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


Study comparing two influenza treatments for people aged 13 to 65 years

Can you or someone you know help us with this study? 

Even if you don’t have influenza right now; you can pre-register your interest in this study by contacting our friendly and experienced nurses today.

Helen Knight 9845 1430
Pamela Cheung 9845 1408
Elizabeth Clarke 9845 1437
Nurses’ mobile 0418 209 323

Then you can fully enrol in the study later if you get influenza.
Anyone aged 13 to 65 years can join. 

Even if you have not pre-registered your interest before you get sick with influenza you can still call us when you are ill.

Why pre-register your interest?
If you pre-register your interest in this study we will provide you with extra information about the study so you can think about participating before you are ill with the flu.
As soon as you think you have influenza symptoms you must act fast if you wish to join the study. You can be included in the study only if your symptoms have been present for less than 48 hours. Starting treatment even earlier may also mean that your symptoms can be controlled earlier.

If you have the flu right now
Please contact us immediately by telephone. You must act fast if you want to participate in the study. 

Other ways you can help
People do not always hear about our studies. Please pass this information along to others who may be able to help.

- See more on our Active Clinical Studies page.