Safety and Tolerability of a Cell-Derived Influenza Vaccine in Healthy Adults Aged ≥18 Years and ≤ 49 Years

Phase 1

Completed

• Conditions: Healthy
• Interventions: Biological: Seasonal cell-derived influenza vaccine; Biological: Placebo Comparator

• Registration Number: NCT00599443
• Lead Sponsor: Solvay Pharmaceuticals

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-10
• Study First Submitted: 2008-01-10
• Study First Submitted QC: 2008-01-10
• Study First Posted: 2008-01-23
• Primary Completion: 2008-05
• Study Completion: 2008-05
• Status Verified: 2008-06
• Last Update Submitted: 2008-06-27
• Last Update Posted: 2008-06-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Seasonal cell-derived influenza vaccine	-
2	Placebo Comparator	-

Primary Outcome Measures

Name	Time	Method
Safety and tolerability of one dose of cell-derived influenza vaccine in healthy adults aged ≧18 years and ≦ 49 years after vaccination.	3 weeks
Long-term safety	6 months

Secondary Outcome Measures

Name	Time	Method
HI antibody titers	3 weeks