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.

Phase 1

• Conditions: Active immunization against invasive meningococcal diseases caused by Neisseria meningitidis serogroups A, C, W-135 and Y; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2012-002575-34-Outside-EU/EEA
• Lead Sponsor: GlaxoSmithKline Biologicals

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-07-23
• Last Update Posted: 3 October 2016

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 156

Inclusion Criteria

•Subjects’ parent(s)/Legally Acceptable Representative(s) [LAR(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 study HIB-MENC-TT-016 (106445) as per protocol.
Are the trial subjects under 18? yes
Number of subjects for this age range: 156
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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 (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs within six months prior to the vaccine dose.
•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 (pharmaceutical product or device).
•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 Guillain-Barré syndrome (GBS). History of a simple, single febrile seizure is permitted.
•Acute disease and/or fever at the time of enrollment.
•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):
•Previous administration of a meningococcal vaccine with the exception of the meningococcal vaccination given in HIB-MENC-TT-016 and the booster vaccination in this particular study.
•History of meningococcal disease

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified