An AE is any untoward medical occurrence in a participant temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of a study intervention. Injection-site AEs solicited on the Vaccine Report Card (VRC) consisted of erythema (redness), induration (hard lump), pain (tenderness) and swelling.

Participants who received at least 1 dose of study vaccination based on the group to which they were randomized, and corresponding to the study vaccination they actually received. One participant randomized to V114, who inadvertently received both V114 and Prevenar 13™, was excluded from this analysis.

An AE is any untoward medical occurrence in a participant temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of a study intervention. Systemic AEs solicited on the VRC consisted of decreased appetite (loss of appetite), irritability, somnolence (drowsiness) and urticaria (hive/welts).

Participants who received at least 1 dose of study vaccination based on the group to which they were randomized, and corresponding to the study vaccination they actually received. One participant randomized to V114, who inadvertently received both V114 and Prevenar 13™, was excluded from this analysis.

A serious adverse event (SAE) is an AE that results in death, is life threatening, results in a persistent or significant disability or incapacity, results in or prolongs an existing hospitalization, is a congenital anomaly or birth defect, is a cancer, is an overdose, or is another important medical event. The relatedness of a vaccine to a SAE is determined by an investigator who is a qualified physician.

Participants who received at least 1 dose of study vaccination based on the group to which they were randomized, and corresponding to the study vaccination they actually received. One participant randomized to V114, who inadvertently received both V114 and Prevenar 13™, was excluded from this analysis.

Sera from participants was used to measure vaccine-induced anti-PnPs serotype-specific IgG for each serotype using pneumococcal electrochemiluminescence (PnECL). The Geometric Mean Concentration (GMC) for each of the 13 serotypes shared by both V114 and Prevenar 13™ (Serotypes 1 to 23F); and the 2 serotypes unique to V114 (Serotypes 22F and 33F) was assessed. Per protocol, within-group CIs were not calculated.

All randomized participants without deviations from the protocol that may substantially affect the results. Deviations include, but are not limited to, failure to receive vaccination; receipt of prohibited medication or vaccine; failure to receive vaccination at the required time point; failure to receive the required vaccination dose; and collection of blood sample at a time point outside of the prespecified time window.

Sera from participants was used to measure vaccine-induced anti-PnPs serotype-specific IgG for the 15 serotypes using pneumococcal electrochemiluminescence (PnECL). The percentage of participants that achieve the threshold value of ≥0.35 μg/mL for each of the 13 serotypes shared by both V114 and Prevenar 13™ (Serotypes 1 to 23F); and the 2 serotypes unique to V114 (Serotypes 22F and 33F) was assessed.

All randomized participants without deviations from the protocol that may substantially affect the results. Deviations include, but are not limited to, failure to receive vaccination; receipt of prohibited medication or vaccine; failure to receive vaccination at the required time point; failure to receive the required vaccination dose; and collection of blood sample at a time point outside of the prespecified time window.

Sera from participants was used to measure vaccine-induced responses to 10 pre-specified Infanrix™ hexa antigens with the following threshold (% ≥) values: Diphtheria toxoid-0.1 international unit (IU)/mL;Tetanus toxoid-0.1 IU/mL; Pertussis pertussis toxin (PT)-5 endotoxin unit (EU)/mL; Pertussis filamentous hemagglutinin (FHA)-5 EU/mL; Pertussis pertactin (PRN)-5 EU/mL; Haemophilus influenzae type b (Hib) polyribosylribitol phosphate (PRP)-0.15 μg/mL; hepatitis B surface antigen (HBsAg)-10 mIU/mL; Poliovirus 1,2 and 3-1:8 neutralizing antibodies (NAb) dilution.

All randomized participants without deviations from the protocol that may substantially affect the results. Deviations include, but are not limited to, failure to receive vaccination; receipt of prohibited medication or vaccine; failure to receive vaccination at the required time point; failure to receive the required vaccination dose; and collection of blood sample at a time point outside of the prespecified time window.

Sera from participants was used to measure vaccine-induced antibodies in response to vaccination with Rotarix™ by assessing the GMT for IgA. Per protocol, within-group CIs were not calculated.

All randomized participants without deviations from the protocol that may substantially affect the results. Deviations include, but are not limited to, failure to receive vaccination; receipt of prohibited medication or vaccine; failure to receive vaccination at the required time point; failure to receive the required vaccination dose; and collection of blood sample at a time point outside of the prespecified time window.

Sera from participants was used to measure vaccine-induced anti-PnPs serotype-specific IgG for each serotype using PnECL. The GMC for each of the 13 serotypes shared by both V114 and Prevenar 13™ (Serotypes 1 to 23F); and the 2 serotypes unique to V114 (Serotypes 22F and 33F) was assessed. Per protocol, within-group CIs were not calculated.

All randomized participants without deviations from the protocol that may substantially affect the results. Deviations include, but are not limited to, failure to receive vaccination; receipt of prohibited medication or vaccine; failure to receive vaccination at the required time point; failure to receive the required vaccination dose; and collection of blood sample at a time point outside of the prespecified time window.

Sera from participants was used to measure vaccine-induced anti-PnPs serotype-specific IgG for the 15 serotypes using PnECL. The percentage of participants that achieve the threshold value of ≥0.35 μg/mL for each of the 13 serotypes shared by both V114 and Prevenar 13™ (Serotypes 1 to 23F); and the 2 serotypes unique to V114 (Serotypes 22F and 33F) was assessed.

All randomized participants without deviations from the protocol that may substantially affect the results. Deviations include, but are not limited to, failure to receive vaccination; receipt of prohibited medication or vaccine; failure to receive vaccination at the required time point; failure to receive the required vaccination dose; and collection of blood sample at a time point outside of the prespecified time window.

Sera from participants was used to measure vaccine-induced anti-PnPs serotype-specific OPA using the multiplexed opsonophagocytic assay (MOPA). The GMT for each of the 13 serotypes shared by both V114 and Prevenar 13™ (Serotypes 1 to 23F); and the 2 serotypes unique to V114 (Serotypes 22F and 33F) was assessed. The within-group CIs were obtained by exponentiating the CIs of the mean of the natural log values based on the t-distribution.

All randomized participants without deviations from the protocol that may substantially affect the results. Deviations include, but are not limited to, failure to receive vaccination; receipt of prohibited medication or vaccine; failure to receive vaccination at the required time point; failure to receive the required vaccination dose; and collection of blood sample at a time point outside of the prespecified time window.

Sera from participants was used to measure vaccine-induced anti-PnPs serotype-specific OPA using the MOPA. The threshold dilution (% ≥) for each of the 13 serotypes shared by both V114 and Prevenar 13™ (Serotypes 1 to 23F) were as follows: 1:9, 1:19, 1:34, 1:27, 1:232, 1:40, 1:61, 1:151, 1:62, 1:115, 1:31, 1:113, 1:55. For Serotypes 22F and 33F the threshold dilution was 1:15 and 1:20 respectively. The within-group CIs were based on the exact binomial method of Clopper and Pearson.

All randomized participants without deviations from the protocol that may substantially affect the results. Deviations include, but are not limited to, failure to receive vaccination; receipt of prohibited medication or vaccine; failure to receive vaccination at the required time point; failure to receive the required vaccination dose; and collection of blood sample at a time point outside of the prespecified time window.

Sera from participants was used to measure vaccine-induced anti-PnPs serotype-specific IgG for the 15 serotypes using PnECL. As pre-specified in the protocol the percentage of participants from the two serotypes unique to V114 (Serotypes 22F and 33F) are presented, as well as the percentage of participants with the lowest response rate from any of the 13 shared serotypes randomized to Prevenar 13™ (Serotype 3).

All randomized participants without deviations from the protocol that may substantially affect the results. For each pre-specified serotype, participants were only analyzed for the treatment group that they were randomized to.