Study to evaluate safety and immunogenicity of GSK’s meningococcal ABCWY vaccine when given to healthy adolescents and adults, previously vaccinated with meningococcal ACWY vaccine
- Conditions
- Healthy volunteers (active immunization against invasive disease caused by N. meningitidis serogroups A, B, C, W and Y)MedDRA version: 20.1Level: PTClassification code 10027202Term: Meningitis bacterialSystem Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
- Registration Number
- EUCTR2019-004982-42-Outside-EU/EEA
- Lead Sponsor
- GlaxoSmithKline Biologics SA (GSK)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- A
- Sex
- All
- Target Recruitment
- Not specified
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 and not more than 6 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 + 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.
Are the trial subjects under 18? yes
Number of subjects for this age range: 606
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 600
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
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) or =0.5 mg/kg/day or =20 mg/day whichever is the maximum dose for pediatric participants, or equivalent. 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
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 (oral/intravenous/intramuscular), with mean prednisone =20 mg/day (for adult participants), or =0.5 mg/kg/day, or =20 mg/day which
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method