Efficacy Study of Two Influenza Vaccines and Placebo in Healthy Adult Subjects - Full Text View

Sponsors and Collaborators:	Novartis Novartis Vaccines
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00630331

Purpose

The present study will evaluate clinical efficacy, safety, tolerability and immunogenicity of both Novartis Vaccines' cell-derived influenza vaccine and egg-derived influenza vaccine in healthy adults 18 to 49 years of age.

Condition	Intervention	Phase
Influenza	Biological: Cell-derived influenza vaccine Biological: Egg-derived influenza virus vaccine Biological: Placebo	Phase III

MedlinePlus related topics: Flu

Drug Information available for: Influenza Vaccines Fluvirin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Single Blind (Subject), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Phase III, Randomized, Observer-Blind, Placebo-Controlled, Multicenter Study to Assess Clinical Efficacy of a Cell-Derived Subunit Influenza Vaccine and an Egg-Derived Subunit Influenza Vaccine in the 2007-2008 Influenza Season in Healthy Adult Subjects

Further study details as provided by Novartis:

Primary Outcome Measures:

Protection of a cell-derived influenza vaccine or of an egg-derived influenza vaccine compared to placebo against illness caused by virus-confirmed community-acquired influenza wild type strains antigenically similar to those contained in the vaccines [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Protection against illness caused by all virus-confirmed community-acquired influenza wild type strains regardless of antigenic match to those contained in the vaccines [ Time Frame: 6 month ] [ Designated as safety issue: No ]
Collection of local and systemic reactions as well as all AEs and collection of all SAEs. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Seroprotection and by percentage of subjects achieving seroconversion [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	11700
Study Start Date:	October 2007
Estimated Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Biological: Cell-derived influenza vaccine 1 dose 0.5 ml cell-derived influenza vaccine, administered in the deltoid muscle
2: Experimental	Biological: Egg-derived influenza virus vaccine 1 dose 0.5ml egg-derived influenza virus vaccine, administered in the deltoid muscle
3: Placebo Comparator	Biological: Placebo 1 dose 0.5mkl of phosphate buffered solution

Eligibility

Ages Eligible for Study:	18 Years to 49 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

healthy subjects 18 to 49 years of age;
able to comply with all study procedures, including availability and willingness to be actively followed throughout the ensuing influenza season with weekly telephone calls and to comply with the need for prompt collection of nasal and throat specimens in the event of influenza symptoms.

Exclusion Criteria:

history of anaphylaxis or serious reaction after administration of any vaccine, or hypersensitivity to any vaccine component;
any health condition for which the inactivated vaccine is recommended by the Advisory Committee on Immunization Practices (ACIP) including chronic diseases of the pulmonary or cardiovascular systems (including asthma), chronic metabolic diseases (including diabetes), renal dysfunction, hemoglobinopathies, immune deficiency disease (including HIV infection) or on-going immunosuppressive therapy;
employment in professions prone to influenza transmission to or from high-risk populations; or living in the same household as an immunocompromised person;
receipt of another investigational agent within 90 days, or receipt of another vaccine within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to Visit 1;
laboratory-confirmed influenza disease or receipt of an influenza vaccine within 6 months prior to Visit 1;
pregnant or breast-feeding females or females of childbearing potential and sexually active, that did not use any of the birth control methods for at least 2 months prior to study entry and/or refusing to use a reliable contraceptive method during the first 3 weeks after vaccination;
research staff directly involved with the clinical study or family members or household members of research staff.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00630331

Show 56 Study Locations

Sponsors and Collaborators

Novartis

Novartis Vaccines

Investigators

Study Chair:

Novartis Vaccines

More Information

Responsible Party:	Novartis Vaccines ( Novartis )
Study ID Numbers:	V58P13, 2007-002871-15, 11580
Study First Received:	February 28, 2008
Last Updated:	March 28, 2008
ClinicalTrials.gov Identifier:	NCT00630331
Health Authority:	United States: Food and Drug Administration; Finland: National Agency for Medicines; Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products

Keywords provided by Novartis:

Influenza
Flu
Cell Culture-Derived
Egg-Derived
Healthy Adults
Efficacy

Safety
Immunogenicity
Trivalent
Inactivated
Influenza-Like Illness
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:

RNA Virus Infections

ClinicalTrials.gov processed this record on January 15, 2009