Immunogenicity and Safety of a Quadrivalent Meningococcal Conjugate Vaccine in Healthy Adults, Adolescents, and Children in India and Healthy Adolescents and Children in the Republic of South Africa (MET55)

  • STATUS
    Recruiting
  • days left to enroll
    89
  • participants needed
    1332
  • sponsor
    Sanofi Pasteur, a Sanofi Company
Updated on 19 March 2022
Accepts healthy volunteers

Summary

The primary objective of this study is to demonstrate the non-inferiority of immunogenicity of a single dose of MenACYW conjugate vaccine compared to Menactra® in adolescents and children aged 2 to 17 years in terms of serum bactericidal assay using human complement (hSBA) titers.

The secondary objectives of the study are:

  • To describe the antibody titers to the meningococcal serogroups A, C, Y, and W before and at Day 30 after vaccination with MenACYW conjugate vaccine or a licensed meningococcal vaccine in adults in India aged 18 to 55 years (Menactra®) or ≥ 56 years (Quadri Meningo™)
  • To describe the antibody titers to the meningococcal serogroups A, C, Y, and W before and at Day 30 after vaccination with MenACYW conjugate vaccine or Menactra® in children and adolescents aged 2 to 17 years in India and/or Republic of South Africa (RSA)

Description

Study duration per participant is approximately 31 to 45 days

Details
Condition Healthy Volunteers (Meningococcal Infection)
Treatment Meningococcal Polysaccharide (serogroups A,C,Y and W-135) Diphtheria Toxoid Conjugate Vaccine, Meningococcal polysaccharide (serogroups A,C,Y and W) tetanus toxoid conjugate vaccine, Meningococcal polysaccharide (serogroups A, C, Y and W-135) vaccine
Clinical Study IdentifierNCT04143061
SponsorSanofi Pasteur, a Sanofi Company
Last Modified on19 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Age in the defined range on the day of inclusion
For Adults: Aged ≥ 18 years on the day of inclusion
For Children and Adolescents: Aged 2 to 17 years on the day of inclusion
Z-score of ≥ -2 standard deviations (SD) on the Weight-for-height table of the World Health Organization (WHO) Child Growth Standards
For children : Children aged 2 to 5 years must have a Z-score of ≥ -2 SD on the Weight-for-height table of the WHO Child Growth Standards
Informed consent obtained
For adults: Informed consent form has been signed and dated by the subject and by an independent witness, if required by local regulations
For children and adolescents: Assent form has been signed and dated by the subject (for subjects 7 to 17 years of age), and informed consent form has been signed and dated by the parent(s) or legally acceptable representative and by an independent witness, if required by local regulations
Able to attend all scheduled visits and to comply with all trial procedures
For adults: Able to attend all scheduled visits and to comply with all trial procedures
For children and adolescents: Participants and parent / legally acceptable representative are able to attend all scheduled visits and to comply with all trial procedures

Exclusion Criteria

Participant is pregnant, or lactating, or of childbearing potential and not using an effective method of contraception or abstinence from at least 4 weeks prior to vaccination until at least 4 weeks after vaccination. To be considered of non-childbearing potential, a female must be pre-menarche, or post-menopausal for at least 1 year, or surgically sterile
Participation at the time of study enrollment (or in the 4 weeks preceding the trial vaccination) 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 (28 days) preceding the trial vaccination or planned receipt of any vaccine in the 4 weeks following vaccination except for oral poliovirus vaccine (OPV) in India, received during national immunization days. In India, OPV may be received with a gap of at least 2 weeks before the study vaccine. This exception includes monovalent and bivalent OPV
Previous vaccination against meningococcal disease with either the trial vaccine or another vaccine (i.e., mono- or polyvalent, polysaccharide, or conjugate meningococcal vaccine containing serogroups A, C,Y, or W; or meningococcal B serogroup containing 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 infection, confirmed either clinically, serologically, or microbiologically
At high risk for meningococcal infection during the trial (specifically, but not limited to, subjects with persistent complement deficiency, with anatomic or functional asplenia, or subjects traveling to countries with high endemic or epidemic disease)
Known systemic hypersensitivity to latex or to any of the vaccine components, or history of a life-threatening reaction to the vaccine(s) used in the trial or to a vaccine containing any of the same substances
Verbal report of thrombocytopenia, as reported by the subject or the subject's parent / legally acceptable representative, contraindicating intramuscular vaccination in the Investigator's opinion
Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination in the Investigator's opinion
Personal history of Guillain-Barré syndrome
Personal history of an Arthus-like reaction after vaccination with a tetanus toxoid-containing vaccine within 10 years of the proposed study vaccination
Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily
Current alcohol abuse or drug addiction
Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion
Any condition which, in the opinion of the Investigator, might interfere with the evaluation of the study objectives
Moderate or severe acute illness/infection (according to Investigator judgment) on the day of vaccination, febrile illness (temperature ≥ 38.0 C), persistent diarrhea, vomiting. 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 an Investigator or employee of the Investigator or study center with direct involvement in the proposed study, or identified as an immediate family member (i.e., parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed study
The above information is not intended to contain all considerations relevant to a patient's
potential participation in a clinical trial
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