Study of a Quadrivalent Meningococcal Conjugate Vaccine as a Single Dose Compared With a Single D… (NCT04368429) | Clinical Trial Compass
CompletedPhase 3
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
Japan360 participantsStarted 2020-05-22
Plain-language 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®.
Who can participate
Age range2 Years – 55 Years
SexALL
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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 vac…
What they're measuring
1
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