Clinical trial NCT01890759: Immunogenicity and Safety of Menactra® Vaccine in Subjects Aged 9 to 23 Months in India and in the Russian Federation
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Meningitis
Meningococcal Infection
Keywords: Meningitis
Meningococcal Infection
Menactra®
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2013-07-02
Enrollment: 300
Sex: ALL
Minimum age (years): 9
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: 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®
timeFrame: Day 0 (pre-vaccination) and Day 28 post-second vaccination
Secondary outcomes:
measure: 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®
timeFrame: Day 0 (pre-vaccination) and Day 28 post-vaccination
measure: 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®
timeFrame: Day 0 (pre-vaccination) and Day 28 post-vaccination
measure: 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®
timeFrame: Day 0 (pre-vaccination) and Day 28 post-vaccination
measure: 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®
timeFrame: Day 0 (pre-vaccination) and Day 28 post-vaccination
measure: 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®
timeFrame: Day 0 (pre-vaccination) and Day 28 post-vaccination
measure: 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®
timeFrame: Day 0 (pre-vaccination) and Day 28 post-vaccination
measure: 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®
timeFrame: Day 0 (pre-vaccination) and Day 28 post-vaccination
measure: 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®
timeFrame: Day 0 (pre-vaccination) and Day 28 post-vaccination
measure: 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®
timeFrame: Day 0 (pre-vaccination) and Day 28 post-vaccination
measure: 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®
timeFrame: Day 0 (pre-vaccination) and Day 28 post-vaccination
measure: Serum Bactericidal Assay Using Human Complement Antibody Geometric Mean Titer Ratios of Meningococcal Serogroups A, C, Y, and W-135 Following Vaccination With Menactra®
timeFrame: Day 0 (pre-vaccination) and Day 28 post-vaccination
measure: 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®
timeFrame: Day 0 (pre-vaccination) and Day 28 post-vaccination
measure: Percentage of Participants Reporting Solicited Injection Site or Systemic Reactions Following Each Vaccination With Menactra®
timeFrame: Day 0 up to Day 7 post-each vaccination
Other outcomes:
Locations:
city: Vadodara
country: India
state: Gujarat
city: Kolkata
country: India
state: West Bengal
city: Lucknow
country: India
city: Vellore
country: India
city: Murmansk
country: Russian Federation
city: Perm'
country: Russian Federation
city: Saint Petersburg
country: Russian Federation
city: Yekaterinburg
country: Russian Federation
Study officials:
affiliation: Sanofi Pasteur SA
name: Medical Director
role: STUDY_DIRECTOR
References: