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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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.|