A Study of Meningococcal Vaccine, Menactra® in Healthy Subjects in India
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|ClinicalTrials.gov Identifier: NCT01086969|
Recruitment Status : Completed
First Posted : March 15, 2010
Results First Posted : February 3, 2012
Last Update Posted : February 6, 2012
The purpose of this study is to assess the safety and immunogenicity of a single dose of Menactra® vaccine to support registration.
- To describe the antibody titers measured by serum bactericidal activity using baby rabbit complement (SBA-BR) before and after Menactra® vaccination.
- To describe the safety profile of participants after one dose of Menactra®.
|Condition or disease||Intervention/treatment||Phase|
|Meningococcal Infection Meningitis||Biological: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate (Menactra®)||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||300 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Safety and Immunogenicity Study for Use of Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (Menactra®) in Healthy Subjects 2-55 Years of Age in India|
|Study Start Date :||June 2010|
|Actual Primary Completion Date :||February 2011|
|Actual Study Completion Date :||June 2011|
Experimental: Study Group
Participants in three age cohorts - Children: 2 - 11 years of age; Adolescents: 12 - 17 years of age, and Adults: 18 - 55 years of age will be enrolled.
Biological: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate (Menactra®)
0.5 mL, Intramuscular
Other Name: Menactra®
- Number of Participants With Vaccine Antibody Titers at ≥ 8 Before and After Menactra Vaccination [ Time Frame: Baseline and 21 days post-vaccination ]Antibodies to Menactra vaccine were measured by the Serum bactericidal assay baby rabbit complement (SBA BR) Test.
- Serum Bactericidal Assay Baby Rabbit Complement (SBA BR) Geometric Mean Titers Before and Post Menactra Vaccination [ Time Frame: Day 0 and Day 30 post-vaccination ]Antibodies to Menactra antigens determined by the serum bactericidal assay baby rabbit complement (SBA-BR) test.
- Percentage of Participants With at Least a 4-fold Increase in Antibodies to Menactra Vaccine Antigens Post Vaccination [ Time Frame: Day 0 to 30 post-vaccination ]Antibodies to Menactra antigens determined by the serum bactericidal assay baby rabbit complement (SBA-BR) test.
- Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Following Menactra Vaccination [ Time Frame: Day 0 to 7 post-vaccination ]Solicited injection site: Pain, Erythema (Redness), and Swelling. Solicited Systemic reaction: Fever (Temperature), Headache, Malaise, and Myalgia
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01086969
|Bangalore, India, 560070|
|Mumbai, India, 400022|
|New Delhi, India, 110002|
|Study Director:||Medical Director||Sanofi Pasteur SA.|