Study to Evaluate the Consistency of Three Consecutive Production Lots of Influenza Vaccine in Healthy Subjects 18 to 49 Years Old

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1507 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

Study Completion Date

2008-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Influenza

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Influenza virus vaccine (lot A)

Lot A of the investigational influenza virus vaccine

Group Type EXPERIMENTAL

Lot A of Influenza virus vaccine

Intervention Type BIOLOGICAL

1 injection of the trivalent subunit influenza virus vaccine (lot A) administered intramuscularly

Influenza virus vaccine (lot B)

Lot B of the investigational influenza virus vaccine

Group Type EXPERIMENTAL

Lot B of Influenza virus vaccine

Intervention Type BIOLOGICAL

1 injection of the trivalent subunit influenza virus vaccine (lot B) administered intramuscularly

Influenza virus vaccine (lot C)

Lot C of the investigational influenza virus vaccine

Group Type EXPERIMENTAL

Lot C of Influenza virus vaccine

Intervention Type BIOLOGICAL

1 injection of the trivalent subunit influenza virus vaccine (lot C) administered intramuscularly

Influenza virus vaccine (pooled)

Pooled data of all three lots (Lot A, B and C) of the investigational influenza virus vaccine

Group Type EXPERIMENTAL

All 3 consecutive lots of influenza virus vaccine pooled

Intervention Type BIOLOGICAL

1 injection of the pooled trivalent subunit influenza virus vaccine administered intramuscularly

Comparator influenza vaccine

A US licensed influenza virus vaccine

Group Type ACTIVE_COMPARATOR

Comparator influenza virus vaccine

Intervention Type BIOLOGICAL

1 injection of the trivalent subunit influenza virus vaccine administered intramuscularly

Interventions

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Lot A of Influenza virus vaccine

1 injection of the trivalent subunit influenza virus vaccine (lot A) administered intramuscularly

Intervention Type BIOLOGICAL

Lot B of Influenza virus vaccine

1 injection of the trivalent subunit influenza virus vaccine (lot B) administered intramuscularly

Intervention Type BIOLOGICAL

Lot C of Influenza virus vaccine

1 injection of the trivalent subunit influenza virus vaccine (lot C) administered intramuscularly

Intervention Type BIOLOGICAL

Comparator influenza virus vaccine

1 injection of the trivalent subunit influenza virus vaccine administered intramuscularly

Intervention Type BIOLOGICAL

All 3 consecutive lots of influenza virus vaccine pooled

1 injection of the pooled trivalent subunit influenza virus vaccine administered intramuscularly

Intervention Type BIOLOGICAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

49 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes