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Phase 3 N=360 Randomized Quadruple-blind Prevention

Study of a Quadrivalent Meningococcal Conjugate Vaccine as a Single Dose Compared With a Single Dose of a Meningococcal Reference Vaccine in Children, Adolescents, and Adults 2 to 55 Years of Age

Meningococcal Immunisation (Healthy Volunteers)

Enrolled (actual)
360
Serious AEs
0.0%
Results posted
Oct 2021
Primary outcome: Primary: Percentage of Participants With Vaccine Seroresponse For Meningococcal Serogroup A, C, Y And W Following Vaccination With MenACYW Conjugate and Menactra® Vaccine: Non-Inferiority Analysis — 85.6; 65.4; 96.6; 62.6 percentage of participants

Study Design & Population

Study type
Interventional
Phase
Phase 3
Interventions
Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine (MenACYW Conjugate Vaccine) (Biological); Meningococcal (Groups A, C, Y and W 135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (Biological)
Age
Pediatric, Adult · 2+ yrs
Sex
All
Sponsor
Sanofi
Primary completion
Nov 2020

Outcome Measures

OutcomeResultp-value
PRIMARY
Percentage of Participants With Vaccine Seroresponse For Meningococcal Serogroup A, C, Y And W Following Vaccination With MenACYW Conjugate and Menactra® Vaccine: Non-Inferiority Analysis
85.6; 65.4; 96.6; 62.6; 97.7; 63.5
SECONDARY
Percentage of Participants With Vaccine Seroresponse For Meningococcal Serogroup A, C, Y And W Following Vaccination With MenACYW Conjugate and Menactra® Vaccine
85.6; 65.4; 96.6; 62.6; 97.7; 63.5
SECONDARY
Percentage of Participants With hSBA Antibody Titer >=1:4 and >=1:8 Following Vaccination With MenACYW Conjugate and Menactra® Vaccine
82.8; 82.1; 42.5; 46.9; 98.3; 98.9
SECONDARY
Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroup A, C, Y And W Following Vaccination With MenACYW Conjugate and Menactra® Vaccine
5.79; 5.96; 123; 41.3; 4.47; 5.27
SECONDARY
Percentage of Participants With hSBA Titers Following Vaccination With MenACYW Conjugate and Menactra® Vaccine
1.7; 1.1; 1.7; 6.1; 2.9; 12.3
SECONDARY
Percentage of Participants With >=4-Fold Rise In hSBA Titers Following Vaccination With MenACYW Conjugate and Menactra® Vaccine
85.6; 65.4; 96.6; 62.6; 97.7; 63.5
SECONDARY
Number of Participants Reporting Immediate Adverse Events (AEs) Following Vaccination With MenACYW Conjugate and Menactra® Vaccine
0; 0
SECONDARY
Number of Participants Reporting Solicited Injection Site And Systemic Reactions Following Vaccination With MenACYW Conjugate and Menactra® Vaccine
72; 66; 16; 8; 14; 6
SECONDARY
Number of Participants Reporting Unsolicited Adverse Events Following Vaccination With MenACYW Conjugate and Menactra® Vaccine
15; 11
SECONDARY
Number of Participants Reporting Serious Adverse Events (SAEs) Following Vaccination With MenACYW Conjugate and Menactra® Vaccine
0; 0

Summary

Primary Objective: To demonstrate the non-inferiority of the antibody responses to meningococcal serogroups A, C, Y, and W following the administration of a single dose of Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine (MenACYW Conjugate vaccine) compared with those observed following the administration of a single dose of Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (Menactra® vaccine). Secondary Objective: Immunogenicity: To describe the antibody responses to the meningococcal serogroups A, C, Y, and W before and 30 days (+14 days) after vaccination with MenACYW Conjugate vaccine or Menactra®. Safety: To describe the safety profile of MenACYW Conjugate vaccine and that of Menactra®.

Eligibility Criteria

Inclusion criteria

  • Aged 2 to 55 years on the day of inclusion.
  • Informed consent form had been signed and dated by the participants or participants' parents/legally acceptable representatives as applicable. In addition: Participants 7 to 19 years provided written assent.
  • Participants (and participants' parents/legally acceptable representatives for the 2 to 19 years age groups) were able to attend all scheduled visits and complied with all study procedures.

Exclusion criteria

  • Participant was pregnant, or lactating, or of childbearing potential (to be considered of non-childbearing potential, a female must be pre-menarche or post-menopausal for at least 1 year, surgically sterile, or using an effective method of contraception* or abstinence from at least 4 weeks prior to vaccination until at least 4 weeks after vaccination).

*Effective methods of contraception included oral contraception (pill), intrauterine device, or condoms used with spermicide.

  • Participation in the 4 weeks preceding the study vaccination or planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure.
  • Receipt of any vaccine in the 4 weeks preceding the study vaccination or planned receipt of any vaccine prior to Visit 2 except for influenza vaccination, which may be received at least 2 weeks before or after the study investigational vaccines. This exception includes monovalent pandemic influenza vaccines and multivalent influenza vaccines.
  • Previous vaccination against meningococcal disease with either the study vaccine or another vaccine (i.e., mono- or polyvalent, polysaccharide, or Conjugate meningococcal vaccine containing serogroups A, C, Y, or W; or meningococcal B 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 study (specifically, but not limited to, subjects with persistent complement deficiency, with anatomic or functional asplenia, or participants traveling to countries with high endemic or epidemic disease).
  • Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccines used in the study or to a vaccine containing any of the same substances.
  • Laboratory confirmed / self-reported thrombocytopenia, contraindicating IM vaccination in the Investigator's judgment
  • Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating IM vaccination in the Investigator's judgement.
  • History of Guillain-Barre syndrome.
  • History of convulsions.
  • History of an Arthus-like reaction after vaccination with a tetanus toxoid-containing vaccine and a diphtheria 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, was at a stage where it might interfere with study conduct or completion.
  • Moderate or severe acute illness/infection (according to Investigator judgment) on the day of vaccination or febrile illness (temperature greater than or equal to (>=) 99.5 degree Fahrenheit or >= 37.5 degree Celsius). A prospective participant should not be included in the study until the condition had resolved or the febrile event had subsided.
  • Receipt of oral or injectable antibiotic therapy within 72 hours prior to
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04368429). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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