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

Catholic Kwandong University

Status and phase: Completed; Phase 4

Conditions: Immune Response; Safety

Treatments: Biological: quadrivalent influenza vaccine; Biological: bivalent BNT162b2 mRNA original/omicron BA.4-5 vaccine

Study type: Interventional

Funder types: Other

Identifiers

NCT05970887

IS22OISE0060

Details and patient eligibility

About

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.

Full description

This was an open-label, non-randomized clinical trial conducted at the International St. Mary's Hospital in Incheon, South Korea. This study included two study groups: Concomitant administration of bivalent BA.4/BA.5 mRNA COVID-19 booster and quadrivalent influenza vaccination (QIV) and separate administration of influenza vaccination followed by bivalent BA.4/BA.5 mRNA booster ≥4 weeks later

• immunogenicity analysis : Blood was drawn at baseline and follow-up visit 4 weeks (day 28±7) after immunization.
• safety analysis : At 7 days after each vaccine dose, the participants were requested to record the occurrence, severity of solicited adverse events (AEs) through a standardized electronic questionnaire. Participants were also asked to record any unsolicited AEs during the 28 days after vaccination.

Enrollment: 154 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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154 participants in 3 patient groups, including a placebo group

C group

Experimental group

Description:

Concomitant administration of bivalent mRNA COVID-19 booster and quadrivalent influenza vaccination

Treatment:

Biological: quadrivalent influenza vaccine

Biological: bivalent BNT162b2 mRNA original/omicron BA.4-5 vaccine

S group (COVID-19 vaccine only)

Placebo Comparator group

Description:

separate administration of influenza vaccination followed by bivalent BA.4/BA.5 mRNA booster ≥4 weeks later

Treatment:

Biological: bivalent BNT162b2 mRNA original/omicron BA.4-5 vaccine

S group (influenza vaccine only)

Placebo Comparator group

Description:

separate administration of influenza vaccination followed by bivalent BA.4/BA.5 mRNA booster ≥4 weeks later

Treatment:

Biological: quadrivalent influenza vaccine