Immunogenicity and Safety Study of GSK's MenABCWY Vaccine in Healthy Adolescents and Adults Previously Primed With MenACWY Vaccine

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 3

Conditions: Meningitis, Meningococcal

Treatments: Combination Product: MenABCWY vaccine; Combination Product: MenB vaccine; Combination Product: Placebo; Biological: MenACWY vaccine

Study type: Interventional

Funder types: Industry

Identifiers

NCT04707391

2019-004982-42 (EudraCT Number)

213171

Details and patient eligibility

About

The purpose of this study was to assess immunogenicity and safety of MenABCWY vaccine in healthy adolescents and adults aged 15 to 25 years previously vaccinated with MenACWY vaccine.

Enrollment: 1,250 patients

Sex: All

Ages: 15 to 25 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Participants and/or participants' parents/LARs, who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g., completion of the eDiary, return for follow-up visits).

2. Written or witnessed/thumb printed informed consent obtained from the participant/participant's parent(s)/LAR(s) of the participant prior to performance of any study specific procedure.

3. Written or witnessed/thumb printed informed assent obtained from participants below the legal age of consent prior to performance of any study specific procedure.

4. Previous vaccination with 1 dose of MenACWY vaccine at an age of 10 years or older, with an interval of at least 4 years between the previous MenACWY vaccine and enrollment (informed consent and assent [as applicable]) into this study.

5. A male or female between, and including, 15 and 25 years of age (i.e., 25 years and 364 days) at the time of the first vaccination.

6. Healthy participants as established by medical history, physical examination, and clinical judgment of the investigator before entering into the study.

7. 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.

8. 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 intervention period and for 30 days after completion of the vaccination series.

Exclusion criteria

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 enrollment.

3. History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine(s)/product.

4. Hypersensitivity, including allergy, to any component of vaccines, including diphtheria toxoid (CRM 197) and latex medicinal products or medical equipment whose use is foreseen in this study.

5. Progressive, unstable or uncontrolled clinical conditions

6. Clinical conditions representing a contraindication to intramuscular vaccination and blood draws.

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 (oral/intravenous/intramuscular) for more than 14 consecutive days within 90 days prior to study vaccination until the following post vaccination blood sample. This will mean prednisone ≥20 mg/day (for adult participants and ≥0.5 mg/kg/day with maximum ≥20 mg/day for pediatric 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 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, generalized tonic-clonic seizures, partial complex seizures, partial simple seizures). History of febrile convulsions should not lead to exclusion.

9. Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study.

10. Use of any investigational or non-registered product (drug, vaccine, or medical device) other than the study vaccine(s)/product during the period beginning 30 days before the first dose of study vaccine(s)/product (Day -29 to Day 1), or planned use during the study period.

11. Previous vaccination against any group B meningococcal vaccine at any time prior to informed consent and assent as applicable (according to the participant's age).

12. Previous vaccination with 2 or more doses of MenACWY vaccine.

13. Administration/planned administration of immunoglobulins and/or any blood products or plasma derivatives during the period starting 3 months before any dose of study vaccine(s)/product until the following post-vaccination blood sample.

14. Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs during the period starting 3 months prior to any vaccine/product dose until the following post-vaccination blood sample. For corticosteroids, this will mean prednisone equivalent ≥20 mg/day for adult participants and ≥0.5 mg/kg/day with maximum ≥20 mg/day for pediatric participants. Inhaled and topical steroids are allowed.

15. 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).

16. Child in care.

17. Pregnant or lactating female.

18. Female planning to become pregnant or planning to discontinue contraceptive precautions.

19. History of/current chronic alcohol and/or drug abuse.

20. Involvement in the study as a study staff member or being immediate dependents, family, or household member of a study staff member.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

1,250 participants in 2 patient groups

ABCWY Group

Experimental group

Description:

Participants received 2 doses of the MenABCWY vaccine on Day 1 and Day 181 (0,6-month schedule) and 1 dose of placebo on Day 211.

Treatment:

Combination Product: Placebo

Combination Product: MenABCWY vaccine

ACWY Group

Active Comparator group

Description:

Participants received 1 dose of MenACWY vaccine on Day 1 and 2 doses of MenB vaccine on Day 181 and Day 211.

Treatment:

Biological: MenACWY vaccine

Combination Product: MenB vaccine