Safety and Tolerability of a Cell-Derived Influenza Vaccine in Healthy Adults Aged ≥18 Years and ≤ 49 Years - Full Text View

Sponsor:	Solvay Pharmaceuticals
Information provided by:	Solvay Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00599443

Purpose

A controlled, double blinded study to determine the safety and reactogenicity in healthy adults of a single dose of a trivalent cell-derived influenza vaccine administered by intramuscular injection.

Condition	Intervention	Phase
Healthy	Biological: Seasonal cell-derived influenza vaccine Biological: Placebo Comparator	Phase I

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Prevention
Official Title:	Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Tolerability of a Cell-Derived Influenza Vaccine in Healthy Adults Aged ≥18 Years and ≤ 49 Years.

Resource links provided by NLM:

MedlinePlus related topics: Flu

Drug Information available for: Fluvirin Influenza Vaccines

U.S. FDA Resources

Further study details as provided by Solvay Pharmaceuticals:

Primary Outcome Measures:

Safety and tolerability of one dose of cell-derived influenza vaccine in healthy adults aged ≧18 years and ≦ 49 years after vaccination. [ Time Frame: 3 weeks ] [ Designated as safety issue: Yes ]
Long-term safety [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

HI antibody titers [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]

Enrollment:	120
Study Start Date:	October 2007
Study Completion Date:	May 2008
Primary Completion Date:	May 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1	Biological: Seasonal cell-derived influenza vaccine 0.5 mL im, single dose
Placebo Comparator: 2	Biological: Placebo Comparator 0.5 mL im, single dose

Eligibility

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

Criteria

Inclusion Criteria:

Healthy female or male subjects aged ≧18 and ≦49 years
Willing and able to give informed consent

Exclusion Criteria:

Influenza vaccination of laboratory confirmed influenza infection within six months of informed consent,
presence of any significant medical condition,
a serious adverse reaction after a previous (influenza) vaccination,
underlying medical conditions for which annual influenza vaccine is recommended by the Advisory Committee on Immunization Practices (ACIP),
chronic diseases requiring long-term immunosuppressive therapy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00599443

Sponsors and Collaborators

Solvay Pharmaceuticals

Investigators

Study Director:

Global Clinical Director Solvay

Solvay Pharmaceuticals

More Information

No publications provided

Responsible Party:	Wil Cramer, Solvay Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00599443 History of Changes
Other Study ID Numbers:	S203.1.001
Study First Received:	January 10, 2008
Last Updated:	June 27, 2008
Health Authority:	United States: Food and Drug Administration

Keywords provided by Solvay Pharmaceuticals:

Cell-derived subunit influenza vaccine
Safety
Reactogenicity

Additional relevant MeSH terms:

Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections

Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on February 09, 2012