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ISRCTN
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ISRCTN17662153
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DOI
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10.1186/ISRCTN17662153
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ClinicalTrials.gov identifier
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EudraCT number
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Public title
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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)
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Scientific title
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Acronym
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N/A
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Serial number at source
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PsA-TT-001
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Study hypothesis
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Exploratory study whose primary objective is to test reactogenicity and safety. The comparison between groups will be descriptive.
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Lay summary
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Ethics approval
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Ethics approval received 23/06/2005
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Study design
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A phase I, double-blind, randomised trial
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Countries of recruitment
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India
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Disease/condition/study domain
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Meningococcal disease
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Participants - inclusion criteria
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Healthy adults between 18 and 35 years of age
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Participants - exclusion criteria
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Any condition that may affect the health of the subject or the interpretation of the results; pregnancy or lactation
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Anticipated start date
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01/08/2005
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Anticipated end date
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31/07/2006
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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72
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Interventions
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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
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Primary outcome measure(s)
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Incidence of adverse events including solicited adverse events and laboratory abnormalities over 4 weeks post-vaccination
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Secondary outcome measure(s)
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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
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Sources of funding
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Program for Appropriate Technology in Health (PATH) (USA) - grant from the Bill and Melinda Gates Foundation
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Trial website
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Publications
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Contact name
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Dr
Marie-Pierre
Preziosi
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Address
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World Health Organization
20 Avenue Appia
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City/town
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Geneva-27
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Zip/Postcode
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CH-1211
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Country
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Switzerland
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Tel
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+41 22 791 3744
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Fax
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+41 22 791 4860
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Email
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preziosim@who.int
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Sponsor
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Serum Institute of India Limited (SIIL) (Secondary Sponsor - Program for Appropriate Technology in Health [PATH], USA)
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Address
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212/2, Hadapsar
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City/town
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Pune
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Zip/Postcode
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411028
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Country
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India
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Tel
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+91 206 993 900 ext. 2384
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Fax
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+91 206 993 945
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Email
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contact@seruminstitute.com
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Sponsor website:
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http://www.seruminstitute.com/
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Date applied
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22/07/2005
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Last edited
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10/09/2007
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Date ISRCTN assigned
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22/07/2005
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