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

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.

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.

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.

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.

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.

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.

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.