Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Tolerability of a Cell-Derived Influenza Vaccine in Healthy Adults Aged ≥18 Years and ≤ 49 Years.

Solvay Pharmaceuticals0 sites120 target enrollmentOctober 2007

ConditionsHealthy

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Healthy
Sponsor: Solvay Pharmaceuticals
Enrollment: 120
Primary Endpoint: Safety and tolerability of one dose of cell-derived influenza vaccine in healthy adults aged ≧18 years and ≦ 49 years after vaccination.
Status: Completed
Last Updated: 17 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

A controlled, double blinded study to determine the safety and reactogenicity in healthy adults of a single dose of a trivalent cell-derived influenza vaccine administered by intramuscular injection.

Registry

clinicaltrials.gov

Start Date

October 2007

End Date

May 2008

Last Updated

17 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Solvay Pharmaceuticals

Eligibility Criteria

Inclusion Criteria

•Healthy female or male subjects aged ≧18 and ≦49 years
•Willing and able to give informed consent

Exclusion Criteria

•Influenza vaccination of laboratory confirmed influenza infection within six months of informed consent,
•presence of any significant medical condition,
•a serious adverse reaction after a previous (influenza) vaccination,
•underlying medical conditions for which annual influenza vaccine is recommended by the Advisory Committee on Immunization Practices (ACIP),
•chronic diseases requiring long-term immunosuppressive therapy