Study to assess the immunogenicity and safety of GSK's meningococcal group B vaccine when administered concomitantly with GSK's meningococcal MenACWY conjugate vaccine in healthy subjects of 16-18 years of age.

Phase 1

• Conditions: Active immunization against invasive meningococcal disease caused by 5 different serogroups of N. meningitidis by concomitant administration of meningococcal group B vaccine and meningococcal MenACWY conjugate vaccine; MedDRA version: 20.0Level: PTClassification code 10027199Term: MeningitisSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2016-003722-16-IT
• Lead Sponsor: GLAXOSMITHKLINE BIOLOGICALS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-08-02
• Last Update Posted: 30 August 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 945

Inclusion Criteria

Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol or/and 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.
• Previous vaccination with 1 dose of quadrivalent meningococcal
conjugate vaccine (MenACWY, Menveo or Menactra) at least 4 years
prior to informed consent and assent as applicable.
• Written or /witnessed/thumb printed informed consent obtained
from the subject/parent(s)/LAR(s) of the subject prior to performance
of any study specific procedure.
• Written informed assent obtained from the subject (if applicable)
along with informed consent from the subject's parent(s)/LAR(s) prior
to performing any study specific procedure.
• A male or female between, and including, 16 and 18 years of age at
the time of the first vaccination.
• Healthy subjects as established by medical history and clinical
examination before entering into the study.
• Female subjects of non-childbearing potential may be enrolled in the
study. Non-childbearing potential is defined as pre-menarche, current
bilateral tubal ligation or occlusion, hysterectomy, bilateral
ovariectomy or post-menopause.
• Female subjects of childbearing potential may be enrolled in the
study, if the subject:
has practiced adequate contraception for 30 days prior to vaccination,
and
has a negative pregnancy test on the day of vaccination, and
has agreed to continue adequate contraception during the entire
treatment period and for 2 months after completion of the vaccination
series.
Are the trial subjects under 18? yes
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 500
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Medical conditions
• Progressive, unstable or uncontrolled clinical conditions.
• Clinical conditions representing a contraindication to intramuscular
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 study vaccination. This will
mean prednisone =20 mg/day (for adult subjects) or =0.5 mg/kg/day
or 20 mg/day whichever is the maximum dose for paediatric subjects,
or equivalent. Inhaled and topical steroids are allowed.
Administration of antineoplastic or immunomodulating agents or
radiotherapy within 90 days prior to informed consent.
• Are obese at screening (obesity is defined as a BMI of = 95th
percentile for age and gender).
• Any other clinical condition that, in the opinion of the investigator,
XML File Identifier: LC2h0w8o+1kUDrK+HIYC3dHFyec=
Page 17/30
might pose additional risk to the subject due to participation in the
study.
• History of any reaction or hypersensitivity likely to be exacerbated by
any component of the vaccines.
• History of any reaction or hypersensitivity likely to be exacerbated by
any medicinal products or medical equipment whose use is foreseen in
this study.
• Current or previous, confirmed or suspected disease caused by N.
meningitidis.
• Known contact to an individual with any laboratory-confirmed N.
meningitidis infection within 60 days, prior to enrolment.
• History of neuroinflammatory or autoimmune condition.
• Recurrent history or un-controlled neurological disorders or seizures.
Prior/Concomitant therapy
• Use of any investigational or non-registered product other than the
study vaccine(s) during the period starting 30 days before the informed
consent or planned use during the study period.
• Administration of immunoglobulins and/or any blood products or
plasma derivatives during the period starting 180 days before the
informed consent or planned administration during the study period.
• Previous vaccination with any group B meningococcal vaccine at any
time prior to informed consent and assent as applicable.
• Previous vaccination with 2 doses of quadrivalent meningococcal
conjugate vaccine (MenACWY, Menveo or Menactra).
Prior/Concurrent clinical study experience
• Subject 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,
will not be enrolled.
Other exclusions
• Child in care.
• Pregnant or lactating female.
• Female planning to become pregnant or planning to discontinue
contraceptive precautions.
• Any study personnel or immediate dependants, family, or household
member.

Study & Design

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