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

NCT05310084 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1134

Last updated 2024-06-12

Study results available
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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

Interventions

BIOLOGICAL

BNT162b2

Intramuscular injection

OTHER

Placebo

Saline intramuscular injection

BIOLOGICAL

Seasonal Inactivated Influenza Vaccine

SIIV intramuscular injection

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-04-20
Primary Completion
2022-10-05
Completion
2022-10-05
FDA Drug
Yes

Countries

  • Australia
  • New Zealand

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05310084 on ClinicalTrials.gov