| Primary | Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1 | Local reactions were recorded daily using an electronic diary. Local reactions included redness, swelling and pain at injection site. Redness and swelling were graded as mild (0.5 to 2.5 centimeters [cm]), moderate (2.5 to 7.0 cm) and, severe (greater than [>] 7 cm). Pain at injection site was graded as mild (hurt if gently touched (example, whimpers, winces, protests, or withdraws), moderate (hurt if gently touched [with crying]), and severe (caused limitation of limb movement). Participants may be represented in more than 1 row. Here, "Any" for redness, swelling and pain at injection site represents any grade of these local reactions among mild, moderate or severe. | Safety population of infant series included all participants who received at least 1 dose of study vaccine during infant series. Here, "Overall Number of Participants analyzed" signifies participants who were evaluable for this outcome measure. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Within 7 days after Vaccination 1 | | | | ID | Title | Description |
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| OG000 | 13vPnC: Multi-dose Vial (With Preservative) | Infant series: participants were randomized to receive a single 0.5 mL dose of 13vPnC with preservative 2-PE from a MDV, intramuscularly at age of 6 weeks (Vaccination 1), 10 weeks (Vaccination 2) and 14 weeks (Vaccination 3) along with 2 routine vaccines: 1) DTP-Hib-HBV vaccine, 2) rotavirus vaccine. Participants were followed-up to 1 month after Vaccination 3. Infant series was followed by toddler dose. Toddler dose: participants were administered with a single 0.5 mL dose of 13vPnC vaccine with preservative 2-PE from MDV, intramuscularly at age of 12 months (Vaccination 4) along with routine hepatitis A virus vaccine. Participants were followed-up to 1 month after Vaccination 4. Different limbs were used to administer study vaccine and routine vaccines (according to local clinical practice). | | OG001 | 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Infant series: participants were randomized to receive a single 0.5 mL dose of 13vPnC without preservative 2-PE from a single-dose PFS, intramuscularly at age of 6 weeks (Vaccination 1), 10 weeks (Vaccination 2) and 14 weeks (Vaccination 3) along with 2 routine vaccines: 1) DTP-Hib-HBV vaccine, 2) rotavirus vaccine. Participants were followed-up to 1 month after Vaccination 3. Infant series was followed by toddler dose. Toddler dose: participants were administered with a single 0.5 mL dose of 13vPnC vaccine without preservative 2-PE from single dose PFS, intramuscularly at age of 12 months (Vaccination 4) along with routine hepatitis A virus vaccine. Participants were followed-up to 1 month after Vaccination 4. Different limbs were used to administer study vaccine and routine vaccines (according to local clinical practice). |
| | | Title | Denominators | Categories |
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| Redness: Any | | | Title | Measurements |
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| - OG00019.7(13.6 to 27.1)
- OG00116.9(11.2 to 23.9)
|
| | Redness: Mild | | |
| |
| Primary | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | Systemic events included fever, decreased appetite, drowsiness(increased sleep) and irritability,were recorded daily using an electronic diary. Fever graded as:1)less than (<)38.0 degrees Celsius [C], 2)greater than or equal to(>=)38.0 degree C to 38.4 degree C, 3)38.5 degree C to 38.9 degree C, 4) 39.0 degree C to 40.0 degree C, 5) >40.0 degree C. Decreased appetite graded as: mild(decreased interest in eating), moderate(decreased oral intake), and severe(refusal to feed). Drowsiness graded as:mild(increased or prolonged sleeping bouts), moderate(slightly subdued; interfering 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). Participants may be represented in >1 row. Here,"Any" for decreased appetite, drowsiness, irritability represents any grade of these systemic reactions among mild, moderate or severe. | Safety population for infant series included all participants who received at least 1 dose of study vaccine during infant series. Here, "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Within 7 days after Vaccination 1 | | | | ID | Title | Description |
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| OG000 | 13vPnC: Multi-dose Vial (With Preservative) | Infant series: participants were randomized to receive a single 0.5 mL dose of 13vPnC with preservative 2-PE from a MDV, intramuscularly at age of 6 weeks (Vaccination 1), 10 weeks (Vaccination 2) and 14 weeks (Vaccination 3) along with 2 routine vaccines: 1) DTP-Hib-HBV vaccine, 2) rotavirus vaccine. Participants were followed-up to 1 month after Vaccination 3. Infant series was followed by toddler dose. Toddler dose: participants were administered with a single 0.5 mL dose of 13vPnC vaccine with preservative 2-PE from MDV, intramuscularly at age of 12 months (Vaccination 4) along with routine hepatitis A virus vaccine. Participants were followed-up to 1 month after Vaccination 4. Different limbs were used to administer study vaccine and routine vaccines (according to local clinical practice). |
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| Primary | Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2 | Local reactions were recorded daily using an electronic diary. Local reactions included redness, swelling and pain at injection site. Redness and swelling were graded as mild (0.5 to 2.5 cm), moderate (2.5 to 7.0 cm) and, severe (> 7 cm). Pain at injection site was graded as mild (hurt if gently touched (example, whimpers, winces, protests, or withdraws), moderate (hurt if gently touched [with crying]), and severe (caused limitation of limb movement). Participants may be represented in more than 1 row. Here, "Any" for redness, swelling and pain at injection site represents any grade of these local reactions among mild, moderate or severe. | Safety population for infant series included all participants who received at least 1 dose of study vaccine during infant series. Here, "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Within 7 days after Vaccination 2 | | | | ID | Title | Description |
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| OG000 | 13vPnC: Multi-dose Vial (With Preservative) | Infant series: participants were randomized to receive a single 0.5 mL dose of 13vPnC with preservative 2-PE from a MDV, intramuscularly at age of 6 weeks (Vaccination 1), 10 weeks (Vaccination 2) and 14 weeks (Vaccination 3) along with 2 routine vaccines: 1) DTP-Hib-HBV vaccine, 2) rotavirus vaccine. Participants were followed-up to 1 month after Vaccination 3. Infant series was followed by toddler dose. Toddler dose: participants were administered with a single 0.5 mL dose of 13vPnC vaccine with preservative 2-PE from MDV, intramuscularly at age of 12 months (Vaccination 4) along with routine hepatitis A virus vaccine. Participants were followed-up to 1 month after Vaccination 4. Different limbs were used to administer study vaccine and routine vaccines (according to local clinical practice). |
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| Primary | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 | Systemic events included fever, decreased appetite, drowsiness(increased sleep) and irritability, were recorded daily using an electronic diary. Fever graded as:1) < 38.0 degrees C, 2) >= 38.0 degree C to 38.4 degree C, 3)38.5 degree C to 38.9 degree C, 4) 39.0 degree C to 40.0 degree C, 5) >40.0 degree C. Decreased appetite graded as: mild(decreased interest in eating), moderate(decreased oral intake), and severe(refusal to feed). Drowsiness graded as: mild (increased or prolonged sleeping bouts), moderate (slightly subdued; interfering 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). Participants may be represented in >1 row. Here, "Any" for decreased appetite, drowsiness, irritability represents any grade of these systemic reactions among mild, moderate or severe. | Safety population for infant series included all participants who received at least 1 dose of study vaccine during infant series. Here, "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Within 7 days after Vaccination 2 | | | | ID | Title | Description |
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| OG000 | 13vPnC: Multi-dose Vial (With Preservative) | Infant series: participants were randomized to receive a single 0.5 mL dose of 13vPnC with preservative 2-PE from a MDV, intramuscularly at age of 6 weeks (Vaccination 1), 10 weeks (Vaccination 2) and 14 weeks (Vaccination 3) along with 2 routine vaccines: 1) DTP-Hib-HBV vaccine, 2) rotavirus vaccine. Participants were followed-up to 1 month after Vaccination 3. Infant series was followed by toddler dose. Toddler dose: participants were administered with a single 0.5 mL dose of 13vPnC vaccine with preservative 2-PE from MDV, intramuscularly at age of 12 months (Vaccination 4) along with routine hepatitis A virus vaccine. Participants were followed-up to 1 month after Vaccination 4. Different limbs were used to administer study vaccine and routine vaccines (according to local clinical practice). |
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| Primary | Percentage of Participants With Local Reactions Within 7 Days After Vaccination 3 | Local reactions were recorded daily using an electronic diary. Local reactions included redness, swelling and pain at injection site. Redness and swelling were graded as mild (0.5 to 2.5 cm), moderate (2.5 to 7.0 cm) and, severe (> 7 cm). Pain at injection site was graded as mild (hurt if gently touched (example, whimpers, winces, protests, or withdraws), moderate (hurt if gently touched [with crying]), and severe (caused limitation of limb movement). Participants may be represented in more than 1 row. Here, "Any" for redness, swelling and pain at injection site represents any grade of these local reactions among mild, moderate or severe. | Safety population for infant series included all participants who received at least 1 dose of study vaccine during infant series. Here, "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Within 7 days after Vaccination 3 | | | | ID | Title | Description |
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| OG000 | 13vPnC: Multi-dose Vial (With Preservative) | Infant series: participants were randomized to receive a single 0.5 mL dose of 13vPnC with preservative 2-PE from a MDV, intramuscularly at age of 6 weeks (Vaccination 1), 10 weeks (Vaccination 2) and 14 weeks (Vaccination 3) along with 2 routine vaccines: 1) DTP-Hib-HBV vaccine, 2) rotavirus vaccine. Participants were followed-up to 1 month after Vaccination 3. Infant series was followed by toddler dose. Toddler dose: participants were administered with a single 0.5 mL dose of 13vPnC vaccine with preservative 2-PE from MDV, intramuscularly at age of 12 months (Vaccination 4) along with routine hepatitis A virus vaccine. Participants were followed-up to 1 month after Vaccination 4. Different limbs were used to administer study vaccine and routine vaccines (according to local clinical practice). |
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| Primary | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 3 | Systemic events included fever, decreased appetite, drowsiness(increased sleep) and irritability, were recorded daily using an electronic diary. Fever graded as:1) < 38.0 degrees C, 2) >= 38.0 degree C to 38.4 degree C, 3)38.5 degree C to 38.9 degree C, 4) 39.0 degree C to 40.0 degree C, 5) >40.0 degree C. Decreased appetite graded as: mild(decreased interest in eating), moderate(decreased oral intake), and severe(refusal to feed). Drowsiness graded as: mild (increased or prolonged sleeping bouts), moderate (slightly subdued; interfering 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). Participants may be represented in >1 row. Here, "Any" for decreased appetite, drowsiness, irritability represents any grade of these systemic reactions among mild, moderate or severe. | Safety population for infant series included all participants who received at least 1 dose of study vaccine during infant series. Here, "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Within 7 days after Vaccination 3 | | | | ID | Title | Description |
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| OG000 | 13vPnC: Multi-dose Vial (With Preservative) | Infant series: participants were randomized to receive a single 0.5 mL dose of 13vPnC with preservative 2-PE from a MDV, intramuscularly at age of 6 weeks (Vaccination 1), 10 weeks (Vaccination 2) and 14 weeks (Vaccination 3) along with 2 routine vaccines: 1) DTP-Hib-HBV vaccine, 2) rotavirus vaccine. Participants were followed-up to 1 month after Vaccination 3. Infant series was followed by toddler dose. Toddler dose: participants were administered with a single 0.5 mL dose of 13vPnC vaccine with preservative 2-PE from MDV, intramuscularly at age of 12 months (Vaccination 4) along with routine hepatitis A virus vaccine. Participants were followed-up to 1 month after Vaccination 4. Different limbs were used to administer study vaccine and routine vaccines (according to local clinical practice). |
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| Primary | Percentage of Participants With Local Reactions Within 7 Days After Vaccination 4 | Local reactions were recorded daily using an electronic diary. Local reactions included redness, swelling and pain at injection site. Redness and swelling were graded as mild (0.5 to 2.5 cm), moderate (2.5 to 7.0 cm) and, severe (> 7 cm). Pain at injection site was graded as mild (hurt if gently touched (example, whimpers, winces, protests, or withdraws), moderate (hurt if gently touched [with crying]), and severe (caused limitation of limb movement). Participants may be represented in more than 1 row. Here, "Any" for redness, swelling and pain at injection site represents any grade of these local reactions among mild, moderate or severe. | Safety population for toddler dose included all participants who received at least 1 dose of study vaccine during toddler dosing. Here, "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Within 7 days after Vaccination 4 | | | | ID | Title | Description |
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| OG000 | 13vPnC: Multi-dose Vial (With Preservative) | Infant series: participants were randomized to receive a single 0.5 mL dose of 13vPnC with preservative 2-PE from a MDV, intramuscularly at age of 6 weeks (Vaccination 1), 10 weeks (Vaccination 2) and 14 weeks (Vaccination 3) along with 2 routine vaccines: 1) DTP-Hib-HBV vaccine, 2) rotavirus vaccine. Participants were followed-up to 1 month after Vaccination 3. Infant series was followed by toddler dose. Toddler dose: participants were administered with a single 0.5 mL dose of 13vPnC vaccine with preservative 2-PE from MDV, intramuscularly at age of 12 months (Vaccination 4) along with routine hepatitis A virus vaccine. Participants were followed-up to 1 month after Vaccination 4. Different limbs were used to administer study vaccine and routine vaccines (according to local clinical practice). |
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| Primary | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 4 | Systemic events included fever, decreased appetite, drowsiness(increased sleep) and irritability, were recorded daily using an electronic diary. Fever graded as:1) < 38.0 degrees C, 2) >= 38.0 degree C to 38.4 degree C, 3)38.5 degree C to 38.9 degree C, 4) 39.0 degree C to 40.0 degree C, 5) >40.0 degree C. Decreased appetite graded as: mild(decreased interest in eating), moderate(decreased oral intake), and severe(refusal to feed). Drowsiness graded as: mild (increased or prolonged sleeping bouts), moderate (slightly subdued; interfering 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). Participants may be represented in >1 row. Here, "Any" for decreased appetite, drowsiness, irritability represents any grade of these systemic reactions among mild, moderate or severe. | Safety population for toddler dose included all participants who received at least 1 dose of study vaccine during toddler dosing. Here, "Overall Number of Participants Analyzed, N" signifies participants who were evaluable for this outcome measure. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Within 7 days after Vaccination 4 | | | | ID | Title | Description |
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| OG000 | 13vPnC: Multi-dose Vial (With Preservative) | Infant series: participants were randomized to receive a single 0.5 mL dose of 13vPnC with preservative 2-PE from a MDV, intramuscularly at age of 6 weeks (Vaccination 1), 10 weeks (Vaccination 2) and 14 weeks (Vaccination 3) along with 2 routine vaccines: 1) DTP-Hib-HBV vaccine, 2) rotavirus vaccine. Participants were followed-up to 1 month after Vaccination 3. Infant series was followed by toddler dose. Toddler dose: participants were administered with a single 0.5 mL dose of 13vPnC vaccine with preservative 2-PE from MDV, intramuscularly at age of 12 months (Vaccination 4) along with routine hepatitis A virus vaccine. Participants were followed-up to 1 month after Vaccination 4. Different limbs were used to administer study vaccine and routine vaccines (according to local clinical practice). |
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| Primary | Percentage of Participants With Adverse Events (AEs) After Vaccination 1 up to 1 Month After Vaccination 3 | An AE was any untoward medical occurrence in a participant who received study vaccine without regard to possibility of causal relationship. | Safety population for infant series included all participants who received at least 1 dose of study vaccine during infant series. | Posted | | Number | 95% Confidence Interval | percentage of participants | | From Vaccination 1 up to 1 Month after Vaccination 3 (for a maximum study duration of 3 months) | | | | ID | Title | Description |
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| OG000 | 13vPnC: Multi-dose Vial (With Preservative) | Infant series: participants were randomized to receive a single 0.5 mL dose of 13vPnC with preservative 2-PE from a MDV, intramuscularly at age of 6 weeks (Vaccination 1), 10 weeks (Vaccination 2) and 14 weeks (Vaccination 3) along with 2 routine vaccines: 1) DTP-Hib-HBV vaccine, 2) rotavirus vaccine. Participants were followed-up to 1 month after Vaccination 3. Infant series was followed by toddler dose. Toddler dose: participants were administered with a single 0.5 mL dose of 13vPnC vaccine with preservative 2-PE from MDV, intramuscularly at age of 12 months (Vaccination 4) along with routine hepatitis A virus vaccine. Participants were followed-up to 1 month after Vaccination 4. Different limbs were used to administer study vaccine and routine vaccines (according to local clinical practice). | | OG001 | 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | |
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| Primary | Percentage of Participants With Adverse Events (AEs) From Vaccination 4 up to 1 Month After Vaccination 4 | An AE was any untoward medical occurrence in a participant who received study vaccine without regard to possibility of causal relationship. | Safety population for toddler dose included all participants who received at least 1 dose of study vaccine during toddler dosing. | Posted | | Number | 95% Confidence Interval | percentage of participants | | From Vaccination 4 up to 1 month after Vaccination 4 (for a maximum study duration of 1 month) | | | | ID | Title | Description |
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| OG000 | 13vPnC: Multi-dose Vial (With Preservative) | Infant series: participants were randomized to receive a single 0.5 mL dose of 13vPnC with preservative 2-PE from a MDV, intramuscularly at age of 6 weeks (Vaccination 1), 10 weeks (Vaccination 2) and 14 weeks (Vaccination 3) along with 2 routine vaccines: 1) DTP-Hib-HBV vaccine, 2) rotavirus vaccine. Participants were followed-up to 1 month after Vaccination 3. Infant series was followed by toddler dose. Toddler dose: participants were administered with a single 0.5 mL dose of 13vPnC vaccine with preservative 2-PE from MDV, intramuscularly at age of 12 months (Vaccination 4) along with routine hepatitis A virus vaccine. Participants were followed-up to 1 month after Vaccination 4. Different limbs were used to administer study vaccine and routine vaccines (according to local clinical practice). | | OG001 | 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | |
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| Primary | Percentage of Participants With Serious Adverse Events (SAEs) After Vaccination 1 up to 1 Month After Vaccination 4 | An AE was any untoward medical occurrence in a participant who received study vaccine without regard to possibility of causal relationship. A SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. | Safety population included all participants who received at least 1 dose of study vaccine in study. | Posted | | Number | 95% Confidence Interval | percentage of participants | | From Vaccination 1 up to 1 month after Vaccination 4 (for a maximum study duration of 11.5 months) | | | | ID | Title | Description |
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| OG000 | 13vPnC: Multi-dose Vial (With Preservative) | This arm represents the combined Infant series and Toddler dose. Infant series: participants were randomized to receive a single 0.5 mL dose of 13vPnC with preservative 2-PE from a MDV, intramuscularly at age of 6 weeks (Vaccination 1), 10 weeks (Vaccination 2) and 14 weeks (Vaccination 3) along with 2 routine vaccines: 1) DTP-Hib-HBV vaccine, 2) rotavirus vaccine. Participants were followed-up to 1 month after Vaccination 3. Infant series was followed by toddler dose. Toddler dose: participants were administered with a single 0.5 mL dose of 13vPnC vaccine with preservative 2-PE from MDV, intramuscularly at age of 12 months (Vaccination 4) along with routine hepatitis A virus vaccine. Participants were followed-up to 1 month after Vaccination 4. Different limbs were used to administer study vaccine and routine vaccines (according to local clinical practice). |
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| Primary | Number of Participants With New Diagnosed Chronic Medical Condition (NDCMC) From 1 Month After Vaccination 3 up to Vaccination 4 | A newly diagnosed chronic medical condition was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects. | Safety population for study included all participants who received at least 1 dose of study vaccine in study. | Posted | | Count of Participants | | Participants | | From 1 month after Vaccination 3 up to Vaccination 4 (for a maximum study duration of 7.5 months) | | | | ID | Title | Description |
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| OG000 | 13vPnC: Multi-dose Vial (With Preservative) | This arm represents the combined Infant series and Toddler dose. Infant series: participants were randomized to receive a single 0.5 mL dose of 13vPnC with preservative 2-PE from a MDV, intramuscularly at age of 6 weeks (Vaccination 1), 10 weeks (Vaccination 2) and 14 weeks (Vaccination 3) along with 2 routine vaccines: 1) DTP-Hib-HBV vaccine, 2) rotavirus vaccine. Participants were followed-up to 1 month after Vaccination 3. Infant series was followed by toddler dose. Toddler dose: participants were administered with a single 0.5 mL dose of 13vPnC vaccine with preservative 2-PE from MDV, intramuscularly at age of 12 months (Vaccination 4) along with routine hepatitis A virus vaccine. Participants were followed-up to 1 month after Vaccination 4. Different limbs were used to administer study vaccine and routine vaccines (according to local clinical practice). | | OG001 | 13vPnC: Single-dose Prefilled Syringe (Without Preservative) |
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| Secondary | Percentage of Participants With Immunoglobulin G (IgG) Concentrations Greater Than or Equal to (>=) Pre-defined Thresholds for Each of the Pneumococcal Serotypes Measured 1 Month After Vaccination 3 | Percentage of participants achieving predefined antibody threshold: >=0.35 microgram per milliliter (mcg/mL) for the 10 pneumococcal serotypes 1, 3, 4, 6A, 7F, 9V, 14, 18C, 19F and 23F; threshold >= 0.23 mcg/mL for serotype 5, threshold >= 0.10 mcg/mL for serotype 6B, threshold >= 0.12 mcg/mL for serotype 19A, along with the corresponding 95 percent (%) confidence interval (CI) are reported. | Evaluable immunogenicity population(EIP) for infant series: all eligible participants aged 6 weeks at time of Dose 1, who received 3 doses of infant series vaccine, had blood drawn post Dose 3 within 27 to 56 days(inclusive) post Dose 3, had at least 1 valid and determinate assay result post Dose 3, and had no major protocol violations. | Posted | | Number | 95% Confidence Interval | percentage of participants | | 1 month after Vaccination 3 | | | | ID | Title | Description |
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| OG000 | 13vPnC: Multi-dose Vial (With Preservative) | Infant series: participants were randomized to receive a single 0.5 mL dose of 13vPnC with preservative 2-PE from a MDV, intramuscularly at age of 6 weeks (Vaccination 1), 10 weeks (Vaccination 2) and 14 weeks (Vaccination 3) along with 2 routine vaccines: 1) DTP-Hib-HBV vaccine, 2) rotavirus vaccine. Participants were followed-up to 1 month after Vaccination 3. Infant series was followed by toddler dose. Toddler dose: participants were administered with a single 0.5 mL dose of 13vPnC vaccine with preservative 2-PE from MDV, intramuscularly at age of 12 months (Vaccination 4) along with routine hepatitis A virus vaccine. Participants were followed-up to 1 month after Vaccination 4. Different limbs were used to administer study vaccine and routine vaccines (according to local clinical practice). |
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| Secondary | Percentage of Participants With Immunoglobulin G (IgG) Concentrations Greater Than or Equal to (>=) Pre-defined Thresholds for Each of the Pneumococcal Serotypes Measured 1 Month After Vaccination 4 | Percentage of participants achieving predefined antibody threshold >=0.35 mcg/mL for the 10 pneumococcal serotypes 1, 3, 4, 6A, 7F, 9V, 14, 18C, 19F and 23F, threshold >= 0.23 mcg/mL for serotype 5, threshold >= 0.10 mcg/mL for serotype 6B, threshold >= 0.12 mcg/mL for serotype 19A, along with the corresponding 95% CI are reported. | EIP for toddler dose: all eligible participants who received 3 doses in infant series and 1 toddler dose of vaccine, had blood drawn post Dose 4 within 27 to 56 days (inclusive) post Dose 4, had at least 1 valid and determinate assay result post Dose 4, and had no major protocol violations. "N": signifies participants evaluable for this measure. | Posted | | Number | 95% Confidence Interval | percentage of participants | | 1 month after Vaccination 4 | | | | ID | Title | Description |
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| OG000 | 13vPnC: Multi-dose Vial (With Preservative) | Infant series: participants were randomized to receive a single 0.5 mL dose of 13vPnC with preservative 2-PE from a MDV, intramuscularly at age of 6 weeks (Vaccination 1), 10 weeks (Vaccination 2) and 14 weeks (Vaccination 3) along with 2 routine vaccines: 1) DTP-Hib-HBV vaccine, 2) rotavirus vaccine. Participants were followed-up to 1 month after Vaccination 3. Infant series was followed by toddler dose. Toddler dose: participants were administered with a single 0.5 mL dose of 13vPnC vaccine with preservative 2-PE from MDV, intramuscularly at age of 12 months (Vaccination 4) along with routine hepatitis A virus vaccine. Participants were followed-up to 1 month after Vaccination 4. Different limbs were used to administer study vaccine and routine vaccines (according to local clinical practice). |
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| Secondary | Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 3 | Antibody (IgG) GMCs for the 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) and corresponding 2-sided 95% CI are reported. | Evaluable immunogenicity population for infant series: all eligible participants aged 6 weeks at time of Dose 1, who received 3 doses of infant series vaccine, had blood drawn post-Dose 3 within 27 to 56 days (inclusive) post Dose 3, had at least 1 valid and determinate assay result post Dose 3, and had no major protocol violations. | Posted | | Geometric Mean | 95% Confidence Interval | mcg/mL | | 1 month after Vaccination 3 | | | | ID | Title | Description |
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| OG000 | 13vPnC: Multi-dose Vial (With Preservative) | Infant series: participants were randomized to receive a single 0.5 mL dose of 13vPnC with preservative 2-PE from a MDV, intramuscularly at age of 6 weeks (Vaccination 1), 10 weeks (Vaccination 2) and 14 weeks (Vaccination 3) along with 2 routine vaccines: 1) DTP-Hib-HBV vaccine, 2) rotavirus vaccine. Participants were followed-up to 1 month after Vaccination 3. Infant series was followed by toddler dose. Toddler dose: participants were administered with a single 0.5 mL dose of 13vPnC vaccine with preservative 2-PE from MDV, intramuscularly at age of 12 months (Vaccination 4) along with routine hepatitis A virus vaccine. Participants were followed-up to 1 month after Vaccination 4. Different limbs were used to administer study vaccine and routine vaccines (according to local clinical practice). | | OG001 |
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| Secondary | Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 4 | Antibody (IgG) GMCs for the 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) and corresponding 2-sided 95% CI are reported. | Evaluable immunogenicity population for toddler dose: all eligible participants who received 3 doses in infant series and 1 toddler dose of vaccine, had blood drawn post Dose 4 within 27 to 56 days (inclusive) post Dose 4, had at least 1 valid and determinate assay result post Dose 4, and had no major protocol violations. | Posted | | Geometric Mean | 95% Confidence Interval | mcg/mL | | 1 month after Vaccination 4 | | | | ID | Title | Description |
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| OG000 | 13vPnC: Multi-dose Vial (With Preservative) | Infant series: participants were randomized to receive a single 0.5 mL dose of 13vPnC with preservative 2-PE from a MDV, intramuscularly at age of 6 weeks (Vaccination 1), 10 weeks (Vaccination 2) and 14 weeks (Vaccination 3) along with 2 routine vaccines: 1) DTP-Hib-HBV vaccine, 2) rotavirus vaccine. Participants were followed-up to 1 month after Vaccination 3. Infant series was followed by toddler dose. Toddler dose: participants were administered with a single 0.5 mL dose of 13vPnC vaccine with preservative 2-PE from MDV, intramuscularly at age of 12 months (Vaccination 4) along with routine hepatitis A virus vaccine. Participants were followed-up to 1 month after Vaccination 4. Different limbs were used to administer study vaccine and routine vaccines (according to local clinical practice). | | OG001 |
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| Secondary | Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 3 | Antibody-mediated serum OPA against the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) was measured centrally using a pneumococcal OPA assay. Initial results were measured as OPA titers, which were then logarithmically transformed for analysis; geometric means calculated and expressed as GMTs. | Evaluable immunogenicity population for infant series: all eligible participants aged 6 weeks at time of Dose 1, who received 3 doses of infant series vaccine, had blood drawn post Dose 3 within 27 to 56 days (inclusive) post Dose 3, had at least 1 valid and determinate assay result post Dose 3, and had no major protocol violations. | Posted | | Geometric Mean | 95% Confidence Interval | titer (1/dilution) | | 1 month after Vaccination 3 | | | | ID | Title | Description |
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| OG000 | 13vPnC: Multi-dose Vial (With Preservative) | Infant series: participants were randomized to receive a single 0.5 mL dose of 13vPnC with preservative 2-PE from a MDV, intramuscularly at age of 6 weeks (Vaccination 1), 10 weeks (Vaccination 2) and 14 weeks (Vaccination 3) along with 2 routine vaccines: 1) DTP-Hib-HBV vaccine, 2) rotavirus vaccine. Participants were followed-up to 1 month after Vaccination 3. Infant series was followed by toddler dose. Toddler dose: participants were administered with a single 0.5 mL dose of 13vPnC vaccine with preservative 2-PE from MDV, intramuscularly at age of 12 months (Vaccination 4) along with routine hepatitis A virus vaccine. Participants were followed-up to 1 month after Vaccination 4. Different limbs were used to administer study vaccine and routine vaccines (according to local clinical practice). |
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| Secondary | Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 4 | Antibody-mediated serum OPA against the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) was measured centrally using a pneumococcal OPA assay. Initial results were measured as OPA titers, which were then logarithmically transformed for analysis; geometric means calculated and expressed as GMTs. | Evaluable immunogenicity population for toddler dose: all eligible participants who received 3 doses in infant series and 1 toddler dose of vaccine, had blood drawn post Dose 4 within 27 to 56 days (inclusive) post Dose 4, had at least 1 valid and determinate assay result post Dose 4, and had no major protocol violations. | Posted | | Geometric Mean | 95% Confidence Interval | titer (1/dilution) | | 1 month after Vaccination 4 | | | | ID | Title | Description |
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| OG000 | 13vPnC: Multi-dose Vial (With Preservative) | Infant series: participants were randomized to receive a single 0.5 mL dose of 13vPnC with preservative 2-PE from a MDV, intramuscularly at age of 6 weeks (Vaccination 1), 10 weeks (Vaccination 2) and 14 weeks (Vaccination 3) along with 2 routine vaccines: 1) DTP-Hib-HBV vaccine, 2) rotavirus vaccine. Participants were followed-up to 1 month after Vaccination 3. Infant series was followed by toddler dose. Toddler dose: participants were administered with a single 0.5 mL dose of 13vPnC vaccine with preservative 2-PE from MDV, intramuscularly at age of 12 months (Vaccination 4) along with routine hepatitis A virus vaccine. Participants were followed-up to 1 month after Vaccination 4. Different limbs were used to administer study vaccine and routine vaccines (according to local clinical practice). |
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| Secondary | Percentage of Participants With Opsonophagocytic Activity (OPA) Titers >= Lower Limit of Quantitation (LLOQ) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 3 | Percentage of participants achieving OPA titer >=LLOQ along with 95% CI for the 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) determined in blood samples of participants was presented. LLOQ (measured in mcg/mL) for each serotype is as follows: Serotype 1=18; Serotype 3=12; Serotype 4=21; Serotype 5=29; Serotype 6A=37; Serotype 6B=43; Serotype 7F=113; Serotype 9V=141; Serotype 14=35; Serotype 18C=31; Serotype 19A=18; Serotype 19F=48; Serotype 23F=13. | Evaluable immunogenicity population for infant series was analyzed. "Overall Number of Participants Analyzed": signifies participants evaluable for this outcome measure. "Number Analyzed": signifies participants evaluable for specific serotype. | Posted | | Number | 95% Confidence Interval | percentage of participants | | 1 month after Vaccination 3 | | | | ID | Title | Description |
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| OG000 | 13vPnC: Multi-dose Vial (With Preservative) | Infant series: participants were randomized to receive a single 0.5 mL dose of 13vPnC with preservative 2-PE from a MDV, intramuscularly at age of 6 weeks (Vaccination 1), 10 weeks (Vaccination 2) and 14 weeks (Vaccination 3) along with 2 routine vaccines: 1) DTP-Hib-HBV vaccine, 2) rotavirus vaccine. Participants were followed-up to 1 month after Vaccination 3. Infant series was followed by toddler dose. Toddler dose: participants were administered with a single 0.5 mL dose of 13vPnC vaccine with preservative 2-PE from MDV, intramuscularly at age of 12 months (Vaccination 4) along with routine hepatitis A virus vaccine. Participants were followed-up to 1 month after Vaccination 4. Different limbs were used to administer study vaccine and routine vaccines (according to local clinical practice). |
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| Secondary | Percentage of Participants With Opsonophagocytic Activity (OPA) Titers >= Lower Limit of Quantitation (LLOQ) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 4 | Percentage of participants achieving OPA titer >=LLOQ along with 95% CI for the 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) determined in blood samples of participants was presented. LLOQ (measured in mcg/mL) for each serotype is as follows: Serotype 1=18; Serotype 3=12; Serotype 4=21; Serotype 5=29; Serotype 6A=37; Serotype 6B=43; Serotype 7F=113; Serotype 9V=141; Serotype 14=35; Serotype 18C=31; Serotype 19A=18; Serotype 19F=48; Serotype 23F=13. | Evaluable immunogenicity population for toddler dose was analyzed. "Overall Number of Participants Analyzed": signifies participants evaluable for this outcome measure. "Number Analyzed": signifies participants evaluable for specific serotype. | Posted | | Number | 95% Confidence Interval | percentage of participants | | 1 month after Vaccination 4 | | | | ID | Title | Description |
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| OG000 | 13vPnC: Multi-dose Vial (With Preservative) | Infant series: participants were randomized to receive a single 0.5 mL dose of 13vPnC with preservative 2-PE from a MDV, intramuscularly at age of 6 weeks (Vaccination 1), 10 weeks (Vaccination 2) and 14 weeks (Vaccination 3) along with 2 routine vaccines: 1) DTP-Hib-HBV vaccine, 2) rotavirus vaccine. Participants were followed-up to 1 month after Vaccination 3. Infant series was followed by toddler dose. Toddler dose: participants were administered with a single 0.5 mL dose of 13vPnC vaccine with preservative 2-PE from MDV, intramuscularly at age of 12 months (Vaccination 4) along with routine hepatitis A virus vaccine. Participants were followed-up to 1 month after Vaccination 4. Different limbs were used to administer study vaccine and routine vaccines (according to local clinical practice). |
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