NCT00617851

Study to Evaluate the Consistency of Three Consecutive Production Lots of Influenza Vaccine in Healthy Subjects 18 to 49 Years Old

A Phase III, Randomized, Controlled, Observer-Blind, Single-Center Study to Evaluate the Consistency of Three Consecutive Lots of a Trivalent Subunit Influenza Vaccine Produced in Embryonated Hen Eggs in Healthy Subjects Aged 18 to 49 Years

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,507 (actual)
• Sponsor: Novartis Vaccines · Industry
• Sex: All
• Age: 18 Years – 49 Years
• Healthy volunteers: Accepted

Summary

The purpose of this research is to demonstrate immunologic equivalence of three consecutive production lots of the subunit influenza vaccine compared to egg-derived inactivated influenza vaccine in healthy subjects 18 to 49 years of ages. In addition, this study is to show how safe and well tolerated a conventional inactivated subunit influenza vaccine, licensed in many countries outside the United States, is compared to an inactivated influenza vaccine, licensed in the United States.

Conditions

• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	Lot A of Influenza virus vaccine	1 injection of the trivalent subunit influenza virus vaccine (lot A) administered intramuscularly
BIOLOGICAL	Lot B of Influenza virus vaccine	1 injection of the trivalent subunit influenza virus vaccine (lot B) administered intramuscularly
BIOLOGICAL	Lot C of Influenza virus vaccine	1 injection of the trivalent subunit influenza virus vaccine (lot C) administered intramuscularly
BIOLOGICAL	Comparator influenza virus vaccine	1 injection of the trivalent subunit influenza virus vaccine administered intramuscularly
BIOLOGICAL	All 3 consecutive lots of influenza virus vaccine pooled	1 injection of the pooled trivalent subunit influenza virus vaccine administered intramuscularly

Timeline

• Start date: 2007-11-01
• Primary completion: 2007-12-01
• Completion: 2008-06-01
• First posted: 2008-02-18
• Last updated: 2012-05-08
• Results posted: 2010-06-24

Locations

2 sites across 1 country: Dominican Republic