A phase II, observer-blind, randomised, active controlled study to compare the safety, immunogenicity, and induction of immunological memory of a meningococcal A conjugate vaccine, a meningococcal ACYW polysaccharide vaccine and a hib conjugate vaccine, administered in healthy toddlers 12 - 23 months of age

Serum Institute of India Limited (SIIL)0 sites600 target enrollmentSeptember 21, 2006

Overview

Registry

who.int

Start Date

September 21, 2006

End Date

November 28, 2008

Last Updated

7 years ago

Study Type

Interventional

Sex

All

Sponsor

Serum Institute of India Limited (SIIL)

•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

•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