Healthy individuals or individuals with stable comorbidities which increase their risk of complications from influenza infection.
Conditions
Brief summary
1.Immunogenicity responses of 3 lots of aQIVc HD compared in pairs in terms of Day 29 ratio of Geometric Mean Titer (GMTr), from antibodies measured via HI assay using cell-derived target viruses for the 4 vaccine strains. 2. Immunogenicity responses of aQIVc HD vs QIVr and aQIV in terms of: - Day 29 GMT and GMTr - Day 1 to Day 29 Seroconversion rate (SCR) and SCR difference from antibodies measured via HI assay using cell-derived target viruses for the 4 vaccine strains.
Detailed description
Immunogenicity responses of aQIVc HD in comparison with aQIV vaccine in subjects aged 65 years and older in terms of Day 29 Geometric mean titer (GMT) and GMT ratio of antibodies measured via HI assay using cell-derived target viruses for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria vaccine strains, and Day 1 to Day 29 Seroconversion rate (SCR) and SCR difference., Immunogenicity responses of aQIVc HD, QIVr and aQIV vaccines in terms of Day 29 Geometric mean titer (GMT) and GMT ratio of antibodies measured via HI assay using cell-derived target viruses for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria vaccine strains, overall and by age subgroup., Safety of aQIVc HD, QIVr and aQIV in terms of percentage of subjects with: - Solicited Local and Systemic Reactions from Day 1 to Day 7. - Unsolicited Adverse Events from Day 1 to Day 29. - Serious Adverse Events, AEs Leading to Withdrawal, Adverse Events of Special Interest and Medically Attended Adverse Events from Day 1 to Day 365.
Interventions
DRUGBVR-1B)
DRUGA/DARWIN/9/2021 (H3N2) - LIKE STRAIN (A/DARWIN/6/2021
DRUGIVR-227)
DRUGadjuvanted Quadrivalent Subunit Inactivated Cell-derived Influenza Vaccine
DRUGB/PHUKET/3073/2013-LIKE STRAIN (B/PHUKET/3073/2013
DRUGINFLUENZA VIRUS B/AUSTRIA/1359417/2021-LIKE STRAIN (B/AUSTRIA/1359417/2021
DRUGBVR-26)
DRUGINFLUENZA B VIRUS YAMAGATA LINEAGE HAEMAGGLUTININ
DRUGRECOMBINANT
DRUGINFLUENZA A VIRUS SUBTYPE H1N1 HAEMAGGLUTININ
DRUGA/VICTORIA/2570/2019 (H1N1)PDM09-LIKE STRAIN (A/VICTORIA/2570/2019
DRUGIVR-215)
DRUGINFLUENZA A VIRUS SUBTYPE H3N2 HAEMAGGLUTININ
DRUGINFLUENZA B VIRUS VICTORIA LINEAGE HAEMAGGLUTININ
Sponsors
Seqirus UK Limited, Seqirus UK Limited, Seqirus UK Limited
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Immunogenicity responses of 3 lots of aQIVc HD compared in pairs in terms of Day 29 ratio of Geometric Mean Titer (GMTr), from antibodies measured via HI assay using cell-derived target viruses for the 4 vaccine strains. 2. Immunogenicity responses of aQIVc HD vs QIVr and aQIV in terms of: - Day 29 GMT and GMTr - Day 1 to Day 29 Seroconversion rate (SCR) and SCR difference from antibodies measured via HI assay using cell-derived target viruses for the 4 vaccine strains. | — |
Secondary
| Measure | Time frame |
|---|---|
| Immunogenicity responses of aQIVc HD in comparison with aQIV vaccine in subjects aged 65 years and older in terms of Day 29 Geometric mean titer (GMT) and GMT ratio of antibodies measured via HI assay using cell-derived target viruses for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria vaccine strains, and Day 1 to Day 29 Seroconversion rate (SCR) and SCR difference., Immunogenicity responses of aQIVc HD, QIVr and aQIV vaccines in terms of Day 29 Geometric mean titer (GMT) and GMT ratio of antibodies measured via HI assay using cell-derived target viruses for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria vaccine strains, overall and by age subgroup., Safety of aQIVc HD, QIVr and aQIV in terms of percentage of subjects with: - Solicited Local and Systemic Reactions from Day 1 to Day 7. - Unsolicited Adverse Events from Day 1 to Day 29. - Serious Adverse Events, AEs Leading to Withdrawal, Adverse Events of Special Interest and Medically Attended Adverse Events from Day 1 to Day 365. | — |
Countries
Denmark, Estonia, Germany
Outcome results
None listed