Immunogenicity and Safety of Trivalent Recombinant Hemagglutinin Influenza Vaccine in Healthy Adults
Evaluation of the Immunogenicity and Safety of Two Preparations of Trivalent Recombinant Baculovirus-Expressed Hemagglutinin Influenza Vaccine Administered Intramuscularly in Healthy Adults Ages 18-49 Years.
1 other identifier
interventional
459
1 country
3
Brief Summary
The purpose of this study was to determine the dose-related safety, immunogenicity, and protective efficacy of a trivalent recombinant hemagglutinin influenza vaccine in healthy adults.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Nov 2004
Shorter than P25 for phase_2
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2005
CompletedFirst Submitted
Initial submission to the registry
May 17, 2006
CompletedFirst Posted
Study publicly available on registry
May 19, 2006
CompletedJanuary 12, 2010
January 1, 2010
9 months
May 17, 2006
January 8, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Evaluation of safety and reactogenicity of trivalent recombinant hemagglutinin influenza vaccine in healthy adults aged 18-49 years
influenza season
Secondary Outcomes (2)
Evaluation of the protective efficacy of a trivalent recombinant hemagglutinin influenza vaccine at two different formulations in healthy adults aged 18-49 years
influenza season
Evaluation of the immunogenicity of the H1 and B components when formulated at either 15μg or 45μg per component in healthy adults aged 18-49 years
28 days
Study Arms (3)
Low Dose
EXPERIMENTALRecombinant Trivalent Hemagglutinin Influenza Vaccine, 2004/05 formulation containing 45μg of each hemagglutinin derived from A/Wyoming/3/03(H3N2) and 15μg from A/New Caledonia/20/99(H1N1) and B/Jiangsu/10/03
Full Dose
EXPERIMENTALRecombinant Trivalent Hemagglutinin Influenza Vaccine, 2004/05 formulation containing 45μg of each hemagglutinin derived from A/Wyoming/3/03(H3N2), A/New Caledonia/20/99(H1N1) and B/Jiangsu/10/03
Placebo
PLACEBO COMPARATOR0.9% Sodium Chloride
Interventions
0.5mL dose for IM injection
Eligibility Criteria
You may qualify if:
- Medically stable adults, aged 18-49 years.
- Provided informed consent prior to any study procedures.
- Able to comply with all study procedures.
- Available for follow-up for the duration of the influenza season.
- Women of child-bearing potential had a negative urine pregnancy test at the time of randomization and were willing to use an adequate form of contraception during the course of the study.
You may not qualify if:
- Any history of immunodeficiency or treatment with immunosuppressive medications. (Use of inhaled steroids or of topical steroids was not considered immunosuppressive; receipt of systemic glucocorticosteroids was not allowed if daily intake was \>10 mg of prednisone or equivalent).
- Presence of high-risk conditions or other characteristics considered to be indications for influenza vaccination, as defined by the Advisory Committee on Immunization Practices (ACIP).
- Acute febrile illness (defined as having a temperature ≥100degreesF) or upper respiratory tract illness within 72 hours of vaccination.
- Use of experimental vaccines or any influenza vaccine after May 31st 2004 for the 2005 Southern Hemisphere or 2004 to 2005 Northern hemisphere epidemic seasons.
- Use of any experimental medication within 30 days prior to study vaccination
- Women who were pregnant or breast-feeding.
- Subjects with a history of Guillain-Barré syndrome.
- Receipt of parenteral immunoglobulin within 30 days prior to study vaccination.
- Any acute or chronic condition that, in the opinion of the investigator, would render vaccination unsafe or interfere with the evaluation of response.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Rochester Medical Center
Rochester, New York, 14642, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229, United States
University of Virginia Health System
Charlottesville, Virginia, 22908, United States
Related Publications (1)
Treanor JJ, Schiff GM, Hayden FG, Brady RC, Hay CM, Meyer AL, Holden-Wiltse J, Liang H, Gilbert A, Cox M. Safety and immunogenicity of a baculovirus-expressed hemagglutinin influenza vaccine: a randomized controlled trial. JAMA. 2007 Apr 11;297(14):1577-82. doi: 10.1001/jama.297.14.1577.
PMID: 17426277RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
John Treanor, MD
University of Rochester
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
May 17, 2006
First Posted
May 19, 2006
Study Start
November 1, 2004
Primary Completion
August 1, 2005
Study Completion
August 1, 2005
Last Updated
January 12, 2010
Record last verified: 2010-01