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

  • STATUS
    Recruiting
  • End date
    Nov 18, 2022
  • participants needed
    945
  • sponsor
    GlaxoSmithKline
Updated on 26 January 2021
vaccination
conjugate vaccine
menactra
menacwy
meningococcal conjugate
menveo

Summary

The purpose of this study is to evaluate the immunogenicity, safety and tolerability of rMenB+OMV NZ and MenACWY vaccines when concomitantly administered to healthy subjects 16-18 years of age.

Description

As per the recommendation from Center for Biologics Evaluation and Research (CBER) the study has been amended to include a new "agar-overlay" serum bactericidal assay using human serum complement (hSBA). Additional changes include validation of the MenB manual to measure immunogenicity of the meningococcal group B vaccine, a modification in the definition of 4-fold increase in post-vaccination hSBA titer definition when the pre-vaccination titer is below the limit of detection, and a modification in the population set to be used for safety analysis wherein the exposed set is to be used for all safety analyses.

Details
Condition Meningococcal infection
Treatment Placebo, Meningococcal Group B Vaccine (GSK3536829A) (rMenB+OMV NZ), Meningococcal MenACWY Conjugate Vaccine (GSK3536820A) (MenA lyo + MenCWY liquid)
Clinical Study IdentifierNCT04318548
SponsorGlaxoSmithKline
Last Modified on26 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 16 yrs and 18 yrs?
Gender: Male or Female
Do you have Meningococcal infection?
Do you have any of these conditions: Do you have Meningococcal infection??
Do you have any of these conditions: Do you have Meningococcal infection??
Do you have any of these conditions: Do you have Meningococcal infection??
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

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, 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
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