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)
Phase 1
Completed
- Conditions
- Meningococcal diseaseInfections and Infestations
- Registration Number
- ISRCTN17662153
- Lead Sponsor
- Serum Institute of India Limited (SIIL) (Secondary Sponsor - Program for Appropriate Technology in Health [PATH], USA)
- Brief Summary
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26553690 2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26553670
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 72
Inclusion Criteria
Healthy adults between 18 and 35 years of age
Exclusion Criteria
Any condition that may affect the health of the subject or the interpretation of the results; pregnancy or lactation
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of adverse events including solicited adverse events and laboratory abnormalities over 4 weeks post-vaccination
- Secondary Outcome Measures
Name Time Method <br> 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<br> 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<br>