A/H1N1 Immunogenicity and Safety in Adults

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

408 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2010-04-30

Brief Summary

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The purpose of the study is to obtain immunogenicity and safety data at different dose levels of an investigational H1N1 pandemic influenza vaccine in healthy adults 18 years of age and older.

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Detailed Description

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Conditions

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Influenza Pandemic Influenza

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Cohort 1/Dose Level A

Subjects in Cohort 1 will be randomized 1:1 to receive two vaccinations of Dose A or Dose B of H1N1 pandemic influenza vaccine at a 21-day interval.

Group Type EXPERIMENTAL

H1N1 pandemic influenza vaccine (whole virion, Vero Cell-derived, inactivated)

Intervention Type BIOLOGICAL

Two injections at a 21-day interval (Days 1 and 22)

Cohort 1/Dose B

Subjects in Cohort 1 will be randomized 1:1 to receive two vaccinations of Dose A or Dose B of H1N1 pandemic influenza vaccine at a 21-day interval.

Group Type EXPERIMENTAL

H1N1 pandemic influenza vaccine (whole virion, Vero Cell-derived, inactivated)

Intervention Type BIOLOGICAL

Two injections at a 21-day interval (Days 1 and 22)

Cohort 2/Dose C

A second cohort may be enrolled with all subjects in this cohort receiving two vaccinations of Dose C of H1N1 pandemic influenza vaccine at a 21-day interval.

Group Type EXPERIMENTAL

H1N1 pandemic influenza vaccine (whole virion, Vero Cell-derived, inactivated)

Intervention Type BIOLOGICAL

Two injections at a 21-day interval (Days 1 and 22)

Interventions

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H1N1 pandemic influenza vaccine (whole virion, Vero Cell-derived, inactivated)

Two injections at a 21-day interval (Days 1 and 22)

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Subject is 18 to 59 years old (age stratum A) or 60 years of age or older (age stratum B) at the time of screening
* Subject has an understanding of the study, agrees to its provisions, and gives written informed consent prior to study entry
* Subject is generally healthy, as determined by the investigator's clinical judgment through collection of medical history and the performance of a physical examination
* Subject is physically and mentally capable of participating in the study and willing to adhere to study procedures to include completion of all elements of the study diary
* If female of childbearing potential, subject has a negative urine pregnancy test result within 24 hours prior to the scheduled first vaccination and agrees to employ adequate birth control measures for the duration of the study

Exclusion Criteria

* Subject has participated in another clinical study involving an investigational drug, biological product or device within 30 days prior to study enrollment or is scheduled to participate in another clinical study involving an investigational drug, biological or device during the course of this study
* Subject has a history of exposure to A/H1N1/California/07/2009 virus or a history of vaccination with A/H1N1/California/07/2009 antigen or a closely related influenza virus antigen
* Subject has inherited or acquired immune deficiency
* Subject currently has or has a recent history of significant neurological, cardiovascular or pulmonary (including asthma), hepatic, metabolic, rheumatic, autoimmune, hematological or renal disorder

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes