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A phase I, double-blind, randomized study to evaluate the safety and immunogenicity of a new Meningococcal A Conjugate vaccine versus a Meningococcal Polysaccharide A+C reference vaccine and a Tetanus Toxoid control vaccine, given as single intramuscular injections in healthy adults from 18 to 35 years of age (India)
ISRCTN ISRCTN17662153
DOI 10.1186/ISRCTN17662153
ClinicalTrials.gov identifier
EudraCT number
Public title A phase I, double-blind, randomized study to evaluate the safety and immunogenicity of a new Meningococcal A Conjugate vaccine versus a Meningococcal Polysaccharide A+C reference vaccine and a Tetanus Toxoid control vaccine, given as single intramuscular injections in healthy adults from 18 to 35 years of age (India)
Scientific title
Acronym N/A
Serial number at source PsA-TT-001
Study hypothesis Exploratory study whose primary objective is to test reactogenicity and safety. The comparison between groups will be descriptive.
Lay summary
Ethics approval Ethics approval received 23/06/2005
Study design A phase I, double-blind, randomised trial
Countries of recruitment India
Disease/condition/study domain Meningococcal disease
Participants - inclusion criteria Healthy adults between 18 and 35 years of age
Participants - exclusion criteria Any condition that may affect the health of the subject or the interpretation of the results; pregnancy or lactation
Anticipated start date 01/08/2005
Anticipated end date 31/07/2006
Status of trial Completed
Patient information material
Target number of participants 72
Interventions Single intramuscular injection of one of the following:
1. Study vaccine group: Serum Institute of India Limited (SIIL) PsA-TT (Meningococcal A Polysaccharide conjugated to Tetanus Toxoid)
2. Reference vaccine group: Sanofi Pasteur Meningococcal Polysaccharide Vaccine A+C
3. Control vaccine group: Serum Institute of India Limited (SIIL) Tetanus Toxoid (Adsorbed) IP
Primary outcome measure(s) Incidence of adverse events including solicited adverse events and laboratory abnormalities over 4 weeks post-vaccination
Secondary outcome measure(s) 1. Descriptive assessment of the immune response 4 weeks post-vaccination in terms of serum bactericidal activity using baby rabbit complement (SBA/BRC) and anti-PsA IgG response
2. Descriptive assessment of the persistence of an immune response 24 and 48 weeks post-vaccination in terms of SBA/BRC and anti-PsA IgG response
Sources of funding Program for Appropriate Technology in Health (PATH) (USA) - grant from the Bill and Melinda Gates Foundation
Trial website
Publications
Contact name Dr  Marie-Pierre  Preziosi
  Address World Health Organization
20 Avenue Appia
  City/town Geneva-27
  Zip/Postcode CH-1211
  Country Switzerland
  Tel +41 22 791 3744
  Fax +41 22 791 4860
  Email preziosim@who.int
Sponsor Serum Institute of India Limited (SIIL) (Secondary Sponsor - Program for Appropriate Technology in Health [PATH], USA)
  Address 212/2, Hadapsar
  City/town Pune
  Zip/Postcode 411028
  Country India
  Tel +91 206 993 900 ext. 2384
  Fax +91 206 993 945
  Email contact@seruminstitute.com
  Sponsor website: http://www.seruminstitute.com/
Date applied 22/07/2005
Last edited 10/09/2007
Date ISRCTN assigned 22/07/2005
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