suspension in prefilled syringe for intramuscular injection, 0.5 mL, only one dose

An AE was any untoward medical occurrence in a study participant administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage.

Number of participants with NDCMCs from 1 month after the last study vaccination (13vPnC or Hib vaccine) to 6 months after the last study vaccination in Cohorts 2, 3, and 4. An NDCMC was defined as a disease or medical condition that was not identified prior to study start and was expected to be persistent or otherwise long-lasting in its effects.

An SAE was any untoward medical occurrence at any dose that resulted in death, was life-threatening (immediate risk of death), required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect or considered to be an important medical event.

Serotype-specific IgG concentrations to the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in all participants from the blood samples taken before vaccination and 1 month after vaccination in each of the 3 cohorts. GMC and corresponding 2-sided 95% CI were evaluated. GMs were calculated using all participants with available data for the specified blood draw.

Serotype-specific OPA titers to the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in a randomly selected subset of approximately 50 participants receiving 13vPnC and approximately 25 participants receiving Hib vaccine from the blood samples taken before vaccination and 1 month after the last 13vPnC vaccination in each of the 3 cohorts.

Serotype-specific IgG concentrations to the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in all participants from the blood samples taken 1 month after the infant series in Cohort 1 and the last dose of vaccination (13vPnC or Hib vaccine) in Cohorts 2, 3, 4.

Serotype-specific OPA titers to the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in a randomly selected subset of about 50 participants receiving 13vPnC from the blood samples taken 1 month after the infant series in Cohort 1 and the last vaccination (13vPnC or Hib vaccine) in each of the 3 cohorts.

An AE was any untoward medical occurrence in a study participant administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage.

Number of Participants With NDCMCs from 1 month after vaccination 3 to vaccination 4 in Cohort 1. An NDCMC was defined as a disease or medical condition that was not identified prior to study start and was expected to be persistent or otherwise long-lasting in its effects.

Number of Participants With AEs from vaccination 4 to 1 month after vaccination 4 in Cohort 1. An AE was any untoward medical occurrence in a study participant administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage.

Number of Participants With NDCMCs from 1 month after vaccination 4 to 6 months after vaccination 4 in Cohort 1. An NDCMC was defined as a disease or medical condition that was not identified prior to study start and was expected to be persistent or otherwise long-lasting in its effects.

Number of Participants With SAEs from the signing of the ICD to 6 months after vaccination 4. An SAE was any untoward medical occurrence at any dose that resulted in death, was life-threatening (immediate risk of death), required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect or considered to be an important medical event.

Serotype-specific IgG concentrations to the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in all participants from the blood samples taken after last vaccination in Cohort 1. GMC and corresponding 2-sided 95% CI were evaluated. GMs were calculated using all participants with available data for the specified blood draw.

Participants vaccinated 2 doses of Hib Vaccine (single intramuscular injection): Vaccination 1 (Visit 1): 7 to <12 months of age; Vaccination 2: at least 28 days after Visit 1.

Participants vaccinated 2 doses of 13vPnC (single intramuscular injection): Vaccination 1 (Visit 1): >=1 to <2 years of age; Vaccination 2: at least 56 days after Visit 1.

Participants vaccinated 1 dose of Hib vaccine (single intramuscular injection): Vaccination 1: >=1 to <2 years of age.

Participants vaccinated 1 dose of 13vPnC (single intramuscular injection): Vaccination 1: >=2 to <6 years of age.

Participants vaccinated 1 dose of Hib vaccine (single intramuscular injection): Vaccination 1: >=2 to <6 years of age.

Total of all reporting groups

The ages of participants in Cohort 1 and 2 were counted in different 'Unit of Measures' from Cohort 3 and 4, and thus they were reported in separated 'Baseline Measures'. Cohort 1 and 2 were reported here.

The ages of participants in Cohort 1 and 2 were counted in different 'Unit of Measures' from Cohort 3 and 4, and thus they were reported in separated 'Baseline Measures'. Cohort 3 and 4 were reported here.

The ages of participants in Cohort 1 and 2 were counted in different 'Unit of Measures' from Cohort 3 and 4, and thus they were reported in separated 'Baseline Measures'. Cohort 3 and 4 were reported here.

Local reactions (redness, swelling, and tenderness) at the site of the investigational product injection were monitored daily for 7 days after each vaccination. Temperature were collected at bedtime daily for 7 days and at any time during the 7 days that fever is suspected. Fever is defined as temperature of greater than or equal to 38.0ºC (100.4ºF). Other systemic events (decreased appetite, drowsiness and irritability) were recorded for 7 days after each investigational product vaccination.

The safety population included all participants who received at least 1 dose of the investigational product.

Local reactions (redness, swelling, and tenderness) at the site of the investigational product injection were monitored daily for 7 days after each vaccination. Temperature were collected at bedtime daily for 7 days and at any time during the 7 days that fever is suspected. Fever is defined as temperature of greater than or equal to 38.0ºC (100.4ºF). Other systemic events (decreased appetite, drowsiness and irritability) were recorded for 7 days after each investigational product vaccination.

The safety population included all participants who received at least 1 dose of the investigational product.

Local reactions (redness, swelling, and tenderness) at the site of the investigational product injection were monitored daily for 7 days after each vaccination. Temperature were collected at bedtime daily for 7 days and at any time during the 7 days that fever is suspected. Fever is defined as temperature of greater than or equal to 38.0ºC (100.4ºF). Other systemic events (fatigue, headache, vomiting, diarrhea, muscle pain and joint pain) were recorded for 7 days after each investigational product vaccination.

The safety population included all participants who received at least 1 dose of the investigational product.

An AE was any untoward medical occurrence in a study participant administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage.

The safety population included all participants who received at least 1 dose of the investigational product.

Number of participants with NDCMCs from 1 month after the last study vaccination (13vPnC or Hib vaccine) to 6 months after the last study vaccination in Cohorts 2, 3, and 4. An NDCMC was defined as a disease or medical condition that was not identified prior to study start and was expected to be persistent or otherwise long-lasting in its effects.

The safety population included all participants who received at least 1 dose of the investigational product.

An SAE was any untoward medical occurrence at any dose that resulted in death, was life-threatening (immediate risk of death), required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect or considered to be an important medical event.

The safety population included all participants who received at least 1 dose of the investigational product.

Serotype-specific OPA titers to the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in a randomly selected subset of about 50 participants receiving 13vPnC from the blood samples taken 1 month after the infant series in Cohort 1 and the last 13vPnC vaccination in each of the 3 cohorts. GMT and corresponding 2-sided 95% CI were evaluated. GMs were calculated using all participants with available data for the specified blood draw.

Evaluable analysis set included all participants evaluable for the study at randomization; received all study vaccinations for Cohort 2-4, received all 3 infant series doses for Cohort 1; had blood draw for assay testing within 27-56 days after 3rd vaccination for Cohort 1, visit 3 for Cohort 2, visit 2 for Cohort 3 and visit 1 for Cohort 4 and the sample from this blood draw provided at least 1 valid and determinate assay result; received no prohibited vaccine; had no major protocol violation.

Serotype-specific IgG concentrations to the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in all participants from the blood samples taken before vaccination and 1 month after vaccination in each of the 3 cohorts. GMC and corresponding 2-sided 95% CI were evaluated. GMs were calculated using all participants with available data for the specified blood draw.

Evaluable analysis set included all participants evaluable for the study at randomization; received all study vaccinations for Cohort 2-4; had blood draw for assay testing within 27-56 days after visit 3 for Cohort 2, visit 2 for Cohort 3 and visit 1 for Cohort 4 and the sample from this blood draw provided at least 1 valid and determinate assay result; received no prohibited vaccine; had no major protocol violation.

Serotype-specific OPA titers to the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in a randomly selected subset of approximately 50 participants receiving 13vPnC and approximately 25 participants receiving Hib vaccine from the blood samples taken before vaccination and 1 month after the last 13vPnC vaccination in each of the 3 cohorts.

Evaluable analysis set included all participants evaluable for the study at randomization; received all study vaccinations for Cohort 2-4; had blood draw for assay testing within 27-56 days after visit 3 for Cohort 2, visit 2 for Cohort 3 and visit 1 for Cohort 4 and the sample from this blood draw provided at least 1 valid and determinate assay result; received no prohibited vaccine; had no major protocol violation.

Serotype-specific IgG concentrations to the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in all participants from the blood samples taken 1 month after the infant series in Cohort 1 and the last dose of vaccination (13vPnC or Hib vaccine) in Cohorts 2, 3, 4.

Evaluable analysis set included all participants evaluable for the study at randomization; received all study vaccinations for Cohort 2-4, received all 3 infant series doses for Cohort 1; had blood draw for assay testing within 27-56 days after 3rd vaccination for Cohort 1, visit 3 for Cohort 2, visit 2 for Cohort 3 and visit 1 for Cohort 4 and the sample from this blood draw provided at least 1 valid and determinate assay result; received no prohibited vaccine; had no major protocol violation.

Serotype-specific OPA titers to the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in a randomly selected subset of about 50 participants receiving 13vPnC from the blood samples taken 1 month after the infant series in Cohort 1 and the last vaccination (13vPnC or Hib vaccine) in each of the 3 cohorts.

Evaluable analysis set included all participants evaluable for the study at randomization; received all study vaccinations for Cohort 2-4, received all 3 infant series doses for Cohort 1; had blood draw for assay testing within 27-56 days after 3rd vaccination for Cohort 1, visit 3 for Cohort 2, visit 2 for Cohort 3 and visit 1 for Cohort 4 and the sample from this blood draw provided at least 1 valid and determinate assay result; received no prohibited vaccine; had no major protocol violation.

An AE was any untoward medical occurrence in a study participant administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage.

The safety population included all participants who received at least 1 dose of the investigational product.

Number of Participants With NDCMCs from 1 month after vaccination 3 to vaccination 4 in Cohort 1. An NDCMC was defined as a disease or medical condition that was not identified prior to study start and was expected to be persistent or otherwise long-lasting in its effects.

The safety population were participants who received at least 1 dose of the investigational product.

Number of Participants With AEs from vaccination 4 to 1 month after vaccination 4 in Cohort 1. An AE was any untoward medical occurrence in a study participant administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage.

The safety population were participants who received at least 1 dose of the investigational product.

Number of Participants With NDCMCs from 1 month after vaccination 4 to 6 months after vaccination 4 in Cohort 1. An NDCMC was defined as a disease or medical condition that was not identified prior to study start and was expected to be persistent or otherwise long-lasting in its effects.

The safety population were participants who received at least 1 dose of the investigational product.

Number of Participants With SAEs from the signing of the ICD to 6 months after vaccination 4. An SAE was any untoward medical occurrence at any dose that resulted in death, was life-threatening (immediate risk of death), required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect or considered to be an important medical event.

The safety population were participants who received at least 1 dose of the investigational product.

Serotype-specific IgG concentrations to the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in all participants from the blood samples taken after last vaccination in Cohort 1. GMC and corresponding 2-sided 95% CI were evaluated. GMs were calculated using all participants with available data for the specified blood draw.

Evaluable analysis set was analyzed. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure and 'Number Analyzed' signifies participants evaluable at specific rows.

Participants vaccinated 3 doses of 13vPnC (single intramuscular injection): Vaccination 1 (Visit 1): 7 to <12 months of age; Vaccination 2 (Visit 2): at least 28 days after Visit 1; Vaccination 3: 365 days to <450 days of age and at least 56 days after Visit 2.

Participants vaccinated 2 doses of Hib Vaccine (single intramuscular injection): Vaccination 1 (Visit 1): 7 to <12 months of age; Vaccination 2: at least 28 days after Visit 1;

Participants vaccinated 2 doses of 13vPnC (single intramuscular injection): Vaccination 1 (Visit 1): >=1 to <2 years of age; Vaccination 2: at least 56 days after Visit 1.

Participants vaccinated 1 dose of Hib vaccine (single intramuscular injection): Vaccination 1: >=1 to <2 years of age;

Participants vaccinated 1 dose of 13vPnC (single intramuscular injection): Vaccination 1: >=2 to <6 years of age.

Participants vaccinated 1 dose of Hib vaccine (single intramuscular injection): Vaccination 1: >=2 to <6 years of age.