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 children 2 to 10 years of age

Serum Institute of India Limited (SIIL)0 sites340 target enrollmentAugust 14, 2007

Overview

Registry

who.int

Start Date

August 14, 2007

End Date

November 20, 2007

Last Updated

7 years ago

Study Type

Interventional

Sex

All

Sponsor

Serum Institute of India Limited (SIIL)

•1\. Age 2 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
•6\. Fully vaccinated according to the local Expanded Program on Immunisation (EPI) schedule

•1\. Previous vaccination against Neisseria meningitidis
•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 or inhaled corticosteroids, this means prednisone, or equivalent, greater than 0\.5 mg/kg/day; topical 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 judgment)