Study of a Quadrivalent Influenza Vaccine Administered Intramuscularly in Children/Adolescents and Adults
Summary
The aim of the study is to assess the safety profile of a quadrivalent influenza vaccine (QIV) and to demonstrate that 3 different industrial lots of QIV induce an equivalent immune response in children/adolescents (9 to 17 years of age) and adults (18 to 60 years of age). Primary Objective: * To describe the safety profile (injection site reactions and systemic events) of each vaccine during the 21 days following vaccination, and serious adverse events (including adverse events of special interest) throughout the study in all adult and child/adolescent participants. Secondary Objectives: * To demonstrate that the 3 different industrial lots of quadrivalent influenza vaccine (QIV) induce an equivalent immune response at 21 days post-vaccination in both age groups (lot consistency) * To describe the compliance of the immunogenicity of QIV to the European Medicines Agency Note for Guidance (NfG) (CPMP/BWP/214/96) in each age group.
Timeline
- Start
- 2012-03
- Primary completion
- 2012-10
- Completion
- 2012-12
Outcome
Met primary endpoint
paper IIV4 met all European Medicines Agency immunogenicity criteria for adults for all 4 strains. PMID 25843270 ↗
paper Antibody responses to IIV4 were equivalent among vaccine lots and comparable between age groups for each of the 4 strains. PMID 25843270 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Quadrivalent influenza vaccine | Vaccine | 0.5 ml | Intramuscular |
| Comparator | Trivalent Influenza Vaccine | Vaccine | 0.5 ml | Intramuscular |