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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT01890759
First received: June 27, 2013
Last updated: July 15, 2014
Last verified: July 2014
  Purpose

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.

Condition Intervention Phase
Meningitis
Meningococcal Infection
Biological: Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Number of participants with serum bactericidal assay using human complement [SBA-HC] titers ≥ 1:8 post vaccination with Menactra® [ Time Frame: Day 28 post second vaccination ] [ Designated as safety issue: No ]
    Antibody titers measured by serum bactericidal assay using human complement (SBA-HC). Seroprotection defined as a post-vaccination titer of ≥ 1:8


Secondary Outcome Measures:
  • Serum Bovine Albumin Baby Rabbit and Human Complement Geometric Mean Titers Following Vaccination With Menactra® Vaccine [ Time Frame: Day 28 post second vaccination ] [ Designated as safety issue: No ]
    Antibody titers measured by serum bactericidal assay using baby rabbit and human complement.

  • Number of participants with serum bactericidal assay using baby rabbits complement [SBA-BR] titers ≥ 1:8 post-vaccination with Menactra® [ Time Frame: Day 28 post second vaccination ] [ Designated as safety issue: No ]
    Antibody titers measured by serum bactericidal assay using baby rabbit complement (SBA-BR). Seroprotection defined as a post-vaccination titer of ≥ 1:8

  • Occurrence and intensity of solicited injection site and systemic reactions and unsolicited adverse events occurring after each Menactra® vaccination [ Time Frame: Day 0 up to Month 6 post vaccination ] [ Designated as safety issue: No ]
    Solicited Injection site: Tenderness, Erythema and Swelling: Solicited Systemic: Fever (Temperature), Vomiting, Crying abnormal, Drowsiness, Appetite lost, and Irritability


Estimated Enrollment: 200
Study Start Date: June 2013
Estimated Study Completion Date: February 2016
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Study Group
Participants at age 9 to 17 months of enrollment will receive 2 doses on Menactra vaccine at 3 to 6 months apart
Biological: Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine
0.5 mL, Intramuscular
Other Name: Menactra®

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.

  Eligibility

Ages Eligible for Study:   9 Months to 17 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  • influenza vaccination, which may be received at least 2 weeks before study vaccines.
  • 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
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01890759

Locations
India
Kolkata, West Bengal, India, 700017
Lucknow, India, 226003
Russian Federation
Ekaterinburg, Russian Federation, 620028
Murmansk, Russian Federation, 183031
Perm', Russian Federation, 614066
St Pertersbourg, Russian Federation, 197022
Sponsors and Collaborators
Sanofi Pasteur, a Sanofi Company
Investigators
Study Director: Medical Director Sanofi Pasteur SA
  More Information

Additional Information:
No publications provided

Responsible Party: Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT01890759     History of Changes
Other Study ID Numbers: MTA70, U1111-1122-2171
Study First Received: June 27, 2013
Last Updated: July 15, 2014
Health Authority: India: Drugs Controller General of India
Russia: Ministry of Health of the Russian Federation

Keywords provided by Sanofi:
Meningitis
Meningococcal Infection
Menactra®

Additional relevant MeSH terms:
Meningitis
Meningococcal Infections
Central Nervous System Infections
Central Nervous System Diseases
Nervous System Diseases
Neisseriaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on July 31, 2014