Pneumococcal Conjugate Vaccine
Conditions
Brief summary
This study is to evaluate the safety, tolerability and immunogenicity of 13-valent pneumococcal Conjugate Vaccine in children with Sickle Cell Disease who have already been vaccinated with 23-valent polysaccharide vaccine. The study will measure the amount of antibodies (the proteins that fight off germs) produced by children with Sickle Cell Disease after they have been given the 13-valent pneumococcal vaccine between 6 and less than 18 years of age. They will be given the vaccination twice, each vaccination separated by approximately 6 months.
Interventions
BIOLOGICAL13-valent Pneumoccocal Conjugate Vaccine
2 doses of 13vPnC will be administered by intramuscular injection separated by approximately 6 months.
Sponsors
Pfizer
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* Male or female subject between the ages of \>=6 to \<18 years. * Diagnosis of SCD * 23vPS vaccination at least 6 months prior to enrollment.
Exclusion criteria
* Previous vaccination with pneumococcal conjugate vaccine. * Previous reaction to any vaccine or vaccine-related component or contraindication to vaccination with pneumococcal conjugate vaccine.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Fold Rise (GMFR) in Serotype-Specific Pneumococcal Immunoglobulin G (IgG) From 1 Month After 13vPnC Dose 1 to 1 Month After 13vPnC Dose 2 | 1 Month After 13vPnC Dose 1, 1 Month After 13vPnC Dose 2 | GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from 1 month after 13vPnC Dose 1 to 1 month after 13vPnC Dose 2 were computed using the logarithmically transformed assay results. Confidence interval (CI) for GMFR were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise. GMFRs were calculated using all participants with available data from both 1 month after 13vPnC Dose 1 and after 13vPnC Dose 2 blood draws. Here number of participants analyzed signifies the evaluable immunogenicity population and N signifies participants with a determinate IgG antibody concentration for the given serotype at both 1 Month After 13vPnC Dose 1 and 1 Month After 13vPnC Dose 2 blood draws. Participants may be represented in more than 1 category. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ratio of Geometric Mean Fold Rise (GMFR) in Serotype-Specific Pneumococcal Immunoglobulin G (IgG) From 13vPnC Dose 1 to 13vPnC Dose 2 | Before 13vPnC Dose 1, 1 month after 13vPnC Dose 1, before 13vPnC Dose 2, 1 month after 13vPnC Dose 2 | GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were computed using the logarithmically transformed assay results for Dose 1 (after Dose 1/before Dose 1) and for Dose 2 (after Dose 2/before Dose 2). CI for the ratio of GMFR (Dose 2/Dose 1) were back transformations of a CI based on the Student t distribution for the mean logarithm of the measures (Dose 2 - Dose 1). Here number of participants analyzed signifies the evaluable immunogenicity population and N signifies participants with determinate IgG antibody concentration for given serotype at before 13vPnC Dose 1, 1 month after 13vPnC Dose 1, before 13vPnC Dose 2 and 1 month after 13vPnC Dose 2 blood draws. Participants may be represented in more than 1 category. |
| Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody | Before 13vPnC Dose 1, 1 month after 13vPnC Dose 1, before 13vPnC Dose 2, 1 month after 13vPnC Dose 2 | Antibody GMC for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) are presented. GMC (13vPnC) and corresponding 2-sided 95 percent (%) CIs were evaluated. Geometric means were calculated using all participants with available data for the specified blood draw. CI for GMC were back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations. Here number of participants analyzed signifies the evaluable immunogenicity population and N signifies participants with determinate IgG antibody concentration for the given serotype at specified time point. Participants may be represented in more than 1 category. |
| Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Year After 13vPnC Dose 2 | 1 year after 13vPnC Dose 2 | Antibody GMC for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) are presented. GMC (13vPnC) and corresponding 2-sided 95 percent (%) CIs were evaluated. Geometric means were calculated using all participants with available data for the specified blood draw. CI for GMC were back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations. Here number of participants analyzed signifies the evaluable immunogenicity population at 1-year follow-up and N signifies participants with determinate IgG antibody concentration for the given serotype. Participants may be represented in more than 1 category. |
| Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) | Before 13vPnC Dose 1, 1 month after 13vPnC Dose 1, before 13vPnC Dose 2, 1 month after 13vPnC Dose 2 | Antibody GMTs as measured by OPA assay for 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). GMT and corresponding 2-sided 95% CIs were evaluated. CIs for the GMTs are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the titers. GMTs were calculated using all participants with available data for the specified blood draw. Here number of participants analyzed signifies the evaluable immunogenicity population and N signifies participants with determinate OPA antibody titer for the given serotype at specified time point. Participants may be represented in more than 1 category. |
| Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Year After 13vPnC Dose 2 | 1 year after 13vPnC Dose 2 | Antibody GMTs as measured by OPA assay for 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). GMT and corresponding 2-sided 95% CIs were evaluated. CIs for the GMTs are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the titers. GMTs were calculated using all participants with available data for the specified blood draw. Here number of participants analyzed signifies the evaluable immunogenicity population at 1-year follow-up and N signifies participants with determinate OPA antibody titer for the given serotype. Participants may be represented in more than 1 category. |
| Geometric Mean Fold Rise (GMFR) in Serotype-Specific Pneumococcal Immunoglobulin G (IgG) From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 1 | Before 13vPnC Dose 1, 1 month after 13vPnC Dose 1 | GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from before 13vPnC Dose 1 to 1 month after 13vPnC Dose 1 were computed using the logarithmically transformed assay results. CI for GMFR were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise. GMFRs were calculated using all participants with available data from before 13vPnC Dose 1 and 1 month after 13vPnC Dose 1 blood draws. Here number of participants analyzed signifies the evaluable immunogenicity population and N signifies participants with determinate IgG antibody concentration for the given serotype at both the before 13vPnC Dose 1 and 1 month after 13vPnC Dose 1 blood draws. Participants may be represented in more than 1 category. |
| Geometric Mean Fold Rise (GMFR) in Serotype-Specific Pneumococcal Immunoglobulin G (IgG) From Before 13vPnC Dose 2 to 1 Month After 13vPnC Dose 2 | Before 13vPnC Dose 2, 1 month after 13vPnC Dose 2 | GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from before 13vPnC Dose 2 to 1 month after 13vPnC Dose 2 were computed using the logarithmically transformed assay results. CI for GMFR were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise. GMFRs were calculated using all participants with available data from before 13vPnC Dose 2 and 1 month after 13vPnC Dose 2 blood draws. Here number of participants analyzed signifies the evaluable immunogenicity population and N signifies participants with determinate IgG antibody concentration for the given serotype at both the before 13vPnC Dose 2 and 1 month after 13vPnC Dose 2 blood draws. Participants may be represented in more than 1 category. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Prespecified Systemic Events: 13vPnC Dose 1 | Within 7 days after 13vPnC Dose 1 | Specific systemic events (fever \>=38 degrees Celsius\[C\], vomiting, diarrhea, headache, fatigue, muscle pain, joint pain, use of antipyretic medications) were prompted for each day and reported using an electronic diary. Fatigue, headache, muscle pain and joint pain were scaled as: Any(symptom present); Mild(did not interfere with activity); Moderate(some interference); Severe(prevented routine daily activity). Vomiting was scaled as: Any(vomiting present); Mild(1-2 times in 24 hours); Moderate(\>2 times in 24 hours); Severe(required intravenous hydration). Diarrhea was scaled as: Any(diarrhea present); Mild(2-3 loose stools in 24 hours);Moderate(4-5 loose stools 24 hours); Severe(\>=6 loose stools in 24 hours). Here number of participants analyzed signifies the safety population for Dose 1 and N signifies those participants who reported Yes for at least 1 day or No for all days for specified systemic event. Participants may be represented in more than 1 category. |
| Percentage of Participants With Prespecified Systemic Events: 13vPnC Dose 2 | Within 7 days after 13vPnC Dose 2 | Specific systemic events (fever \>=38 degrees C, vomiting, diarrhea, headache, fatigue, muscle pain, joint pain, and use of antipyretic medications) were prompted for each day, and reported using an electronic diary. Fatigue, headache, muscle pain and joint pain were scaled as: Any(symptom present); Mild(did not interfere with activity); Moderate(some interference); Severe(prevented routine daily activity). Vomiting was scaled as: Any(vomiting present); Mild(1-2 times in 24 hours); Moderate(\>2 times in 24 hours); Severe (required intravenous hydration). Diarrhea was scaled as: Any(diarrhea present); Mild(2-3 loose stools in 24 hours); Moderate(4-5 loose stools 24 hours); Severe(\>=6 loose stools in 24 hours). Here number of participants analyzed signifies the safety population for Dose 2 and N signifies those participants who reported Yes for at least 1 day or No for all days for specified systemic event. Participants may be represented in more than 1 category. |
| Percentage of Participants With Prespecified Local Reactions: 13vPnC Dose 1 | Within 7 days after 13vPnC Dose 1 | Specific local reactions were prompted for each day, and reported using an electronic diary. Redness and Swelling were scaled as: Any (redness present or swelling present); Mild (less than \<2.5 centimeters \[cm\] for participants aged 6 to \<12 years and 2.5 to 5.0 cm for participants aged greater than or equal to \[\>=\] 12 years); Moderate (2.5 to 7.0 cm for participants aged 6 to \<12 years and 5.1 to 10.0 cm for participants aged \>=12 years); Severe (\>7 cm for participants aged 6 to \<12 years and \>10 cm for participants aged \>=12 years). Pain was scaled as: Any (pain present); Mild (did not interfere with activity); Moderate (interfered with activity); Severe (prevented daily activity). Here Number of participants analyzed signifies the safety population for Dose 1 and N signifies those participants who reported Yes for at least 1 day or No for all days for specified local reaction. Participants may be represented in more than 1 category. |
| Percentage of Participants With Prespecified Local Reactions: 13vPnC Dose 2 | Within 7 days after 13vPnC Dose 2 | Specific local reactions were prompted for each day, and reported using an electronic diary. Redness and Swelling were scaled as: Any (redness present or swelling present); Mild (\<2.5 cm for participants aged 6 to \<12 years and 2.5 to 5.0 cm for participants aged \>=12 years); Moderate (2.5 to 7.0 cm for participants aged 6 to \<12 years and 5.1 to 10.0 cm for participants aged \>=12 years); Severe (\>7 cm for participants aged 6 to \<12 years and \>10 cm for participants aged \>=12 years). Pain was scaled as: Any (pain present); Mild (did not interfere with activity); Moderate (interfered with activity); Severe (prevented daily activity). Here number of participants analyzed signifies the safety population for Dose 2 and N signifies those participants who reported Yes for at least 1 day or No for all days for specified local reaction. Participants may be represented in more than 1 category. |
Countries
Egypt, France, Italy, Lebanon, Saudi Arabia, United Kingdom, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 13vPnC Participants previously immunized with 23-valent pneumococcal polysaccharide vaccine (23vPS) received 2 single 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection, 6 months apart. | 158 |
| Total | 158 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| After 6-month FU to 1-year FU | Did Not Continue After 6-Month FU | 58 |
| After 6-month FU to 1-year FU | Failed to Return | 2 |
| Up to 6-month Follow-up(FU) | Adverse Event | 1 |
| Up to 6-month Follow-up(FU) | Failed to Return | 1 |
| Up to 6-month Follow-up(FU) | Lost to Follow-up | 5 |
| Up to 6-month Follow-up(FU) | Parent/Legal Guardian Request | 2 |
| Up to 6-month Follow-up(FU) | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | 13vPnC |
|---|---|
| Age, Continuous | 13.3 years STANDARD_DEVIATION 3.08 |
| Sex: Female, Male Female | 76 Participants |
| Sex: Female, Male Male | 82 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 133 / 158 | 100 / 140 | 1 / 147 | 1 / 87 |
| serious Total, serious adverse events | 40 / 158 | 11 / 140 | 28 / 147 | 16 / 87 |
Outcome results
Primary
Geometric Mean Fold Rise (GMFR) in Serotype-Specific Pneumococcal Immunoglobulin G (IgG) From 1 Month After 13vPnC Dose 1 to 1 Month After 13vPnC Dose 2
GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from 1 month after 13vPnC Dose 1 to 1 month after 13vPnC Dose 2 were computed using the logarithmically transformed assay results. Confidence interval (CI) for GMFR were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise. GMFRs were calculated using all participants with available data from both 1 month after 13vPnC Dose 1 and after 13vPnC Dose 2 blood draws. Here number of participants analyzed signifies the evaluable immunogenicity population and N signifies participants with a determinate IgG antibody concentration for the given serotype at both 1 Month After 13vPnC Dose 1 and 1 Month After 13vPnC Dose 2 blood draws. Participants may be represented in more than 1 category.
Time frame: 1 Month After 13vPnC Dose 1, 1 Month After 13vPnC Dose 2
Population: Evaluable immunogenicity population: eligible participants who received all study vaccinations; had valid and determinate assay result; had blood drawn within pre-specified time-frames; had no major protocol violation (including use of prohibited vaccine/medication, immunoglobulins or chronic systemic corticosteroids).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 13vPnC | Geometric Mean Fold Rise (GMFR) in Serotype-Specific Pneumococcal Immunoglobulin G (IgG) From 1 Month After 13vPnC Dose 1 to 1 Month After 13vPnC Dose 2 | Serotype 4 (N = 137) | 0.75 fold rise |
| 13vPnC | Geometric Mean Fold Rise (GMFR) in Serotype-Specific Pneumococcal Immunoglobulin G (IgG) From 1 Month After 13vPnC Dose 1 to 1 Month After 13vPnC Dose 2 | Serotype 6B (N = 136) | 0.89 fold rise |
| 13vPnC | Geometric Mean Fold Rise (GMFR) in Serotype-Specific Pneumococcal Immunoglobulin G (IgG) From 1 Month After 13vPnC Dose 1 to 1 Month After 13vPnC Dose 2 | Serotype 9V (N = 136) | 0.82 fold rise |
| 13vPnC | Geometric Mean Fold Rise (GMFR) in Serotype-Specific Pneumococcal Immunoglobulin G (IgG) From 1 Month After 13vPnC Dose 1 to 1 Month After 13vPnC Dose 2 | Serotype 19F (N = 136) | 1.05 fold rise |
| 13vPnC | Geometric Mean Fold Rise (GMFR) in Serotype-Specific Pneumococcal Immunoglobulin G (IgG) From 1 Month After 13vPnC Dose 1 to 1 Month After 13vPnC Dose 2 | Serotype 23F (N = 135) | 0.91 fold rise |
| 13vPnC | Geometric Mean Fold Rise (GMFR) in Serotype-Specific Pneumococcal Immunoglobulin G (IgG) From 1 Month After 13vPnC Dose 1 to 1 Month After 13vPnC Dose 2 | Serotype 3 (N = 134) | 0.82 fold rise |
| 13vPnC | Geometric Mean Fold Rise (GMFR) in Serotype-Specific Pneumococcal Immunoglobulin G (IgG) From 1 Month After 13vPnC Dose 1 to 1 Month After 13vPnC Dose 2 | Serotype 5 (N = 136) | 0.90 fold rise |
| 13vPnC | Geometric Mean Fold Rise (GMFR) in Serotype-Specific Pneumococcal Immunoglobulin G (IgG) From 1 Month After 13vPnC Dose 1 to 1 Month After 13vPnC Dose 2 | Serotype 7F (N = 137) | 0.75 fold rise |
| 13vPnC | Geometric Mean Fold Rise (GMFR) in Serotype-Specific Pneumococcal Immunoglobulin G (IgG) From 1 Month After 13vPnC Dose 1 to 1 Month After 13vPnC Dose 2 | Serotype 14 (N = 137) | 0.75 fold rise |
| 13vPnC | Geometric Mean Fold Rise (GMFR) in Serotype-Specific Pneumococcal Immunoglobulin G (IgG) From 1 Month After 13vPnC Dose 1 to 1 Month After 13vPnC Dose 2 | Serotype 18C (N = 137) | 0.70 fold rise |
| 13vPnC | Geometric Mean Fold Rise (GMFR) in Serotype-Specific Pneumococcal Immunoglobulin G (IgG) From 1 Month After 13vPnC Dose 1 to 1 Month After 13vPnC Dose 2 | Serotype 1 (N = 137) | 0.88 fold rise |
| 13vPnC | Geometric Mean Fold Rise (GMFR) in Serotype-Specific Pneumococcal Immunoglobulin G (IgG) From 1 Month After 13vPnC Dose 1 to 1 Month After 13vPnC Dose 2 | Serotype 6A (N = 136) | 0.95 fold rise |
| 13vPnC | Geometric Mean Fold Rise (GMFR) in Serotype-Specific Pneumococcal Immunoglobulin G (IgG) From 1 Month After 13vPnC Dose 1 to 1 Month After 13vPnC Dose 2 | Serotype 19A (N = 137) | 0.83 fold rise |
Secondary
Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody
Antibody GMC for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) are presented. GMC (13vPnC) and corresponding 2-sided 95 percent (%) CIs were evaluated. Geometric means were calculated using all participants with available data for the specified blood draw. CI for GMC were back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations. Here number of participants analyzed signifies the evaluable immunogenicity population and N signifies participants with determinate IgG antibody concentration for the given serotype at specified time point. Participants may be represented in more than 1 category.
Time frame: Before 13vPnC Dose 1, 1 month after 13vPnC Dose 1, before 13vPnC Dose 2, 1 month after 13vPnC Dose 2
Population: Evaluable immunogenicity population: eligible participants who received all study vaccinations; had valid and determinate assay result; had blood drawn within pre-specified time-frames; had no major protocol violation (including use of prohibited vaccine/medication, immunoglobulins or chronic systemic corticosteroids).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 13vPnC | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody | 1 Month After 13vPnC Dose 2: Serotype 7F (N = 137) | 7.06 microgram per milliliter (mcg/mL) |
| 13vPnC | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody | 1 Month After 13vPnC Dose 2: Serotype 1 (N = 137) | 4.51 microgram per milliliter (mcg/mL) |
| 13vPnC | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody | Before 13vPnC Dose 2: Serotype 6A (N = 135) | 9.05 microgram per milliliter (mcg/mL) |
| 13vPnC | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody | Before 13vPnC Dose 2: Serotype 7F (N = 138) | 4.09 microgram per milliliter (mcg/mL) |
| 13vPnC | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody | Before 13vPnC Dose 2: Serotype 19A (N = 138) | 15.13 microgram per milliliter (mcg/mL) |
| 13vPnC | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody | 1 Month After 13vPnC Dose 2: Serotype 4 (N = 137) | 5.09 microgram per milliliter (mcg/mL) |
| 13vPnC | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody | 1 Month After 13vPnC Dose 2: Serotype 6B (N= 137) | 24.52 microgram per milliliter (mcg/mL) |
| 13vPnC | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody | 1 Month After 13vPnC Dose 2: Serotype 9V (N= 136) | 7.46 microgram per milliliter (mcg/mL) |
| 13vPnC | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody | 1 Month After 13vPnC Dose 2: Serotype 14 (N = 137) | 26.19 microgram per milliliter (mcg/mL) |
| 13vPnC | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody | 1 Month After 13vPnC Dose 2: Serotype 18C (N= 137) | 5.44 microgram per milliliter (mcg/mL) |
| 13vPnC | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody | 1 Month After 13vPnC Dose 2: Serotype 19F (N= 136) | 20.56 microgram per milliliter (mcg/mL) |
| 13vPnC | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody | 1 Month After 13vPnC Dose 2: Serotype 23F (N= 135) | 16.18 microgram per milliliter (mcg/mL) |
| 13vPnC | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody | Before 13vPnC Dose 2: Serotype 18C (N = 138) | 3.73 microgram per milliliter (mcg/mL) |
| 13vPnC | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody | Before 13vPnC Dose 2: Serotype 19F (N = 137) | 10.34 microgram per milliliter (mcg/mL) |
| 13vPnC | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody | Before 13vPnC Dose 2: Serotype 23F (N = 137) | 8.07 microgram per milliliter (mcg/mL) |
| 13vPnC | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody | Before 13vPnC Dose 2: Serotype 1 (N = 137) | 2.65 microgram per milliliter (mcg/mL) |
| 13vPnC | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody | Before 13vPnC Dose 2: Serotype 3 (N = 135) | 1.27 microgram per milliliter (mcg/mL) |
| 13vPnC | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody | Before 13vPnC Dose 2: Serotype 5 (N = 137) | 4.91 microgram per milliliter (mcg/mL) |
| 13vPnC | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody | 1 Month After 13vPnC Dose 2: Serotype 3 (N = 134) | 1.67 microgram per milliliter (mcg/mL) |
| 13vPnC | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody | 1 Month After 13vPnC Dose 2: Serotype 5 (N = 136) | 6.33 microgram per milliliter (mcg/mL) |
| 13vPnC | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody | 1 Month After 13vPnC Dose 2: Serotype 6A (N = 136) | 16.37 microgram per milliliter (mcg/mL) |
| 13vPnC | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody | 1 Month After 13vPnC Dose 2: Serotype 19A (N= 137) | 22.19 microgram per milliliter (mcg/mL) |
| 13vPnC | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody | 1 Month After 13vPnC Dose 1: Serotype 19F (N= 138) | 20.40 microgram per milliliter (mcg/mL) |
| 13vPnC | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody | Before 13vPnC Dose 1: Serotype 4 (N = 136) | 1.01 microgram per milliliter (mcg/mL) |
| 13vPnC | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody | Before 13vPnC Dose 1: Serotype 6B (N = 138) | 5.79 microgram per milliliter (mcg/mL) |
| 13vPnC | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody | Before 13vPnC Dose 1: Serotype 9V (N = 138) | 3.01 microgram per milliliter (mcg/mL) |
| 13vPnC | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody | Before 13vPnC Dose 1: Serotype 14 (N = 138) | 6.30 microgram per milliliter (mcg/mL) |
| 13vPnC | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody | Before 13vPnC Dose 1: Serotype 18C (N = 137) | 1.40 microgram per milliliter (mcg/mL) |
| 13vPnC | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody | Before 13vPnC Dose 1: Serotype 19F (N = 134) | 4.46 microgram per milliliter (mcg/mL) |
| 13vPnC | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody | Before 13vPnC Dose 1: Serotype 23F (N = 138) | 2.80 microgram per milliliter (mcg/mL) |
| 13vPnC | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody | Before 13vPnC Dose 1: Serotype 1 (N = 129) | 1.57 microgram per milliliter (mcg/mL) |
| 13vPnC | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody | Before 13vPnC Dose 1: Serotype 3 (N = 133) | 1.02 microgram per milliliter (mcg/mL) |
| 13vPnC | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody | Before 13vPnC Dose 1: Serotype 5 (N = 138) | 4.14 microgram per milliliter (mcg/mL) |
| 13vPnC | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody | Before 13vPnC Dose 1: Serotype 6A (N = 132) | 4.62 microgram per milliliter (mcg/mL) |
| 13vPnC | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody | Before 13vPnC Dose 1: Serotype 7F (N = 137) | 2.16 microgram per milliliter (mcg/mL) |
| 13vPnC | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody | Before 13vPnC Dose 1: Serotype 19A (N = 138) | 8.16 microgram per milliliter (mcg/mL) |
| 13vPnC | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody | 1 Month After 13vPnC Dose 1: Serotype 4 (N = 138) | 6.85 microgram per milliliter (mcg/mL) |
| 13vPnC | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody | 1 Month After 13vPnC Dose 1: Serotype 6B (N= 137) | 27.25 microgram per milliliter (mcg/mL) |
| 13vPnC | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody | 1 Month After 13vPnC Dose 1: Serotype 9V (N= 138) | 9.31 microgram per milliliter (mcg/mL) |
| 13vPnC | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody | 1 Month After 13vPnC Dose 1: Serotype 14 (N = 138) | 34.63 microgram per milliliter (mcg/mL) |
| 13vPnC | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody | 1 Month After 13vPnC Dose 1: Serotype 18C (N= 138) | 7.83 microgram per milliliter (mcg/mL) |
| 13vPnC | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody | 1 Month After 13vPnC Dose 1: Serotype 23F (N= 137) | 18.25 microgram per milliliter (mcg/mL) |
| 13vPnC | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody | 1 Month After 13vPnC Dose 1: Serotype 1 (N = 138) | 5.24 microgram per milliliter (mcg/mL) |
| 13vPnC | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody | 1 Month After 13vPnC Dose 1: Serotype 3 (N = 138) | 2.04 microgram per milliliter (mcg/mL) |
| 13vPnC | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody | 1 Month After 13vPnC Dose 1: Serotype 5 (N = 138) | 7.19 microgram per milliliter (mcg/mL) |
| 13vPnC | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody | 1 Month After 13vPnC Dose 1: Serotype 6A (N = 138) | 17.61 microgram per milliliter (mcg/mL) |
| 13vPnC | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody | 1 Month After 13vPnC Dose 1: Serotype 7F (N = 138) | 9.46 microgram per milliliter (mcg/mL) |
| 13vPnC | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody | 1 Month After 13vPnC Dose 1: Serotype 19A (N= 138) | 26.82 microgram per milliliter (mcg/mL) |
| 13vPnC | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody | Before 13vPnC Dose 2: Serotype 4 (N = 138) | 2.77 microgram per milliliter (mcg/mL) |
| 13vPnC | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody | Before 13vPnC Dose 2: Serotype 6B (N = 138) | 13.67 microgram per milliliter (mcg/mL) |
| 13vPnC | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody | Before 13vPnC Dose 2: Serotype 9V (N = 138) | 5.19 microgram per milliliter (mcg/mL) |
| 13vPnC | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody | Before 13vPnC Dose 2: Serotype 14 (N = 138) | 21.07 microgram per milliliter (mcg/mL) |
Secondary
Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Year After 13vPnC Dose 2
Antibody GMC for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) are presented. GMC (13vPnC) and corresponding 2-sided 95 percent (%) CIs were evaluated. Geometric means were calculated using all participants with available data for the specified blood draw. CI for GMC were back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations. Here number of participants analyzed signifies the evaluable immunogenicity population at 1-year follow-up and N signifies participants with determinate IgG antibody concentration for the given serotype. Participants may be represented in more than 1 category.
Time frame: 1 year after 13vPnC Dose 2
Population: Evaluable immunogenicity population at 1-year follow-up: eligible participants who received all study vaccinations; had valid and determinate assay result; had blood drawn within pre-specified time-frames; had no major protocol violation (including use of prohibited vaccine/medication, immunoglobulins or chronic systemic corticosteroids).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 13vPnC | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Year After 13vPnC Dose 2 | Serotype 4 (N = 81) | 1.94 mcg/mL |
| 13vPnC | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Year After 13vPnC Dose 2 | Serotype 6B (N = 81) | 11.77 mcg/mL |
| 13vPnC | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Year After 13vPnC Dose 2 | Serotype 9V (N = 81) | 4.50 mcg/mL |
| 13vPnC | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Year After 13vPnC Dose 2 | Serotype 14 (N = 81) | 15.89 mcg/mL |
| 13vPnC | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Year After 13vPnC Dose 2 | Serotype 19F (N = 81) | 9.87 mcg/mL |
| 13vPnC | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Year After 13vPnC Dose 2 | Serotype 23F (N = 81) | 7.70 mcg/mL |
| 13vPnC | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Year After 13vPnC Dose 2 | Serotype 1 (N = 79) | 2.12 mcg/mL |
| 13vPnC | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Year After 13vPnC Dose 2 | Serotype 3 (N = 67) | 1.01 mcg/mL |
| 13vPnC | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Year After 13vPnC Dose 2 | Serotype 7F (N = 81) | 3.47 mcg/mL |
| 13vPnC | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Year After 13vPnC Dose 2 | Serotype 19A (N = 81) | 13.30 mcg/mL |
| 13vPnC | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Year After 13vPnC Dose 2 | Serotype 18C (N = 81) | 2.64 mcg/mL |
| 13vPnC | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Year After 13vPnC Dose 2 | Serotype 5 (N = 81) | 4.38 mcg/mL |
| 13vPnC | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Year After 13vPnC Dose 2 | Serotype 6A (N = 81) | 7.94 mcg/mL |
Secondary
Geometric Mean Fold Rise (GMFR) in Serotype-Specific Pneumococcal Immunoglobulin G (IgG) From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 1
GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from before 13vPnC Dose 1 to 1 month after 13vPnC Dose 1 were computed using the logarithmically transformed assay results. CI for GMFR were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise. GMFRs were calculated using all participants with available data from before 13vPnC Dose 1 and 1 month after 13vPnC Dose 1 blood draws. Here number of participants analyzed signifies the evaluable immunogenicity population and N signifies participants with determinate IgG antibody concentration for the given serotype at both the before 13vPnC Dose 1 and 1 month after 13vPnC Dose 1 blood draws. Participants may be represented in more than 1 category.
Time frame: Before 13vPnC Dose 1, 1 month after 13vPnC Dose 1
Population: Evaluable immunogenicity population: eligible participants who received all study vaccinations; had valid and determinate assay result; had blood drawn within pre-specified time-frames; had no major protocol violation (including use of prohibited vaccine/medication, immunoglobulins or chronic systemic corticosteroids).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 13vPnC | Geometric Mean Fold Rise (GMFR) in Serotype-Specific Pneumococcal Immunoglobulin G (IgG) From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 1 | Serotype 4 (N = 136) | 6.91 fold rise |
| 13vPnC | Geometric Mean Fold Rise (GMFR) in Serotype-Specific Pneumococcal Immunoglobulin G (IgG) From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 1 | Serotype 6B (N = 137) | 4.72 fold rise |
| 13vPnC | Geometric Mean Fold Rise (GMFR) in Serotype-Specific Pneumococcal Immunoglobulin G (IgG) From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 1 | Serotype 9V (N = 138) | 3.10 fold rise |
| 13vPnC | Geometric Mean Fold Rise (GMFR) in Serotype-Specific Pneumococcal Immunoglobulin G (IgG) From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 1 | Serotype 19F (N = 134) | 4.76 fold rise |
| 13vPnC | Geometric Mean Fold Rise (GMFR) in Serotype-Specific Pneumococcal Immunoglobulin G (IgG) From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 1 | Serotype 23F (N = 137) | 6.58 fold rise |
| 13vPnC | Geometric Mean Fold Rise (GMFR) in Serotype-Specific Pneumococcal Immunoglobulin G (IgG) From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 1 | Serotype 3 (N = 133) | 2.03 fold rise |
| 13vPnC | Geometric Mean Fold Rise (GMFR) in Serotype-Specific Pneumococcal Immunoglobulin G (IgG) From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 1 | Serotype 5 (N = 138) | 1.74 fold rise |
| 13vPnC | Geometric Mean Fold Rise (GMFR) in Serotype-Specific Pneumococcal Immunoglobulin G (IgG) From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 1 | Serotype 6A (N = 132) | 4.10 fold rise |
| 13vPnC | Geometric Mean Fold Rise (GMFR) in Serotype-Specific Pneumococcal Immunoglobulin G (IgG) From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 1 | Serotype 7F (N = 137) | 4.38 fold rise |
| 13vPnC | Geometric Mean Fold Rise (GMFR) in Serotype-Specific Pneumococcal Immunoglobulin G (IgG) From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 1 | Serotype 14 (N = 138) | 5.50 fold rise |
| 13vPnC | Geometric Mean Fold Rise (GMFR) in Serotype-Specific Pneumococcal Immunoglobulin G (IgG) From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 1 | Serotype 18C (N = 137) | 5.58 fold rise |
| 13vPnC | Geometric Mean Fold Rise (GMFR) in Serotype-Specific Pneumococcal Immunoglobulin G (IgG) From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 1 | Serotype 1 (N = 129) | 3.60 fold rise |
| 13vPnC | Geometric Mean Fold Rise (GMFR) in Serotype-Specific Pneumococcal Immunoglobulin G (IgG) From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 1 | Serotype 19A (N = 138) | 3.28 fold rise |
Secondary
Geometric Mean Fold Rise (GMFR) in Serotype-Specific Pneumococcal Immunoglobulin G (IgG) From Before 13vPnC Dose 2 to 1 Month After 13vPnC Dose 2
GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from before 13vPnC Dose 2 to 1 month after 13vPnC Dose 2 were computed using the logarithmically transformed assay results. CI for GMFR were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise. GMFRs were calculated using all participants with available data from before 13vPnC Dose 2 and 1 month after 13vPnC Dose 2 blood draws. Here number of participants analyzed signifies the evaluable immunogenicity population and N signifies participants with determinate IgG antibody concentration for the given serotype at both the before 13vPnC Dose 2 and 1 month after 13vPnC Dose 2 blood draws. Participants may be represented in more than 1 category.
Time frame: Before 13vPnC Dose 2, 1 month after 13vPnC Dose 2
Population: Evaluable immunogenicity population: eligible participants who received all study vaccinations; had valid and determinate assay result; had blood drawn within pre-specified time-frames; had no major protocol violation (including use of prohibited vaccine/medication, immunoglobulins or chronic systemic corticosteroids).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 13vPnC | Geometric Mean Fold Rise (GMFR) in Serotype-Specific Pneumococcal Immunoglobulin G (IgG) From Before 13vPnC Dose 2 to 1 Month After 13vPnC Dose 2 | Serotype 6B (N = 137) | 1.80 fold rise |
| 13vPnC | Geometric Mean Fold Rise (GMFR) in Serotype-Specific Pneumococcal Immunoglobulin G (IgG) From Before 13vPnC Dose 2 to 1 Month After 13vPnC Dose 2 | Serotype 7F (N = 137) | 1.75 fold rise |
| 13vPnC | Geometric Mean Fold Rise (GMFR) in Serotype-Specific Pneumococcal Immunoglobulin G (IgG) From Before 13vPnC Dose 2 to 1 Month After 13vPnC Dose 2 | Serotype 4 (N = 137) | 1.86 fold rise |
| 13vPnC | Geometric Mean Fold Rise (GMFR) in Serotype-Specific Pneumococcal Immunoglobulin G (IgG) From Before 13vPnC Dose 2 to 1 Month After 13vPnC Dose 2 | Serotype 9V (N = 136) | 1.48 fold rise |
| 13vPnC | Geometric Mean Fold Rise (GMFR) in Serotype-Specific Pneumococcal Immunoglobulin G (IgG) From Before 13vPnC Dose 2 to 1 Month After 13vPnC Dose 2 | Serotype 14 (N = 137) | 1.24 fold rise |
| 13vPnC | Geometric Mean Fold Rise (GMFR) in Serotype-Specific Pneumococcal Immunoglobulin G (IgG) From Before 13vPnC Dose 2 to 1 Month After 13vPnC Dose 2 | Serotype 18C (N = 137) | 1.47 fold rise |
| 13vPnC | Geometric Mean Fold Rise (GMFR) in Serotype-Specific Pneumococcal Immunoglobulin G (IgG) From Before 13vPnC Dose 2 to 1 Month After 13vPnC Dose 2 | Serotype 19F (N = 135) | 2.08 fold rise |
| 13vPnC | Geometric Mean Fold Rise (GMFR) in Serotype-Specific Pneumococcal Immunoglobulin G (IgG) From Before 13vPnC Dose 2 to 1 Month After 13vPnC Dose 2 | Serotype 6A (N = 133) | 1.80 fold rise |
| 13vPnC | Geometric Mean Fold Rise (GMFR) in Serotype-Specific Pneumococcal Immunoglobulin G (IgG) From Before 13vPnC Dose 2 to 1 Month After 13vPnC Dose 2 | Serotype 19A (N = 137) | 1.48 fold rise |
| 13vPnC | Geometric Mean Fold Rise (GMFR) in Serotype-Specific Pneumococcal Immunoglobulin G (IgG) From Before 13vPnC Dose 2 to 1 Month After 13vPnC Dose 2 | Serotype 23F (N = 135) | 2.04 fold rise |
| 13vPnC | Geometric Mean Fold Rise (GMFR) in Serotype-Specific Pneumococcal Immunoglobulin G (IgG) From Before 13vPnC Dose 2 to 1 Month After 13vPnC Dose 2 | Serotype 1 (N = 136) | 1.73 fold rise |
| 13vPnC | Geometric Mean Fold Rise (GMFR) in Serotype-Specific Pneumococcal Immunoglobulin G (IgG) From Before 13vPnC Dose 2 to 1 Month After 13vPnC Dose 2 | Serotype 3 (N = 133) | 1.36 fold rise |
| 13vPnC | Geometric Mean Fold Rise (GMFR) in Serotype-Specific Pneumococcal Immunoglobulin G (IgG) From Before 13vPnC Dose 2 to 1 Month After 13vPnC Dose 2 | Serotype 5 (N = 135) | 1.30 fold rise |
Secondary
Ratio of Geometric Mean Fold Rise (GMFR) in Serotype-Specific Pneumococcal Immunoglobulin G (IgG) From 13vPnC Dose 1 to 13vPnC Dose 2
GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were computed using the logarithmically transformed assay results for Dose 1 (after Dose 1/before Dose 1) and for Dose 2 (after Dose 2/before Dose 2). CI for the ratio of GMFR (Dose 2/Dose 1) were back transformations of a CI based on the Student t distribution for the mean logarithm of the measures (Dose 2 - Dose 1). Here number of participants analyzed signifies the evaluable immunogenicity population and N signifies participants with determinate IgG antibody concentration for given serotype at before 13vPnC Dose 1, 1 month after 13vPnC Dose 1, before 13vPnC Dose 2 and 1 month after 13vPnC Dose 2 blood draws. Participants may be represented in more than 1 category.
Time frame: Before 13vPnC Dose 1, 1 month after 13vPnC Dose 1, before 13vPnC Dose 2, 1 month after 13vPnC Dose 2
Population: Evaluable immunogenicity population: eligible participants who received all study vaccinations; had valid and determinate assay result; had blood drawn within pre-specified time-frames; had no major protocol violation (including use of prohibited vaccine/medication, immunoglobulins or chronic systemic corticosteroids).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 13vPnC | Ratio of Geometric Mean Fold Rise (GMFR) in Serotype-Specific Pneumococcal Immunoglobulin G (IgG) From 13vPnC Dose 1 to 13vPnC Dose 2 | Serotype 4 (N = 135) | 0.26 ratio of GMFR |
| 13vPnC | Ratio of Geometric Mean Fold Rise (GMFR) in Serotype-Specific Pneumococcal Immunoglobulin G (IgG) From 13vPnC Dose 1 to 13vPnC Dose 2 | Serotype 6B (N = 136) | 0.38 ratio of GMFR |
| 13vPnC | Ratio of Geometric Mean Fold Rise (GMFR) in Serotype-Specific Pneumococcal Immunoglobulin G (IgG) From 13vPnC Dose 1 to 13vPnC Dose 2 | Serotype 9V (N = 136) | 0.49 ratio of GMFR |
| 13vPnC | Ratio of Geometric Mean Fold Rise (GMFR) in Serotype-Specific Pneumococcal Immunoglobulin G (IgG) From 13vPnC Dose 1 to 13vPnC Dose 2 | Serotype 14 (N = 137) | 0.22 ratio of GMFR |
| 13vPnC | Ratio of Geometric Mean Fold Rise (GMFR) in Serotype-Specific Pneumococcal Immunoglobulin G (IgG) From 13vPnC Dose 1 to 13vPnC Dose 2 | Serotype 18C (N = 136) | 0.26 ratio of GMFR |
| 13vPnC | Ratio of Geometric Mean Fold Rise (GMFR) in Serotype-Specific Pneumococcal Immunoglobulin G (IgG) From 13vPnC Dose 1 to 13vPnC Dose 2 | Serotype 19F (N = 132) | 0.44 ratio of GMFR |
| 13vPnC | Ratio of Geometric Mean Fold Rise (GMFR) in Serotype-Specific Pneumococcal Immunoglobulin G (IgG) From 13vPnC Dose 1 to 13vPnC Dose 2 | Serotype 23F (N = 135) | 0.32 ratio of GMFR |
| 13vPnC | Ratio of Geometric Mean Fold Rise (GMFR) in Serotype-Specific Pneumococcal Immunoglobulin G (IgG) From 13vPnC Dose 1 to 13vPnC Dose 2 | Serotype 1 (N = 127) | 0.47 ratio of GMFR |
| 13vPnC | Ratio of Geometric Mean Fold Rise (GMFR) in Serotype-Specific Pneumococcal Immunoglobulin G (IgG) From 13vPnC Dose 1 to 13vPnC Dose 2 | Serotype 3 (N = 130) | 0.66 ratio of GMFR |
| 13vPnC | Ratio of Geometric Mean Fold Rise (GMFR) in Serotype-Specific Pneumococcal Immunoglobulin G (IgG) From 13vPnC Dose 1 to 13vPnC Dose 2 | Serotype 5 (N = 135) | 0.75 ratio of GMFR |
| 13vPnC | Ratio of Geometric Mean Fold Rise (GMFR) in Serotype-Specific Pneumococcal Immunoglobulin G (IgG) From 13vPnC Dose 1 to 13vPnC Dose 2 | Serotype 6A (N = 127) | 0.45 ratio of GMFR |
| 13vPnC | Ratio of Geometric Mean Fold Rise (GMFR) in Serotype-Specific Pneumococcal Immunoglobulin G (IgG) From 13vPnC Dose 1 to 13vPnC Dose 2 | Serotype 7F (N = 136) | 0.39 ratio of GMFR |
| 13vPnC | Ratio of Geometric Mean Fold Rise (GMFR) in Serotype-Specific Pneumococcal Immunoglobulin G (IgG) From 13vPnC Dose 1 to 13vPnC Dose 2 | Serotype 19A (N = 137) | 0.45 ratio of GMFR |
Secondary
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT)
Antibody GMTs as measured by OPA assay for 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). GMT and corresponding 2-sided 95% CIs were evaluated. CIs for the GMTs are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the titers. GMTs were calculated using all participants with available data for the specified blood draw. Here number of participants analyzed signifies the evaluable immunogenicity population and N signifies participants with determinate OPA antibody titer for the given serotype at specified time point. Participants may be represented in more than 1 category.
Time frame: Before 13vPnC Dose 1, 1 month after 13vPnC Dose 1, before 13vPnC Dose 2, 1 month after 13vPnC Dose 2
Population: Evaluable immunogenicity population: eligible participants who received all study vaccinations; had valid and determinate assay result; had blood drawn within pre-specified time-frames; had no major protocol violation (including use of prohibited vaccine/medication, immunoglobulins or chronic systemic corticosteroids).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 13vPnC | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) | Before 13vPnC Dose 1: Serotype 4 (N = 105) | 215 titer |
| 13vPnC | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) | Before 13vPnC Dose 1: Serotype 6B (N = 105) | 626 titer |
| 13vPnC | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) | Before 13vPnC Dose 1: Serotype 9V (N = 109) | 234 titer |
| 13vPnC | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) | Before 13vPnC Dose 1: Serotype 14 (N = 115) | 628 titer |
| 13vPnC | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) | Before 13vPnC Dose 1: Serotype 18C (N = 95) | 426 titer |
| 13vPnC | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) | Before 13vPnC Dose 1: Serotype 19F (N = 96) | 94 titer |
| 13vPnC | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) | Before 13vPnC Dose 1: Serotype 23F (N = 106) | 34 titer |
| 13vPnC | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) | Before 13vPnC Dose 1: Serotype 1 (N = 131) | 7 titer |
| 13vPnC | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) | Before 13vPnC Dose 1: Serotype 3 (N = 107) | 13 titer |
| 13vPnC | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) | Before 13vPnC Dose 1: Serotype 5 (N = 131) | 10 titer |
| 13vPnC | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) | Before 13vPnC Dose 1: Serotype 6A (N = 116) | 246 titer |
| 13vPnC | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) | Before 13vPnC Dose 1: Serotype 19A (N = 127) | 137 titer |
| 13vPnC | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) | 1 Month After 13vPnC Dose 1: Serotype 4 (N = 108) | 2670 titer |
| 13vPnC | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) | 1 Month After 13vPnC Dose 1: Serotype 6B (N= 116) | 7535 titer |
| 13vPnC | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) | 1 Month After 13vPnC Dose 1: Serotype 14 (N = 117) | 2288 titer |
| 13vPnC | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) | 1 Month After 13vPnC Dose 1: Serotype 18C (N= 103) | 4326 titer |
| 13vPnC | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) | 1 Month After 13vPnC Dose 1: Serotype 19F (N = 89) | 1429 titer |
| 13vPnC | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) | 1 Month After 13vPnC Dose 1: Serotype 23F (N= 106) | 1607 titer |
| 13vPnC | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) | 1 Month After 13vPnC Dose 1: Serotype 3 (N = 112) | 115 titer |
| 13vPnC | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) | 1 Month After 13vPnC Dose 1: Serotype 5 (N = 121) | 277 titer |
| 13vPnC | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) | 1 Month After 13vPnC Dose 1: Serotype 6A (N = 117) | 7845 titer |
| 13vPnC | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) | 1 Month After 13vPnC Dose 1: Serotype 7F (N = 123) | 3348 titer |
| 13vPnC | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) | 1 Month After 13vPnC Dose 1: Serotype 19A (N =118) | 1449 titer |
| 13vPnC | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) | Before 13vPnC Dose 2: Serotype 4 (N = 104) | 1331 titer |
| 13vPnC | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) | Before 13vPnC Dose 2: Serotype 6B (N = 108) | 4174 titer |
| 13vPnC | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) | Before 13vPnC Dose 2: Serotype 9V (N = 99) | 1445 titer |
| 13vPnC | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) | Before 13vPnC Dose 2: Serotype 23F (N = 94) | 897 titer |
| 13vPnC | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) | Before 13vPnC Dose 2: Serotype 1 (N = 107) | 23 titer |
| 13vPnC | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) | Before 13vPnC Dose 2: Serotype 3 (N = 120) | 56 titer |
| 13vPnC | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) | Before 13vPnC Dose 2: Serotype 5 (N = 107) | 98 titer |
| 13vPnC | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) | Before 13vPnC Dose 2: Serotype 6A (N = 113) | 4005 titer |
| 13vPnC | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) | Before 13vPnC Dose 2: Serotype 7F (N = 112) | 1791 titer |
| 13vPnC | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) | 1 Month After 13vPnC Dose 2: Serotype 6B (N= 107) | 7601 titer |
| 13vPnC | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) | 1 Month After 13vPnC Dose 2: Serotype 9V (N = 96) | 3467 titer |
| 13vPnC | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) | 1 Month After 13vPnC Dose 2: Serotype 14 (N = 110) | 2081 titer |
| 13vPnC | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) | 1 Month After 13vPnC Dose 2: Serotype 18C (N= 103) | 5271 titer |
| 13vPnC | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) | 1 Month After 13vPnC Dose 2: Serotype 19F (N = 89) | 1507 titer |
| 13vPnC | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) | 1 Month After 13vPnC Dose 2: Serotype 1 (N = 106) | 78 titer |
| 13vPnC | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) | 1 Month After 13vPnC Dose 2: Serotype 6A (N = 111) | 7633 titer |
| 13vPnC | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) | 1 Month After 13vPnC Dose 2: Serotype 7F (N = 114) | 3723 titer |
| 13vPnC | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) | Before 13vPnC Dose 1: Serotype 7F (N = 120) | 344 titer |
| 13vPnC | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) | 1 Month After 13vPnC Dose 1: Serotype 9V (N= 103) | 2312 titer |
| 13vPnC | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) | 1 Month After 13vPnC Dose 1: Serotype 1 (N = 123) | 56 titer |
| 13vPnC | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) | Before 13vPnC Dose 2: Serotype 14 (N = 106) | 1652 titer |
| 13vPnC | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) | Before 13vPnC Dose 2: Serotype 18C (N = 101) | 1928 titer |
| 13vPnC | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) | Before 13vPnC Dose 2: Serotype 19F (N = 92) | 516 titer |
| 13vPnC | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) | Before 13vPnC Dose 2: Serotype 19A (N = 108) | 677 titer |
| 13vPnC | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) | 1 Month After 13vPnC Dose 2: Serotype 4 (N = 105) | 3051 titer |
| 13vPnC | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) | 1 Month After 13vPnC Dose 2: Serotype 23F (N= 105) | 2330 titer |
| 13vPnC | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) | 1 Month After 13vPnC Dose 2: Serotype 3 (N = 109) | 105 titer |
| 13vPnC | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) | 1 Month After 13vPnC Dose 2: Serotype 5 (N = 118) | 273 titer |
| 13vPnC | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) | 1 Month After 13vPnC Dose 2: Serotype 19A (N= 115) | 1314 titer |
Secondary
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Year After 13vPnC Dose 2
Antibody GMTs as measured by OPA assay for 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). GMT and corresponding 2-sided 95% CIs were evaluated. CIs for the GMTs are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the titers. GMTs were calculated using all participants with available data for the specified blood draw. Here number of participants analyzed signifies the evaluable immunogenicity population at 1-year follow-up and N signifies participants with determinate OPA antibody titer for the given serotype. Participants may be represented in more than 1 category.
Time frame: 1 year after 13vPnC Dose 2
Population: Evaluable immunogenicity population at 1-year follow-up: eligible participants who received all study vaccinations; had valid and determinate assay result; had blood drawn within pre-specified time-frames; had no major protocol violation (including use of prohibited vaccine/medication, immunoglobulins or chronic systemic corticosteroids).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 13vPnC | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Year After 13vPnC Dose 2 | Serotype 4 (N = 58) | 1107 titer |
| 13vPnC | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Year After 13vPnC Dose 2 | Serotype 6B (N = 59) | 3412 titer |
| 13vPnC | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Year After 13vPnC Dose 2 | Serotype 9V (N = 66) | 1690 titer |
| 13vPnC | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Year After 13vPnC Dose 2 | Serotype 18C (N = 59) | 1604 titer |
| 13vPnC | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Year After 13vPnC Dose 2 | Serotype 23F (N = 58) | 924 titer |
| 13vPnC | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Year After 13vPnC Dose 2 | Serotype 3 (N = 72) | 31 titer |
| 13vPnC | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Year After 13vPnC Dose 2 | Serotype 5 (N = 71) | 102 titer |
| 13vPnC | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Year After 13vPnC Dose 2 | Serotype 6A (N = 72) | 2485 titer |
| 13vPnC | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Year After 13vPnC Dose 2 | Serotype 7F (N = 73) | 2166 titer |
| 13vPnC | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Year After 13vPnC Dose 2 | Serotype 19A (N = 73) | 589 titer |
| 13vPnC | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Year After 13vPnC Dose 2 | Serotype 14 (N = 64) | 1595 titer |
| 13vPnC | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Year After 13vPnC Dose 2 | Serotype 19F (N = 55) | 620 titer |
| 13vPnC | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Year After 13vPnC Dose 2 | Serotype 1 (N = 73) | 25 titer |
Other Pre-specified
Percentage of Participants With Prespecified Local Reactions: 13vPnC Dose 1
Specific local reactions were prompted for each day, and reported using an electronic diary. Redness and Swelling were scaled as: Any (redness present or swelling present); Mild (less than \<2.5 centimeters \[cm\] for participants aged 6 to \<12 years and 2.5 to 5.0 cm for participants aged greater than or equal to \[\>=\] 12 years); Moderate (2.5 to 7.0 cm for participants aged 6 to \<12 years and 5.1 to 10.0 cm for participants aged \>=12 years); Severe (\>7 cm for participants aged 6 to \<12 years and \>10 cm for participants aged \>=12 years). Pain was scaled as: Any (pain present); Mild (did not interfere with activity); Moderate (interfered with activity); Severe (prevented daily activity). Here Number of participants analyzed signifies the safety population for Dose 1 and N signifies those participants who reported Yes for at least 1 day or No for all days for specified local reaction. Participants may be represented in more than 1 category.
Time frame: Within 7 days after 13vPnC Dose 1
Population: Safety population for Dose 1 included all participants who received Dose 1 of study vaccine and had safety data available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC | Percentage of Participants With Prespecified Local Reactions: 13vPnC Dose 1 | Pain: Any (N = 144) | 89.6 percentage of participants |
| 13vPnC | Percentage of Participants With Prespecified Local Reactions: 13vPnC Dose 1 | Pain: Mild (N = 132) | 81.8 percentage of participants |
| 13vPnC | Percentage of Participants With Prespecified Local Reactions: 13vPnC Dose 1 | Pain: Moderate (N = 113) | 56.6 percentage of participants |
| 13vPnC | Percentage of Participants With Prespecified Local Reactions: 13vPnC Dose 1 | Pain: Severe (N = 90) | 11.1 percentage of participants |
| 13vPnC | Percentage of Participants With Prespecified Local Reactions: 13vPnC Dose 1 | Redness: Any (N = 93) | 23.7 percentage of participants |
| 13vPnC | Percentage of Participants With Prespecified Local Reactions: 13vPnC Dose 1 | Redness: Mild (N = 93) | 20.4 percentage of participants |
| 13vPnC | Percentage of Participants With Prespecified Local Reactions: 13vPnC Dose 1 | Redness: Moderate (N = 90) | 8.9 percentage of participants |
| 13vPnC | Percentage of Participants With Prespecified Local Reactions: 13vPnC Dose 1 | Redness: Severe (N = 87) | 1.1 percentage of participants |
| 13vPnC | Percentage of Participants With Prespecified Local Reactions: 13vPnC Dose 1 | Swelling: Any (N = 108) | 49.1 percentage of participants |
| 13vPnC | Percentage of Participants With Prespecified Local Reactions: 13vPnC Dose 1 | Swelling: Mild (N = 101) | 37.6 percentage of participants |
| 13vPnC | Percentage of Participants With Prespecified Local Reactions: 13vPnC Dose 1 | Swelling: Moderate (N = 100) | 26.0 percentage of participants |
| 13vPnC | Percentage of Participants With Prespecified Local Reactions: 13vPnC Dose 1 | Swelling: Severe (N = 87) | 1.1 percentage of participants |
Other Pre-specified
Percentage of Participants With Prespecified Local Reactions: 13vPnC Dose 2
Specific local reactions were prompted for each day, and reported using an electronic diary. Redness and Swelling were scaled as: Any (redness present or swelling present); Mild (\<2.5 cm for participants aged 6 to \<12 years and 2.5 to 5.0 cm for participants aged \>=12 years); Moderate (2.5 to 7.0 cm for participants aged 6 to \<12 years and 5.1 to 10.0 cm for participants aged \>=12 years); Severe (\>7 cm for participants aged 6 to \<12 years and \>10 cm for participants aged \>=12 years). Pain was scaled as: Any (pain present); Mild (did not interfere with activity); Moderate (interfered with activity); Severe (prevented daily activity). Here number of participants analyzed signifies the safety population for Dose 2 and N signifies those participants who reported Yes for at least 1 day or No for all days for specified local reaction. Participants may be represented in more than 1 category.
Time frame: Within 7 days after 13vPnC Dose 2
Population: Safety population for Dose 2 included all participants who received Dose 2 of study vaccine and had safety data available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC | Percentage of Participants With Prespecified Local Reactions: 13vPnC Dose 2 | Swelling: Moderate (N = 73) | 35.6 percentage of participants |
| 13vPnC | Percentage of Participants With Prespecified Local Reactions: 13vPnC Dose 2 | Swelling: Severe (N = 63) | 0.0 percentage of participants |
| 13vPnC | Percentage of Participants With Prespecified Local Reactions: 13vPnC Dose 2 | Pain: Mild (N = 103) | 77.7 percentage of participants |
| 13vPnC | Percentage of Participants With Prespecified Local Reactions: 13vPnC Dose 2 | Pain: Moderate (N = 82) | 53.7 percentage of participants |
| 13vPnC | Percentage of Participants With Prespecified Local Reactions: 13vPnC Dose 2 | Redness: Any (N = 67) | 26.9 percentage of participants |
| 13vPnC | Percentage of Participants With Prespecified Local Reactions: 13vPnC Dose 2 | Redness: Mild (N = 66) | 15.2 percentage of participants |
| 13vPnC | Percentage of Participants With Prespecified Local Reactions: 13vPnC Dose 2 | Redness: Moderate (N = 64) | 14.1 percentage of participants |
| 13vPnC | Percentage of Participants With Prespecified Local Reactions: 13vPnC Dose 2 | Redness: Severe (N = 63) | 0.0 percentage of participants |
| 13vPnC | Percentage of Participants With Prespecified Local Reactions: 13vPnC Dose 2 | Swelling: Any (N = 84) | 53.6 percentage of participants |
| 13vPnC | Percentage of Participants With Prespecified Local Reactions: 13vPnC Dose 2 | Swelling: Mild (N = 77) | 37.7 percentage of participants |
| 13vPnC | Percentage of Participants With Prespecified Local Reactions: 13vPnC Dose 2 | Pain: Any (N = 111) | 85.6 percentage of participants |
| 13vPnC | Percentage of Participants With Prespecified Local Reactions: 13vPnC Dose 2 | Pain: Severe (N = 69) | 15.9 percentage of participants |
Other Pre-specified
Percentage of Participants With Prespecified Systemic Events: 13vPnC Dose 1
Specific systemic events (fever \>=38 degrees Celsius\[C\], vomiting, diarrhea, headache, fatigue, muscle pain, joint pain, use of antipyretic medications) were prompted for each day and reported using an electronic diary. Fatigue, headache, muscle pain and joint pain were scaled as: Any(symptom present); Mild(did not interfere with activity); Moderate(some interference); Severe(prevented routine daily activity). Vomiting was scaled as: Any(vomiting present); Mild(1-2 times in 24 hours); Moderate(\>2 times in 24 hours); Severe(required intravenous hydration). Diarrhea was scaled as: Any(diarrhea present); Mild(2-3 loose stools in 24 hours);Moderate(4-5 loose stools 24 hours); Severe(\>=6 loose stools in 24 hours). Here number of participants analyzed signifies the safety population for Dose 1 and N signifies those participants who reported Yes for at least 1 day or No for all days for specified systemic event. Participants may be represented in more than 1 category.
Time frame: Within 7 days after 13vPnC Dose 1
Population: Safety population for Dose 1 included all participants who received Dose 1 of study vaccine and had safety data available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC | Percentage of Participants With Prespecified Systemic Events: 13vPnC Dose 1 | Vomiting: Any (N = 91) | 15.4 percentage of participants |
| 13vPnC | Percentage of Participants With Prespecified Systemic Events: 13vPnC Dose 1 | Fever: >38.9, =<40 degrees C (N = 79) | 3.8 percentage of participants |
| 13vPnC | Percentage of Participants With Prespecified Systemic Events: 13vPnC Dose 1 | Fever: >38.4, =<38.9 degrees C (N = 82) | 7.3 percentage of participants |
| 13vPnC | Percentage of Participants With Prespecified Systemic Events: 13vPnC Dose 1 | Fever: >=38, =<38.4 degrees C (N = 81) | 13.6 percentage of participants |
| 13vPnC | Percentage of Participants With Prespecified Systemic Events: 13vPnC Dose 1 | Fever: >40 degrees C (N = 79) | 1.3 percentage of participants |
| 13vPnC | Percentage of Participants With Prespecified Systemic Events: 13vPnC Dose 1 | Vomiting: Mild (N = 89) | 11.2 percentage of participants |
| 13vPnC | Percentage of Participants With Prespecified Systemic Events: 13vPnC Dose 1 | Vomiting: Moderate (N = 90) | 6.7 percentage of participants |
| 13vPnC | Percentage of Participants With Prespecified Systemic Events: 13vPnC Dose 1 | Vomiting: Severe (N = 87) | 0.0 percentage of participants |
| 13vPnC | Percentage of Participants With Prespecified Systemic Events: 13vPnC Dose 1 | Diarrhea: Any (N = 90) | 13.3 percentage of participants |
| 13vPnC | Percentage of Participants With Prespecified Systemic Events: 13vPnC Dose 1 | Diarrhea: Mild (N = 87) | 6.9 percentage of participants |
| 13vPnC | Percentage of Participants With Prespecified Systemic Events: 13vPnC Dose 1 | Diarrhea: Moderate (N = 90) | 6.7 percentage of participants |
| 13vPnC | Percentage of Participants With Prespecified Systemic Events: 13vPnC Dose 1 | Diarrhea: Severe (N = 87) | 2.3 percentage of participants |
| 13vPnC | Percentage of Participants With Prespecified Systemic Events: 13vPnC Dose 1 | Fatigue: Moderate (N = 104) | 44.2 percentage of participants |
| 13vPnC | Percentage of Participants With Prespecified Systemic Events: 13vPnC Dose 1 | Headache: Any (N = 110) | 53.6 percentage of participants |
| 13vPnC | Percentage of Participants With Prespecified Systemic Events: 13vPnC Dose 1 | Headache: Mild (N = 105) | 42.9 percentage of participants |
| 13vPnC | Percentage of Participants With Prespecified Systemic Events: 13vPnC Dose 1 | Headache: Moderate (N = 101) | 34.7 percentage of participants |
| 13vPnC | Percentage of Participants With Prespecified Systemic Events: 13vPnC Dose 1 | Headache: Severe (N = 92) | 12.0 percentage of participants |
| 13vPnC | Percentage of Participants With Prespecified Systemic Events: 13vPnC Dose 1 | Fatigue: Any (N = 118) | 66.1 percentage of participants |
| 13vPnC | Percentage of Participants With Prespecified Systemic Events: 13vPnC Dose 1 | Fatigue: Mild (N = 108) | 48.1 percentage of participants |
| 13vPnC | Percentage of Participants With Prespecified Systemic Events: 13vPnC Dose 1 | Fatigue: Severe (N = 90) | 14.4 percentage of participants |
| 13vPnC | Percentage of Participants With Prespecified Systemic Events: 13vPnC Dose 1 | Muscle Pain: Any (N = 127) | 74.8 percentage of participants |
| 13vPnC | Percentage of Participants With Prespecified Systemic Events: 13vPnC Dose 1 | Joint Pain: Mild (N = 98) | 23.5 percentage of participants |
| 13vPnC | Percentage of Participants With Prespecified Systemic Events: 13vPnC Dose 1 | Muscle Pain: Mild (N = 114) | 58.8 percentage of participants |
| 13vPnC | Percentage of Participants With Prespecified Systemic Events: 13vPnC Dose 1 | Muscle Pain: Moderate (N = 108) | 47.2 percentage of participants |
| 13vPnC | Percentage of Participants With Prespecified Systemic Events: 13vPnC Dose 1 | Muscle Pain: Severe (N = 89) | 10.1 percentage of participants |
| 13vPnC | Percentage of Participants With Prespecified Systemic Events: 13vPnC Dose 1 | Joint Pain: Any (N = 103) | 39.8 percentage of participants |
| 13vPnC | Percentage of Participants With Prespecified Systemic Events: 13vPnC Dose 1 | Joint Pain: Moderate (N = 94) | 23.4 percentage of participants |
| 13vPnC | Percentage of Participants With Prespecified Systemic Events: 13vPnC Dose 1 | Joint Pain: Severe (N = 89) | 4.5 percentage of participants |
| 13vPnC | Percentage of Participants With Prespecified Systemic Events: 13vPnC Dose 1 | Use of Antipyretic Medications (N = 110) | 58.2 percentage of participants |
Other Pre-specified
Percentage of Participants With Prespecified Systemic Events: 13vPnC Dose 2
Specific systemic events (fever \>=38 degrees C, vomiting, diarrhea, headache, fatigue, muscle pain, joint pain, and use of antipyretic medications) were prompted for each day, and reported using an electronic diary. Fatigue, headache, muscle pain and joint pain were scaled as: Any(symptom present); Mild(did not interfere with activity); Moderate(some interference); Severe(prevented routine daily activity). Vomiting was scaled as: Any(vomiting present); Mild(1-2 times in 24 hours); Moderate(\>2 times in 24 hours); Severe (required intravenous hydration). Diarrhea was scaled as: Any(diarrhea present); Mild(2-3 loose stools in 24 hours); Moderate(4-5 loose stools 24 hours); Severe(\>=6 loose stools in 24 hours). Here number of participants analyzed signifies the safety population for Dose 2 and N signifies those participants who reported Yes for at least 1 day or No for all days for specified systemic event. Participants may be represented in more than 1 category.
Time frame: Within 7 days after 13vPnC Dose 2
Population: Safety population for Dose 2 included all participants who received Dose 2 of study vaccine and had safety data available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC | Percentage of Participants With Prespecified Systemic Events: 13vPnC Dose 2 | Fatigue: Any (N = 96) | 62.5 percentage of participants |
| 13vPnC | Percentage of Participants With Prespecified Systemic Events: 13vPnC Dose 2 | Joint Pain: Severe (N = 65) | 6.2 percentage of participants |
| 13vPnC | Percentage of Participants With Prespecified Systemic Events: 13vPnC Dose 2 | Fever: >=38, =<38.4 degrees C (N = 63) | 9.5 percentage of participants |
| 13vPnC | Percentage of Participants With Prespecified Systemic Events: 13vPnC Dose 2 | Fever: >38.4, =<38.9 degrees C (N = 59) | 6.8 percentage of participants |
| 13vPnC | Percentage of Participants With Prespecified Systemic Events: 13vPnC Dose 2 | Fever: >38.9, =<40 degrees C (N = 63) | 6.3 percentage of participants |
| 13vPnC | Percentage of Participants With Prespecified Systemic Events: 13vPnC Dose 2 | Fever: >40 degrees C (N = 60) | 1.7 percentage of participants |
| 13vPnC | Percentage of Participants With Prespecified Systemic Events: 13vPnC Dose 2 | Vomiting: Any (N = 67) | 13.4 percentage of participants |
| 13vPnC | Percentage of Participants With Prespecified Systemic Events: 13vPnC Dose 2 | Vomiting: Mild (N = 65) | 9.2 percentage of participants |
| 13vPnC | Percentage of Participants With Prespecified Systemic Events: 13vPnC Dose 2 | Vomiting: Moderate (N = 64) | 4.7 percentage of participants |
| 13vPnC | Percentage of Participants With Prespecified Systemic Events: 13vPnC Dose 2 | Vomiting: Severe (N = 64) | 1.6 percentage of participants |
| 13vPnC | Percentage of Participants With Prespecified Systemic Events: 13vPnC Dose 2 | Diarrhea: Any (N = 68) | 25.0 percentage of participants |
| 13vPnC | Percentage of Participants With Prespecified Systemic Events: 13vPnC Dose 2 | Diarrhea: Mild (N = 68) | 19.1 percentage of participants |
| 13vPnC | Percentage of Participants With Prespecified Systemic Events: 13vPnC Dose 2 | Diarrhea: Moderate (N = 66) | 12.1 percentage of participants |
| 13vPnC | Percentage of Participants With Prespecified Systemic Events: 13vPnC Dose 2 | Diarrhea: Severe (N = 63) | 3.2 percentage of participants |
| 13vPnC | Percentage of Participants With Prespecified Systemic Events: 13vPnC Dose 2 | Headache: Any (N = 86) | 59.3 percentage of participants |
| 13vPnC | Percentage of Participants With Prespecified Systemic Events: 13vPnC Dose 2 | Headache: Mild (N = 74) | 41.9 percentage of participants |
| 13vPnC | Percentage of Participants With Prespecified Systemic Events: 13vPnC Dose 2 | Headache: Moderate (N = 76) | 36.8 percentage of participants |
| 13vPnC | Percentage of Participants With Prespecified Systemic Events: 13vPnC Dose 2 | Headache: Severe (N = 66) | 10.6 percentage of participants |
| 13vPnC | Percentage of Participants With Prespecified Systemic Events: 13vPnC Dose 2 | Fatigue: Mild (N = 84) | 48.8 percentage of participants |
| 13vPnC | Percentage of Participants With Prespecified Systemic Events: 13vPnC Dose 2 | Fatigue: Moderate (N = 83) | 41.0 percentage of participants |
| 13vPnC | Percentage of Participants With Prespecified Systemic Events: 13vPnC Dose 2 | Fatigue: Severe (N = 67) | 13.4 percentage of participants |
| 13vPnC | Percentage of Participants With Prespecified Systemic Events: 13vPnC Dose 2 | Muscle Pain: Any (N = 98) | 75.5 percentage of participants |
| 13vPnC | Percentage of Participants With Prespecified Systemic Events: 13vPnC Dose 2 | Muscle Pain: Mild (N = 87) | 60.9 percentage of participants |
| 13vPnC | Percentage of Participants With Prespecified Systemic Events: 13vPnC Dose 2 | Muscle Pain: Moderate (N = 84) | 45.2 percentage of participants |
| 13vPnC | Percentage of Participants With Prespecified Systemic Events: 13vPnC Dose 2 | Muscle Pain: Severe (N = 67) | 16.4 percentage of participants |
| 13vPnC | Percentage of Participants With Prespecified Systemic Events: 13vPnC Dose 2 | Joint Pain: Any (N = 78) | 44.9 percentage of participants |
| 13vPnC | Percentage of Participants With Prespecified Systemic Events: 13vPnC Dose 2 | Joint Pain: Mild (N = 72) | 34.7 percentage of participants |
| 13vPnC | Percentage of Participants With Prespecified Systemic Events: 13vPnC Dose 2 | Joint Pain: Moderate (N = 70) | 21.4 percentage of participants |
| 13vPnC | Percentage of Participants With Prespecified Systemic Events: 13vPnC Dose 2 | Use of Antipyretic Medications (N = 78) | 43.6 percentage of participants |