Trial Outcomes & Findings for Immune Response In Children Revaccinated With Pneumococcal Conjugate Vaccine (NCT NCT00853749)
NCT ID: NCT00853749
Last Updated: 2021-11-11
Results Overview
Percentage of participants achieving predefined antibody threshold ≥ 0.35 mcg/mL along with the corresponding 95 percent (%) Confidence Interval (CI) for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2-sided CI based on the observed proportion of participants.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
89 participants
Primary outcome timeframe
Day 28
Results posted on
2021-11-11
Participant Flow
Participant milestones
| Measure |
PCV/23vPS/13vPnC
For this study, participants received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly. Participants previously must have also received an infant series of 9-valent pneumococcal-conjugate-meningococcal serogroup C conjugate combination vaccine (9V-MnCC) also known as pneumococcal conjugate vaccine (PCV) followed by a toddler dose of 23-valent pneumococcal polysaccharide vaccine (23vPS).
|
PCV/PCV/13vPnC
For this study, participants received a single 0.5 mL dose of 13vPnC administered intramuscularly. Participants must have also previously received 9V-MnCC followed by a toddler dose of 9V-MnCC (also referred to as PCV).
|
|---|---|---|
|
Overall Study
STARTED
|
50
|
39
|
|
Overall Study
Vaccinated
|
50
|
39
|
|
Overall Study
COMPLETED
|
50
|
38
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
PCV/23vPS/13vPnC
For this study, participants received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly. Participants previously must have also received an infant series of 9-valent pneumococcal-conjugate-meningococcal serogroup C conjugate combination vaccine (9V-MnCC) also known as pneumococcal conjugate vaccine (PCV) followed by a toddler dose of 23-valent pneumococcal polysaccharide vaccine (23vPS).
|
PCV/PCV/13vPnC
For this study, participants received a single 0.5 mL dose of 13vPnC administered intramuscularly. Participants must have also previously received 9V-MnCC followed by a toddler dose of 9V-MnCC (also referred to as PCV).
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
Baseline Characteristics
Immune Response In Children Revaccinated With Pneumococcal Conjugate Vaccine
Baseline characteristics by cohort
| Measure |
PCV/23vPS/13vPnC
n=50 Participants
For this study, participants received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly. Participants previously must have also received an infant series of 9-valent pneumococcal-conjugate-meningococcal serogroup C conjugate combination vaccine (9V-MnCC) also known as pneumococcal conjugate vaccine (PCV) followed by a toddler dose of 23-valent pneumococcal polysaccharide vaccine (23vPS).
|
PCV/PCV/13vPnC
n=39 Participants
For this study, participants received a single 0.5 mL dose of 13vPnC administered intramuscularly. Participants must have also previously received 9V-MnCC followed by a toddler dose of 9V-MnCC (also referred to as PCV).
|
Total
n=89 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
7.6 years
STANDARD_DEVIATION 0.2 • n=93 Participants
|
7.6 years
STANDARD_DEVIATION 0.2 • n=4 Participants
|
7.6 years
STANDARD_DEVIATION 0.2 • n=27 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=93 Participants
|
20 Participants
n=4 Participants
|
45 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=93 Participants
|
19 Participants
n=4 Participants
|
44 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Day 28Population: Evaluable Immunogenicity Population: received 1 dose of 13vPnC at Visit 1, blood drawn within specified timeframes, at least 1 valid and determinate assay result at Visits 1 and 3, no major protocol violations, and no prohibited vaccines. N=number of participants with a determinate IgG antibody concentration to the given serotype.
Percentage of participants achieving predefined antibody threshold ≥ 0.35 mcg/mL along with the corresponding 95 percent (%) Confidence Interval (CI) for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2-sided CI based on the observed proportion of participants.
Outcome measures
| Measure |
PCV/23vPS/13vPnC
n=50 Participants
For this study, participants received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly. Participants previously must have also received an infant series of 9-valent pneumococcal-conjugate-meningococcal serogroup C conjugate combination vaccine (9V-MnCC) also known as pneumococcal conjugate vaccine (PCV) followed by a toddler dose of 23-valent pneumococcal polysaccharide vaccine (23vPS).
|
PCV/PCV/13vPnC
n=37 Participants
For this study, participants received a single 0.5 mL dose of 13vPnC administered intramuscularly. Participants must have also previously received 9V-MnCC followed by a toddler dose of 9V-MnCC (also referred to as PCV).
|
|---|---|---|
|
Percentage of Participants Achieving a Predefined Serotype-specific Immunoglobulin G (IgG) Antibody Concentration Greater Than or Equal to ( ≥) 0.35 Micrograms Per Milliliter (mcg/mL) Measured 1 Month After Vaccination
Common Serotype 4
|
100.0 Percentage of participants
Interval 92.9 to 100.0
|
97.3 Percentage of participants
Interval 85.8 to 99.9
|
|
Percentage of Participants Achieving a Predefined Serotype-specific Immunoglobulin G (IgG) Antibody Concentration Greater Than or Equal to ( ≥) 0.35 Micrograms Per Milliliter (mcg/mL) Measured 1 Month After Vaccination
Common Serotype 6B
|
100.0 Percentage of participants
Interval 92.9 to 100.0
|
100.0 Percentage of participants
Interval 90.5 to 100.0
|
|
Percentage of Participants Achieving a Predefined Serotype-specific Immunoglobulin G (IgG) Antibody Concentration Greater Than or Equal to ( ≥) 0.35 Micrograms Per Milliliter (mcg/mL) Measured 1 Month After Vaccination
Common Serotype 9V
|
100.0 Percentage of participants
Interval 92.9 to 100.0
|
100.0 Percentage of participants
Interval 90.5 to 100.0
|
|
Percentage of Participants Achieving a Predefined Serotype-specific Immunoglobulin G (IgG) Antibody Concentration Greater Than or Equal to ( ≥) 0.35 Micrograms Per Milliliter (mcg/mL) Measured 1 Month After Vaccination
Common Serotype 14
|
100.0 Percentage of participants
Interval 92.7 to 100.0
|
100.0 Percentage of participants
Interval 90.5 to 100.0
|
|
Percentage of Participants Achieving a Predefined Serotype-specific Immunoglobulin G (IgG) Antibody Concentration Greater Than or Equal to ( ≥) 0.35 Micrograms Per Milliliter (mcg/mL) Measured 1 Month After Vaccination
Common Serotype18C
|
100.0 Percentage of participants
Interval 92.9 to 100.0
|
97.3 Percentage of participants
Interval 85.8 to 99.9
|
|
Percentage of Participants Achieving a Predefined Serotype-specific Immunoglobulin G (IgG) Antibody Concentration Greater Than or Equal to ( ≥) 0.35 Micrograms Per Milliliter (mcg/mL) Measured 1 Month After Vaccination
Common Serotype 19F
|
100.0 Percentage of participants
Interval 92.9 to 100.0
|
100.0 Percentage of participants
Interval 90.5 to 100.0
|
|
Percentage of Participants Achieving a Predefined Serotype-specific Immunoglobulin G (IgG) Antibody Concentration Greater Than or Equal to ( ≥) 0.35 Micrograms Per Milliliter (mcg/mL) Measured 1 Month After Vaccination
Common Serotype 23F
|
100.0 Percentage of participants
Interval 92.9 to 100.0
|
100.0 Percentage of participants
Interval 90.5 to 100.0
|
|
Percentage of Participants Achieving a Predefined Serotype-specific Immunoglobulin G (IgG) Antibody Concentration Greater Than or Equal to ( ≥) 0.35 Micrograms Per Milliliter (mcg/mL) Measured 1 Month After Vaccination
Additional Serotype 1
|
100.0 Percentage of participants
Interval 92.9 to 100.0
|
97.3 Percentage of participants
Interval 85.8 to 99.9
|
|
Percentage of Participants Achieving a Predefined Serotype-specific Immunoglobulin G (IgG) Antibody Concentration Greater Than or Equal to ( ≥) 0.35 Micrograms Per Milliliter (mcg/mL) Measured 1 Month After Vaccination
Additional Serotype 3
|
100.0 Percentage of participants
Interval 92.9 to 100.0
|
100.0 Percentage of participants
Interval 90.5 to 100.0
|
|
Percentage of Participants Achieving a Predefined Serotype-specific Immunoglobulin G (IgG) Antibody Concentration Greater Than or Equal to ( ≥) 0.35 Micrograms Per Milliliter (mcg/mL) Measured 1 Month After Vaccination
Additional Serotype 5
|
100.0 Percentage of participants
Interval 92.9 to 100.0
|
100.0 Percentage of participants
Interval 90.5 to 100.0
|
|
Percentage of Participants Achieving a Predefined Serotype-specific Immunoglobulin G (IgG) Antibody Concentration Greater Than or Equal to ( ≥) 0.35 Micrograms Per Milliliter (mcg/mL) Measured 1 Month After Vaccination
Additional Serotype 6A
|
100.0 Percentage of participants
Interval 92.9 to 100.0
|
100.0 Percentage of participants
Interval 90.5 to 100.0
|
|
Percentage of Participants Achieving a Predefined Serotype-specific Immunoglobulin G (IgG) Antibody Concentration Greater Than or Equal to ( ≥) 0.35 Micrograms Per Milliliter (mcg/mL) Measured 1 Month After Vaccination
Additional Serotype 7F
|
100.0 Percentage of participants
Interval 92.9 to 100.0
|
100.0 Percentage of participants
Interval 90.5 to 100.0
|
|
Percentage of Participants Achieving a Predefined Serotype-specific Immunoglobulin G (IgG) Antibody Concentration Greater Than or Equal to ( ≥) 0.35 Micrograms Per Milliliter (mcg/mL) Measured 1 Month After Vaccination
Additional Serotype 19A
|
100.0 Percentage of participants
Interval 92.9 to 100.0
|
100.0 Percentage of participants
Interval 90.5 to 100.0
|
PRIMARY outcome
Timeframe: Day 28Population: Evaluable Immunogenicity Population; N=number of participants with a determinate OPA antibody titer to the given serotype.
Percentage of participants achieving OPA along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2-sided CI based on the observed proportion of participants.
Outcome measures
| Measure |
PCV/23vPS/13vPnC
n=50 Participants
For this study, participants received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly. Participants previously must have also received an infant series of 9-valent pneumococcal-conjugate-meningococcal serogroup C conjugate combination vaccine (9V-MnCC) also known as pneumococcal conjugate vaccine (PCV) followed by a toddler dose of 23-valent pneumococcal polysaccharide vaccine (23vPS).
|
PCV/PCV/13vPnC
n=37 Participants
For this study, participants received a single 0.5 mL dose of 13vPnC administered intramuscularly. Participants must have also previously received 9V-MnCC followed by a toddler dose of 9V-MnCC (also referred to as PCV).
|
|---|---|---|
|
Percentage of Participants Achieving Opsonophagocytic Assay (OPA) Titers ≥ 1:8 Measured 1 Month After Vaccination
Common Serotype 4
|
98.0 Percentage of participants
Interval 89.4 to 99.9
|
97.2 Percentage of participants
Interval 85.5 to 99.9
|
|
Percentage of Participants Achieving Opsonophagocytic Assay (OPA) Titers ≥ 1:8 Measured 1 Month After Vaccination
Common Serotype 6B
|
100.0 Percentage of participants
Interval 92.7 to 100.0
|
100.0 Percentage of participants
Interval 90.3 to 100.0
|
|
Percentage of Participants Achieving Opsonophagocytic Assay (OPA) Titers ≥ 1:8 Measured 1 Month After Vaccination
Common Serotype 9V
|
100.0 Percentage of participants
Interval 92.7 to 100.0
|
100.0 Percentage of participants
Interval 90.3 to 100.0
|
|
Percentage of Participants Achieving Opsonophagocytic Assay (OPA) Titers ≥ 1:8 Measured 1 Month After Vaccination
Common Serotype 14
|
100.0 Percentage of participants
Interval 92.7 to 100.0
|
100.0 Percentage of participants
Interval 90.3 to 100.0
|
|
Percentage of Participants Achieving Opsonophagocytic Assay (OPA) Titers ≥ 1:8 Measured 1 Month After Vaccination
Common Serotype 18C
|
100.0 Percentage of participants
Interval 92.9 to 100.0
|
100.0 Percentage of participants
Interval 90.0 to 100.0
|
|
Percentage of Participants Achieving Opsonophagocytic Assay (OPA) Titers ≥ 1:8 Measured 1 Month After Vaccination
Common Serotype 19F
|
100.0 Percentage of participants
Interval 92.7 to 100.0
|
100.0 Percentage of participants
Interval 90.0 to 100.0
|
|
Percentage of Participants Achieving Opsonophagocytic Assay (OPA) Titers ≥ 1:8 Measured 1 Month After Vaccination
Common Serotype 23F
|
98.0 Percentage of participants
Interval 89.4 to 99.9
|
100.0 Percentage of participants
Interval 89.7 to 100.0
|
|
Percentage of Participants Achieving Opsonophagocytic Assay (OPA) Titers ≥ 1:8 Measured 1 Month After Vaccination
Additional Serotype 1
|
100.0 Percentage of participants
Interval 92.9 to 100.0
|
97.3 Percentage of participants
Interval 85.8 to 99.9
|
|
Percentage of Participants Achieving Opsonophagocytic Assay (OPA) Titers ≥ 1:8 Measured 1 Month After Vaccination
Additional Serotype 3
|
98.0 Percentage of participants
Interval 89.1 to 99.9
|
100.0 Percentage of participants
Interval 90.3 to 100.0
|
|
Percentage of Participants Achieving Opsonophagocytic Assay (OPA) Titers ≥ 1:8 Measured 1 Month After Vaccination
Additional Serotype 5
|
98.0 Percentage of participants
Interval 89.4 to 99.9
|
97.3 Percentage of participants
Interval 85.8 to 99.9
|
|
Percentage of Participants Achieving Opsonophagocytic Assay (OPA) Titers ≥ 1:8 Measured 1 Month After Vaccination
Additional Serotype 6A
|
100.0 Percentage of participants
Interval 92.9 to 100.0
|
100.0 Percentage of participants
Interval 90.5 to 100.0
|
|
Percentage of Participants Achieving Opsonophagocytic Assay (OPA) Titers ≥ 1:8 Measured 1 Month After Vaccination
Additional Serotype 7F
|
98.0 Percentage of participants
Interval 89.4 to 99.9
|
100.0 Percentage of participants
Interval 90.3 to 100.0
|
|
Percentage of Participants Achieving Opsonophagocytic Assay (OPA) Titers ≥ 1:8 Measured 1 Month After Vaccination
Additional Serotype 19A
|
100.0 Percentage of participants
Interval 92.9 to 100.0
|
100.0 Percentage of participants
Interval 90.5 to 100.0
|
SECONDARY outcome
Timeframe: Day 28Population: Evaluable Immunogenicity Population; In accordance with the recommendation of the lab completing the assays, values above the upper limit were assigned a value of 8.0 and those below the lower limit were assigned a value of 0.10. N=number of participants with a determinate avidity index for the specified serotype.
Avidity assay had measurable range of 0.117 to 7.5. Results expressed as avidity index (AI). Geometric mean avidity presented for 3 common pneumococcal serotypes (serotype 6B, 19F, and 23F) and 2 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1 and 5).
Outcome measures
| Measure |
PCV/23vPS/13vPnC
n=50 Participants
For this study, participants received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly. Participants previously must have also received an infant series of 9-valent pneumococcal-conjugate-meningococcal serogroup C conjugate combination vaccine (9V-MnCC) also known as pneumococcal conjugate vaccine (PCV) followed by a toddler dose of 23-valent pneumococcal polysaccharide vaccine (23vPS).
|
PCV/PCV/13vPnC
n=36 Participants
For this study, participants received a single 0.5 mL dose of 13vPnC administered intramuscularly. Participants must have also previously received 9V-MnCC followed by a toddler dose of 9V-MnCC (also referred to as PCV).
|
|---|---|---|
|
Antibody Response Measured 1 Month After Vaccination (Avidity Assay)
Additional serotype 1
|
1.42 AI
Interval 1.15 to 1.76
|
4.68 AI
Interval 3.62 to 6.04
|
|
Antibody Response Measured 1 Month After Vaccination (Avidity Assay)
Additional serotype 5
|
1.85 AI
Interval 1.46 to 2.36
|
5.85 AI
Interval 4.81 to 7.11
|
|
Antibody Response Measured 1 Month After Vaccination (Avidity Assay)
Common serotype 6B
|
2.43 AI
Interval 1.77 to 3.35
|
5.48 AI
Interval 4.38 to 6.86
|
|
Antibody Response Measured 1 Month After Vaccination (Avidity Assay)
Common serotype 19F
|
2.17 AI
Interval 1.69 to 2.79
|
2.46 AI
Interval 1.88 to 3.21
|
|
Antibody Response Measured 1 Month After Vaccination (Avidity Assay)
Common serotype 23F
|
3.02 AI
Interval 2.36 to 3.85
|
6.43 AI
Interval 5.33 to 7.76
|
SECONDARY outcome
Timeframe: Day 28Population: Evaluable Immunogenicity Population; N=number of participants with a determinate antibody titre to the specified serotype.
Antibody response as measured by OPA, 1 month after vaccination. Geometric mean titers (GMTs) calculated using all participants with available data for the specified blood draw. CIs were back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.
Outcome measures
| Measure |
PCV/23vPS/13vPnC
n=50 Participants
For this study, participants received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly. Participants previously must have also received an infant series of 9-valent pneumococcal-conjugate-meningococcal serogroup C conjugate combination vaccine (9V-MnCC) also known as pneumococcal conjugate vaccine (PCV) followed by a toddler dose of 23-valent pneumococcal polysaccharide vaccine (23vPS).
|
PCV/PCV/13vPnC
n=37 Participants
For this study, participants received a single 0.5 mL dose of 13vPnC administered intramuscularly. Participants must have also previously received 9V-MnCC followed by a toddler dose of 9V-MnCC (also referred to as PCV).
|
|---|---|---|
|
Antibody Response Measured 1 Month After Vaccination (OPA)
Common Serotype 4
|
2374 GMT
Interval 1656.3 to 3404.0
|
3765 GMT
Interval 2339.1 to 6059.8
|
|
Antibody Response Measured 1 Month After Vaccination (OPA)
Common Serotype 6B
|
11156 GMT
Interval 9073.5 to 13715.2
|
11477 GMT
Interval 8418.5 to 15646.8
|
|
Antibody Response Measured 1 Month After Vaccination (OPA)
Common Serotype 9V
|
1651 GMT
Interval 1067.8 to 2553.3
|
1713 GMT
Interval 1087.0 to 2700.0
|
|
Antibody Response Measured 1 Month After Vaccination (OPA)
Common Serotype 14
|
3041 GMT
Interval 2311.4 to 4001.1
|
3048 GMT
Interval 2318.3 to 4006.9
|
|
Antibody Response Measured 1 Month After Vaccination (OPA)
Common Serotype 18C
|
3230 GMT
Interval 2616.1 to 3987.1
|
5684 GMT
Interval 3122.2 to 10349.6
|
|
Antibody Response Measured 1 Month After Vaccination (OPA)
Common Serotype 19F
|
1266 GMT
Interval 1013.9 to 1582.0
|
1198 GMT
Interval 842.3 to 1703.9
|
|
Antibody Response Measured 1 Month After Vaccination (OPA)
Common Serotype 23F
|
1678 GMT
Interval 1212.3 to 2322.1
|
2714 GMT
Interval 1970.1 to 3739.5
|
|
Antibody Response Measured 1 Month After Vaccination (OPA)
Additional Serotype 1
|
217 GMT
Interval 162.6 to 290.5
|
1087 GMT
Interval 717.5 to 1646.3
|
|
Antibody Response Measured 1 Month After Vaccination (OPA)
Additional Serotype 3
|
153 GMT
Interval 117.2 to 200.2
|
188 GMT
Interval 146.6 to 240.8
|
|
Antibody Response Measured 1 Month After Vaccination (OPA)
Additional Serotype 5
|
264 GMT
Interval 178.5 to 389.9
|
719 GMT
Interval 500.9 to 1032.4
|
|
Antibody Response Measured 1 Month After Vaccination (OPA)
Additional Serotype 6A
|
7060 GMT
Interval 5352.2 to 9312.6
|
5034 GMT
Interval 3336.6 to 7594.4
|
|
Antibody Response Measured 1 Month After Vaccination (OPA)
Additional Serotype 7F
|
5835 GMT
Interval 4160.0 to 8184.1
|
7887 GMT
Interval 6447.9 to 9647.0
|
|
Antibody Response Measured 1 Month After Vaccination (OPA)
Additional Serotype 19A
|
1256 GMT
Interval 990.9 to 1591.9
|
1556 GMT
Interval 1108.8 to 2182.2
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 28Population: Evaluable Immunogenicity Population; N=number of participants with a determinate antibody concentration to the specified serotype.
Antibody GMC as measured by mcg/mL for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. GMC (13vPnC) and corresponding 2-sided 95% CIs were evaluated. CIs were back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations. GMCs were calculated using all participants with available data for the specified blood draw.
Outcome measures
| Measure |
PCV/23vPS/13vPnC
n=50 Participants
For this study, participants received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly. Participants previously must have also received an infant series of 9-valent pneumococcal-conjugate-meningococcal serogroup C conjugate combination vaccine (9V-MnCC) also known as pneumococcal conjugate vaccine (PCV) followed by a toddler dose of 23-valent pneumococcal polysaccharide vaccine (23vPS).
|
PCV/PCV/13vPnC
n=37 Participants
For this study, participants received a single 0.5 mL dose of 13vPnC administered intramuscularly. Participants must have also previously received 9V-MnCC followed by a toddler dose of 9V-MnCC (also referred to as PCV).
|
|---|---|---|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal IgG Antibody 1 Month After Vaccination
Common serotype 4
|
4.18 mcg/mL
Interval 3.38 to 5.16
|
11.34 mcg/mL
Interval 7.74 to 16.62
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal IgG Antibody 1 Month After Vaccination
Common serotype 6B
|
29.51 mcg/mL
Interval 21.32 to 40.83
|
41.70 mcg/mL
Interval 29.01 to 59.96
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal IgG Antibody 1 Month After Vaccination
Common serotype 9V
|
4.31 mcg/mL
Interval 3.68 to 5.04
|
7.39 mcg/mL
Interval 6.05 to 9.03
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal IgG Antibody 1 Month After Vaccination
Common serotype 14
|
17.47 mcg/mL
Interval 12.76 to 23.93
|
22.78 mcg/mL
Interval 15.75 to 32.96
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal IgG Antibody 1 Month After Vaccination
Common serotype 18C
|
2.76 mcg/mL
Interval 2.15 to 3.56
|
4.83 mcg/mL
Interval 3.48 to 6.71
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal IgG Antibody 1 Month After Vaccination
Common serotype 19F
|
9.78 mcg/mL
Interval 7.45 to 12.83
|
11.60 mcg/mL
Interval 8.46 to 15.92
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal IgG Antibody 1 Month After Vaccination
Common serotype 23F
|
7.89 mcg/mL
Interval 6.18 to 10.07
|
12.25 mcg/mL
Interval 8.92 to 16.81
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal IgG Antibody 1 Month After Vaccination
Additional serotype 1
|
5.28 mcg/mL
Interval 4.22 to 6.61
|
19.43 mcg/mL
Interval 13.77 to 27.41
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal IgG Antibody 1 Month After Vaccination
Additional serotype 3
|
3.28 mcg/mL
Interval 2.44 to 4.41
|
2.87 mcg/mL
Interval 2.19 to 3.76
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal IgG Antibody 1 Month After Vaccination
Additional serotype 5
|
5.75 mcg/mL
Interval 4.64 to 7.12
|
15.98 mcg/mL
Interval 11.99 to 21.3
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal IgG Antibody 1 Month After Vaccination
Additional serotype 6A
|
11.16 mcg/mL
Interval 8.8 to 14.16
|
14.07 mcg/mL
Interval 10.64 to 18.61
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal IgG Antibody 1 Month After Vaccination
Additional serotype 7F
|
7.13 mcg/mL
Interval 5.67 to 8.96
|
8.05 mcg/mL
Interval 5.94 to 10.91
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal IgG Antibody 1 Month After Vaccination
Additional serotype 19A
|
14.62 mcg/mL
Interval 11.49 to 18.59
|
17.07 mcg/mL
Interval 12.92 to 22.55
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 1 through Day 4Population: Safety Population: all participants who receive at least 1 dose of the study vaccine; N=number of participants reporting yes for at least 1 day or no for all days and "number analyzed" signifies participants reporting the specific characteristic.
Local reactions were reported by the parent/legal guardian using a diary card. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters \[cm\] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (\> 7.0 cm). Participants may have been represented in more than 1 category.
Outcome measures
| Measure |
PCV/23vPS/13vPnC
n=50 Participants
For this study, participants received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly. Participants previously must have also received an infant series of 9-valent pneumococcal-conjugate-meningococcal serogroup C conjugate combination vaccine (9V-MnCC) also known as pneumococcal conjugate vaccine (PCV) followed by a toddler dose of 23-valent pneumococcal polysaccharide vaccine (23vPS).
|
PCV/PCV/13vPnC
n=39 Participants
For this study, participants received a single 0.5 mL dose of 13vPnC administered intramuscularly. Participants must have also previously received 9V-MnCC followed by a toddler dose of 9V-MnCC (also referred to as PCV).
|
|---|---|---|
|
Percentage of Participants Reporting Prespecified Local Reactions Within 4 Days of Vaccination
Tenderness: Any
|
88.0 Percentage of participants
|
76.9 Percentage of participants
|
|
Percentage of Participants Reporting Prespecified Local Reactions Within 4 Days of Vaccination
Tenderness: Significant
|
12.0 Percentage of participants
|
20.5 Percentage of participants
|
|
Percentage of Participants Reporting Prespecified Local Reactions Within 4 Days of Vaccination
Redness: Any
|
50.0 Percentage of participants
|
66.7 Percentage of participants
|
|
Percentage of Participants Reporting Prespecified Local Reactions Within 4 Days of Vaccination
Redness: Mild
|
10.0 Percentage of participants
|
15.8 Percentage of participants
|
|
Percentage of Participants Reporting Prespecified Local Reactions Within 4 Days of Vaccination
Redness: Moderate
|
40.0 Percentage of participants
|
52.6 Percentage of participants
|
|
Percentage of Participants Reporting Prespecified Local Reactions Within 4 Days of Vaccination
Redness: Severe
|
10.0 Percentage of participants
|
21.1 Percentage of participants
|
|
Percentage of Participants Reporting Prespecified Local Reactions Within 4 Days of Vaccination
Swelling: Any
|
44.0 Percentage of participants
|
59.0 Percentage of participants
|
|
Percentage of Participants Reporting Prespecified Local Reactions Within 4 Days of Vaccination
Swelling: Mild
|
16.3 Percentage of participants
|
26.3 Percentage of participants
|
|
Percentage of Participants Reporting Prespecified Local Reactions Within 4 Days of Vaccination
Swelling: Moderate
|
28.6 Percentage of participants
|
44.7 Percentage of participants
|
|
Percentage of Participants Reporting Prespecified Local Reactions Within 4 Days of Vaccination
Swelling: Severe
|
2.0 Percentage of participants
|
7.9 Percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 1 through Day 4Population: Safety; N=number of participants reporting yes for at least 1 day or no for all days and number analyzed signifies participants reporting the specific characteristic.
Pre-specified systemic events (any fever 38 degrees Celsius \[C\], decreased appetite, irritability, increased sleep, and decreased sleep) were reported using a diary card. Participants may have been represented in more than 1 category.
Outcome measures
| Measure |
PCV/23vPS/13vPnC
n=50 Participants
For this study, participants received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly. Participants previously must have also received an infant series of 9-valent pneumococcal-conjugate-meningococcal serogroup C conjugate combination vaccine (9V-MnCC) also known as pneumococcal conjugate vaccine (PCV) followed by a toddler dose of 23-valent pneumococcal polysaccharide vaccine (23vPS).
|
PCV/PCV/13vPnC
n=39 Participants
For this study, participants received a single 0.5 mL dose of 13vPnC administered intramuscularly. Participants must have also previously received 9V-MnCC followed by a toddler dose of 9V-MnCC (also referred to as PCV).
|
|---|---|---|
|
Percentage of Participants Reporting Prespecified Systemic Reactions Within 4 Days of Vaccination
Fever ≥ 38 degrees C but ≤ 39 degrees C
|
2.0 Percentage of participants
|
2.8 Percentage of participants
|
|
Percentage of Participants Reporting Prespecified Systemic Reactions Within 4 Days of Vaccination
Decreased appetite
|
12.2 Percentage of participants
|
10.3 Percentage of participants
|
|
Percentage of Participants Reporting Prespecified Systemic Reactions Within 4 Days of Vaccination
Irritability
|
18.4 Percentage of participants
|
11.4 Percentage of participants
|
|
Percentage of Participants Reporting Prespecified Systemic Reactions Within 4 Days of Vaccination
Increased sleep
|
4.0 Percentage of participants
|
12.8 Percentage of participants
|
|
Percentage of Participants Reporting Prespecified Systemic Reactions Within 4 Days of Vaccination
Decreased sleep
|
—
|
5.1 Percentage of participants
|
|
Percentage of Participants Reporting Prespecified Systemic Reactions Within 4 Days of Vaccination
Rash
|
6.0 Percentage of participants
|
2.6 Percentage of participants
|
Adverse Events
PCV/23vPS/13vPnC
Serious events: 0 serious events
Other events: 44 other events
Deaths: 0 deaths
PCV/PCV/13vPnC
Serious events: 0 serious events
Other events: 30 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
PCV/23vPS/13vPnC
n=50 participants at risk
For this study, participants received a single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) administered intramuscularly. Participants previously must have also received an infant series of 9-valent pneumococcal-conjugate-meningococcal serogroup C conjugate combination vaccine (9V-MnCC) also known as pneumococcal conjugate vaccine (PCV) followed by a toddler dose of 23-valent pneumococcal polysaccharide vaccine (23vPS).
Other AEs (non-serious events): the number affected (N) for nonsystematic (unsolicited) Other Adverse Events N=8; systematic (solicited) Local Reactions N=44; systematic (solicited) Systemic Events N=9.
|
PCV/PCV/13vPnC
n=39 participants at risk
For this study, participants received a single 0.5 mL dose of 13vPnC, administered intramuscularly. Participants must have also previously received 9V-MnCC followed by a toddler dose of 9V-MnCC (also referred to as PCV).
Other AEs (non-serious events): the number affected (N) for nonsystematic (unsolicited) Other Adverse Events N=7; systematic (solicited) Local Reactions N=30; systematic (solicited) Systemic Events N=5.
|
|---|---|---|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
2.0%
1/50 • Baseline through 1 Month after last study vaccination (28 Days). Local reactions and systemic events assessed within 4 days of dose (Day 1 through Day 4)
The same event may appear as both an adverse event (AE) and a Serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/39 • Baseline through 1 Month after last study vaccination (28 Days). Local reactions and systemic events assessed within 4 days of dose (Day 1 through Day 4)
The same event may appear as both an adverse event (AE) and a Serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Vomiting
|
4.0%
2/50 • Baseline through 1 Month after last study vaccination (28 Days). Local reactions and systemic events assessed within 4 days of dose (Day 1 through Day 4)
The same event may appear as both an adverse event (AE) and a Serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.6%
1/39 • Baseline through 1 Month after last study vaccination (28 Days). Local reactions and systemic events assessed within 4 days of dose (Day 1 through Day 4)
The same event may appear as both an adverse event (AE) and a Serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Diarrhoea
|
4.0%
2/50 • Baseline through 1 Month after last study vaccination (28 Days). Local reactions and systemic events assessed within 4 days of dose (Day 1 through Day 4)
The same event may appear as both an adverse event (AE) and a Serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/39 • Baseline through 1 Month after last study vaccination (28 Days). Local reactions and systemic events assessed within 4 days of dose (Day 1 through Day 4)
The same event may appear as both an adverse event (AE) and a Serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Abdominal pain
|
2.0%
1/50 • Baseline through 1 Month after last study vaccination (28 Days). Local reactions and systemic events assessed within 4 days of dose (Day 1 through Day 4)
The same event may appear as both an adverse event (AE) and a Serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/39 • Baseline through 1 Month after last study vaccination (28 Days). Local reactions and systemic events assessed within 4 days of dose (Day 1 through Day 4)
The same event may appear as both an adverse event (AE) and a Serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/50 • Baseline through 1 Month after last study vaccination (28 Days). Local reactions and systemic events assessed within 4 days of dose (Day 1 through Day 4)
The same event may appear as both an adverse event (AE) and a Serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.6%
1/39 • Baseline through 1 Month after last study vaccination (28 Days). Local reactions and systemic events assessed within 4 days of dose (Day 1 through Day 4)
The same event may appear as both an adverse event (AE) and a Serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Pyrexia
|
2.0%
1/50 • Baseline through 1 Month after last study vaccination (28 Days). Local reactions and systemic events assessed within 4 days of dose (Day 1 through Day 4)
The same event may appear as both an adverse event (AE) and a Serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/39 • Baseline through 1 Month after last study vaccination (28 Days). Local reactions and systemic events assessed within 4 days of dose (Day 1 through Day 4)
The same event may appear as both an adverse event (AE) and a Serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Viral infection
|
0.00%
0/50 • Baseline through 1 Month after last study vaccination (28 Days). Local reactions and systemic events assessed within 4 days of dose (Day 1 through Day 4)
The same event may appear as both an adverse event (AE) and a Serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
7.7%
3/39 • Baseline through 1 Month after last study vaccination (28 Days). Local reactions and systemic events assessed within 4 days of dose (Day 1 through Day 4)
The same event may appear as both an adverse event (AE) and a Serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Influenza
|
2.0%
1/50 • Baseline through 1 Month after last study vaccination (28 Days). Local reactions and systemic events assessed within 4 days of dose (Day 1 through Day 4)
The same event may appear as both an adverse event (AE) and a Serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.6%
1/39 • Baseline through 1 Month after last study vaccination (28 Days). Local reactions and systemic events assessed within 4 days of dose (Day 1 through Day 4)
The same event may appear as both an adverse event (AE) and a Serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/50 • Baseline through 1 Month after last study vaccination (28 Days). Local reactions and systemic events assessed within 4 days of dose (Day 1 through Day 4)
The same event may appear as both an adverse event (AE) and a Serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.6%
1/39 • Baseline through 1 Month after last study vaccination (28 Days). Local reactions and systemic events assessed within 4 days of dose (Day 1 through Day 4)
The same event may appear as both an adverse event (AE) and a Serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Pharyngitis
|
2.0%
1/50 • Baseline through 1 Month after last study vaccination (28 Days). Local reactions and systemic events assessed within 4 days of dose (Day 1 through Day 4)
The same event may appear as both an adverse event (AE) and a Serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/39 • Baseline through 1 Month after last study vaccination (28 Days). Local reactions and systemic events assessed within 4 days of dose (Day 1 through Day 4)
The same event may appear as both an adverse event (AE) and a Serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/50 • Baseline through 1 Month after last study vaccination (28 Days). Local reactions and systemic events assessed within 4 days of dose (Day 1 through Day 4)
The same event may appear as both an adverse event (AE) and a Serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.6%
1/39 • Baseline through 1 Month after last study vaccination (28 Days). Local reactions and systemic events assessed within 4 days of dose (Day 1 through Day 4)
The same event may appear as both an adverse event (AE) and a Serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
2.0%
1/50 • Baseline through 1 Month after last study vaccination (28 Days). Local reactions and systemic events assessed within 4 days of dose (Day 1 through Day 4)
The same event may appear as both an adverse event (AE) and a Serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/39 • Baseline through 1 Month after last study vaccination (28 Days). Local reactions and systemic events assessed within 4 days of dose (Day 1 through Day 4)
The same event may appear as both an adverse event (AE) and a Serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
2.0%
1/50 • Baseline through 1 Month after last study vaccination (28 Days). Local reactions and systemic events assessed within 4 days of dose (Day 1 through Day 4)
The same event may appear as both an adverse event (AE) and a Serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/39 • Baseline through 1 Month after last study vaccination (28 Days). Local reactions and systemic events assessed within 4 days of dose (Day 1 through Day 4)
The same event may appear as both an adverse event (AE) and a Serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Tenderness (Any)
|
88.0%
44/50 • Baseline through 1 Month after last study vaccination (28 Days). Local reactions and systemic events assessed within 4 days of dose (Day 1 through Day 4)
The same event may appear as both an adverse event (AE) and a Serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
76.9%
30/39 • Baseline through 1 Month after last study vaccination (28 Days). Local reactions and systemic events assessed within 4 days of dose (Day 1 through Day 4)
The same event may appear as both an adverse event (AE) and a Serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Tenderness (Significant)
|
12.0%
6/50 • Baseline through 1 Month after last study vaccination (28 Days). Local reactions and systemic events assessed within 4 days of dose (Day 1 through Day 4)
The same event may appear as both an adverse event (AE) and a Serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
20.5%
8/39 • Baseline through 1 Month after last study vaccination (28 Days). Local reactions and systemic events assessed within 4 days of dose (Day 1 through Day 4)
The same event may appear as both an adverse event (AE) and a Serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Redness (Any)
|
50.0%
25/50 • Baseline through 1 Month after last study vaccination (28 Days). Local reactions and systemic events assessed within 4 days of dose (Day 1 through Day 4)
The same event may appear as both an adverse event (AE) and a Serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
66.7%
26/39 • Baseline through 1 Month after last study vaccination (28 Days). Local reactions and systemic events assessed within 4 days of dose (Day 1 through Day 4)
The same event may appear as both an adverse event (AE) and a Serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Redness (Mild)
|
10.0%
5/50 • Baseline through 1 Month after last study vaccination (28 Days). Local reactions and systemic events assessed within 4 days of dose (Day 1 through Day 4)
The same event may appear as both an adverse event (AE) and a Serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
15.8%
6/38 • Baseline through 1 Month after last study vaccination (28 Days). Local reactions and systemic events assessed within 4 days of dose (Day 1 through Day 4)
The same event may appear as both an adverse event (AE) and a Serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Redness (Moderate)
|
40.0%
20/50 • Baseline through 1 Month after last study vaccination (28 Days). Local reactions and systemic events assessed within 4 days of dose (Day 1 through Day 4)
The same event may appear as both an adverse event (AE) and a Serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
52.6%
20/38 • Baseline through 1 Month after last study vaccination (28 Days). Local reactions and systemic events assessed within 4 days of dose (Day 1 through Day 4)
The same event may appear as both an adverse event (AE) and a Serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Redness (Severe)
|
10.0%
5/50 • Baseline through 1 Month after last study vaccination (28 Days). Local reactions and systemic events assessed within 4 days of dose (Day 1 through Day 4)
The same event may appear as both an adverse event (AE) and a Serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
21.1%
8/38 • Baseline through 1 Month after last study vaccination (28 Days). Local reactions and systemic events assessed within 4 days of dose (Day 1 through Day 4)
The same event may appear as both an adverse event (AE) and a Serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Swelling (Any)
|
44.0%
22/50 • Baseline through 1 Month after last study vaccination (28 Days). Local reactions and systemic events assessed within 4 days of dose (Day 1 through Day 4)
The same event may appear as both an adverse event (AE) and a Serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
59.0%
23/39 • Baseline through 1 Month after last study vaccination (28 Days). Local reactions and systemic events assessed within 4 days of dose (Day 1 through Day 4)
The same event may appear as both an adverse event (AE) and a Serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Swelling (Mild)
|
16.3%
8/49 • Baseline through 1 Month after last study vaccination (28 Days). Local reactions and systemic events assessed within 4 days of dose (Day 1 through Day 4)
The same event may appear as both an adverse event (AE) and a Serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
26.3%
10/38 • Baseline through 1 Month after last study vaccination (28 Days). Local reactions and systemic events assessed within 4 days of dose (Day 1 through Day 4)
The same event may appear as both an adverse event (AE) and a Serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Swelling (Moderate)
|
28.6%
14/49 • Baseline through 1 Month after last study vaccination (28 Days). Local reactions and systemic events assessed within 4 days of dose (Day 1 through Day 4)
The same event may appear as both an adverse event (AE) and a Serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
44.7%
17/38 • Baseline through 1 Month after last study vaccination (28 Days). Local reactions and systemic events assessed within 4 days of dose (Day 1 through Day 4)
The same event may appear as both an adverse event (AE) and a Serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Swelling (Severe)
|
2.0%
1/49 • Baseline through 1 Month after last study vaccination (28 Days). Local reactions and systemic events assessed within 4 days of dose (Day 1 through Day 4)
The same event may appear as both an adverse event (AE) and a Serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
7.9%
3/38 • Baseline through 1 Month after last study vaccination (28 Days). Local reactions and systemic events assessed within 4 days of dose (Day 1 through Day 4)
The same event may appear as both an adverse event (AE) and a Serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Fever ≥ 38°C but ≤ 39°C
|
2.0%
1/49 • Baseline through 1 Month after last study vaccination (28 Days). Local reactions and systemic events assessed within 4 days of dose (Day 1 through Day 4)
The same event may appear as both an adverse event (AE) and a Serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.8%
1/36 • Baseline through 1 Month after last study vaccination (28 Days). Local reactions and systemic events assessed within 4 days of dose (Day 1 through Day 4)
The same event may appear as both an adverse event (AE) and a Serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Fever > 39°C but ≤ 40°C
|
0.00%
0/49 • Baseline through 1 Month after last study vaccination (28 Days). Local reactions and systemic events assessed within 4 days of dose (Day 1 through Day 4)
The same event may appear as both an adverse event (AE) and a Serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/36 • Baseline through 1 Month after last study vaccination (28 Days). Local reactions and systemic events assessed within 4 days of dose (Day 1 through Day 4)
The same event may appear as both an adverse event (AE) and a Serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Fever > 40°C
|
0.00%
0/49 • Baseline through 1 Month after last study vaccination (28 Days). Local reactions and systemic events assessed within 4 days of dose (Day 1 through Day 4)
The same event may appear as both an adverse event (AE) and a Serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/36 • Baseline through 1 Month after last study vaccination (28 Days). Local reactions and systemic events assessed within 4 days of dose (Day 1 through Day 4)
The same event may appear as both an adverse event (AE) and a Serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Decreased appetite
|
12.2%
6/49 • Baseline through 1 Month after last study vaccination (28 Days). Local reactions and systemic events assessed within 4 days of dose (Day 1 through Day 4)
The same event may appear as both an adverse event (AE) and a Serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
10.3%
4/39 • Baseline through 1 Month after last study vaccination (28 Days). Local reactions and systemic events assessed within 4 days of dose (Day 1 through Day 4)
The same event may appear as both an adverse event (AE) and a Serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Irritability
|
18.4%
9/49 • Baseline through 1 Month after last study vaccination (28 Days). Local reactions and systemic events assessed within 4 days of dose (Day 1 through Day 4)
The same event may appear as both an adverse event (AE) and a Serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
11.4%
4/35 • Baseline through 1 Month after last study vaccination (28 Days). Local reactions and systemic events assessed within 4 days of dose (Day 1 through Day 4)
The same event may appear as both an adverse event (AE) and a Serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Increased sleep
|
4.0%
2/50 • Baseline through 1 Month after last study vaccination (28 Days). Local reactions and systemic events assessed within 4 days of dose (Day 1 through Day 4)
The same event may appear as both an adverse event (AE) and a Serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
12.8%
5/39 • Baseline through 1 Month after last study vaccination (28 Days). Local reactions and systemic events assessed within 4 days of dose (Day 1 through Day 4)
The same event may appear as both an adverse event (AE) and a Serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Decreased sleep
|
0.00%
0/48 • Baseline through 1 Month after last study vaccination (28 Days). Local reactions and systemic events assessed within 4 days of dose (Day 1 through Day 4)
The same event may appear as both an adverse event (AE) and a Serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
5.1%
2/39 • Baseline through 1 Month after last study vaccination (28 Days). Local reactions and systemic events assessed within 4 days of dose (Day 1 through Day 4)
The same event may appear as both an adverse event (AE) and a Serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Rash
|
6.0%
3/50 • Baseline through 1 Month after last study vaccination (28 Days). Local reactions and systemic events assessed within 4 days of dose (Day 1 through Day 4)
The same event may appear as both an adverse event (AE) and a Serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.6%
1/39 • Baseline through 1 Month after last study vaccination (28 Days). Local reactions and systemic events assessed within 4 days of dose (Day 1 through Day 4)
The same event may appear as both an adverse event (AE) and a Serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER