Safety and reactogenicity of GSK Biologicals’ DTPa-IPV/Hib (Infanrix-IPV/Hib) in infants To assess the safety and reactogenicity of the study vaccine administered as a three-dose primary vaccination course.

• Pays Aucun
• Organes Aucun
• Spécialités Aucune

Long Term Follow-up (LTFU) study 16-20 yrs after vaccine dose of hepatitis b with/without Hepatitis B immunoglobulin (HBIG) in newborns to Hepatitis B envelope antigen positive (HBeAg+) mothers To evaluate the anti-Hepatitis Bs persistence up to Year 20 after the first vaccine dose of the primary vaccination. To evaluate the prevalence and incidence of other Hepatitis B markers (Hepatitis B...

• Pays Aucun
• Organes Aucun
• Spécialités Aucune

A phase II, observer-blind, randomized trial to evaluate the safety and immunogenicity of a two-dose schedule of the A/California/7/2009 (H1N1)v-like candidate vaccine manufactured in Dresden adjuvanted with AS03A in adults aged 18 to 60 years To evaluate the humoral response of two doses of the H1N1 vaccine (A/California/7/2009 (H1N1)v-like) containing an antigen-sparing dose of HA with AS03A in terms of haemagglutination inhibition (HI) a...

• Pays Aucun
• Organes Aucun
• Spécialités Aucune

A phase II, open, controlled study to evaluate the reactogenicity and the immunogenicity of GlaxoSmithKline Biologicals AS25 adjuvanted influenza vaccine (FluAS25) in elderly adults previously vaccinated in FluAS25-003 clinical trial with the same candidate vaccine. Fluarix™ administered in young and elderly adults will be used as reference To evaluate in elderly adults, the safety and reactogenicity of repeated vaccination with FluAS25, during 21 days following the intramuscular administration of the vaccine. Fluarix administered to you...

• Pays Aucun
• Organes Aucun
• Spécialités Aucune

A Phase IIIA, open, randomized study to assess immunogenicity and safety of Fluarix™/Influsplit SSW® 2010/2011 or Pandemrix™ vaccination in adults aged 18 years and above previously vaccinated with one dose of Pandemrix™ To evaluate the humoral response in terms of haemagglutination inhibition (HI) antibodies against each influenza vaccine strain corresponding to the influenza vaccine administered, at Day 21, in subje...

• Pays Aucun
• Organes Aucun
• Spécialités Aucune

A phase III, randomised, observer-blind, multicentre study to evaluate the immunogenicity and safety of a 2-dose vaccination with the new process manufactured adjuvanted pandemic H1N1 influenza candidate vaccine in children aged 3 to 9 years old To evaluate whether the humoral immune response of the 3.75 µg dosage with AS03A H1N1 candidate vaccine meets or exceeds the CHMP criteria at 21 days post-dose 2 vaccination. To evaluate whether the h...

• Pays Aucun
• Organes Aucun
• Spécialités Aucune

Study to evaluate the efficacy, safety and immunogenicity of two or three doses of GSK Biologicals’ oral live attenuated human rotavirus (HRV) vaccine given concomitantly with routine EPI vaccinations in healthy infants To determine if the GSK Biologicals' HRV vaccine (pooled HRV groups) given concomitantly with routine EPI vaccinations can prevent severe RV GE (>11 on the 20-point Vesikari scoring system) caused by ...

• Pays Aucun
• Organes Aucun
• Spécialités Aucune

The long-term antibody persistence of GSK Biologicals’ MenACWY-TT vaccine (GSK134612) versus Mencevax ACWY in healthy ado-lescents and adults and booster response to MenACWY-TT vaccine administered at 10 years post-primary vaccination • To evaluate the long-term persistence of the serum bactericidal (antibody) titers induced by MenACWY-TT vaccine as compared to Mencevax ACWY when administered to individuals 11-55 years of age in te...

• Pays Aucun
• Organes Aucun
• Spécialités Aucune

A phase IIIB, partially blind, randomized study to evaluate the immunogenicity and safety of GlaxoSmithKline Biologicals’ measles-mumps-rubella-varicella vaccine (MeMuRu-OKA) given to healthy children during the second year of life following a 4-week and a 12-month interval between two doses Primary objective To assess the immunogenicity of a 4-week interval and a 12-month interval between two doses of MeMuRu-OKA 42-56 days after the second dose for all antigens.

• Pays Aucun
• Organes Aucun
• Spécialités Aucune

Cross-vaccination study of GSK Biologicals’ Herpes Zoster subunit (HZ/su) vaccine (GSK 1437173A) in subjects who previously received placebo in ZOSTER-006 (NCT01165177) and ZOSTER-022 (NCT01165229) studies To evaluate the safety, in terms of unsolicited adverse events (AE), Serious Adverse Events (SAE) and potential Immune Mediated Disease (pIMD) in all subjects, following administration of each dose of...

• Pays Aucun
• Organes Aucun
• Spécialités Aucune