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Clinical trial

Immunogenicity and Safety of Concomitant Administration of Omicron-containing Bivalent COVID-19 Vaccines With Seasonal Influenza Vaccines

ID
Name
IS22OISE0060
Description
The goal is to evaluate the immunogenicity and safety of coadministration of a bivalent BA.4/BA.5-adapted COVID-19 booster vaccine, and influenza vaccine among healthy adults during 2022-23 season.
Trial arms
Trial start
2022-10-12
Estimated PCD
2022-12-15
Trial end
2023-12-15
Status
Completed
Phase
Early phase I
Treatment
bivalent BNT162b2 mRNA original/omicron BA.4-5 vaccine
The bivalent BNT162b2 mRNA original/omicron BA.4-5 vaccine is a combination of 15-µg of mRNA encoding the wild-type (WT) spike protein and 15-µg of mRNA encoding the spike protein of the Omicron BA.4/BA.5 subvariant.
Arms:
C group, S group (COVID-19 vaccine only)
quadrivalent influenza vaccine
The quadrivalent influenza vaccine is an inactivated vaccine containing 15μg HA/strain in each 0.5-mL dose, containing four influenza vaccine strains from the 2022-2023 northern hemisphere season
Arms:
C group, S group (influenza vaccine only)
Size
154
Primary endpoint
seroconversion rate of anti-severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spike (S) immunoglobulin (IgG) between the C and S groups
at 28 days after booster dose
Eligibility criteria
Inclusion Criteria: * who agreed to receive both bivalent booster COVID-19 vaccine and influenza vaccine * Only individuals who had passed at least 3 months after the last confirmation of SARS-CoV-2 infection and/or the third dose of COVID-19 vaccination Exclusion Criteria: * Individuals with a contraindication to any of the vaccine compounds were excluded from the study
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'prospective, non-randomized clinical cohort study', 'primaryPurpose': 'BASIC_SCIENCE', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 154, 'type': 'ACTUAL'}}
Updated at
2024-03-26

1 organization

2 products

2 indications

Organization
Catholic Kwandong University
Product
BNT162b2 mRNA
Indication
immune response
Indication
Safety
Product
Quadrivalent Influenza Vaccine