NCT01210898

Immunogenicity and Safety of V70P5 Revaccination Subjects

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 197 (actual)
• Sponsor: Novartis Vaccines · Industry
• Sex: All
• Age: 18 Months – 96 Months
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	Adjuvanted seasonal influenza vaccine	Full or half dose of adjuvanted seasonal influenza vaccine; Full or half dose of unadjuvanted seasonal influenza vaccine

Timeline

• Start date: 2010-09-01
• Primary completion: 2011-01-01
• Completion: 2011-12-01
• First posted: 2010-09-29
• Last updated: 2016-12-01

Locations

16 sites across 1 country: Finland