Summary:
PHASE 2
The purpose of this study:
This study is designed to describe the immunogenicity and safety of 2 doses of N. meningitidis group A, B, C, W, and Y vaccine (MenABCWY) separated by either 2 or 4 years in adolescents aged 11 to 15 years at enrolment.
- 11 - 14 years old (i.e., 14 years + 364 days at first vax)
- Number of visits: 14 visits: 6 site / 8 phone calls
- 3 VACCINES
- 30-day diary post Vaccines
- Proof of VAX needed
Inclusion Criteria
All participants must satisfy ALL the following criteria at study entry:
- 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).
- 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) prior to performing any study specific procedure.
- 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.
- Healthy participants as established by medical history, physical examination and clinical judgement of the investigator before entering into the study.
- Female participants of non-childbearing potential may be enrolled in the study. Nonchildbearing potential is defined as pre-menarche, hysterectomy, bilateral salpingectomy or bilateral ovariectomy.
- 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
Medical conditions
- Current or previous, confirmed or suspected disease caused by N. meningitidis
- Household contact with and/or intimate exposure to an individual with laboratory confirmed N. meningitidis infection within 60 days of enrolment.
- Progressive, unstable or uncontrolled clinical conditions.
- Clinical conditions representing a contraindication to intramuscular vaccination and blood draws.
- 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.
- 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.
- 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 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).
- Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study.
Prior/Concomitant therapy
- Use of any investigational or non-registered product (drug, vaccine or medical device) other than the study vaccine(s)/product(s) during the period starting 30 days before the first dose of study vaccine(s)/product(s) (Day -29 to Day 1), or planned use during the study period.
- Previous vaccination with any meningococcal (MenB or MenACWY) vaccine at any time prior to informed consent/ assent (as applicable) with the exception of meningococcal C (conjugated or polysaccharide) vaccination, if the last dose of MenC was received at ≤24 months of age.
- Administration of immunoglobulins and/or any blood products or plasma derivatives during the period starting 3 months before the administration of study vaccine/product or planned administration before the next blood sampling visit.
- Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs during the period starting 90 days prior to the first vaccine/product dose(s). For corticosteroids, this will mean prednisone equivalent ≥20 mg/day for adult participants / ≥0.5 mg/kg/day with maximum of 20 mg/day for pediatric participants. Inhaled and topical steroids are allowed.
Prior/Concurrent clinical study experience
- 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).
Other Exclusions
- Child in care (Please refer to the Glossary of terms for the complete definition of child in care)**
- Pregnant or lactating female.
- Female planning to become pregnant / planning to discontinue contraceptive precautions during the windows reported in the inclusion criterion.
- History of /current chronic alcohol abuse and/or drug abuse as determined by the investigator
- Any study personnel or immediate dependents, family, or household members.