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NCT01730144
Studying Cell Immune Responses to a Live Flu Vaccine in Healthy Adults
trial in Normal Physiology in 10 participants. Completed in 12 July 2019.
17 April 2013
Quick facts
| Lead sponsor | National Institute of Allergy and Infectious Diseases (NIAID) |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 10 |
| Start date | 17 November 2012 |
| Primary completion | 17 April 2013 |
| Estimated completion | 12 July 2019 |
| Sites | 1 location across United States |
Conditions studied
- Normal Physiology — all drugs for Normal Physiology →
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Who can join
Adults 18 to 49, any sex, with Normal Physiology. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Background: \- One form of the influenza vaccine is a nasal spray. It uses a live but weakened flu virus. Researchers want to better under how the live vaccine interacts with the body s immune system. They will test the nasal spray flu vaccine (called FluMist) against a saline (salt water) nasal spray. They will then look at blood and nasal cell samples to see how the vaccine affects these cells immune response. Objectives: \- To look at immune changes in nasal and blood cells in people who receive live flu vaccine. Eligibility: \- Healthy volunteers between 18 and 49 years of age. Design: * Participants will have five outpatient visits for this study. Each visit will last up to 2 hours. * At the first visit, participants will have a physical exam and medical history. They will give blood and urine samples. Nasal cell samples will also be collected. * A week later, participants will have either the nasal spray flu vaccine or a saline spray. They will know which spray they will receive. Blood samples will be collected. * Two days after the vaccination, they will have another physical exam. Blood and nasal cell samples will be collected. * At the final two visits (1 week and 1 month after the vaccination), more blood samples will be collected. * Those who had the saline spray will be able to have the actual vaccine spray at the last study visit. * The ratio of participants who receive vaccine to those who receive saline will be 4:1.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT01730144
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT01730144 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by National Institute of Allergy and Infectious Diseases (NIAID)
- Last refreshed: 18 October 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01730144.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing