MENACWYMEN7B-003

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

29 Nov 2021 → 22 Nov 2025

Decision date (initial)

2024-01-19

Transition trial

Yes

Low-intervention

No

Rare-disease indication

Yes

Vulnerable population

Yes

Funding sources

Vaccines

External identifiers

EU CT number

2023-506449-40-00

EudraCT number

2021-001367-24

ClinicalTrials.gov

NCT05082285

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Prophylaxis

•To evaluate the safety and reactogenicity of the 2 formulations of MenABCWY-2nd Gen vaccine, the MenABCWY-1st Gen, the MenB vaccine and the MenACWY-TT vaccine.
•To assess the immune response to the 2 formulations of MenABCWY-2nd Gen vaccine, to the MenABCWY-1st Gen and to the MenB vaccine against all serogroup B indicator strains
•To assess the immune response to the 2 formulations of MenABCWY-2nd Gen vaccine, to the MenABCWY-1st Gen vaccine and to the MenACWY-TT vaccine against serogroups A, C, W and Y

Conditions and MedDRA coding

Infections, Meningococcal

Study design 1 period

Regulatory references

Scientific advice from competent authorities

Paul-Ehrlich-Institut, The Spanish Agency Of Medicines And Medical Devices

Plan to share IPD

Yes

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. 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.
2. Written or witnessed/thumb printed informed consent obtained from the parent(s)/LAR(s) of the participant prior to performance of any study specific procedure.
3. Healthy participants as established by medical history and clinical examination before entering into the study.
4. A male or female between, and including, 55 and 89 days of age (approximately 2 MoA) at the time of the first study vaccination.
5. Born after a gestation period of ≥37 weeks, with a birth weight ≥2.5 kg.

Exclusion criteria 19

1. Current or previous, confirmed or suspected disease caused by N. meningitidis.
2. 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 starting from birth until Visit 5. This will mean prednisone equivalent ≥0.5 mg/kg/day with maximum 20 mg/day. Inhaled and topical steroids are allowed. - Administration of antineoplastic and immunomodulating agents or radiotherapy from birth. - Administration of long-acting immune-modifying drugs at any time during the study period (e.g. infliximab)..
3. Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study.
4. Use of any investigational or non-registered product (drug, vaccine or medical device) other than the study vaccines from birth, or planned use during the study period.
5. Previous vaccination with any meningococcal vaccine.
6. Administration of immunoglobulins and/or any blood products or plasma derivatives from birth or planned administration during the study period until Visit 5.
7. Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs during the period starting from birth until Visit 5. For corticosteroids, this will mean prednisone equivalent ≥0.5 mg/kg/day with maximum 20 mg/day. Inhaled and topical steroids are allowed.
8. Household contact with and/or intimate exposure to an individual with laboratory confirmed N. meningitidis infection from birth.
9. Progressive, unstable or uncontrolled clinical conditions.
10. Clinical conditions representing a contraindication to intramuscular vaccination and blood draws.
11. Any neuroinflammatory disorders (including but not limited to: demyelinating disorders, encephalitis or myelitis of any origin), congenital and peripartum neurological conditions, encephalopathies, seizures (including all subtypes such as: absence seizures, generalised tonic-clonic seizures, partial complex seizures, partial simple seizures or febrile convulsions).
12. Congenital or peripartum disorders resulting in a chronic condition (including but not limited to chromosomal abnormalities, cerebral palsy, metabolism or synthesis disorders, cardiac disorders).
13. Major congenital defects, as assessed by the investigator
14. History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine(s)/product(s).
15. 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.
16. 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 (drug or medical device).
17. Child in care.
18. Study personnel as an immediate family or household member.
19. For contraindications to administering routine vaccines foreseen in the study, refer to their approved product label/package insert.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. Number and percentage of participants with: -solicited administration site and systemic events during the 7 days (including the day of vaccination) after each vaccination. -any unsolicited adverse events (AEs), including medically attended adverse events (MAEs), serious adverse events (SAEs), AEs leading to withdrawal and adverse events of special interest (AESIs), during the 30 days after each vaccination. -MAEs, SAEs, AEs leading to withdrawal and AESIs throughout the study.
2. Percentages of participants with human serum bactericidal assay (hSBA) titres ≥lower limit of quantitation (LLOQ) and the hSBA geometric mean titres (GMTs) for each A, C, W and Y serogroup and each serogroup B indicator strain at: -1 month after the second vaccination (Day 91) -pre-third vaccination (Day 301) -1 month after the third vaccination (Day 331) hSBA geometric mean ratios (GMRs) for each A, C, W and Y serogroup and B indicator strains at Day 331 compared to pre third vaccination

Investigational products

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

Test 3

Comparator 2

Auxiliary 3

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 13

Locations

3 EU/EEA countries · 22 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

Summary of results Art. 37(4) CTR

Layperson summary Annex V

Documents 40 files

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

Application history

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