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Quadrivalent versus trivalent influenza vaccine study in children and adolescents
2015-005482-23Phase 3
Key facts
- Status
- Completed
- Start
- Apr 2016
- Countries
- 1
- Sponsor
- Abbott Laboratories
- Modality
- Vaccines & Immunotherapeutics
- Conditions
- influenza
01
Overview
Phase 3, randomised, double-blind trial of quadrivalent influenza vaccine and influenza vaccine in influenza (3 arms), sponsored by Abbott Laboratories. Primary endpoints: Post-vaccination geometric mean HI antibody titers against the 4 vaccine strains and Non-inferiority of quadrivalent influenza vaccine versus trivalent influenza vaccines for shared strains. Started Apr 2016; status: completed.
02
Design
3 arms- Study design
- RandomizedDouble-blind
Quadrivalent influenza vaccine
Participants received Abbott's candidate quadrivalent influenza vaccine.
Trivalent influenza vaccine with B-Victoria lineage
Participants received active comparator Influvac trivalent vaccine containing the B-Victoria lineage strain.
Trivalent influenza vaccine with B-Yamagata lineage
Participants received active comparator Influvac trivalent vaccine containing the B-Yamagata lineage strain.
03
Who it enrols
Children and adolescents aged 3 to 17 years in stable health, including those with controlled underlying illnesses, were eligible. The protocol excluded children in care.
04
Endpoints
Primary
Post-vaccination geometric mean HI antibody titers against the 4 vaccine strains
Non-inferiority of quadrivalent influenza vaccine versus trivalent influenza vaccines for shared strains
Secondary
Superiority against alternate-lineage B strain
Safety
Immunogenicity
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