NCT01890759CompletedPhase 3
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 Company8 sites in 2 countries300 target enrollmentStarted: June 25, 2013Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Enrollment
- 300
- Locations
- 8
- 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®
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 9 Months to 17 Months (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
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
Intervention: Meningococcal Diphtheria Toxoid Vaccine (Biological)
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
- 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 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)
- 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)
Investigators
Study Sites (8)
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