A phase II/III, observer-blind, randomised, active controlled study to compare the safety and immunogenicity of a meningococcal A conjugate vaccine (PsA-TT) with meningococcal ACWY polysaccharide vaccine administered in healthy subjects 2 to 29 years of age

Serum Institute of India Limited (SIIL)0 sites900 target enrollmentAugust 14, 2007

Overview

Registry

who.int

Start Date

August 14, 2007

End Date

September 20, 2008

Last Updated

7 years ago

Study Type

Interventional

Sex

All

Sponsor

Serum Institute of India Limited (SIIL)

•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)

•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