Immunogenicity and Safety of Menactra® Vaccine in Subjects Aged 9 to 23 Months in India and in the Russian Federation

NCT01890759 | Completed Phase 3 Results FDA Drug

• 3 other identifiers: MTA70U1111-1122-2171CTRI/2014/12/005272
• Study Type: interventional
• Target: 300
• Locations: 2 countries
• Sites: 8

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.

Conditions

Meningitis; Meningococcal Infection

Keywords

Meningitis; Meningococcal Infection; Menactra®

Outcome Measures

Primary Outcomes (1)

• 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®

  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.

  Day 0 (pre-vaccination) and Day 28 post-second vaccination

Secondary Outcomes (13)

• 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 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 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 Human Complement Before and Following Vaccination With Menactra®

  Day 0 (pre-vaccination) and Day 28 post-vaccination

Study Arms (1)

Meningococcal Diphtheria Toxoid Vaccine

EXPERIMENTAL

Participants at age 9 to 17 months of enrollment will receive 2 doses on Menactra vaccine at 3 to 6 months apart

Biological: Meningococcal Diphtheria Toxoid Vaccine

Interventions

Meningococcal Diphtheria Toxoid Vaccine BIOLOGICAL

0.5 mL, Intramuscular

Also known as: Menactra®

Meningococcal Diphtheria Toxoid Vaccine

Eligibility Criteria

• Age: 9 Months - 17 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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
• Known or suspected systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine used in the trial or to a vaccine containing any of the same substances
• Known thrombocytopenia, contraindicating intramuscular vaccination
• In an emergency setting, or hospitalized involuntarily
• Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion
• For subjects enrolled at Indian sites: Moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination or febrile illness (temperature ≥ 38.0°C).
• For subjects enrolled at Russian sites: Acute disease of any severity on the day of vaccination or febrile illness (axillary temperature ≥ 37.0°C).

Sponsors & Collaborators

• Sanofi Pasteur, a Sanofi Company: lead

Study Sites (8)

Unknown Facility

Vadodara, Gujarat, 390022, India

Location

Unknown Facility

Kolkata, West Bengal, 700017, India

Location

Unknown Facility

Lucknow, 226003, India

Location

Unknown Facility

Vellore, 632004, India

Location

Unknown Facility

Murmansk, 183031, Russia

Location

Unknown Facility

Perm, 614066, Russia

Location

Unknown Facility

Saint Petersburg, 197022, Russia

Location

Unknown Facility

Yekaterinburg, 620028, Russia

Location

Related Links

• Related Info

MeSH Terms

Conditions

Meningitis; Meningococcal Infections

Interventions

Meningococcal Vaccines

Condition Hierarchy (Ancestors)

Neuroinflammatory Diseases; Nervous System Diseases; Neisseriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Bacterial Vaccines; Vaccines; Biological Products; Complex Mixtures

Results Point of Contact

• Title: Medical Director
• Organization: Sanofi Pasteur Inc.

RegistryContactUs@sanofipasteur.com

Study Officials

• Medical Director

  Sanofi Pasteur SA

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2013
• First Posted: July 2, 2013
• Study Start: June 25, 2013
• Primary Completion: April 12, 2016
• Study Completion: April 12, 2016
• Last Updated: April 19, 2022
• Results First Posted: August 21, 2017

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will share

Locations

IN (4); RU (4)