WHO ICTRP trial
A phase II, observer-blind, randomized study to evaluate the immunogenicity…
EUCTR2006-000554-46-FI · EU Clinical Trials Register · Not Recruiting
Key facts
| Trial ID | EUCTR2006-000554-46-FI |
|---|---|
| Public title | A phase II, observer-blind, randomized study to evaluate the immunogenicity, safety and reactogenicity of GlaxoSmithKline (GSK) Biologicals’ combined DSSITGDPa-HBV-IPV/Hib vaccine containing diphtheria toxoid from the Statens Serum Institute (SSI) of Denmark and tetanus toxoid from GSK Biologicals’ Kft [GD], compared to the currently licensed GSK Biologicals’ DTPa-HBV-IPV/Hib vaccine (Infanrix hexa) when administered to healthy infants at 2, 3 and 4 months of age. - DTPa-HBV-IPV-116 |
| Scientific title | A phase II, observer-blind, randomized study to evaluate the immunogenicity, safety and reactogenicity of GlaxoSmithKline (GSK) Biologicals’ combined DSSITGDPa-HBV-IPV/Hib vaccine containing diphtheria toxoid from the Statens Serum Institute (SSI) of Denmark and tetanus toxoid from GSK Biologicals’… |
| Primary sponsor | GlaxoSmithKline Biologicals |
| Registry | EU Clinical Trials Register |
| Recruitment status | Not Recruiting |
| Study type | Interventional clinical trial of medicinal product |
| Countries | Finland |
| Conditions | Primary immunization of healthy infants in the first year of life against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and Haemophilus influenzae type b diseases. |
| Interventions | Product Name: Diphtheria, tetanus, acellular pertussis, hepatitis B, poliomyelitis and H. influenzae type b vaccin Product Code: DTPa-HBV-IPV/Hib Pharmaceutical Form: Suspension for injection INN or Proposed INN: diphtheria toxoid Current… |
| Registration date | May 6, 2006 |
| Target size | 450 |
| Secondary IDs | 106786 |
| Registry page | clinicaltrialsregister.eu |
At a glance
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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: