A Phase II, Observer-Blind, Parallel Groups, Single Center, Extension Study to Evaluate the Immunogenicity and Safety Following a Single Intramuscular Dose of Influenza Vaccines in Healthy Children Who Received Either One or the Other Vaccine in the Previous V70P2 Study.

NCT00644540 Phase 2 COMPLETED

The purpose of this research is to evaluate the immunogenicity of a single dose of Influenza Vaccines (0.5mL or 0.25mL) in healthy children aged up to 35 months or 36 up to 48 months. To evaluate the safety and tolerability of a single 0.25mL IM of injection influenza vaccines in healthy children aged up to 35 months; to evaluate the safety and tolerability of a single 0.50mL IM injection of influenza vaccines in healthy children aged up to 48 months.

Details

Lead sponsor	Novartis Vaccines
Phase	Phase 2
Status	COMPLETED
Enrolment	89
Start date	2007-11
Completion	2008-06

Conditions

• FLU

Interventions

• Influenza Trivalent Inactivated Vaccines
• Influenza Trivalent Inactivated Vaccines

Primary outcomes

• To evaluate the immunogenicity of a single 0.25mL or 0.5mL IM injection of two different influenza vaccines, in terms of post-immunization geometric mean titers (GMTs), as measured by HI test, in healthy children aged up to 48 months. — 181 days

Countries

Finland