Completed clinical studies
A phase IV, randomised, observer-blind, placebo-controlled, multi-centre study to evaluate the efficacy, safety and tolerability of CSL Limited’s Influenza Virus Vaccine in adults aged 18 to 65 years (Protocol No. CSLCT-USF-06-28)
Description/Overview: To demonstrate that the efficacy of CSL’s influenza virus vaccine (IVV) versus placebo (vaccine diluent) in the prevention of laboratory confirmed influenza A/B is significantly >40% in healthy adults.
Approving authority: The Children’s Hospital at Westmead Human Research Ethics Committee (HREC)
Sponsor: CSL Limited
Project start date: 3 March 2008
Project end date: 25 February 2009
Enrolments: CLOSED
Information brochure: not available
Vaccination Phase: A Phase III, open, randomised, controlled, multi-centre study to demonstrate the non-inferiority of the meningococcal serogroup C and the Haemophilus influenzae type b immune response of GlaxoSmithKline (GSK) Biologicals’ conjugate Hib-MenC vaccine co-administered with GSK Biologicals’ measles-mumps-rubella vaccine, Priorix, versus MenC-CRM197 conjugate vaccine co-administered with GSK Biologicals’ Hib vaccine, Hiberix, and Priorix in 12–18-month old toddlers primed in infancy with a Hib vaccine but not with a meningococcal serogroup C vaccine; and to evaluate the long-term antibody persistence up to 5 years after the administration of the Hib-MenC vaccine (Protocol No. 106445)
Description/Overview: Primary immunisation against meningococcal serogroup C and booster immunisation against Haemophilus influenzae type b diseases of healthy children aged 12-18 months of age. This study has two phases: the vaccination phase 106445 (HibMenC-TT-016) and the long-term persistence phase (HibMenC-TT-017 Ext: 016 to HibMenC-TT-21 Ext: 016) with assessments of long-term protection at 1, 2, 3, 4 and 5 years after vaccination. This is the Vaccination Phase of the study.
Approving authority: The Children’s Hospital at Westmead Human Research Ethics Committee (HREC)
Sponsor: GlaxoSmithKline Biologicals
Project start date: May 2006
Project end date: May 2007
Enrolments: CLOSED
Information brochure: not available
Long-term Persistence Phase: A phase III, open, randomised, controlled, multi-centre study to demonstrate the non-inferiority of the meningococcal serogroup C and the Haemophilus influenzae type b immune response of GlaxoSmithKline (GSK) Biologicals’ conjugate Hib-MenC vaccine co-administered with GSK Biologicals’ measles-mumps-rubella vaccine, Priorix, versus MenC-CRM197 conjugate vaccine co-administered with GSK Biologicals’ Hib vaccine, Hiberix, and Priorix in 12-18 month old toddlers primed in infancy with a Hib vaccine but not with a meningococcal serogroup C vaccine; and to evaluate the long-term antibody persistence up to 5 years after the administration of the Hib-MenC vaccine (Protocol No. 106446)
Description/Overview: This study has two phases: the vaccination phase 106445 (HibMenC-TT-016) and the long term persistence phase (HibMenC-TT-017 Ext: 016 to HibMenC-TT-21 Ext: 016) with assessments of long-term protection at 1, 2, 3, 4 and 5 years after vaccination. This is the Long-term Persistence Phase of the study.
Approving authority: The Children’s Hospital at Westmead Human Research Ethics Committee (HREC)
Sponsor: GlaxoSmithKline Biologicals
Project start date: 28 August 2007
Project end date: 28 August 2008
Enrolments: CLOSED
Information brochure: not available
A phase IV, open, multicentric study to evaluate the immune response to a hepatitis B challenge dose in healthy subjects, 72 to 78 months after they received a primary vaccination course of GSK Biologicals’ Engerix-B (thiomersal-free 20ug or preservative-free 10ug) vaccine, in the primary study HBV-280 (Protocol No. 108988 [HBV-314])
Description/Overview: Assess the immune response to a challenge dose of hepatitis B vaccine administered in subjects who previously received a complete hepatitis B primary vaccination course, 72–78 months ago in the HBV-280 study.
Approving authority: The Children’s Hospital at Westmead Human Research Ethics Committee (HREC)
Sponsor: GlaxoSmithKline Biologicals
Project start date: 3 October 2007
Project end date: September 2008
Enrolments: CLOSED
Information brochure: not available
An open, phase IV, non randomised, single-centre study with two groups to assess the immunogenicity and reactogenicity of a booster dose of GlaxoSmithKline (GSK) Biologicals’ combined reduced antigen content diphtheria-tetanus toxoids and acellular pertussis vaccine (Boostrix), when administered in adults, 10 years after previous booster vaccination in study 263855/002 (dTpa-002) (Protocol No. 110804 [dTpa (Boostrix)-039 Ext:002 Y10])
Description/Overview: To evaluate the persistence of antibodies against all vaccine antigens and to evaluate the immunogenicity and reactogenicity of a second dTpa booster dose.
Approving authority: Sydney West Area Health Service Human Research Ethics Committee
Sponsor: GlaxoSmithKline Biologicals
Project start date: 15 October 2007
Project end date: July 2008
Enrolments: CLOSED
Information brochure: not available
