None listed
Conditions
Interventions
Intervention1: PsA-TT Conjugate Vaccine: 0.5 ml Single dose of 10 µ
g
Control Intervention1: Meningococcal Polysaccharide AC Vaccine: 0.5 ml Single dose of 50 µ
Sponsors
Serum Institute of India Limited
Program for Appropriate Technology in Health PATH
Eligibility
Inclusion criteria
Inclusion criteria: 1.Age 5 to 10 years of age (both included) 2.Written informed consent obtained from parents or legal 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.Parents or legal 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
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 meningitidis2. Known exposure to Neisseria meningitidis during the three previous months3. 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 immunization4. 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 vaccines6. Administration of immunoglobulins and/or any blood products within 90 days prior to the administration of study vaccines or planned administration during the vaccine period7. Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying agents since birth (including systemic corticosteroids, this means prednisone, or equivalent, ³ 0.5 mg/kg/day; topical steroids including inhaled steroids are allowed.)8. A family history of congenital or hereditary immunodeficiency9. History of meningitis or seizures or any neurological disorder10. Major congenital defects or serious chronic illness (as per investigator?s judgment)11. Acute disease at the time of enrollment (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 objectives13. 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 study14. Non residence in the study area or intent to move out within 3 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To demonstrate the consistency of the immunogenicity at 28 days after a single dose of three consecutive lots of the PsA-TT vaccine given to children at 5 to 10 years of age.Timepoint: 28th day post vaccination | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety: · To evaluate the safety of a single dose of three consecutive lots of the PsA-TT vaccine and of the Meningococcal Polysaccharide Vaccine A+C (PsAC) when administered to healthy children at 5 to 10 years of age, 28 days and 56 days (two months) after vaccination.Immunogenicity: · To evaluate the immunogenicity at 28 days after a single dose of PsAC vaccine in children 5 to 10 years of ageTimepoint: 28 days and 56 days (two months) after vaccination. | — |
Countries
India
Contacts
Public ContactDr Prasad Kulkarni
Serum Institute of India Ltd
Outcome results
None listed