Safety Study of Recombinant M2e Influenza-A Vaccine in Healthy Adults

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

87 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-07-31

Study Completion Date

2009-02-28

Brief Summary

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This multi-center study will be conducted in the United States with up to 80 healthy adult subjects. Subjects will be scheduled to receive a total of two (2) injections with 1 injection each administered.

Subjects will be randomized according to a randomization scheme.

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Detailed Description

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All subjects will be followed up for 60 days post-randomization and through the influenza season. Following the influenza season, a subset of the subjects will receive a booster vaccine at the 12 month time point. The subjects will further be assessed at 2 days, 7 days, 15 days, 30 days and 6 months following the booster vaccination.

Conditions

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Influenza

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Study Group 1

ACAM-FLU-A low dose + Adjuvant 1

Group Type EXPERIMENTAL

Influenza A Vaccine: ACAM FLU-A

Intervention Type BIOLOGICAL

0.5 mL ACAM-FLU-A low dose + Adjuvant 1, Intramuscular

Study Group 2

ACAM-FLU-A low dose + Adjuvant 2

Group Type EXPERIMENTAL

Influenza A Vaccine: ACAM FLU-A

Intervention Type BIOLOGICAL

0.5 mL ACAM-FLU-A low dose + Adjuvant 2, Intramuscular

Study Group 3

ACAM-FLU-A low dose

Group Type EXPERIMENTAL

Influenza A Vaccine: ACAM FLU-A

Intervention Type BIOLOGICAL

0.5 mL ACAM FLU-A low dose, Intramuscular

Study Group 4

Saline placebo

Group Type PLACEBO_COMPARATOR

Saline placebo

Intervention Type BIOLOGICAL

0.5 mL, Intramuscular

Interventions

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Influenza A Vaccine: ACAM FLU-A

0.5 mL ACAM-FLU-A low dose + Adjuvant 1, Intramuscular

Intervention Type BIOLOGICAL

Influenza A Vaccine: ACAM FLU-A

0.5 mL ACAM-FLU-A low dose + Adjuvant 2, Intramuscular

Intervention Type BIOLOGICAL

Influenza A Vaccine: ACAM FLU-A

0.5 mL ACAM FLU-A low dose, Intramuscular

Intervention Type BIOLOGICAL

Saline placebo

0.5 mL, Intramuscular

Intervention Type BIOLOGICAL

Other Intervention Names

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ACAM FLU-A ACAM FLU-A ACAM FLU-A USP Saline

Eligibility Criteria

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Inclusion Criteria

* Adult males or females 18 - 40 years of age in good general health

Exclusion Criteria

* Known allergies or severe reactions to any of the vaccine components including those to adjuvants
* History of severe allergic reactions, including angioedema;
* History of asthma or recurrent wheezing; (current or within past 2 years);
* History of neurological symptoms or signs following administration of any vaccine;

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes