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 study is currently recruiting participants.
Verified March 2014 by GlaxoSmithKline
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01777308
First received: January 24, 2013
Last updated: March 27, 2014
Last verified: March 2014
  Purpose

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 and 4 years after MenACWY-TT booster vaccination.

This is an extension study of the Hib-MenC-TT-016 study (NCT number: NCT00326118).


Condition Intervention Phase
Infections, Meningococcal
Biological: Meningococcal conjugate vaccine GSK134612
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Immunogenicity with respect to the components of the investigational vaccine in terms of vaccine response. [ Time Frame: One month after booster vaccination (Month 73). ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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). ] [ Designated as safety issue: No ]
  • Immunogenicity with respect to the components of the investigational vaccine in terms of antibody titres. [ Time Frame: 2 and 4 years after booster vaccination (i.e Month 96 and Month 120 respectively). ] [ Designated as safety issue: No ]
  • Occurrence of solicited local and general symptoms. [ Time Frame: Within 4 days (Day 0 - Day 3) following booster vaccination. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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 120). ] [ Designated as safety issue: No ]

Estimated Enrollment: 260
Study Start Date: May 2013
Estimated Study Completion Date: September 2018
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: HibMenC group
Subjects vaccinated with Hib-MenC-TT + Priorix in the primary study.
Biological: Meningococcal conjugate vaccine GSK134612
Single dose to be administrated intramuscularly in the deltoid of the non-dominant arm.
Experimental: Hib+MCC group
Subjects vaccinated with Meningitec + Hiberix + Priorix in the primary study.
Biological: Meningococcal conjugate vaccine GSK134612
Single dose to be administrated intramuscularly in the deltoid of the non-dominant arm.

  Eligibility

Ages Eligible for Study:   84 Months to 95 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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 and Visit 4.

The following criteria should be checked for the long-term persistence phase at two and four years after booster vaccination (Visit 3 and Visit 4):

In case an exclusion criterion becomes applicable, the subject will not enter the long-term follow-up of that particular year 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01777308

Contacts
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com

Locations
Australia, Australian Capital Territory
GSK Investigational Site Recruiting
Garran, Australian Capital Territory, Australia, 2606
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Australia, New South Wales
GSK Investigational Site Recruiting
Randwick, New South Wales, Australia, 2031
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Recruiting
Westmead, New South Wales, Australia, 2145
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Australia, Queensland
GSK Investigational Site Recruiting
Herston, Queensland, Australia, 4029
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Australia, South Australia
GSK Investigational Site Recruiting
North Adelaide, South Australia, Australia, 5006
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Australia, Victoria
GSK Investigational Site Recruiting
Carlton, Victoria, Australia, 3053
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Australia, Western Australia
GSK Investigational Site Recruiting
Subiaco, Western Australia, Australia, 6008
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01777308     History of Changes
Other Study ID Numbers: 116727, 2012-002575-34
Study First Received: January 24, 2013
Last Updated: March 27, 2014
Health Authority: Australia : Therapeutic Goods Administration (TGA)

Keywords provided by GlaxoSmithKline:
Immunogenicity
Booster
Healthy
Vaccine response
Safety
Neisseria meningiditis
Antibody persistence
Meningococcal conjugate vaccine

Additional relevant MeSH terms:
Meningococcal Infections
Neisseriaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on April 15, 2014