NCT00310804

Safety and Immunogenicity of 3 Lots of Cell-derived Subunit Influenza Vaccine as Compared to 1 Lot to Egg-derived Subunit Influenza Vaccine in Healthy Adults (>=18 to <=60)

A Phase III, Randomized, Controlled, Observer-Blind, Multi-Center Study to Evaluate Safety, Tolerability and Immunogenicity of a Single Intramuscular Dose of Three Lots of a Trivalent Subunit Influenza Vaccine Produced in Mammalian Cell Culture Or of a Trivalent Subunit Influenza Vaccine Produced in Embryonated Hen Eggs, in Healthy Adult Subjects Aged >=18 to <=60

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,200 (actual)
• Sponsor: Novartis Vaccines · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

The present study aims to evaluate safety, tolerability and immunogenicity of three lots of Chiron's cell-derived subunit influenza vaccine in healthy adult subjects as compared to a conventional egg-derived control vaccine licensed in Europe.

Conditions

• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	Cell-Derived Trivalent Subunit Influenza Vaccine Lot 1 (cTIV)	One single 0.5ml intramuscular injection of Cell Derived Trivalent Subunit Influenza Vaccine (cTIV) from Lot 1
BIOLOGICAL	Cell-Derived Trivalent Subunit Influenza Vaccine Lot 2 (cTIV)	One single 0.5ml intramuscular injection of Cell Derived Trivalent Subunit Influenza Vaccine (cTIV) from Lot 2
BIOLOGICAL	Cell-Derived Trivalent Subunit Influenza Vaccine Lot 3 (cTIV)	One single 0.5ml intramuscular injection of Cell Derived Trivalent Subunit Influenza Vaccine (cTIV) from Lot 3
BIOLOGICAL	Egg-Derived Trivalent Subunit Influenza Vaccine (TIV)	One single 0.5ml intramuscular injection of Egg Derived Trivalent Subunit Influenza Vaccine (TIV).

Timeline

• Start date: 2005-09-01
• Primary completion: 2005-10-01
• Completion: 2006-04-01
• First posted: 2006-04-05
• Last updated: 2019-08-15
• Results posted: 2013-01-18

Locations

2 sites across 1 country: Lithuania