WHO ICTRP trial
Immunogenicity and safety study of GlaxoSmithKline (GSK) Biologicals? influenza…
EUCTR2012-001230-34-ES · EU Clinical Trials Register · Not Recruiting
Key facts
| Trial ID | EUCTR2012-001230-34-ES |
|---|---|
| Public title | Immunogenicity and safety study of GlaxoSmithKline (GSK) Biologicals? influenza vaccine when administered in children who previously participated in study 115345 |
| Scientific title | A phase III, open-label, multicentre study to evaluate the immunogenicity, safety and reactogenicity of a revaccination dose of the GlaxoSmithKline Biologicals' quadrivalent seasonal influenza candidate vaccine GSK2321138A, administered to children who previously participated in study 115345 (FLU… |
| Primary sponsor | GlaxoSmithKline S.A. |
| Registry | EU Clinical Trials Register |
| Recruitment status | Not Recruiting |
| Study type | Interventional clinical trial of medicinal product |
| Phase | Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no |
| Countries | Czech Republic;Poland;Spain;United Kingdom |
| Conditions | Healthy volunteers (Immunization against influenza A and B in children aged 18 to 47 months) MedDRA version: 14.1 Level: LLT Classification code 10022001 Term: Influenza (epidemic) System Organ Class: 10021881 - Infections and infestations… |
| Interventions | Product Name: Vacuna antigripal estacional tetravalente (Flu D-QIV) Product Code: GSK2321138A Pharmaceutical Form: Suspension for injection in pre-filled syringe INN or Proposed INN: Virión fraccionado, inactivado CAS Number: N/A Other… |
| Registration date | Sep 7, 2012 |
| Target size | 452 |
| Secondary IDs | 116023 |
| Registry page | clinicaltrialsregister.eu |
At a glance
- Yes Results available
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About WHO ICTRP trial registrations
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Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: