Healthy volunteers (Active immunization against IMD caused by Neisseria Meningitidis (N.meningitidis) serogroups A, B, C, W and Y) MedDRA version: 20.0 Level: PT Classification code 10027249 Term: Meningitis meningococcal System Organ Class: 10021881 - Infections and infestations
Conditions
Sponsors
GlaxoSmithKline Biologicals SA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • 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. • 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. • Healthy participants as established by medical history and clinical examination before entering into the study. • A male or female between, and including, 55 and 89 days of age (approximately 2 MoA) at the time of the first study vaccination. • Born after a gestation period of =37 weeks, with a birth weight =2.5 kg. Are the trial subjects under 18? yes Number of subjects for this age range: 688 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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 from birth. • Progressive, unstable or uncontrolled clinical conditions. • Clinical conditions representing a contraindication to intramuscular vaccination and blood draws. • Any neuroinflammatory disorders, congenital and peripartum neurological conditions, encephalopathies, seizures. • Congenital or peripartum disorders resulting in a chronic condition • Major congenital defects, as assessed by the investigator. • 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 or 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. • 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 vaccines from birth, or planned use during the study period. • Previous vaccination with any meningococcal vaccine. • Administration of immunoglobulins and/or any blood products or plasma derivatives from birth or planned administration during the study period until Visit 5. • 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. 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. • Study personnel as an immediate family or household member. • For contraindications to administering routine vaccines foreseen in the study, refer to their approved product label/package insert.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): 1. Percentage of participants with solicited administration site events 2. Percentage of participants with solicited systemic events 3. Percentage of participants with any unsolicited adverse events (AEs), including all medically attended adverse events (MAEs), serious adverse events (SAEs), AEs leading to withdrawal, and adverse events of special interest (AESIs) 4. Percentages of participants with MAEs, SAEs, AEs leading to withdrawal, and AESIs 5. Percentage of participants with human serum bactericidal assay (hSBA) titers = lower limit of quantitation (LLOQ) for each serogroup B indicator strain 6. Percentage of participants with hSBA titers = LLOQ for each serogroup B indicator strain 7. Percentage of participants with hSBA titers = LLOQ for each serogroup B indicator strain 8. hSBA geometric mean titers (GMTs) for each serogroup B indicator strain 9. hSBA GMTs for each serogroup B indicator strain 10. hSBA GMTs for each serogroup B indicator strain 11. Within group hSBA geometric mean ratios (GMRs) for each serogroup B indicator strain 12. Percentage of participants with hSBA titers = LLOQ for each A, C, W and Y serogroup 13. Percentage of participants with hSBA titers = LLOQ for each A, C, W and Y serogroup 14. Percentage of participants with hSBA titers = LLOQ for each A, C, W and Y serogroup 15. hSBA GMTs for each A, C, W and Y serogroup 16. hSBA GMTs for each A, C, W and Y serogroup 17. hSBA GMTs for each A, C, W and Y serogroup 18. Within group hSBA GMRs for each A, C, W and Y serogroup;Timepoint(s) of evaluation of this end point: 1, 2. During the 7 days (including the day of vaccination) after each vaccination (vaccines administered on Day 1 and 61 and Day 301) 3. During the 30 days (including the day of vaccination) after each vaccination (vaccines administered on Day 1 and 61 and Day 301) 4. During the study period (Day 1 through Day 481) 5, 8, 12, 15. At 1 month after the second vaccination (Day 91) 6, 9, 13, 16. At pre-third va | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable | — |
Countries
Finland, Germany, Italy, Poland, South Africa, Spain, United Kingdom
Contacts
Public ContactClinical Disclosure Advisor
GlaxoSmithKline Biologicals
Outcome results
None listed