A Phase 2, Open-label, Controlled, Multi-Center Extension Study to Evaluate 4-Year Antibody Persistence and Booster Response Fol-lowing MenABCWY Vaccination in Healthy Adolescents and Young Adults who Previously Participated in Studies V102_02 (NCT01210885) and V102_02E1 (NCT01367158).

Phase 1

• Conditions: Healthy volunteers (Immunisation against meningococcal infections); MedDRA version: 19.0Level: SOCClassification code 10021881Term: Infections and infestationsSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2016-004420-29-Outside-EU/EEA
• Lead Sponsor: GlaxoSmithKline Biologicals

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-12-14
• Last Update Posted: 9 January 2017

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 171

Inclusion Criteria

• Individuals who received either 2 doses of MenABCWY+OMV or a single dose of MenACWY followed by a dose of placebo, with the last study vaccine given approximately 48 to 56 months before study V102_02E2 (NCT01367158), who received Tdap only in V102_02E1 (NCT01367158) study and who received no other meningococcal vaccines;
Or
• A proportional number of subjects in each site aged 15 through 23 years on the day of informed consent/assent who did not participate in the V102_02 (NCT01210885) study and have not previously received any meningococcal vaccine.
• Individuals who /whose parent(s)/legal guardian(s) have vol-untarily given written informed consent/assent after the nature of the study has been explained according to local regulatory requirements, prior to study entry.
• Individuals who can comply with study procedures including blood draws and follow-up.
• Males
Or
• Females of non-childbearing potential
Or
• Females of childbearing potential who are not pregnant or breastfeeding and who are using an effective birth control method which they have used for at least 30 days prior to study entry, and which they intend to use for at least 30 days after the last study vaccination.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 171
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 171

Exclusion Criteria

• History of any meningococcal vaccine administration (study group C)
Or
• History of any meningococcal vaccine administration other than vaccination given in the parent V102_02 (NCT01210885) study (study groups A and B).
• Progressive, unstable or uncontrolled clinical conditions.
• Hypersensitivity, including allergy, to any component of vaccines (including diphtheria toxoid (CRM197) and latex) whose use is foreseen in this study.
• Clinical conditions representing a contraindication to intra-muscular vaccination and blood draws.
• Abnormal function of the immune system resulting from:
Clinical conditions.
• Systemic administration of corticosteroids (PO/IV/IM) for more than 14 consecutive days within 90 days prior to enrollment.
• Administration of antineoplastic and immunomodulating agents or radiotherapy within 90 days prior to informed consent.
• Received immunoglobulins or any blood products within 90 days prior to enrollment.
• Received an investigational or non-registered medicinal product within 30 days prior to enrollment.
• Received any other vaccines within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to enrolment in this study or who are planning to receive any vaccine within 14 days from the study vaccines.
• Study personnel as an immediate family or household mem-ber.
• Who have experienced a moderate or severe acute infection and/or fever (defined as temperature >= 38°C) within 3 days prior to enrollment.
• Who have received systemic antibiotic treatment within 3 days prior to enrollment.
• Any other clinical condition that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the subject due to participation in the study.

Study & Design

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