Last reviewed · How we verify
NCT01511419
Reactogenicity, Safety and Immunogenicity of a Live Monovalent A/17/Mallard/Netherlands/00/95 (H7N3) Influenza Vaccine
Phase 1 trial testing LAIV H7N3 in Influenza in 40 participants. Completed in 1 July 2012.
1 June 2012
Quick facts
| Lead sponsor | PATH |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | prevention |
| Enrollment | 40 |
| Start date | 1 April 2012 |
| Primary completion | 1 June 2012 |
| Estimated completion | 1 July 2012 |
| Sites | 1 location across Russia |
Drugs / interventions tested
- LAIV H7N3 — full drug profile →
- placebo
Conditions studied
- Influenza — all drugs for Influenza →
- Avian Influenza — all drugs for Avian Influenza →
Sponsor
PATH — full company profile →
Who can join
Adults 18 to 49, any sex, with Influenza or Avian Influenza. Healthy volunteers can join.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Number of Participants With Immediate Reactions
Time frame: 2 hours post-administration on Days 0 and 28
From administration of any dose, immediate reaction measured as observed by study staff or reported by the subject to study staff in case of an anaphylactic reaction. -
Adverse Events Associated With Intranasal Vaccination
Time frame: Greater than 2 hours through 7 days following any dose
From solicited local and systemic reactions -
All Other Adverse Events
Time frame: 7 days following any dose
Including unsolicited events and abnormal laboratory findings -
Participants With Serious Adverse Events (SAEs)
Time frame: Within 4 weeks of receipt of any dose
Including abnormal laboratory findings
Sponsor's own description
The study hypothesis is that two doses of cold-adapted, live monovalent A/17/mallard/Netherlands/00/95 (H7N3) influenza vaccine will be safe and immunogenic in healthy adults.
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 NCT01511419
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Trials by the same sponsor.
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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 NCT01511419 (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 PATH
- Last refreshed: 22 January 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/NCT01511419.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing