Safety and Immunogenicity Study of 20vPnC When Coadministered With a Booster Dose of BNT162b2

An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Percentage of participants with AEs and the associated 2-sided 95% CI based on the Clopper and Pearson method was presented. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this outcome measure.

Time frame: From day of vaccination (Day 1) up to 1 month after vaccination

Population: Safety population included all participants who received at least 1 dose of the study intervention and had safety follow-up after vaccination.

Local reactions included pain at injection site, redness and swelling and were 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) and 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 daily activity, moderate: interfered with daily activity and severe: prevented daily activity. Percentage of participants with local reactions at each injection site within 10 days after vaccination and the associated 2-sided 95% confidence interval (CI) based on the Clopper and Pearson method was presented.

Time frame: Within 10 days after vaccination

Population: Safety population included all participants who received at least 1 dose of the study intervention and had safety follow-up after vaccination. Here, Overall Number of Participants Analyzed signifies number of participants with any e-diary data reported after vaccination.

A SAE was defined as any untoward medical occurrence that, at any dose, resulted in death; was life-threatening (immediate risk of death); required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); resulted in congenital anomaly/birth defect; was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic or that was considered to be an important medical event. Percentage of participants with SAEs and the associated 2-sided 95% CI based on the Clopper and Pearson method was presented.

Time frame: From day of vaccination (Day 1) up to 6 months after vaccination

Population: Safety population included all participants who received at least 1 dose of the study intervention and had safety follow-up after vaccination.

Systemic events including fever, fatigue, headache, chills, muscle pain and joint pain were recorded by participants using an e-diary. Fever was defined as temperature \>=38.0 degree Celsius (C) and categorized as \>=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, chills, 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. Percentage of participants with systemic events within 7 days after vaccination and the associated 2-sided 95% CI based on the Clopper and Pearson method was presented.

Time frame: Within 7 days after vaccination

Population: Safety population included all participants who received at least 1 dose of the study intervention and had safety follow-up after vaccination. Here, Overall Number of Participants Analyzed (N) signifies number of participants with any e-diary data reported after vaccination.

IgG levels were measured in serum samples using severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) full-length S-binding assay. GMCs and 2-sided CIs were calculated by exponentiating the mean logarithm of the concentrations and the corresponding CIs and based on the Student t distribution. Data for this outcome measure was planned to be analyzed for coadministration group (20vPnC + BNT162b2) and BNT162b2 only group (BNT162b2 + saline) as specified in protocol.

Time frame: 1 month after vaccination with BNT162b2

Population: EIP: all randomized participants who received assigned vaccination; had at least 1 valid immunogenicity result from blood sample collected within 20 to 49 days after vaccination at Day 1; had no other major protocol deviations as determined by clinician. Participants with SARS-CoV-2 infection up to 1 month after vaccination (including subclinical infection, ie positive for N-binding antibody) were excluded from analysis. N=participants with valid assay results at specified sampling time point.

The GMFR for each vaccine group was defined as the geometric mean of the fold rises in the assay results from before to approximately 1 month after vaccination. GMFRs and the corresponding 2-sided 95% CIs were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs and based on the Student t distribution. Data for this outcome measure was planned to be analyzed for coadministration group (20vPnC + BNT162b2) and BNT162b2 only group (BNT162b2 + saline) as specified in the protocol.

Time frame: Before vaccination to 1 month after vaccination with BNT162b2

Population: EIP: participants received assigned vaccination; at least 1 valid immunogenicity result from sample collected within 20 to 49 days after Day1 vaccination; no other major protocol deviations determined by clinician. Participants with SARS-CoV-2 infection upto 1 month after vaccination (including subclinical infection, ie positive for N-binding antibody)excluded from analysis. N=participants with valid full-length S-binding IgG from before and 1 month after BNT162b2 booster dose sample collection.

OPA titers were measured from serum samples for 20vPnC serotypes: 1, 3, 4, 5, 6A, 6B, 7F,8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F. GMTs and 2-sided CIs were calculated by exponentiating the mean logarithm of the OPA titers and the corresponding CIs and based on the Student t distribution. Data for this outcome measure was planned to be analyzed for coadministration group (20vPnC + BNT162b2) and 20vPnC only group (20vPnC + saline) as specified in protocol.

Time frame: 1 month after vaccination with 20vPnC

Population: Evaluable immunogenicity population (EIP): all randomized participants who received assigned vaccination; had at least 1 valid immunogenicity result from the blood sample collected within 20 to 49 days after vaccination at Day 1; had no other major protocol deviations as determined by clinician. Here, Number Analyzed signifies participants with valid OPA titers for the specified serotype.