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

Safety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05970887
• Other study ID #: IS22OISE0060
• Status: Completed
• Phase: Phase 4
• Start date: October 12, 2022
• Est. completion date: December 15, 2023

Study information

• Verified date: March 2024
• Source: Catholic Kwandong University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 154
• Est. completion date: December 15, 2023
• Est. primary completion date: December 15, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Immune Response
• Safety

Intervention

Biological:
• 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.
• 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

Locations

Country	Name	City	State
Korea, Republic of	International St. Mary's hospital	Incheon	Seo-gu

Sponsors (2)

Lead Sponsor	Collaborator
Catholic Kwandong University	Korea University Guro Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	seroconversion rate of anti-severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spike (S) immunoglobulin (IgG) between the C and S groups	seroconversion rate of anti-SARS-CoV-2 S IgG	at 28 days after booster dose
Secondary	seroconversion rate of neutralizing antibody against SARS-CoV-2	seroconversion rate of neutralizing antibody against wild type, Omicron BA.5	at 28 days after booster dose
Secondary	geometric mean titer against SARS-CoV-2	geometric mean titer against SARS-CoV-2 (Anti-S IgG, neutralizing antibody)	at 28 days after booster dose
Secondary	seroconversion rate of four influenza strains	seroconversion rate of four influenza strains	at 28 days after immunization
Secondary	seropositive rate of four influenza strains	seropositive rate of four influenza strains	at 28 days after immunization
Secondary	geometric mean titer against four influenza strain	geometric mean titer against four influenza strain	at 28 days after immunization
Secondary	The incidence rate of adverse events (AEs)	The incidence rate of AEs within 7 days, AEs within 28 days, and serious AEs	within 28 days