A Phase III, Randomized, Controlled, Observer-Blind, Single-Center Study to Evaluate the Consistency of Three Consecutive Lots of a Trivalent Subunit Influenza Vaccine Produced in Embryonated Hen Eggs in Healthy Subjects Aged 18 to 49 Years
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 1,507
- Locations
- 2
- Primary Endpoint
- Geometric Mean Titers (GMTs), by Vaccine Lots
Study Overview
Brief Summary
The purpose of this research is to demonstrate immunologic equivalence of three consecutive production lots of the subunit influenza vaccine compared to egg-derived inactivated influenza vaccine in healthy subjects 18 to 49 years of ages. In addition, this study is to show how safe and well tolerated a conventional inactivated subunit influenza vaccine, licensed in many countries outside the United States, is compared to an inactivated influenza vaccine, licensed in the United States.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 49 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •18 to 49 years of age;
- •In good health as determined by medical history and physical examination;
- •Able and willing to provide written informed consent prior to any study procedure;
- •Able to comply with all study procedures and available for all clinic visits scheduled in the study.
Exclusion Criteria
- •Any serious disease, such as: cancer, autoimmune disease (including rheumatoid arthritis), advanced arteriosclerotic disease or complicated diabetes mellitus
- •History of any anaphylaxis, serious vaccine reactions, or hypersensitivity to eggs, egg protein, chicken feathers, influenza viral protein, neomycin, polymyxin, or any other vaccine component, chemically related substance, or component of the potential packaging materials (latex);
- •Known or suspected impairment/alteration of immune function
- •Receipt of an influenza vaccine within 6 months prior to Visit 1;
- •Current drug or alcohol abuse or a history of drug or alcohol abuse that in the investigator's opinion would interfere with safety of the subject or the evaluation of the study objectives;
- •Laboratory-confirmed influenza disease within 6 months prior to Visit 1
Arms & Interventions
Influenza virus vaccine (lot A)
Lot A of the investigational influenza virus vaccine
Intervention: Lot A of Influenza virus vaccine (Biological)
Influenza virus vaccine (lot B)
Lot B of the investigational influenza virus vaccine
Intervention: Lot B of Influenza virus vaccine (Biological)
Influenza virus vaccine (lot C)
Lot C of the investigational influenza virus vaccine
Intervention: Lot C of Influenza virus vaccine (Biological)
Influenza virus vaccine (pooled)
Pooled data of all three lots (Lot A, B and C) of the investigational influenza virus vaccine
Intervention: All 3 consecutive lots of influenza virus vaccine pooled (Biological)
Comparator influenza vaccine
A US licensed influenza virus vaccine
Intervention: Comparator influenza virus vaccine (Biological)
Outcomes
Primary Outcomes
Geometric Mean Titers (GMTs), by Vaccine Lots
Time Frame: 21 days after vaccination
The immunologic equivalence of three consecutive production lots of the influenza virus vaccine was measured in terms of GMTs for all vaccine influenza strains.
Secondary Outcomes
- Geometric Mean Titers (GMTs), by Vaccine Group and Strain(21 days after vaccination)
- Number of Subjects Reporting Solicited Local and Systemic Symptoms(7 days after vaccination)
- Number of Subjects With at Least One Unsolicited Adverse Event(3 weeks after vaccination)
- Percentage of Subjects With Seroprotection and Seroconversion (Strain A/H1N1)(21 days after vaccination)
- Percentage of Subjects With Seroprotection and Seroconversion (Strain A/H3N2)(21 days after vaccination)
- Percentage of Subjects With Seroprotection and Seroconversion (Strain B)(21 days after vaccination)