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NCT00345904
A Phase III Study for Evaluation of Immunogenicity and Reactogenicity of Fluarix™ (Influsplit SSW®) 2006/2007 in People Aged 18 Years or Above
Phase 3 trial testing Fluarix in Influenza in 120 participants. Completed in 1 August 2006.
Quick facts
| Lead sponsor | GlaxoSmithKline |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | single group |
| Masking | none |
| Primary purpose | prevention |
| Enrollment | 120 |
| Start date | 1 July 2006 |
| Estimated completion | 1 August 2006 |
| Sites | 4 locations across Germany |
Drugs / interventions tested
- Fluarix
Conditions studied
- Influenza — all drugs for Influenza →
Sponsor
GlaxoSmithKline — full company profile →
Who can join
18 and older, any sex, with Influenza. Healthy volunteers can join.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
- to evaluate the humoral immune response in terms of anti-Haemmagglutinin antibodies 21 days post-vaccination
Sponsor's own description
Vaccination is currently the most effective mean of controlling influenza and preventing its complications and mortality in persons at risk. Because of the variable nature of influenza viruses, the composition of influenza vaccines changes almost every year, to target the 3 main circulating strains. Each year the influenza vaccine formulation may thus be different and clinical studies are mandated to ensure that the immunogenicity and safety of the vaccine formulated from the three annual circulating strains are similar to what was observed during the previous years. This study is designed to test the immunogenicity and reactogenicity of the Fluarix™ vaccine containing the influenza strains recommended for the 2006-2007 season.
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 NCT00345904
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Fluarix
Trials testing the same drug.
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- NCT01711736 — Study to Evaluate Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Quadrivalent Influenza Vaccine GSK2282 · Phase 3 · completed
- NCT01096056 — Trial to Evaluate the Safety and the Immunogenicity of GSK Biologicals' Influenza Vaccine GSK2186877A in Healthy Childre · Phase 1 · completed
Other recruiting trials for Influenza
Currently open trials in the same condition.
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- NCT07302256 — A Clinical Trial of Influenza Virus Split Vaccine for Individuals Aged 60 Years and Above · Phase 1 · recruiting
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Other GlaxoSmithKline trials
Trials by the same sponsor.
- NCT07569081 — A Study Evaluating the Efficacy and Safety of Momelotinib in Participants With Vacuoles, E1-enzyme, X-linked, Autoinflam · Phase 2, PHASE3 · not yet recruiting
- 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 NCT00345904 (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 GlaxoSmithKline
- Last refreshed: 27 September 2016
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/NCT00345904.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing