A Phase IIb, Randomized, Observer-Blind study to Describe the Safety, Tolerability, and Immunogenicity of MenABCWY Administered on Different Dosing Schedules in Healthy Adolescents

Overview

Sponsor-declared trial summary

Key facts

Sponsor

GlaxoSmithKline Biologicals

Participant type

Pediatric, Healthy volunteers

Age range

0-17 years

Gender

Male and Female

Therapeutic area

Diseases [C] - Bacterial Infections and Mycoses [C01]

Trial duration

3 Mar 2022 → ongoing

Decision date (initial)

2023-12-19

Transition trial

Yes

Low-intervention

No

Rare-disease indication

Yes

Vulnerable population

Yes

Funding sources

GlaxoSmithKline Biologicals SA (GSK)

External identifiers

EU CT number

2023-504301-37-00

EudraCT number

2021-001670-33

ClinicalTrials.gov

NCT05087056

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy

Immunogenicity:
• To assess the immune response to 2 doses of the MenABCWY vaccine administered on a 0- and 24-month schedule, and a 0- and 48-month schedule against N. meningitidis serogroup B indicator strains
Safety:
• To evaluate the safety and reactogenicity of the MenABCWY vaccine.

Secondary objectives 1

1. To assess the immune response to 1 and 2 doses of the MenABCWY vaccine administered on a 0- and 24-month schedule, and a 0- and 48-month schedule against N. meningitidis serogroups A, C, W and Y.

Conditions and MedDRA coding

Meningitis, Meningococcal

Study design 1 period

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

1. Participants 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 (e.g. completion of the eDiaries, return for follow-up visits and is available for telephone calls).
2. 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.
3. Written informed assent obtained from the participant (if applicable) prior to performing any study specific procedure.
4. A male or female between, and including, 11 and 14 years of age (i.e. 14 years + 364 days) at the time of the first vaccination.
5. Healthy participants as established by medical history, physical examination and clinical judgement of the investigator before entering into the study.
6. Female participants of non-childbearing potential may be enrolled in the study. Non-childbearing potential is defined as pre-menarche, hysterectomy, bilateral salpingectomy or bilateral ovariectomy
7. Female participants of childbearing potential may be enrolled in the study, if the participant: -has practiced adequate contraception for 30 days prior to first vaccination, and -has a negative pregnancy test* on the day of vaccination, and -has agreed to follow adequate contraception for 30 days before each of the 2 subsequent vaccinations and for 30 days after each vaccination. * Urine samples for pregnancy testing will be collected from female participants of childbearing potential at Visit 1, Visit 3 and Visit 5 prior to the vaccination.

Exclusion criteria 8

1. Current or previous, confirmed or suspected disease caused by N. meningitidis.
2. Household contact with and/or intimate exposure to an individual with laboratory confirmed N. meningitidis infection within 60 days of enrolment.
3. Progressive, unstable or uncontrolled clinical conditions.
4. Clinical conditions representing a contraindication to intramuscular vaccination and blood draws.
5. Any neuroinflammatory (including but not limited to: demyelinating disorders, encephalitis or myelitis of any origin), congenital neurological conditions, encephalopathies, seizures (including all subtypes such as: absence seizures, generalised tonic-clonic seizures, partial complex seizures, partial simple seizures). History of febrile convulsions should not lead to exclusion.
6. 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 (CRM197) and latex medicinal products or medical equipment whose use is foreseen in this study.
7. Abnormal function or modification of the immune system resulting from: -Autoimmune disorders (including, but not limited to: blood, endocrine, hepatic, muscular, nervous system or skin autoimmune disorders; lupus erythematosus and associated conditions; rheumatoid arthritis and associated conditions; scleroderma and associated disorders) or immunodeficiency syndromes (including, but not limited to: acquired immunodeficiency syndromes and primary immunodeficiency syndromes). -Systemic administration of corticosteroids (PO/IV/IM) for more than 14 consecutive days within 90 days prior to study vaccination. This will mean prednisone equivalent ≥20 mg/day for adult participants / ≥0.5 mg/kg/day with maximum 20 mg/day for paediatric participants. 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).
8. Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. The percentages of participants with hSBA titers ≥ lower limit of quantitation (LLOQ) for each N. meningitidis serogroup B indicator strains at - baseline (Day 1 [Month 0]) and, - 1 month after the second dose of MenABCWY (Day 751 [Month 25]) for the ABCWY-24 group and Day 1471 [Month 49] for the ABCWY-48 group).
2. The%of participants with solicited administration site and systemic events during the 7 days following each vaccination at Day 1, Day 721,and Day 1441.The % of participants with any unsolicited AEs including all SAEs, AEs leading to withdrawal,AESIs and medically attended AEs during the 30 days following each vaccination at Day 1,Day 721,and Day 1441.The % of participants with SAEs, AEs leading to withdrawal, AESIs and medically attended AEs during the 6 months following the first vaccination

Secondary endpoints 1

1. The percentages of participants with hSBA titers ≥ LLOQ for N. meningitidis serogroups A, C, W and Y at - baseline (Day 1 [Month 0]), - 1 month after the first dose of MenABCWY (Day 31 [Month 1]) and, - 1 month after the second dose of MenABCWY (Day 751 [Month 25]) for the ABCWY-24 group and Day 1471 [Month 49] for the ABCWY-48 group).

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

GlaxoSmithKline Biologicals

Sponsor organisation

GlaxoSmithKline Biologicals

Address

Rue De L'institut 89

City

Rixensart

Postcode

1330

Country

Belgium

Scientific contact point

Organisation

GlaxoSmithKline Biologicals

Contact name

EU GSK Clinical Trials Call Center

Public contact point

Organisation

GlaxoSmithKline Biologicals

Contact name

EU GSK Clinical Trials Call Center

Third parties 7

Locations

1 EU/EEA country · 6 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 16 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

7 submissions — initial application plus substantial / non-substantial modifications