
Additional serotype 5
|
3.24 Mcg/mL
Interval 2.45 to 4.27
|
6.80 Mcg/mL
Interval 4.75 to 9.74
|
|
Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5
7vPnC serotype 4
|
0.20 Mcg/mL
Interval 0.12 to 0.33
|
5.96 Mcg/mL
Interval 4.1 to 8.65
|
|
Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5
7vPnC serotype 6B
|
5.89 Mcg/mL
Interval 4.61 to 7.51
|
66.72 Mcg/mL
Interval 50.19 to 88.7
|
|
Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5
Additional serotype 1
|
1.04 Mcg/mL
Interval 0.71 to 1.54
|
11.59 Mcg/mL
Interval 7.34 to 18.3
|
|
Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5
Additional serotype 6A
|
3.78 Mcg/mL
Interval 2.85 to 5.03
|
29.11 Mcg/mL
Interval 19.04 to 44.5
|
|
Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5
Additional serotype 7F
|
1.38 Mcg/mL
Interval 0.93 to 2.05
|
9.92 Mcg/mL
Interval 7.03 to 14.01
|
|
Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5
Additional serotype 19A
|
7.05 Mcg/mL
Interval 5.52 to 8.99
|
21.29 Mcg/mL
Interval 14.9 to 30.43
|
SECONDARY outcome
Timeframe: Baseline (Visit 1), Day 28 (Visit 5)Population: Evaluable Immunogenicity population; GMCs calculated using all participants with available data at both the prevaccination and postvaccination blood draws.
Pneumococcal IgG GMCs measured as Mcg/mL for the 13 pneumococcal serotypes (7vPnC serotypes 4, 6B, 9V, 14, 18C, 19F, 23F and additional serotypes 1, 3, 5, 6A, 7F, and 19A). The 2-sided, 95% CIs for the GMCs were constructed by back transformation of the CIs for the mean of the logarithmically transformed assay results computed using the Student t distribution.
Outcome measures
| Measure |
7vPnC / 13vPnC
n=35 Participants
13vPnC administered as a single 0.5 mL dose IM. Participants had previously received 7vPnC in study D118-P8.
|
MnCC / 13vPnC
n=35 Participants
13vPnC administered as a single 0.5 mL dose IM. Participants had previously received MnCC in study D118-P8.
|
|---|---|---|
|
Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5
Additional serotype 1
|
0.70 Mcg/mL
Interval 0.43 to 1.15
|
5.30 Mcg/mL
Interval 3.4 to 8.26
|
|
Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5
Additional serotype 5
|
3.83 Mcg/mL
Interval 2.77 to 5.31
|
7.39 Mcg/mL
Interval 4.98 to 10.96
|
|
Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5
Additional serotype 6A
|
3.82 Mcg/mL
Interval 2.79 to 5.23
|
17.05 Mcg/mL
Interval 10.82 to 26.87
|
|
Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5
Additional serotype 19A
|
6.18 Mcg/mL
Interval 4.57 to 8.35
|
20.17 Mcg/mL
Interval 15.28 to 26.63
|
|
Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5
7vPnC serotype 4
|
0.15 Mcg/mL
Interval 0.07 to 0.29
|
2.86 Mcg/mL
Interval 2.0 to 4.07
|
|
Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5
7vPnC serotype 6B
|
3.97 Mcg/mL
Interval 2.78 to 5.67
|
22.62 Mcg/mL
Interval 14.56 to 35.16
|
|
Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5
7vPnC serotype 9V
|
1.69 Mcg/mL
Interval 1.2 to 2.38
|
4.70 Mcg/mL
Interval 3.49 to 6.33
|
|
Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5
7vPnC serotype 14
|
0.79 Mcg/mL
Interval 0.43 to 1.43
|
18.50 Mcg/mL
Interval 10.1 to 33.9
|
|
Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5
7vPnC serotype 18C
|
0.72 Mcg/mL
Interval 0.46 to 1.13
|
9.79 Mcg/mL
Interval 6.43 to 14.9
|
|
Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5
7vPnC serotype 19F
|
2.01 Mcg/mL
Interval 1.32 to 3.05
|
18.02 Mcg/mL
Interval 11.56 to 28.08
|
|
Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5
7vPnC serotype 23F
|
2.31 Mcg/mL
Interval 1.7 to 3.14
|
20.80 Mcg/mL
Interval 13.07 to 33.08
|
|
Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5
Additional serotype 3
|
1.16 Mcg/mL
Interval 0.73 to 1.86
|
1.81 Mcg/mL
Interval 1.25 to 2.62
|
|
Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5
Additional serotype 7F
|
1.12 Mcg/mL
Interval 0.73 to 1.72
|
5.94 Mcg/mL
Interval 4.08 to 8.65
|
SECONDARY outcome
Timeframe: Baseline (Visit 1), Day 7 (Visit 4)Population: Evaluable Immunogenicity population; GMCs calculated using all participants with available data at both the prevaccination and postvaccination blood draws.
Pneumococcal IgG GMCs measured as Mcg/mL for the 13 pneumococcal serotypes (7vPnC serotypes 4, 6B, 9V, 14, 18C, 19F, 23F and additional serotypes 1, 3, 5, 6A, 7F, and 19A). The 2-sided, 95% CIs for the GMCs were constructed by back transformation of the CIs for the mean of the logarithmically transformed assay results computed using the Student t distribution.
Outcome measures
| Measure |
7vPnC / 13vPnC
n=38 Participants
13vPnC administered as a single 0.5 mL dose IM. Participants had previously received 7vPnC in study D118-P8.
|
MnCC / 13vPnC
n=38 Participants
13vPnC administered as a single 0.5 mL dose IM. Participants had previously received MnCC in study D118-P8.
|
|---|---|---|
|
Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4
7vPnC serotype 4
|
0.20 Mcg/mL
Interval 0.12 to 0.33
|
3.21 Mcg/mL
Interval 2.1 to 4.9
|
|
Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4
7vPnC serotype 6B
|
5.89 Mcg/mL
Interval 4.61 to 7.51
|
29.46 Mcg/mL
Interval 20.74 to 41.86
|
|
Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4
7vPnC serotype 9V
|
1.54 Mcg/mL
Interval 1.19 to 2.0
|
5.96 Mcg/mL
Interval 4.57 to 7.76
|
|
Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4
7vPnC serotype 14
|
0.58 Mcg/mL
Interval 0.39 to 0.86
|
10.25 Mcg/mL
Interval 6.85 to 15.33
|
|
Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4
7vPnC serotype 18C
|
0.75 Mcg/mL
Interval 0.48 to 1.18
|
3.17 Mcg/mL
Interval 2.26 to 4.42
|
|
Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4
7vPnC serotype 19F
|
2.94 Mcg/mL
Interval 2.08 to 4.15
|
7.46 Mcg/mL
Interval 5.43 to 10.25
|
|
Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4
7vPnC serotype 23F
|
2.51 Mcg/mL
Interval 1.92 to 3.27
|
10.56 Mcg/mL
Interval 7.69 to 14.51
|
|
Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4
Additional serotype 1
|
1.04 Mcg/mL
Interval 0.71 to 1.54
|
4.42 Mcg/mL
Interval 2.93 to 6.67
|
|
Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4
Additional serotype 3
|
1.30 Mcg/mL
Interval 0.83 to 2.04
|
2.12 Mcg/mL
Interval 1.54 to 2.92
|
|
Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4
Additional serotype 5
|
3.24 Mcg/mL
Interval 2.45 to 4.27
|
5.40 Mcg/mL
Interval 4.08 to 7.15
|
|
Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4
Additional serotype 6A
|
3.78 Mcg/mL
Interval 2.85 to 5.03
|
13.60 Mcg/mL
Interval 9.01 to 20.53
|
|
Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4
Additional serotype 7F
|
1.38 Mcg/mL
Interval 0.93 to 2.05
|
4.70 Mcg/mL
Interval 3.26 to 6.78
|
|
Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4
Additional serotype 19A
|
7.05 Mcg/mL
Interval 5.52 to 8.99
|
13.40 Mcg/mL
Interval 10.3 to 17.42
|
SECONDARY outcome
Timeframe: Baseline (Visit 1), Day 7 (Visit 4)Population: Evaluable Immunogenicity population; GMCs calculated using all participants with available data at both the prevaccination and postvaccination blood draws. N=number of participants with valid and determinate assay results for both the prevaccination and postvaccination blood draw.
Pneumococcal IgG GMCs measured as Mcg/mL for the 13 pneumococcal serotypes (7vPnC serotypes 4, 6B, 9V, 14, 18C, 19F, 23F and additional serotypes 1, 3, 5, 6A, 7F, and 19A). The 2-sided, 95% CIs for the GMCs were constructed by back transformation of the CIs for the mean of the logarithmically transformed assay results computed using the Student t distribution.
Outcome measures
| Measure |
7vPnC / 13vPnC
n=35 Participants
13vPnC administered as a single 0.5 mL dose IM. Participants had previously received 7vPnC in study D118-P8.
|
MnCC / 13vPnC
n=35 Participants
13vPnC administered as a single 0.5 mL dose IM. Participants had previously received MnCC in study D118-P8.
|
|---|---|---|
|
Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4
7vPnC serotype 4
|
0.15 Mcg/mL
Interval 0.07 to 0.29
|
1.21 Mcg/mL
Interval 0.7 to 2.11
|
|
Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4
7vPnC serotype 6B
|
3.97 Mcg/mL
Interval 2.78 to 5.67
|
9.42 Mcg/mL
Interval 6.23 to 14.24
|
|
Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4
7vPnC serotype 9V
|
1.69 Mcg/mL
Interval 1.2 to 2.38
|
3.41 Mcg/mL
Interval 2.51 to 4.65
|
|
Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4
7vPnC serotype 14
|
0.79 Mcg/mL
Interval 0.43 to 1.43
|
5.22 Mcg/mL
Interval 2.76 to 9.86
|
|
Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4
7vPnC serotype 18C
|
0.72 Mcg/mL
Interval 0.46 to 1.13
|
3.53 Mcg/mL
Interval 2.16 to 5.76
|
|
Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4
7vPnC serotype 19F
|
2.01 Mcg/mL
Interval 1.32 to 3.05
|
5.47 Mcg/mL
Interval 3.51 to 8.54
|
|
Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4
7vPnC serotype 23F
|
2.31 Mcg/mL
Interval 1.7 to 3.14
|
6.51 Mcg/mL
Interval 4.24 to 10.01
|
|
Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4
Additional serotype 1
|
0.70 Mcg/mL
Interval 0.43 to 1.15
|
2.65 Mcg/mL
Interval 1.75 to 4.0
|
|
Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4
Additional serotype 3
|
1.11 Mcg/mL
Interval 0.67 to 1.82
|
1.46 Mcg/mL
Interval 0.97 to 2.2
|
|
Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4
Additional serotype 5
|
3.83 Mcg/mL
Interval 2.77 to 5.31
|
5.00 Mcg/mL
Interval 3.49 to 7.15
|
|
Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4
Additional serotype 6A
|
3.82 Mcg/mL
Interval 2.79 to 5.23
|
7.79 Mcg/mL
Interval 5.17 to 11.72
|
|
Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4
Additional serotype 7F
|
1.12 Mcg/mL
Interval 0.73 to 1.72
|
3.21 Mcg/mL
Interval 2.25 to 4.59
|
|
Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4
Additional serotype 19A
|
6.18 Mcg/mL
Interval 4.57 to 8.35
|
12.03 Mcg/mL
Interval 8.83 to 16.39
|
SECONDARY outcome
Timeframe: Baseline (Visit 1), Day 28 (Visit 5)Population: Evaluable Immunogenicity population; GMTs calculated using all participants with available data at both the prevaccination and postvaccination blood draws.
Antibody geometric mean titers as measured by opsonophagocytic activity (OPA) assay for 13 pneumococcal serotypes (7vPnC serotypes 4, 6B, 9V, 14, 18C, 19F, 23F and additional serotypes 1, 3, 5, 6A, 7F, and 19A). The 2-sided, 95% CIs for the GMTs were constructed by back transformation of the CIs for the mean of the logarithmically transformed assay results computed using the Student t distribution.
Outcome measures
| Measure |
7vPnC / 13vPnC
n=38 Participants
13vPnC administered as a single 0.5 mL dose IM. Participants had previously received 7vPnC in study D118-P8.
|
MnCC / 13vPnC
n=38 Participants
13vPnC administered as a single 0.5 mL dose IM. Participants had previously received MnCC in study D118-P8.
|
|---|---|---|
|
Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5
7vPnC serotype 4
|
22 Titer
Interval 6.3 to 80.7
|
4535 Titer
Interval 2836.5 to 7251.3
|
|
Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5
7vPnC serotype 6B
|
1024 Titer
Interval 488.4 to 2148.4
|
11939 Titer
Interval 8748.1 to 16293.9
|
|
Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5
7vPnC serotype 9V
|
43 Titer
Interval 13.4 to 137.3
|
6709 Titer
Interval 5097.5 to 8829.4
|
|
Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5
7vPnC serotype 14
|
159 Titer
Interval 63.7 to 396.0
|
5946 Titer
Interval 4361.1 to 8107.6
|
|
Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5
7vPnC serotype 18C
|
54 Titer
Interval 19.5 to 149.5
|
5067 Titer
Interval 3375.1 to 7607.2
|
|
Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5
7vPnC serotype 19F
|
33 Titer
Interval 15.1 to 73.3
|
1623 Titer
Interval 995.2 to 2647.9
|
|
Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5
7vPnC serotype 23F
|
87 Titer
Interval 34.1 to 223.4
|
2799 Titer
Interval 2048.5 to 3823.2
|
|
Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5
Additional serotype 1
|
6 Titer
Interval 4.3 to 7.4
|
440 Titer
Interval 301.8 to 641.2
|
|
Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5
Additional serotype 3
|
11 Titer
Interval 6.9 to 16.6
|
111 Titer
Interval 87.1 to 141.1
|
|
Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5
Additional serotype 5
|
4 Titer
Interval 3.6 to 5.6
|
277 Titer
Interval 145.2 to 526.4
|
|
Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5
Additional serotype 6A
|
17 Titer
Interval 7.1 to 39.7
|
9029 Titer
Interval 6255.0 to 13034.0
|
|
Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5
Additional serotype 7F
|
60 Titer
Interval 17.7 to 205.3
|
7036 Titer
Interval 4886.0 to 10131.8
|
|
Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5
Additional serotype 19A
|
76 Titer
Interval 36.7 to 157.5
|
1869 Titer
Interval 1099.8 to 3177.3
|
SECONDARY outcome
Timeframe: Baseline (Visit 1), Day 28 (Visit 5)Population: Evaluable Immunogenicity population; GMTs calculated using all participants with available data at both the prevaccination and postvaccination blood draws. N=number of participants with valid and determinate assay results for both the prevaccination and postvaccination blood draw.
Antibody geometric mean titers as measured by opsonophagocytic activity (OPA) assay for 13 pneumococcal serotypes (7vPnC serotypes 4, 6B, 9V, 14, 18C, 19F, 23F and additional serotypes 1, 3, 5, 6A, 7F, and 19A). The 2-sided, 95% CIs for the GMTs were constructed by back transformation of the CIs for the mean of the logarithmically transformed assay results computed using the Student t distribution.
Outcome measures
| Measure |
7vPnC / 13vPnC
n=35 Participants
13vPnC administered as a single 0.5 mL dose IM. Participants had previously received 7vPnC in study D118-P8.
|
MnCC / 13vPnC
n=35 Participants
13vPnC administered as a single 0.5 mL dose IM. Participants had previously received MnCC in study D118-P8.
|
|---|---|---|
|
Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5
7vPnC serotype 4
|
28 Titer
Interval 4.5 to 174.3
|
4704 Titer
Interval 2958.0 to 7481.1
|
|
Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5
7vPnC serotype 6B
|
288 Titer
Interval 74.8 to 1106.9
|
11607 Titer
Interval 7762.6 to 17354.1
|
|
Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5
7vPnC serotype 9V
|
120 Titer
Interval 37.9 to 382.8
|
7457 Titer
Interval 5702.3 to 9751.9
|
|
Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5
7vPnC serotype 14
|
262 Titer
Interval 98.1 to 700.5
|
7006 Titer
Interval 4997.7 to 9822.1
|
|
Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5
7vPnC serotype 18C
|
25 Titer
Interval 8.4 to 75.7
|
5736 Titer
Interval 4141.4 to 7943.8
|
|
Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5
7vPnC serotype 19F
|
23 Titer
Interval 10.5 to 50.6
|
2696 Titer
Interval 1831.0 to 3968.5
|
|
Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5
7vPnC serotype 23F
|
11 Titer
Interval 5.0 to 23.5
|
5197 Titer
Interval 3599.2 to 7503.1
|
|
Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5
Additional serotype 1
|
5 Titer
Interval 4.0 to 6.6
|
341 Titer
Interval 221.9 to 524.9
|
|
Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5
Additional serotype 3
|
11 Titer
Interval 7.0 to 18.2
|
98 Titer
Interval 75.2 to 126.9
|
|
Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5
Additional serotype 5
|
4 Titer
Interval 3.7 to 5.0
|
336 Titer
Interval 175.4 to 642.2
|
|
Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5
Additional serotype 6A
|
24 Titer
Interval 8.9 to 64.2
|
10488 Titer
Interval 7460.6 to 14744.7
|
|
Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5
Additional serotype 7F
|
76 Titer
Interval 21.1 to 275.2
|
6098 Titer
Interval 4392.9 to 8464.9
|
|
Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5
Additional serotype 19A
|
39 Titer
Interval 19.9 to 78.1
|
2424 Titer
Interval 1696.6 to 3462.4
|
SECONDARY outcome
Timeframe: Baseline (Visit 1), Day 7 (Visit 4)Population: Evaluable Immunogenicity population; GMTs calculated using all participants with available data at both the prevaccination and postvaccination blood draws. N=number of participants with valid and determinate assay results for both the prevaccination and postvaccination blood draw.
Antibody geometric mean titers as measured by opsonophagocytic activity (OPA) assay for 13 pneumococcal serotypes (7vPnC serotypes 4, 6B, 9V, 14, 18C, 19F, 23F and additional serotypes 1, 3, 5, 6A, 7F, and 19A). The 2-sided, 95% CIs for the GMTs were constructed by back transformation of the CIs for the mean of the logarithmically transformed assay results computed using the Student t distribution.
Outcome measures
| Measure |
7vPnC / 13vPnC
n=37 Participants
13vPnC administered as a single 0.5 mL dose IM. Participants had previously received 7vPnC in study D118-P8.
|
MnCC / 13vPnC
n=37 Participants
13vPnC administered as a single 0.5 mL dose IM. Participants had previously received MnCC in study D118-P8.
|
|---|---|---|
|
Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4
Additional serotype 7F
|
60 Titer
Interval 17.7 to 205.3
|
4601 Titer
Interval 2998.3 to 7060.6
|
|
Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4
Additional serotype 5
|
4 Titer
Interval 3.6 to 5.6
|
185 Titer
Interval 100.9 to 337.5
|
|
Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4
Additional serotype 6A
|
17 Titer
Interval 7.1 to 39.7
|
8072 Titer
Interval 5195.8 to 12538.8
|
|
Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4
Additional serotype 19A
|
76 Titer
Interval 36.7 to 157.5
|
1345 Titer
Interval 767.4 to 2357.7
|
|
Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4
7vPnC serotype 14
|
148 Titer
Interval 58.2 to 375.7
|
3497 Titer
Interval 2440.8 to 5009.1
|
|
Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4
7vPnC serotype 18C
|
58 Titer
Interval 20.6 to 163.8
|
5922 Titer
Interval 3784.0 to 9268.9
|
|
Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4
7vPnC serotype 19F
|
40 Titer
Interval 17.4 to 91.6
|
1243 Titer
Interval 620.6 to 2489.8
|
|
Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4
7vPnC serotype 4
|
19 Titer
Interval 6.0 to 62.8
|
5449 Titer
Interval 3118.6 to 9519.8
|
|
Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4
7vPnC serotype 6B
|
1034 Titer
Interval 505.1 to 2116.9
|
7885 Titer
Interval 5792.0 to 10734.0
|
|
Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4
7vPnC serotype 9V
|
43 Titer
Interval 13.4 to 137.3
|
6497 Titer
Interval 4357.4 to 9687.5
|
|
Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4
7vPnC serotype 23F
|
79 Titer
Interval 31.4 to 201.3
|
1487 Titer
Interval 884.7 to 2499.5
|
|
Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4
Additional serotype 1
|
6 Titer
Interval 4.3 to 7.6
|
367 Titer
Interval 228.8 to 587.3
|
|
Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4
Additional serotype 3
|
11 Titer
Interval 6.9 to 16.6
|
119 Titer
Interval 82.1 to 172.0
|
SECONDARY outcome
Timeframe: Baseline (Visit 1), Day 7 (Visit 4)Population: Evaluable Immunogenicity population; GMTs calculated using all participants with available data at both the prevaccination and postvaccination blood draws. N=number of participants with valid and determinate assay results for both the prevaccination and postvaccination blood draw.
Antibody geometric mean titers as measured by opsonophagocytic activity (OPA) assay for 13 pneumococcal serotypes (7vPnC serotypes 4, 6B, 9V, 14, 18C, 19F, 23F and additional serotypes 1, 3, 5, 6A, 7F, and 19A). The 2-sided, 95% CIs for the GMTs were constructed by back transformation of the CIs for the mean of the logarithmically transformed assay results computed using the Student t distribution.
Outcome measures
| Measure |
7vPnC / 13vPnC
n=34 Participants
13vPnC administered as a single 0.5 mL dose IM. Participants had previously received 7vPnC in study D118-P8.
|
MnCC / 13vPnC
n=34 Participants
13vPnC administered as a single 0.5 mL dose IM. Participants had previously received MnCC in study D118-P8.
|
|---|---|---|
|
Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4
7vPnC serotype 23F
|
11 Titer
Interval 5.0 to 23.5
|
991 Titer
Interval 501.3 to 1959.3
|
|
Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4
Additional serotype 1
|
5 Titer
Interval 4.0 to 6.5
|
385 Titer
Interval 249.4 to 595.6
|
|
Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4
Additional serotype 3
|
12 Titer
Interval 7.2 to 19.0
|
101 Titer
Interval 72.2 to 141.7
|
|
Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4
Additional serotype 7F
|
95 Titer
Interval 24.7 to 363.8
|
3577 Titer
Interval 1774.8 to 7208.2
|
|
Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4
7vPnC serotype 14
|
280 Titer
Interval 103.1 to 760.7
|
6209 Titer
Interval 4253.9 to 9063.3
|
|
Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4
7vPnC serotype 18C
|
25 Titer
Interval 8.4 to 75.7
|
5193 Titer
Interval 3658.1 to 7372.3
|
|
Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4
7vPnC serotype 4
|
40 Titer
Interval 6.3 to 254.0
|
6782 Titer
Interval 3687.6 to 12471.3
|
|
Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4
7vPnC serotype 6B
|
405 Titer
Interval 103.5 to 1584.7
|
7195 Titer
Interval 4585.5 to 11289.8
|
|
Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4
7vPnC serotype 9V
|
116 Titer
Interval 36.8 to 364.9
|
7855 Titer
Interval 5532.9 to 11152.1
|
|
Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4
Additional serotype 19A
|
39 Titer
Interval 19.9 to 78.1
|
1763 Titer
Interval 1220.1 to 2547.6
|
|
Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4
7vPnC serotype 19F
|
20 Titer
Interval 9.4 to 44.7
|
1855 Titer
Interval 1055.8 to 3258.2
|
|
Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4
Additional serotype 5
|
4 Titer
Interval 3.7 to 5.0
|
258 Titer
Interval 132.3 to 503.4
|
|
Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4
Additional serotype 6A
|
23 Titer
Interval 8.7 to 59.1
|
6107 Titer
Interval 4149.7 to 8987.5
|
SECONDARY outcome
Timeframe: Day 28 (Visit 5)Population: Evaluable Immunogenicity population; GMCs were calculated using all participants with available data for the specified blood draw. N=number of participants with a determinate OPA antibody concentration for the serotypes.
Pneumococcal IgG GMCs measured as Mcg/mL for the 13 pneumococcal serotypes (7vPnC serotypes 4, 6B, 9V, 14, 18C, 19F, 23F and additional serotypes 1, 3, 5, 6A, 7F, and 19A). The 2-sided, 95% CIs for the GMCs were constructed by back transformation of the CIs for the mean of the logarithmically transformed assay results computed using the Student t distribution.
Outcome measures
| Measure |
7vPnC / 13vPnC
n=38 Participants
13vPnC administered as a single 0.5 mL dose IM. Participants had previously received 7vPnC in study D118-P8.
|
MnCC / 13vPnC
n=35 Participants
13vPnC administered as a single 0.5 mL dose IM. Participants had previously received MnCC in study D118-P8.
|
|---|---|---|
|
Comparison of Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 5)
7vPnC serotype 4
|
5.73 Mcg/mL
Interval 4.21 to 7.81
|
2.92 Mcg/mL
Interval 2.22 to 3.83
|
|
Comparison of Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 5)
7vPnC serotype 6B
|
66.72 Mcg/mL
Interval 50.19 to 88.7
|
22.62 Mcg/mL
Interval 14.56 to 35.16
|
|
Comparison of Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 5)
7vPnC serotype 9V
|
8.72 Mcg/mL
Interval 6.68 to 11.4
|
4.70 Mcg/mL
Interval 3.49 to 6.33
|
|
Comparison of Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 5)
7vPnC serotype 18C
|
5.72 Mcg/mL
Interval 4.18 to 7.82
|
9.04 Mcg/mL
Interval 5.98 to 13.68
|
|
Comparison of Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 5)
7vPnC serotype 19F
|
14.17 Mcg/mL
Interval 9.54 to 21.07
|
15.80 Mcg/mL
Interval 10.0 to 24.96
|
|
Comparison of Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 5)
7vPnC serotype 23F
|
17.20 Mcg/mL
Interval 12.44 to 23.77
|
20.80 Mcg/mL
Interval 13.07 to 33.08
|
|
Comparison of Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 5)
Additional serotype 1
|
9.55 Mcg/mL
Interval 6.46 to 14.13
|
5.63 Mcg/mL
Interval 3.67 to 8.64
|
|
Comparison of Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 5)
Additional serotype 3
|
2.13 Mcg/mL
Interval 1.58 to 2.87
|
1.71 Mcg/mL
Interval 1.2 to 2.44
|
|
Comparison of Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 5)
Additional serotype 5
|
6.80 Mcg/mL
Interval 4.75 to 9.74
|
7.52 Mcg/mL
Interval 5.12 to 11.04
|
|
Comparison of Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 5)
Additional serotype 7F
|
9.92 Mcg/mL
Interval 7.03 to 14.01
|
5.75 Mcg/mL
Interval 3.98 to 8.33
|
|
Comparison of Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 5)
Additional serotype 19A
|
21.29 Mcg/mL
Interval 14.9 to 30.43
|
20.17 Mcg/mL
Interval 15.28 to 26.63
|
|
Comparison of Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 5)
7vPnC serotype 14
|
41.45 Mcg/mL
Interval 27.72 to 61.97
|
18.50 Mcg/mL
Interval 10.1 to 33.9
|
|
Comparison of Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 5)
Additional serotype 6A
|
29.11 Mcg/mL
Interval 19.04 to 44.5
|
16.08 Mcg/mL
Interval 10.18 to 25.4
|
SECONDARY outcome
Timeframe: Day 7 (Visit 4)Population: Evaluable Immunogenicity population; GMCs were calculated using all participants with available data for the specified blood draw. N=number of participants with a determinate OPA antibody concentration for the serotypes.
Pneumococcal IgG GMCs measured as Mcg/mL for the 13 pneumococcal serotypes (7vPnC serotypes 4, 6B, 9V, 14, 18C, 19F, 23F and additional serotypes 1, 3, 5, 6A, 7F, and 19A). The 2-sided, 95% CIs for the GMCs were constructed by back transformation of the CIs for the mean of the logarithmically transformed assay results computed using the Student t distribution.
Outcome measures
| Measure |
7vPnC / 13vPnC
n=38 Participants
13vPnC administered as a single 0.5 mL dose IM. Participants had previously received 7vPnC in study D118-P8.
|
MnCC / 13vPnC
n=35 Participants
13vPnC administered as a single 0.5 mL dose IM. Participants had previously received MnCC in study D118-P8.
|
|---|---|---|
|
Comparison of Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 4)
7vPnC serotype 4
|
3.00 Mcg/mL
Interval 2.07 to 4.35
|
1.37 Mcg/mL
Interval 0.9 to 2.1
|
|
Comparison of Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 4)
7vPnC serotype 6B
|
29.46 Mcg/mL
Interval 20.74 to 41.86
|
9.42 Mcg/mL
Interval 6.23 to 14.24
|
|
Comparison of Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 4)
7vPnC serotype 14
|
10.25 Mcg/mL
Interval 6.85 to 15.33
|
5.22 Mcg/mL
Interval 2.76 to 9.86
|
|
Comparison of Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 4)
7vPnC serotype 18C
|
3.09 Mcg/mL
Interval 2.22 to 4.29
|
3.45 Mcg/mL
Interval 2.16 to 5.52
|
|
Comparison of Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 4)
Additional serotype 5
|
5.40 Mcg/mL
Interval 4.08 to 7.15
|
5.12 Mcg/mL
Interval 3.6 to 7.28
|
|
Comparison of Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 4)
Additional serotype 6A
|
13.60 Mcg/mL
Interval 9.01 to 20.53
|
7.25 Mcg/mL
Interval 4.75 to 11.06
|
|
Comparison of Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 4)
Additional serotype 7F
|
4.70 Mcg/mL
Interval 3.26 to 6.78
|
3.17 Mcg/mL
Interval 2.24 to 4.48
|
|
Comparison of Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 4)
Additional serotype 19A
|
13.40 Mcg/mL
Interval 10.3 to 17.42
|
12.03 Mcg/mL
Interval 8.83 to 16.39
|
|
Comparison of Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 4)
7vPnC serotype 9V
|
5.75 Mcg/mL
Interval 4.4 to 7.51
|
3.41 Mcg/mL
Interval 2.51 to 4.65
|
|
Comparison of Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 4)
7vPnC serotype 19F
|
7.66 Mcg/mL
Interval 5.66 to 10.36
|
4.85 Mcg/mL
Interval 3.09 to 7.62
|
|
Comparison of Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 4)
7vPnC serotype 23F
|
10.56 Mcg/mL
Interval 7.69 to 14.51
|
6.51 Mcg/mL
Interval 4.24 to 10.01
|
|
Comparison of Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 4)
Additional serotype 1
|
3.98 Mcg/mL
Interval 2.82 to 5.62
|
2.83 Mcg/mL
Interval 1.86 to 4.32
|
|
Comparison of Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 4)
Additional serotype 3
|
2.02 Mcg/mL
Interval 1.48 to 2.76
|
1.40 Mcg/mL
Interval 0.95 to 2.06
|
SECONDARY outcome
Timeframe: Day 28 (Visit 5)Population: Evaluable Immunogenicity population; GMTs were calculated using all participants with available data for the specified blood draw. N=number of participants with a determinate OPA antibody titer for the serotypes.
Antibody geometric mean titers as measured by opsonophagocytic activity (OPA) assay for 13 pneumococcal serotypes (7vPnC serotypes 4, 6B, 9V, 14, 18C, 19F, 23F and additional serotypes 1, 3, 5, 6A, 7F, and 19A). The 2-sided, 95% CIs for the GMTs were constructed by back transformation of the CIs for the mean of the logarithmically transformed assay results computed using the Student t distribution.
Outcome measures
| Measure |
7vPnC / 13vPnC
n=38 Participants
13vPnC administered as a single 0.5 mL dose IM. Participants had previously received 7vPnC in study D118-P8.
|
MnCC / 13vPnC
n=35 Participants
13vPnC administered as a single 0.5 mL dose IM. Participants had previously received MnCC in study D118-P8.
|
|---|---|---|
|
Comparison of Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 5)
7vPnC serotype 23F
|
2752 Titer
Interval 2074.6 to 3651.3
|
4841 Titer
Interval 3574.5 to 6555.1
|
|
Comparison of Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 5)
Additional serotype 19A
|
2120 Titer
Interval 1308.0 to 3435.3
|
2340 Titer
Interval 1667.0 to 3285.4
|
|
Comparison of Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 5)
7vPnC serotype 4
|
4626 Titer
Interval 3322.5 to 6441.2
|
6065 Titer
Interval 4590.9 to 8012.5
|
|
Comparison of Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 5)
7vPnC serotype 6B
|
11451 Titer
Interval 8290.4 to 15817.9
|
10380 Titer
Interval 7515.2 to 14336.9
|
|
Comparison of Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 5)
7vPnC serotype 9V
|
6346 Titer
Interval 5152.2 to 7817.5
|
7555 Titer
Interval 5916.7 to 9646.8
|
|
Comparison of Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 5)
7vPnC serotype 14
|
5898 Titer
Interval 4481.0 to 7762.1
|
7031 Titer
Interval 5195.6 to 9515.5
|
|
Comparison of Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 5)
7vPnC serotype 18C
|
5090 Titer
Interval 3428.4 to 7557.7
|
6005 Titer
Interval 4389.3 to 8214.6
|
|
Comparison of Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 5)
7vPnC serotype 19F
|
1623 Titer
Interval 995.2 to 2647.9
|
2696 Titer
Interval 1831.0 to 3968.5
|
|
Comparison of Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 5)
Additional serotype 1
|
449 Titer
Interval 312.8 to 643.2
|
347 Titer
Interval 228.3 to 527.4
|
|
Comparison of Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 5)
Additional serotype 3
|
113 Titer
Interval 89.2 to 143.5
|
99 Titer
Interval 77.0 to 126.3
|
|
Comparison of Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 5)
Additional serotype 5
|
296 Titer
Interval 158.8 to 549.9
|
336 Titer
Interval 175.4 to 642.2
|
|
Comparison of Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 5)
Additional serotype 6A
|
9458 Titer
Interval 6674.2 to 13404.0
|
10842 Titer
Interval 7904.9 to 14870.9
|
|
Comparison of Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 5)
Additional serotype 7F
|
6740 Titer
Interval 4933.2 to 9207.7
|
6050 Titer
Interval 4515.0 to 8106.7
|
SECONDARY outcome
Timeframe: Day 7 (Visit 4)Population: Evaluable Immunogenicity population; GMTs were calculated using all participants with available data for the specified blood draw. N=number of participants with a determinate OPA antibody titer for the serotypes.
Antibody geometric mean titers as measured by opsonophagocytic activity (OPA) assay for 13 pneumococcal serotypes (7vPnC serotypes 4, 6B, 9V, 14, 18C, 19F, 23F and additional serotypes 1, 3, 5, 6A, 7F, and 19A). The 2-sided, 95% CIs for the GMTs were constructed by back transformation of the CIs for the mean of the logarithmically transformed assay results computed using the Student t distribution.
Outcome measures
| Measure |
7vPnC / 13vPnC
n=38 Participants
13vPnC administered as a single 0.5 mL dose IM. Participants had previously received 7vPnC in study D118-P8.
|
MnCC / 13vPnC
n=35 Participants
13vPnC administered as a single 0.5 mL dose IM. Participants had previously received MnCC in study D118-P8.
|
|---|---|---|
|
Comparison of Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 4)
7vPnC serotype 6B
|
8082 Titer
Interval 5743.5 to 11372.6
|
6450 Titer
Interval 4477.8 to 9290.2
|
|
Comparison of Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 4)
Additional serotype 5
|
200 Titer
Interval 111.2 to 358.6
|
258 Titer
Interval 132.3 to 503.4
|
|
Comparison of Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 4)
Additional serotype 7F
|
4750 Titer
Interval 3291.8 to 6852.9
|
3760 Titer
Interval 2106.7 to 6709.5
|
|
Comparison of Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 4)
Additional serotype 19A
|
1504 Titer
Interval 911.2 to 2484.1
|
1761 Titer
Interval 1242.8 to 2496.0
|
|
Comparison of Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 4)
7vPnC serotype 4
|
5567 Titer
Interval 3202.5 to 9678.7
|
8339 Titer
Interval 6154.1 to 11299.5
|
|
Comparison of Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 4)
7vPnC serotype 9V
|
6865 Titer
Interval 4826.7 to 9763.7
|
7806 Titer
Interval 5491.4 to 11095.6
|
|
Comparison of Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 4)
7vPnC serotype 14
|
3596 Titer
Interval 2613.0 to 4948.5
|
5994 Titer
Interval 4246.9 to 8460.1
|
|
Comparison of Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 4)
7vPnC serotype 18C
|
5833 Titer
Interval 3770.5 to 9023.7
|
5266 Titer
Interval 3779.3 to 7338.4
|
|
Comparison of Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 4)
7vPnC serotype 19F
|
1243 Titer
Interval 620.6 to 2489.8
|
1855 Titer
Interval 1055.8 to 3258.2
|
|
Comparison of Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 4)
7vPnC serotype 23F
|
1575 Titer
Interval 987.7 to 2511.7
|
1141 Titer
Interval 655.1 to 1986.8
|
|
Comparison of Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 4)
Additional serotype 1
|
379 Titer
Interval 241.8 to 594.9
|
393 Titer
Interval 257.2 to 600.3
|
|
Comparison of Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 4)
Additional serotype 3
|
117 Titer
Interval 81.3 to 167.5
|
104 Titer
Interval 75.4 to 143.4
|
|
Comparison of Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 4)
Additional serotype 6A
|
8534 Titer
Interval 5631.9 to 12931.6
|
6199 Titer
Interval 4357.6 to 8818.6
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline up to 4 days after vaccination on Day 1Population: Safety population included all participants who received the vaccine. N=number of participants with analyzable data for reactogenicity events (reported Yes for at least 1 day or No for all days).
Local reactions reported using the diary card during the 4-day reactogenicity period after vaccination. Tenderness at injection site scaled as Any (tenderness present) or Significant (present and interfered with limb movement). Redness and swelling at injection site scaled as Any (redness or swelling present); Mild (0.5 centimeters \[cm\] to 2.0 cm); Moderate (2.5 to 7.0 cm); or Severe (\> 7.0 cm). Participants may be represented in \>1 category.
Outcome measures
| Measure |
7vPnC / 13vPnC
n=38 Participants
13vPnC administered as a single 0.5 mL dose IM. Participants had previously received 7vPnC in study D118-P8.
|
MnCC / 13vPnC
n=36 Participants
13vPnC administered as a single 0.5 mL dose IM. Participants had previously received MnCC in study D118-P8.
|
|---|---|---|
|
Percentage of Participants Reporting Pre-specified Local Reactions Within 4 Days After Vaccination
Tenderness: Any
|
92.1 percentage of participants
|
86.1 percentage of participants
|
|
Percentage of Participants Reporting Pre-specified Local Reactions Within 4 Days After Vaccination
Tenderness: Significant
|
10.5 percentage of participants
|
19.4 percentage of participants
|
|
Percentage of Participants Reporting Pre-specified Local Reactions Within 4 Days After Vaccination
Swelling: Any
|
10.5 percentage of participants
|
5.6 percentage of participants
|
|
Percentage of Participants Reporting Pre-specified Local Reactions Within 4 Days After Vaccination
Swelling: Mild
|
2.6 percentage of participants
|
2.8 percentage of participants
|
|
Percentage of Participants Reporting Pre-specified Local Reactions Within 4 Days After Vaccination
Swelling: Moderate
|
10.5 percentage of participants
|
2.8 percentage of participants
|
|
Percentage of Participants Reporting Pre-specified Local Reactions Within 4 Days After Vaccination
Redness: Moderate
|
5.3 percentage of participants
|
2.8 percentage of participants
|
|
Percentage of Participants Reporting Pre-specified Local Reactions Within 4 Days After Vaccination
Redness: Any
|
5.3 percentage of participants
|
5.6 percentage of participants
|
|
Percentage of Participants Reporting Pre-specified Local Reactions Within 4 Days After Vaccination
Redness: Mild
|
0.0 percentage of participants
|
2.8 percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline up to 4 days after vaccination on Day 1Population: Safety population; N=number of participants with analyzable data for reactogenicity events (reported Yes for at least 1 day or No for all days).
Systemic events reported using the diary card during the 4-day reactogenicity period after vaccination. Temperature scaled as Fever ≥38 but ≤39 degrees Celsius (C) (mild), \>39 but ≤40 degrees C (moderate), or \>40 degrees C (severe). Presence of Decreased appetite, Irritability, Increased sleep, Decreased sleep, Rash, and Hives; also scaled as Mild (easily tolerated, minimal discomfort; not interfering with activities), Moderate (sufficiently discomforting to interfere with normal activities), or Severe (may prevent normal activities and require medical intervention).
Outcome measures
| Measure |
7vPnC / 13vPnC
n=38 Participants
13vPnC administered as a single 0.5 mL dose IM. Participants had previously received 7vPnC in study D118-P8.
|
MnCC / 13vPnC
n=36 Participants
13vPnC administered as a single 0.5 mL dose IM. Participants had previously received MnCC in study D118-P8.
|
|---|---|---|
|
Percentage of Participants Reporting Pre-specified Systemic Events Within 4 Days After Vaccination
Fever ≥38 but ≤39 degrees C
|
2.9 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants Reporting Pre-specified Systemic Events Within 4 Days After Vaccination
Decreased appetite
|
7.9 percentage of participants
|
16.7 percentage of participants
|
|
Percentage of Participants Reporting Pre-specified Systemic Events Within 4 Days After Vaccination
Decreased appetite: Mild
|
7.9 percentage of participants
|
11.1 percentage of participants
|
|
Percentage of Participants Reporting Pre-specified Systemic Events Within 4 Days After Vaccination
Decreased appetite: Moderate
|
2.6 percentage of participants
|
8.3 percentage of participants
|
|
Percentage of Participants Reporting Pre-specified Systemic Events Within 4 Days After Vaccination
Irritability
|
18.4 percentage of participants
|
13.9 percentage of participants
|
|
Percentage of Participants Reporting Pre-specified Systemic Events Within 4 Days After Vaccination
Irritability: Mild
|
13.2 percentage of participants
|
11.1 percentage of participants
|
|
Percentage of Participants Reporting Pre-specified Systemic Events Within 4 Days After Vaccination
Irritability: Moderate
|
5.3 percentage of participants
|
5.6 percentage of participants
|
|
Percentage of Participants Reporting Pre-specified Systemic Events Within 4 Days After Vaccination
Increased sleep: Severe
|
2.6 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants Reporting Pre-specified Systemic Events Within 4 Days After Vaccination
Decreased sleep
|
7.9 percentage of participants
|
11.1 percentage of participants
|
|
Percentage of Participants Reporting Pre-specified Systemic Events Within 4 Days After Vaccination
Decreased sleep: Mild
|
5.3 percentage of participants
|
8.3 percentage of participants
|
|
Percentage of Participants Reporting Pre-specified Systemic Events Within 4 Days After Vaccination
Decreased sleep: Moderate
|
2.6 percentage of participants
|
2.8 percentage of participants
|
|
Percentage of Participants Reporting Pre-specified Systemic Events Within 4 Days After Vaccination
Rash
|
5.3 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants Reporting Pre-specified Systemic Events Within 4 Days After Vaccination
Rash: Mild
|
5.3 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants Reporting Pre-specified Systemic Events Within 4 Days After Vaccination
Increased sleep
|
26.3 percentage of participants
|
33.3 percentage of participants
|
|
Percentage of Participants Reporting Pre-specified Systemic Events Within 4 Days After Vaccination
Increased sleep: Mild
|
15.8 percentage of participants
|
25.0 percentage of participants
|
|
Percentage of Participants Reporting Pre-specified Systemic Events Within 4 Days After Vaccination
Increased sleep: Moderate
|
13.2 percentage of participants
|
13.9 percentage of participants
|
Adverse Events
7vPnC / 13vPnC
Serious events: 0 serious events
Other events: 38 other events
Deaths: 0 deaths
MnCC / 13vPnC
Serious events: 0 serious events
Other events: 36 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
7vPnC / 13vPnC
n=38 participants at risk
13vPnC administered as a single 0.5 mL dose IM. Participants had previously received 7vPnC in study D118-P8.
Adverse Events include Local reactions and Systemic events collected on the diary card and reported in the diary-related case report form (systematic assessment) and other Adverse Events collected on the case report form (non-systematic methods).
Other Adverse Events N=22; Local reactions N=38; Systemic events N=38.
|
MnCC / 13vPnC
n=36 participants at risk
13vPnC administered as a single 0.5 mL dose IM. Participants had previously received MnCC in study D118-P8.
Adverse Events include Local reactions and Systemic events collected on the diary card and reported in the diary-related case report form (systematic assessment) and other Adverse Events collected on the case report form (non-systematic methods).
Other Adverse Events N=20; Local reactions N=36; Systemic events N=36.
|
|---|---|---|
|
Blood and lymphatic system disorders
Lymphoid tissue hyperplasia
|
2.6%
1/38 • Baseline up to Day 4 after vaccination for local reactions and systemic events or up to Day 194 (Visit 6 / Days 166 to 194 Follow-up Telephone Visit to assess AEs)
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 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/36 • Baseline up to Day 4 after vaccination for local reactions and systemic events or up to Day 194 (Visit 6 / Days 166 to 194 Follow-up Telephone Visit to assess AEs)
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 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
|
|
Cardiac disorders
Palpitations
|
2.6%
1/38 • Baseline up to Day 4 after vaccination for local reactions and systemic events or up to Day 194 (Visit 6 / Days 166 to 194 Follow-up Telephone Visit to assess AEs)
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 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/36 • Baseline up to Day 4 after vaccination for local reactions and systemic events or up to Day 194 (Visit 6 / Days 166 to 194 Follow-up Telephone Visit to assess AEs)
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 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
|
|
Congenital, familial and genetic disorders
Congenital flat feet
|
0.00%
0/38 • Baseline up to Day 4 after vaccination for local reactions and systemic events or up to Day 194 (Visit 6 / Days 166 to 194 Follow-up Telephone Visit to assess AEs)
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 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
|
5.6%
2/36 • Baseline up to Day 4 after vaccination for local reactions and systemic events or up to Day 194 (Visit 6 / Days 166 to 194 Follow-up Telephone Visit to assess AEs)
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 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
|
|
Ear and labyrinth disorders
Cerumen impaction
|
0.00%
0/38 • Baseline up to Day 4 after vaccination for local reactions and systemic events or up to Day 194 (Visit 6 / Days 166 to 194 Follow-up Telephone Visit to assess AEs)
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 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
|
2.8%
1/36 • Baseline up to Day 4 after vaccination for local reactions and systemic events or up to Day 194 (Visit 6 / Days 166 to 194 Follow-up Telephone Visit to assess AEs)
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 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
|
|
Ear and labyrinth disorders
Ear congestion
|
2.6%
1/38 • Baseline up to Day 4 after vaccination for local reactions and systemic events or up to Day 194 (Visit 6 / Days 166 to 194 Follow-up Telephone Visit to assess AEs)
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 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/36 • Baseline up to Day 4 after vaccination for local reactions and systemic events or up to Day 194 (Visit 6 / Days 166 to 194 Follow-up Telephone Visit to assess AEs)
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 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
|
|
Ear and labyrinth disorders
Ear pain
|
2.6%
1/38 • Baseline up to Day 4 after vaccination for local reactions and systemic events or up to Day 194 (Visit 6 / Days 166 to 194 Follow-up Telephone Visit to assess AEs)
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 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/36 • Baseline up to Day 4 after vaccination for local reactions and systemic events or up to Day 194 (Visit 6 / Days 166 to 194 Follow-up Telephone Visit to assess AEs)
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 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Diarrhoea
|
2.6%
1/38 • Baseline up to Day 4 after vaccination for local reactions and systemic events or up to Day 194 (Visit 6 / Days 166 to 194 Follow-up Telephone Visit to assess AEs)
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 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/36 • Baseline up to Day 4 after vaccination for local reactions and systemic events or up to Day 194 (Visit 6 / Days 166 to 194 Follow-up Telephone Visit to assess AEs)
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 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Vomiting
|
2.6%
1/38 • Baseline up to Day 4 after vaccination for local reactions and systemic events or up to Day 194 (Visit 6 / Days 166 to 194 Follow-up Telephone Visit to assess AEs)
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 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/36 • Baseline up to Day 4 after vaccination for local reactions and systemic events or up to Day 194 (Visit 6 / Days 166 to 194 Follow-up Telephone Visit to assess AEs)
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 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Injection site pain
|
10.5%
4/38 • Baseline up to Day 4 after vaccination for local reactions and systemic events or up to Day 194 (Visit 6 / Days 166 to 194 Follow-up Telephone Visit to assess AEs)
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 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
|
11.1%
4/36 • Baseline up to Day 4 after vaccination for local reactions and systemic events or up to Day 194 (Visit 6 / Days 166 to 194 Follow-up Telephone Visit to assess AEs)
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 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Pyrexia
|
7.9%
3/38 • Baseline up to Day 4 after vaccination for local reactions and systemic events or up to Day 194 (Visit 6 / Days 166 to 194 Follow-up Telephone Visit to assess AEs)
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 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
|
2.8%
1/36 • Baseline up to Day 4 after vaccination for local reactions and systemic events or up to Day 194 (Visit 6 / Days 166 to 194 Follow-up Telephone Visit to assess AEs)
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 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Injection site swelling
|
2.6%
1/38 • Baseline up to Day 4 after vaccination for local reactions and systemic events or up to Day 194 (Visit 6 / Days 166 to 194 Follow-up Telephone Visit to assess AEs)
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 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/36 • Baseline up to Day 4 after vaccination for local reactions and systemic events or up to Day 194 (Visit 6 / Days 166 to 194 Follow-up Telephone Visit to assess AEs)
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 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
|
|
Immune system disorders
Seasonal allergy
|
2.6%
1/38 • Baseline up to Day 4 after vaccination for local reactions and systemic events or up to Day 194 (Visit 6 / Days 166 to 194 Follow-up Telephone Visit to assess AEs)
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 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/36 • Baseline up to Day 4 after vaccination for local reactions and systemic events or up to Day 194 (Visit 6 / Days 166 to 194 Follow-up Telephone Visit to assess AEs)
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 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Otitis externa
|
2.6%
1/38 • Baseline up to Day 4 after vaccination for local reactions and systemic events or up to Day 194 (Visit 6 / Days 166 to 194 Follow-up Telephone Visit to assess AEs)
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 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
|
5.6%
2/36 • Baseline up to Day 4 after vaccination for local reactions and systemic events or up to Day 194 (Visit 6 / Days 166 to 194 Follow-up Telephone Visit to assess AEs)
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 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Pharyngitis
|
5.3%
2/38 • Baseline up to Day 4 after vaccination for local reactions and systemic events or up to Day 194 (Visit 6 / Days 166 to 194 Follow-up Telephone Visit to assess AEs)
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 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/36 • Baseline up to Day 4 after vaccination for local reactions and systemic events or up to Day 194 (Visit 6 / Days 166 to 194 Follow-up Telephone Visit to assess AEs)
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 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Acute sinusitis
|
0.00%
0/38 • Baseline up to Day 4 after vaccination for local reactions and systemic events or up to Day 194 (Visit 6 / Days 166 to 194 Follow-up Telephone Visit to assess AEs)
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 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
|
2.8%
1/36 • Baseline up to Day 4 after vaccination for local reactions and systemic events or up to Day 194 (Visit 6 / Days 166 to 194 Follow-up Telephone Visit to assess AEs)
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 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Bronchitis
|
2.6%
1/38 • Baseline up to Day 4 after vaccination for local reactions and systemic events or up to Day 194 (Visit 6 / Days 166 to 194 Follow-up Telephone Visit to assess AEs)
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 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/36 • Baseline up to Day 4 after vaccination for local reactions and systemic events or up to Day 194 (Visit 6 / Days 166 to 194 Follow-up Telephone Visit to assess AEs)
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 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Gastritis viral
|
2.6%
1/38 • Baseline up to Day 4 after vaccination for local reactions and systemic events or up to Day 194 (Visit 6 / Days 166 to 194 Follow-up Telephone Visit to assess AEs)
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 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/36 • Baseline up to Day 4 after vaccination for local reactions and systemic events or up to Day 194 (Visit 6 / Days 166 to 194 Follow-up Telephone Visit to assess AEs)
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 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Pneumonia
|
2.6%
1/38 • Baseline up to Day 4 after vaccination for local reactions and systemic events or up to Day 194 (Visit 6 / Days 166 to 194 Follow-up Telephone Visit to assess AEs)
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 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/36 • Baseline up to Day 4 after vaccination for local reactions and systemic events or up to Day 194 (Visit 6 / Days 166 to 194 Follow-up Telephone Visit to assess AEs)
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 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/38 • Baseline up to Day 4 after vaccination for local reactions and systemic events or up to Day 194 (Visit 6 / Days 166 to 194 Follow-up Telephone Visit to assess AEs)
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 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
|
2.8%
1/36 • Baseline up to Day 4 after vaccination for local reactions and systemic events or up to Day 194 (Visit 6 / Days 166 to 194 Follow-up Telephone Visit to assess AEs)
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 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Upper respiratory tract infection
|
2.6%
1/38 • Baseline up to Day 4 after vaccination for local reactions and systemic events or up to Day 194 (Visit 6 / Days 166 to 194 Follow-up Telephone Visit to assess AEs)
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 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/36 • Baseline up to Day 4 after vaccination for local reactions and systemic events or up to Day 194 (Visit 6 / Days 166 to 194 Follow-up Telephone Visit to assess AEs)
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 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
2.6%
1/38 • Baseline up to Day 4 after vaccination for local reactions and systemic events or up to Day 194 (Visit 6 / Days 166 to 194 Follow-up Telephone Visit to assess AEs)
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 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/36 • Baseline up to Day 4 after vaccination for local reactions and systemic events or up to Day 194 (Visit 6 / Days 166 to 194 Follow-up Telephone Visit to assess AEs)
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 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/38 • Baseline up to Day 4 after vaccination for local reactions and systemic events or up to Day 194 (Visit 6 / Days 166 to 194 Follow-up Telephone Visit to assess AEs)
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 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
|
5.6%
2/36 • Baseline up to Day 4 after vaccination for local reactions and systemic events or up to Day 194 (Visit 6 / Days 166 to 194 Follow-up Telephone Visit to assess AEs)
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 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Joint sprain
|
5.3%
2/38 • Baseline up to Day 4 after vaccination for local reactions and systemic events or up to Day 194 (Visit 6 / Days 166 to 194 Follow-up Telephone Visit to assess AEs)
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 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/36 • Baseline up to Day 4 after vaccination for local reactions and systemic events or up to Day 194 (Visit 6 / Days 166 to 194 Follow-up Telephone Visit to assess AEs)
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 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/38 • Baseline up to Day 4 after vaccination for local reactions and systemic events or up to Day 194 (Visit 6 / Days 166 to 194 Follow-up Telephone Visit to assess AEs)
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 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
|
2.8%
1/36 • Baseline up to Day 4 after vaccination for local reactions and systemic events or up to Day 194 (Visit 6 / Days 166 to 194 Follow-up Telephone Visit to assess AEs)
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 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Avulsion fracture
|
0.00%
0/38 • Baseline up to Day 4 after vaccination for local reactions and systemic events or up to Day 194 (Visit 6 / Days 166 to 194 Follow-up Telephone Visit to assess AEs)
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 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
|
2.8%
1/36 • Baseline up to Day 4 after vaccination for local reactions and systemic events or up to Day 194 (Visit 6 / Days 166 to 194 Follow-up Telephone Visit to assess AEs)
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 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
2.6%
1/38 • Baseline up to Day 4 after vaccination for local reactions and systemic events or up to Day 194 (Visit 6 / Days 166 to 194 Follow-up Telephone Visit to assess AEs)
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 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/36 • Baseline up to Day 4 after vaccination for local reactions and systemic events or up to Day 194 (Visit 6 / Days 166 to 194 Follow-up Telephone Visit to assess AEs)
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 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/38 • Baseline up to Day 4 after vaccination for local reactions and systemic events or up to Day 194 (Visit 6 / Days 166 to 194 Follow-up Telephone Visit to assess AEs)
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 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
|
2.8%
1/36 • Baseline up to Day 4 after vaccination for local reactions and systemic events or up to Day 194 (Visit 6 / Days 166 to 194 Follow-up Telephone Visit to assess AEs)
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 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.00%
0/38 • Baseline up to Day 4 after vaccination for local reactions and systemic events or up to Day 194 (Visit 6 / Days 166 to 194 Follow-up Telephone Visit to assess AEs)
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 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
|
2.8%
1/36 • Baseline up to Day 4 after vaccination for local reactions and systemic events or up to Day 194 (Visit 6 / Days 166 to 194 Follow-up Telephone Visit to assess AEs)
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 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.00%
0/38 • Baseline up to Day 4 after vaccination for local reactions and systemic events or up to Day 194 (Visit 6 / Days 166 to 194 Follow-up Telephone Visit to assess AEs)
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 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
|
2.8%
1/36 • Baseline up to Day 4 after vaccination for local reactions and systemic events or up to Day 194 (Visit 6 / Days 166 to 194 Follow-up Telephone Visit to assess AEs)
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 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/38 • Baseline up to Day 4 after vaccination for local reactions and systemic events or up to Day 194 (Visit 6 / Days 166 to 194 Follow-up Telephone Visit to assess AEs)
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 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
|
2.8%
1/36 • Baseline up to Day 4 after vaccination for local reactions and systemic events or up to Day 194 (Visit 6 / Days 166 to 194 Follow-up Telephone Visit to assess AEs)
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 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Traumatic brain injury
|
0.00%
0/38 • Baseline up to Day 4 after vaccination for local reactions and systemic events or up to Day 194 (Visit 6 / Days 166 to 194 Follow-up Telephone Visit to assess AEs)
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 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
|
2.8%
1/36 • Baseline up to Day 4 after vaccination for local reactions and systemic events or up to Day 194 (Visit 6 / Days 166 to 194 Follow-up Telephone Visit to assess AEs)
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 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/38 • Baseline up to Day 4 after vaccination for local reactions and systemic events or up to Day 194 (Visit 6 / Days 166 to 194 Follow-up Telephone Visit to assess AEs)
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 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
|
5.6%
2/36 • Baseline up to Day 4 after vaccination for local reactions and systemic events or up to Day 194 (Visit 6 / Days 166 to 194 Follow-up Telephone Visit to assess AEs)
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 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Dehydration
|
2.6%
1/38 • Baseline up to Day 4 after vaccination for local reactions and systemic events or up to Day 194 (Visit 6 / Days 166 to 194 Follow-up Telephone Visit to assess AEs)
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 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/36 • Baseline up to Day 4 after vaccination for local reactions and systemic events or up to Day 194 (Visit 6 / Days 166 to 194 Follow-up Telephone Visit to assess AEs)
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 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/38 • Baseline up to Day 4 after vaccination for local reactions and systemic events or up to Day 194 (Visit 6 / Days 166 to 194 Follow-up Telephone Visit to assess AEs)
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 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
|
2.8%
1/36 • Baseline up to Day 4 after vaccination for local reactions and systemic events or up to Day 194 (Visit 6 / Days 166 to 194 Follow-up Telephone Visit to assess AEs)
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 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Patellofemoral pain syndrome
|
0.00%
0/38 • Baseline up to Day 4 after vaccination for local reactions and systemic events or up to Day 194 (Visit 6 / Days 166 to 194 Follow-up Telephone Visit to assess AEs)
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 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
|
2.8%
1/36 • Baseline up to Day 4 after vaccination for local reactions and systemic events or up to Day 194 (Visit 6 / Days 166 to 194 Follow-up Telephone Visit to assess AEs)
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 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
2.6%
1/38 • Baseline up to Day 4 after vaccination for local reactions and systemic events or up to Day 194 (Visit 6 / Days 166 to 194 Follow-up Telephone Visit to assess AEs)
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 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/36 • Baseline up to Day 4 after vaccination for local reactions and systemic events or up to Day 194 (Visit 6 / Days 166 to 194 Follow-up Telephone Visit to assess AEs)
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 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Headache
|
5.3%
2/38 • Baseline up to Day 4 after vaccination for local reactions and systemic events or up to Day 194 (Visit 6 / Days 166 to 194 Follow-up Telephone Visit to assess AEs)
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 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
|
8.3%
3/36 • Baseline up to Day 4 after vaccination for local reactions and systemic events or up to Day 194 (Visit 6 / Days 166 to 194 Follow-up Telephone Visit to assess AEs)
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 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Hypersomnia
|
2.6%
1/38 • Baseline up to Day 4 after vaccination for local reactions and systemic events or up to Day 194 (Visit 6 / Days 166 to 194 Follow-up Telephone Visit to assess AEs)
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 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
|
5.6%
2/36 • Baseline up to Day 4 after vaccination for local reactions and systemic events or up to Day 194 (Visit 6 / Days 166 to 194 Follow-up Telephone Visit to assess AEs)
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 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/38 • Baseline up to Day 4 after vaccination for local reactions and systemic events or up to Day 194 (Visit 6 / Days 166 to 194 Follow-up Telephone Visit to assess AEs)
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 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
|
5.6%
2/36 • Baseline up to Day 4 after vaccination for local reactions and systemic events or up to Day 194 (Visit 6 / Days 166 to 194 Follow-up Telephone Visit to assess AEs)
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 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Dizziness
|
2.6%
1/38 • Baseline up to Day 4 after vaccination for local reactions and systemic events or up to Day 194 (Visit 6 / Days 166 to 194 Follow-up Telephone Visit to assess AEs)
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 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/36 • Baseline up to Day 4 after vaccination for local reactions and systemic events or up to Day 194 (Visit 6 / Days 166 to 194 Follow-up Telephone Visit to assess AEs)
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 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Presyncope
|
2.6%
1/38 • Baseline up to Day 4 after vaccination for local reactions and systemic events or up to Day 194 (Visit 6 / Days 166 to 194 Follow-up Telephone Visit to assess AEs)
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 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/36 • Baseline up to Day 4 after vaccination for local reactions and systemic events or up to Day 194 (Visit 6 / Days 166 to 194 Follow-up Telephone Visit to assess AEs)
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 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Syncope
|
2.6%
1/38 • Baseline up to Day 4 after vaccination for local reactions and systemic events or up to Day 194 (Visit 6 / Days 166 to 194 Follow-up Telephone Visit to assess AEs)
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 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/36 • Baseline up to Day 4 after vaccination for local reactions and systemic events or up to Day 194 (Visit 6 / Days 166 to 194 Follow-up Telephone Visit to assess AEs)
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 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/38 • Baseline up to Day 4 after vaccination for local reactions and systemic events or up to Day 194 (Visit 6 / Days 166 to 194 Follow-up Telephone Visit to assess AEs)
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 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
|
2.8%
1/36 • Baseline up to Day 4 after vaccination for local reactions and systemic events or up to Day 194 (Visit 6 / Days 166 to 194 Follow-up Telephone Visit to assess AEs)
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 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
|
|
Renal and urinary disorders
Haematuria
|
2.6%
1/38 • Baseline up to Day 4 after vaccination for local reactions and systemic events or up to Day 194 (Visit 6 / Days 166 to 194 Follow-up Telephone Visit to assess AEs)
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 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/36 • Baseline up to Day 4 after vaccination for local reactions and systemic events or up to Day 194 (Visit 6 / Days 166 to 194 Follow-up Telephone Visit to assess AEs)
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 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
2.6%
1/38 • Baseline up to Day 4 after vaccination for local reactions and systemic events or up to Day 194 (Visit 6 / Days 166 to 194 Follow-up Telephone Visit to assess AEs)
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 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/36 • Baseline up to Day 4 after vaccination for local reactions and systemic events or up to Day 194 (Visit 6 / Days 166 to 194 Follow-up Telephone Visit to assess AEs)
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 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
|
|
Reproductive system and breast disorders
Gynaecomastia
|
0.00%
0/38 • Baseline up to Day 4 after vaccination for local reactions and systemic events or up to Day 194 (Visit 6 / Days 166 to 194 Follow-up Telephone Visit to assess AEs)
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 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
|
2.8%
1/36 • Baseline up to Day 4 after vaccination for local reactions and systemic events or up to Day 194 (Visit 6 / Days 166 to 194 Follow-up Telephone Visit to assess AEs)
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 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
10.5%
4/38 • Baseline up to Day 4 after vaccination for local reactions and systemic events or up to Day 194 (Visit 6 / Days 166 to 194 Follow-up Telephone Visit to assess AEs)
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 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
|
2.8%
1/36 • Baseline up to Day 4 after vaccination for local reactions and systemic events or up to Day 194 (Visit 6 / Days 166 to 194 Follow-up Telephone Visit to assess AEs)
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 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
7.9%
3/38 • Baseline up to Day 4 after vaccination for local reactions and systemic events or up to Day 194 (Visit 6 / Days 166 to 194 Follow-up Telephone Visit to assess AEs)
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 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
|
2.8%
1/36 • Baseline up to Day 4 after vaccination for local reactions and systemic events or up to Day 194 (Visit 6 / Days 166 to 194 Follow-up Telephone Visit to assess AEs)
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 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
2.6%
1/38 • Baseline up to Day 4 after vaccination for local reactions and systemic events or up to Day 194 (Visit 6 / Days 166 to 194 Follow-up Telephone Visit to assess AEs)
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 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
|
5.6%
2/36 • Baseline up to Day 4 after vaccination for local reactions and systemic events or up to Day 194 (Visit 6 / Days 166 to 194 Follow-up Telephone Visit to assess AEs)
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 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.6%
1/38 • Baseline up to Day 4 after vaccination for local reactions and systemic events or up to Day 194 (Visit 6 / Days 166 to 194 Follow-up Telephone Visit to assess AEs)
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 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
|
2.8%
1/36 • Baseline up to Day 4 after vaccination for local reactions and systemic events or up to Day 194 (Visit 6 / Days 166 to 194 Follow-up Telephone Visit to assess AEs)
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 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
2.6%
1/38 • Baseline up to Day 4 after vaccination for local reactions and systemic events or up to Day 194 (Visit 6 / Days 166 to 194 Follow-up Telephone Visit to assess AEs)
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 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
|
2.8%
1/36 • Baseline up to Day 4 after vaccination for local reactions and systemic events or up to Day 194 (Visit 6 / Days 166 to 194 Follow-up Telephone Visit to assess AEs)
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 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
0.00%
0/38 • Baseline up to Day 4 after vaccination for local reactions and systemic events or up to Day 194 (Visit 6 / Days 166 to 194 Follow-up Telephone Visit to assess AEs)
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 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
|
2.8%
1/36 • Baseline up to Day 4 after vaccination for local reactions and systemic events or up to Day 194 (Visit 6 / Days 166 to 194 Follow-up Telephone Visit to assess AEs)
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 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Acne
|
5.3%
2/38 • Baseline up to Day 4 after vaccination for local reactions and systemic events or up to Day 194 (Visit 6 / Days 166 to 194 Follow-up Telephone Visit to assess AEs)
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 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
|
2.8%
1/36 • Baseline up to Day 4 after vaccination for local reactions and systemic events or up to Day 194 (Visit 6 / Days 166 to 194 Follow-up Telephone Visit to assess AEs)
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 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/38 • Baseline up to Day 4 after vaccination for local reactions and systemic events or up to Day 194 (Visit 6 / Days 166 to 194 Follow-up Telephone Visit to assess AEs)
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 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
|
2.8%
1/36 • Baseline up to Day 4 after vaccination for local reactions and systemic events or up to Day 194 (Visit 6 / Days 166 to 194 Follow-up Telephone Visit to assess AEs)
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 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Ingrowing nail
|
0.00%
0/38 • Baseline up to Day 4 after vaccination for local reactions and systemic events or up to Day 194 (Visit 6 / Days 166 to 194 Follow-up Telephone Visit to assess AEs)
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 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
|
2.8%
1/36 • Baseline up to Day 4 after vaccination for local reactions and systemic events or up to Day 194 (Visit 6 / Days 166 to 194 Follow-up Telephone Visit to assess AEs)
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 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Tenderness: Any
|
92.1%
35/38 • Baseline up to Day 4 after vaccination for local reactions and systemic events or up to Day 194 (Visit 6 / Days 166 to 194 Follow-up Telephone Visit to assess AEs)
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 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
|
86.1%
31/36 • Baseline up to Day 4 after vaccination for local reactions and systemic events or up to Day 194 (Visit 6 / Days 166 to 194 Follow-up Telephone Visit to assess AEs)
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 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Tenderness: Significant
|
10.5%
4/38 • Baseline up to Day 4 after vaccination for local reactions and systemic events or up to Day 194 (Visit 6 / Days 166 to 194 Follow-up Telephone Visit to assess AEs)
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 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
|
19.4%
7/36 • Baseline up to Day 4 after vaccination for local reactions and systemic events or up to Day 194 (Visit 6 / Days 166 to 194 Follow-up Telephone Visit to assess AEs)
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 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Swelling: Any
|
10.5%
4/38 • Baseline up to Day 4 after vaccination for local reactions and systemic events or up to Day 194 (Visit 6 / Days 166 to 194 Follow-up Telephone Visit to assess AEs)
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 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
|
5.6%
2/36 • Baseline up to Day 4 after vaccination for local reactions and systemic events or up to Day 194 (Visit 6 / Days 166 to 194 Follow-up Telephone Visit to assess AEs)
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 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Swelling: Mild
|
2.6%
1/38 • Baseline up to Day 4 after vaccination for local reactions and systemic events or up to Day 194 (Visit 6 / Days 166 to 194 Follow-up Telephone Visit to assess AEs)
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 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
|
2.8%
1/36 • Baseline up to Day 4 after vaccination for local reactions and systemic events or up to Day 194 (Visit 6 / Days 166 to 194 Follow-up Telephone Visit to assess AEs)
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 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Swelling: Moderate
|
10.5%
4/38 • Baseline up to Day 4 after vaccination for local reactions and systemic events or up to Day 194 (Visit 6 / Days 166 to 194 Follow-up Telephone Visit to assess AEs)
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 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
|
2.8%
1/36 • Baseline up to Day 4 after vaccination for local reactions and systemic events or up to Day 194 (Visit 6 / Days 166 to 194 Follow-up Telephone Visit to assess AEs)
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 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Redness: Any
|
5.3%
2/38 • Baseline up to Day 4 after vaccination for local reactions and systemic events or up to Day 194 (Visit 6 / Days 166 to 194 Follow-up Telephone Visit to assess AEs)
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 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
|
5.6%
2/36 • Baseline up to Day 4 after vaccination for local reactions and systemic events or up to Day 194 (Visit 6 / Days 166 to 194 Follow-up Telephone Visit to assess AEs)
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 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Redness: Mild
|
0.00%
0/38 • Baseline up to Day 4 after vaccination for local reactions and systemic events or up to Day 194 (Visit 6 / Days 166 to 194 Follow-up Telephone Visit to assess AEs)
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 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
|
2.8%
1/36 • Baseline up to Day 4 after vaccination for local reactions and systemic events or up to Day 194 (Visit 6 / Days 166 to 194 Follow-up Telephone Visit to assess AEs)
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 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Redness: Moderate
|
5.3%
2/38 • Baseline up to Day 4 after vaccination for local reactions and systemic events or up to Day 194 (Visit 6 / Days 166 to 194 Follow-up Telephone Visit to assess AEs)
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 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
|
2.8%
1/36 • Baseline up to Day 4 after vaccination for local reactions and systemic events or up to Day 194 (Visit 6 / Days 166 to 194 Follow-up Telephone Visit to assess AEs)
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 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Fever ≥38 degrees C but ≤39 degrees C
|
2.9%
1/34 • Baseline up to Day 4 after vaccination for local reactions and systemic events or up to Day 194 (Visit 6 / Days 166 to 194 Follow-up Telephone Visit to assess AEs)
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 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/35 • Baseline up to Day 4 after vaccination for local reactions and systemic events or up to Day 194 (Visit 6 / Days 166 to 194 Follow-up Telephone Visit to assess AEs)
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 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Decreased appetite
|
7.9%
3/38 • Baseline up to Day 4 after vaccination for local reactions and systemic events or up to Day 194 (Visit 6 / Days 166 to 194 Follow-up Telephone Visit to assess AEs)
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 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
|
16.7%
6/36 • Baseline up to Day 4 after vaccination for local reactions and systemic events or up to Day 194 (Visit 6 / Days 166 to 194 Follow-up Telephone Visit to assess AEs)
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 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Decreased appetite: Mild
|
7.9%
3/38 • Baseline up to Day 4 after vaccination for local reactions and systemic events or up to Day 194 (Visit 6 / Days 166 to 194 Follow-up Telephone Visit to assess AEs)
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 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
|
11.1%
4/36 • Baseline up to Day 4 after vaccination for local reactions and systemic events or up to Day 194 (Visit 6 / Days 166 to 194 Follow-up Telephone Visit to assess AEs)
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 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Decreased appetite: Moderate
|
2.6%
1/38 • Baseline up to Day 4 after vaccination for local reactions and systemic events or up to Day 194 (Visit 6 / Days 166 to 194 Follow-up Telephone Visit to assess AEs)
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 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
|
8.3%
3/36 • Baseline up to Day 4 after vaccination for local reactions and systemic events or up to Day 194 (Visit 6 / Days 166 to 194 Follow-up Telephone Visit to assess AEs)
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 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Irritability
|
18.4%
7/38 • Baseline up to Day 4 after vaccination for local reactions and systemic events or up to Day 194 (Visit 6 / Days 166 to 194 Follow-up Telephone Visit to assess AEs)
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 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
|
13.9%
5/36 • Baseline up to Day 4 after vaccination for local reactions and systemic events or up to Day 194 (Visit 6 / Days 166 to 194 Follow-up Telephone Visit to assess AEs)
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 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Irritability: Mild
|
13.2%
5/38 • Baseline up to Day 4 after vaccination for local reactions and systemic events or up to Day 194 (Visit 6 / Days 166 to 194 Follow-up Telephone Visit to assess AEs)
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 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
|
11.1%
4/36 • Baseline up to Day 4 after vaccination for local reactions and systemic events or up to Day 194 (Visit 6 / Days 166 to 194 Follow-up Telephone Visit to assess AEs)
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 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Irritability: Moderate
|
5.3%
2/38 • Baseline up to Day 4 after vaccination for local reactions and systemic events or up to Day 194 (Visit 6 / Days 166 to 194 Follow-up Telephone Visit to assess AEs)
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 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
|
5.6%
2/36 • Baseline up to Day 4 after vaccination for local reactions and systemic events or up to Day 194 (Visit 6 / Days 166 to 194 Follow-up Telephone Visit to assess AEs)
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 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Increased sleep
|
26.3%
10/38 • Baseline up to Day 4 after vaccination for local reactions and systemic events or up to Day 194 (Visit 6 / Days 166 to 194 Follow-up Telephone Visit to assess AEs)
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 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
|
33.3%
12/36 • Baseline up to Day 4 after vaccination for local reactions and systemic events or up to Day 194 (Visit 6 / Days 166 to 194 Follow-up Telephone Visit to assess AEs)
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 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Increased sleep: Mild
|
15.8%
6/38 • Baseline up to Day 4 after vaccination for local reactions and systemic events or up to Day 194 (Visit 6 / Days 166 to 194 Follow-up Telephone Visit to assess AEs)
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 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
|
25.0%
9/36 • Baseline up to Day 4 after vaccination for local reactions and systemic events or up to Day 194 (Visit 6 / Days 166 to 194 Follow-up Telephone Visit to assess AEs)
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 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Increased sleep: Moderate
|
13.2%
5/38 • Baseline up to Day 4 after vaccination for local reactions and systemic events or up to Day 194 (Visit 6 / Days 166 to 194 Follow-up Telephone Visit to assess AEs)
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 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
|
13.9%
5/36 • Baseline up to Day 4 after vaccination for local reactions and systemic events or up to Day 194 (Visit 6 / Days 166 to 194 Follow-up Telephone Visit to assess AEs)
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 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Increased sleep: Severe
|
2.6%
1/38 • Baseline up to Day 4 after vaccination for local reactions and systemic events or up to Day 194 (Visit 6 / Days 166 to 194 Follow-up Telephone Visit to assess AEs)
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 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/36 • Baseline up to Day 4 after vaccination for local reactions and systemic events or up to Day 194 (Visit 6 / Days 166 to 194 Follow-up Telephone Visit to assess AEs)
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 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Decreased sleep
|
7.9%
3/38 • Baseline up to Day 4 after vaccination for local reactions and systemic events or up to Day 194 (Visit 6 / Days 166 to 194 Follow-up Telephone Visit to assess AEs)
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 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
|
11.1%
4/36 • Baseline up to Day 4 after vaccination for local reactions and systemic events or up to Day 194 (Visit 6 / Days 166 to 194 Follow-up Telephone Visit to assess AEs)
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 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Decreased sleep: Mild
|
5.3%
2/38 • Baseline up to Day 4 after vaccination for local reactions and systemic events or up to Day 194 (Visit 6 / Days 166 to 194 Follow-up Telephone Visit to assess AEs)
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 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
|
8.3%
3/36 • Baseline up to Day 4 after vaccination for local reactions and systemic events or up to Day 194 (Visit 6 / Days 166 to 194 Follow-up Telephone Visit to assess AEs)
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 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Decreased sleep: Moderate
|
2.6%
1/38 • Baseline up to Day 4 after vaccination for local reactions and systemic events or up to Day 194 (Visit 6 / Days 166 to 194 Follow-up Telephone Visit to assess AEs)
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 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
|
2.8%
1/36 • Baseline up to Day 4 after vaccination for local reactions and systemic events or up to Day 194 (Visit 6 / Days 166 to 194 Follow-up Telephone Visit to assess AEs)
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 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Rash
|
5.3%
2/38 • Baseline up to Day 4 after vaccination for local reactions and systemic events or up to Day 194 (Visit 6 / Days 166 to 194 Follow-up Telephone Visit to assess AEs)
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 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/36 • Baseline up to Day 4 after vaccination for local reactions and systemic events or up to Day 194 (Visit 6 / Days 166 to 194 Follow-up Telephone Visit to assess AEs)
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 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Rash: Mild
|
5.3%
2/38 • Baseline up to Day 4 after vaccination for local reactions and systemic events or up to Day 194 (Visit 6 / Days 166 to 194 Follow-up Telephone Visit to assess AEs)
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 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/36 • Baseline up to Day 4 after vaccination for local reactions and systemic events or up to Day 194 (Visit 6 / Days 166 to 194 Follow-up Telephone Visit to assess AEs)
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 1 subject and as nonserious in another subject, or 1 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