FLU-VACS Comparative Study in Adults
Public ClinicalTrials.gov record NCT00133523. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Comparative Study of Influenza Vaccines in Adults - FLU-VACS
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study is to compare 2 licensed flu vaccines to each other and to placebo (inactive substance). The study will be conducted among healthy adult participants aged 18-49 years and is expected to last 3 years. During year 1, participants will be assigned to receive 1 of the 2 licensed flu vaccines or placebo, given as either nasal spray (live-attenuated vaccine or placebo) or injection (inactivated vaccine or placebo). Participants will receive the same assigned vaccine or placebo during year 2. During year 3, participants will be followed, but will not receive flu vaccine. Each year blood samples will be collected before and 1 month after each vaccination and at the end of each flu season in order to measure how the body responds to the vaccine and how well participants were protected from the flu. During the flu season, participants with flu-like illness will provide information on symptoms and provide a throat swab to test for virus identification.
Study identification
- NCT ID
- NCT00133523
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 4
- Enrollment
- 2,349 participants
Conditions and interventions
Conditions
Interventions
- Cold-adapted live attenuated influenza virus vaccine, trivalent Biological
- Placebo Other
- Trivalent inactivated influenza vaccine Biological
Biological · Other
Eligibility (public fields only)
- Age range
- 18 Years to 49 Years
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 30, 2004
- Primary completion
- Jun 30, 2007
- Completion
- Jun 30, 2007
- Last update posted
- Dec 4, 2014
2004 – 2007
United States locations
- U.S. sites
- 6
- U.S. states
- 1
- U.S. cities
- 5
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Ann Arbor West | Ann Arbor | Michigan | 48103 | — |
| University of Michigan | Ann Arbor | Michigan | 48109-2029 | — |
| Western Michigan University Health Services | Kalamazoo | Michigan | 49008 | — |
| Livonia East | Livonia | Michigan | 48150 | — |
| Central Michigan University Health Services | Mount Pleasant | Michigan | 48859 | — |
| Eastern Michigan University Health Services | Ypsilanti | Michigan | 48197 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00133523, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Dec 4, 2014 · Synced Sep 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00133523 live on ClinicalTrials.gov.