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

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 3

Conditions: Infections, Meningococcal

Treatments: Biological: Meningococcal conjugate vaccine GSK134612

Study type: Interventional

Funder types: Industry

Identifiers

NCT01777308

116727

2012-002575-34 (EudraCT Number)

Details and patient eligibility

About

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).

Enrollment: 156 patients

Sex: All

Ages: 84 to 95 months old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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156 participants in 2 patient groups

Menitorix Group

Experimental group

Description:

Subjects who were primed with Menitorix™ (Hib-MenC-TT) + Priorix™ (MMR) vaccines in the primary study HIB-MENC-TT-016 (NCT00326118) received one dose of Nimenrix™ (MenACWY-TT) booster vaccine at Month 72 post primary vaccination (booster visit 1). The MenACWY-TT vaccine was administered intramuscularly (IM) in the deltoid region of the non-dominant arm.

Treatment:

Biological: Meningococcal conjugate vaccine GSK134612

Meningitec + Hiberix Group

Experimental group

Description:

Subjects who were primed with Meningitec™ (MCC) + Hiberix™ (Hib) + Priorix™ (MMR) vaccine in the primary study HIB-MENC-TT-016 (NCT00326118) received one dose of Nimenrix™ (MenACWY-TT) booster vaccine at Month 72 post primary vaccination (booster visit 1). The MenACWY-TT vaccine was administered intramuscularly (IM) in the deltoid region of the non-dominant arm.

Treatment:

Biological: Meningococcal conjugate vaccine GSK134612