Active clinical studies
Organised by project commencement dates:
- 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)
- An unblinded randomised study of influenza A/H1N1 2009 resistance to oseltamivir and zanamivir
- Immunogenicity and safety of acellular pertussis vaccine at birth
- An unblinded randomised study of influenza A/H1N1 2009 resistance under standard and double dose oseltamivir
- Influenza Resistance Information Study (IRIS)
- A phase IV, open label, multi-centre study to evaluate the safety and tolerability of CSL Limited’s influenza virus vaccine in paediatric population aged 6 months to 18 years (Protocol No. CSLCT-USF-06-29)
- Long-term immunity following hepatitis B vaccination in infancy
- Nasopharyngeal carriage of Streptococcus pneumoniae in children with HIV/AIDS and their primary caregivers
- Social, economic and health benefits of vaccinating children in day care against influenza (PIVOT)
- The burden of influenza in patients with recurrent ischaemic vascular events
- Immunogenicity and duration of immunity in immunosuppressed children vaccinated with HPV vaccine
- Economic and social benefits of treating and preventing influenza in aged care facilities
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 2012
Enrolments: CLOSED
Information brochure: Not available
An unblinded randomised study of influenza A/H1N1 2009 resistance to oseltamivir and zanamivir
Description/Overview: Patients with clinical symptoms indicative of influenza, who present within 72 hours of the onset of fever during confirmed influenza activity in the community, will be randomised to receive immediate treatment with oseltamivir or zanamivir according to standard age appropriate dose. Patients will have baseline virus samples taken for typing and oseltamivir and zanamivir sensitivity and also on completion of treatment (after 5 days of treatment).
This study will assess the frequency of emergence of oseltamivir and zanamivir resistant influenza viruses, and their virological characteristics, in patients treated with oseltamivir and zanamivir for influenza caused by A/H1N1 2009 (‘swine flu’) and other human influenza viruses.
Approving authority: Sydney West Area Health Service Human Research Ethics Committee, Westmead Campus
Sponsor: NHMRC Project Grant No: 633032, GSK Australia
Project start date: August 2009
Project end date: December 2010
Enrolments: Enrolling now
More information: Telephone 02 9845 1430
Immunogenicity and safety of acellular pertussis vaccine at birth
Description/Overview: In Australia, some hospitalisations and deaths from whooping cough (pertussis) occur in babies less than 2 months old. At present, pertussis-containing vaccines are first given to babies when they are between 6 and 8 weeks old. The aim of this study is to see if giving babies the pertussis vaccine (Pa vaccine) earlier than 6 weeks old, with the first dose at birth, means that they are better protected. Newborns will be randomised into two groups; (1) those receiving hepatitis B and acellular pertussis vaccine at birth (0–5 days old) and (2) those receiving hepatitis B vaccine only. Antibody responses to pertussis antigens and safety will be measured. This study will be conducted in Sydney, Melbourne, Adelaide and Perth.
Approving authority: The Children's Hospital at Westmead Human Research Ethics Committee (HREC)
Sponsor: NHMRC Project Grant No: 570756
Project start date: June 2009
Project end date: June 2012
Enrolments: To commence in September 2009
Information brochure: PDF
An unblinded randomised study of influenza A/H1N1 2009 resistance under standard and double dose oseltamivir
Description/Overview: This is an unblinded randomised study. Patients with clinical symptoms indicative of influenza, who present within 48 hours of the onset of fever during confirmed influenza activity in the community, will be randomised to receive immediate treatment with oseltamivir at a standard age appropriate dose or a double dose, twice daily for 5 days. Patients will have baseline virus samples taken for typing and oseltamivir sensitivity and also on day 5 of treatment (day 5±1).
This study will assess the frequency of emergence of oseltamivir resistant viruses, and their virological characteristics, in patients treated with standard and double dose oseltamivir for influenza caused by A/H1N1 2009 (‘swine flu’) and other human influenza viruses.
Approving authority: The Children’s Hospital at Westmead Human Research Ethics Committee (HREC)
Sponsor: Investigator initiated, funded by Roche Products Pty Ltd
Project start date: June 2009
Project end date: February 2011
Enrolments: Enrolling now
More information: Telephone 02 9845 1430
Influenza Resistance Information Study (IRIS)
Description/Overview: This is a prospective, multi-centre study to examine natural prevalence and/or emergence of resistance to antivirals among influenza virus isolates and of the clinical outcome of patients with influenza.
The primary objective is to assist in early detection of influenza resistant to antivirals and describe the clinical outcome of patients infected with influenza according to subtype and susceptibility.
Approving authority: The Children’s Hospital at Westmead Human Research Ethics Committee (HREC)
Sponsor: Hoffmann-La Roche Inc.
Project start date: April 2009
Project end date: March 2012
Enrolments: Enrolling now
More information: Telephone 02 9845 1430
A phase IV, open label, multi-centre study to evaluate the safety and tolerability of CSL Limited’s influenza virus vaccine in paediatric population aged 6 months to 18 years (Protocol No. CSLCT-USF-06-29)
Description/Overview: CSL’s influenza virus vaccine (CSL’s IVV) is a trivalent, purified, inactivated, split virion vaccine. The vaccine contains the influenza A and B virus strains recommended by the World Health Organization (WHO) for the upcoming influenza season. CSL’s IVV is approved by the Therapeutic Goods Administration (TGA) in Australia for the prevention of influenza in adults and in children aged 6 months and older. The dosage regimen and route of administration proposed in this protocol is as per the TGA approved conditions for the vaccine.
CSL’s IVV was approved by the Food and Drug Administration (FDA) in the USA under accelerated approval regulations on the basis that further adequate and well-controlled confirmatory clinical studies be performed to verify and describe clinical benefit. CSL has committed to conduct several post-marketing clinical studies, including this study which is being conducted to assess vaccine safety and tolerability in a paediatric population.
Approving authority: The Children’s Hospital at Westmead Human Research Ethics Committee (HREC)
Sponsor: CSL Limited
Project start date: 2 March 2009
Project end date: 31 December 2009
Enrolments: CLOSED
Information brochure: PDF
Long-term immunity following hepatitis B vaccination in infancy
Description/Overview: A second risk period of exposure to hepatitis B occurs during adolescence. This study aims to measure the persistence of hepatitis B immunity in adolescents who received hepatitis B vaccines at birth and in infancy and measure responses to a booster dose of hepatitis B vaccine to assess for immune memory.
Approving authority: The Children's Hospital at Westmead Human Research Ethics Committee (HREC)
Sponsor: NHMRC Project Grant No: 396700
Project start date: 2008
Project end date: June 2010
Enrolments: OPEN (2007–2010)
Information brochure: not available
Nasopharyngeal carriage of Streptococcus pneumoniae in children with HIV/AIDS and their primary caregivers
Description/Overview: This study aims to determine the serotype distribution of pneumococcal carriage among HIV-infected children and their primary caregivers in Muheza, Tanzania, to assess the potential benefit of pneumococcal vaccination.
Approving authority: The Children’s Hospital at Westmead Human Research Ethics Committee (HREC) and the National Institute of Medical Research, Tanzania
Sponsor: Wyeth Pharmaceuticals, Collegeville, Pennsylvania, USA
Project start date: 2008
Project end date: 2010
Enrolments: in Tanzania
Information brochure: not available
Social, economic and health benefits of vaccinating children in day care against influenza (PIVOT)
Description/Overview: To determine the social, economic and health benefits of influenza prevention in pre-school children attending day care centres during two consecutive influenza seasons. This study will determine both direct child benefits (protection, continuity of day care) and indirect advantages – reductions in disruption to childcare work absences, illness and psychosocial distress in the extended family (staff, parents).
Approving authority: The Children’s Hospital at Westmead Human Research Ethics Committee (HREC)
Sponsor: Australian Research Council (ARC) Linkage Project LP0884126, Sanofi Pasteur and KU Children’s Services
Project start date: November, 2008
Project end date: 30 April 2011
Enrolments: OPEN (Recruitment Period March 2009 to 31 July 2009; March 2010 to 31 July 2010)
Information brochure: PDF
The burden of influenza in patients with recurrent ischaemic vascular events
Description/Overview: A case-control study which aims to investigate whether influenza infection is a significant and unrecognised underlying precipitant of acute ischaemic events and stroke during the winter season. The study is being conducted at Westmead Hospital during the winter season of 2009; subjects will be recruited from Cardiology, the Stroke Unit, and the eye and fracture outpatient clinics. This study will be a major contribution to new knowledge and directly inform national and international policy debate.
Approving authority: Sydney West Area Health Service Human Research Ethics Committee, The Children’s Hospital at Westmead and the University of Sydney
Sponsor: GlaxoSmithKline Biologicals
Project start date: 27 June 2008
Project end date: June 2012
Enrolments: OPEN
Information brochure: not available
Immunogenicity and duration of immunity in immunosuppressed children vaccinated with HPV vaccine
Description/Overview: Genital HPV is the necessary cause for cervical cancer, as well as a major contributing cause of several other cancers and conditions. There are now effective vaccines against the main oncogenic HPV types, HPV16 and 18. Most research and discussion has focused around targeting the vaccine to young women and older adolescents. Based on this, a national free HPV vaccination program for adolescent girls commenced in 2007. There is no research on the use of this vaccine in immunosuppressed individuals. Therefore, information on the immunogenicity, safety and duration of efficacy of HPV vaccine when administered to immunosuppressed children is needed.
The aim of this study is to determine the immunogenicity, safety and persistence of immunity following HPV vaccination in three groups of immunosuppressed children: recipients of allogenic bone marrow transplants, recipients of liver transplants, and patients with inflammatory bowel disease who are on long-term immunosuppressive therapy.
Approving authority: The Children’s Hospital at Westmead Human Research Ethics Committee (HREC)
Sponsor: CSL Limited
Project start date: 22 April 2007
Project end date: End of 2009
Enrolments: OPEN
Information brochure: not available
Economic and social benefits of treating and preventing influenza in aged care facilities
Description/Overview: To assess the value of the anti-influenza drug oseltamivir (Tamiflu) for treatment only, compared with its use for both treatment and prevention, for staff and residents of aged care facilities (ACFs) during an influenza outbreak; to collect data on the emergence of drug resistance to oseltamivir; to model the best use of oseltamivir when planning for influenza outbreaks in : a) aged care facilities, projecting for the ageing Australian population, and b) the likely forthcoming global pandemic of influenza.
Approving authority: The Children’s Hospital at Westmead Human Research Ethics Committee (HREC)
Sponsor: Australian Research Council (ARC) Linkage Project LP0668279, Moran Health Care Group and Roche Products Pty Ltd
Project start date: March 2006
Project end date: 30 April 2009
Enrolments: CLOSED
Information brochure: not available
