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

Solvay

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Biological: Seasonal cell-derived influenza vaccine; Biological: Placebo Comparator

Study type: Interventional

Funder types: Industry

Identifiers

NCT00599443

S203.1.001

Details and patient eligibility

About

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.

Enrollment: 120 patients

Sex: All

Ages: 18 to 49 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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120 participants in 2 patient groups, including a placebo group

1

Experimental group

Treatment:

Biological: Seasonal cell-derived influenza vaccine

2

Placebo Comparator group

Treatment:

Biological: Placebo Comparator