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

NCT ID: NCT01890759

Last Updated: 2022-04-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-06-25
• Study Completion Date: 2016-04-12

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.

Conditions

Meningitis; Meningococcal Infection

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Meningococcal Diphtheria Toxoid Vaccine

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

Group Type: EXPERIMENTAL

Meningococcal Diphtheria Toxoid Vaccine

Intervention Type: BIOLOGICAL

0.5 mL, Intramuscular

Interventions

Meningococcal Diphtheria Toxoid Vaccine

0.5 mL, Intramuscular

Intervention Type: BIOLOGICAL

Other Intervention Names

Menactra®

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
• 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
• Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, 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).

A prospective subject should not be included in the study until the condition has resolved or the febrile event has subsided.

• Receipt of oral or injectable antibiotic therapy within 72 hours prior to the first blood draw
• Identified as a natural or adopted child of the Investigator or employee with direct involvement in the proposed study
• Personal history of Guillain-Barré Syndrome.

• Minimum Eligible Age: 9 Months
• Maximum Eligible Age: 17 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sanofi Pasteur, a Sanofi Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Sanofi Pasteur SA

Locations

Vadodara, Gujarat, India

Kolkata, West Bengal, India

Lucknow, , India

Vellore, , India

Murmansk, , Russia

Perm, , Russia

Saint Petersburg, , Russia

Yekaterinburg, , Russia

Countries

India; Russia

Related Links

http://www.sanofipasteur.com

Related Info

Other Identifiers

U1111-1122-2171

Identifier Type: OTHER

Identifier Source: secondary_id

CTRI/2014/12/005272

Identifier Type: REGISTRY

Identifier Source: secondary_id

MTA70

Identifier Type: -

Identifier Source: org_study_id