A Phase IIIB, Observer-Blind, Randomized, Parallel Groups, Extension Study to Evaluate the Immunogenicity and Safety Following a Single Intramuscular Dose of a Sub-unit Adjuvanted or a Non-adjuvanted Influenza Vaccines in Healthy Children Previously Vaccinated in the V70P5 Study

NCT01210898 Phase 3 COMPLETED

This study will evaluate the safety and immunogenicity of children previously primed in the V70P5 study when revaccinated with adjuvanted or unadjuvanted seasonal influenza vaccine.

Details

Lead sponsor	Novartis Vaccines
Phase	Phase 3
Status	COMPLETED
Enrolment	197
Start date	2010-09
Completion	2011-12

Conditions

• Influenza

Interventions

• Adjuvanted seasonal influenza vaccine

Primary outcomes

• Evaluate immunogenicity of children primed and revaccinated with adjuvanted influenza vaccine by GMR, seroprotection — 22 days post vaccination
• Evaluate immunogenicity of children primed and revaccinated with a half dose of adjuvanted influenza vaccine by GMR, Seroprotection and seroconversion — 22 days post vaccination
• Evaluate immunogenicity of children primed with adjuvanted influenza vaccine and revaccinated with unadjuvanted influenza vaccine by GMR, Seroprotection and seroconversion — 22 days post vaccination
• Safety and tolerability of a single dose of adjuvanted or unadjuvanted influenza vaccine stratified according to previous influenza vaccine received — 22 days post vaccination

Countries

Finland