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

This study has been completed.
Sponsor:
Information provided by:
Solvay Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00599443
First received: January 10, 2008
Last updated: June 27, 2008
Last verified: June 2008
  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 1

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:


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 April 15, 2014