Pneumococcal Infections, Pneumococcal Conjugate Vaccine
Conditions
Brief summary
The purpose of this study is to assess the safety and immunogenicity of 13-valent Pneumococcal conjugate vaccine in Chinese infant and young children.
Interventions
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
42 Days to 5 Years
Healthy volunteers
Yes
Inclusion criteria
* Evidence of a personally signed and dated ICD indicating that the parent(s)/legal guardian has been informed of all pertinent aspects of the study. * Aged 6 weeks (42 days) to \<6 years at the time of consent. * Healthy infants and children as determined by medical history, physical examination, and judgment of the investigator.
Exclusion criteria
* Participation in other studies involving investigational drug(s)/vaccine(s) since birth (Cohort 1 only) or in the 6 months prior to study entry (Cohorts 2, 3, and 4) and/or during study participation. * Other acute or chronic medical or psychiatric condition, including recent laboratory abnormality, that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study. * Vaccination with licensed or investigational pneumococcal vaccine. * Previous vaccination with licensed or investigational Hib vaccine.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each of the Pneumococcal Serotypes Measured in Cohorts 2, 3 and 4 Compared to IgG GMCs Measured in Cohort 1 | Cohort 1: 1 month after the 3rd dose of 13vPnC (infant series dose). Cohort 2, 3, 4: 1 month after the last dose of 13vPnC. | 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 13vPnC in Cohorts 2, 3, 4. GMC and corresponding 2-sided 95% confidence intervals (CI) were evaluated. Geometric means (GMs) were calculated using all participants with available data for the specified blood draw. |
| Number of Participants With Local Reactions and Systemic Events Within 7 Days After Each Vaccination in Cohort 2 | Within 7 Days After Each Vaccination | 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. |
| Number of Participants With Local Reactions and Systemic Events Within 7 Days After Each Vaccination in Cohort 3 | Within 7 Days After Each Vaccination | 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. |
| Number of Participants With Local Reactions and Systemic Events Within 7 Days After Each Vaccination in Cohort 4 | Within 7 Days After Each Vaccination | 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. |
| Number of Participants With Adverse Event (AE) From the Signing of the Informed Consent Document (ICD) to 1 Month After the Last Vaccination in Cohorts 2, 3, 4 | From the signing of ICD to 1 month after the last vaccination (13vPnC or Hib) in Cohort 2, 3 and 4. | 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 Newly Diagnosed Chronic Medical Conditions (NDCMCs) From 1 Month to 6 Months After the Last Vaccination in Cohorts 2, 3, 4 | From 1 month to 6 months (5 months) after the last vaccination in Cohorts 2,3,4. | 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. |
| Number of Participants With SAE From the Signing of the ICD to 6 Months After the Last Vaccination in Cohorts 2, 3, 4 | From the signing of ICD to 6 month after the last vaccination (13vPnC or Hib) in Cohorts 2, 3 and 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With AE From Toddler Dose Until 1 Month After the Toddler Dose in Cohort 1 | From Vaccination 4 to 1 month after Vaccination 4 in Cohort 1. | 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 to 6 Months After the Toddler Dose in Cohort 1 | From 1 month to 6 months (5 months) after Vaccination 4 in Cohort 1. | 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 Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for Each of the Pneumococcal Serotypes Measured in Cohorts 2, 3 and 4 Compared to IgG GMTs Measured in Cohort 1. | Cohort 1: 1 month after the 3rd dose of 13vPnC. Cohort 2, 3, 4: 1 month after the last dose of 13vPnC. | 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. |
| Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohort 1 at 12, 24, 36 and 48 Months After Last Vaccination in Cohort 1 (Infant Series) | Cohort 1 (infant series): 12, 24, 36 and 48 Months After Last Vaccination in Cohort 1 | 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. |
| Number of Participants With SAEs From the Signing of the ICD to 6 Months After the Toddler Dose in Cohort 1 | From the Signing of the ICD to 6 Months After the Vaccination 4. | 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 Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Cohort 2, 3, 4: Before Vaccination and 1 Month After the Last Dose | 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. |
| The Serotype-specific OPA GMT for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Cohort 2, 3, 4: Before Vaccination and 1 Month After the Last Dose | 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. |
| Percentage of Participants Achieving Pneumococcal Serotype-specific IgG Concentration ≥0.35 mcg/mL for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC). | Cohort 1: 1 month after the 3rd dose of 13vPnC. Cohorts 2, 3, 4: 1 month after the last dose of 13vPnC and Hib Vaccine. | 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. |
| Percentage of Participants Achieving Serotype-specific Pneumococcal OPA Titer ≥ Lower Limit of Quantitation (LLOQ) for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC). | Cohort 1: 1 month after the 3rd dose of 13vPnC. Cohorts 2, 3, 4: 1 month after the last dose of 13vPnC and Hib Vaccine. | 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. |
| Number of Participants With AE From the Signing of the ICD to 1 Month After the Infant Series in Cohort 1 | From the signing of ICD to 1 month after the 3rd dose of 13vPnC 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 3 to Vaccination 4 in Cohort 1 | From 1 month after Vaccination 3 to Vaccination 4. | 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. |
Countries
China
Participant flow
Recruitment details
This study presents results following completion of all vaccinations, including data from 6-month follow-up after the last study vaccination. This study was conducted in China.
Pre-assignment details
With the 280 additional participants included, a total of 986 participants were screened in this study, of whom 936 participants were enrolled or randomized, and 932 of 936 participants were vaccinated.
Participants by arm
| Arm | Count |
|---|---|
| Cohort 1 Participants vaccinated the first 3 of doses of 13vPnC (single intramuscular injection): Vaccination 1 (Visit 1): 42 to 56 days of age; Vaccination 2 (Visit 2): 42 to 70 days after Visit 1; Vaccination 3: 42 to 70 days after Visit 2; Vaccination 4: 365 to 455 days of age. | 125 |
| Cohort 2_13vPnC 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. | 236 |
| Cohort 2_Hib Vaccine 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. | 117 |
| Cohort 3_13vPnC 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. | 165 |
| Cohort 3_Hib Vaccine Participants vaccinated 1 dose of Hib vaccine (single intramuscular injection): Vaccination 1: \>=1 to \<2 years of age. | 83 |
| Cohort 4_13vPnC Participants vaccinated 1 dose of 13vPnC (single intramuscular injection): Vaccination 1: \>=2 to \<6 years of age. | 138 |
| Cohort 4_Hib Vaccine Participants vaccinated 1 dose of Hib vaccine (single intramuscular injection): Vaccination 1: \>=2 to \<6 years of age. | 68 |
| Total | 932 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 |
|---|---|---|---|---|---|---|---|---|
| Follow-up Period | Withdrawal by parent/guardian | 1 | 13 | 9 | 9 | 7 | 7 | 1 |
| Vaccination Period | Adverse Event | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
| Vaccination Period | Noncompliance With Investigational Product | 3 | 0 | 0 | 0 | 0 | 0 | 0 |
| Vaccination Period | Other | 6 | 0 | 0 | 0 | 0 | 0 | 0 |
| Vaccination Period | Withdrawal by Parent/guardian | 26 | 21 | 10 | 19 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Cohort 1 | Cohort 2_13vPnC | Cohort 2_Hib Vaccine | Total | Cohort 3_13vPnC | Cohort 3_Hib Vaccine | Cohort 4_13vPnC | Cohort 4_Hib Vaccine |
|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 49.0 Days | 284.0 Days | 281.0 Days | 1.9 Years | 1.5 Years | 1.6 Years | 3.1 Years | 3.3 Years |
| Race/Ethnicity, Customized Ethnicity_Non-Hispanic/Non-Latino | 125 Participants | 236 Participants | 117 Participants | 932 Participants | 165 Participants | 83 Participants | 138 Participants | 68 Participants |
| Race/Ethnicity, Customized Race_Asian | 125 Participants | 236 Participants | 117 Participants | 932 Participants | 165 Participants | 83 Participants | 138 Participants | 68 Participants |
| Sex: Female, Male Female | 59 Participants | 115 Participants | 50 Participants | 436 Participants | 83 Participants | 36 Participants | 56 Participants | 37 Participants |
| Sex: Female, Male Male | 66 Participants | 121 Participants | 67 Participants | 496 Participants | 82 Participants | 47 Participants | 82 Participants | 31 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk |
|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 125 | 0 / 236 | 0 / 117 | 0 / 165 | 0 / 83 | 0 / 138 | 0 / 68 |
| other Total, other adverse events | 13 / 125 | 182 / 236 | 74 / 117 | 99 / 165 | 26 / 83 | 66 / 138 | 29 / 68 |
| serious Total, serious adverse events | 9 / 125 | 5 / 236 | 1 / 117 | 2 / 165 | 0 / 83 | 2 / 138 | 1 / 68 |
Outcome results
Primary
Number of Participants With Adverse Event (AE) From the Signing of the Informed Consent Document (ICD) to 1 Month After the Last Vaccination in Cohorts 2, 3, 4
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.
Time frame: From the signing of ICD to 1 month after the last vaccination (13vPnC or Hib) in Cohort 2, 3 and 4.
Population: The safety population included all participants who received at least 1 dose of the investigational product.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1_Infant Series | Number of Participants With Adverse Event (AE) From the Signing of the Informed Consent Document (ICD) to 1 Month After the Last Vaccination in Cohorts 2, 3, 4 | 76 Participants |
| Cohort 2_13vPnC | Number of Participants With Adverse Event (AE) From the Signing of the Informed Consent Document (ICD) to 1 Month After the Last Vaccination in Cohorts 2, 3, 4 | 29 Participants |
| Cohort 3_13vPnC | Number of Participants With Adverse Event (AE) From the Signing of the Informed Consent Document (ICD) to 1 Month After the Last Vaccination in Cohorts 2, 3, 4 | 21 Participants |
| Cohort 4_vPnC | Number of Participants With Adverse Event (AE) From the Signing of the Informed Consent Document (ICD) to 1 Month After the Last Vaccination in Cohorts 2, 3, 4 | 1 Participants |
| Cohort 2_13vPnC_Vaccination 3 | Number of Participants With Adverse Event (AE) From the Signing of the Informed Consent Document (ICD) to 1 Month After the Last Vaccination in Cohorts 2, 3, 4 | 11 Participants |
| Cohort 4_Hib Vaccine | Number of Participants With Adverse Event (AE) From the Signing of the Informed Consent Document (ICD) to 1 Month After the Last Vaccination in Cohorts 2, 3, 4 | 1 Participants |
Primary
Number of Participants With Local Reactions and Systemic Events Within 7 Days After Each Vaccination in Cohort 2
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.
Time frame: Within 7 Days After Each Vaccination
Population: The safety population included all participants who received at least 1 dose of the investigational product.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1_Infant Series | Number of Participants With Local Reactions and Systemic Events Within 7 Days After Each Vaccination in Cohort 2 | Local Reactions | 66 Participants |
| Cohort 1_Infant Series | Number of Participants With Local Reactions and Systemic Events Within 7 Days After Each Vaccination in Cohort 2 | Systemic Events | 23 Participants |
| Cohort 2_13vPnC | Number of Participants With Local Reactions and Systemic Events Within 7 Days After Each Vaccination in Cohort 2 | Local Reactions | 18 Participants |
| Cohort 2_13vPnC | Number of Participants With Local Reactions and Systemic Events Within 7 Days After Each Vaccination in Cohort 2 | Systemic Events | 7 Participants |
| Cohort 3_13vPnC | Number of Participants With Local Reactions and Systemic Events Within 7 Days After Each Vaccination in Cohort 2 | Local Reactions | 20 Participants |
| Cohort 3_13vPnC | Number of Participants With Local Reactions and Systemic Events Within 7 Days After Each Vaccination in Cohort 2 | Systemic Events | 23 Participants |
| Cohort 4_vPnC | Number of Participants With Local Reactions and Systemic Events Within 7 Days After Each Vaccination in Cohort 2 | Systemic Events | 5 Participants |
| Cohort 4_vPnC | Number of Participants With Local Reactions and Systemic Events Within 7 Days After Each Vaccination in Cohort 2 | Local Reactions | 14 Participants |
| Cohort 2_13vPnC_Vaccination 3 | Number of Participants With Local Reactions and Systemic Events Within 7 Days After Each Vaccination in Cohort 2 | Local Reactions | 4 Participants |
| Cohort 2_13vPnC_Vaccination 3 | Number of Participants With Local Reactions and Systemic Events Within 7 Days After Each Vaccination in Cohort 2 | Systemic Events | 1 Participants |
Primary
Number of Participants With Local Reactions and Systemic Events Within 7 Days After Each Vaccination in Cohort 3
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.
Time frame: Within 7 Days After Each Vaccination
Population: The safety population included all participants who received at least 1 dose of the investigational product.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1_Infant Series | Number of Participants With Local Reactions and Systemic Events Within 7 Days After Each Vaccination in Cohort 3 | Local Reactions | 45 Participants |
| Cohort 1_Infant Series | Number of Participants With Local Reactions and Systemic Events Within 7 Days After Each Vaccination in Cohort 3 | Systemic Events | 26 Participants |
| Cohort 2_13vPnC | Number of Participants With Local Reactions and Systemic Events Within 7 Days After Each Vaccination in Cohort 3 | Local Reactions | 10 Participants |
| Cohort 2_13vPnC | Number of Participants With Local Reactions and Systemic Events Within 7 Days After Each Vaccination in Cohort 3 | Systemic Events | 7 Participants |
| Cohort 3_13vPnC | Number of Participants With Local Reactions and Systemic Events Within 7 Days After Each Vaccination in Cohort 3 | Local Reactions | 9 Participants |
| Cohort 3_13vPnC | Number of Participants With Local Reactions and Systemic Events Within 7 Days After Each Vaccination in Cohort 3 | Systemic Events | 4 Participants |
Primary
Number of Participants With Local Reactions and Systemic Events Within 7 Days After Each Vaccination in Cohort 4
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.
Time frame: Within 7 Days After Each Vaccination
Population: The safety population included all participants who received at least 1 dose of the investigational product.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1_Infant Series | Number of Participants With Local Reactions and Systemic Events Within 7 Days After Each Vaccination in Cohort 4 | Local Reactions | 48 Participants |
| Cohort 1_Infant Series | Number of Participants With Local Reactions and Systemic Events Within 7 Days After Each Vaccination in Cohort 4 | Systemic Events | 17 Participants |
| Cohort 2_13vPnC | Number of Participants With Local Reactions and Systemic Events Within 7 Days After Each Vaccination in Cohort 4 | Local Reactions | 21 Participants |
| Cohort 2_13vPnC | Number of Participants With Local Reactions and Systemic Events Within 7 Days After Each Vaccination in Cohort 4 | Systemic Events | 10 Participants |
Primary
Number of Participants With Newly Diagnosed Chronic Medical Conditions (NDCMCs) From 1 Month to 6 Months After the Last Vaccination in Cohorts 2, 3, 4
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.
Time frame: From 1 month to 6 months (5 months) after the last vaccination in Cohorts 2,3,4.
Population: The safety population included all participants who received at least 1 dose of the investigational product.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1_Infant Series | Number of Participants With Newly Diagnosed Chronic Medical Conditions (NDCMCs) From 1 Month to 6 Months After the Last Vaccination in Cohorts 2, 3, 4 | 0 Participants |
| Cohort 2_13vPnC | Number of Participants With Newly Diagnosed Chronic Medical Conditions (NDCMCs) From 1 Month to 6 Months After the Last Vaccination in Cohorts 2, 3, 4 | 0 Participants |
| Cohort 3_13vPnC | Number of Participants With Newly Diagnosed Chronic Medical Conditions (NDCMCs) From 1 Month to 6 Months After the Last Vaccination in Cohorts 2, 3, 4 | 0 Participants |
| Cohort 4_vPnC | Number of Participants With Newly Diagnosed Chronic Medical Conditions (NDCMCs) From 1 Month to 6 Months After the Last Vaccination in Cohorts 2, 3, 4 | 0 Participants |
| Cohort 2_13vPnC_Vaccination 3 | Number of Participants With Newly Diagnosed Chronic Medical Conditions (NDCMCs) From 1 Month to 6 Months After the Last Vaccination in Cohorts 2, 3, 4 | 0 Participants |
| Cohort 4_Hib Vaccine | Number of Participants With Newly Diagnosed Chronic Medical Conditions (NDCMCs) From 1 Month to 6 Months After the Last Vaccination in Cohorts 2, 3, 4 | 0 Participants |
Primary
Number of Participants With SAE From the Signing of the ICD to 6 Months After the Last Vaccination in Cohorts 2, 3, 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.
Time frame: From the signing of ICD to 6 month after the last vaccination (13vPnC or Hib) in Cohorts 2, 3 and 4.
Population: The safety population included all participants who received at least 1 dose of the investigational product.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1_Infant Series | Number of Participants With SAE From the Signing of the ICD to 6 Months After the Last Vaccination in Cohorts 2, 3, 4 | 5 Participants |
| Cohort 2_13vPnC | Number of Participants With SAE From the Signing of the ICD to 6 Months After the Last Vaccination in Cohorts 2, 3, 4 | 1 Participants |
| Cohort 3_13vPnC | Number of Participants With SAE From the Signing of the ICD to 6 Months After the Last Vaccination in Cohorts 2, 3, 4 | 2 Participants |
| Cohort 4_vPnC | Number of Participants With SAE From the Signing of the ICD to 6 Months After the Last Vaccination in Cohorts 2, 3, 4 | 0 Participants |
| Cohort 2_13vPnC_Vaccination 3 | Number of Participants With SAE From the Signing of the ICD to 6 Months After the Last Vaccination in Cohorts 2, 3, 4 | 2 Participants |
| Cohort 4_Hib Vaccine | Number of Participants With SAE From the Signing of the ICD to 6 Months After the Last Vaccination in Cohorts 2, 3, 4 | 1 Participants |
Primary
The Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each of the Pneumococcal Serotypes Measured in Cohorts 2, 3 and 4 Compared to IgG GMCs Measured in Cohort 1
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 13vPnC in Cohorts 2, 3, 4. GMC and corresponding 2-sided 95% confidence intervals (CI) were evaluated. Geometric means (GMs) were calculated using all participants with available data for the specified blood draw.
Time frame: Cohort 1: 1 month after the 3rd dose of 13vPnC (infant series dose). Cohort 2, 3, 4: 1 month after the last dose of 13vPnC.
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Cohort 1_Infant Series | The Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each of the Pneumococcal Serotypes Measured in Cohorts 2, 3 and 4 Compared to IgG GMCs Measured in Cohort 1 | Serotype 6B | 4.62 mcg/mL |
| Cohort 1_Infant Series | The Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each of the Pneumococcal Serotypes Measured in Cohorts 2, 3 and 4 Compared to IgG GMCs Measured in Cohort 1 | Serotype 3 | 0.63 mcg/mL |
| Cohort 1_Infant Series | The Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each of the Pneumococcal Serotypes Measured in Cohorts 2, 3 and 4 Compared to IgG GMCs Measured in Cohort 1 | Serotype 19F | 4.95 mcg/mL |
| Cohort 1_Infant Series | The Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each of the Pneumococcal Serotypes Measured in Cohorts 2, 3 and 4 Compared to IgG GMCs Measured in Cohort 1 | Serotype 19A | 3.44 mcg/mL |
| Cohort 1_Infant Series | The Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each of the Pneumococcal Serotypes Measured in Cohorts 2, 3 and 4 Compared to IgG GMCs Measured in Cohort 1 | Serotype 18C | 4.94 mcg/mL |
| Cohort 1_Infant Series | The Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each of the Pneumococcal Serotypes Measured in Cohorts 2, 3 and 4 Compared to IgG GMCs Measured in Cohort 1 | Serotype 4 | 3.96 mcg/mL |
| Cohort 1_Infant Series | The Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each of the Pneumococcal Serotypes Measured in Cohorts 2, 3 and 4 Compared to IgG GMCs Measured in Cohort 1 | Serotype 1 | 5.40 mcg/mL |
| Cohort 1_Infant Series | The Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each of the Pneumococcal Serotypes Measured in Cohorts 2, 3 and 4 Compared to IgG GMCs Measured in Cohort 1 | Serotype 14 | 15.09 mcg/mL |
| Cohort 1_Infant Series | The Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each of the Pneumococcal Serotypes Measured in Cohorts 2, 3 and 4 Compared to IgG GMCs Measured in Cohort 1 | Serotype 9V | 3.66 mcg/mL |
| Cohort 1_Infant Series | The Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each of the Pneumococcal Serotypes Measured in Cohorts 2, 3 and 4 Compared to IgG GMCs Measured in Cohort 1 | Serotype 6A | 5.35 mcg/mL |
| Cohort 1_Infant Series | The Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each of the Pneumococcal Serotypes Measured in Cohorts 2, 3 and 4 Compared to IgG GMCs Measured in Cohort 1 | Serotype 23F | 4.36 mcg/mL |
| Cohort 1_Infant Series | The Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each of the Pneumococcal Serotypes Measured in Cohorts 2, 3 and 4 Compared to IgG GMCs Measured in Cohort 1 | Serotype 7F | 7.14 mcg/mL |
| Cohort 1_Infant Series | The Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each of the Pneumococcal Serotypes Measured in Cohorts 2, 3 and 4 Compared to IgG GMCs Measured in Cohort 1 | Serotype 5 | 3.50 mcg/mL |
| Cohort 2_13vPnC | The Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each of the Pneumococcal Serotypes Measured in Cohorts 2, 3 and 4 Compared to IgG GMCs Measured in Cohort 1 | Serotype 4 | 2.97 mcg/mL |
| Cohort 2_13vPnC | The Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each of the Pneumococcal Serotypes Measured in Cohorts 2, 3 and 4 Compared to IgG GMCs Measured in Cohort 1 | Serotype 1 | 3.75 mcg/mL |
| Cohort 2_13vPnC | The Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each of the Pneumococcal Serotypes Measured in Cohorts 2, 3 and 4 Compared to IgG GMCs Measured in Cohort 1 | Serotype 3 | 1.19 mcg/mL |
| Cohort 2_13vPnC | The Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each of the Pneumococcal Serotypes Measured in Cohorts 2, 3 and 4 Compared to IgG GMCs Measured in Cohort 1 | Serotype 6A | 3.12 mcg/mL |
| Cohort 2_13vPnC | The Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each of the Pneumococcal Serotypes Measured in Cohorts 2, 3 and 4 Compared to IgG GMCs Measured in Cohort 1 | Serotype 9V | 2.24 mcg/mL |
| Cohort 2_13vPnC | The Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each of the Pneumococcal Serotypes Measured in Cohorts 2, 3 and 4 Compared to IgG GMCs Measured in Cohort 1 | Serotype 18C | 2.25 mcg/mL |
| Cohort 2_13vPnC | The Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each of the Pneumococcal Serotypes Measured in Cohorts 2, 3 and 4 Compared to IgG GMCs Measured in Cohort 1 | Serotype 19A | 3.62 mcg/mL |
| Cohort 2_13vPnC | The Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each of the Pneumococcal Serotypes Measured in Cohorts 2, 3 and 4 Compared to IgG GMCs Measured in Cohort 1 | Serotype 5 | 3.07 mcg/mL |
| Cohort 2_13vPnC | The Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each of the Pneumococcal Serotypes Measured in Cohorts 2, 3 and 4 Compared to IgG GMCs Measured in Cohort 1 | Serotype 6B | 2.20 mcg/mL |
| Cohort 2_13vPnC | The Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each of the Pneumococcal Serotypes Measured in Cohorts 2, 3 and 4 Compared to IgG GMCs Measured in Cohort 1 | Serotype 7F | 5.73 mcg/mL |
| Cohort 2_13vPnC | The Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each of the Pneumococcal Serotypes Measured in Cohorts 2, 3 and 4 Compared to IgG GMCs Measured in Cohort 1 | Serotype 14 | 10.89 mcg/mL |
| Cohort 2_13vPnC | The Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each of the Pneumococcal Serotypes Measured in Cohorts 2, 3 and 4 Compared to IgG GMCs Measured in Cohort 1 | Serotype 19F | 4.50 mcg/mL |
| Cohort 2_13vPnC | The Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each of the Pneumococcal Serotypes Measured in Cohorts 2, 3 and 4 Compared to IgG GMCs Measured in Cohort 1 | Serotype 23F | 2.04 mcg/mL |
| Cohort 3_13vPnC | The Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each of the Pneumococcal Serotypes Measured in Cohorts 2, 3 and 4 Compared to IgG GMCs Measured in Cohort 1 | Serotype 19A | 5.55 mcg/mL |
| Cohort 3_13vPnC | The Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each of the Pneumococcal Serotypes Measured in Cohorts 2, 3 and 4 Compared to IgG GMCs Measured in Cohort 1 | Serotype 4 | 4.04 mcg/mL |
| Cohort 3_13vPnC | The Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each of the Pneumococcal Serotypes Measured in Cohorts 2, 3 and 4 Compared to IgG GMCs Measured in Cohort 1 | Serotype 19F | 5.04 mcg/mL |
| Cohort 3_13vPnC | The Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each of the Pneumococcal Serotypes Measured in Cohorts 2, 3 and 4 Compared to IgG GMCs Measured in Cohort 1 | Serotype 14 | 9.79 mcg/mL |
| Cohort 3_13vPnC | The Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each of the Pneumococcal Serotypes Measured in Cohorts 2, 3 and 4 Compared to IgG GMCs Measured in Cohort 1 | Serotype 18C | 3.88 mcg/mL |
| Cohort 3_13vPnC | The Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each of the Pneumococcal Serotypes Measured in Cohorts 2, 3 and 4 Compared to IgG GMCs Measured in Cohort 1 | Serotype 6B | 2.47 mcg/mL |
| Cohort 3_13vPnC | The Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each of the Pneumococcal Serotypes Measured in Cohorts 2, 3 and 4 Compared to IgG GMCs Measured in Cohort 1 | Serotype 9V | 3.31 mcg/mL |
| Cohort 3_13vPnC | The Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each of the Pneumococcal Serotypes Measured in Cohorts 2, 3 and 4 Compared to IgG GMCs Measured in Cohort 1 | Serotype 5 | 2.57 mcg/mL |
| Cohort 3_13vPnC | The Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each of the Pneumococcal Serotypes Measured in Cohorts 2, 3 and 4 Compared to IgG GMCs Measured in Cohort 1 | Serotype 6A | 3.19 mcg/mL |
| Cohort 3_13vPnC | The Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each of the Pneumococcal Serotypes Measured in Cohorts 2, 3 and 4 Compared to IgG GMCs Measured in Cohort 1 | Serotype 3 | 1.32 mcg/mL |
| Cohort 3_13vPnC | The Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each of the Pneumococcal Serotypes Measured in Cohorts 2, 3 and 4 Compared to IgG GMCs Measured in Cohort 1 | Serotype 7F | 7.87 mcg/mL |
| Cohort 3_13vPnC | The Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each of the Pneumococcal Serotypes Measured in Cohorts 2, 3 and 4 Compared to IgG GMCs Measured in Cohort 1 | Serotype 23F | 2.26 mcg/mL |
| Cohort 3_13vPnC | The Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each of the Pneumococcal Serotypes Measured in Cohorts 2, 3 and 4 Compared to IgG GMCs Measured in Cohort 1 | Serotype 1 | 4.38 mcg/mL |
| Cohort 4_vPnC | The Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each of the Pneumococcal Serotypes Measured in Cohorts 2, 3 and 4 Compared to IgG GMCs Measured in Cohort 1 | Serotype 23F | 2.80 mcg/mL |
| Cohort 4_vPnC | The Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each of the Pneumococcal Serotypes Measured in Cohorts 2, 3 and 4 Compared to IgG GMCs Measured in Cohort 1 | Serotype 1 | 4.40 mcg/mL |
| Cohort 4_vPnC | The Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each of the Pneumococcal Serotypes Measured in Cohorts 2, 3 and 4 Compared to IgG GMCs Measured in Cohort 1 | Serotype 6A | 3.39 mcg/mL |
| Cohort 4_vPnC | The Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each of the Pneumococcal Serotypes Measured in Cohorts 2, 3 and 4 Compared to IgG GMCs Measured in Cohort 1 | Serotype 5 | 2.92 mcg/mL |
| Cohort 4_vPnC | The Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each of the Pneumococcal Serotypes Measured in Cohorts 2, 3 and 4 Compared to IgG GMCs Measured in Cohort 1 | Serotype 19A | 11.62 mcg/mL |
| Cohort 4_vPnC | The Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each of the Pneumococcal Serotypes Measured in Cohorts 2, 3 and 4 Compared to IgG GMCs Measured in Cohort 1 | Serotype 6B | 2.96 mcg/mL |
| Cohort 4_vPnC | The Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each of the Pneumococcal Serotypes Measured in Cohorts 2, 3 and 4 Compared to IgG GMCs Measured in Cohort 1 | Serotype 4 | 4.47 mcg/mL |
| Cohort 4_vPnC | The Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each of the Pneumococcal Serotypes Measured in Cohorts 2, 3 and 4 Compared to IgG GMCs Measured in Cohort 1 | Serotype 9V | 3.68 mcg/mL |
| Cohort 4_vPnC | The Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each of the Pneumococcal Serotypes Measured in Cohorts 2, 3 and 4 Compared to IgG GMCs Measured in Cohort 1 | Serotype 14 | 6.94 mcg/mL |
| Cohort 4_vPnC | The Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each of the Pneumococcal Serotypes Measured in Cohorts 2, 3 and 4 Compared to IgG GMCs Measured in Cohort 1 | Serotype 18C | 5.60 mcg/mL |
| Cohort 4_vPnC | The Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each of the Pneumococcal Serotypes Measured in Cohorts 2, 3 and 4 Compared to IgG GMCs Measured in Cohort 1 | Serotype 3 | 1.12 mcg/mL |
| Cohort 4_vPnC | The Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each of the Pneumococcal Serotypes Measured in Cohorts 2, 3 and 4 Compared to IgG GMCs Measured in Cohort 1 | Serotype 7F | 7.08 mcg/mL |
| Cohort 4_vPnC | The Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each of the Pneumococcal Serotypes Measured in Cohorts 2, 3 and 4 Compared to IgG GMCs Measured in Cohort 1 | Serotype 19F | 5.44 mcg/mL |
Secondary
Number of Participants With AE From the Signing of the ICD to 1 Month After the Infant Series 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.
Time frame: From the signing of ICD to 1 month after the 3rd dose of 13vPnC in Cohort 1.
Population: The safety population included all participants who received at least 1 dose of the investigational product.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1_Infant Series | Number of Participants With AE From the Signing of the ICD to 1 Month After the Infant Series in Cohort 1 | 14 Participants |
Secondary
Number of Participants With AE From Toddler Dose Until 1 Month After the Toddler Dose in Cohort 1
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.
Time frame: From Vaccination 4 to 1 month after Vaccination 4 in Cohort 1.
Population: The safety population were participants who received at least 1 dose of the investigational product.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1_Infant Series | Number of Participants With AE From Toddler Dose Until 1 Month After the Toddler Dose in Cohort 1 | 5 Participants |
Secondary
Number of Participants With NDCMCs From 1 Month After Vaccination 3 to Vaccination 4 in Cohort 1
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.
Time frame: From 1 month after Vaccination 3 to Vaccination 4.
Population: The safety population were participants who received at least 1 dose of the investigational product.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1_Infant Series | Number of Participants With NDCMCs From 1 Month After Vaccination 3 to Vaccination 4 in Cohort 1 | 0 Participants |
Secondary
Number of Participants With NDCMCs From 1 Month to 6 Months After the Toddler Dose in Cohort 1
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.
Time frame: From 1 month to 6 months (5 months) after Vaccination 4 in Cohort 1.
Population: The safety population were participants who received at least 1 dose of the investigational product.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1_Infant Series | Number of Participants With NDCMCs From 1 Month to 6 Months After the Toddler Dose in Cohort 1 | 0 Participants |
Secondary
Number of Participants With SAEs From the Signing of the ICD to 6 Months After the Toddler Dose in Cohort 1
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.
Time frame: From the Signing of the ICD to 6 Months After the Vaccination 4.
Population: The safety population were participants who received at least 1 dose of the investigational product.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1_Infant Series | Number of Participants With SAEs From the Signing of the ICD to 6 Months After the Toddler Dose in Cohort 1 | 9 Participants |
Secondary
Percentage of Participants Achieving Pneumococcal Serotype-specific IgG Concentration ≥0.35 mcg/mL for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC).
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.
Time frame: Cohort 1: 1 month after the 3rd dose of 13vPnC. Cohorts 2, 3, 4: 1 month after the last dose of 13vPnC and Hib Vaccine.
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort 1_Infant Series | Percentage of Participants Achieving Pneumococcal Serotype-specific IgG Concentration ≥0.35 mcg/mL for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC). | Serotype 19F | 98.6 Percentage of Participants |
| Cohort 1_Infant Series | Percentage of Participants Achieving Pneumococcal Serotype-specific IgG Concentration ≥0.35 mcg/mL for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC). | Serotype 4 | 100.0 Percentage of Participants |
| Cohort 1_Infant Series | Percentage of Participants Achieving Pneumococcal Serotype-specific IgG Concentration ≥0.35 mcg/mL for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC). | Serotype 23F | 95.8 Percentage of Participants |
| Cohort 1_Infant Series | Percentage of Participants Achieving Pneumococcal Serotype-specific IgG Concentration ≥0.35 mcg/mL for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC). | Serotype 18C | 100.0 Percentage of Participants |
| Cohort 1_Infant Series | Percentage of Participants Achieving Pneumococcal Serotype-specific IgG Concentration ≥0.35 mcg/mL for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC). | Serotype 1 | 100.0 Percentage of Participants |
| Cohort 1_Infant Series | Percentage of Participants Achieving Pneumococcal Serotype-specific IgG Concentration ≥0.35 mcg/mL for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC). | Serotype 5 | 100.0 Percentage of Participants |
| Cohort 1_Infant Series | Percentage of Participants Achieving Pneumococcal Serotype-specific IgG Concentration ≥0.35 mcg/mL for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC). | Serotype 19A | 100.0 Percentage of Participants |
| Cohort 1_Infant Series | Percentage of Participants Achieving Pneumococcal Serotype-specific IgG Concentration ≥0.35 mcg/mL for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC). | Serotype 3 | 83.3 Percentage of Participants |
| Cohort 1_Infant Series | Percentage of Participants Achieving Pneumococcal Serotype-specific IgG Concentration ≥0.35 mcg/mL for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC). | Serotype 7F | 100.0 Percentage of Participants |
| Cohort 1_Infant Series | Percentage of Participants Achieving Pneumococcal Serotype-specific IgG Concentration ≥0.35 mcg/mL for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC). | Serotype 6B | 100.0 Percentage of Participants |
| Cohort 1_Infant Series | Percentage of Participants Achieving Pneumococcal Serotype-specific IgG Concentration ≥0.35 mcg/mL for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC). | Serotype 14 | 97.2 Percentage of Participants |
| Cohort 1_Infant Series | Percentage of Participants Achieving Pneumococcal Serotype-specific IgG Concentration ≥0.35 mcg/mL for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC). | Serotype 6A | 100.0 Percentage of Participants |
| Cohort 1_Infant Series | Percentage of Participants Achieving Pneumococcal Serotype-specific IgG Concentration ≥0.35 mcg/mL for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC). | Serotype 9V | 100.0 Percentage of Participants |
| Cohort 2_13vPnC | Percentage of Participants Achieving Pneumococcal Serotype-specific IgG Concentration ≥0.35 mcg/mL for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC). | Serotype 19A | 100.0 Percentage of Participants |
| Cohort 2_13vPnC | Percentage of Participants Achieving Pneumococcal Serotype-specific IgG Concentration ≥0.35 mcg/mL for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC). | Serotype 9V | 98.3 Percentage of Participants |
| Cohort 2_13vPnC | Percentage of Participants Achieving Pneumococcal Serotype-specific IgG Concentration ≥0.35 mcg/mL for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC). | Serotype 7F | 99.4 Percentage of Participants |
| Cohort 2_13vPnC | Percentage of Participants Achieving Pneumococcal Serotype-specific IgG Concentration ≥0.35 mcg/mL for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC). | Serotype 3 | 97.7 Percentage of Participants |
| Cohort 2_13vPnC | Percentage of Participants Achieving Pneumococcal Serotype-specific IgG Concentration ≥0.35 mcg/mL for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC). | Serotype 19F | 98.9 Percentage of Participants |
| Cohort 2_13vPnC | Percentage of Participants Achieving Pneumococcal Serotype-specific IgG Concentration ≥0.35 mcg/mL for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC). | Serotype 4 | 99.4 Percentage of Participants |
| Cohort 2_13vPnC | Percentage of Participants Achieving Pneumococcal Serotype-specific IgG Concentration ≥0.35 mcg/mL for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC). | Serotype 1 | 99.4 Percentage of Participants |
| Cohort 2_13vPnC | Percentage of Participants Achieving Pneumococcal Serotype-specific IgG Concentration ≥0.35 mcg/mL for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC). | Serotype 5 | 100.0 Percentage of Participants |
| Cohort 2_13vPnC | Percentage of Participants Achieving Pneumococcal Serotype-specific IgG Concentration ≥0.35 mcg/mL for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC). | Serotype 18C | 97.7 Percentage of Participants |
| Cohort 2_13vPnC | Percentage of Participants Achieving Pneumococcal Serotype-specific IgG Concentration ≥0.35 mcg/mL for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC). | Serotype 6A | 97.7 Percentage of Participants |
| Cohort 2_13vPnC | Percentage of Participants Achieving Pneumococcal Serotype-specific IgG Concentration ≥0.35 mcg/mL for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC). | Serotype 23F | 95.5 Percentage of Participants |
| Cohort 2_13vPnC | Percentage of Participants Achieving Pneumococcal Serotype-specific IgG Concentration ≥0.35 mcg/mL for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC). | Serotype 14 | 99.4 Percentage of Participants |
| Cohort 2_13vPnC | Percentage of Participants Achieving Pneumococcal Serotype-specific IgG Concentration ≥0.35 mcg/mL for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC). | Serotype 6B | 96.0 Percentage of Participants |
| Cohort 3_13vPnC | Percentage of Participants Achieving Pneumococcal Serotype-specific IgG Concentration ≥0.35 mcg/mL for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC). | Serotype 1 | 4.2 Percentage of Participants |
| Cohort 3_13vPnC | Percentage of Participants Achieving Pneumococcal Serotype-specific IgG Concentration ≥0.35 mcg/mL for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC). | Serotype 4 | 5.6 Percentage of Participants |
| Cohort 3_13vPnC | Percentage of Participants Achieving Pneumococcal Serotype-specific IgG Concentration ≥0.35 mcg/mL for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC). | Serotype 19F | 29.2 Percentage of Participants |
| Cohort 3_13vPnC | Percentage of Participants Achieving Pneumococcal Serotype-specific IgG Concentration ≥0.35 mcg/mL for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC). | Serotype 3 | 4.2 Percentage of Participants |
| Cohort 3_13vPnC | Percentage of Participants Achieving Pneumococcal Serotype-specific IgG Concentration ≥0.35 mcg/mL for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC). | Serotype 6A | 33.3 Percentage of Participants |
| Cohort 3_13vPnC | Percentage of Participants Achieving Pneumococcal Serotype-specific IgG Concentration ≥0.35 mcg/mL for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC). | Serotype 7F | 4.2 Percentage of Participants |
| Cohort 3_13vPnC | Percentage of Participants Achieving Pneumococcal Serotype-specific IgG Concentration ≥0.35 mcg/mL for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC). | Serotype 14 | 6.9 Percentage of Participants |
| Cohort 3_13vPnC | Percentage of Participants Achieving Pneumococcal Serotype-specific IgG Concentration ≥0.35 mcg/mL for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC). | Serotype 9V | 31.9 Percentage of Participants |
| Cohort 3_13vPnC | Percentage of Participants Achieving Pneumococcal Serotype-specific IgG Concentration ≥0.35 mcg/mL for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC). | Serotype 19A | 63.9 Percentage of Participants |
| Cohort 3_13vPnC | Percentage of Participants Achieving Pneumococcal Serotype-specific IgG Concentration ≥0.35 mcg/mL for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC). | Serotype 6B | 23.6 Percentage of Participants |
| Cohort 3_13vPnC | Percentage of Participants Achieving Pneumococcal Serotype-specific IgG Concentration ≥0.35 mcg/mL for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC). | Serotype 5 | 69.4 Percentage of Participants |
| Cohort 3_13vPnC | Percentage of Participants Achieving Pneumococcal Serotype-specific IgG Concentration ≥0.35 mcg/mL for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC). | Serotype 23F | 14.1 Percentage of Participants |
| Cohort 3_13vPnC | Percentage of Participants Achieving Pneumococcal Serotype-specific IgG Concentration ≥0.35 mcg/mL for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC). | Serotype 18C | 5.6 Percentage of Participants |
| Cohort 4_vPnC | Percentage of Participants Achieving Pneumococcal Serotype-specific IgG Concentration ≥0.35 mcg/mL for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC). | Serotype 7F | 98.4 Percentage of Participants |
| Cohort 4_vPnC | Percentage of Participants Achieving Pneumococcal Serotype-specific IgG Concentration ≥0.35 mcg/mL for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC). | Serotype 1 | 97.6 Percentage of Participants |
| Cohort 4_vPnC | Percentage of Participants Achieving Pneumococcal Serotype-specific IgG Concentration ≥0.35 mcg/mL for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC). | Serotype 3 | 94.5 Percentage of Participants |
| Cohort 4_vPnC | Percentage of Participants Achieving Pneumococcal Serotype-specific IgG Concentration ≥0.35 mcg/mL for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC). | Serotype 4 | 97.6 Percentage of Participants |
| Cohort 4_vPnC | Percentage of Participants Achieving Pneumococcal Serotype-specific IgG Concentration ≥0.35 mcg/mL for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC). | Serotype 5 | 100.0 Percentage of Participants |
| Cohort 4_vPnC | Percentage of Participants Achieving Pneumococcal Serotype-specific IgG Concentration ≥0.35 mcg/mL for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC). | Serotype 6A | 97.6 Percentage of Participants |
| Cohort 4_vPnC | Percentage of Participants Achieving Pneumococcal Serotype-specific IgG Concentration ≥0.35 mcg/mL for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC). | Serotype 6B | 97.6 Percentage of Participants |
| Cohort 4_vPnC | Percentage of Participants Achieving Pneumococcal Serotype-specific IgG Concentration ≥0.35 mcg/mL for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC). | Serotype 9V | 99.2 Percentage of Participants |
| Cohort 4_vPnC | Percentage of Participants Achieving Pneumococcal Serotype-specific IgG Concentration ≥0.35 mcg/mL for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC). | Serotype 14 | 98.4 Percentage of Participants |
| Cohort 4_vPnC | Percentage of Participants Achieving Pneumococcal Serotype-specific IgG Concentration ≥0.35 mcg/mL for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC). | Serotype 18C | 98.4 Percentage of Participants |
| Cohort 4_vPnC | Percentage of Participants Achieving Pneumococcal Serotype-specific IgG Concentration ≥0.35 mcg/mL for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC). | Serotype 19A | 100.0 Percentage of Participants |
| Cohort 4_vPnC | Percentage of Participants Achieving Pneumococcal Serotype-specific IgG Concentration ≥0.35 mcg/mL for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC). | Serotype 19F | 97.6 Percentage of Participants |
| Cohort 4_vPnC | Percentage of Participants Achieving Pneumococcal Serotype-specific IgG Concentration ≥0.35 mcg/mL for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC). | Serotype 23F | 97.6 Percentage of Participants |
| Cohort 2_13vPnC_Vaccination 3 | Percentage of Participants Achieving Pneumococcal Serotype-specific IgG Concentration ≥0.35 mcg/mL for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC). | Serotype 5 | 85.7 Percentage of Participants |
| Cohort 2_13vPnC_Vaccination 3 | Percentage of Participants Achieving Pneumococcal Serotype-specific IgG Concentration ≥0.35 mcg/mL for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC). | Serotype 19A | 90.9 Percentage of Participants |
| Cohort 2_13vPnC_Vaccination 3 | Percentage of Participants Achieving Pneumococcal Serotype-specific IgG Concentration ≥0.35 mcg/mL for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC). | Serotype 18C | 15.6 Percentage of Participants |
| Cohort 2_13vPnC_Vaccination 3 | Percentage of Participants Achieving Pneumococcal Serotype-specific IgG Concentration ≥0.35 mcg/mL for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC). | Serotype 9V | 40.8 Percentage of Participants |
| Cohort 2_13vPnC_Vaccination 3 | Percentage of Participants Achieving Pneumococcal Serotype-specific IgG Concentration ≥0.35 mcg/mL for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC). | Serotype 23F | 26.0 Percentage of Participants |
| Cohort 2_13vPnC_Vaccination 3 | Percentage of Participants Achieving Pneumococcal Serotype-specific IgG Concentration ≥0.35 mcg/mL for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC). | Serotype 4 | 6.5 Percentage of Participants |
| Cohort 2_13vPnC_Vaccination 3 | Percentage of Participants Achieving Pneumococcal Serotype-specific IgG Concentration ≥0.35 mcg/mL for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC). | Serotype 6A | 56.6 Percentage of Participants |
| Cohort 2_13vPnC_Vaccination 3 | Percentage of Participants Achieving Pneumococcal Serotype-specific IgG Concentration ≥0.35 mcg/mL for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC). | Serotype 1 | 10.4 Percentage of Participants |
| Cohort 2_13vPnC_Vaccination 3 | Percentage of Participants Achieving Pneumococcal Serotype-specific IgG Concentration ≥0.35 mcg/mL for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC). | Serotype 14 | 22.1 Percentage of Participants |
| Cohort 2_13vPnC_Vaccination 3 | Percentage of Participants Achieving Pneumococcal Serotype-specific IgG Concentration ≥0.35 mcg/mL for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC). | Serotype 6B | 50.6 Percentage of Participants |
| Cohort 2_13vPnC_Vaccination 3 | Percentage of Participants Achieving Pneumococcal Serotype-specific IgG Concentration ≥0.35 mcg/mL for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC). | Serotype 19F | 44.2 Percentage of Participants |
| Cohort 2_13vPnC_Vaccination 3 | Percentage of Participants Achieving Pneumococcal Serotype-specific IgG Concentration ≥0.35 mcg/mL for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC). | Serotype 3 | 11.7 Percentage of Participants |
| Cohort 2_13vPnC_Vaccination 3 | Percentage of Participants Achieving Pneumococcal Serotype-specific IgG Concentration ≥0.35 mcg/mL for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC). | Serotype 7F | 21.1 Percentage of Participants |
| Cohort 4_Hib Vaccine | Percentage of Participants Achieving Pneumococcal Serotype-specific IgG Concentration ≥0.35 mcg/mL for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC). | Serotype 4 | 99.2 Percentage of Participants |
| Cohort 4_Hib Vaccine | Percentage of Participants Achieving Pneumococcal Serotype-specific IgG Concentration ≥0.35 mcg/mL for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC). | Serotype 9V | 100.0 Percentage of Participants |
| Cohort 4_Hib Vaccine | Percentage of Participants Achieving Pneumococcal Serotype-specific IgG Concentration ≥0.35 mcg/mL for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC). | Serotype 6A | 100.0 Percentage of Participants |
| Cohort 4_Hib Vaccine | Percentage of Participants Achieving Pneumococcal Serotype-specific IgG Concentration ≥0.35 mcg/mL for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC). | Serotype 14 | 100.0 Percentage of Participants |
| Cohort 4_Hib Vaccine | Percentage of Participants Achieving Pneumococcal Serotype-specific IgG Concentration ≥0.35 mcg/mL for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC). | Serotype 5 | 99.2 Percentage of Participants |
| Cohort 4_Hib Vaccine | Percentage of Participants Achieving Pneumococcal Serotype-specific IgG Concentration ≥0.35 mcg/mL for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC). | Serotype 18C | 100.0 Percentage of Participants |
| Cohort 4_Hib Vaccine | Percentage of Participants Achieving Pneumococcal Serotype-specific IgG Concentration ≥0.35 mcg/mL for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC). | Serotype 1 | 99.2 Percentage of Participants |
| Cohort 4_Hib Vaccine | Percentage of Participants Achieving Pneumococcal Serotype-specific IgG Concentration ≥0.35 mcg/mL for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC). | Serotype 19A | 100.0 Percentage of Participants |
| Cohort 4_Hib Vaccine | Percentage of Participants Achieving Pneumococcal Serotype-specific IgG Concentration ≥0.35 mcg/mL for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC). | Serotype 3 | 98.5 Percentage of Participants |
| Cohort 4_Hib Vaccine | Percentage of Participants Achieving Pneumococcal Serotype-specific IgG Concentration ≥0.35 mcg/mL for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC). | Serotype 23F | 96.9 Percentage of Participants |
| Cohort 4_Hib Vaccine | Percentage of Participants Achieving Pneumococcal Serotype-specific IgG Concentration ≥0.35 mcg/mL for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC). | Serotype 19F | 100.0 Percentage of Participants |
| Cohort 4_Hib Vaccine | Percentage of Participants Achieving Pneumococcal Serotype-specific IgG Concentration ≥0.35 mcg/mL for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC). | Serotype 7F | 99.2 Percentage of Participants |
| Cohort 4_Hib Vaccine | Percentage of Participants Achieving Pneumococcal Serotype-specific IgG Concentration ≥0.35 mcg/mL for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC). | Serotype 6B | 99.2 Percentage of Participants |
| Cohort 4_Hib Vaccine | Percentage of Participants Achieving Pneumococcal Serotype-specific IgG Concentration ≥0.35 mcg/mL for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC). | Serotype 9V | 59.7 Percentage of Participants |
| Cohort 4_Hib Vaccine | Percentage of Participants Achieving Pneumococcal Serotype-specific IgG Concentration ≥0.35 mcg/mL for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC). | Serotype 5 | 88.1 Percentage of Participants |
| Cohort 4_Hib Vaccine | Percentage of Participants Achieving Pneumococcal Serotype-specific IgG Concentration ≥0.35 mcg/mL for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC). | Serotype 7F | 37.3 Percentage of Participants |
| Cohort 4_Hib Vaccine | Percentage of Participants Achieving Pneumococcal Serotype-specific IgG Concentration ≥0.35 mcg/mL for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC). | Serotype 14 | 41.8 Percentage of Participants |
| Cohort 4_Hib Vaccine | Percentage of Participants Achieving Pneumococcal Serotype-specific IgG Concentration ≥0.35 mcg/mL for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC). | Serotype 6B | 77.6 Percentage of Participants |
| Cohort 4_Hib Vaccine | Percentage of Participants Achieving Pneumococcal Serotype-specific IgG Concentration ≥0.35 mcg/mL for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC). | Serotype 19F | 70.1 Percentage of Participants |
| Cohort 4_Hib Vaccine | Percentage of Participants Achieving Pneumococcal Serotype-specific IgG Concentration ≥0.35 mcg/mL for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC). | Serotype 1 | 23.9 Percentage of Participants |
| Cohort 4_Hib Vaccine | Percentage of Participants Achieving Pneumococcal Serotype-specific IgG Concentration ≥0.35 mcg/mL for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC). | Serotype 4 | 4.5 Percentage of Participants |
| Cohort 4_Hib Vaccine | Percentage of Participants Achieving Pneumococcal Serotype-specific IgG Concentration ≥0.35 mcg/mL for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC). | Serotype 18C | 40.9 Percentage of Participants |
| Cohort 4_Hib Vaccine | Percentage of Participants Achieving Pneumococcal Serotype-specific IgG Concentration ≥0.35 mcg/mL for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC). | Serotype 23F | 52.2 Percentage of Participants |
| Cohort 4_Hib Vaccine | Percentage of Participants Achieving Pneumococcal Serotype-specific IgG Concentration ≥0.35 mcg/mL for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC). | Serotype 6A | 86.6 Percentage of Participants |
| Cohort 4_Hib Vaccine | Percentage of Participants Achieving Pneumococcal Serotype-specific IgG Concentration ≥0.35 mcg/mL for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC). | Serotype 19A | 94.0 Percentage of Participants |
| Cohort 4_Hib Vaccine | Percentage of Participants Achieving Pneumococcal Serotype-specific IgG Concentration ≥0.35 mcg/mL for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC). | Serotype 3 | 19.4 Percentage of Participants |
Secondary
Percentage of Participants Achieving Serotype-specific Pneumococcal OPA Titer ≥ Lower Limit of Quantitation (LLOQ) for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC).
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.
Time frame: Cohort 1: 1 month after the 3rd dose of 13vPnC. Cohorts 2, 3, 4: 1 month after the last dose of 13vPnC and Hib Vaccine.
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort 1_Infant Series | Percentage of Participants Achieving Serotype-specific Pneumococcal OPA Titer ≥ Lower Limit of Quantitation (LLOQ) for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC). | Serotype 19F | 97.3 Percentage of Participants |
| Cohort 1_Infant Series | Percentage of Participants Achieving Serotype-specific Pneumococcal OPA Titer ≥ Lower Limit of Quantitation (LLOQ) for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC). | Serotype 4 | 100.0 Percentage of Participants |
| Cohort 1_Infant Series | Percentage of Participants Achieving Serotype-specific Pneumococcal OPA Titer ≥ Lower Limit of Quantitation (LLOQ) for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC). | Serotype 23F | 97.3 Percentage of Participants |
| Cohort 1_Infant Series | Percentage of Participants Achieving Serotype-specific Pneumococcal OPA Titer ≥ Lower Limit of Quantitation (LLOQ) for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC). | Serotype 18C | 100.0 Percentage of Participants |
| Cohort 1_Infant Series | Percentage of Participants Achieving Serotype-specific Pneumococcal OPA Titer ≥ Lower Limit of Quantitation (LLOQ) for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC). | Serotype 1 | 100.0 Percentage of Participants |
| Cohort 1_Infant Series | Percentage of Participants Achieving Serotype-specific Pneumococcal OPA Titer ≥ Lower Limit of Quantitation (LLOQ) for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC). | Serotype 5 | 100.0 Percentage of Participants |
| Cohort 1_Infant Series | Percentage of Participants Achieving Serotype-specific Pneumococcal OPA Titer ≥ Lower Limit of Quantitation (LLOQ) for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC). | Serotype 19A | 100.0 Percentage of Participants |
| Cohort 1_Infant Series | Percentage of Participants Achieving Serotype-specific Pneumococcal OPA Titer ≥ Lower Limit of Quantitation (LLOQ) for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC). | Serotype 3 | 100.0 Percentage of Participants |
| Cohort 1_Infant Series | Percentage of Participants Achieving Serotype-specific Pneumococcal OPA Titer ≥ Lower Limit of Quantitation (LLOQ) for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC). | Serotype 7F | 100.0 Percentage of Participants |
| Cohort 1_Infant Series | Percentage of Participants Achieving Serotype-specific Pneumococcal OPA Titer ≥ Lower Limit of Quantitation (LLOQ) for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC). | Serotype 6B | 100.0 Percentage of Participants |
| Cohort 1_Infant Series | Percentage of Participants Achieving Serotype-specific Pneumococcal OPA Titer ≥ Lower Limit of Quantitation (LLOQ) for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC). | Serotype 14 | 100.0 Percentage of Participants |
| Cohort 1_Infant Series | Percentage of Participants Achieving Serotype-specific Pneumococcal OPA Titer ≥ Lower Limit of Quantitation (LLOQ) for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC). | Serotype 6A | 100.0 Percentage of Participants |
| Cohort 1_Infant Series | Percentage of Participants Achieving Serotype-specific Pneumococcal OPA Titer ≥ Lower Limit of Quantitation (LLOQ) for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC). | Serotype 9V | 100.0 Percentage of Participants |
| Cohort 2_13vPnC | Percentage of Participants Achieving Serotype-specific Pneumococcal OPA Titer ≥ Lower Limit of Quantitation (LLOQ) for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC). | Serotype 19A | 100.0 Percentage of Participants |
| Cohort 2_13vPnC | Percentage of Participants Achieving Serotype-specific Pneumococcal OPA Titer ≥ Lower Limit of Quantitation (LLOQ) for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC). | Serotype 9V | 100.0 Percentage of Participants |
| Cohort 2_13vPnC | Percentage of Participants Achieving Serotype-specific Pneumococcal OPA Titer ≥ Lower Limit of Quantitation (LLOQ) for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC). | Serotype 7F | 100.0 Percentage of Participants |
| Cohort 2_13vPnC | Percentage of Participants Achieving Serotype-specific Pneumococcal OPA Titer ≥ Lower Limit of Quantitation (LLOQ) for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC). | Serotype 3 | 100.0 Percentage of Participants |
| Cohort 2_13vPnC | Percentage of Participants Achieving Serotype-specific Pneumococcal OPA Titer ≥ Lower Limit of Quantitation (LLOQ) for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC). | Serotype 19F | 100.0 Percentage of Participants |
| Cohort 2_13vPnC | Percentage of Participants Achieving Serotype-specific Pneumococcal OPA Titer ≥ Lower Limit of Quantitation (LLOQ) for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC). | Serotype 4 | 100.0 Percentage of Participants |
| Cohort 2_13vPnC | Percentage of Participants Achieving Serotype-specific Pneumococcal OPA Titer ≥ Lower Limit of Quantitation (LLOQ) for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC). | Serotype 1 | 96.6 Percentage of Participants |
| Cohort 2_13vPnC | Percentage of Participants Achieving Serotype-specific Pneumococcal OPA Titer ≥ Lower Limit of Quantitation (LLOQ) for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC). | Serotype 5 | 100.0 Percentage of Participants |
| Cohort 2_13vPnC | Percentage of Participants Achieving Serotype-specific Pneumococcal OPA Titer ≥ Lower Limit of Quantitation (LLOQ) for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC). | Serotype 18C | 98.9 Percentage of Participants |
| Cohort 2_13vPnC | Percentage of Participants Achieving Serotype-specific Pneumococcal OPA Titer ≥ Lower Limit of Quantitation (LLOQ) for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC). | Serotype 6A | 100.0 Percentage of Participants |
| Cohort 2_13vPnC | Percentage of Participants Achieving Serotype-specific Pneumococcal OPA Titer ≥ Lower Limit of Quantitation (LLOQ) for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC). | Serotype 23F | 95.4 Percentage of Participants |
| Cohort 2_13vPnC | Percentage of Participants Achieving Serotype-specific Pneumococcal OPA Titer ≥ Lower Limit of Quantitation (LLOQ) for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC). | Serotype 14 | 100.0 Percentage of Participants |
| Cohort 2_13vPnC | Percentage of Participants Achieving Serotype-specific Pneumococcal OPA Titer ≥ Lower Limit of Quantitation (LLOQ) for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC). | Serotype 6B | 94.3 Percentage of Participants |
| Cohort 3_13vPnC | Percentage of Participants Achieving Serotype-specific Pneumococcal OPA Titer ≥ Lower Limit of Quantitation (LLOQ) for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC). | Serotype 1 | 5.9 Percentage of Participants |
| Cohort 3_13vPnC | Percentage of Participants Achieving Serotype-specific Pneumococcal OPA Titer ≥ Lower Limit of Quantitation (LLOQ) for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC). | Serotype 4 | 23.5 Percentage of Participants |
| Cohort 3_13vPnC | Percentage of Participants Achieving Serotype-specific Pneumococcal OPA Titer ≥ Lower Limit of Quantitation (LLOQ) for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC). | Serotype 19F | 17.6 Percentage of Participants |
| Cohort 3_13vPnC | Percentage of Participants Achieving Serotype-specific Pneumococcal OPA Titer ≥ Lower Limit of Quantitation (LLOQ) for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC). | Serotype 3 | 29.4 Percentage of Participants |
| Cohort 3_13vPnC | Percentage of Participants Achieving Serotype-specific Pneumococcal OPA Titer ≥ Lower Limit of Quantitation (LLOQ) for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC). | Serotype 6A | 14.7 Percentage of Participants |
| Cohort 3_13vPnC | Percentage of Participants Achieving Serotype-specific Pneumococcal OPA Titer ≥ Lower Limit of Quantitation (LLOQ) for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC). | Serotype 7F | 61.8 Percentage of Participants |
| Cohort 3_13vPnC | Percentage of Participants Achieving Serotype-specific Pneumococcal OPA Titer ≥ Lower Limit of Quantitation (LLOQ) for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC). | Serotype 14 | 41.2 Percentage of Participants |
| Cohort 3_13vPnC | Percentage of Participants Achieving Serotype-specific Pneumococcal OPA Titer ≥ Lower Limit of Quantitation (LLOQ) for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC). | Serotype 9V | 41.2 Percentage of Participants |
| Cohort 3_13vPnC | Percentage of Participants Achieving Serotype-specific Pneumococcal OPA Titer ≥ Lower Limit of Quantitation (LLOQ) for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC). | Serotype 19A | 26.5 Percentage of Participants |
| Cohort 3_13vPnC | Percentage of Participants Achieving Serotype-specific Pneumococcal OPA Titer ≥ Lower Limit of Quantitation (LLOQ) for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC). | Serotype 6B | 11.8 Percentage of Participants |
| Cohort 3_13vPnC | Percentage of Participants Achieving Serotype-specific Pneumococcal OPA Titer ≥ Lower Limit of Quantitation (LLOQ) for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC). | Serotype 5 | 14.7 Percentage of Participants |
| Cohort 3_13vPnC | Percentage of Participants Achieving Serotype-specific Pneumococcal OPA Titer ≥ Lower Limit of Quantitation (LLOQ) for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC). | Serotype 23F | 35.3 Percentage of Participants |
| Cohort 3_13vPnC | Percentage of Participants Achieving Serotype-specific Pneumococcal OPA Titer ≥ Lower Limit of Quantitation (LLOQ) for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC). | Serotype 18C | 14.7 Percentage of Participants |
| Cohort 4_vPnC | Percentage of Participants Achieving Serotype-specific Pneumococcal OPA Titer ≥ Lower Limit of Quantitation (LLOQ) for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC). | Serotype 7F | 100.0 Percentage of Participants |
| Cohort 4_vPnC | Percentage of Participants Achieving Serotype-specific Pneumococcal OPA Titer ≥ Lower Limit of Quantitation (LLOQ) for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC). | Serotype 1 | 96.2 Percentage of Participants |
| Cohort 4_vPnC | Percentage of Participants Achieving Serotype-specific Pneumococcal OPA Titer ≥ Lower Limit of Quantitation (LLOQ) for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC). | Serotype 3 | 100.0 Percentage of Participants |
| Cohort 4_vPnC | Percentage of Participants Achieving Serotype-specific Pneumococcal OPA Titer ≥ Lower Limit of Quantitation (LLOQ) for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC). | Serotype 4 | 100.0 Percentage of Participants |
| Cohort 4_vPnC | Percentage of Participants Achieving Serotype-specific Pneumococcal OPA Titer ≥ Lower Limit of Quantitation (LLOQ) for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC). | Serotype 5 | 100.0 Percentage of Participants |
| Cohort 4_vPnC | Percentage of Participants Achieving Serotype-specific Pneumococcal OPA Titer ≥ Lower Limit of Quantitation (LLOQ) for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC). | Serotype 6A | 100.0 Percentage of Participants |
| Cohort 4_vPnC | Percentage of Participants Achieving Serotype-specific Pneumococcal OPA Titer ≥ Lower Limit of Quantitation (LLOQ) for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC). | Serotype 6B | 98.7 Percentage of Participants |
| Cohort 4_vPnC | Percentage of Participants Achieving Serotype-specific Pneumococcal OPA Titer ≥ Lower Limit of Quantitation (LLOQ) for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC). | Serotype 9V | 100.0 Percentage of Participants |
| Cohort 4_vPnC | Percentage of Participants Achieving Serotype-specific Pneumococcal OPA Titer ≥ Lower Limit of Quantitation (LLOQ) for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC). | Serotype 14 | 100.0 Percentage of Participants |
| Cohort 4_vPnC | Percentage of Participants Achieving Serotype-specific Pneumococcal OPA Titer ≥ Lower Limit of Quantitation (LLOQ) for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC). | Serotype 18C | 98.7 Percentage of Participants |
| Cohort 4_vPnC | Percentage of Participants Achieving Serotype-specific Pneumococcal OPA Titer ≥ Lower Limit of Quantitation (LLOQ) for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC). | Serotype 19A | 100.0 Percentage of Participants |
| Cohort 4_vPnC | Percentage of Participants Achieving Serotype-specific Pneumococcal OPA Titer ≥ Lower Limit of Quantitation (LLOQ) for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC). | Serotype 19F | 100.0 Percentage of Participants |
| Cohort 4_vPnC | Percentage of Participants Achieving Serotype-specific Pneumococcal OPA Titer ≥ Lower Limit of Quantitation (LLOQ) for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC). | Serotype 23F | 96.2 Percentage of Participants |
| Cohort 2_13vPnC_Vaccination 3 | Percentage of Participants Achieving Serotype-specific Pneumococcal OPA Titer ≥ Lower Limit of Quantitation (LLOQ) for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC). | Serotype 5 | 4.8 Percentage of Participants |
| Cohort 2_13vPnC_Vaccination 3 | Percentage of Participants Achieving Serotype-specific Pneumococcal OPA Titer ≥ Lower Limit of Quantitation (LLOQ) for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC). | Serotype 19A | 47.6 Percentage of Participants |
| Cohort 2_13vPnC_Vaccination 3 | Percentage of Participants Achieving Serotype-specific Pneumococcal OPA Titer ≥ Lower Limit of Quantitation (LLOQ) for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC). | Serotype 18C | 21.4 Percentage of Participants |
| Cohort 2_13vPnC_Vaccination 3 | Percentage of Participants Achieving Serotype-specific Pneumococcal OPA Titer ≥ Lower Limit of Quantitation (LLOQ) for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC). | Serotype 9V | 76.2 Percentage of Participants |
| Cohort 2_13vPnC_Vaccination 3 | Percentage of Participants Achieving Serotype-specific Pneumococcal OPA Titer ≥ Lower Limit of Quantitation (LLOQ) for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC). | Serotype 23F | 33.3 Percentage of Participants |
| Cohort 2_13vPnC_Vaccination 3 | Percentage of Participants Achieving Serotype-specific Pneumococcal OPA Titer ≥ Lower Limit of Quantitation (LLOQ) for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC). | Serotype 4 | 23.8 Percentage of Participants |
| Cohort 2_13vPnC_Vaccination 3 | Percentage of Participants Achieving Serotype-specific Pneumococcal OPA Titer ≥ Lower Limit of Quantitation (LLOQ) for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC). | Serotype 6A | 31.0 Percentage of Participants |
| Cohort 2_13vPnC_Vaccination 3 | Percentage of Participants Achieving Serotype-specific Pneumococcal OPA Titer ≥ Lower Limit of Quantitation (LLOQ) for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC). | Serotype 1 | 7.1 Percentage of Participants |
| Cohort 2_13vPnC_Vaccination 3 | Percentage of Participants Achieving Serotype-specific Pneumococcal OPA Titer ≥ Lower Limit of Quantitation (LLOQ) for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC). | Serotype 14 | 45.2 Percentage of Participants |
| Cohort 2_13vPnC_Vaccination 3 | Percentage of Participants Achieving Serotype-specific Pneumococcal OPA Titer ≥ Lower Limit of Quantitation (LLOQ) for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC). | Serotype 6B | 35.7 Percentage of Participants |
| Cohort 2_13vPnC_Vaccination 3 | Percentage of Participants Achieving Serotype-specific Pneumococcal OPA Titer ≥ Lower Limit of Quantitation (LLOQ) for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC). | Serotype 19F | 26.2 Percentage of Participants |
| Cohort 2_13vPnC_Vaccination 3 | Percentage of Participants Achieving Serotype-specific Pneumococcal OPA Titer ≥ Lower Limit of Quantitation (LLOQ) for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC). | Serotype 3 | 38.1 Percentage of Participants |
| Cohort 2_13vPnC_Vaccination 3 | Percentage of Participants Achieving Serotype-specific Pneumococcal OPA Titer ≥ Lower Limit of Quantitation (LLOQ) for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC). | Serotype 7F | 90.5 Percentage of Participants |
| Cohort 4_Hib Vaccine | Percentage of Participants Achieving Serotype-specific Pneumococcal OPA Titer ≥ Lower Limit of Quantitation (LLOQ) for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC). | Serotype 4 | 100.0 Percentage of Participants |
| Cohort 4_Hib Vaccine | Percentage of Participants Achieving Serotype-specific Pneumococcal OPA Titer ≥ Lower Limit of Quantitation (LLOQ) for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC). | Serotype 9V | 100.0 Percentage of Participants |
| Cohort 4_Hib Vaccine | Percentage of Participants Achieving Serotype-specific Pneumococcal OPA Titer ≥ Lower Limit of Quantitation (LLOQ) for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC). | Serotype 6A | 100.0 Percentage of Participants |
| Cohort 4_Hib Vaccine | Percentage of Participants Achieving Serotype-specific Pneumococcal OPA Titer ≥ Lower Limit of Quantitation (LLOQ) for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC). | Serotype 14 | 100.0 Percentage of Participants |
| Cohort 4_Hib Vaccine | Percentage of Participants Achieving Serotype-specific Pneumococcal OPA Titer ≥ Lower Limit of Quantitation (LLOQ) for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC). | Serotype 5 | 98.6 Percentage of Participants |
| Cohort 4_Hib Vaccine | Percentage of Participants Achieving Serotype-specific Pneumococcal OPA Titer ≥ Lower Limit of Quantitation (LLOQ) for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC). | Serotype 18C | 100.0 Percentage of Participants |
| Cohort 4_Hib Vaccine | Percentage of Participants Achieving Serotype-specific Pneumococcal OPA Titer ≥ Lower Limit of Quantitation (LLOQ) for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC). | Serotype 1 | 95.8 Percentage of Participants |
| Cohort 4_Hib Vaccine | Percentage of Participants Achieving Serotype-specific Pneumococcal OPA Titer ≥ Lower Limit of Quantitation (LLOQ) for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC). | Serotype 19A | 100.0 Percentage of Participants |
| Cohort 4_Hib Vaccine | Percentage of Participants Achieving Serotype-specific Pneumococcal OPA Titer ≥ Lower Limit of Quantitation (LLOQ) for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC). | Serotype 3 | 100.0 Percentage of Participants |
| Cohort 4_Hib Vaccine | Percentage of Participants Achieving Serotype-specific Pneumococcal OPA Titer ≥ Lower Limit of Quantitation (LLOQ) for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC). | Serotype 23F | 97.2 Percentage of Participants |
| Cohort 4_Hib Vaccine | Percentage of Participants Achieving Serotype-specific Pneumococcal OPA Titer ≥ Lower Limit of Quantitation (LLOQ) for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC). | Serotype 19F | 100.0 Percentage of Participants |
| Cohort 4_Hib Vaccine | Percentage of Participants Achieving Serotype-specific Pneumococcal OPA Titer ≥ Lower Limit of Quantitation (LLOQ) for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC). | Serotype 7F | 100.0 Percentage of Participants |
| Cohort 4_Hib Vaccine | Percentage of Participants Achieving Serotype-specific Pneumococcal OPA Titer ≥ Lower Limit of Quantitation (LLOQ) for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC). | Serotype 6B | 100.0 Percentage of Participants |
| Cohort 4_Hib Vaccine | Percentage of Participants Achieving Serotype-specific Pneumococcal OPA Titer ≥ Lower Limit of Quantitation (LLOQ) for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC). | Serotype 9V | 97.2 Percentage of Participants |
| Cohort 4_Hib Vaccine | Percentage of Participants Achieving Serotype-specific Pneumococcal OPA Titer ≥ Lower Limit of Quantitation (LLOQ) for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC). | Serotype 5 | 11.1 Percentage of Participants |
| Cohort 4_Hib Vaccine | Percentage of Participants Achieving Serotype-specific Pneumococcal OPA Titer ≥ Lower Limit of Quantitation (LLOQ) for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC). | Serotype 7F | 100.0 Percentage of Participants |
| Cohort 4_Hib Vaccine | Percentage of Participants Achieving Serotype-specific Pneumococcal OPA Titer ≥ Lower Limit of Quantitation (LLOQ) for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC). | Serotype 14 | 83.3 Percentage of Participants |
| Cohort 4_Hib Vaccine | Percentage of Participants Achieving Serotype-specific Pneumococcal OPA Titer ≥ Lower Limit of Quantitation (LLOQ) for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC). | Serotype 6B | 80.6 Percentage of Participants |
| Cohort 4_Hib Vaccine | Percentage of Participants Achieving Serotype-specific Pneumococcal OPA Titer ≥ Lower Limit of Quantitation (LLOQ) for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC). | Serotype 19F | 63.9 Percentage of Participants |
| Cohort 4_Hib Vaccine | Percentage of Participants Achieving Serotype-specific Pneumococcal OPA Titer ≥ Lower Limit of Quantitation (LLOQ) for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC). | Serotype 1 | 5.6 Percentage of Participants |
| Cohort 4_Hib Vaccine | Percentage of Participants Achieving Serotype-specific Pneumococcal OPA Titer ≥ Lower Limit of Quantitation (LLOQ) for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC). | Serotype 4 | 55.6 Percentage of Participants |
| Cohort 4_Hib Vaccine | Percentage of Participants Achieving Serotype-specific Pneumococcal OPA Titer ≥ Lower Limit of Quantitation (LLOQ) for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC). | Serotype 18C | 52.8 Percentage of Participants |
| Cohort 4_Hib Vaccine | Percentage of Participants Achieving Serotype-specific Pneumococcal OPA Titer ≥ Lower Limit of Quantitation (LLOQ) for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC). | Serotype 23F | 72.2 Percentage of Participants |
| Cohort 4_Hib Vaccine | Percentage of Participants Achieving Serotype-specific Pneumococcal OPA Titer ≥ Lower Limit of Quantitation (LLOQ) for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC). | Serotype 6A | 80.6 Percentage of Participants |
| Cohort 4_Hib Vaccine | Percentage of Participants Achieving Serotype-specific Pneumococcal OPA Titer ≥ Lower Limit of Quantitation (LLOQ) for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC). | Serotype 19A | 83.3 Percentage of Participants |
| Cohort 4_Hib Vaccine | Percentage of Participants Achieving Serotype-specific Pneumococcal OPA Titer ≥ Lower Limit of Quantitation (LLOQ) for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC). | Serotype 3 | 80.6 Percentage of Participants |
Secondary
Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohort 1 at 12, 24, 36 and 48 Months After Last Vaccination in Cohort 1 (Infant Series)
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.
Time frame: Cohort 1 (infant series): 12, 24, 36 and 48 Months After Last Vaccination in Cohort 1
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Cohort 1_Infant Series | Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohort 1 at 12, 24, 36 and 48 Months After Last Vaccination in Cohort 1 (Infant Series) | Serotype 1: 12 Months After Last Vaccination in Cohort 1 | 1.35 Microgram/milliliter |
| Cohort 1_Infant Series | Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohort 1 at 12, 24, 36 and 48 Months After Last Vaccination in Cohort 1 (Infant Series) | Serotype 1: 24 Months After Last Vaccination in Cohort 1 | 0.88 Microgram/milliliter |
| Cohort 1_Infant Series | Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohort 1 at 12, 24, 36 and 48 Months After Last Vaccination in Cohort 1 (Infant Series) | Serotype 1: 36 Months After Last Vaccination in Cohort 1 | 0.77 Microgram/milliliter |
| Cohort 1_Infant Series | Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohort 1 at 12, 24, 36 and 48 Months After Last Vaccination in Cohort 1 (Infant Series) | Serotype 1: 48 Months After Last Vaccination in Cohort 1 | 0.79 Microgram/milliliter |
| Cohort 1_Infant Series | Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohort 1 at 12, 24, 36 and 48 Months After Last Vaccination in Cohort 1 (Infant Series) | Serotype 3: 12 Months After Last Vaccination in Cohort 1 | 0.27 Microgram/milliliter |
| Cohort 1_Infant Series | Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohort 1 at 12, 24, 36 and 48 Months After Last Vaccination in Cohort 1 (Infant Series) | Serotype 3: 24 Months After Last Vaccination in Cohort 1 | 0.22 Microgram/milliliter |
| Cohort 1_Infant Series | Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohort 1 at 12, 24, 36 and 48 Months After Last Vaccination in Cohort 1 (Infant Series) | Serotype 3: 36 Months After Last Vaccination in Cohort 1 | 0.18 Microgram/milliliter |
| Cohort 1_Infant Series | Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohort 1 at 12, 24, 36 and 48 Months After Last Vaccination in Cohort 1 (Infant Series) | Serotype 3: 48 Months After Last Vaccination in Cohort 1 | 0.19 Microgram/milliliter |
| Cohort 1_Infant Series | Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohort 1 at 12, 24, 36 and 48 Months After Last Vaccination in Cohort 1 (Infant Series) | Serotype 4: 12 Months After Last Vaccination in Cohort 1 | 1.10 Microgram/milliliter |
| Cohort 1_Infant Series | Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohort 1 at 12, 24, 36 and 48 Months After Last Vaccination in Cohort 1 (Infant Series) | Serotype 4: 24 Months After Last Vaccination in Cohort 1 | 0.54 Microgram/milliliter |
| Cohort 1_Infant Series | Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohort 1 at 12, 24, 36 and 48 Months After Last Vaccination in Cohort 1 (Infant Series) | Serotype 4: 36 Months After Last Vaccination in Cohort 1 | 0.58 Microgram/milliliter |
| Cohort 1_Infant Series | Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohort 1 at 12, 24, 36 and 48 Months After Last Vaccination in Cohort 1 (Infant Series) | Serotype 4: 48 Months After Last Vaccination in Cohort 1 | 0.32 Microgram/milliliter |
| Cohort 1_Infant Series | Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohort 1 at 12, 24, 36 and 48 Months After Last Vaccination in Cohort 1 (Infant Series) | Serotype 5: 12 Months After Last Vaccination in Cohort 1 | 1.56 Microgram/milliliter |
| Cohort 1_Infant Series | Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohort 1 at 12, 24, 36 and 48 Months After Last Vaccination in Cohort 1 (Infant Series) | Serotype 5: 24 Months After Last Vaccination in Cohort 1 | 1.03 Microgram/milliliter |
| Cohort 1_Infant Series | Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohort 1 at 12, 24, 36 and 48 Months After Last Vaccination in Cohort 1 (Infant Series) | Serotype 5: 36 Months After Last Vaccination in Cohort 1 | 1.03 Microgram/milliliter |
| Cohort 1_Infant Series | Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohort 1 at 12, 24, 36 and 48 Months After Last Vaccination in Cohort 1 (Infant Series) | Serotype 5: 48 Months After Last Vaccination in Cohort 1 | 1.19 Microgram/milliliter |
| Cohort 1_Infant Series | Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohort 1 at 12, 24, 36 and 48 Months After Last Vaccination in Cohort 1 (Infant Series) | Serotype 6A: 12 Months After Last Vaccination in Cohort 1 | 2.10 Microgram/milliliter |
| Cohort 1_Infant Series | Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohort 1 at 12, 24, 36 and 48 Months After Last Vaccination in Cohort 1 (Infant Series) | Serotype 6A: 24 Months After Last Vaccination in Cohort 1 | 1.40 Microgram/milliliter |
| Cohort 1_Infant Series | Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohort 1 at 12, 24, 36 and 48 Months After Last Vaccination in Cohort 1 (Infant Series) | Serotype 6A: 36 Months After Last Vaccination in Cohort 1 | 2.79 Microgram/milliliter |
| Cohort 1_Infant Series | Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohort 1 at 12, 24, 36 and 48 Months After Last Vaccination in Cohort 1 (Infant Series) | Serotype 6A: 48 Months After Last Vaccination in Cohort 1 | 3.06 Microgram/milliliter |
| Cohort 1_Infant Series | Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohort 1 at 12, 24, 36 and 48 Months After Last Vaccination in Cohort 1 (Infant Series) | Serotype 6B: 12 Months After Last Vaccination in Cohort 1 | 2.40 Microgram/milliliter |
| Cohort 1_Infant Series | Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohort 1 at 12, 24, 36 and 48 Months After Last Vaccination in Cohort 1 (Infant Series) | Serotype 6B: 24 Months After Last Vaccination in Cohort 1 | 2.12 Microgram/milliliter |
| Cohort 1_Infant Series | Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohort 1 at 12, 24, 36 and 48 Months After Last Vaccination in Cohort 1 (Infant Series) | Serotype 6B: 36 Months After Last Vaccination in Cohort 1 | 3.29 Microgram/milliliter |
| Cohort 1_Infant Series | Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohort 1 at 12, 24, 36 and 48 Months After Last Vaccination in Cohort 1 (Infant Series) | Serotype 6B: 48 Months After Last Vaccination in Cohort 1 | 3.73 Microgram/milliliter |
| Cohort 1_Infant Series | Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohort 1 at 12, 24, 36 and 48 Months After Last Vaccination in Cohort 1 (Infant Series) | Serotype 7F: 12 Months After Last Vaccination in Cohort 1 | 1.55 Microgram/milliliter |
| Cohort 1_Infant Series | Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohort 1 at 12, 24, 36 and 48 Months After Last Vaccination in Cohort 1 (Infant Series) | Serotype 7F: 24 Months After Last Vaccination in Cohort 1 | 0.77 Microgram/milliliter |
| Cohort 1_Infant Series | Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohort 1 at 12, 24, 36 and 48 Months After Last Vaccination in Cohort 1 (Infant Series) | Serotype 7F: 36 Months After Last Vaccination in Cohort 1 | 0.62 Microgram/milliliter |
| Cohort 1_Infant Series | Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohort 1 at 12, 24, 36 and 48 Months After Last Vaccination in Cohort 1 (Infant Series) | Serotype 7F: 48 Months After Last Vaccination in Cohort 1 | 0.53 Microgram/milliliter |
| Cohort 1_Infant Series | Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohort 1 at 12, 24, 36 and 48 Months After Last Vaccination in Cohort 1 (Infant Series) | Serotype 9V: 12 Months After Last Vaccination in Cohort 1 | 1.32 Microgram/milliliter |
| Cohort 1_Infant Series | Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohort 1 at 12, 24, 36 and 48 Months After Last Vaccination in Cohort 1 (Infant Series) | Serotype 9V: 24 Months After Last Vaccination in Cohort 1 | 0.88 Microgram/milliliter |
| Cohort 1_Infant Series | Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohort 1 at 12, 24, 36 and 48 Months After Last Vaccination in Cohort 1 (Infant Series) | Serotype 9V: 36 Months After Last Vaccination in Cohort 1 | 0.84 Microgram/milliliter |
| Cohort 1_Infant Series | Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohort 1 at 12, 24, 36 and 48 Months After Last Vaccination in Cohort 1 (Infant Series) | Serotype 9V: 48 Months After Last Vaccination in Cohort 1 | 0.95 Microgram/milliliter |
| Cohort 1_Infant Series | Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohort 1 at 12, 24, 36 and 48 Months After Last Vaccination in Cohort 1 (Infant Series) | Serotype 14: 12 Months After Last Vaccination in Cohort 1 | 2.77 Microgram/milliliter |
| Cohort 1_Infant Series | Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohort 1 at 12, 24, 36 and 48 Months After Last Vaccination in Cohort 1 (Infant Series) | Serotype 14: 24 Months After Last Vaccination in Cohort 1 | 2.03 Microgram/milliliter |
| Cohort 1_Infant Series | Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohort 1 at 12, 24, 36 and 48 Months After Last Vaccination in Cohort 1 (Infant Series) | Serotype 14: 36 Months After Last Vaccination in Cohort 1 | 2.49 Microgram/milliliter |
| Cohort 1_Infant Series | Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohort 1 at 12, 24, 36 and 48 Months After Last Vaccination in Cohort 1 (Infant Series) | Serotype 14: 48 Months After Last Vaccination in Cohort 1 | 2.14 Microgram/milliliter |
| Cohort 1_Infant Series | Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohort 1 at 12, 24, 36 and 48 Months After Last Vaccination in Cohort 1 (Infant Series) | Serotype 18C: 12 Months After Last Vaccination in Cohort 1 | 1.24 Microgram/milliliter |
| Cohort 1_Infant Series | Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohort 1 at 12, 24, 36 and 48 Months After Last Vaccination in Cohort 1 (Infant Series) | Serotype 18C: 24 Months After Last Vaccination in Cohort 1 | 0.72 Microgram/milliliter |
| Cohort 1_Infant Series | Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohort 1 at 12, 24, 36 and 48 Months After Last Vaccination in Cohort 1 (Infant Series) | Serotype 18C: 36 Months After Last Vaccination in Cohort 1 | 0.67 Microgram/milliliter |
| Cohort 1_Infant Series | Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohort 1 at 12, 24, 36 and 48 Months After Last Vaccination in Cohort 1 (Infant Series) | Serotype 18C: 48 Months After Last Vaccination in Cohort 1 | 0.60 Microgram/milliliter |
| Cohort 1_Infant Series | Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohort 1 at 12, 24, 36 and 48 Months After Last Vaccination in Cohort 1 (Infant Series) | Serotype 19A: 12 Months After Last Vaccination in Cohort 1 | 2.92 Microgram/milliliter |
| Cohort 1_Infant Series | Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohort 1 at 12, 24, 36 and 48 Months After Last Vaccination in Cohort 1 (Infant Series) | Serotype 19A: 24 Months After Last Vaccination in Cohort 1 | 3.52 Microgram/milliliter |
| Cohort 1_Infant Series | Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohort 1 at 12, 24, 36 and 48 Months After Last Vaccination in Cohort 1 (Infant Series) | Serotype 19A: 36 Months After Last Vaccination in Cohort 1 | 6.39 Microgram/milliliter |
| Cohort 1_Infant Series | Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohort 1 at 12, 24, 36 and 48 Months After Last Vaccination in Cohort 1 (Infant Series) | Serotype 19A: 48 Months After Last Vaccination in Cohort 1 | 7.53 Microgram/milliliter |
| Cohort 1_Infant Series | Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohort 1 at 12, 24, 36 and 48 Months After Last Vaccination in Cohort 1 (Infant Series) | Serotype 19F: 12 Months After Last Vaccination in Cohort 1 | 2.88 Microgram/milliliter |
| Cohort 1_Infant Series | Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohort 1 at 12, 24, 36 and 48 Months After Last Vaccination in Cohort 1 (Infant Series) | Serotype 19F: 24 Months After Last Vaccination in Cohort 1 | 2.73 Microgram/milliliter |
| Cohort 1_Infant Series | Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohort 1 at 12, 24, 36 and 48 Months After Last Vaccination in Cohort 1 (Infant Series) | Serotype 19F: 36 Months After Last Vaccination in Cohort 1 | 4.06 Microgram/milliliter |
| Cohort 1_Infant Series | Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohort 1 at 12, 24, 36 and 48 Months After Last Vaccination in Cohort 1 (Infant Series) | Serotype 19F: 48 Months After Last Vaccination in Cohort 1 | 3.51 Microgram/milliliter |
| Cohort 1_Infant Series | Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohort 1 at 12, 24, 36 and 48 Months After Last Vaccination in Cohort 1 (Infant Series) | Serotype 23F: 12 Months After Last Vaccination in Cohort 1 | 2.14 Microgram/milliliter |
| Cohort 1_Infant Series | Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohort 1 at 12, 24, 36 and 48 Months After Last Vaccination in Cohort 1 (Infant Series) | Serotype 23F: 24 Months After Last Vaccination in Cohort 1 | 1.72 Microgram/milliliter |
| Cohort 1_Infant Series | Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohort 1 at 12, 24, 36 and 48 Months After Last Vaccination in Cohort 1 (Infant Series) | Serotype 23F: 36 Months After Last Vaccination in Cohort 1 | 1.92 Microgram/milliliter |
| Cohort 1_Infant Series | Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohort 1 at 12, 24, 36 and 48 Months After Last Vaccination in Cohort 1 (Infant Series) | Serotype 23F: 48 Months After Last Vaccination in Cohort 1 | 2.15 Microgram/milliliter |
Secondary
The Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine.
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.
Time frame: Cohort 2, 3, 4: Before Vaccination and 1 Month After the Last Dose
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Cohort 1_Infant Series | The Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 6B - 1 Month After the Last Dose | 2.20 mcg/mL |
| Cohort 1_Infant Series | The Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 23F - 1 Month After the Last Dose | 2.04 mcg/mL |
| Cohort 1_Infant Series | The Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 23F - Before Vaccination | 0.11 mcg/mL |
| Cohort 1_Infant Series | The Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 19F - 1 Month After the Last Dose | 4.50 mcg/mL |
| Cohort 1_Infant Series | The Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 18C - 1 Month After the Last Dose | 2.25 mcg/mL |
| Cohort 1_Infant Series | The Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 18C - Before Vaccination | 0.01 mcg/mL |
| Cohort 1_Infant Series | The Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 14 - 1 Month After the Last Dose | 10.89 mcg/mL |
| Cohort 1_Infant Series | The Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 3 - 1 Month After the Last Dose | 1.19 mcg/mL |
| Cohort 1_Infant Series | The Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 14 - Before Vaccination | 0.03 mcg/mL |
| Cohort 1_Infant Series | The Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 4 - Before Vaccination | 0.01 mcg/mL |
| Cohort 1_Infant Series | The Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 19A - Before Vaccination | 0.36 mcg/mL |
| Cohort 1_Infant Series | The Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 9V - 1 Month After the Last Dose | 2.24 mcg/mL |
| Cohort 1_Infant Series | The Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 9V - Before Vaccination | 0.13 mcg/mL |
| Cohort 1_Infant Series | The Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 4 - 1 Month After the Last Dose | 2.97 mcg/mL |
| Cohort 1_Infant Series | The Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 7F - 1 Month After the Last Dose | 5.73 mcg/mL |
| Cohort 1_Infant Series | The Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 5 - Before Vaccination | 0.38 mcg/mL |
| Cohort 1_Infant Series | The Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 7F - Before Vaccination | 0.03 mcg/mL |
| Cohort 1_Infant Series | The Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 5 - 1 Month After the Last Dose | 3.07 mcg/mL |
| Cohort 1_Infant Series | The Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 1 - Before Vaccination | 0.02 mcg/mL |
| Cohort 1_Infant Series | The Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 19F - Before Vaccination | 0.08 mcg/mL |
| Cohort 1_Infant Series | The Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 6B - Before Vaccination | 0.15 mcg/mL |
| Cohort 1_Infant Series | The Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 6A - Before Vaccination | 0.15 mcg/mL |
| Cohort 1_Infant Series | The Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 1 - 1 Month After the Last Dose | 3.75 mcg/mL |
| Cohort 1_Infant Series | The Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 19A - 1 Month After the Last Dose | 3.62 mcg/mL |
| Cohort 1_Infant Series | The Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 6A - 1 Month After the Last Dose | 3.12 mcg/mL |
| Cohort 1_Infant Series | The Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 3 - Before Vaccination | 0.03 mcg/mL |
| Cohort 2_13vPnC | The Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 19A - 1 Month After the Last Dose | 0.50 mcg/mL |
| Cohort 2_13vPnC | The Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 19F - Before Vaccination | 0.11 mcg/mL |
| Cohort 2_13vPnC | The Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 1 - 1 Month After the Last Dose | 0.04 mcg/mL |
| Cohort 2_13vPnC | The Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 23F - 1 Month After the Last Dose | 0.17 mcg/mL |
| Cohort 2_13vPnC | The Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 4 - 1 Month After the Last Dose | 0.02 mcg/mL |
| Cohort 2_13vPnC | The Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 18C - 1 Month After the Last Dose | 0.02 mcg/mL |
| Cohort 2_13vPnC | The Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 7F - 1 Month After the Last Dose | 0.05 mcg/mL |
| Cohort 2_13vPnC | The Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 19F - 1 Month After the Last Dose | 0.13 mcg/mL |
| Cohort 2_13vPnC | The Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 1 - Before Vaccination | 0.02 mcg/mL |
| Cohort 2_13vPnC | The Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 6B - Before Vaccination | 0.15 mcg/mL |
| Cohort 2_13vPnC | The Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 18C - Before Vaccination | 0.01 mcg/mL |
| Cohort 2_13vPnC | The Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 7F - Before Vaccination | 0.03 mcg/mL |
| Cohort 2_13vPnC | The Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 14 - 1 Month After the Last Dose | 0.02 mcg/mL |
| Cohort 2_13vPnC | The Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 3 - Before Vaccination | 0.03 mcg/mL |
| Cohort 2_13vPnC | The Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 5 - Before Vaccination | 0.36 mcg/mL |
| Cohort 2_13vPnC | The Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 3 - 1 Month After the Last Dose | 0.04 mcg/mL |
| Cohort 2_13vPnC | The Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 19A - Before Vaccination | 0.38 mcg/mL |
| Cohort 2_13vPnC | The Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 14 - Before Vaccination | 0.02 mcg/mL |
| Cohort 2_13vPnC | The Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 23F - Before Vaccination | 0.11 mcg/mL |
| Cohort 2_13vPnC | The Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 9V - 1 Month After the Last Dose | 0.20 mcg/mL |
| Cohort 2_13vPnC | The Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 6B - 1 Month After the Last Dose | 0.21 mcg/mL |
| Cohort 2_13vPnC | The Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 4 - Before Vaccination | 0.01 mcg/mL |
| Cohort 2_13vPnC | The Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 6A - Before Vaccination | 0.16 mcg/mL |
| Cohort 2_13vPnC | The Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 5 - 1 Month After the Last Dose | 0.51 mcg/mL |
| Cohort 2_13vPnC | The Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 9V - Before Vaccination | 0.16 mcg/mL |
| Cohort 2_13vPnC | The Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 6A - 1 Month After the Last Dose | 0.20 mcg/mL |
| Cohort 3_13vPnC | The Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 5 - 1 Month After the Last Dose | 2.57 mcg/mL |
| Cohort 3_13vPnC | The Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 1 - Before Vaccination | 0.07 mcg/mL |
| Cohort 3_13vPnC | The Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 1 - 1 Month After the Last Dose | 4.38 mcg/mL |
| Cohort 3_13vPnC | The Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 3 - 1 Month After the Last Dose | 1.32 mcg/mL |
| Cohort 3_13vPnC | The Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 4 - Before Vaccination | 0.03 mcg/mL |
| Cohort 3_13vPnC | The Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 4 - 1 Month After the Last Dose | 4.04 mcg/mL |
| Cohort 3_13vPnC | The Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 19A - 1 Month After the Last Dose | 5.55 mcg/mL |
| Cohort 3_13vPnC | The Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 19F - Before Vaccination | 0.23 mcg/mL |
| Cohort 3_13vPnC | The Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 19F - 1 Month After the Last Dose | 5.04 mcg/mL |
| Cohort 3_13vPnC | The Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 23F - Before Vaccination | 0.19 mcg/mL |
| Cohort 3_13vPnC | The Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 23F - 1 Month After the Last Dose | 2.26 mcg/mL |
| Cohort 3_13vPnC | The Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 3 - Before Vaccination | 0.07 mcg/mL |
| Cohort 3_13vPnC | The Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 5 - Before Vaccination | 0.69 mcg/mL |
| Cohort 3_13vPnC | The Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 6A - Before Vaccination | 0.30 mcg/mL |
| Cohort 3_13vPnC | The Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 6A - 1 Month After the Last Dose | 3.19 mcg/mL |
| Cohort 3_13vPnC | The Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 6B - Before Vaccination | 0.30 mcg/mL |
| Cohort 3_13vPnC | The Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 6B - 1 Month After the Last Dose | 2.47 mcg/mL |
| Cohort 3_13vPnC | The Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 7F - Before Vaccination | 0.10 mcg/mL |
| Cohort 3_13vPnC | The Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 7F - 1 Month After the Last Dose | 7.87 mcg/mL |
| Cohort 3_13vPnC | The Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 9V - Before Vaccination | 0.25 mcg/mL |
| Cohort 3_13vPnC | The Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 9V - 1 Month After the Last Dose | 3.31 mcg/mL |
| Cohort 3_13vPnC | The Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 14 - Before Vaccination | 0.03 mcg/mL |
| Cohort 3_13vPnC | The Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 14 - 1 Month After the Last Dose | 9.79 mcg/mL |
| Cohort 3_13vPnC | The Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 18C - Before Vaccination | 0.04 mcg/mL |
| Cohort 3_13vPnC | The Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 18C - 1 Month After the Last Dose | 3.88 mcg/mL |
| Cohort 3_13vPnC | The Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 19A - Before Vaccination | 0.65 mcg/mL |
| Cohort 4_vPnC | The Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 18C - 1 Month After the Last Dose | 0.07 mcg/mL |
| Cohort 4_vPnC | The Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 7F - Before Vaccination | 0.11 mcg/mL |
| Cohort 4_vPnC | The Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 1 - 1 Month After the Last Dose | 0.07 mcg/mL |
| Cohort 4_vPnC | The Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 3 - 1 Month After the Last Dose | 0.09 mcg/mL |
| Cohort 4_vPnC | The Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 18C - Before Vaccination | 0.05 mcg/mL |
| Cohort 4_vPnC | The Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 4 - 1 Month After the Last Dose | 0.03 mcg/mL |
| Cohort 4_vPnC | The Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 19A - Before Vaccination | 0.69 mcg/mL |
| Cohort 4_vPnC | The Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 7F - 1 Month After the Last Dose | 0.13 mcg/mL |
| Cohort 4_vPnC | The Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 19F - Before Vaccination | 0.23 mcg/mL |
| Cohort 4_vPnC | The Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 3 - Before Vaccination | 0.07 mcg/mL |
| Cohort 4_vPnC | The Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 9V - 1 Month After the Last Dose | 0.34 mcg/mL |
| Cohort 4_vPnC | The Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 6A - Before Vaccination | 0.36 mcg/mL |
| Cohort 4_vPnC | The Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 4 - Before Vaccination | 0.04 mcg/mL |
| Cohort 4_vPnC | The Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 9V - Before Vaccination | 0.27 mcg/mL |
| Cohort 4_vPnC | The Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 23F - Before Vaccination | 0.22 mcg/mL |
| Cohort 4_vPnC | The Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 6B - Before Vaccination | 0.35 mcg/mL |
| Cohort 4_vPnC | The Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 5 - Before Vaccination | 0.63 mcg/mL |
| Cohort 4_vPnC | The Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 19F - 1 Month After the Last Dose | 0.27 mcg/mL |
| Cohort 4_vPnC | The Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 5 - 1 Month After the Last Dose | 0.74 mcg/mL |
| Cohort 4_vPnC | The Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 14 - 1 Month After the Last Dose | 0.07 mcg/mL |
| Cohort 4_vPnC | The Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 23F - 1 Month After the Last Dose | 0.27 mcg/mL |
| Cohort 4_vPnC | The Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 6B - 1 Month After the Last Dose | 0.38 mcg/mL |
| Cohort 4_vPnC | The Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 19A - 1 Month After the Last Dose | 0.88 mcg/mL |
| Cohort 4_vPnC | The Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 14 - Before Vaccination | 0.05 mcg/mL |
| Cohort 4_vPnC | The Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 6A - 1 Month After the Last Dose | 0.42 mcg/mL |
| Cohort 4_vPnC | The Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 1 - Before Vaccination | 0.07 mcg/mL |
| Cohort 2_13vPnC_Vaccination 3 | The Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 3 - 1 Month After the Last Dose | 1.12 mcg/mL |
| Cohort 2_13vPnC_Vaccination 3 | The Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 18C - Before Vaccination | 0.20 mcg/mL |
| Cohort 2_13vPnC_Vaccination 3 | The Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 6A - Before Vaccination | 0.79 mcg/mL |
| Cohort 2_13vPnC_Vaccination 3 | The Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 6A - 1 Month After the Last Dose | 3.39 mcg/mL |
| Cohort 2_13vPnC_Vaccination 3 | The Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 5 - 1 Month After the Last Dose | 2.92 mcg/mL |
| Cohort 2_13vPnC_Vaccination 3 | The Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 6B - Before Vaccination | 0.80 mcg/mL |
| Cohort 2_13vPnC_Vaccination 3 | The Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 19A - Before Vaccination | 1.72 mcg/mL |
| Cohort 2_13vPnC_Vaccination 3 | The Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 6B - 1 Month After the Last Dose | 2.96 mcg/mL |
| Cohort 2_13vPnC_Vaccination 3 | The Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 5 - Before Vaccination | 1.04 mcg/mL |
| Cohort 2_13vPnC_Vaccination 3 | The Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 7F - Before Vaccination | 0.25 mcg/mL |
| Cohort 2_13vPnC_Vaccination 3 | The Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 4 - 1 Month After the Last Dose | 4.47 mcg/mL |
| Cohort 2_13vPnC_Vaccination 3 | The Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 18C - 1 Month After the Last Dose | 5.60 mcg/mL |
| Cohort 2_13vPnC_Vaccination 3 | The Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 7F - 1 Month After the Last Dose | 7.08 mcg/mL |
| Cohort 2_13vPnC_Vaccination 3 | The Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 4 - Before Vaccination | 0.07 mcg/mL |
| Cohort 2_13vPnC_Vaccination 3 | The Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 9V - Before Vaccination | 0.55 mcg/mL |
| Cohort 2_13vPnC_Vaccination 3 | The Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 1 - Before Vaccination | 0.18 mcg/mL |
| Cohort 2_13vPnC_Vaccination 3 | The Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 9V - 1 Month After the Last Dose | 3.68 mcg/mL |
| Cohort 2_13vPnC_Vaccination 3 | The Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 14 - Before Vaccination | 0.19 mcg/mL |
| Cohort 2_13vPnC_Vaccination 3 | The Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 3 - Before Vaccination | 0.14 mcg/mL |
| Cohort 2_13vPnC_Vaccination 3 | The Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 14 - 1 Month After the Last Dose | 6.94 mcg/mL |
| Cohort 2_13vPnC_Vaccination 3 | The Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 19F - 1 Month After the Last Dose | 5.44 mcg/mL |
| Cohort 2_13vPnC_Vaccination 3 | The Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 1 - 1 Month After the Last Dose | 4.40 mcg/mL |
| Cohort 2_13vPnC_Vaccination 3 | The Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 23F - Before Vaccination | 0.54 mcg/mL |
| Cohort 2_13vPnC_Vaccination 3 | The Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 19F - Before Vaccination | 0.62 mcg/mL |
| Cohort 2_13vPnC_Vaccination 3 | The Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 23F - 1 Month After the Last Dose | 2.80 mcg/mL |
| Cohort 2_13vPnC_Vaccination 3 | The Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 19A - 1 Month After the Last Dose | 11.62 mcg/mL |
| Cohort 4_Hib Vaccine | The Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 19A - 1 Month After the Last Dose | 1.33 mcg/mL |
| Cohort 4_Hib Vaccine | The Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 14 - Before Vaccination | 0.20 mcg/mL |
| Cohort 4_Hib Vaccine | The Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 3 - Before Vaccination | 0.13 mcg/mL |
| Cohort 4_Hib Vaccine | The Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 5 - 1 Month After the Last Dose | 0.89 mcg/mL |
| Cohort 4_Hib Vaccine | The Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 19A - Before Vaccination | 1.44 mcg/mL |
| Cohort 4_Hib Vaccine | The Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 5 - Before Vaccination | 0.97 mcg/mL |
| Cohort 4_Hib Vaccine | The Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 6A - 1 Month After the Last Dose | 0.80 mcg/mL |
| Cohort 4_Hib Vaccine | The Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 14 - 1 Month After the Last Dose | 0.20 mcg/mL |
| Cohort 4_Hib Vaccine | The Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 1 - 1 Month After the Last Dose | 0.16 mcg/mL |
| Cohort 4_Hib Vaccine | The Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 6B - Before Vaccination | 0.70 mcg/mL |
| Cohort 4_Hib Vaccine | The Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 6A - Before Vaccination | 0.79 mcg/mL |
| Cohort 4_Hib Vaccine | The Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 19F - 1 Month After the Last Dose | 0.53 mcg/mL |
| Cohort 4_Hib Vaccine | The Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 19F - Before Vaccination | 0.57 mcg/mL |
| Cohort 4_Hib Vaccine | The Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 18C - Before Vaccination | 0.20 mcg/mL |
| Cohort 4_Hib Vaccine | The Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 1 - Before Vaccination | 0.21 mcg/mL |
| Cohort 4_Hib Vaccine | The Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 9V - Before Vaccination | 0.41 mcg/mL |
| Cohort 4_Hib Vaccine | The Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 18C - 1 Month After the Last Dose | 0.18 mcg/mL |
| Cohort 4_Hib Vaccine | The Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 3 - 1 Month After the Last Dose | 0.12 mcg/mL |
| Cohort 4_Hib Vaccine | The Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 23F - 1 Month After the Last Dose | 0.44 mcg/mL |
| Cohort 4_Hib Vaccine | The Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 4 - Before Vaccination | 0.07 mcg/mL |
| Cohort 4_Hib Vaccine | The Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 23F - Before Vaccination | 0.45 mcg/mL |
| Cohort 4_Hib Vaccine | The Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 9V - 1 Month After the Last Dose | 0.45 mcg/mL |
| Cohort 4_Hib Vaccine | The Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 7F - 1 Month After the Last Dose | 0.21 mcg/mL |
| Cohort 4_Hib Vaccine | The Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 7F - Before Vaccination | 0.25 mcg/mL |
| Cohort 4_Hib Vaccine | The Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 4 - 1 Month After the Last Dose | 0.06 mcg/mL |
| Cohort 4_Hib Vaccine | The Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 6B - 1 Month After the Last Dose | 0.62 mcg/mL |
Secondary
The Serotype-specific OPA GMT for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine.
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.
Time frame: Cohort 2, 3, 4: Before Vaccination and 1 Month After the Last Dose
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Cohort 1_Infant Series | The Serotype-specific OPA GMT for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 4 - Before Vaccination | 5.5 GMT |
| Cohort 1_Infant Series | The Serotype-specific OPA GMT for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 6B - 1 Month After the Last Dose | 2181.6 GMT |
| Cohort 1_Infant Series | The Serotype-specific OPA GMT for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 3 - Before Vaccination | 5.8 GMT |
| Cohort 1_Infant Series | The Serotype-specific OPA GMT for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 18C - 1 Month After the Last Dose | 1486.6 GMT |
| Cohort 1_Infant Series | The Serotype-specific OPA GMT for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 6B - Before Vaccination | 5.1 GMT |
| Cohort 1_Infant Series | The Serotype-specific OPA GMT for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 18C - Before Vaccination | 4.3 GMT |
| Cohort 1_Infant Series | The Serotype-specific OPA GMT for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 4 - 1 Month After the Last Dose | 2172.2 GMT |
| Cohort 1_Infant Series | The Serotype-specific OPA GMT for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 19F - Before Vaccination | 4.3 GMT |
| Cohort 1_Infant Series | The Serotype-specific OPA GMT for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 23F - 1 Month After the Last Dose | 5640.0 GMT |
| Cohort 1_Infant Series | The Serotype-specific OPA GMT for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 1 - 1 Month After the Last Dose | 142.7 GMT |
| Cohort 1_Infant Series | The Serotype-specific OPA GMT for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 14 - 1 Month After the Last Dose | 4108.0 GMT |
| Cohort 1_Infant Series | The Serotype-specific OPA GMT for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 19A - 1 Month After the Last Dose | 2611.3 GMT |
| Cohort 1_Infant Series | The Serotype-specific OPA GMT for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 5 - Before Vaccination | 4.3 GMT |
| Cohort 1_Infant Series | The Serotype-specific OPA GMT for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 3 - 1 Month After the Last Dose | 249.0 GMT |
| Cohort 1_Infant Series | The Serotype-specific OPA GMT for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 7F - Before Vaccination | 63.0 GMT |
| Cohort 1_Infant Series | The Serotype-specific OPA GMT for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 14 - Before Vaccination | 9.8 GMT |
| Cohort 1_Infant Series | The Serotype-specific OPA GMT for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 1 - Before Vaccination | 4.1 GMT |
| Cohort 1_Infant Series | The Serotype-specific OPA GMT for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 9V - 1 Month After the Last Dose | 4154.1 GMT |
| Cohort 1_Infant Series | The Serotype-specific OPA GMT for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 5 - 1 Month After the Last Dose | 286.3 GMT |
| Cohort 1_Infant Series | The Serotype-specific OPA GMT for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 6A - 1 Month After the Last Dose | 6042.7 GMT |
| Cohort 1_Infant Series | The Serotype-specific OPA GMT for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 23F - Before Vaccination | 5.1 GMT |
| Cohort 1_Infant Series | The Serotype-specific OPA GMT for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 19A - Before Vaccination | 5.3 GMT |
| Cohort 1_Infant Series | The Serotype-specific OPA GMT for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 9V - Before Vaccination | 9.3 GMT |
| Cohort 1_Infant Series | The Serotype-specific OPA GMT for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 19F - 1 Month After the Last Dose | 1158.4 GMT |
| Cohort 1_Infant Series | The Serotype-specific OPA GMT for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 6A - Before Vaccination | 5.0 GMT |
| Cohort 1_Infant Series | The Serotype-specific OPA GMT for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 7F - 1 Month After the Last Dose | 10234.6 GMT |
| Cohort 2_13vPnC | The Serotype-specific OPA GMT for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 6A - Before Vaccination | 4.0 GMT |
| Cohort 2_13vPnC | The Serotype-specific OPA GMT for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 7F - Before Vaccination | 29.6 GMT |
| Cohort 2_13vPnC | The Serotype-specific OPA GMT for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 6A - 1 Month After the Last Dose | 5.9 GMT |
| Cohort 2_13vPnC | The Serotype-specific OPA GMT for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 6B - 1 Month After the Last Dose | 5.7 GMT |
| Cohort 2_13vPnC | The Serotype-specific OPA GMT for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 6B - Before Vaccination | 4.0 GMT |
| Cohort 2_13vPnC | The Serotype-specific OPA GMT for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 1 - 1 Month After the Last Dose | 4.9 GMT |
| Cohort 2_13vPnC | The Serotype-specific OPA GMT for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 19F - 1 Month After the Last Dose | 5.9 GMT |
| Cohort 2_13vPnC | The Serotype-specific OPA GMT for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 19F - Before Vaccination | 4.6 GMT |
| Cohort 2_13vPnC | The Serotype-specific OPA GMT for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 3 - Before Vaccination | 6.7 GMT |
| Cohort 2_13vPnC | The Serotype-specific OPA GMT for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 19A - 1 Month After the Last Dose | 6.4 GMT |
| Cohort 2_13vPnC | The Serotype-specific OPA GMT for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 3 - 1 Month After the Last Dose | 7.4 GMT |
| Cohort 2_13vPnC | The Serotype-specific OPA GMT for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 1 - Before Vaccination | 4.2 GMT |
| Cohort 2_13vPnC | The Serotype-specific OPA GMT for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 19A - Before Vaccination | 5.8 GMT |
| Cohort 2_13vPnC | The Serotype-specific OPA GMT for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 18C - 1 Month After the Last Dose | 6.5 GMT |
| Cohort 2_13vPnC | The Serotype-specific OPA GMT for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 4 - Before Vaccination | 5.0 GMT |
| Cohort 2_13vPnC | The Serotype-specific OPA GMT for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 23F - 1 Month After the Last Dose | 20.2 GMT |
| Cohort 2_13vPnC | The Serotype-specific OPA GMT for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 18C - Before Vaccination | 4.4 GMT |
| Cohort 2_13vPnC | The Serotype-specific OPA GMT for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 4 - 1 Month After the Last Dose | 10.3 GMT |
| Cohort 2_13vPnC | The Serotype-specific OPA GMT for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 14 - 1 Month After the Last Dose | 26.6 GMT |
| Cohort 2_13vPnC | The Serotype-specific OPA GMT for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 14 - Before Vaccination | 12.7 GMT |
| Cohort 2_13vPnC | The Serotype-specific OPA GMT for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 5 - Before Vaccination | 4.0 GMT |
| Cohort 2_13vPnC | The Serotype-specific OPA GMT for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 23F - Before Vaccination | 4.7 GMT |
| Cohort 2_13vPnC | The Serotype-specific OPA GMT for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 9V - 1 Month After the Last Dose | 20.6 GMT |
| Cohort 2_13vPnC | The Serotype-specific OPA GMT for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 5 - 1 Month After the Last Dose | 6.2 GMT |
| Cohort 2_13vPnC | The Serotype-specific OPA GMT for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 9V - Before Vaccination | 11.3 GMT |
| Cohort 2_13vPnC | The Serotype-specific OPA GMT for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 7F - 1 Month After the Last Dose | 94.0 GMT |
| Cohort 3_13vPnC | The Serotype-specific OPA GMT for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 3 - Before Vaccination | 11.9 GMT |
| Cohort 3_13vPnC | The Serotype-specific OPA GMT for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 6A - Before Vaccination | 6.9 GMT |
| Cohort 3_13vPnC | The Serotype-specific OPA GMT for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 1 - Before Vaccination | 4.0 GMT |
| Cohort 3_13vPnC | The Serotype-specific OPA GMT for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 1 - 1 Month After the Last Dose | 93.3 GMT |
| Cohort 3_13vPnC | The Serotype-specific OPA GMT for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 3 - 1 Month After the Last Dose | 332.3 GMT |
| Cohort 3_13vPnC | The Serotype-specific OPA GMT for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 4 - Before Vaccination | 6.3 GMT |
| Cohort 3_13vPnC | The Serotype-specific OPA GMT for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 4 - 1 Month After the Last Dose | 2682.8 GMT |
| Cohort 3_13vPnC | The Serotype-specific OPA GMT for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 5 - Before Vaccination | 4.2 GMT |
| Cohort 3_13vPnC | The Serotype-specific OPA GMT for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 5 - 1 Month After the Last Dose | 164.5 GMT |
| Cohort 3_13vPnC | The Serotype-specific OPA GMT for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 6A - 1 Month After the Last Dose | 7661.8 GMT |
| Cohort 3_13vPnC | The Serotype-specific OPA GMT for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 6B - Before Vaccination | 8.2 GMT |
| Cohort 3_13vPnC | The Serotype-specific OPA GMT for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 6B - 1 Month After the Last Dose | 4986.3 GMT |
| Cohort 3_13vPnC | The Serotype-specific OPA GMT for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 7F - Before Vaccination | 195.8 GMT |
| Cohort 3_13vPnC | The Serotype-specific OPA GMT for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 7F - 1 Month After the Last Dose | 14963.5 GMT |
| Cohort 3_13vPnC | The Serotype-specific OPA GMT for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 9V - Before Vaccination | 59.5 GMT |
| Cohort 3_13vPnC | The Serotype-specific OPA GMT for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 9V - 1 Month After the Last Dose | 7220.1 GMT |
| Cohort 3_13vPnC | The Serotype-specific OPA GMT for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 14 - Before Vaccination | 30.0 GMT |
| Cohort 3_13vPnC | The Serotype-specific OPA GMT for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 14 - 1 Month After the Last Dose | 6885.4 GMT |
| Cohort 3_13vPnC | The Serotype-specific OPA GMT for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 18C - Before Vaccination | 6.1 GMT |
| Cohort 3_13vPnC | The Serotype-specific OPA GMT for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 18C - 1 Month After the Last Dose | 1890.4 GMT |
| Cohort 3_13vPnC | The Serotype-specific OPA GMT for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 19A - Before Vaccination | 11.1 GMT |
| Cohort 3_13vPnC | The Serotype-specific OPA GMT for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 19A - 1 Month After the Last Dose | 3560.0 GMT |
| Cohort 3_13vPnC | The Serotype-specific OPA GMT for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 19F - Before Vaccination | 6.2 GMT |
| Cohort 3_13vPnC | The Serotype-specific OPA GMT for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 19F - 1 Month After the Last Dose | 1854.0 GMT |
| Cohort 3_13vPnC | The Serotype-specific OPA GMT for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 23F - Before Vaccination | 15.0 GMT |
| Cohort 3_13vPnC | The Serotype-specific OPA GMT for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 23F - 1 Month After the Last Dose | 6693.6 GMT |
| Cohort 4_vPnC | The Serotype-specific OPA GMT for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 19A - 1 Month After the Last Dose | 15.5 GMT |
| Cohort 4_vPnC | The Serotype-specific OPA GMT for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 3 - Before Vaccination | 11.3 GMT |
| Cohort 4_vPnC | The Serotype-specific OPA GMT for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 14 - Before Vaccination | 19.1 GMT |
| Cohort 4_vPnC | The Serotype-specific OPA GMT for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 19F - Before Vaccination | 6.1 GMT |
| Cohort 4_vPnC | The Serotype-specific OPA GMT for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 1 - 1 Month After the Last Dose | 4.8 GMT |
| Cohort 4_vPnC | The Serotype-specific OPA GMT for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 23F - 1 Month After the Last Dose | 19.4 GMT |
| Cohort 4_vPnC | The Serotype-specific OPA GMT for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 6B - Before Vaccination | 9.7 GMT |
| Cohort 4_vPnC | The Serotype-specific OPA GMT for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 9V - Before Vaccination | 74.5 GMT |
| Cohort 4_vPnC | The Serotype-specific OPA GMT for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 19F - 1 Month After the Last Dose | 9.5 GMT |
| Cohort 4_vPnC | The Serotype-specific OPA GMT for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 6B - 1 Month After the Last Dose | 20.2 GMT |
| Cohort 4_vPnC | The Serotype-specific OPA GMT for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 4 - 1 Month After the Last Dose | 10.6 GMT |
| Cohort 4_vPnC | The Serotype-specific OPA GMT for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 6A - 1 Month After the Last Dose | 17.8 GMT |
| Cohort 4_vPnC | The Serotype-specific OPA GMT for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 7F - Before Vaccination | 432.7 GMT |
| Cohort 4_vPnC | The Serotype-specific OPA GMT for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 6A - Before Vaccination | 8.2 GMT |
| Cohort 4_vPnC | The Serotype-specific OPA GMT for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 23F - Before Vaccination | 11.1 GMT |
| Cohort 4_vPnC | The Serotype-specific OPA GMT for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 14 - 1 Month After the Last Dose | 39.0 GMT |
| Cohort 4_vPnC | The Serotype-specific OPA GMT for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 7F - 1 Month After the Last Dose | 707.1 GMT |
| Cohort 4_vPnC | The Serotype-specific OPA GMT for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 18C - Before Vaccination | 6.3 GMT |
| Cohort 4_vPnC | The Serotype-specific OPA GMT for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 4 - Before Vaccination | 9.5 GMT |
| Cohort 4_vPnC | The Serotype-specific OPA GMT for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 18C - 1 Month After the Last Dose | 7.9 GMT |
| Cohort 4_vPnC | The Serotype-specific OPA GMT for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 9V - 1 Month After the Last Dose | 154.3 GMT |
| Cohort 4_vPnC | The Serotype-specific OPA GMT for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 3 - 1 Month After the Last Dose | 13.4 GMT |
| Cohort 4_vPnC | The Serotype-specific OPA GMT for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 1 - Before Vaccination | 4.2 GMT |
| Cohort 4_vPnC | The Serotype-specific OPA GMT for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 19A - Before Vaccination | 13.8 GMT |
| Cohort 4_vPnC | The Serotype-specific OPA GMT for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 5 - 1 Month After the Last Dose | 5.1 GMT |
| Cohort 4_vPnC | The Serotype-specific OPA GMT for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 5 - Before Vaccination | 4.1 GMT |
| Cohort 2_13vPnC_Vaccination 3 | The Serotype-specific OPA GMT for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 18C - 1 Month After the Last Dose | 2111.9 GMT |
| Cohort 2_13vPnC_Vaccination 3 | The Serotype-specific OPA GMT for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 7F - 1 Month After the Last Dose | 17107.3 GMT |
| Cohort 2_13vPnC_Vaccination 3 | The Serotype-specific OPA GMT for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 19A - Before Vaccination | 60.3 GMT |
| Cohort 2_13vPnC_Vaccination 3 | The Serotype-specific OPA GMT for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 23F - 1 Month After the Last Dose | 4234.7 GMT |
| Cohort 2_13vPnC_Vaccination 3 | The Serotype-specific OPA GMT for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 14 - 1 Month After the Last Dose | 7504.5 GMT |
| Cohort 2_13vPnC_Vaccination 3 | The Serotype-specific OPA GMT for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 9V - Before Vaccination | 458.9 GMT |
| Cohort 2_13vPnC_Vaccination 3 | The Serotype-specific OPA GMT for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 19F - Before Vaccination | 24.7 GMT |
| Cohort 2_13vPnC_Vaccination 3 | The Serotype-specific OPA GMT for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 14 - Before Vaccination | 132.6 GMT |
| Cohort 2_13vPnC_Vaccination 3 | The Serotype-specific OPA GMT for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 1 - 1 Month After the Last Dose | 40.9 GMT |
| Cohort 2_13vPnC_Vaccination 3 | The Serotype-specific OPA GMT for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 3 - 1 Month After the Last Dose | 244.8 GMT |
| Cohort 2_13vPnC_Vaccination 3 | The Serotype-specific OPA GMT for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 4 - Before Vaccination | 23.4 GMT |
| Cohort 2_13vPnC_Vaccination 3 | The Serotype-specific OPA GMT for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 23F - Before Vaccination | 106.0 GMT |
| Cohort 2_13vPnC_Vaccination 3 | The Serotype-specific OPA GMT for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 6B - Before Vaccination | 53.6 GMT |
| Cohort 2_13vPnC_Vaccination 3 | The Serotype-specific OPA GMT for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 9V - 1 Month After the Last Dose | 10533.5 GMT |
| Cohort 2_13vPnC_Vaccination 3 | The Serotype-specific OPA GMT for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 4 - 1 Month After the Last Dose | 4236.3 GMT |
| Cohort 2_13vPnC_Vaccination 3 | The Serotype-specific OPA GMT for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 6A - 1 Month After the Last Dose | 5849.3 GMT |
| Cohort 2_13vPnC_Vaccination 3 | The Serotype-specific OPA GMT for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 18C - Before Vaccination | 12.7 GMT |
| Cohort 2_13vPnC_Vaccination 3 | The Serotype-specific OPA GMT for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 5 - 1 Month After the Last Dose | 79.3 GMT |
| Cohort 2_13vPnC_Vaccination 3 | The Serotype-specific OPA GMT for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 6B - 1 Month After the Last Dose | 3775.2 GMT |
| Cohort 2_13vPnC_Vaccination 3 | The Serotype-specific OPA GMT for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 19A - 1 Month After the Last Dose | 3055.1 GMT |
| Cohort 2_13vPnC_Vaccination 3 | The Serotype-specific OPA GMT for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 5 - Before Vaccination | 4.7 GMT |
| Cohort 2_13vPnC_Vaccination 3 | The Serotype-specific OPA GMT for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 6A - Before Vaccination | 45.5 GMT |
| Cohort 2_13vPnC_Vaccination 3 | The Serotype-specific OPA GMT for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 19F - 1 Month After the Last Dose | 1629.7 GMT |
| Cohort 2_13vPnC_Vaccination 3 | The Serotype-specific OPA GMT for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 1 - Before Vaccination | 4.6 GMT |
| Cohort 2_13vPnC_Vaccination 3 | The Serotype-specific OPA GMT for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 7F - Before Vaccination | 1155.2 GMT |
| Cohort 2_13vPnC_Vaccination 3 | The Serotype-specific OPA GMT for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 3 - Before Vaccination | 27.1 GMT |
| Cohort 4_Hib Vaccine | The Serotype-specific OPA GMT for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 7F - Before Vaccination | 892.7 GMT |
| Cohort 4_Hib Vaccine | The Serotype-specific OPA GMT for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 5 - 1 Month After the Last Dose | 4.8 GMT |
| Cohort 4_Hib Vaccine | The Serotype-specific OPA GMT for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 19F - 1 Month After the Last Dose | 41.1 GMT |
| Cohort 4_Hib Vaccine | The Serotype-specific OPA GMT for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 7F - 1 Month After the Last Dose | 1090.7 GMT |
| Cohort 4_Hib Vaccine | The Serotype-specific OPA GMT for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 1 - Before Vaccination | 5.5 GMT |
| Cohort 4_Hib Vaccine | The Serotype-specific OPA GMT for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 9V - Before Vaccination | 850.2 GMT |
| Cohort 4_Hib Vaccine | The Serotype-specific OPA GMT for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 5 - Before Vaccination | 4.2 GMT |
| Cohort 4_Hib Vaccine | The Serotype-specific OPA GMT for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 9V - 1 Month After the Last Dose | 795.1 GMT |
| Cohort 4_Hib Vaccine | The Serotype-specific OPA GMT for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 4 - 1 Month After the Last Dose | 19.2 GMT |
| Cohort 4_Hib Vaccine | The Serotype-specific OPA GMT for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 14 - Before Vaccination | 210.6 GMT |
| Cohort 4_Hib Vaccine | The Serotype-specific OPA GMT for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 14 - 1 Month After the Last Dose | 294.9 GMT |
| Cohort 4_Hib Vaccine | The Serotype-specific OPA GMT for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 4 - Before Vaccination | 15.9 GMT |
| Cohort 4_Hib Vaccine | The Serotype-specific OPA GMT for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 18C - Before Vaccination | 20.3 GMT |
| Cohort 4_Hib Vaccine | The Serotype-specific OPA GMT for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 3 - 1 Month After the Last Dose | 28.4 GMT |
| Cohort 4_Hib Vaccine | The Serotype-specific OPA GMT for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 23F - Before Vaccination | 70.5 GMT |
| Cohort 4_Hib Vaccine | The Serotype-specific OPA GMT for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 18C - 1 Month After the Last Dose | 24.6 GMT |
| Cohort 4_Hib Vaccine | The Serotype-specific OPA GMT for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 19A - Before Vaccination | 52.0 GMT |
| Cohort 4_Hib Vaccine | The Serotype-specific OPA GMT for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 3 - Before Vaccination | 40.0 GMT |
| Cohort 4_Hib Vaccine | The Serotype-specific OPA GMT for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 6A - Before Vaccination | 137.4 GMT |
| Cohort 4_Hib Vaccine | The Serotype-specific OPA GMT for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 19A - 1 Month After the Last Dose | 54.3 GMT |
| Cohort 4_Hib Vaccine | The Serotype-specific OPA GMT for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 1 - 1 Month After the Last Dose | 4.4 GMT |
| Cohort 4_Hib Vaccine | The Serotype-specific OPA GMT for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 23F - 1 Month After the Last Dose | 97.2 GMT |
| Cohort 4_Hib Vaccine | The Serotype-specific OPA GMT for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 19F - Before Vaccination | 38.5 GMT |
| Cohort 4_Hib Vaccine | The Serotype-specific OPA GMT for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 6B - Before Vaccination | 94.9 GMT |
| Cohort 4_Hib Vaccine | The Serotype-specific OPA GMT for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 6A - 1 Month After the Last Dose | 101.8 GMT |
| Cohort 4_Hib Vaccine | The Serotype-specific OPA GMT for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. | Serotype 6B - 1 Month After the Last Dose | 117.7 GMT |
Secondary
The Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for Each of the Pneumococcal Serotypes Measured in Cohorts 2, 3 and 4 Compared to IgG GMTs Measured in Cohort 1.
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.
Time frame: Cohort 1: 1 month after the 3rd dose of 13vPnC. Cohort 2, 3, 4: 1 month after the last dose of 13vPnC.
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Cohort 1_Infant Series | The Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for Each of the Pneumococcal Serotypes Measured in Cohorts 2, 3 and 4 Compared to IgG GMTs Measured in Cohort 1. | Serotype 1 | 201.7 GMT |
| Cohort 1_Infant Series | The Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for Each of the Pneumococcal Serotypes Measured in Cohorts 2, 3 and 4 Compared to IgG GMTs Measured in Cohort 1. | Serotype 3 | 112.9 GMT |
| Cohort 1_Infant Series | The Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for Each of the Pneumococcal Serotypes Measured in Cohorts 2, 3 and 4 Compared to IgG GMTs Measured in Cohort 1. | Serotype 4 | 1857.8 GMT |
| Cohort 1_Infant Series | The Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for Each of the Pneumococcal Serotypes Measured in Cohorts 2, 3 and 4 Compared to IgG GMTs Measured in Cohort 1. | Serotype 5 | 645.9 GMT |
| Cohort 1_Infant Series | The Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for Each of the Pneumococcal Serotypes Measured in Cohorts 2, 3 and 4 Compared to IgG GMTs Measured in Cohort 1. | Serotype 6A | 5996.2 GMT |
| Cohort 1_Infant Series | The Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for Each of the Pneumococcal Serotypes Measured in Cohorts 2, 3 and 4 Compared to IgG GMTs Measured in Cohort 1. | Serotype 6B | 2331.6 GMT |
| Cohort 1_Infant Series | The Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for Each of the Pneumococcal Serotypes Measured in Cohorts 2, 3 and 4 Compared to IgG GMTs Measured in Cohort 1. | Serotype 9V | 5386.5 GMT |
| Cohort 1_Infant Series | The Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for Each of the Pneumococcal Serotypes Measured in Cohorts 2, 3 and 4 Compared to IgG GMTs Measured in Cohort 1. | Serotype 14 | 2859.4 GMT |
| Cohort 1_Infant Series | The Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for Each of the Pneumococcal Serotypes Measured in Cohorts 2, 3 and 4 Compared to IgG GMTs Measured in Cohort 1. | Serotype 19A | 1677.3 GMT |
| Cohort 1_Infant Series | The Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for Each of the Pneumococcal Serotypes Measured in Cohorts 2, 3 and 4 Compared to IgG GMTs Measured in Cohort 1. | Serotype 19F | 744.4 GMT |
| Cohort 1_Infant Series | The Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for Each of the Pneumococcal Serotypes Measured in Cohorts 2, 3 and 4 Compared to IgG GMTs Measured in Cohort 1. | Serotype 23F | 3833.2 GMT |
| Cohort 1_Infant Series | The Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for Each of the Pneumococcal Serotypes Measured in Cohorts 2, 3 and 4 Compared to IgG GMTs Measured in Cohort 1. | Serotype 7F | 10413.4 GMT |
| Cohort 1_Infant Series | The Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for Each of the Pneumococcal Serotypes Measured in Cohorts 2, 3 and 4 Compared to IgG GMTs Measured in Cohort 1. | Serotype 18C | 2677.9 GMT |
| Cohort 2_13vPnC | The Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for Each of the Pneumococcal Serotypes Measured in Cohorts 2, 3 and 4 Compared to IgG GMTs Measured in Cohort 1. | Serotype 3 | 249.0 GMT |
| Cohort 2_13vPnC | The Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for Each of the Pneumococcal Serotypes Measured in Cohorts 2, 3 and 4 Compared to IgG GMTs Measured in Cohort 1. | Serotype 1 | 142.7 GMT |
| Cohort 2_13vPnC | The Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for Each of the Pneumococcal Serotypes Measured in Cohorts 2, 3 and 4 Compared to IgG GMTs Measured in Cohort 1. | Serotype 9V | 4154.1 GMT |
| Cohort 2_13vPnC | The Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for Each of the Pneumococcal Serotypes Measured in Cohorts 2, 3 and 4 Compared to IgG GMTs Measured in Cohort 1. | Serotype 4 | 2172.2 GMT |
| Cohort 2_13vPnC | The Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for Each of the Pneumococcal Serotypes Measured in Cohorts 2, 3 and 4 Compared to IgG GMTs Measured in Cohort 1. | Serotype 5 | 286.3 GMT |
| Cohort 2_13vPnC | The Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for Each of the Pneumococcal Serotypes Measured in Cohorts 2, 3 and 4 Compared to IgG GMTs Measured in Cohort 1. | Serotype 6B | 2181.6 GMT |
| Cohort 2_13vPnC | The Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for Each of the Pneumococcal Serotypes Measured in Cohorts 2, 3 and 4 Compared to IgG GMTs Measured in Cohort 1. | Serotype 14 | 4108.0 GMT |
| Cohort 2_13vPnC | The Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for Each of the Pneumococcal Serotypes Measured in Cohorts 2, 3 and 4 Compared to IgG GMTs Measured in Cohort 1. | Serotype 7F | 10234.6 GMT |
| Cohort 2_13vPnC | The Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for Each of the Pneumococcal Serotypes Measured in Cohorts 2, 3 and 4 Compared to IgG GMTs Measured in Cohort 1. | Serotype 19A | 2611.3 GMT |
| Cohort 2_13vPnC | The Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for Each of the Pneumococcal Serotypes Measured in Cohorts 2, 3 and 4 Compared to IgG GMTs Measured in Cohort 1. | Serotype 18C | 1486.6 GMT |
| Cohort 2_13vPnC | The Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for Each of the Pneumococcal Serotypes Measured in Cohorts 2, 3 and 4 Compared to IgG GMTs Measured in Cohort 1. | Serotype 19F | 1158.4 GMT |
| Cohort 2_13vPnC | The Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for Each of the Pneumococcal Serotypes Measured in Cohorts 2, 3 and 4 Compared to IgG GMTs Measured in Cohort 1. | Serotype 23F | 5640.0 GMT |
| Cohort 2_13vPnC | The Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for Each of the Pneumococcal Serotypes Measured in Cohorts 2, 3 and 4 Compared to IgG GMTs Measured in Cohort 1. | Serotype 6A | 6042.7 GMT |
| Cohort 3_13vPnC | The Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for Each of the Pneumococcal Serotypes Measured in Cohorts 2, 3 and 4 Compared to IgG GMTs Measured in Cohort 1. | Serotype 6B | 4986.3 GMT |
| Cohort 3_13vPnC | The Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for Each of the Pneumococcal Serotypes Measured in Cohorts 2, 3 and 4 Compared to IgG GMTs Measured in Cohort 1. | Serotype 18C | 1890.4 GMT |
| Cohort 3_13vPnC | The Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for Each of the Pneumococcal Serotypes Measured in Cohorts 2, 3 and 4 Compared to IgG GMTs Measured in Cohort 1. | Serotype 1 | 93.3 GMT |
| Cohort 3_13vPnC | The Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for Each of the Pneumococcal Serotypes Measured in Cohorts 2, 3 and 4 Compared to IgG GMTs Measured in Cohort 1. | Serotype 14 | 6885.4 GMT |
| Cohort 3_13vPnC | The Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for Each of the Pneumococcal Serotypes Measured in Cohorts 2, 3 and 4 Compared to IgG GMTs Measured in Cohort 1. | Serotype 3 | 332.3 GMT |
| Cohort 3_13vPnC | The Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for Each of the Pneumococcal Serotypes Measured in Cohorts 2, 3 and 4 Compared to IgG GMTs Measured in Cohort 1. | Serotype 23F | 6693.6 GMT |
| Cohort 3_13vPnC | The Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for Each of the Pneumococcal Serotypes Measured in Cohorts 2, 3 and 4 Compared to IgG GMTs Measured in Cohort 1. | Serotype 19F | 1854.0 GMT |
| Cohort 3_13vPnC | The Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for Each of the Pneumococcal Serotypes Measured in Cohorts 2, 3 and 4 Compared to IgG GMTs Measured in Cohort 1. | Serotype 4 | 2682.8 GMT |
| Cohort 3_13vPnC | The Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for Each of the Pneumococcal Serotypes Measured in Cohorts 2, 3 and 4 Compared to IgG GMTs Measured in Cohort 1. | Serotype 9V | 7220.1 GMT |
| Cohort 3_13vPnC | The Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for Each of the Pneumococcal Serotypes Measured in Cohorts 2, 3 and 4 Compared to IgG GMTs Measured in Cohort 1. | Serotype 6A | 7661.8 GMT |
| Cohort 3_13vPnC | The Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for Each of the Pneumococcal Serotypes Measured in Cohorts 2, 3 and 4 Compared to IgG GMTs Measured in Cohort 1. | Serotype 19A | 3560.0 GMT |
| Cohort 3_13vPnC | The Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for Each of the Pneumococcal Serotypes Measured in Cohorts 2, 3 and 4 Compared to IgG GMTs Measured in Cohort 1. | Serotype 5 | 164.5 GMT |
| Cohort 3_13vPnC | The Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for Each of the Pneumococcal Serotypes Measured in Cohorts 2, 3 and 4 Compared to IgG GMTs Measured in Cohort 1. | Serotype 7F | 14963.5 GMT |
| Cohort 4_vPnC | The Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for Each of the Pneumococcal Serotypes Measured in Cohorts 2, 3 and 4 Compared to IgG GMTs Measured in Cohort 1. | Serotype 5 | 79.3 GMT |
| Cohort 4_vPnC | The Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for Each of the Pneumococcal Serotypes Measured in Cohorts 2, 3 and 4 Compared to IgG GMTs Measured in Cohort 1. | Serotype 6A | 5849.3 GMT |
| Cohort 4_vPnC | The Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for Each of the Pneumococcal Serotypes Measured in Cohorts 2, 3 and 4 Compared to IgG GMTs Measured in Cohort 1. | Serotype 18C | 2111.9 GMT |
| Cohort 4_vPnC | The Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for Each of the Pneumococcal Serotypes Measured in Cohorts 2, 3 and 4 Compared to IgG GMTs Measured in Cohort 1. | Serotype 7F | 17107.3 GMT |
| Cohort 4_vPnC | The Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for Each of the Pneumococcal Serotypes Measured in Cohorts 2, 3 and 4 Compared to IgG GMTs Measured in Cohort 1. | Serotype 9V | 10533.5 GMT |
| Cohort 4_vPnC | The Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for Each of the Pneumococcal Serotypes Measured in Cohorts 2, 3 and 4 Compared to IgG GMTs Measured in Cohort 1. | Serotype 14 | 7504.5 GMT |
| Cohort 4_vPnC | The Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for Each of the Pneumococcal Serotypes Measured in Cohorts 2, 3 and 4 Compared to IgG GMTs Measured in Cohort 1. | Serotype 19F | 1629.7 GMT |
| Cohort 4_vPnC | The Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for Each of the Pneumococcal Serotypes Measured in Cohorts 2, 3 and 4 Compared to IgG GMTs Measured in Cohort 1. | Serotype 19A | 3055.1 GMT |
| Cohort 4_vPnC | The Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for Each of the Pneumococcal Serotypes Measured in Cohorts 2, 3 and 4 Compared to IgG GMTs Measured in Cohort 1. | Serotype 23F | 4234.7 GMT |
| Cohort 4_vPnC | The Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for Each of the Pneumococcal Serotypes Measured in Cohorts 2, 3 and 4 Compared to IgG GMTs Measured in Cohort 1. | Serotype 1 | 40.9 GMT |
| Cohort 4_vPnC | The Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for Each of the Pneumococcal Serotypes Measured in Cohorts 2, 3 and 4 Compared to IgG GMTs Measured in Cohort 1. | Serotype 3 | 244.8 GMT |
| Cohort 4_vPnC | The Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for Each of the Pneumococcal Serotypes Measured in Cohorts 2, 3 and 4 Compared to IgG GMTs Measured in Cohort 1. | Serotype 4 | 4236.3 GMT |
| Cohort 4_vPnC | The Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for Each of the Pneumococcal Serotypes Measured in Cohorts 2, 3 and 4 Compared to IgG GMTs Measured in Cohort 1. | Serotype 6B | 3775.2 GMT |