Immunogenicity, Reactogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' MenACWY-TT Vaccine Administered 6 Years Post-MenC Primary Vaccination in Healthy Subjects Who Were 12-18 Months at Primary Vaccination
This trial is active, not recruiting.
|Treatment||meningococcal conjugate vaccine gsk134612|
|Start date||May 2013|
|End date||July 2014|
|Trial size||156 participants|
|Trial identifier||NCT01777308, 116727, 2012-002575-34|
The purpose of this study is to evaluate the immunogenicity, reactogenicity and safety of a booster dose of GSK Biologicals' MenACWY-TT vaccine administered at 6 years post-primary vaccination with either GSK Biologicals' Hib-MenC-TT vaccine (Menitorix™) or Hiberix™ and Meningitec™, in healthy subjects aged 12-18 months at primary vaccination and to evaluate the long-term antibody persistence at 2 years after MenACWY-TT booster vaccination.
This is an extension study of the Hib-MenC-TT-016 study (NCT number: NCT00326118).
|United States||No locations recruiting|
|Other Countries||No locations recruiting|
|Garran, Australia||GSK Investigational Site||no longer recruiting|
|Randwick, Australia||GSK Investigational Site||no longer recruiting|
|Westmead, Australia||GSK Investigational Site||no longer recruiting|
|Herston, Australia||GSK Investigational Site||no longer recruiting|
|Sherwood, Australia||GSK Investigational Site||no longer recruiting|
|North Adelaide, Australia||GSK Investigational Site||no longer recruiting|
|Carlton, Australia||GSK Investigational Site||no longer recruiting|
|Subiaco, Australia||GSK Investigational Site||no longer recruiting|
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
Immunogenicity with respect to the components of the investigational vaccine in terms of vaccine response.
time frame: One month after booster vaccination (Month 73).
Immunogenicity with respect to the components of the investigational vaccine in terms of antibody titres and concentrations.
time frame: One month after booster vaccination (Month 73).
Immunogenicity with respect to the components of the investigational vaccine in terms of antibody titres.
time frame: 2 years after booster vaccination (i.e Month 96).
Occurrence of solicited local and general symptoms.
time frame: Within 4 days (Day 0 - Day 3) following booster vaccination.
Occurrence of unsolicited adverse events, serious adverse events (SAEs), Guillain-Barre syndrome (GBS) and new onset of chronic illness(es) (NOCIs).
time frame: Within 31 days (Day 0 - Day 30) following booster vaccination.
Occurrence of SAEs related to MenACWY-TT booster vaccination or related to study participation or concurrent GSK medication/vaccine or any fatal SAE.
time frame: Through the entire study period (Day 0 to Month 96).
Male or female participants from 84 months up to 95 months old.
Inclusion Criteria: - Subjects' parent(s)/Legally Acceptable Representative(s) who, in the opinion of the investigator, can and will comply, with the requirements of the protocol. - A male or female between, and including, 84 and 95 months of age at the time of the booster vaccination. - Written informed consent obtained from the parent(s)/LAR(s) of the subject and written informed assent obtained from the subject in accordance with local laws and regulations. - Healthy subjects as established by medical history and history-directed physical examination before entering into the study. - Having completed the vaccination in the study [Hib-MenC-TT-016 (106445)] as per protocol. Exclusion Criteria: - Child in care. - Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the dose of study vaccine, or planned use during the study period. - Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the vaccine dose. For corticosteroids, this will mean prednisone ≥ 0.5 mg/kg/day, or equivalent. Inhaled and topical steroids are allowed. - Administration of a vaccine not foreseen by the study protocol within the period starting 30 days before and ending 30 days after the study vaccine dose, with the exception of a licensed inactivated influenza vaccine which can be administered at any time during the study according to the local recommendations. - Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational vaccine/product. - Previous vaccination with meningococcal vaccine except the meningococcal vaccination received in the Hib-MenC-TT-016 study. - History of meningococcal disease. - Any confirmed or suspected immunosuppressive or immunodeficient condition (congenital or secondary), including Human Immunodeficiency Virus (HIV)infection, based on medical history and physical examination (no laboratory testing required). - Family history of congenital or hereditary immunodeficiency. - History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine, and history of serious allergic reaction (anaphylaxis) following the administration of vaccine(s). - Major congenital defects or serious chronic illness. - History of any neurological disorders or seizures, including GBS. History of a simple, single febrile seizure is permitted. - Acute disease and/or fever at the time of enrollment. - Fever is defined as temperature ≥ 37.5°C for oral, axillary or tympanic route, or ≥ 38.0°C for rectal route. The preferred route for recording temperature in this study will be oral. - Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever may be enrolled at the discretion of the investigator. - Administration of immunoglobulins and/or any blood products within the 3 months preceding the study vaccination or planned administration during the booster vaccination phase of the study (i.e. between Visit 1 and Visit 2) and within 3 months preceding the blood sampling at Visit 3. The following criteria should be checked for the long-term persistence phase at two years after booster vaccination (Visit 3): In case an exclusion criterion becomes applicable, the subject will not enter the long-term follow-up and the reason will be documented. - Previous administration of a meningococcal vaccine with the exception of the meningococcal vaccination given in the primary study and the booster vaccination in this particular study. - History of meningococcal disease.
|Official title||The Vaccine Response and Long-term Antibody Persistence of GSK Biologicals' MenACWY-TT Vaccine (GSK134612) Administered as One Dose at 6 Years Post-MenC Primary Vaccination in Healthy Subjects Aged 12-18 Months at Primary Vaccination|
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