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NCT01659086
Study to Evaluate the Safety and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Influenza Vaccines GSK2654911A and GSK2654909A Administered to Adults 18 to 64 Years of Age
Phase 1 trial testing Investigational H9N2 vaccine GSK2654911A in Influenza in 422 participants. Completed in 19 March 2014.
26 October 2012
Quick facts
| Lead sponsor | GlaxoSmithKline |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | prevention |
| Enrollment | 422 |
| Start date | 22 August 2012 |
| Primary completion | 26 October 2012 |
| Estimated completion | 19 March 2014 |
| Sites | 4 locations across Canada, United States |
Drugs / interventions tested
- Investigational H9N2 vaccine GSK2654911A — full drug profile →
- Investigational H9N2 vaccine GSK2654909A — full drug profile →
- Placebo
Conditions studied
- Influenza — all drugs for Influenza →
Sponsor
GlaxoSmithKline — full company profile →
Who can join
Adults 18 to 64, any sex, with Influenza. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The purpose of this study is to evaluate the safety, reactogenicity, and immunogenicity of different formulations of a two-dose primary series and booster vaccination of monovalent Influenza H9N2 vaccine manufactured in Quebec, Canada with and without adjuvant, in adults 18 to 64 years of age.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Pandemic preparedness through vaccine development for avian influenza viruses.
Cargnin Faccin F, Perez DR. · · 2024 · cited 34× · PMID 38807261 · DOI 10.1080/21645515.2024.2347019 -
Evaluation of a primary course of H9N2 vaccine with or without AS03 adjuvant in adults: A phase I/II randomized trial.
Madan A, Collins H, Sheldon E, Frenette L, et al · · 2017 · cited 11× · PMID 28720281 · DOI 10.1016/j.vaccine.2017.07.013
Verify or expand the search:
- PubMed search for NCT01659086
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other GlaxoSmithKline trials
Trials by the same sponsor.
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- NCT07406347 — A Trial to Evaluate the Safety and Reactogenicity of an Investigational Pneumococcal Vaccine in Infants Receiving 3-dose · Phase 1 · not yet recruiting
- NCT07286266 — A Study to Investigate GSK5733584 Compared With Chemotherapy in Participants With Platinum-resistant Ovarian Cancer (BEH · Phase 3 · not yet recruiting
- NCT07286331 — A Study to Investigate GSK5733584 Compared With Chemotherapy in Participants With Recurrent Endometrial Cancer (BEHOLD-E · Phase 3 · not yet recruiting
- NCT07406334 — A Trial to Evaluate the Safety and Reactogenicity of an Investigational Pneumococcal Vaccine in Toddlers 12 to 15 Months · Phase 1 · not yet recruiting
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 NCT01659086 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by GlaxoSmithKline
- Last refreshed: 18 June 2018
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/NCT01659086.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing