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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 ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01777308
First received: January 24, 2013
Last updated: September 25, 2014
Last verified: August 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 ]

Enrollment: 156
Study Start Date: May 2013
Estimated Study Completion Date: September 2018
Primary Completion Date: July 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01777308

Locations
Australia, Australian Capital Territory
GSK Investigational Site
Garran, Australian Capital Territory, Australia, 2606
Australia, New South Wales
GSK Investigational Site
Randwick, New South Wales, Australia, 2031
GSK Investigational Site
Westmead, New South Wales, Australia, 2145
Australia, Queensland
GSK Investigational Site
Herston, Queensland, Australia, 4029
Australia, South Australia
GSK Investigational Site
North Adelaide, South Australia, Australia, 5006
Australia, Victoria
GSK Investigational Site
Carlton, Victoria, Australia, 3053
Australia, Western Australia
GSK Investigational Site
Subiaco, Western Australia, Australia, 6008
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: September 25, 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
Bacterial Infections
Gram-Negative Bacterial Infections
Neisseriaceae Infections

ClinicalTrials.gov processed this record on November 25, 2014