Status:
COMPLETED
Phase II Study to Investigate the Kinetics of the Immune Response Generated by Influenza Virus Vaccine.
Lead Sponsor:
MedImmune LLC
Collaborating Sponsors:
Wyeth is now a wholly owned subsidiary of Pfizer
Conditions:
Influenza
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
The primary objective of this study was to perform a variety of assays on blood, serum, nasal wash and cell samples obtained from healthy adult subjects for the purposes of developing assays for appli...
Detailed Description
This was a randomized, open-label, placebo-controlled, outpatient study carried out in healthy adults 18 to \< 65 years of age. The study was designed to evaluate the kinetics of the immune responses ...
Eligibility Criteria
Inclusion
- Subjects had to have been at least 18 years of age and less than 65 years of age at the time informed consent was obtained;
- Women of child-bearing potential had to use reliable methods of hormonal and/or nonhormonal contraception (which includes cervical cap, diaphragm, condoms with spermicide or IUD) during sexual intercourse throughout the entire study period; a negative urine pregnancy test (with detection limit of less than or equal to 25mIU/mL) no more than 24 hours prior to vaccine administration; and agreed to avoid pregnancy during participation in the study. A urine pregnancy test was also conducted at the completion of study participation. Females who were surgically sterile at time of enrollment were not required to undergo pregnancy testing.
- who were determined by medical history, physical examination and clinical judgement to be eligible for the study.
- who provided written informed consent after the nature of the study has been explained;
- who were available for one month duration of the trial (from enrollment to study completion);
- who could be reached by study staff for the post-vaccination contact \[telephone, clinic or home visit\].
Exclusion
- who were perceived to be unavailable or difficult to contact for evaluation or study visits during the study period;
- with a known or suspected disease of the immune system or those receiving immunosuppressive therapy, including systemic corticosteroids and intranasal steroids; or cytotoxic agents;
- who had an immunosuppressed or an immunocompromised individual living in the same household;
- who had a documented history of hypersensitivity to egg or egg protein or any other component of the study vaccine or placebo;
- who received any commercially-available or investigational injected influenza vaccine in the 6 months prior to enrollment, or a non-study influenza vaccine since enrollment;
- who previously received an intranasally administered influenza vaccine;
- who had any medical conditions that, in the opinion of the investigator, might interfere with interpretation of the study results;
Key Trial Info
Start Date :
September 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2001
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT00192309
Start Date
September 1 2001
End Date
December 1 2001
Last Update
February 14 2012
Active Locations (1)
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1
David M. Radin, MD
Stamford, Connecticut, United States, 06905