Trial to Investigate Immune Responses Elicited by a Liquid Formulation of Influenza Virus Vaccine(CAIV-T)in Healthy Adults Aged 18 to 59 and Healthy Adults Aged 60 Years and Older
This study has been completed.
Sponsor:
MedImmune LLC
Collaborator:
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by:
MedImmune LLC
ClinicalTrials.gov Identifier:
NCT00192153
First received: September 12, 2005
Last updated: October 23, 2006
Last verified: October 2006
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Purpose
The purpose of this clinical study was to evaluate immune responses measuring antibodies in serum and secretions and cellular immune responses generated by CAIV-T vaccine in healthy adults aged 18 years and older as a means to develop assays for application in investigating potential immunological correlates of protection and/or establishing assays to measure vaccine take.
| Condition | Intervention | Phase |
|---|---|---|
|
Influenza |
Biological: CAIV-T or TIV |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Prevention |
| Official Title: | A Randomized, Partially-Blinded, Placebo-Controlled Trial to Investigate Immune Responses Elicited by a Liquid Formulation of Influenza Virus Vaccine, (CAIV-T) in Healthy Adults 18 to 59 Years and Healthy Adults,60 Years/Older |
Resource links provided by NLM:
Further study details as provided by MedImmune LLC:
Primary Outcome Measures:
- To perform a variety of immunological assays using blood, serum, nasal washed an cells for application in the further investigation of immune responses generated by influenza virus vaccine, trivalent, types A and B, live, cold-adapted.
| Estimated Enrollment: | 240 |
| Study Start Date: | July 2001 |
| Estimated Study Completion Date: | October 2001 |
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Healthy adults aged 18 to 59 years or > 60 years.
- Female subjects of childbearing potential who had a negative urine pregnancy test result prior to study vaccination. Females who were surgically sterile or post-menopausal did not require pregnancy testing.
- Adults who were determined by medical history, physical examination and clinical judgment eligible for this study. Subjects with stable pre-existing disease, defined as disease not requiring change in therapy or hospitalization within 12 weeks before receipt of study vaccination, will be eligible.
- Subjects who provided written informed consent after the nature of the study was explained.
- Subjects who were available for the duration of the study (from enrollment to study completion).
- Subjects who could be reached by study staff for the post-vaccination contact [via telephone, clinic or home visit].
Exclusion Criteria:
- For subjects > 60 years of age only:
- Subjects who resided in a nursing home or long-term care facility or other institution receiving skilled or semi-skilled nursing care. An ambulatory subject who resided in a retirement home or village was eligible for participation.
- Subjects with evidence of dementia or other severe cognitive impairment based on Mini Mental State Examination (MMSE) scores. Note: Prior to study vaccination, all subjects >60 years of age must have completed a MMSE.
For all study subjects:
- Subjects who were perceived to be unavailable or difficult to contact for evaluation of study visits during the study period.
- Subjects with a known or suspected disease of the immune system or those receiving immunosuppressive therapy, including systemic corticosteroids; or cytotoxic agents.
- Subjects who resided in the same household as an immunosuppressed or immunocompromised individual.
- Subjects with a documented history of hypersensitivity to egg or egg protein or any other component of the study vaccine, placebo or TIV.
- Subjects who had a current wheezing episode that was considered a change from the subject’s usual clinical state.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00192153
Locations
| United States, Florida | |
| West Coast Medical Associates | |
| New Port Richey, Florida, United States, 34652 | |
| United States, Virginia | |
| University of VA Health Sciences Center | |
| Charlottesville, Virginia, United States, 22908 | |
Sponsors and Collaborators
MedImmune LLC
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
| Principal Investigator: | Robert Walker, MD | MedImmune LLC |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00192153 History of Changes |
| Other Study ID Numbers: | D153 P003 |
| Study First Received: | September 12, 2005 |
| Last Updated: | October 23, 2006 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Influenza, Human Orthomyxoviridae Infections RNA Virus Infections |
Virus Diseases Respiratory Tract Infections Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on May 16, 2013