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 (18-60 Years)

This study has been completed.

First Received: April 3, 2006 Last Updated: September 13, 2006 History of Changes

Sponsors and Collaborators:	Novartis Novartis Vaccines
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00310804

Purpose

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.

Condition	Intervention	Phase
Influenza	Biological: Cell-Derived Trivalent Subunit Influenza Vaccine Biological: Egg-Derived Trivalent Subunit Influenza Vaccine	Phase III

MedlinePlus related topics: Flu

Drug Information available for: Fluvirin Influenza Vaccines

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	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 < 61 Years

Further study details as provided by Novartis:

Primary Outcome Measures:

Seroprotection, GMTs, GMRs and seroconversion rate approximately three weeks after vaccination.
Solicited local and systemic reactions for seven days after vaccination, and other adverse events for approximately three weeks after vaccination.

Secondary Outcome Measures:

Immunogenicity: seroprotection, GMTs, GMRs approximately six months after vaccination; investigation of influenza-like illness for laboratory confirmation of symptomatic influenza. Safety approximately six months after vaccination.

Estimated Enrollment:	1200
Study Start Date:	September 2005

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Healthy males and females of 18 to <61 years of age

Exclusion Criteria:

currently experiencing an acute infectious disease or having had any laboratory confirmed influenza disease within past 6 months
suffering from any serious diseases
history of any anaphylaxis, serious vaccine reactions, or allergy to any of the vaccine component
receipt of influenza vaccine within past 6 months

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00310804

Locations

Lithuania
Dept. Infectious Diseases and Microbiology of Vilnius University
Vilnius, Lithuania
2nd Department of Internal Diseases, Panevezys Hospital,
Panevezys, Lithuania

Sponsors and Collaborators

Novartis

Novartis Vaccines

Investigators

Principal Investigator:

Novartis Vaccines - Drug Information Services

Novartis Vaccines & Diagnostics

More Information

No publications provided

Study ID Numbers:	V58P9, EUDRACT: 2005-002257-47
Study First Received:	April 3, 2006
Last Updated:	September 13, 2006
ClinicalTrials.gov Identifier:	NCT00310804 History of Changes
Health Authority:	Lithuania: State Medicine Control Agency - Ministry of Health

Keywords provided by Novartis:

Influenza
Flu
Cell-Derived
Egg-Derived

Healthy Adults
Safety
Immunogenicity
Vaccination

Study placed in the following topic categories:

Virus Diseases
Respiratory Tract Diseases
Respiratory Tract Infections

Influenza, Human
Healthy
Orthomyxoviridae Infections

Additional relevant MeSH terms:

Virus Diseases
RNA Virus Infections
Respiratory Tract Diseases

Respiratory Tract Infections
Influenza, Human
Orthomyxoviridae Infections

ClinicalTrials.gov processed this record on May 07, 2009