Trial to Evaluate the Safety and Immunogenicity of a 20-Valent Pneumococcal Vaccine in Adults 65 Years of Age or Older With Prior Pneumococcal Vaccination

An AE was any untoward medical occurrence in study participants who received study vaccine without regard to possibility of causal relationship with the treatment.

Time frame: Within 1 month after vaccination

Population: The safety population included participants who received 1 dose of 20vPnC, PPSV23, or 13vPnC and had safety follow-up after vaccination.

Local reactions were recorded using an electronic diary (e-diary). Local reactions included redness, swelling and pain at the injection site. 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).

Time frame: Within 10 days after vaccination

Population: The safety population included participants who received 1 dose of 20vPnC, PPSV23, or 13vPnC and had safety follow-up after vaccination. Here, Overall Number of Participants Analyzed refers to number of participants with any e-diary data reported after vaccination in the safety population.

An NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or was otherwise long-lasting in its effects.

Time frame: Within 6 months after vaccination

Population: The safety population included participants who received 1 dose of 20vPnC, PPSV23, or 13vPnC and had safety follow-up after vaccination.

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

Time frame: Within 6 months after vaccination

Population: The safety population included participants who received 1 dose of 20vPnC, PPSV23, or 13vPnC and had safety follow-up after vaccination.

Systemic events fever, fatigue, headache, muscle pain and joint pain were recorded by using an e-diary. Fever was defined as temperature \>=38.0 degree Celsius (C) and categorized to \>=38.0 to 38.4 degree C, \>38.4 to 38.9 degree C, \>38.9 to 40.0 degree C and \>40.0 degree C. Fatigue, headache, muscle pain and joint pain were graded as mild (did not interfere with activity), moderate (some interference with activity) and severe (prevented daily routine activity).

Time frame: Within 7 days after vaccination

Population: The safety population included participants who received 1 dose of 20vPnC, PPSV23, or 13vPnC and had safety follow-up after vaccination. Here, Overall Number of Participants Analyzed refers to number of participants with any e-diary data reported after vaccination in the safety population.

OPA GMTs were determined for serotypes: 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F and 33F. OPA titer was expressed as reciprocal of the highest serum dilution.

Time frame: 1 month after vaccination

Population: Evaluable immunogenicity population: All participants who received 20vPnC as randomized, enrolled in appropriate cohort based on prior vaccination history, had Visit 2 blood collection within 27 to 49 days after vaccination, had at least 1 valid and determinate OPA titer for any serotype for Visit 2, had no major protocol deviations. Data for this outcome measure were planned to be analyzed for 20vPnC groups of each cohort. Number Analyzed =number of participants evaluable for each serotypes.

Percentage of participants with a \>=4-fold rise in pneumococcal OPA titers from before vaccination to 1 month after vaccination were calculated for pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F and 33F.

Time frame: From before vaccination to 1 month after vaccination

Population: Evaluable immunogenicity population: All participants who received 20vPnC as randomized, enrolled in appropriate cohort based on prior vaccination history, had Visit 2 blood collection within 27 to 49 days after vaccination, had at least 1 valid and determinate OPA titer for any serotype for Visit 2, had no major protocol deviations. Data for this outcome measure were planned to be analyzed for 20vPnC groups of each cohort. Number Analyzed =number of participants evaluable for each serotype.

The percentage of participants with OPA titers \>=LLOQ at 1 month after vaccination were calculated for pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F and 33F.

Time frame: 1 month after vaccination

Population: Evaluable immunogenicity population: All participants who received 20vPnC as randomized, enrolled in appropriate cohort based on prior vaccination history, had Visit 2 blood collection within 27 to 49 days after vaccination, had at least 1 valid and determinate OPA titer for any serotype for Visit 2, had no major protocol deviations. Data for this outcome measure were planned to be analyzed for 20vPnC groups of each cohort. Number Analyzed =number of participants evaluable for each serotype.

OPA GMFR is the ratio of OPA GMTs, 1 month after vaccination to before vaccination. OPA GMFRs from before to 1 month after vaccination were calculated for pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F and 33F.

Time frame: From before vaccination to 1 month after vaccination

Population: Evaluable immunogenicity population was analyzed. Data for this outcome measure were planned to be analyzed for 20vPnC groups of each cohort. Number analyzed= number of participants evaluable with OPA titers available at both time points for each serotype.