A Phase IIIB, Randomized, Observer-blind, Multicenter Study to Assess the Safety and Immunogenicity of GSK's Meningococcal Group B Vaccine When Administered Concomitantly With GSK's Meningococcal MenACWY Conjugate Vaccine to Healthy Subjects of 16-18 Years of Age

STATUS

Recruiting
End date

Feb 23, 2024
participants needed

945
sponsor

GlaxoSmithKline

Send

Updated on 21 October 2022

See if I qualify

vaccination

conjugate vaccine

menactra

menacwy

meningococcal conjugate

menveo

Accepts healthy volunteers

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	Infections, Meningococcal
Treatment	Placebo, Meningococcal Group B Vaccine (GSK3536829A) (rMenB+OMV NZ), Meningococcal MenACWY Conjugate Vaccine (GSK3536820A) (MenA lyo + MenCWY liquid)
Clinical Study Identifier	NCT04318548
Sponsor	GlaxoSmithKline
Last Modified on	21 October 2022

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Eligibility		Yes	No	Not Sure
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
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
	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, Menactra or MenQuadfi)
	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 dependents, family, or household member

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Study Definition

Wikipedia

A Phase IIIB, Randomized, Observer-blind, Multicenter Study to Assess the Safety and Immunogenicity of GSK's Meningococcal Group B Vaccine When Administered Concomitantly With GSK's Meningococcal MenACWY Conjugate Vaccine to Healthy Subjects of 16-18 Years of Age