Meningococcal A disease Infections and Infestations Meningococcal A disease
Conditions
Interventions
The intervention is vaccination at day zero of one of the three vaccines: study vaccine, reference vaccine (Mencevax) or control vaccine (Hiberix) , followed by a booster vaccination 32 weeks later wi
Sponsors
Serum Institute of India Limited (SIIL)
Program for Appropriate Technology in Health (PATH)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age 12 to 23 months of age (both included) 2. Written informed consent obtained from the mother, father, or guardian of the child 3. Free of obvious health problems as established by medical history including physical examination and clinical judgment of the investigator 4. Mother, father, or guardian capable and willing to bring their child or to receive home visits for their child for all follow-up visits 5. Residence in the study area 6. Fully vaccinated according to local Expanded Program on Immunisation (EPI) schedule
Exclusion criteria
Exclusion criteria: 1. Previous vaccination against serogroup A Neisseria meningitidis 2. Known exposure to serogroup A Neisseria meningitidis during the three previous months 3. History of allergic disease or known hypersensitivity to any component of the three study vaccines 4. History of Serious Adverse Reactions (SAR) following administration of vaccines included in the local program of immunization 5. Administration of any other vaccine within 60 days prior to administration of study vaccines or planned vaccination during the first four weeks after the study vaccination 6. Use of any investigational or non-registered drug within 90 days prior to the administration of study vaccines 7. Administration of immunoglobulins and/or any blood products since birth or planned administration during the vaccine period 8. Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying agents since birth (including systemic or inhaled corticosteroids, this means prednisone or equivalent, 0.5 mg/kg/day [topical steroids are allowed]) 9. A family history of congenital or hereditary immunodeficiency 10. History of meningitis or seizures or any neurological disorder 11. Major congenital defects or serious chronic illness, including malnutrition (as per investigator's judgment) 12. 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 13. 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 14. 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 15. Non-residence in the study area or intent to move out within one year
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 rank Signaling Block Age (rSBA) assay. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The percentage of subjects with local and systemic adverse events, including solicited adverse reactions and events, and Serious Adverse Events (SAEs), as measured at four and 28 days after the primary vaccination (reactogenicity and short-term safety) 2. The percentage of subjects with local and systemic adverse events, including solicited adverse reactions and events, and SAEs, as measured at four and 28 days after the booster vaccination (reactogenicity and short-term safety) 3. 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 the Enzyme-Linked ImmunoadSorbent 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
Outcome results
None listed