Immunogenicity of Concomitant Administration of COVID-19 Vaccines With Influenza Vaccines

Catholic Kwandong University

Status and phase: Active, not recruiting; Phase 4

Conditions: Contaminant Injected; COVID-19; Influenza; Vaccine Reaction

Treatments: Biological: Omicron-containing COVID-19 vaccine; Biological: influenza vaccine

Study type: Interventional

Funder types: Other

Identifiers

NCT06091410

IS23OIME0055

Details and patient eligibility

About

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.

Full 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.

Enrollment: 62 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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)

Exclusion criteria

• individuals with a contraindication to any of the vaccine compounds
• individuals with a history of influenza infection within the past 6 months

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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62 participants in 3 patient groups, including a placebo group

C group

Experimental group

Description:

concomitant administration of COVID-19 booster and quadrivalent influenza vaccination

Treatment:

Biological: influenza vaccine

Biological: Omicron-containing COVID-19 vaccine

S group (COVID-19 vaccine only)

Placebo Comparator group

Description:

separate administration of influenza vaccination followed by COVID-19 booster 4 weeks later

Treatment:

Biological: Omicron-containing COVID-19 vaccine

S group (influenza vaccine only)

Placebo Comparator group

Description:

separate administration of influenza vaccination followed by COVID-19 booster 4 weeks later

Treatment:

Biological: influenza vaccine