Immunogenicity and Safety of a Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (Menactra®) in Subjects Aged 9 to 23 Months in India and in the Russian Federation

Sanofi Pasteur, a Sanofi Company0 sites300 target enrollmentJune 25, 2013

ConditionsMeningitis Meningococcal Infection

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Meningitis
Sponsor: Sanofi Pasteur, a Sanofi Company
Enrollment: 300
Primary Endpoint: Percentage of Participants Achieving Seroprotection Using a Serum Bactericidal Assay Human Complement With Antibody Titers ≥ 1:8 for Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra®
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

The purpose of this study is to assess the immunogenicity and safety of Menactra® vaccine given as a two-dose series in infants and toddlers.

Primary Objectives:

To assess the seroprotection rate (percentage of subjects with a serum bactericidal assay using human complement [SBA-HC] titer ≥ 1:8) 28 days after the second of 2 doses of Menactra® administered 3 to 6 months apart.

Secondary Objectives:

To assess the immune responses to meningococcal antigens (serogroups A, C, Y, and W-135) 28 days following the second vaccination with Menactra® using SBA-HC and SBA-BR titers.
To assess the safety profile of Menactra® after each and any vaccination.

Detailed Description

Study participants will receive 2 doses on Menactra® vaccine at 3 to 6 months apart and will be monitored for safety and immunogenicity. The planned duration of each subject's participation in the trial will be from 118 to 215 days.

Registry

clinicaltrials.gov

Start Date

June 25, 2013

End Date

April 12, 2016

Last Updated

4 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Sanofi Pasteur, a Sanofi Company

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Male and female subjects aged 9 to 17 months on the day of inclusion
•Informed consent form has been signed and dated by the parent(s) or other legally acceptable representative(s) (if applicable)
•Subject and parent/legally acceptable representative (if applicable) able to attend all scheduled visits and to comply with all trial procedures.

Exclusion Criteria

•Participation in the 4 weeks preceding inclusion or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure.
•Receipt of any vaccine in the 4 weeks preceding each trial vaccination or planned receipt of any vaccine in the 4 weeks following each trial vaccination, except for:
•(i) influenza vaccination, which may be received at least 2 weeks before study vaccines.
•(ii) measles (M) or measles, mumps, rubella (MMR) routine vaccination, which can be administered concomitantly with the first dose of study vaccine as per routine immunization schedule
•(iii) for subjects enrolled at Indian sites: oral poliomyelitis vaccine (OPV) received during National Immunization Days (NIDs) and supplementary immunization activity days (SIADs)
•Previous vaccination against meningococcal disease with either the study vaccine or another meningococcal vaccine
•Receipt of immune globulins, blood or blood-derived products in the past 3 months
•Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
•History of meningococcal diseases, confirmed either clinically, serologically, or microbiologically
•At high risk, in the opinion of the Investigator, for meningococcal disease during the trial

Outcomes

Primary Outcomes

Percentage of Participants Achieving Seroprotection Using a Serum Bactericidal Assay Human Complement With Antibody Titers ≥ 1:8 for Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra®

Time Frame: Day 0 (pre-vaccination) and Day 28 post-second vaccination

Functional antibody activity against the meningococcal serogroups A, C, Y, and W-135 antigens contained in Menactra vaccine was measured using a SBA-HC assay. Seroprotection was defined as antibody titers ≥ 1:8.

Secondary Outcomes

Percentage of Participants With At Least Four-Fold Rise in Threshold in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers by Serum Bactericidal Assay Using Human Complement Following Vaccination With Menactra®(Day 0 (pre-vaccination) and Day 28 post-vaccination)
Percentage of Participants Achieving the Threshold Using a Serum Bactericidal Assay Human Complement With Antibody Titers ≥ 1:4 for Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra®(Day 0 (pre-vaccination) and Day 28 post-vaccination)
Percentage of Participants Achieving the Threshold in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers ≥ 1:8 by Serum Bactericidal Assay Using Human Complement Before and Following Vaccination With Menactra®(Day 0 (pre-vaccination) and Day 28 post-vaccination)
Percentage of Participants Achieving the Threshold in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers ≥ 1:8 by Serum Bactericidal Assay Using Baby Rabbit Complement Before and Following Vaccination With Menactra®(Day 0 (pre-vaccination) and Day 28 post-vaccination)
Percentage of Participants Achieving the Threshold in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers ≥ 1:4 by Serum Bactericidal Assay Using Baby Rabbit Complement Before and Following Vaccination With Menactra®(Day 0 (pre-vaccination) and Day 28 post-vaccination)
Percentage of Participants Achieving the Threshold in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers ≥ 1:4 by Serum Bactericidal Assay Using Human Complement Before and Following Vaccination With Menactra®(Day 0 (pre-vaccination) and Day 28 post-vaccination)
Percentage of Participants With At Least Four-Fold Rise in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers by Serum Bactericidal Assay Using Baby Rabbit Complement Following Vaccination With Menactra®(Day 0 (pre-vaccination) and Day 28 post-vaccination)
Serum Bactericidal Assay Using Human Complement Antibody Geometric Mean Titers of Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra®(Day 0 (pre-vaccination) and Day 28 post-vaccination)
Percentage of Participants Reporting Solicited Injection Site or Systemic Reactions Following Each Vaccination With Menactra®(Day 0 up to Day 7 post-each vaccination)
Percentage of Participants With At Least Four-Fold Rise in Threshold Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers by Serum Bactericidal Assay Using Human Complement Following Vaccination With Menactra®(Day 0 (pre-vaccination) and Day 28 post-vaccination)
Serum Bactericidal Assay Using Human Complement Antibody Geometric Mean Titer Ratios of Meningococcal Serogroups A, C, Y, and W-135 Following Vaccination With Menactra®(Day 0 (pre-vaccination) and Day 28 post-vaccination)
Serum Bactericidal Assay Using Baby Rabbit Complement Geometric Mean Titer Ratios of Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra®(Day 0 (pre-vaccination) and Day 28 post-vaccination)
Serum Bactericidal Assay Using Baby Rabbit Complement Geometric Mean Titers of Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra®(Day 0 (pre-vaccination) and Day 28 post-vaccination)