An Open Label Phase 1/2 Study to Assess Immunogenicity and Safety of Different Dose Levels of H1N1 Pandemic Influenza Vaccine in Healthy Adults Aged 18 Years and Older

Resilience Government Services, Inc.5 sites in 2 countries408 target enrollmentAugust 2009

ConditionsInfluenza Pandemic Influenza

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Influenza
Sponsor: Resilience Government Services, Inc.
Enrollment: 408
Locations: 5
Primary Endpoint: Number of subjects achieving antibody levels to A/H1N1/California/07/2009 virus that meet the definition of seroprotection and seroconversion at 21 days after the second vaccination
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

August 2009

End Date

April 2010

Last Updated

10 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Resilience Government Services, Inc.

Eligibility Criteria

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

Outcomes

Primary Outcomes

Number of subjects achieving antibody levels to A/H1N1/California/07/2009 virus that meet the definition of seroprotection and seroconversion at 21 days after the second vaccination

Time Frame: 42 days