Study to Assess Effectiveness of GlaxoSmithKline's (GSK's) Meningococcal Group B and Combined ABCWY Vaccines in Healthy Adolescents and Young Adults.

  • STATUS
    Recruiting
  • End date
    Jun 30, 2022
  • participants needed
    3651
  • sponsor
    GlaxoSmithKline
Updated on 1 May 2021
Investigator
US GSK Clinical Trials Call Center
Primary Contact
GSK Investigational Site (9.4 mi away) Contact
+100 other location
vaccination
conjugate vaccine
bexsero
menacwy

Summary

The purpose of this study is to evaluate the effectiveness of 2 doses or 3 doses of GSK's licenced meningococcal group B Bexsero (rMenB+OMV NZ) vaccine and of 2 doses of GSK's investigational combined meningococcal (MenABCWY) vaccine (GSK3536819A) in healthy adolescents and young adults. The immunogenicity and safety will also be evaluated in the study.

Description

As per the feedback from Center for Biologics Evaluation and Research (CBER) the scope of this post-marketing commitment study has been extended to demonstrate the effectiveness, immunogenicity and safety of GSK's investigational combined meningococcal ABCWY vaccine along with the rMenB+OMV NZ vaccine. Note that the rMenB+OMV and MenACWY vaccines provided to MenB_0_2_6, MenB_0_6 group and MenACWY group respectively at day 211 are only as part of standard care of treatment and to maintain blinding. These vaccination schedules are not considered for any endpoint evaluations.

Details
Condition Meningococcal infection
Treatment Placebo, rMenB+OMV NZ vaccine, Meningococcal Groups A, C, W and Y Conjugate Vaccine (MenACWY), MenABCWY-1, MenABCWY-2, MenABCWY-3
Clinical Study IdentifierNCT04502693
SponsorGlaxoSmithKline
Last Modified on1 May 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Subjects 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
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) prior to performing any study specific procedure
A male or female between, and including, 10 and 25 years of age (i.e. 25 years + 364 days) at the time of the first vaccination
Healthy subjects as established by medical history physical examination and clinical judgment of the investigator before entering into the study
Subjects who are either unvaccinated with MenACWY vaccine or have received a single previous dose of MenACWY vaccine can participate in the study, if they have received it at least 4 years prior to informed consent and assent as applicable (with the exception of meningococcal C vaccination, if the last dose of MenC was received at 24 months of age)
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 until 30 days after completion of Visit 6
A female is considered to be of non-childbearing potential prior to menarche and after natural or induced menopause. Natural menopause is recognized to have occurred after 12 consecutive months of amenorrhea for which there is no other obvious pathological or physiological cause. Induced menopause is recognized to have occurred after hysterectomy, after bilateral oophorectomy, or iatrogenic ablation of ovarian function

Exclusion Criteria

Medical conditions
Current or previous, confirmed or suspected disease caused by N. meningitidis
Household contact with and/or intimate exposure to an individual with laboratory confirmed N. meningitidis infection within 60 days of enrolment
Progressive, unstable or uncontrolled clinical conditions
Clinical conditions representing a contraindication to intramuscular vaccination and blood draws
Any neuroinflammatory, congenital neurological conditions, encephalopathies, seizures. History of febrile convulsions should not lead to exclusion
History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine(s)/product(s)
Hypersensitivity, including allergy, to any component of vaccines, including diphtheria toxoid (CRM 197) and latex medicinal products or medical equipment whose use is foreseen in this study
Abnormal function or modification of the immune system resulting from
Autoimmune disorders or immunodeficiency syndromes
Systemic administration of corticosteroids (PO/IV/IM) for more than 14 consecutive days within 90 days prior to study vaccination until the post-vaccination 3 blood sample (Visit 6). This will mean prednisone - 20 mg/day (for adult subjects) or 0.5 mg/kg/day (for paediatric subjects), or equivalent. Inhaled and topical steroids are allowed
Administration of antineoplastic and immunomodulating agents or radiotherapy within 90 days prior to study vaccination
Administration of long-acting immune-modifying drugs at any time during the study period (e.g. infliximab)
Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination
Prior/Concomitant therapy
Use of any investigational or non-registered product other than the study vaccine(s)/product(s) during the period starting 30 days before the first dose of study vaccine(s)/product(s) (Day -29 to Day 1), or planned use during the study period
Previous vaccination against any group B meningococcal vaccine at any time prior to informed consent and assent as applicable
Administration of immunoglobulins and/or any blood products or plasma derivatives during the period starting 90 days before the first dose of study vaccine/ product or planned administration during the study period until the post-vaccination 3 blood sample (Visit 6)
Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs during the period starting 90 days prior to the vaccine/product dose(s) until the post-vaccination 3 blood sample (Visit 6). For corticosteroids, this will mean prednisone 20 mg/day (for adult subjects) or 0.5 mg/kg/day (for paediatric subjects), or equivalent. Inhaled and topical steroids are allowed
Prior/Concurrent clinical study experience
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
Other exclusions
Child in care
Pregnant or lactating female
Female planning to become pregnant or planning to discontinue contraceptive precautions
History of /current chronic alcohol abuse and/or drug abuse as determined by the investigator
Any study personnel or immediate dependants, family, or household member
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