| Primary | Percentage of Participants With Local Reactions (LR) Within 7 Days After Dose 1 | Local reactions included pain at injection site, redness and swelling were measured and recorded in measuring device (caliper) units. 1 measuring device unit =0.5 centimeter (cm). Pain at injection site was graded as mild: hurts if gently touched; moderate: hurts if gently touched with crying; severe: limited limb movement. Redness and swelling were graded as mild: >0 to 2.0 cm; moderate >2.0 to 7.0 cm; and severe: >7.0 cm. | Safety population included all the participants who received at least 1 dose of the IP with safety follow up after Dose 1. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Within 7 Days after Dose 1 | | | | ID | Title | Description |
|---|
| OG000 | 20vPnC (SC) | Participants received 4 doses of 0.5 mL 20vPnC SC into the anterolateral thigh. The time interval between Dose 1, 2 and 3 was 4 to 8 weeks from the previous vaccination. Participants completed Dose 1, 2 and 3 by 12 months of age. Dose 4 was administered at least after 60 days of Dose 3. | | OG001 | 13vPnC (SC) | Participants received 4 doses of 0.5 mL 13vPnC SC into the anterolateral thigh. The time interval between Dose 1, 2 and 3 was 4 to 8 weeks from the previous vaccination. Participants completed Dose 1, 2 and 3 by 12 months of age. Dose 4 was administered at least after 60 days of Dose 3. | | OG002 | 20vPnC (IM) | Participants received 4 doses of 0.5 mL 20vPnC IM into the anterolateral thigh muscle. The time interval between Dose 1, 2 and 3 was 4 to 8 weeks from the previous vaccination. Participants completed Dose 1, 2 and 3 by 12 months of age. Dose 4 was administered at least after 60 days of Dose 3. |
| | | Title | Denominators | Categories |
|---|
| Redness: Mild | | | Title | Measurements |
|---|
| - OG00058.2± 51.5(51.5 to 64.7)
- OG00151.3± 44.6(44.6 to 58.1)
- OG00226.3± 20.5(20.5 to 32.7)
|
|
| |
| Primary | Percentage of Participants With Local Reactions Within 7 Days After Dose 2 | Local reactions included pain at injection site, redness and swelling were measured and recorded in measuring device (caliper) units. 1 measuring device unit =0.5 cm. Pain at injection site was graded as mild: hurts if gently touched; moderate: hurts if gently touched with crying; severe: limited limb movement. Redness and swelling were graded as mild: >0 to 2.0 cm; moderate >2.0 to 7.0 cm; and severe: >7.0 cm. | Safety population included all the participants who received at least 1 dose of the IP with safety follow up after Dose 2. Here, "Number of Participants Analyzed" = number of participants with any e-diary data reported after Dose 2. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Within 7 Days after Dose 2 | | | | ID | Title | Description |
|---|
| OG000 | 20vPnC (SC) | Participants received 4 doses of 0.5 mL 20vPnC SC into the anterolateral thigh. The time interval between Dose 1, 2 and 3 was 4 to 8 weeks from the previous vaccination. Participants completed Dose 1, 2 and 3 by 12 months of age. Dose 4 was administered at least after 60 days of Dose 3. | | OG001 | 13vPnC (SC) | Participants received 4 doses of 0.5 mL 13vPnC SC into the anterolateral thigh. The time interval between Dose 1, 2 and 3 was 4 to 8 weeks from the previous vaccination. Participants completed Dose 1, 2 and 3 by 12 months of age. Dose 4 was administered at least after 60 days of Dose 3. |
|
| Primary | Percentage of Participants With Local Reactions Within 7 Days After Dose 3 | Local reactions included pain at injection site, redness and swelling were measured and recorded in measuring device (caliper) units. 1 measuring device unit =0.5 cm. Pain at injection site was graded as mild: hurts if gently touched; moderate: hurts if gently touched with crying; severe: limited limb movement. Redness and swelling were graded as mild: >0 to 2.0 cm; moderate >2.0 to 7.0 cm; and severe: >7.0 cm. | Safety population included all the participants who received at least 1 dose of the IP with safety follow up after Dose 3. Here, "Overall Number of Participants Analyzed" = number of participants with any e-diary data reported after Dose 3. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Within 7 Days after Dose 3 | | | | ID | Title | Description |
|---|
| OG000 | 20vPnC (SC) | Participants received 4 doses of 0.5 mL 20vPnC SC into the anterolateral thigh. The time interval between Dose 1, 2 and 3 was 4 to 8 weeks from the previous vaccination. Participants completed Dose 1, 2 and 3 by 12 months of age. Dose 4 was administered at least after 60 days of Dose 3. | | OG001 | 13vPnC (SC) | Participants received 4 doses of 0.5 mL 13vPnC SC into the anterolateral thigh. The time interval between Dose 1, 2 and 3 was 4 to 8 weeks from the previous vaccination. Participants completed Dose 1, 2 and 3 by 12 months of age. Dose 4 was administered at least after 60 days of Dose 3. |
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| Primary | Percentage of Participants With Local Reactions Within 7 Days After Dose 4 | Local reactions included pain at injection site, redness and swelling were measured and recorded in measuring device (caliper) units. 1 measuring device unit =0.5 cm. Pain at injection site was graded as mild: hurts if gently touched; moderate: hurts if gently touched with crying; severe: limited limb movement. Redness and swelling were graded as mild: >0 to 2.0 cm; moderate >2.0 to 7.0 cm; and severe: >7.0 cm. | Safety population included all the participants who received at least 1 dose of the IP with safety follow up after Dose 4. Here, "Number of Participants Analyzed" = number of participants with any e-diary data reported after Dose 4. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Within 7 Days after Dose 4 | | | | ID | Title | Description |
|---|
| OG000 | 20vPnC (SC) | Participants received 4 doses of 0.5 mL 20vPnC SC into the anterolateral thigh. The time interval between Dose 1, 2 and 3 was 4 to 8 weeks from the previous vaccination. Participants completed Dose 1, 2 and 3 by 12 months of age. Dose 4 was administered at least after 60 days of Dose 3. | | OG001 | 13vPnC (SC) | Participants received 4 doses of 0.5 mL 13vPnC SC into the anterolateral thigh. The time interval between Dose 1, 2 and 3 was 4 to 8 weeks from the previous vaccination. Participants completed Dose 1, 2 and 3 by 12 months of age. Dose 4 was administered at least after 60 days of Dose 3. |
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| Primary | Percentage of Participants With Systemic Events Within 7 Days After Dose 1 | Systemic events included fever, decreased appetite, drowsiness and irritability. Fever was defined as an axillary temperature greater than or equal to (>=) 37.5 degree Celsius (C), and categorized as >=37.5 to 38.4 degree C, greater than (>)38.4 to 38.9 degree C,>38.9 to 40.0 degree C and >40.0 degree C; decreased appetite was graded as mild (decreased interest in eating), moderate (decreased oral intake) and severe (refusal to feed); drowsiness was graded as mild (increased or prolonged sleeping bouts), moderate (slightly subdued, interfered with daily activity) and severe (disabling, not interested in usual daily activity); Irritability: graded as mild (easily consolable), moderate (required increased attention) and severe (inconsolable, crying could not be comforted). | Safety population included all the participants who received at least 1 dose of the IP with safety follow up Dose 1. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Within 7 Days After Dose 1 | | | | ID | Title | Description |
|---|
| OG000 | 20vPnC (SC) | Participants received 4 doses of 0.5 mL 20vPnC SC into the anterolateral thigh. The time interval between Dose 1, 2 and 3 was 4 to 8 weeks from the previous vaccination. Participants completed Dose 1, 2 and 3 by 12 months of age. Dose 4 was administered at least after 60 days of Dose 3. | | OG001 | 13vPnC (SC) | Participants received 4 doses of 0.5 mL 13vPnC SC into the anterolateral thigh. The time interval between Dose 1, 2 and 3 was 4 to 8 weeks from the previous vaccination. Participants completed Dose 1, 2 and 3 by 12 months of age. Dose 4 was administered at least after 60 days of Dose 3. |
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| Primary | Percentage of Participants With Systemic Events Within 7 Days After Dose 2 | Systemic events included fever, decreased appetite, drowsiness and irritability. Fever was defined as an axillary temperature >=37.5 degree C and categorized as >=37.5 to 38.4 degree C,>38.4 to 38.9 degree C,>38.9 to 40.0 degree C and >40.0 degree C; decreased appetite was graded as mild (decreased interest in eating), moderate (decreased oral intake) and severe (refusal to feed); drowsiness was graded as mild (increased or prolonged sleeping bouts), moderate (slightly subdued, interfered with daily activity) and severe (disabling, not interested in usual daily activity); Irritability: graded as mild (easily consolable), moderate (required increased attention) and severe (inconsolable, crying could not be comforted). | Safety population included all the participants who received at least 1 dose of the IP with safety follow up after Dose 2. Here, "Overall Number of Participants Analyzed" = number of participants with any e-diary data reported after Dose 2. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Within 7 Days After Dose 2 | | | | ID | Title | Description |
|---|
| OG000 | 20vPnC (SC) | Participants received 4 doses of 0.5 mL 20vPnC SC into the anterolateral thigh. The time interval between Dose 1, 2 and 3 was 4 to 8 weeks from the previous vaccination. Participants completed Dose 1, 2 and 3 by 12 months of age. Dose 4 was administered at least after 60 days of Dose 3. | | OG001 | 13vPnC (SC) | |
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| Primary | Percentage of Participants With Systemic Events Within 7 Days After Dose 3 | Systemic events included fever, decreased appetite, drowsiness and irritability. Fever was defined as an axillary temperature >=37.5 degree C and categorized as >=37.5 to 38.4 degree C,>38.4 to 38.9 degree C,>38.9 to 40.0 degree C and >40.0 degree C; decreased appetite was graded as mild (decreased interest in eating), moderate (decreased oral intake) and severe (refusal to feed); drowsiness was graded as mild (increased or prolonged sleeping bouts), moderate (slightly subdued, interfered with daily activity) and severe (disabling, not interested in usual daily activity); Irritability: graded as mild (easily consolable), moderate (required increased attention) and severe (inconsolable, crying could not be comforted). | Safety population included all the participants who received at least 1 dose of the IP with safety follow up after Dose 3. Here, "Overall Number of Participants Analyzed" = number of participants with any e-diary data reported after Dose 3 | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Within 7 Days After Dose 3 | | | | ID | Title | Description |
|---|
| OG000 | 20vPnC (SC) | Participants received 4 doses of 0.5 mL 20vPnC SC into the anterolateral thigh. The time interval between Dose 1, 2 and 3 was 4 to 8 weeks from the previous vaccination. Participants completed Dose 1, 2 and 3 by 12 months of age. Dose 4 was administered at least after 60 days of Dose 3. | | OG001 | 13vPnC (SC) | |
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| Primary | Percentage of Participants With Systemic Events Within 7 Days After Dose 4 | Systemic events included fever, decreased appetite, drowsiness and irritability. Fever was defined as an axillary temperature >=37.5 degree C and categorized as >=37.5 to 38.4 degree C,>38.4 to 38.9 degree C,>38.9 to 40.0 degree C and >40.0 degree C; decreased appetite was graded as mild (decreased interest in eating), moderate (decreased oral intake) and severe (refusal to feed); drowsiness was graded as mild (increased or prolonged sleeping bouts), moderate (slightly subdued, interfered with daily activity) and severe (disabling, not interested in usual daily activity); Irritability: graded as mild (easily consolable), moderate (required increased attention) and severe (inconsolable, crying could not be comforted). | Safety population included all the participants who received at least 1 dose of the IP with safety follow up after Dose 4. Here, "Overall Number of Participants Analyzed" = number of participants with any e-diary data reported after Dose 4. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Within 7 Days After Dose 4 | | | | ID | Title | Description |
|---|
| OG000 | 20vPnC (SC) | Participants received 4 doses of 0.5 mL 20vPnC SC into the anterolateral thigh. The time interval between Dose 1, 2 and 3 was 4 to 8 weeks from the previous vaccination. Participants completed Dose 1, 2 and 3 by 12 months of age. Dose 4 was administered at least after 60 days of Dose 3. | | OG001 | 13vPnC (SC) | |
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| Primary | Percentage of Participants With Adverse Events (AEs) From Dose 1 to 1 Month After Dose 3 | An adverse event (AE) was any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. | Safety population included all the participants who received at least 1 dose of the IP and had safety data after any dose. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Day 1 of Dose 1 to 1 Month after Dose 3 | | | | ID | Title | Description |
|---|
| OG000 | 20vPnC (SC) | Participants received 4 doses of 0.5 mL 20vPnC SC into the anterolateral thigh. The time interval between Dose 1, 2 and 3 was 4 to 8 weeks from the previous vaccination. Participants completed Dose 1, 2 and 3 by 12 months of age. Dose 4 was administered at least after 60 days of Dose 3. | | OG001 | 13vPnC (SC) | Participants received 4 doses of 0.5 mL 13vPnC SC into the anterolateral thigh. The time interval between Dose 1, 2 and 3 was 4 to 8 weeks from the previous vaccination. Participants completed Dose 1, 2 and 3 by 12 months of age. Dose 4 was administered at least after 60 days of Dose 3. | | OG002 | 20vPnC (IM) | Participants received 4 doses of 0.5 mL 20vPnC IM into the anterolateral thigh muscle. The time interval between Dose 1, 2 and 3 was 4 to 8 weeks from the previous vaccination. Participants completed Dose 1, 2 and 3 by 12 months of age. Dose 4 was administered at least after 60 days of Dose 3. |
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| Primary | Percentage of Participants With AEs From Dose 4 to 1 Month After Dose 4 | An AE was any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. | Safety population included all the participants who received at least 1 dose of the IP with safety follow up after any dose. Here, "Number of Participants Analyzed" = number of participants who received Dose 4. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | From Dose 4 to 1 Month after Dose 4 | | | | ID | Title | Description |
|---|
| OG000 | 20vPnC (SC) | Participants received 4 doses of 0.5 mL 20vPnC SC into the anterolateral thigh. The time interval between Dose 1, 2 and 3 was 4 to 8 weeks from the previous vaccination. Participants completed Dose 1, 2 and 3 by 12 months of age. Dose 4 was administered at least after 60 days of Dose 3. | | OG001 | 13vPnC (SC) | Participants received 4 doses of 0.5 mL 13vPnC SC into the anterolateral thigh. The time interval between Dose 1, 2 and 3 was 4 to 8 weeks from the previous vaccination. Participants completed Dose 1, 2 and 3 by 12 months of age. Dose 4 was administered at least after 60 days of Dose 3. | | OG002 | 20vPnC (IM) | |
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| Primary | Percentage of Participants With Serious Adverse Events (SAEs) From Dose 1 to 1 Month After Dose 4 | A serious AE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent or significant disability/ incapacity; congenital anomaly/birth defect and other important medical events. | Safety population included all the participants who received at least 1 dose of the IP with safety follow up after any dose. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | From Dose 1 to 1 Month after Dose 4 | | | | ID | Title | Description |
|---|
| OG000 | 20vPnC (SC) | Participants received 4 doses of 0.5 mL 20vPnC SC into the anterolateral thigh. The time interval between Dose 1, 2 and 3 was 4 to 8 weeks from the previous vaccination. Participants completed Dose 1, 2 and 3 by 12 months of age. Dose 4 was administered at least after 60 days of Dose 3. | | OG001 | 13vPnC (SC) | Participants received 4 doses of 0.5 mL 13vPnC SC into the anterolateral thigh. The time interval between Dose 1, 2 and 3 was 4 to 8 weeks from the previous vaccination. Participants completed Dose 1, 2 and 3 by 12 months of age. Dose 4 was administered at least after 60 days of Dose 3. | | OG002 | 20vPnC (IM) |
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| Primary | Percentage of Participants With Newly Diagnosed Chronic Medical Conditions (NDCMCs) From Dose 1 to 1 Month After Dose 4 | An NDCMC was defined as a significant disease or medical condition, not previously identified, that is expected to be persistent or was otherwise long-lasting in its effects. | Safety population included all the participants who received at least 1 dose of the IP with safety follow up after any dose. Here, "Overall Number of Participants Analyzed" = participants evaluable for this outcome measure. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | From Dose 1 to 1 Month after Dose 4 | | | | ID | Title | Description |
|---|
| OG000 | 20vPnC (SC) | Participants received 4 doses of 0.5 mL 20vPnC SC into the anterolateral thigh. The time interval between Dose 1, 2 and 3 was 4 to 8 weeks from the previous vaccination. Participants completed Dose 1, 2 and 3 by 12 months of age. Dose 4 was administered at least after 60 days of Dose 3. | | OG001 | 13vPnC (SC) | Participants received 4 doses of 0.5 mL 13vPnC SC into the anterolateral thigh. The time interval between Dose 1, 2 and 3 was 4 to 8 weeks from the previous vaccination. Participants completed Dose 1, 2 and 3 by 12 months of age. Dose 4 was administered at least after 60 days of Dose 3. | | OG002 | 20vPnC (IM) |
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| Primary | Percentage of Participants With Predefined Pneumococcal Serotype-specific Immunoglobulin G (IgG) Concentrations 1 Month After Dose 3 | Pneumococcal serotype-specific IgG Concentrations were measured for 20vPnC serotypes: 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F. Assay results below the lower limit of quantitation (LLOQ) were set to 0.5*LLOQ. The predefined levels, >=0.35 micrograms/mL for all serotypes except for serotypes 5 (>=0.23 micrograms/mL), 6B (>=0.10 micrograms/mL) and 19A (>=0.12 micrograms/mL). | Dose 3 evaluable immunogenicity population included eligible participants who were 2 to 6 months of age at first vaccination, received first 3 doses as randomized, had at least 1 valid immunogenicity results from blood collection within 27 to 56 days after Dose 3, had no other major protocol deviations per clinician.Here, "N" = participants with an IgG concentration greater than or equal to(>=)predefined level for given serotype,"n" =participants with valid assay results for specified serotype. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | 1 Month after Dose 3 | | | | ID | Title | Description |
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| OG000 | 20vPnC (SC) | Participants received 4 doses of 0.5 mL 20vPnC SC into the anterolateral thigh. The time interval between Dose 1, 2 and 3 was 4 to 8 weeks from the previous vaccination. Participants completed Dose 1, 2 and 3 by 12 months of age. Dose 4 was administered at least after 60 days of Dose 3. | | OG001 | 13vPnC (SC) | |
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| Secondary | Geometric Mean Concentration of Pneumococcal Serotype-Specific IgG Concentrations 1 Month After Dose 3 | Pneumococcal serotype-specific IgG concentrations were measured for 20vPnC serotypes: 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F. Assay results below the LLOQ were set to 0.5*LLOQ. | Dose 3 evaluable immunogenicity population included eligible participants who were 2 to 6 months of age at first vaccination, received first 3 doses as randomized, had at least 1 valid immunogenicity results from blood collection within 27 to 56 days after Dose 3, and had no other major protocol deviations per clinician. Here, "N" = participants with an IgG concentration >= predefined level for given serotype and "n" =participants with valid assay results for specified serotype. | Posted | | Geometric Mean | 95% Confidence Interval | Micrograms per milliliter | | 1 Month after Dose 3 | | | | ID | Title | Description |
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| OG000 | 20vPnC (SC) | Participants received 4 doses of 0.5 mL 20vPnC SC into the anterolateral thigh. The time interval between Dose 1, 2 and 3 was 4 to 8 weeks from the previous vaccination. Participants completed Dose 1, 2 and 3 by 12 months of age. Dose 4 was administered at least after 60 days of Dose 3. | | OG001 | 13vPnC (SC) | Participants received 4 doses of 0.5 mL 13vPnC SC into the anterolateral thigh. The time interval between Dose 1, 2 and 3 was 4 to 8 weeks from the previous vaccination. Participants completed Dose 1, 2 and 3 by 12 months of age. Dose 4 was administered at least after 60 days of Dose 3. |
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| Secondary | Geometric Mean Concentration of Pneumococcal Serotype-Specific IgG Concentrations 1 Month After Dose 4 | Pneumococcal serotype-specific IgG concentrations were measured for 20vPnC serotypes: 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F. | Dose 4 evaluable immunogenicity population included eligible participants who were 2 to 6 months of age at Dose 1 and 12 to 15 months of age at Dose 4, received all 4 doses as randomized, had at least 1 valid assay result from the blood collection within 27 to 56 days after Dose 4, and had no other major protocol deviations per clinician. Here,"N" = participants with an IgG concentration >= predefined level for given serotype and "n"=participants with valid assay results for specified serotype. | Posted | | Geometric Mean | 95% Confidence Interval | Micrograms per milliliter | | 1 Month after Dose 4 | | | | ID | Title | Description |
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| OG000 | 20vPnC (SC) | Participants received 4 doses of 0.5 mL 20vPnC SC into the anterolateral thigh. The time interval between Dose 1, 2 and 3 was 4 to 8 weeks from the previous vaccination. Participants completed Dose 1, 2 and 3 by 12 months of age. Dose 4 was administered at least after 60 days of Dose 3. | | OG001 | 13vPnC (SC) | Participants received 4 doses of 0.5 mL 13vPnC SC into the anterolateral thigh. The time interval between Dose 1, 2 and 3 was 4 to 8 weeks from the previous vaccination. Participants completed Dose 1, 2 and 3 by 12 months of age. Dose 4 was administered at least after 60 days of Dose 3. |
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| Secondary | Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 | 20vPnC serotypes included: 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F. OPA titers were determined in randomly selected subsets of sera from each vaccine group. | For 1 month after Dose 3 and before Dose 4: Dose 3 evaluable immunogenicity population set were analyzed and for 1 month after Dose 4: Dose 4 evaluable immunogenicity population for 1 month after Dose 4 OPA GMTs were analyzed. Here, "Overall Number of Participants Analyzed"= participants evaluable for this outcome measure and "Number Analyzed"= participants with valid results for the specified serotype. | Posted | | Geometric Mean | 95% Confidence Interval | Titers | | 1 Month after Dose 3, before Dose 4 and 1 Month after Dose 4 | | | | ID | Title | Description |
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| OG000 | 20vPnC (SC) | Participants received 4 doses of 0.5 mL 20vPnC SC into the anterolateral thigh. The time interval between Dose 1, 2 and 3 was 4 to 8 weeks from the previous vaccination. Participants completed Dose 1, 2 and 3 by 12 months of age. Dose 4 was administered at least after 60 days of Dose 3. | | OG001 | 13vPnC (SC) | Participants received 4 doses of 0.5 mL 13vPnC SC into the anterolateral thigh. The time interval between Dose 1, 2 and 3 was 4 to 8 weeks from the previous vaccination. Participants completed Dose 1, 2 and 3 by 12 months of age. Dose 4 was administered at least after 60 days of Dose 3. |
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| Secondary | Percentage of Participants With Pre-defined Pneumococcal Serotype-specific IgG Concentrations at 1 Month After Dose 4 | Pneumococcal serotype-specific IgG concentrations were measured for 20vPnC serotypes: 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F. The predefined levels, >=0.35 micrograms/mL for all serotypes except for serotypes 5 (>=0.23 micrograms/mL), 6B (>=0.10 micrograms/mL) and 19A (>=0.12 micrograms/mL). | Dose 4 evaluable immunogenicity population included participants who were eligible randomized aged 2 to 6 months of age at first dose, received all 4 randomized doses with Dose 4 received within defined window 12 to 15 months of age, had at least 1 immunogenicity results within 27 to 56 days, inclusive, after Dose 4,and had no other major protocol deviations per clinician. Here, N=participants evaluable for this outcome measure and n=participants with valid results for specified serotype. | Posted | | Number | | Percentage of participants | | 1 Month after Dose 4 | | | | ID | Title | Description |
|---|
| OG000 | 20vPnC (SC) | Participants received 4 doses of 0.5 mL 20vPnC SC into the anterolateral thigh. The time interval between Dose 1, 2 and 3 was 4 to 8 weeks from the previous vaccination. Participants completed Dose 1, 2 and 3 by 12 months of age. Dose 4 was administered at least after 60 days of Dose 3. | | OG001 | 13vPnC (SC) | Participants received 4 doses of 0.5 mL 13vPnC SC into the anterolateral thigh. The time interval between Dose 1, 2 and 3 was 4 to 8 weeks from the previous vaccination. Participants completed Dose 1, 2 and 3 by 12 months of age. Dose 4 was administered at least after 60 days of Dose 3. |
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| Secondary | Geometric Mean Fold Rise (GMFR) in Serotype-Specific IgG Concentrations From 1 Month After Dose 3 to Before Dose 4 | GMFR of pneumococcal 20vPnC serotypes included: 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F. The GMFR from 1 month after Dose 3 to before Dose 4 was reported from participants in Dose 3 evaluable immunogenicity population. | Dose 3 evaluable immunogenicity population was included. Here, "Overall Number of Participants Analyzed"= participants evaluable for this outcome measure and "Number Analyzed"= participants with valid IgG concentration at both timepoints for the specified serotype. | Posted | | Geometric Mean | 95% Confidence Interval | Fold rise | | 1 Month after Dose 3 to before Dose 4 | | | | ID | Title | Description |
|---|
| OG000 | 20vPnC (SC) | Participants received 4 doses of 0.5 mL 20vPnC SC into the anterolateral thigh. The time interval between Dose 1, 2 and 3 was 4 to 8 weeks from the previous vaccination. Participants completed Dose 1, 2 and 3 by 12 months of age. Dose 4 was administered at least after 60 days of Dose 3. | | OG001 | 13vPnC (SC) | Participants received 4 doses of 0.5 mL 13vPnC SC into the anterolateral thigh. The time interval between Dose 1, 2 and 3 was 4 to 8 weeks from the previous vaccination. Participants completed Dose 1, 2 and 3 by 12 months of age. Dose 4 was administered at least after 60 days of Dose 3. | |
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| Secondary | GMFR in Serotype-Specific IgG Concentrations From 1 Month After Dose 3 to 1 Month After Dose 4 | GMFR of pneumococcal 20vPnC serotypes included: 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F. The GMFR from 1 month after Dose 3 to 1 month after Dose 4 was reported from participants in both the Dose 3 and Dose 4 evaluable immunogenicity population. | Dose 3 and Dose 4 evaluable immunogenicity populations were included. Here, "Overall Number of Participants Analyzed"= participants evaluable for this outcome measure and "Number Analyzed"= participants with valid IgG concentrations at both timepoints for the specified serotype. | Posted | | Geometric Mean | 95% Confidence Interval | Fold rise | | From 1 Month after Dose 3 to 1 Month after Dose 4 | | | | ID | Title | Description |
|---|
| OG000 | 20vPnC (SC) | Participants received 4 doses of 0.5 mL 20vPnC SC into the anterolateral thigh. The time interval between Dose 1, 2 and 3 was 4 to 8 weeks from the previous vaccination. Participants completed Dose 1, 2 and 3 by 12 months of age. Dose 4 was administered at least after 60 days of Dose 3. | | OG001 | 13vPnC (SC) | Participants received 4 doses of 0.5 mL 13vPnC SC into the anterolateral thigh. The time interval between Dose 1, 2 and 3 was 4 to 8 weeks from the previous vaccination. Participants completed Dose 1, 2 and 3 by 12 months of age. Dose 4 was administered at least after 60 days of Dose 3. |
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| Secondary | GMFR in Serotype-Specific IgG Concentrations From Before Dose 4 to 1 Month After Dose 4 | GMFR of pneumococcal 20vPnC serotypes included: 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F. The GMFR from before Dose 4 to 1 month after Dose 4 was reported from participants in the Dose 4 evaluable immunogenicity population. | Dose 4 evaluable immunogenicity population was included. Here, "Overall Number of Participants Analyzed" =participants evaluable for this outcome measure and "Number Analyzed" =participants with valid IgG concentrations at both timepoints for the specified serotype. | Posted | | Geometric Mean | 95% Confidence Interval | Fold rise | | From before Dose 4 to 1 Month after Dose 4 | | | | ID | Title | Description |
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| OG000 | 20vPnC (SC) | Participants received 4 doses of 0.5 mL 20vPnC SC into the anterolateral thigh. The time interval between Dose 1, 2 and 3 was 4 to 8 weeks from the previous vaccination. Participants completed Dose 1, 2 and 3 by 12 months of age. Dose 4 was administered at least after 60 days of Dose 3. | | OG001 | 13vPnC (SC) | Participants received 4 doses of 0.5 mL 13vPnC SC into the anterolateral thigh. The time interval between Dose 1, 2 and 3 was 4 to 8 weeks from the previous vaccination. Participants completed Dose 1, 2 and 3 by 12 months of age. Dose 4 was administered at least after 60 days of Dose 3. | |
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