Pneumococcal Infections
Conditions
Brief summary
This study is to evaluate the safety, tolerability and immunogenicity of a single dose of 13-valent pneumococcal conjugate vaccine in Japanese subjects aged 6 to 64 years who are considered to be at increased risk of pneumococcal disease and who are naive to pneumococcal vaccines.
Interventions
BIOLOGICAL13-valent pneumococcal conjugate vaccine
A single dose (0.5 mL) will be administered intramuscularly into the deltoid muscle at visit 1.
Sponsors
Pfizer
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
* Japanese males and females aged 6 to \<65 years at enrollment. * Subjects with an increased risk of pneumococcal disease determined by documented medical history, physical examination, and clinical judgment of the investigator.
Exclusion criteria
* Previous vaccination with any licensed or investigational pneumococcal vaccine, or planned receipt during study participation. * End-stage disease including but not limited to metastatic malignancy, severe chronic obstructive pulmonary disease (COPD) requiring supplemental oxygen, or end-stage renal disease with or without dialysis. * Graft-versus-host disease (GVHD), history of solid organ transplant within 6 months before investigational product administration or history of HSCT, or potential for solid organ transplant or HSCT during study participation. * Receipt of cytotoxic chemotherapy or blood products within 3 months before investigational product administration or anti-B-cell antibodies within 6 months before investigational product administration through completion of study participation. * Any contraindication to vaccination or vaccine components, including previous anaphylactic reaction to any vaccine or vaccine-related components. * Documented S pneumoniae infection within the past 5 years before investigational product administration.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Reporting Adverse Events (AEs) and Serious Adverse Events (SAEs) | signing of informed consent form (Day 1) up to Day 43 | An AE was any untoward medical occurrence in a participant who received study vaccine without regard to possibility of causal relationship. An SAE is any untoward medical occurrence at any dose that results in death; is life-threatening (immediate risk of death); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); results in congenital anomaly/birth defect. |
| Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Vaccination in Participants Aged Between 6 to <18 Years | Day 1 up to Day 7 | Local reactions were recorded using an electronic daily diary. Local reactions included redness, swelling and pain at injection site. Redness and swelling were graded as mild (0.5 to 2.0 centimeter \[cm\]), moderate (greater than \[\>\] 2.0 to 7.0 cm) and severe (\>7.0 cm) for participants aged 6 to \<12 years, and as mild (2.5 to 5.0 cm), moderate (\>5.0 to 10.0 cm) and, severe (\>10.0 cm) for participants aged 12 to \<18 years. Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), and severe (prevented daily activity). |
| Percentage of Participants Reporting Pre-Specified Local Reactions Within 14 Days After Vaccination in Participants Aged Between 18 to <65 Years | Day 1 up to Day 14 | Local reactions were recorded using an electronic daily diary. Local reactions included redness, swelling and pain at injection site. Redness and swelling were graded as mild (2.5 to 5.0 cm), moderate (\>5.0 to 10.0 cm) and, severe (\>10.0 cm). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), and severe (prevented daily activity). |
| Percentage of Participants Reporting Systemic Events and Use of Antipyretic or Pain Medication Within 7 Days After Vaccination in Participants Aged Between 6 to <18 Years | Day 1 up to Day 7 | Systemic events included fever, vomiting, diarrhea, headache, fatigue, muscle and joint pain, and were recorded by using an e-diary. Use of antipyretic or pain medication was also collected by using an e-diary. Fever was graded as 37.5 to 38.4 degree Celsius (C), 38.5 to 38.9 degree C, 39.0 to 40.0 degree C and \>40.0 degree C. Vomiting was graded as mild (1-2 times in 24 hours), moderate (\>2 times in 24 hours) and severe (required intravenous hydration). Diarrhea was graded as mild (2-3 loose stools in 24 hours), moderate (4-5 loose stools in 24 hours) and severe (greater than or equals to \[\>=\] 6 loose stools in 24 hours). Headache, fatigue, muscle pain and joint pain were graded as mild (no interference with activity), moderate (some interference with activity) and severe (significant, prevented daily activity). |
| Percentage of Participants Reporting Systemic Events and Use of Antipyretic or Pain Medication Within 14 Days After Vaccination in Participants Aged Between 18 to <65 Years | Day 1 up to Day 14 | Systemic events included fever, vomiting, diarrhea, headache, fatigue, muscle and joint pain, and were recorded by using an e-diary. Use of antipyretic or pain medication was also collected by using an e-diary. Fever was graded as 37.5 to 38.4 degree C, 38.5 to 38.9 degree C, 39.0 to 40.0 degree C and \>40.0 degree C. Vomiting was graded as mild (1-2 times in 24 hours), moderate (\>2 times in 24 hours) and severe (required intravenous hydration). Diarrhea was graded as mild (2-3 loose stools in 24 hours), moderate (4-5 loose stools in 24 hours) and severe (\>=6 loose stools in 24 hours). Headache, fatigue, muscle pain and joint pain were graded as mild (no interference with activity), moderate (some interference with activity) and severe (significant, prevented daily activity). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Fold Rises (GMFRs) in Serotype-specific OPA Titers 1 Month After Vaccination | Pre-vaccination to 1 month after vaccination | OPA GMFRs were calculated along with corresponding 2-sided 95% CIs for pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F. GMFRs were computed as the fold rise in titer value at 1 month after vaccination compared to baseline (pre-vaccination). The CIs for GMFRs were back transformations of a CI based on the Student t distribution for the mean difference of the log-transformed assay results before vaccination and 1 month after vaccination. |
| Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) at Pre-vaccination and 1 Month After Vaccination | Pre-vaccination and 1 month after vaccination | Pneumococcal IgG antibody against each of the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) was measured centrally using direct binding Luminex assay. Results were expressed as IgG concentrations. IgG concentrations were logarithmically transformed for analysis; geometric means calculated and expressed as GMCs. Two (2)-sided 95% CIs were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed based on the Student t distribution. |
| GMFRs in Serotype-specific IgG From Before Vaccination to 1 Month After Vaccination | Pre- vaccination to 1 month after vaccination | IgG GMFRs were calculated along with corresponding 2-sided 95% CIs for pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F. GMFRs were computed as the fold rise in concentrations at 1 month after vaccination compared to baseline (pre-vaccination). The CIs for GMFRs were back transformations of a CI based on the Student t distribution for the mean difference of the log-transformed assay results before vaccination and 1 month after vaccination. |
| Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at Pre-vaccination and 1 Month After Vaccination | Pre-vaccination and 1 month after vaccination | Antibody-mediated serum OPA against each of the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) was measured centrally using a quantitative functional microcolony OPA (mcOPA) assay. Results were expressed as OPA titers. OPA titers were logarithmically transformed for analysis; geometric means calculated and expressed as geometric mean titers (GMTs). Two (2)-sided 95% CIs were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed based on the Student t distribution. OPA titer was expressed as reciprocal of highest serum dilution. |
Countries
Japan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 13vPnC: 6 to <18 Years Participants aged between 6 to \<18 years received a single 0.5 mL dose of 13vPnC intramuscularly on Day 1. | 53 |
| 13vPnC: 18 to <65 Years Participants aged between 18 to \<65 years received a single 0.5 mL dose of 13vPnC intramuscularly on Day 1. | 153 |
| Total | 206 |
Baseline characteristics
| Characteristic | 13vPnC: 18 to <65 Years | Total | 13vPnC: 6 to <18 Years |
|---|---|---|---|
| Age, Continuous | 49.0 years STANDARD_DEVIATION 10.12 | 39.6 years STANDARD_DEVIATION 18.18 | 12.7 years STANDARD_DEVIATION 2.66 |
| Race/Ethnicity, Customized Asian | 153 participants | 206 participants | 53 participants |
| Race/Ethnicity, Customized Non-Hispanic/non-Latino/not of Spanish origin | 153 participants | 206 participants | 53 participants |
| Sex: Female, Male Female | 77 Participants | 99 Participants | 22 Participants |
| Sex: Female, Male Male | 76 Participants | 107 Participants | 31 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 53 | 0 / 153 | 0 / 206 |
| other Total, other adverse events | 49 / 53 | 121 / 153 | 170 / 206 |
| serious Total, serious adverse events | 0 / 53 | 0 / 153 | 0 / 206 |
Outcome results
Primary
Percentage of Participants Reporting Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE was any untoward medical occurrence in a participant who received study vaccine without regard to possibility of causal relationship. An SAE is any untoward medical occurrence at any dose that results in death; is life-threatening (immediate risk of death); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); results in congenital anomaly/birth defect.
Time frame: signing of informed consent form (Day 1) up to Day 43
Population: Safety analysis set included all participants who received 1 dose of study vaccine.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC: 6 to <18 Years | Percentage of Participants Reporting Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 16 percentage of participants |
| 13vPnC: 6 to <18 Years | Percentage of Participants Reporting Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 0 percentage of participants |
Primary
Percentage of Participants Reporting Pre-Specified Local Reactions Within 14 Days After Vaccination in Participants Aged Between 18 to <65 Years
Local reactions were recorded using an electronic daily diary. Local reactions included redness, swelling and pain at injection site. Redness and swelling were graded as mild (2.5 to 5.0 cm), moderate (\>5.0 to 10.0 cm) and, severe (\>10.0 cm). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), and severe (prevented daily activity).
Time frame: Day 1 up to Day 14
Population: Safety analysis set included all participants who received 1 dose of study vaccine. Here, Number analyzed signifies participants evaluable for each specified category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC: 6 to <18 Years | Percentage of Participants Reporting Pre-Specified Local Reactions Within 14 Days After Vaccination in Participants Aged Between 18 to <65 Years | Redness: Any | 7.4 percentage of participants |
| 13vPnC: 6 to <18 Years | Percentage of Participants Reporting Pre-Specified Local Reactions Within 14 Days After Vaccination in Participants Aged Between 18 to <65 Years | Redness: Mild | 5.2 percentage of participants |
| 13vPnC: 6 to <18 Years | Percentage of Participants Reporting Pre-Specified Local Reactions Within 14 Days After Vaccination in Participants Aged Between 18 to <65 Years | Redness: Moderate | 2.2 percentage of participants |
| 13vPnC: 6 to <18 Years | Percentage of Participants Reporting Pre-Specified Local Reactions Within 14 Days After Vaccination in Participants Aged Between 18 to <65 Years | Redness: Severe | 0.0 percentage of participants |
| 13vPnC: 6 to <18 Years | Percentage of Participants Reporting Pre-Specified Local Reactions Within 14 Days After Vaccination in Participants Aged Between 18 to <65 Years | Swelling: Any | 12.5 percentage of participants |
| 13vPnC: 6 to <18 Years | Percentage of Participants Reporting Pre-Specified Local Reactions Within 14 Days After Vaccination in Participants Aged Between 18 to <65 Years | Swelling: Mild | 5.1 percentage of participants |
| 13vPnC: 6 to <18 Years | Percentage of Participants Reporting Pre-Specified Local Reactions Within 14 Days After Vaccination in Participants Aged Between 18 to <65 Years | Swelling: Moderate | 7.4 percentage of participants |
| 13vPnC: 6 to <18 Years | Percentage of Participants Reporting Pre-Specified Local Reactions Within 14 Days After Vaccination in Participants Aged Between 18 to <65 Years | Swelling: Severe | 0.0 percentage of participants |
| 13vPnC: 6 to <18 Years | Percentage of Participants Reporting Pre-Specified Local Reactions Within 14 Days After Vaccination in Participants Aged Between 18 to <65 Years | Pain at the injection site: Any | 66.2 percentage of participants |
| 13vPnC: 6 to <18 Years | Percentage of Participants Reporting Pre-Specified Local Reactions Within 14 Days After Vaccination in Participants Aged Between 18 to <65 Years | Pain at the injection site: Mild | 53.8 percentage of participants |
| 13vPnC: 6 to <18 Years | Percentage of Participants Reporting Pre-Specified Local Reactions Within 14 Days After Vaccination in Participants Aged Between 18 to <65 Years | Pain at the injection site: Moderate | 11.0 percentage of participants |
| 13vPnC: 6 to <18 Years | Percentage of Participants Reporting Pre-Specified Local Reactions Within 14 Days After Vaccination in Participants Aged Between 18 to <65 Years | Pain at the injection site: Severe | 1.4 percentage of participants |
Primary
Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Vaccination in Participants Aged Between 6 to <18 Years
Local reactions were recorded using an electronic daily diary. Local reactions included redness, swelling and pain at injection site. Redness and swelling were graded as mild (0.5 to 2.0 centimeter \[cm\]), moderate (greater than \[\>\] 2.0 to 7.0 cm) and severe (\>7.0 cm) for participants aged 6 to \<12 years, and as mild (2.5 to 5.0 cm), moderate (\>5.0 to 10.0 cm) and, severe (\>10.0 cm) for participants aged 12 to \<18 years. Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), and severe (prevented daily activity).
Time frame: Day 1 up to Day 7
Population: Safety analysis set included all participants who received 1 dose of study vaccine. Here, Number analyzed signifies participants evaluable for each specified category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC: 6 to <18 Years | Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Vaccination in Participants Aged Between 6 to <18 Years | Redness: Any | 21.3 percentage of participants |
| 13vPnC: 6 to <18 Years | Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Vaccination in Participants Aged Between 6 to <18 Years | Redness: Mild | 10.6 percentage of participants |
| 13vPnC: 6 to <18 Years | Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Vaccination in Participants Aged Between 6 to <18 Years | Redness: Moderate | 10.6 percentage of participants |
| 13vPnC: 6 to <18 Years | Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Vaccination in Participants Aged Between 6 to <18 Years | Redness: Severe | 0.0 percentage of participants |
| 13vPnC: 6 to <18 Years | Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Vaccination in Participants Aged Between 6 to <18 Years | Swelling: Any | 34.0 percentage of participants |
| 13vPnC: 6 to <18 Years | Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Vaccination in Participants Aged Between 6 to <18 Years | Swelling: Mild | 14.9 percentage of participants |
| 13vPnC: 6 to <18 Years | Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Vaccination in Participants Aged Between 6 to <18 Years | Swelling: Moderate | 17.0 percentage of participants |
| 13vPnC: 6 to <18 Years | Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Vaccination in Participants Aged Between 6 to <18 Years | Swelling: Severe | 2.1 percentage of participants |
| 13vPnC: 6 to <18 Years | Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Vaccination in Participants Aged Between 6 to <18 Years | Pain at the injection site: Any | 78.8 percentage of participants |
| 13vPnC: 6 to <18 Years | Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Vaccination in Participants Aged Between 6 to <18 Years | Pain at the injection site: Mild | 57.7 percentage of participants |
| 13vPnC: 6 to <18 Years | Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Vaccination in Participants Aged Between 6 to <18 Years | Pain at the injection site: Moderate | 21.2 percentage of participants |
| 13vPnC: 6 to <18 Years | Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Vaccination in Participants Aged Between 6 to <18 Years | Pain at the injection site: Severe | 0.0 percentage of participants |
Primary
Percentage of Participants Reporting Systemic Events and Use of Antipyretic or Pain Medication Within 14 Days After Vaccination in Participants Aged Between 18 to <65 Years
Systemic events included fever, vomiting, diarrhea, headache, fatigue, muscle and joint pain, and were recorded by using an e-diary. Use of antipyretic or pain medication was also collected by using an e-diary. Fever was graded as 37.5 to 38.4 degree C, 38.5 to 38.9 degree C, 39.0 to 40.0 degree C and \>40.0 degree C. Vomiting was graded as mild (1-2 times in 24 hours), moderate (\>2 times in 24 hours) and severe (required intravenous hydration). Diarrhea was graded as mild (2-3 loose stools in 24 hours), moderate (4-5 loose stools in 24 hours) and severe (\>=6 loose stools in 24 hours). Headache, fatigue, muscle pain and joint pain were graded as mild (no interference with activity), moderate (some interference with activity) and severe (significant, prevented daily activity).
Time frame: Day 1 up to Day 14
Population: Safety analysis set included all participants who received 1 dose of study vaccine. Here, Number analyzed signifies participants evaluable for each specified category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC: 6 to <18 Years | Percentage of Participants Reporting Systemic Events and Use of Antipyretic or Pain Medication Within 14 Days After Vaccination in Participants Aged Between 18 to <65 Years | Fever: 37.5 degree C to 38.4 degree C | 6.0 percentage of participants |
| 13vPnC: 6 to <18 Years | Percentage of Participants Reporting Systemic Events and Use of Antipyretic or Pain Medication Within 14 Days After Vaccination in Participants Aged Between 18 to <65 Years | Fever: 38.5 degree C to 38.9 degree C | 0.0 percentage of participants |
| 13vPnC: 6 to <18 Years | Percentage of Participants Reporting Systemic Events and Use of Antipyretic or Pain Medication Within 14 Days After Vaccination in Participants Aged Between 18 to <65 Years | Fever: 39.0 degree C to 40.0 degree C | 0.0 percentage of participants |
| 13vPnC: 6 to <18 Years | Percentage of Participants Reporting Systemic Events and Use of Antipyretic or Pain Medication Within 14 Days After Vaccination in Participants Aged Between 18 to <65 Years | Fever: >40.0 degree C | 0.0 percentage of participants |
| 13vPnC: 6 to <18 Years | Percentage of Participants Reporting Systemic Events and Use of Antipyretic or Pain Medication Within 14 Days After Vaccination in Participants Aged Between 18 to <65 Years | Fatigue: Any | 33.1 percentage of participants |
| 13vPnC: 6 to <18 Years | Percentage of Participants Reporting Systemic Events and Use of Antipyretic or Pain Medication Within 14 Days After Vaccination in Participants Aged Between 18 to <65 Years | Fatigue: Mild | 25.4 percentage of participants |
| 13vPnC: 6 to <18 Years | Percentage of Participants Reporting Systemic Events and Use of Antipyretic or Pain Medication Within 14 Days After Vaccination in Participants Aged Between 18 to <65 Years | Fatigue: Moderate | 7.7 percentage of participants |
| 13vPnC: 6 to <18 Years | Percentage of Participants Reporting Systemic Events and Use of Antipyretic or Pain Medication Within 14 Days After Vaccination in Participants Aged Between 18 to <65 Years | Fatigue: Severe | 0.0 percentage of participants |
| 13vPnC: 6 to <18 Years | Percentage of Participants Reporting Systemic Events and Use of Antipyretic or Pain Medication Within 14 Days After Vaccination in Participants Aged Between 18 to <65 Years | Headache: Any | 23.4 percentage of participants |
| 13vPnC: 6 to <18 Years | Percentage of Participants Reporting Systemic Events and Use of Antipyretic or Pain Medication Within 14 Days After Vaccination in Participants Aged Between 18 to <65 Years | Headache: Mild | 19.1 percentage of participants |
| 13vPnC: 6 to <18 Years | Percentage of Participants Reporting Systemic Events and Use of Antipyretic or Pain Medication Within 14 Days After Vaccination in Participants Aged Between 18 to <65 Years | Headache: Moderate | 4.3 percentage of participants |
| 13vPnC: 6 to <18 Years | Percentage of Participants Reporting Systemic Events and Use of Antipyretic or Pain Medication Within 14 Days After Vaccination in Participants Aged Between 18 to <65 Years | Headache: Severe | 0.0 percentage of participants |
| 13vPnC: 6 to <18 Years | Percentage of Participants Reporting Systemic Events and Use of Antipyretic or Pain Medication Within 14 Days After Vaccination in Participants Aged Between 18 to <65 Years | Vomiting: Any | 1.5 percentage of participants |
| 13vPnC: 6 to <18 Years | Percentage of Participants Reporting Systemic Events and Use of Antipyretic or Pain Medication Within 14 Days After Vaccination in Participants Aged Between 18 to <65 Years | Vomiting: Mild | 1.5 percentage of participants |
| 13vPnC: 6 to <18 Years | Percentage of Participants Reporting Systemic Events and Use of Antipyretic or Pain Medication Within 14 Days After Vaccination in Participants Aged Between 18 to <65 Years | Vomiting: Moderate | 0.0 percentage of participants |
| 13vPnC: 6 to <18 Years | Percentage of Participants Reporting Systemic Events and Use of Antipyretic or Pain Medication Within 14 Days After Vaccination in Participants Aged Between 18 to <65 Years | Vomiting: Severe | 0.0 percentage of participants |
| 13vPnC: 6 to <18 Years | Percentage of Participants Reporting Systemic Events and Use of Antipyretic or Pain Medication Within 14 Days After Vaccination in Participants Aged Between 18 to <65 Years | Diarrhea: Any | 18.4 percentage of participants |
| 13vPnC: 6 to <18 Years | Percentage of Participants Reporting Systemic Events and Use of Antipyretic or Pain Medication Within 14 Days After Vaccination in Participants Aged Between 18 to <65 Years | Diarrhea: Mild | 15.6 percentage of participants |
| 13vPnC: 6 to <18 Years | Percentage of Participants Reporting Systemic Events and Use of Antipyretic or Pain Medication Within 14 Days After Vaccination in Participants Aged Between 18 to <65 Years | Diarrhea: Moderate | 2.1 percentage of participants |
| 13vPnC: 6 to <18 Years | Percentage of Participants Reporting Systemic Events and Use of Antipyretic or Pain Medication Within 14 Days After Vaccination in Participants Aged Between 18 to <65 Years | Diarrhea: Severe | 0.7 percentage of participants |
| 13vPnC: 6 to <18 Years | Percentage of Participants Reporting Systemic Events and Use of Antipyretic or Pain Medication Within 14 Days After Vaccination in Participants Aged Between 18 to <65 Years | Muscle pain: Any | 27.3 percentage of participants |
| 13vPnC: 6 to <18 Years | Percentage of Participants Reporting Systemic Events and Use of Antipyretic or Pain Medication Within 14 Days After Vaccination in Participants Aged Between 18 to <65 Years | Muscle pain: Mild | 20.9 percentage of participants |
| 13vPnC: 6 to <18 Years | Percentage of Participants Reporting Systemic Events and Use of Antipyretic or Pain Medication Within 14 Days After Vaccination in Participants Aged Between 18 to <65 Years | Muscle pain: Moderate | 5.8 percentage of participants |
| 13vPnC: 6 to <18 Years | Percentage of Participants Reporting Systemic Events and Use of Antipyretic or Pain Medication Within 14 Days After Vaccination in Participants Aged Between 18 to <65 Years | Muscle pain: Severe | 0.7 percentage of participants |
| 13vPnC: 6 to <18 Years | Percentage of Participants Reporting Systemic Events and Use of Antipyretic or Pain Medication Within 14 Days After Vaccination in Participants Aged Between 18 to <65 Years | Joint pain: Any | 13.8 percentage of participants |
| 13vPnC: 6 to <18 Years | Percentage of Participants Reporting Systemic Events and Use of Antipyretic or Pain Medication Within 14 Days After Vaccination in Participants Aged Between 18 to <65 Years | Joint pain: Mild | 9.4 percentage of participants |
| 13vPnC: 6 to <18 Years | Percentage of Participants Reporting Systemic Events and Use of Antipyretic or Pain Medication Within 14 Days After Vaccination in Participants Aged Between 18 to <65 Years | Joint pain: Moderate | 3.6 percentage of participants |
| 13vPnC: 6 to <18 Years | Percentage of Participants Reporting Systemic Events and Use of Antipyretic or Pain Medication Within 14 Days After Vaccination in Participants Aged Between 18 to <65 Years | Joint pain: Severe | 0.7 percentage of participants |
| 13vPnC: 6 to <18 Years | Percentage of Participants Reporting Systemic Events and Use of Antipyretic or Pain Medication Within 14 Days After Vaccination in Participants Aged Between 18 to <65 Years | Use of antipyretic or pain medication | 8.2 percentage of participants |
Primary
Percentage of Participants Reporting Systemic Events and Use of Antipyretic or Pain Medication Within 7 Days After Vaccination in Participants Aged Between 6 to <18 Years
Systemic events included fever, vomiting, diarrhea, headache, fatigue, muscle and joint pain, and were recorded by using an e-diary. Use of antipyretic or pain medication was also collected by using an e-diary. Fever was graded as 37.5 to 38.4 degree Celsius (C), 38.5 to 38.9 degree C, 39.0 to 40.0 degree C and \>40.0 degree C. Vomiting was graded as mild (1-2 times in 24 hours), moderate (\>2 times in 24 hours) and severe (required intravenous hydration). Diarrhea was graded as mild (2-3 loose stools in 24 hours), moderate (4-5 loose stools in 24 hours) and severe (greater than or equals to \[\>=\] 6 loose stools in 24 hours). Headache, fatigue, muscle pain and joint pain were graded as mild (no interference with activity), moderate (some interference with activity) and severe (significant, prevented daily activity).
Time frame: Day 1 up to Day 7
Population: Safety analysis set included all participants who received 1 dose of study vaccine. Here, Number analyzed signifies participants evaluable for each specified category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC: 6 to <18 Years | Percentage of Participants Reporting Systemic Events and Use of Antipyretic or Pain Medication Within 7 Days After Vaccination in Participants Aged Between 6 to <18 Years | Fever: 37.5 degree C to 38.4 degree C | 12.5 percentage of participants |
| 13vPnC: 6 to <18 Years | Percentage of Participants Reporting Systemic Events and Use of Antipyretic or Pain Medication Within 7 Days After Vaccination in Participants Aged Between 6 to <18 Years | Fever: 38.5 degree C to 38.9 degree C | 2.1 percentage of participants |
| 13vPnC: 6 to <18 Years | Percentage of Participants Reporting Systemic Events and Use of Antipyretic or Pain Medication Within 7 Days After Vaccination in Participants Aged Between 6 to <18 Years | Fever: 39.0 degree C to 40.0 degree C | 0.0 percentage of participants |
| 13vPnC: 6 to <18 Years | Percentage of Participants Reporting Systemic Events and Use of Antipyretic or Pain Medication Within 7 Days After Vaccination in Participants Aged Between 6 to <18 Years | Fever: >40.0 degree C | 0.0 percentage of participants |
| 13vPnC: 6 to <18 Years | Percentage of Participants Reporting Systemic Events and Use of Antipyretic or Pain Medication Within 7 Days After Vaccination in Participants Aged Between 6 to <18 Years | Fatigue: Any | 37.5 percentage of participants |
| 13vPnC: 6 to <18 Years | Percentage of Participants Reporting Systemic Events and Use of Antipyretic or Pain Medication Within 7 Days After Vaccination in Participants Aged Between 6 to <18 Years | Fatigue: Mild | 25.0 percentage of participants |
| 13vPnC: 6 to <18 Years | Percentage of Participants Reporting Systemic Events and Use of Antipyretic or Pain Medication Within 7 Days After Vaccination in Participants Aged Between 6 to <18 Years | Fatigue: Moderate | 10.4 percentage of participants |
| 13vPnC: 6 to <18 Years | Percentage of Participants Reporting Systemic Events and Use of Antipyretic or Pain Medication Within 7 Days After Vaccination in Participants Aged Between 6 to <18 Years | Fatigue: Severe | 2.1 percentage of participants |
| 13vPnC: 6 to <18 Years | Percentage of Participants Reporting Systemic Events and Use of Antipyretic or Pain Medication Within 7 Days After Vaccination in Participants Aged Between 6 to <18 Years | Headache: Any | 24.5 percentage of participants |
| 13vPnC: 6 to <18 Years | Percentage of Participants Reporting Systemic Events and Use of Antipyretic or Pain Medication Within 7 Days After Vaccination in Participants Aged Between 6 to <18 Years | Headache: Mild | 16.3 percentage of participants |
| 13vPnC: 6 to <18 Years | Percentage of Participants Reporting Systemic Events and Use of Antipyretic or Pain Medication Within 7 Days After Vaccination in Participants Aged Between 6 to <18 Years | Headache: Moderate | 6.1 percentage of participants |
| 13vPnC: 6 to <18 Years | Percentage of Participants Reporting Systemic Events and Use of Antipyretic or Pain Medication Within 7 Days After Vaccination in Participants Aged Between 6 to <18 Years | Headache: Severe | 2.0 percentage of participants |
| 13vPnC: 6 to <18 Years | Percentage of Participants Reporting Systemic Events and Use of Antipyretic or Pain Medication Within 7 Days After Vaccination in Participants Aged Between 6 to <18 Years | Vomiting: Any | 0.0 percentage of participants |
| 13vPnC: 6 to <18 Years | Percentage of Participants Reporting Systemic Events and Use of Antipyretic or Pain Medication Within 7 Days After Vaccination in Participants Aged Between 6 to <18 Years | Vomiting: Mild | 0.0 percentage of participants |
| 13vPnC: 6 to <18 Years | Percentage of Participants Reporting Systemic Events and Use of Antipyretic or Pain Medication Within 7 Days After Vaccination in Participants Aged Between 6 to <18 Years | Vomiting: Moderate | 0.0 percentage of participants |
| 13vPnC: 6 to <18 Years | Percentage of Participants Reporting Systemic Events and Use of Antipyretic or Pain Medication Within 7 Days After Vaccination in Participants Aged Between 6 to <18 Years | Vomiting: Severe | 0.0 percentage of participants |
| 13vPnC: 6 to <18 Years | Percentage of Participants Reporting Systemic Events and Use of Antipyretic or Pain Medication Within 7 Days After Vaccination in Participants Aged Between 6 to <18 Years | Diarrhea: Any | 8.3 percentage of participants |
| 13vPnC: 6 to <18 Years | Percentage of Participants Reporting Systemic Events and Use of Antipyretic or Pain Medication Within 7 Days After Vaccination in Participants Aged Between 6 to <18 Years | Diarrhea: Mild | 8.3 percentage of participants |
| 13vPnC: 6 to <18 Years | Percentage of Participants Reporting Systemic Events and Use of Antipyretic or Pain Medication Within 7 Days After Vaccination in Participants Aged Between 6 to <18 Years | Diarrhea: Moderate | 0.0 percentage of participants |
| 13vPnC: 6 to <18 Years | Percentage of Participants Reporting Systemic Events and Use of Antipyretic or Pain Medication Within 7 Days After Vaccination in Participants Aged Between 6 to <18 Years | Diarrhea: Severe | 0.0 percentage of participants |
| 13vPnC: 6 to <18 Years | Percentage of Participants Reporting Systemic Events and Use of Antipyretic or Pain Medication Within 7 Days After Vaccination in Participants Aged Between 6 to <18 Years | Muscle pain: Any | 30.6 percentage of participants |
| 13vPnC: 6 to <18 Years | Percentage of Participants Reporting Systemic Events and Use of Antipyretic or Pain Medication Within 7 Days After Vaccination in Participants Aged Between 6 to <18 Years | Muscle pain: Mild | 26.5 percentage of participants |
| 13vPnC: 6 to <18 Years | Percentage of Participants Reporting Systemic Events and Use of Antipyretic or Pain Medication Within 7 Days After Vaccination in Participants Aged Between 6 to <18 Years | Muscle pain: Moderate | 4.1 percentage of participants |
| 13vPnC: 6 to <18 Years | Percentage of Participants Reporting Systemic Events and Use of Antipyretic or Pain Medication Within 7 Days After Vaccination in Participants Aged Between 6 to <18 Years | Muscle pain: Severe | 0.0 percentage of participants |
| 13vPnC: 6 to <18 Years | Percentage of Participants Reporting Systemic Events and Use of Antipyretic or Pain Medication Within 7 Days After Vaccination in Participants Aged Between 6 to <18 Years | Joint pain: Any | 6.3 percentage of participants |
| 13vPnC: 6 to <18 Years | Percentage of Participants Reporting Systemic Events and Use of Antipyretic or Pain Medication Within 7 Days After Vaccination in Participants Aged Between 6 to <18 Years | Joint pain: Mild | 4.2 percentage of participants |
| 13vPnC: 6 to <18 Years | Percentage of Participants Reporting Systemic Events and Use of Antipyretic or Pain Medication Within 7 Days After Vaccination in Participants Aged Between 6 to <18 Years | Joint pain: Moderate | 2.1 percentage of participants |
| 13vPnC: 6 to <18 Years | Percentage of Participants Reporting Systemic Events and Use of Antipyretic or Pain Medication Within 7 Days After Vaccination in Participants Aged Between 6 to <18 Years | Joint pain: Severe | 0.0 percentage of participants |
| 13vPnC: 6 to <18 Years | Percentage of Participants Reporting Systemic Events and Use of Antipyretic or Pain Medication Within 7 Days After Vaccination in Participants Aged Between 6 to <18 Years | Use of antipyretic or pain medication | 6.4 percentage of participants |
Secondary
Geometric Mean Fold Rises (GMFRs) in Serotype-specific OPA Titers 1 Month After Vaccination
OPA GMFRs were calculated along with corresponding 2-sided 95% CIs for pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F. GMFRs were computed as the fold rise in titer value at 1 month after vaccination compared to baseline (pre-vaccination). The CIs for GMFRs were back transformations of a CI based on the Student t distribution for the mean difference of the log-transformed assay results before vaccination and 1 month after vaccination.
Time frame: Pre-vaccination to 1 month after vaccination
Population: Evaluable immunogenicity set: Eligible participants received study vaccine,took no prohibited vaccine,had blood drawn in specified time frame had atleast 1 valid,determinate OPA titer/IgG concentration result for atleast 1 serotype 1 month after vaccination,no major protocol violation. Number analyzed=participant evaluable for specified row.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 13vPnC: 6 to <18 Years | Geometric Mean Fold Rises (GMFRs) in Serotype-specific OPA Titers 1 Month After Vaccination | Serotype 1 | 15.6 fold rise |
| 13vPnC: 6 to <18 Years | Geometric Mean Fold Rises (GMFRs) in Serotype-specific OPA Titers 1 Month After Vaccination | Serotype 3 | 5.5 fold rise |
| 13vPnC: 6 to <18 Years | Geometric Mean Fold Rises (GMFRs) in Serotype-specific OPA Titers 1 Month After Vaccination | Serotype 4 | 61.7 fold rise |
| 13vPnC: 6 to <18 Years | Geometric Mean Fold Rises (GMFRs) in Serotype-specific OPA Titers 1 Month After Vaccination | Serotype 5 | 11.2 fold rise |
| 13vPnC: 6 to <18 Years | Geometric Mean Fold Rises (GMFRs) in Serotype-specific OPA Titers 1 Month After Vaccination | Serotype 6A | 34.7 fold rise |
| 13vPnC: 6 to <18 Years | Geometric Mean Fold Rises (GMFRs) in Serotype-specific OPA Titers 1 Month After Vaccination | Serotype 6B | 21.9 fold rise |
| 13vPnC: 6 to <18 Years | Geometric Mean Fold Rises (GMFRs) in Serotype-specific OPA Titers 1 Month After Vaccination | Serotype 7F | 12.1 fold rise |
| 13vPnC: 6 to <18 Years | Geometric Mean Fold Rises (GMFRs) in Serotype-specific OPA Titers 1 Month After Vaccination | Serotype 9V | 6.8 fold rise |
| 13vPnC: 6 to <18 Years | Geometric Mean Fold Rises (GMFRs) in Serotype-specific OPA Titers 1 Month After Vaccination | Serotype 14 | 13.2 fold rise |
| 13vPnC: 6 to <18 Years | Geometric Mean Fold Rises (GMFRs) in Serotype-specific OPA Titers 1 Month After Vaccination | Serotype 18C | 26.7 fold rise |
| 13vPnC: 6 to <18 Years | Geometric Mean Fold Rises (GMFRs) in Serotype-specific OPA Titers 1 Month After Vaccination | Serotype 19A | 24.9 fold rise |
| 13vPnC: 6 to <18 Years | Geometric Mean Fold Rises (GMFRs) in Serotype-specific OPA Titers 1 Month After Vaccination | Serotype 19F | 26.6 fold rise |
| 13vPnC: 6 to <18 Years | Geometric Mean Fold Rises (GMFRs) in Serotype-specific OPA Titers 1 Month After Vaccination | Serotype 23F | 50.4 fold rise |
Secondary
GMFRs in Serotype-specific IgG From Before Vaccination to 1 Month After Vaccination
IgG GMFRs were calculated along with corresponding 2-sided 95% CIs for pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F. GMFRs were computed as the fold rise in concentrations at 1 month after vaccination compared to baseline (pre-vaccination). The CIs for GMFRs were back transformations of a CI based on the Student t distribution for the mean difference of the log-transformed assay results before vaccination and 1 month after vaccination.
Time frame: Pre- vaccination to 1 month after vaccination
Population: Evaluable immunogenicity set: Eligible participants received study vaccine, took no prohibited vaccine, had blood drawn in specified time frame had atleast 1 valid, determinate OPA titer/IgG concentration result for atleast 1 serotype 1 month after vaccination, no major protocol violation.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 13vPnC: 6 to <18 Years | GMFRs in Serotype-specific IgG From Before Vaccination to 1 Month After Vaccination | Serotype 1 | 33.445 fold rise |
| 13vPnC: 6 to <18 Years | GMFRs in Serotype-specific IgG From Before Vaccination to 1 Month After Vaccination | Serotype 3 | 4.605 fold rise |
| 13vPnC: 6 to <18 Years | GMFRs in Serotype-specific IgG From Before Vaccination to 1 Month After Vaccination | Serotype 4 | 32.960 fold rise |
| 13vPnC: 6 to <18 Years | GMFRs in Serotype-specific IgG From Before Vaccination to 1 Month After Vaccination | Serotype 5 | 47.565 fold rise |
| 13vPnC: 6 to <18 Years | GMFRs in Serotype-specific IgG From Before Vaccination to 1 Month After Vaccination | Serotype 6A | 23.587 fold rise |
| 13vPnC: 6 to <18 Years | GMFRs in Serotype-specific IgG From Before Vaccination to 1 Month After Vaccination | Serotype 6B | 22.421 fold rise |
| 13vPnC: 6 to <18 Years | GMFRs in Serotype-specific IgG From Before Vaccination to 1 Month After Vaccination | Serotype 7F | 39.843 fold rise |
| 13vPnC: 6 to <18 Years | GMFRs in Serotype-specific IgG From Before Vaccination to 1 Month After Vaccination | Serotype 9V | 22.232 fold rise |
| 13vPnC: 6 to <18 Years | GMFRs in Serotype-specific IgG From Before Vaccination to 1 Month After Vaccination | Serotype 14 | 23.161 fold rise |
| 13vPnC: 6 to <18 Years | GMFRs in Serotype-specific IgG From Before Vaccination to 1 Month After Vaccination | Serotype 18C | 30.833 fold rise |
| 13vPnC: 6 to <18 Years | GMFRs in Serotype-specific IgG From Before Vaccination to 1 Month After Vaccination | Serotype 19A | 15.354 fold rise |
| 13vPnC: 6 to <18 Years | GMFRs in Serotype-specific IgG From Before Vaccination to 1 Month After Vaccination | Serotype 19F | 19.892 fold rise |
| 13vPnC: 6 to <18 Years | GMFRs in Serotype-specific IgG From Before Vaccination to 1 Month After Vaccination | Serotype 23F | 34.809 fold rise |
Secondary
Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) at Pre-vaccination and 1 Month After Vaccination
Pneumococcal IgG antibody against each of the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) was measured centrally using direct binding Luminex assay. Results were expressed as IgG concentrations. IgG concentrations were logarithmically transformed for analysis; geometric means calculated and expressed as GMCs. Two (2)-sided 95% CIs were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed based on the Student t distribution.
Time frame: Pre-vaccination and 1 month after vaccination
Population: Evaluable immunogenicity set: Eligible participants received study vaccine, took no prohibited vaccine, had blood drawn in specified time frame had atleast 1 valid, determinate OPA titer/IgG concentration result for atleast 1 serotype 1 month after vaccination, no major protocol violation.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 13vPnC: 6 to <18 Years | Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) at Pre-vaccination and 1 Month After Vaccination | Pre-vaccination; Serotype 1 | 0.132 microgram per milliliter (mcg/mL) |
| 13vPnC: 6 to <18 Years | Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) at Pre-vaccination and 1 Month After Vaccination | 1 month after vaccination; Serotype 1 | 4.427 microgram per milliliter (mcg/mL) |
| 13vPnC: 6 to <18 Years | Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) at Pre-vaccination and 1 Month After Vaccination | Pre-vaccination; Serotype 3 | 0.115 microgram per milliliter (mcg/mL) |
| 13vPnC: 6 to <18 Years | Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) at Pre-vaccination and 1 Month After Vaccination | 1 month after vaccination; Serotype 3 | 0.531 microgram per milliliter (mcg/mL) |
| 13vPnC: 6 to <18 Years | Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) at Pre-vaccination and 1 Month After Vaccination | Pre-vaccination; Serotype 4 | 0.055 microgram per milliliter (mcg/mL) |
| 13vPnC: 6 to <18 Years | Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) at Pre-vaccination and 1 Month After Vaccination | 1 month after vaccination; Serotype 4 | 1.826 microgram per milliliter (mcg/mL) |
| 13vPnC: 6 to <18 Years | Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) at Pre-vaccination and 1 Month After Vaccination | Pre-vaccination; Serotype 5 | 0.058 microgram per milliliter (mcg/mL) |
| 13vPnC: 6 to <18 Years | Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) at Pre-vaccination and 1 Month After Vaccination | 1 month after vaccination; Serotype 5 | 2.779 microgram per milliliter (mcg/mL) |
| 13vPnC: 6 to <18 Years | Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) at Pre-vaccination and 1 Month After Vaccination | Pre-vaccination; Serotype 6A | 0.173 microgram per milliliter (mcg/mL) |
| 13vPnC: 6 to <18 Years | Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) at Pre-vaccination and 1 Month After Vaccination | 1 month after vaccination; Serotype 6A | 4.070 microgram per milliliter (mcg/mL) |
| 13vPnC: 6 to <18 Years | Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) at Pre-vaccination and 1 Month After Vaccination | Pre-vaccination; Serotype 6B | 0.105 microgram per milliliter (mcg/mL) |
| 13vPnC: 6 to <18 Years | Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) at Pre-vaccination and 1 Month After Vaccination | 1 month after vaccination; Serotype 6B | 2.354 microgram per milliliter (mcg/mL) |
| 13vPnC: 6 to <18 Years | Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) at Pre-vaccination and 1 Month After Vaccination | Pre-vaccination; Serotype 7F | 0.117 microgram per milliliter (mcg/mL) |
| 13vPnC: 6 to <18 Years | Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) at Pre-vaccination and 1 Month After Vaccination | 1 month after vaccination; Serotype 7F | 4.670 microgram per milliliter (mcg/mL) |
| 13vPnC: 6 to <18 Years | Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) at Pre-vaccination and 1 Month After Vaccination | Pre-vaccination; Serotype 9V | 0.067 microgram per milliliter (mcg/mL) |
| 13vPnC: 6 to <18 Years | Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) at Pre-vaccination and 1 Month After Vaccination | 1 month after vaccination; Serotype 9V | 1.483 microgram per milliliter (mcg/mL) |
| 13vPnC: 6 to <18 Years | Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) at Pre-vaccination and 1 Month After Vaccination | Pre-vaccination; Serotype 14 | 0.335 microgram per milliliter (mcg/mL) |
| 13vPnC: 6 to <18 Years | Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) at Pre-vaccination and 1 Month After Vaccination | 1 month after vaccination; Serotype 14 | 7.769 microgram per milliliter (mcg/mL) |
| 13vPnC: 6 to <18 Years | Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) at Pre-vaccination and 1 Month After Vaccination | Pre-vaccination; Serotype 18C | 0.168 microgram per milliliter (mcg/mL) |
| 13vPnC: 6 to <18 Years | Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) at Pre-vaccination and 1 Month After Vaccination | 1 month after vaccination; Serotype 18C | 5.187 microgram per milliliter (mcg/mL) |
| 13vPnC: 6 to <18 Years | Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) at Pre-vaccination and 1 Month After Vaccination | Pre-vaccination; Serotype 19A | 0.496 microgram per milliliter (mcg/mL) |
| 13vPnC: 6 to <18 Years | Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) at Pre-vaccination and 1 Month After Vaccination | 1 month after vaccination; Serotype 19A | 7.616 microgram per milliliter (mcg/mL) |
| 13vPnC: 6 to <18 Years | Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) at Pre-vaccination and 1 Month After Vaccination | Pre-vaccination; Serotype 19F | 0.217 microgram per milliliter (mcg/mL) |
| 13vPnC: 6 to <18 Years | Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) at Pre-vaccination and 1 Month After Vaccination | 1 month after vaccination; Serotype 19F | 4.315 microgram per milliliter (mcg/mL) |
| 13vPnC: 6 to <18 Years | Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) at Pre-vaccination and 1 Month After Vaccination | Pre-vaccination; Serotype 23F | 0.181 microgram per milliliter (mcg/mL) |
| 13vPnC: 6 to <18 Years | Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) at Pre-vaccination and 1 Month After Vaccination | 1 month after vaccination; Serotype 23F | 6.283 microgram per milliliter (mcg/mL) |
Secondary
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at Pre-vaccination and 1 Month After Vaccination
Antibody-mediated serum OPA against each of the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) was measured centrally using a quantitative functional microcolony OPA (mcOPA) assay. Results were expressed as OPA titers. OPA titers were logarithmically transformed for analysis; geometric means calculated and expressed as geometric mean titers (GMTs). Two (2)-sided 95% CIs were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed based on the Student t distribution. OPA titer was expressed as reciprocal of highest serum dilution.
Time frame: Pre-vaccination and 1 month after vaccination
Population: Evaluable immunogenicity population: eligible participants who received the study vaccine and took no prohibited vaccines, had blood drawn within 1 month after vaccination with at least 1 valid and determinate assay and had no major protocol violations. Here, Number analyzed signifies participants evaluable for each specified row.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 13vPnC: 6 to <18 Years | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at Pre-vaccination and 1 Month After Vaccination | Pre-vaccination; Serotype 1 | 10 titers |
| 13vPnC: 6 to <18 Years | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at Pre-vaccination and 1 Month After Vaccination | 1 month after vaccination; Serotype 1 | 152 titers |
| 13vPnC: 6 to <18 Years | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at Pre-vaccination and 1 Month After Vaccination | Pre-vaccination; Serotype 3 | 11 titers |
| 13vPnC: 6 to <18 Years | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at Pre-vaccination and 1 Month After Vaccination | 1 month after vaccination; Serotype 3 | 63 titers |
| 13vPnC: 6 to <18 Years | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at Pre-vaccination and 1 Month After Vaccination | Pre-vaccination; Serotype 4 | 18 titers |
| 13vPnC: 6 to <18 Years | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at Pre-vaccination and 1 Month After Vaccination | 1 month after vaccination; Serotype 4 | 1257 titers |
| 13vPnC: 6 to <18 Years | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at Pre-vaccination and 1 Month After Vaccination | Pre-vaccination; Serotype 5 | 16 titers |
| 13vPnC: 6 to <18 Years | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at Pre-vaccination and 1 Month After Vaccination | 1 month after vaccination; Serotype 5 | 185 titers |
| 13vPnC: 6 to <18 Years | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at Pre-vaccination and 1 Month After Vaccination | Pre-vaccination; Serotype 6A | 57 titers |
| 13vPnC: 6 to <18 Years | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at Pre-vaccination and 1 Month After Vaccination | 1 month after vaccination; Serotype 6A | 2487 titers |
| 13vPnC: 6 to <18 Years | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at Pre-vaccination and 1 Month After Vaccination | Pre-vaccination; Serotype 6B | 72 titers |
| 13vPnC: 6 to <18 Years | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at Pre-vaccination and 1 Month After Vaccination | 1 month after vaccination; Serotype 6B | 1845 titers |
| 13vPnC: 6 to <18 Years | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at Pre-vaccination and 1 Month After Vaccination | Pre-vaccination; Serotype 7F | 167 titers |
| 13vPnC: 6 to <18 Years | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at Pre-vaccination and 1 Month After Vaccination | 1 month after vaccination; Serotype 7F | 2107 titers |
| 13vPnC: 6 to <18 Years | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at Pre-vaccination and 1 Month After Vaccination | Pre-vaccination; Serotype 9V | 204 titers |
| 13vPnC: 6 to <18 Years | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at Pre-vaccination and 1 Month After Vaccination | 1 month after vaccination; Serotype 9V | 1425 titers |
| 13vPnC: 6 to <18 Years | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at Pre-vaccination and 1 Month After Vaccination | Pre-vaccination; Serotype 14 | 129 titers |
| 13vPnC: 6 to <18 Years | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at Pre-vaccination and 1 Month After Vaccination | 1 month after vaccination; Serotype 14 | 1919 titers |
| 13vPnC: 6 to <18 Years | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at Pre-vaccination and 1 Month After Vaccination | Pre-vaccination; Serotype 18C | 61 titers |
| 13vPnC: 6 to <18 Years | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at Pre-vaccination and 1 Month After Vaccination | 1 month after vaccination; Serotype 18C | 1829 titers |
| 13vPnC: 6 to <18 Years | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at Pre-vaccination and 1 Month After Vaccination | Pre-vaccination; Serotype 19A | 38 titers |
| 13vPnC: 6 to <18 Years | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at Pre-vaccination and 1 Month After Vaccination | 1 month after vaccination; Serotype 19A | 955 titers |
| 13vPnC: 6 to <18 Years | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at Pre-vaccination and 1 Month After Vaccination | Pre-vaccination; Serotype 19F | 42 titers |
| 13vPnC: 6 to <18 Years | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at Pre-vaccination and 1 Month After Vaccination | 1 month after vaccination; Serotype 19F | 1126 titers |
| 13vPnC: 6 to <18 Years | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at Pre-vaccination and 1 Month After Vaccination | Pre-vaccination; Serotype 23F | 14 titers |
| 13vPnC: 6 to <18 Years | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at Pre-vaccination and 1 Month After Vaccination | 1 month after vaccination; Serotype 23F | 713 titers |