| Primary | Stage 1: Percentage of Participants With Local Reactions Within 14 Days After Vaccination | Local reactions included pain at injection site, swelling and redness recorded by participants in an electronic diary (e-diary). Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 centimeter (cm). Redness and swelling were graded as mild: greater than (>) 2.0 to 5.0 cm, moderate: >5.0 to 10.0 cm and severe: >10.0 cm. Pain at injection site was graded as mild: did not interfere with activity, moderate: interfered with activity and severe: prevented daily activity. | The safety population of Stage 1 included all participants who received at least 1 dose of c7vPnC or Tdap and had post-vaccination follow-up in Stage 1 and participants who lacked any safety data were excluded from the analysis. | Posted | | Number | 95% Confidence Interval | percentage of participants | | within 14 days after vaccination | | | | ID | Title | Description |
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| OG000 | Stage 1: c7vPnC (50 to 64 Years of Age) | In Stage 1, healthy participants aged 50 to 64 years were randomized to receive a single 0.5 mL intramuscular injection of c7vPnC on Day 1. Participants were followed up to 6 months after vaccination. | | OG001 | Stage 1: Tdap (50 to 64 Years of Age) | In Stage 1, healthy participants aged 50 to 64 years were randomized to receive a single 0.5 mL intramuscular injection of tetanus, diphtheria, and acellular pertussis vaccine (Tdap) as control vaccine on Day 1. Participants were followed up to 6 months after vaccination. |
| | | Title | Denominators | Categories |
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| Redness: Any | | | Title | Measurements |
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| - OG0002.9(0.1 to 15.3)
- OG00112.5(3.5 to 29.0)
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| | Redness: Mild | | |
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| Primary | Stage 2: Percentage of Participants With Local Reactions Within 14 Days After Vaccination | Local reactions included pain at injection site, swelling and redness recorded by participants in an e-diary. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 cm. Redness and swelling were graded as mild: >2.0 to 5.0 cm, moderate: >5.0 to 10.0 cm and severe: >10.0 cm. Pain at injection site was graded as mild: did not interfere with activity, moderate: interfered with activity and severe: prevented daily activity. | The safety population of Stage 2 included all participants who received at least 1 dose of c7vPnC or PPSV23 and had post-vaccination follow-up in Stage 2 and participants who lacked any safety data were excluded from the analysis. | Posted | | Number | 95% Confidence Interval | percentage of participants | | within 14 days after vaccination | | | | ID | Title | Description |
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| OG000 | Stage 2: c7vPnC (65 to 85 Years of Age) | In Stage 2 healthy participants aged 65 to 85 years, previously vaccinated with Prevnar 13, were randomized to receive a single 0.5 mL intramuscular injection of c7vPnC on Day 1 of Stage 2. Participants were followed up to 12 months after vaccination. | | OG001 | Stage 2: PPSV23 (65 to 85 Years of Age) | In Stage 2, healthy participants aged 65 to 85 years, previously vaccinated with Prevnar 13, were randomized to receive a single 0.5 mL intramuscular injection of 23-valent pneumococcal polysaccharide vaccine (PPSV23 ) as control vaccine on Day 1 of Stage 2. Participants were followed up to 12 months after vaccination. |
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| Primary | Stage 1: Percentage of Participants With Systemic Events Within 14 Days After Vaccination | Systemic events included fever, fatigue, headache, muscle pain and joint pain recorded by participants in an e-diary. Fever was categorized as: >=38.0 degrees Celsius (C), >=38.0 to 38.4 degrees C, >38.4 to 38.9 degrees C, >38.9 to 40.0 degrees C and >40.0 degrees C. Fatigue, headache, muscle pain and joint pain were graded as any, mild: did not interfere with activity, moderate: some interference with activity and severe: prevented daily routine activity. | The safety population of Stage 1 included all participants who received at least 1 dose of c7vPnC or Tdap and had post-vaccination follow-up in Stage 1 and participants who lacked any safety data were excluded from the analysis. | Posted | | Number | 95% Confidence Interval | percentage of participants | | within 14 days after vaccination | | | | ID | Title | Description |
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| OG000 | Stage 1: c7vPnC (50 to 64 Years of Age) | In Stage 1, healthy participants aged 50 to 64 years were randomized to receive a single 0.5 mL intramuscular injection of c7vPnC on Day 1. Participants were followed up to 6 months after vaccination. | | OG001 | Stage 1: Tdap (50 to 64 Years of Age) | In Stage 1, healthy participants aged 50 to 64 years were randomized to receive a single 0.5 mL intramuscular injection of tetanus, diphtheria, and acellular pertussis vaccine (Tdap) as control vaccine on Day 1. Participants were followed up to 6 months after vaccination. |
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| Primary | Stage 2: Percentage of Participants With Systemic Events Within 14 Days After Vaccination | Systemic events included fever, fatigue, headache, muscle pain and joint pain recorded by participants in an e-diary. Fever was categorized as: >=38.0 degrees C, >=38.0 to 38.4 degrees C, >38.4 to 38.9 degrees C, >38.9 to 40.0 degrees C and >40.0 degrees C. Fatigue, headache, muscle pain and joint pain were graded as any, mild: did not interfere with activity, moderate: some interference with activity and severe: prevented daily routine activity. | The safety population of Stage 2 included all participants who received at least 1 dose of c7vPnC or PPSV23 and had post-vaccination follow-up in Stage 2 and participants who lacked any safety data were excluded from the analysis. | Posted | | Number | 95% Confidence Interval | percentage of participants | | within 14 days after vaccination | | | | ID | Title | Description |
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| OG000 | Stage 2: c7vPnC (65 to 85 Years of Age) | In Stage 2 healthy participants aged 65 to 85 years, previously vaccinated with Prevnar 13, were randomized to receive a single 0.5 mL intramuscular injection of c7vPnC on Day 1 of Stage 2. Participants were followed up to 12 months after vaccination. | | OG001 | Stage 2: PPSV23 (65 to 85 Years of Age) | In Stage 2, healthy participants aged 65 to 85 years, previously vaccinated with Prevnar 13, were randomized to receive a single 0.5 mL intramuscular injection of 23-valent pneumococcal polysaccharide vaccine (PPSV23 ) as control vaccine on Day 1 of Stage 2. Participants were followed up to 12 months after vaccination. |
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| Primary | Stage 1: Percentage of Participants With Adverse Events (AEs) Within 1 Month After Vaccination | An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. AEs included both serious and non-serious adverse events. Serious adverse event (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. AEs included both AEs and Non-SAEs. | The safety population of Stage 1 included all participants who received at least 1 dose of c7vPnC or Tdap and had post-vaccination follow-up in Stage 1 and participants who lacked any safety data were excluded from the analysis. | Posted | | Number | 95% Confidence Interval | percentage of participants | | within 1 month after vaccination | | | | ID | Title | Description |
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| OG000 | Stage 1: c7vPnC (50 to 64 Years of Age) | In Stage 1, healthy participants aged 50 to 64 years were randomized to receive a single 0.5 mL intramuscular injection of c7vPnC on Day 1. Participants were followed up to 6 months after vaccination. | | OG001 | Stage 1: Tdap (50 to 64 Years of Age) | In Stage 1, healthy participants aged 50 to 64 years were randomized to receive a single 0.5 mL intramuscular injection of tetanus, diphtheria, and acellular pertussis vaccine (Tdap) as control vaccine on Day 1. Participants were followed up to 6 months after vaccination. |
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| Primary | Stage 2: Percentage of Participants With Adverse Events (AEs) Within 1 Month After Vaccination | An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. AEs included both serious and non-serious adverse events. 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. AEs included both AEs and Non-SAEs. | The safety population of Stage 2 included all participants who received at least 1 dose of c7vPnC or PPSV23 and had post-vaccination follow-up in Stage 2 and participants who lacked any safety data were excluded from the analysis. | Posted | | Number | 95% Confidence Interval | percentage of participants | | within 1 month after vaccination | | | | ID | Title | Description |
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| OG000 | Stage 2: c7vPnC (65 to 85 Years of Age) | In Stage 2 healthy participants aged 65 to 85 years, previously vaccinated with Prevnar 13, were randomized to receive a single 0.5 mL intramuscular injection of c7vPnC on Day 1 of Stage 2. Participants were followed up to 12 months after vaccination. | | OG001 | Stage 2: PPSV23 (65 to 85 Years of Age) | In Stage 2, healthy participants aged 65 to 85 years, previously vaccinated with Prevnar 13, were randomized to receive a single 0.5 mL intramuscular injection of 23-valent pneumococcal polysaccharide vaccine (PPSV23 ) as control vaccine on Day 1 of Stage 2. Participants were followed up to 12 months after vaccination. |
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| Primary | Stage 1: Percentage of Participants With Serious Adverse Events (SAEs) Within 6 Months After Vaccination | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. 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. | The safety population of Stage 1 included all participants who received at least 1 dose of c7vPnC or Tdap and had post-vaccination follow-up in Stage 1 and participants who lacked any safety data were excluded from the analysis. | Posted | | Number | 95% Confidence Interval | percentage of participants | | within 6 months after vaccination | | | | ID | Title | Description |
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| OG000 | Stage 1: c7vPnC (50 to 64 Years of Age) | In Stage 1, healthy participants aged 50 to 64 years were randomized to receive a single 0.5 mL intramuscular injection of c7vPnC on Day 1. Participants were followed up to 6 months after vaccination. | | OG001 | Stage 1: Tdap (50 to 64 Years of Age) | In Stage 1, healthy participants aged 50 to 64 years were randomized to receive a single 0.5 mL intramuscular injection of tetanus, diphtheria, and acellular pertussis vaccine (Tdap) as control vaccine on Day 1. Participants were followed up to 6 months after vaccination. |
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| Primary | Stage 2: Percentage of Participants With Serious Adverse Events (SAEs) Within 6 Months After Vaccination | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. 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. | The safety population of Stage 2 included all participants who received at least 1 dose of c7vPnC or PPSV23 and had post-vaccination follow-up in Stage 2 and participants who lacked any safety data were excluded from the analysis. | Posted | | Number | 95% Confidence Interval | percentage of participants | | within 6 months after vaccination | | | | ID | Title | Description |
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| OG000 | Stage 2: c7vPnC (65 to 85 Years of Age) | In Stage 2 healthy participants aged 65 to 85 years, previously vaccinated with Prevnar 13, were randomized to receive a single 0.5 mL intramuscular injection of c7vPnC on Day 1 of Stage 2. Participants were followed up to 12 months after vaccination. | | OG001 | Stage 2: PPSV23 (65 to 85 Years of Age) | In Stage 2, healthy participants aged 65 to 85 years, previously vaccinated with Prevnar 13, were randomized to receive a single 0.5 mL intramuscular injection of 23-valent pneumococcal polysaccharide vaccine (PPSV23 ) as control vaccine on Day 1 of Stage 2. Participants were followed up to 12 months after vaccination. |
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| Primary | Stage 1: Percentage of Participants With Newly Diagnosed Chronic Medical Conditions (NDCMCs) Within 6 Months After Vaccination | An NDCMC was defined as a disease or medical condition, not previously identified, that is expected to be persistent or is otherwise long-lasting in its effects. | The safety population of Stage 1 included all participants who received at least 1 dose of c7vPnC or Tdap and had post-vaccination follow-up in Stage 1 and participants who lacked any safety data were excluded from the analysis. | Posted | | Number | 95% Confidence Interval | percentage of participants | | within 6 months after vaccination | | | | ID | Title | Description |
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| OG000 | Stage 1: c7vPnC (50 to 64 Years of Age) | In Stage 1, healthy participants aged 50 to 64 years were randomized to receive a single 0.5 mL intramuscular injection of c7vPnC on Day 1. Participants were followed up to 6 months after vaccination. | | OG001 | Stage 1: Tdap (50 to 64 Years of Age) | In Stage 1, healthy participants aged 50 to 64 years were randomized to receive a single 0.5 mL intramuscular injection of tetanus, diphtheria, and acellular pertussis vaccine (Tdap) as control vaccine on Day 1. Participants were followed up to 6 months after vaccination. |
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| Primary | Stage 2: Percentage of Participants With Newly Diagnosed Chronic Medical Conditions (NDCMCs) Within 6 Months After Vaccination | An NDCMC was defined as a disease or medical condition, not previously identified, that is expected to be persistent or is otherwise long-lasting in its effects. | The safety population of Stage 2 included all participants who received at least 1 dose of c7vPnC or PPSV23 and had post-vaccination follow-up in Stage 2 and participants who lacked any safety data were excluded from the analysis. | Posted | | Number | 95% Confidence Interval | percentage of participants | | within 6 months after vaccination | | | | ID | Title | Description |
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| OG000 | Stage 2: c7vPnC (65 to 85 Years of Age) | In Stage 2 healthy participants aged 65 to 85 years, previously vaccinated with Prevnar 13, were randomized to receive a single 0.5 mL intramuscular injection of c7vPnC on Day 1 of Stage 2. Participants were followed up to 12 months after vaccination. | | OG001 | Stage 2: PPSV23 (65 to 85 Years of Age) | In Stage 2, healthy participants aged 65 to 85 years, previously vaccinated with Prevnar 13, were randomized to receive a single 0.5 mL intramuscular injection of 23-valent pneumococcal polysaccharide vaccine (PPSV23 ) as control vaccine on Day 1 of Stage 2. Participants were followed up to 12 months after vaccination. |
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| Primary | Stage 2: Percentage of Participants With Serious Adverse Events (SAEs) Within 12 Months After Vaccination | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. 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. | The safety population of Stage 2 included all participants who received at least 1 dose of c7vPnC or PPSV23 and had post-vaccination follow-up in Stage 2 and participants who lacked any safety data were excluded from the analysis. | Posted | | Number | 95% Confidence Interval | percentage of participants | | within 12 months after vaccination | | | | ID | Title | Description |
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| OG000 | Stage 2: c7vPnC (65 to 85 Years of Age) | In Stage 2 healthy participants aged 65 to 85 years, previously vaccinated with Prevnar 13, were randomized to receive a single 0.5 mL intramuscular injection of c7vPnC on Day 1 of Stage 2. Participants were followed up to 12 months after vaccination. | | OG001 | Stage 2: PPSV23 (65 to 85 Years of Age) | In Stage 2, healthy participants aged 65 to 85 years, previously vaccinated with Prevnar 13, were randomized to receive a single 0.5 mL intramuscular injection of 23-valent pneumococcal polysaccharide vaccine (PPSV23 ) as control vaccine on Day 1 of Stage 2. Participants were followed up to 12 months after vaccination. |
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| Primary | Stage 2: Percentage of Participants With Newly Diagnosed Chronic Medical Conditions (NDCMCs) Within 12 Months After Vaccination | An NDCMC was defined as a disease or medical condition, not previously identified, that is expected to be persistent or is otherwise long-lasting in its effects. | The safety population of Stage 2 included all participants who received at least 1 dose of c7vPnC or PPSV23 and had post-vaccination follow-up in Stage 2 and participants who lacked any safety data were excluded from the analysis. | Posted | | Number | 95% Confidence Interval | percentage of participants | | within 12 months after vaccination | | | | ID | Title | Description |
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| OG000 | Stage 2: c7vPnC (65 to 85 Years of Age) | In Stage 2 healthy participants aged 65 to 85 years, previously vaccinated with Prevnar 13, were randomized to receive a single 0.5 mL intramuscular injection of c7vPnC on Day 1 of Stage 2. Participants were followed up to 12 months after vaccination. | | OG001 | Stage 2: PPSV23 (65 to 85 Years of Age) | In Stage 2, healthy participants aged 65 to 85 years, previously vaccinated with Prevnar 13, were randomized to receive a single 0.5 mL intramuscular injection of 23-valent pneumococcal polysaccharide vaccine (PPSV23 ) as control vaccine on Day 1 of Stage 2. Participants were followed up to 12 months after vaccination. |
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| Secondary | Stage 1: Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After Vaccination | Antibody-mediated serum OPA against the 7 pneumococcal serotypes specific to c7vPnC (serotypes 8, 10A, 11A, 12F, 15B, 22F and 33F) were measured using a pneumococcal OPA assay. Results were expressed as OPA GMTs. Assay results below the lower limit of quantitation (LLOQ) were set to 0.5*LLOQ in the analysis. Evaluable immunogenicity population = EIP. | EIP Stage 1:eligible participants with no major protocol deviations, received assigned vaccine, blood collected was within 27-49 days post vaccination, had at least 1 valid and determinate assay result for at least 1 serotype for 1 month after vaccination. 'Number Analyzed' = participants evaluable for this outcome measure at specified rows. | Posted | | Geometric Mean | 95% Confidence Interval | Titer (1/dilution) | | 1 month after vaccination | | | | ID | Title | Description |
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| OG000 | Stage 1: c7vPnC (50 to 64 Years of Age) | In Stage 1, healthy participants aged 50 to 64 years were randomized to receive a single 0.5 mL intramuscular injection of c7vPnC on Day 1. Participants were followed up to 6 months after vaccination. | | OG001 | Stage 1: Tdap (50 to 64 Years of Age) | In Stage 1, healthy participants aged 50 to 64 years were randomized to receive a single 0.5 mL intramuscular injection of tetanus, diphtheria, and acellular pertussis vaccine (Tdap) as control vaccine on Day 1. Participants were followed up to 6 months after vaccination. |
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| Secondary | Stage 2: Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After Vaccination | Antibody-mediated serum OPA against the 7 common pneumococcal serotypes specific to c7vPnC (serotypes 8, 10A, 11A, 12F, 15B, 22F and 33F) were measured using a pneumococcal OPA assay. Results were expressed as OPA GMTs. Assay results below the LLOQ were set to 0.5*LLOQ in the analysis. | EIP Stage 2:eligible participants with no major protocol deviations, received assigned vaccine, blood collected was within 27-49 days post vaccination, had at least 1 valid and determinate assay result for at least 1 serotype for 1 month after vaccination. Here, 'Number Analyzed' = participants evaluable for this outcome measure at specified rows. | Posted | | Geometric Mean | 95% Confidence Interval | Titer (1/dilution) | | within 1 month after vaccination | | | | ID | Title | Description |
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| OG000 | Stage 2: c7vPnC (65 to 85 Years of Age) | In Stage 2 healthy participants aged 65 to 85 years, previously vaccinated with Prevnar 13, were randomized to receive a single 0.5 mL intramuscular injection of c7vPnC on Day 1 of Stage 2. Participants were followed up to 12 months after vaccination. | | OG001 | Stage 2: PPSV23 (65 to 85 Years of Age) | In Stage 2, healthy participants aged 65 to 85 years, previously vaccinated with Prevnar 13, were randomized to receive a single 0.5 mL intramuscular injection of 23-valent pneumococcal polysaccharide vaccine (PPSV23 ) as control vaccine on Day 1 of Stage 2. Participants were followed up to 12 months after vaccination. |
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| Secondary | Stage 1: Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) From Pre-vaccination to 1 Month After Vaccination | GMFR for the 7 pneumococcal serotypes (serotypes 8, 10A, 11A, 12F, 15B, 22F and 33F) from before Vaccination to one month after Vaccination. Assay results below the LLOQ were set to 0.5*LLOQ in the analysis. | EIP Stage 1:eligible participants with no major protocol deviations, received assigned vaccine, blood collected was within 27-49 days post vaccination, had at least 1 valid and determinate assay result for at least 1 serotype for 1 month after vaccination. Here, 'Number Analyzed' = participants evaluable for this outcome measure at specified rows. | Posted | | Geometric Mean | 95% Confidence Interval | fold rise | | before Vaccination to 1 month after Vaccination | | | | ID | Title | Description |
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| OG000 | Stage 1: c7vPnC (50 to 64 Years of Age) | In Stage 1, healthy participants aged 50 to 64 years were randomized to receive a single 0.5 mL intramuscular injection of c7vPnC on Day 1. Participants were followed up to 6 months after vaccination. | | OG001 | Stage 1: Tdap (50 to 64 Years of Age) | In Stage 1, healthy participants aged 50 to 64 years were randomized to receive a single 0.5 mL intramuscular injection of tetanus, diphtheria, and acellular pertussis vaccine (Tdap) as control vaccine on Day 1. Participants were followed up to 6 months after vaccination. |
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| Secondary | Stage 2: Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) From Pre-Vaccination to 1 Month After Vaccination | GMFR for the 7 pneumococcal serotypes (serotypes 8, 10A, 11A, 12F, 15B, 22F and 33F) from before Vaccination to one month after Vaccination. Assay results below the LLOQ were set to 0.5*LLOQ in the analysis. | EIP Stage 2:eligible participants with no major protocol deviations, received assigned vaccine, blood collected was within 27-49 days post vaccination, had at least 1 valid and determinate assay result for at least 1 serotype for 1 month after vaccination. Here, 'Number Analyzed' = participants evaluable for this outcome measure at specified rows. | Posted | | Geometric Mean | 95% Confidence Interval | fold rise | | before Vaccination to 1 month after Vaccination | | | | ID | Title | Description |
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| OG000 | Stage 2: c7vPnC (65 to 85 Years of Age) | In Stage 2 healthy participants aged 65 to 85 years, previously vaccinated with Prevnar 13, were randomized to receive a single 0.5 mL intramuscular injection of c7vPnC on Day 1 of Stage 2. Participants were followed up to 12 months after vaccination. | | OG001 | Stage 2: PPSV23 (65 to 85 Years of Age) | In Stage 2, healthy participants aged 65 to 85 years, previously vaccinated with Prevnar 13, were randomized to receive a single 0.5 mL intramuscular injection of 23-valent pneumococcal polysaccharide vaccine (PPSV23 ) as control vaccine on Day 1 of Stage 2. Participants were followed up to 12 months after vaccination. |
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