Bacterial meningitis Infections and Infestations Meningitis
Conditions
Sponsors
Serum Institute of India Limited (SIIL)
Program for Appropriate Technology in Health (PATH)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: A subject will be eligible for inclusion if ALL of the following apply at the time of enrolment: 1. Age 2 to 29 years of age (both included) 2. Written informed consent obtained from the subject (for subjects equal to 18 years of age)/parents or legal guardian (for subjects less than 18 years of age) 3. Written informed assent from the subject if and as appropriate within the participating community (e.g., for subjects equal to 13 years of age in the Malian site, for subjects equal to 15 years of age in the Senegal site or for subjects equal to 12 years of age in the Gambia site) 4. Free of obvious health problems as established by medical history including physical examination and clinical judgement of the investigator 5. Subject/parents, or legal guardian capable and willing to come/bring their child or to receive home visits for all follow-up visits 6. Residence in the study area 7. Fully vaccinated according to the local Expanded Program on Immunisation (EPI) schedule (for subjects 2 to 3 years of age only)
Exclusion criteria
Exclusion criteria: Subjects with any of the following criteria at study entry will not be eligible for participation: 1. Previous vaccination against Neisseria meningitidis during the six previous years 2. Known exposure to Neisseria meningitidis during the three previous months 3. History of allergic disease or known hypersensitivity to any component of the two study vaccines and/or following administration of vaccines included in the local program of immunisation 4. Administration of any other vaccine within 60 days prior to administration of study vaccines or planned vaccination during the first 28 days after the study vaccination 5. Use of any investigational or non-registered drug within 90 days prior to the administration of study vaccines 6. Administration of immunoglobulins and/or any blood products within 30 days prior to the administration of study vaccines or planned administration during the study period 7. Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying agents within 90 days prior to the administration of study vaccines (Including systemic corticosteroids, this means prednisone, or equivalent, greater than 0.5 mg/kg/day; topical steroids including inhaled steroids are allowed) 8. A family history of congenital or hereditary immunodeficiency 9. History of meningitis or seizures or any neurological disorder 10. Major congenital defects or serious chronic illness, including malnutrition (as per investigator's judgement) 11. Acute disease at the time of enrolment (acute disease is defined as the presence of a moderate or severe illness with or without fever) is a temporary exclusion 12. Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic, or renal functional abnormality, as determined by medical history, physical examination or laboratory tests, which in the opinion of the investigator, might interfere with the study objectives 13. Any condition or criteria that in the opinion of the investigator might compromise the well being of the subject or the compliance with study procedures or interfere with the outcome of the study 14. Non residence in the study area or intent to move out within one year 15. Pregnancy or lactation (a negative pregnancy test will be required before vaccination for all women of childbearing potential) 16. Previous inclusion of five family members in the study (i.e., subjects belonging to the same family - biological father, mother, child, and brothers and sisters may be included up to a maximum of five members from the same family)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The percentage of subjects who show a seroconversion for anti-Meningococcal Polysaccharide A (MenPsA) antibodies, i.e. a four-fold increase in post-immunisation serum titre with respect to pre-immunisation serum titre, at 28 days after a single vaccine dose, as measured by rabbit complement Serum Bactericidal Assay (rSBA). | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety: 1. The percentage of subjects with local and systemic post-immunisation reactions during the first four days, adverse events and Serious Adverse Events (SAEs), as measured at 4 and 28 days after vaccination (reactogenicity and short-term safety) 2. The percentage of subjects with SAEs during the entire study duration, as measured at 182 days (6 months) and 364 days (1 year) (long-term safety) Immunogenicity: 1. The percentage of subjects with anti-MenPsA titre greater than or equal to 1:8 (defined as seroprotection to MenA) at 28 days after a single vaccine dose, as measured by rSBA assay. The percentage of subjects with anti-MenPsA titer greater than or equal to 1:128 (defined as long-term seroprotection to MenA) will be also considered 2. Geometric Mean Titres (GMTs) for anti-MenPsA antibodies at 28 days after a single vaccine dose, as measured by rSBA assay 3. Evaluation of reverse cumulative distribution curves for MenPsA antibody titres at 28 days after a single vaccine dose, as measured by rSBA assay 4. The percentage of subjects who show a seroconversion for anti-MenPsA total Immunoglobulin G (IgG), i.e. a two-fold increase in post-immunisation serum concentration with respect to pre-immunisation serum concentration, at 28 days after a single vaccine dose, as measured by Enzyme-Linked Immunosorbent Assay (ELISA). The percentage of subjects with a four-fold increase in post-immunisation serum concentration with respect to pre-immunisation serum concentration will be also considered | — |
Countries
Gambia, Mali, Senegal
Outcome results
None listed