Primary immunization against Neisseria meningitidis serogroups A, B, C, W-135, and Y. MedDRA version: 20.1 Level: PT Classification code 10027202 Term: Meningitis bacterial System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Product Name: MenABCWY
Pharmaceutical Form: Powder and suspension for suspension for injection
INN or Proposed INN: -
Current Sponsor code: rp287-953
Sponsors
GlaxoSmithKline Biologicals SA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subjects and/or subjects’ parent(s)/Legally Acceptable Representative(s) (LARs) who, in the opinion of the investigator, can and will comply, with the requirements of the protocol (e.g. completion of the pDiary, return for follow-up visits, availability for all visits scheduled in the study). 2. Written informed consent obtained from the subject and/or from the parent(s)/LAR(s) of the subject prior to performing any study specific procedure. 3. Written informed assent obtained from subjects below the legal age of consent prior to performing any study specific procedure. 4. A male or female between, and including, 10 to 25 years of age at the time of the first vaccination. 5. Healthy subjects as established by medical history and clinical examination before entering into the study. 6. Female subjects 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, or bilateral ovariectomy. 7. Female subjects of childbearing potential may be enrolled in the study, if the subject: has practiced highly effective contraception for 30 days prior to vaccination, and has a negative pregnancy test on the day of vaccination, and has agreed to continue highly effective contraception during the entire treatment period and for 2 months after completion of the vaccination series. Are the trial subjects under 18? yes Number of subjects for this age range: 500 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 250 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Female planning to become pregnant or planning to discontinue contraceptive precautions. 2. Pregnant or lactating female. 3. Child in care. Each subject must not have: 4. Current or previous, confirmed or suspected disease caused by N. meningitidis. 5. Known contact to an individual with any laboratory confirmed N. meningitidis infection within 60 days prior to enrollment. 6. Previous vaccination against N. meningitidis at any time prior to informed consent. 7. Progressive, unstable or uncontrolled clinical conditions. 8. Hypersensitivity, including allergy, to any component of vaccines, medicinal products or medical equipment whose use is foreseen in this study. 9. Clinical conditions representing a contraindication to IM vaccination and blood draws. 10. Abnormal function of the immune system resulting from: -Clinical conditions. -Systemic administration of corticosteroids (oral/intravenous/IM) for more than 14 consecutive days within 90 days prior to informed consent. -Administration of antineoplastic and immune-modulating agents or radiotherapy within 90 days prior to informed consent. 11. Received immunoglobulins or any blood products within 180 days prior to informed consent. 12. Received an investigational or non-registered medicinal product within 30 days prior to informed consent. 13. Any other clinical condition that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the subject due to participation in the study. 14. Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational vaccine/product (pharmaceutical product or device). 15. Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic, or renal functional abnormality, as determined by physical examination. 16. Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required). 17. Are obese at screening (e.g. with a body mass index [BMI] > = 30 kg/m2, where BMI reflects obesity and not high muscle mass). 18. Family history of congenital or hereditary immunodeficiency. 19. History of neuroinflammatory or autoimmune condition. 20. History of significant neurological disorder or seizure (history of febrile convulsion should not lead to exclusion). 21. Serious chronic illness. 22. History of chronic alcohol consumption and/or drug abuse (including current consumption/abuse). 23. Any study personnel as an immediate family or household member. 24. Administration of a vaccine not foreseen by the study protocol in the period starting 14 days (for inactivated vaccines), 28 days (for live vaccines), or 7 days (for influenza vaccines) before each dose and ending 14 days (for inactivated vaccines), 28 days (for live vaccine
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: •To assess the immune response to 2 doses of MenABCWY, rMenB+OMV NZ, or rMenB+OMV NZ and MenACWY administered concomitantly in the same arm or in 2 different arms, and to a single dose of MenACWY at 1 month after the last vaccination.;Timepoint(s) of evaluation of this end point: At 1 month after last vaccination; Secondary Objective: Immunogenicity Objective •To assess the immune response to 2 doses of MenABCWY, rMenB+OMV NZ, or rMenB+OMV NZ and MenACWY administered concomitantly in the same arm or in 2 different arms at 1 month after the first vaccination. Safety Objective •To assess the safety and tolerability of 2 doses of MenABCWY, rMenB+OMV NZ, or rMenB+OMV NZ and MenACWY administered concomitantly in the same arm or in 2 different arms, and to a single dose of MenACWY. ; Primary end point(s): Immune responses against N. meningitidis serogroup B* test strains and N. meningitidis serogroups A, C, W-135, and Y, as measured by hSBA, 1 month after the last vaccination in all study groups - hSBA GMTs against each of the N. meningitidis serogroup B test strains and against N. meningitidis serogroups A, C, W-135, and Y hSBA - GMTs against all of N. meningitidis serogroup B test strains (pooled) - Percentage of subjects with hSBA titers = the lower limit of quantitation (LLOQ) against each of the N. meningitidis serogroup B test strains and against N. meningitidis serogroups A, C, W-135, and Y - Percentage of subjects with a 4-fold increase in hSBA titers against N. meningitidis serogroups B test strains and against N. meningitidis serogroups A, C, W-135, and Y - hSBA geometric mean ratios (GMRs) against each of the N. meningitidis serogroup B test strains and against N. meningitidis serogroups A, C, W-135, and Y at 1 month after the last vaccination against baseline (Day 1) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): To assess the immune response to 2 doses of MenABCWY, rMenB+OMV NZ, or rMenB+OMV NZ and MenACWY adminis-tered concomitantly in the same arm or in 2 different arms at 1 month after the first vaccination.;Timepoint(s) of evaluation of this end point: At 1 month after last vaccination | — |
Countries
Czech Republic
Contacts
Public ContactClinical Disclosure Advisor
GlaxoSmithKline Biologicals
Outcome results
None listed