Immunogenicity and Safety of Concomitant Administration of Bivalent COVID-19 Vaccines With Influenza Vaccines
- Conditions
- Immune ResponseSafety
- Interventions
- Biological: bivalent BNT162b2 mRNA original/omicron BA.4-5 vaccineBiological: quadrivalent influenza vaccine
- Registration Number
- NCT05970887
- Lead Sponsor
- Catholic Kwandong University
- Brief Summary
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.
- Detailed 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 154
- 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
- Individuals with a contraindication to any of the vaccine compounds were excluded from the study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description S group (COVID-19 vaccine only) bivalent BNT162b2 mRNA original/omicron BA.4-5 vaccine separate administration of influenza vaccination followed by bivalent BA.4/BA.5 mRNA booster ≥4 weeks later C group bivalent BNT162b2 mRNA original/omicron BA.4-5 vaccine Concomitant administration of bivalent mRNA COVID-19 booster and quadrivalent influenza vaccination C group quadrivalent influenza vaccine Concomitant administration of bivalent mRNA COVID-19 booster and quadrivalent influenza vaccination S group (influenza vaccine only) quadrivalent influenza vaccine separate administration of influenza vaccination followed by bivalent BA.4/BA.5 mRNA booster ≥4 weeks later
- Primary Outcome Measures
Name Time Method 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 seroconversion rate of anti-SARS-CoV-2 S IgG
- Secondary Outcome Measures
Name Time Method seroconversion rate of neutralizing antibody against SARS-CoV-2 at 28 days after booster dose seroconversion rate of neutralizing antibody against wild type, Omicron BA.5
geometric mean titer against SARS-CoV-2 at 28 days after booster dose geometric mean titer against SARS-CoV-2 (Anti-S IgG, neutralizing antibody)
geometric mean titer against four influenza strain at 28 days after immunization geometric mean titer against four influenza strain
seroconversion rate of four influenza strains at 28 days after immunization seroconversion rate of four influenza strains
seropositive rate of four influenza strains at 28 days after immunization seropositive rate of four influenza strains
The incidence rate of adverse events (AEs) within 28 days The incidence rate of AEs within 7 days, AEs within 28 days, and serious AEs
Trial Locations
- Locations (1)
International St. Mary's hospital
🇰🇷Incheon, Seo-gu, Korea, Republic of