Study to Assess Potential Immune Interference When GlaxoSmithKline (GSK) Biologicals' MenABCWY Vaccine is Administered to Healthy Subjects Aged 10-25 Years

NCT ID: NCT03587207

Last Updated: 2020-02-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 520 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-09
• Study Completion Date: 2018-12-19

Brief Summary

The purpose of the current study is to evaluate whether there is immune interference when MenABCWY [consisting of MenACWY lyophilized component and rMenB+OMV NZ (Bexsero) liquid component] is administered to healthy adolescents and adults following a 2-dose vaccination schedule with MenABCWY administered 2 months apart.

Conditions

Meningitis, Meningococcal

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

MenABCWY Group

Healthy subjects between, and including, 10 to 25 years of age at the time of the first vaccination (equally distributed across the 2 age strata of 10 to 17 years and 18 to 25 years) received one dose of MenABCWY twice, 2 months apart (Day 1 and Day 61).

Group Type: EXPERIMENTAL

MenABCWY vaccine

Intervention Type: BIOLOGICAL

Two doses administered intramuscularly in the deltoid region of the non-dominant arm.

rMenBOMV+ACWY_S Group

Healthy subjects between, and including, 10 to 25 years of age at the time of the first vaccination (equally distributed across the 2 age strata of 10 to 17 years and 18 to 25 years) concomitantly received one dose of rMenB+OMV NZ (Bexsero) and one dose of MenACWY (Menveo) in the same arm twice, 2 months apart (Day 1 and Day 61).

Group Type: ACTIVE_COMPARATOR

rMenB+OMV NZ (Bexsero) vaccine

Intervention Type: BIOLOGICAL

Two doses administered 2 months apart intramuscularly in the deltoid region of the non-dominant arm to subjects randomised to the rMenBOMV+ACWY\_S Group, rMenBOMV+ACWY\_D Group and rMenBOMV Group

MenACWY (Menveo) vaccine

Intervention Type: BIOLOGICAL

Two doses administered intramuscularly in the deltoid region of the dominant/non-dominant arm to subjects randomised to the rMenBOMV+ACWY\_S Group and rMenBOMV+ACWY\_D Group and one dose administered intramuscularly in the deltoid region of the dominant/non-dominant arm to subjects randomised to the MenACWY Group

rMenBOMV+ACWY_D Group

Healthy subjects between, and including, 10 to 25 years of age at the time of the first vaccination (equally distributed across the 2 age strata of 10 to 17 years and 18 to 25 years) concomitantly received one dose of rMenB+OMV NZ (Bexsero) and one dose of MenACWY (Menveo) in 2 different arms twice, 2 months apart (Day 1 and Day 61).

Group Type: ACTIVE_COMPARATOR

rMenB+OMV NZ (Bexsero) vaccine

Intervention Type: BIOLOGICAL

Two doses administered 2 months apart intramuscularly in the deltoid region of the non-dominant arm to subjects randomised to the rMenBOMV+ACWY\_S Group, rMenBOMV+ACWY\_D Group and rMenBOMV Group

MenACWY (Menveo) vaccine

Intervention Type: BIOLOGICAL

Two doses administered intramuscularly in the deltoid region of the dominant/non-dominant arm to subjects randomised to the rMenBOMV+ACWY\_S Group and rMenBOMV+ACWY\_D Group and one dose administered intramuscularly in the deltoid region of the dominant/non-dominant arm to subjects randomised to the MenACWY Group

rMenBOMV Group

Healthy subjects between, and including, 10 to 25 years of age at the time of the first vaccination (equally distributed across the 2 age strata of 10 to 17 years and 18 to 25 years) received one dose of rMenB+OMV NZ (Bexsero) twice, 2 months apart (Day 1 and Day 61).

Group Type: ACTIVE_COMPARATOR

rMenB+OMV NZ (Bexsero) vaccine

Intervention Type: BIOLOGICAL

Two doses administered 2 months apart intramuscularly in the deltoid region of the non-dominant arm to subjects randomised to the rMenBOMV+ACWY\_S Group, rMenBOMV+ACWY\_D Group and rMenBOMV Group

MenACWY Group

Healthy subjects between, and including, 10 to 25 years of age at the time of the first vaccination (equally distributed across the 2 age strata of 10 to 17 years and 18 to 25 years) received one dose of MenACWY (Menveo) once at Day 1, which was the first and last vaccination for MenACWY group.

Group Type: ACTIVE_COMPARATOR

MenACWY (Menveo) vaccine

Intervention Type: BIOLOGICAL

Two doses administered intramuscularly in the deltoid region of the dominant/non-dominant arm to subjects randomised to the rMenBOMV+ACWY\_S Group and rMenBOMV+ACWY\_D Group and one dose administered intramuscularly in the deltoid region of the dominant/non-dominant arm to subjects randomised to the MenACWY Group

Interventions

MenABCWY vaccine

Two doses administered intramuscularly in the deltoid region of the non-dominant arm.

Intervention Type: BIOLOGICAL

rMenB+OMV NZ (Bexsero) vaccine

Two doses administered 2 months apart intramuscularly in the deltoid region of the non-dominant arm to subjects randomised to the rMenBOMV+ACWY\_S Group, rMenBOMV+ACWY\_D Group and rMenBOMV Group

Intervention Type: BIOLOGICAL

MenACWY (Menveo) vaccine

Two doses administered intramuscularly in the deltoid region of the dominant/non-dominant arm to subjects randomised to the rMenBOMV+ACWY\_S Group and rMenBOMV+ACWY\_D Group and one dose administered intramuscularly in the deltoid region of the dominant/non-dominant arm to subjects randomised to the MenACWY Group

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Subjects and/or subjects' parent(s)/Legally Acceptable Representative(s) (LARs) who, in the opinion of the investigator, can and will comply, with the requirements of the protocol (e.g. completion of the paper diary (pDiary), return for follow-up visits, availability for all visits scheduled in the study).
• Written informed consent obtained from the subject and/or from the parent(s)/LAR(s) of the subject prior to performing any study specific procedure.
• Written informed assent obtained from subjects below the legal age of consent prior to performing any study specific procedure.
• A male or female between, and including, 10 to 25 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, or bilateral ovariectomy.
• Female subjects of childbearing potential may be enrolled in the study, if the subject:

• has practiced highly effective contraception for 30 days prior to vaccination, and
• has a negative pregnancy test on the day of vaccination, and
• has agreed to continue highly effective contraception during the entire treatment period and for 2 months after completion of the vaccination series.

Exclusion Criteria

• Female planning to become pregnant or planning to discontinue contraceptive precautions
• Pregnant or lactating female
• Child in care
• 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.
• Previous vaccination against N. meningitidis at any time prior to informed consent.
• Progressive, unstable or uncontrolled clinical conditions.
• Hypersensitivity, including allergy, to any component of vaccines, medicinal products or medical equipment whose use is foreseen in this study.
• Clinical conditions representing a contraindication to IM vaccination and blood draws.
• Abnormal function of the immune system resulting from:

• Clinical conditions.
• Systemic administration of corticosteroids (oral/intravenous/IM) for more than 14 consecutive days within 90 days prior to informed consent.
• Administration of antineoplastic and immune modulating agents or radiotherapy within 90 days prior to informed consent.
• Received immunoglobulins or any blood products within 180 days prior to informed consent.
• Received an investigational or non registered medicinal product within 30 days prior to informed consent.
• Any other clinical condition that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the subject due to participation in the study.
• 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.
• Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic, or renal functional abnormality, as determined by physical examination.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
• Are obese at screening.
• Family history of congenital or hereditary immunodeficiency.
• History of neuroinflammatory or autoimmune condition.
• History of significant neurological disorder or seizure.
• Serious chronic illness.
• History of chronic alcohol consumption and/or drug abuse.
• Any study personnel as an immediate family or household member.
• Administration of a vaccine not foreseen by the study protocol in the period starting 14 days (for inactivated vaccines), 28 days (for live vaccines), or 7 days (for influenza vaccines) before each dose and ending 14 days (for inactivated vaccines), 28 days (for live vaccines), or 7 days (for influenza vaccines) after each dose of study vaccine(s) administration.
• Thrombocytopenia, bleeding disorders, or be receiving anticoagulant therapy.

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 25 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline (for GlaxoSmithKline; Human Genome Sciences Inc., a GSK Company; Sirtris, a GSK Company; Stiefel, a GSK Company; ViiV Healthcare)

Locations

GSK Investigational Site

Hradec Králové, , Czechia

Countries

Czechia

References

Beran J, Drazan D, Enweonye I, Bhusal C, Toneatto D. Immunogenicity and Safety of Investigational MenABCWY Vaccine and of 4CMenB and MenACWY Vaccines Administered Concomitantly or Alone: a Phase 2 Randomized Study of Adolescents and Young Adults. mSphere. 2021 Dec 22;6(6):e0055321. doi: 10.1128/mSphere.00553-21. Epub 2021 Nov 17.

Reference Type: DERIVED

PMID: 34787449 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2017-005128-12

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

208205

Identifier Type: -

Identifier Source: org_study_id