NCT05310084

Safety and Immunogenicity of BNT162b2 Coadministered With SIIV in Adults 18 Through 64 Years of Age

A PHASE 3, RANDOMIZED, OBSERVER-BLIND TRIAL TO EVALUATE THE SAFETY AND IMMUNOGENICITY OF BNT162b2 WHEN COADMINISTERED WITH SEASONAL INACTIVATED INFLUENZA VACCINE (SIIV) IN ADULTS 18 THROUGH 64 YEARS OF AGE

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,134 (actual)
• Sponsor: BioNTech SE · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Accepted

Summary

This study will assess the safety and immunogenicity of a fourth dose (booster) of BNT162b2 when coadministered with SIIV compared to separate administration of the vaccines when given 1 month apart (SIIV followed by BNT162b2), in participants who have received 3 prior doses of 30 µg BNT162b2, with the third dose being at least 90 days before Visit 1 (Day 1). * Healthy adults 18 through 64 years of age will be randomized 1:1 to either the co-administration group, or the separate administration group * The duration of the study for each participant will be approximately 2 months * There are 3 scheduled study visits each about 1 month apart * The study will be conducted in New Zealand and Australia.

Conditions

• SARS-CoV-2 Infection
• COVID-19

Interventions

Type	Name	Description
BIOLOGICAL	BNT162b2	Intramuscular injection
OTHER	Placebo	Saline intramuscular injection
BIOLOGICAL	Seasonal Inactivated Influenza Vaccine	SIIV intramuscular injection

Timeline

• Start date: 2022-04-20
• Primary completion: 2022-10-05
• Completion: 2022-10-05
• First posted: 2022-04-04
• Last updated: 2024-06-12
• Results posted: 2023-11-24

Locations

26 sites across 2 countries: Australia, New Zealand

Regulatory

• FDA-regulated drug study