Status:
COMPLETED
Study to Assess the Safety and Immunogenicity of GSK Meningococcal Group B Vaccine When Administered Concomitantly With GSK Meningococcal MenACWY Conjugate Vaccine in Healthy Subjects of 16-18 Years of Age
Lead Sponsor:
GlaxoSmithKline
Conditions:
Infections, Meningococcal
Eligibility:
All Genders
16-18 years
Phase:
PHASE3
Brief 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.
Eligibility Criteria
Inclusion
- Participants who, in the opinion of the investigator, can and will comply with the requirements of the protocol or/and participants' 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 participant/parent(s)/LAR(s) of the participant prior to performance of any study specific procedure.
- Written informed assent obtained from the participant (if applicable) along with informed consent from the participant'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 participants as established by medical history and clinical examination before entering the study.
- Female participants 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 participants of childbearing potential may be enrolled in the study if the participant:
- 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
- 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 participants) or ≥ 0.5 mg/kg/day or 20 mg/day whichever is the maximum dose for pediatric participants, 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 participant 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
- • Participant concurrently participating in another clinical study, at any time during the study period, in which the participant 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.
Key Trial Info
Start Date :
August 25 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 21 2023
Estimated Enrollment :
945 Patients enrolled
Trial Details
Trial ID
NCT04318548
Start Date
August 25 2020
End Date
November 21 2023
Last Update
March 4 2025
Active Locations (53)
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1
GSK Investigational Site
Phoenix, Arizona, United States, 85238
2
GSK Investigational Site
Bell Gardens, California, United States, 90201
3
GSK Investigational Site
Los Angeles, California, United States, 90027
4
GSK Investigational Site
Oakland, California, United States, 94611