Trial to Assess Long-Term Persistence of Antibodies after GSK Meningococcal ABCWY Vaccination and Response to a Booster in Adolescents

Phase 1

• Conditions: Meningococcal diseases; MedDRA version: 20.1Level: PTClassification code 10027202Term: Meningitis bacterialSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2016-002230-69-FI
• Lead Sponsor: GlaxoSmithKline Biologicals S.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-09-16
• Last Update Posted: 18 June 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 852

Inclusion Criteria

Follow-on Participants
• Subjects from Finland and Poland previously enrolled in study V102_15 who have received all planned meningococcal vaccinations in the study
• Who have not received any additional meningococcal vaccination since the last meningococcal vaccination administered in the parent trial.
• Who have given written informed consent or assent (as applicable) after the nature of the study has been explained according to local regulatory requirements, prior to study entry. If the subject is under age 18 at the time of enrollment, the parent(s)/ legal guardian(s) of the subject should have given their written consent.
• Individuals of who the investigator believes can and will comply with the requirements of the protocol (e.g. use of an eDiary, return for follow-up visits, available for phone contacts).
• Individuals in good health as determined by the outcome of medical history, physical examination and clinical judgment of the investigator.

Naive Group
• Male and female individuals of similar age (approximately 12-20 years) to follow-on subjects from V102_15 trial.
• Who have not received any meningococcal vaccination since birth
• Individuals who have given their written informed consent or assent (as applicable) after the nature of the study has been explained according to local regulatory requirements, prior to study entry. If the subject is under age 18 at the time of enrollment, the parent(s)/ legal guardian(s) of the subject should have given their written consent.
• Individuals of who the investigator believes can and will comply with the requirements of the protocol (e.g. use of an eDiary, return for follow-up visits, available for phone contacts).
• Individuals in good health as determined by the outcome of medical history, physical examination and clinical judgment of the investigator.

Are the trial subjects under 18? yes
Number of subjects for this age range: 852
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

Follow-on Participants:
• History of any meningococcal vaccine administration since last meningococcalvaccination administered in V102_15 parent study.
• Current or previous, confirmed or suspected disease caused by N. meningitidis, since termination from parent study.
• Household contact with and/or intimate exposure to an individual with any laboratory confirmed N. meningitidis infection within 60 days of enrollment.
• If the subject is female of childbearing potential, sexually active, and has not used any of the acceptable contraceptive methods for at least 2 months prior to study entry and for the duration of the trial.
• Pregnancy or breast-feeding.
• History of severe allergic reactions after previous vaccinations or hypersensitivity to any vaccine component including diphtheria toxoid (CRM197) and latex.
• Progressive, unstable or uncontrolled clinical conditions.
• Any confirmed or suspected condition with impaired/altered function of immune system (immunodeficient or autoimmune conditions).
• Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within three months prior to the study vaccination or planned use throughout the study period. (For corticosteroids, this means prednisone, or equivalent, = 20 mg/day. Inhaled, intranasal and topical steroids are allowed).
• Administration of blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation in the 3 months prior to study enrolment.
• Received an investigational or non-registered medicinal product within 30 days prior to informed consent.
• Administration of any vaccine within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to enrollment in the study, or within 7 days after vaccination in the study.
• Clinical conditions representing a contraindication to intramuscular vaccination and/or blood draws.
• Who have received systemic antibiotic treatment within 3 days prior to any blood draw.
• Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the subject due to participation in the study.

Naive Individuals
• History of any meningococcal vaccine administration since birth.
• Current or previous, confirmed or suspected disease caused by N. meningitidis.
• Household contact with and/or intimate exposure to an individual with any laboratory confirmed N. meningitidis infection within 60 days of enrollment.
• If the subject is female of childbearing potential, sexually active, and has not used any of the acceptable contraceptive methods1 for at least 2 months prior to study entry and for the duration of the trial.
• Pregnancy or breast-feeding.
• History of severe allergic reactions after previous vaccinations or hypersensitivity to any vaccine component including diphtheria toxoid (CRM197) and latex.
• Progressive, unstable or uncontrolled clinical conditions.
• Any confirmed or suspected condition with impaired/altered function of immune system (immunodeficient or autoimmune conditions).
• Chronic administration (defined as more than 5 days) of immunosuppressants or other immune-modifying drugs within 30 days prior to the study enrolment. (For corticosteroids, this means prednisone, or equivalent, = 20 mg/kg/day. Inhaled, intranasal and topical steroids are allowed).
• Administration of blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation in the past 3 mo

Study & Design

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