An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants with solicited injection-site AEs after any vaccination was assessed. The solicited injection-site AEs assessed were redness/erythema, swelling, and tenderness/pain.

All participants who were randomized and received at least 1 dose of study intervention. Participants were included in the intervention group according to the study intervention actually received. Two participants received the incorrect study intervention that resulted in a regimen inconsistent with the 2 designated regimens planned in this study. Both participants were excluded from the safety analysis population

An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants with solicited systemic AEs was assessed following any vaccination. The solicited systemic AEs assessed were fatigue, headache, myalgia, and pyrexia.

All participants who were randomized and received at least 1 dose of study intervention. Participants were included in the intervention group according to the study intervention actually received. Two participants received the incorrect study intervention that resulted in a regimen inconsistent with the 2 designated regimens planned in this study. Both participants were excluded from the safety analysis population.

A serious adverse event (SAE) is an AE that is life-threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment. Relatedness of an SAE to the study vaccine was determined by the investigator. Following any vaccination, the percentage of serious adverse events was assessed.

All participants who were randomized and received at least 1 dose of study intervention. Participants were included in the intervention group according to the study intervention actually received. Two participants received the incorrect study intervention that resulted in a regimen inconsistent with the 2 designated regimens planned in this study. Both participants were excluded from the safety analysis population.

Serotype-specific OPA to the 13 serotypes common between V116 and PCV15 + PPSV23 and 8 serotypes unique to V116 were determined using a multiplex opsonophagocytic assay (MOPA). GMT is defined as geometric mean titer (1/dil). Serotype-specific OPA GMTs with 95% confidence intervals are presented.

Overall participants analyzed included all randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity analyses. The number analyzed for each serotype is the subset of overall participants analyzed without protocol deviation such as failure to receive study vaccine, failure to receive correct clinical material as per randomization schedule, or receipt of a prohibited medication or prohibited vaccine prior to study vaccination.

The GMC of IgG serotype-specific antibodies to the 13 serotypes common between V116 and PCV15 + PPSV23 and 8 serotypes unique to V116 were quantitated from participants' sera by a multiplex electrochemiluminescence (ECL) assay.

Overall participants analyzed included all randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity analyses. The number analyzed for each serotype is the subset of overall participants analyzed without protocol deviation such as failure to receive study vaccine, failure to receive correct clinical material as per randomization schedule, or receipt of a prohibited medication or prohibited vaccine prior to study vaccination.

Activity for the serotypes contained in V116 and PCV15+PPSV23 (13 serotypes shared with PCV15 and PPSV23 and 8 serotypes unique to V116) was determined using a Multiplexed Opsonophagocytic Assay. Geometric mean fold rise (GMFR) is the geometric mean of fold rise from baseline to postvaccination with V116 and PCV15 + PPSV23.

Overall participants analyzed included all randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity analyses. The number analyzed for each serotype is the subset of overall participants analyzed without protocol deviation such as failure to receive study vaccine, failure to receive correct clinical material as per randomization schedule, or receipt of a prohibited medication or prohibited vaccine prior to study vaccination.

The GMC of IgG serotype-specific antibodies to the 13 serotypes common between V116 and PCV15 + PPSV23 and 8 serotypes unique to V116 were quantitated from participants' sera by a multiplex electrochemiluminescence (ECL) assay. Geometric mean fold rise (GMFR) is the geometric mean of fold rise from baseline to postvaccination with V116 and PCV15 + PPSV23

Overall participants analyzed included all randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity analyses. The number analyzed for each serotype is the subset of overall participants analyzed without protocol deviation such as failure to receive study vaccine, failure to receive correct clinical material as per randomization schedule, or receipt of a prohibited medication or prohibited vaccine prior to study vaccination.

Activity for the serotypes contained in V116 and PCV15+PPSV23 (13 serotypes shared with PCV15 and PPSV23 and 8 serotypes unique to V116) was determined using MOPA. The percentage of participants who had ≥4-fold rise in OPA titers were calculated from baseline to postvaccination with V116 and PCV15 + PPSV23

Overall participants analyzed included all randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity analyses. The number analyzed for each serotype is the subset of overall participants analyzed without protocol deviation such as failure to receive study vaccine, failure to receive correct clinical material as per randomization schedule, or receipt of a prohibited medication or prohibited vaccine prior to study vaccination.

The GMC of IgG serotype-specific antibodies to the 13 serotypes common between V116 and PCV15 + PPSV23 and 8 serotypes unique to V116 were quantitated from participants' sera by a multiplex ECL assay. The percentage of participants who had ≥4-fold rise in IgG concentration was calculated from baseline to postvaccination with V116 and PCV15 + PPSV23

Overall participants analyzed included all randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity analyses. The number analyzed for each serotype is the subset of overall participants analyzed without protocol deviation such as failure to receive study vaccine, failure to receive correct clinical material as per randomization schedule, or receipt of a prohibited medication or prohibited vaccine prior to study vaccination.

An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants with solicited injection-site AEs after any vaccination was assessed. The solicited injection-site AEs assessed were redness/erythema, swelling, and tenderness/pain. Percentage of participants with solicited injection-site AEs from Day 1 of Part B through Day 5 postvaccination in Part B.

All participants who were randomized and received at least 1 dose of study intervention in part B. Participants were included in the intervention group according to the study intervention actually received.

An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants with solicited systemic AEs was assessed following any vaccination. The solicited systemic AEs assessed were fatigue, headache, myalgia, and pyrexia. Percentage of participants with solicited systemic AEs from Day 1 of Part B through Day 5 postvaccination in Part B

All participants who were randomized and received at least 1 dose of study intervention in part B. Participants were included in the intervention group according to the study intervention actually received.

A serious adverse event (SAE) is an AE that is life-threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment. Relatedness of an SAE to the study vaccine was determined by the investigator. Following any vaccination, the percentage of serious adverse events was assessed. Percentage of participants with vaccine-related SAEs from Day 1 of Part B through the duration of participation in Part B

All participants who were randomized and received at least 1 dose of study intervention in part B. Participants were included in the intervention group according to the study intervention actually received.