Immunogenicity of Concomitant Administration of COVID-19 Vaccines With Influenza Vaccines
- Conditions
- COVID-19InfluenzaContaminant InjectedVaccine Reaction
- Interventions
- Biological: Omicron-containing COVID-19 vaccineBiological: influenza vaccine
- Registration Number
- NCT06091410
- Lead Sponsor
- Catholic Kwandong University
- Brief Summary
The goal is to evaluate the in-depth immunogenicity analysis (including B-cell and T-cell response) of coadministration of a omicron-containing COVID-19 vaccine and influenza vaccine among healthy adults during 2023-24 season.
- Detailed Description
This was an open-label, randomized clinical trial conducted at the International St. Mary's Hospital in Incheon, South Korea. This study included two study groups: Concomitant administration of omicron containing messenger ribonucleic acid (mRNA) COVID-19 booster and quadrivalent influenza vaccination (QIV) and separate administration of influenza vaccination followed by mRNA booster ≥4 weeks later
* immunogenicity analysis : Blood was drawn at baseline and follow-up visit 4 weeks, 3 months, 6 months, 10-12 months after immunization(For the COVID-19 vaccine, additional blood sampling will be conducted one week after vaccination).
* 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
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 62
- who agreed to receive both booster COVID-19 vaccine and influenza vaccine
- individuals who have received the COVID-19 vaccine three or more times and have passed at least 3 months after the last vaccination
- individuals with a history of a single SARS-CoV-2 infection during the Omicron outbreak period (January 2022-February 2023)
- individuals with a contraindication to any of the vaccine compounds
- individuals with a history of influenza infection within the past 6 months
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description C group Omicron-containing COVID-19 vaccine concomitant administration of COVID-19 booster and quadrivalent influenza vaccination C group influenza vaccine concomitant administration of COVID-19 booster and quadrivalent influenza vaccination S group (COVID-19 vaccine only) Omicron-containing COVID-19 vaccine separate administration of influenza vaccination followed by COVID-19 booster 4 weeks later S group (influenza vaccine only) influenza vaccine separate administration of influenza vaccination followed by COVID-19 booster 4 weeks later
- Primary Outcome Measures
Name Time Method geometric mean titer against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) at 7, 28 days, 3, 6, and 10-12 months after COVID-19 vaccination geometric mean titer against SARS-CoV-2 (Anti-S immunoglobulin G, Neutralizing antibody)
- Secondary Outcome Measures
Name Time Method The incidence rate of adverse events within 28 days The incidence rate of adverse events within 7 days, 28 days, and serious adverse events
vaccine-induced B-cell responses at 7, 28 days, 6, and 10-12 months after COVID-19 vaccination vaccine-induced B-cell responses and their immune interactions between COVID-19 and influenza vaccines
geometric mean titer against four influenza strain at 28 days and 7 months after influenza vaccination geometric mean titer against four influenza strain
vaccine-induced CD4+ T cell responses at 7, 28 days, 6, and 10-12 months after COVID-19 vaccination vaccine-induced CD4+ T cell responses and their immune interactions between COVID-19 and influenza vaccines
Trial Locations
- Locations (2)
Korea University Guro Hospital
🇰🇷Seoul, Guro-gu, Korea, Republic of
International St. Mary's hospital
🇰🇷Incheon, Seo-gu, Korea, Republic of