CompletedPhase 3

Study to Assess the Safety and Immunogenicity of a Single Dose of a Quadrivalent Meningococcal (MenACYW) Conjugate Vaccine in Older Adults Who Received a Primary Vaccination (3 or More Years Earlier) in Study MET49

United States471 participantsStarted 2019-10-04

Plain-language summary

Primary Objective: To demonstrate sufficiency of the vaccine seroresponse to meningococcal serogroups A, C, W, and Y following administration of a single dose of Meningococcal Polysaccharide (Serogroups A, C, Y, and W 135) Tetanus Toxoid (MenACYW) Conjugate vaccine to Group 1 participants (who received primary vaccination with Menomune vaccine greater than or equal to \[\>= 3\] years earlier at \>= 56 years of age in Study MET49). Secondary Objectives: Secondary Objective 1 - To demonstrate sufficiency of the vaccine seroresponse to meningococcal serogroups A, C, W, and Y following administration of a single dose of MenACYW Conjugate vaccine to Group 2 participants (who received primary vaccination with MenACYW Conjugate vaccine \>= 3 years earlier at \>= 56 years of age in Study MET49). Secondary Objective 2 - To describe vaccine seroresponse rates with respect to serogroups A, C, W, and Y in serum specimens collected 6 days (window, 5-7) post-vaccination in approximately 60 participants from Group 1 (Menomune-primed) and approximately 60 participants from Group 2 (MenACYW Conjugate vaccine-primed). Secondary Objective 3 - To describe antibody persistence \>= 3 years after primary vaccination with Menomune vaccine or MenACYW Conjugate vaccine for participants from all groups.

Who can participate

Age range59 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria: * Received primary vaccination in Study MET49 or Study MET44 at \>= 56 years of age with either Menomune vaccine or MenACYW Conjugate vaccine, as assigned by randomization. ("\>= 56 years" means from the day of the 56th birthday onwards). * Able to attend all scheduled visits and to comply with all study procedures. Exclusion criteria: * 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 and until at least 4 weeks after vaccination. To be considered of non-childbearing potential, a female must be post-menopausal for at least 1 year, or surgically sterile. * Participation in the 4 weeks preceding study enrollment/vaccination or planned participation during the active phase of the present study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure. Note: "Active phase" refers to the period of time from revaccination with MenACYW Conjugate vaccine to the end of the short-term (i.e., \~30 days) follow-up after the vaccination. Accordingly, following the blood draw at Visit 1, participants in Group 3 and Group 4 will have a 2-year inactive phase prior to Visit 2. Prior to Visit 2, participants in Group 3 and Group 4 will have inclusion and exclusion criteria reassessed and will continue with or be excluded from further participation in the trial as appropriate. * Receipt of any vaccine in the 4 weeks (…

What they're measuring

Stage I: Percentage of Participants With Seroresponse for Meningococcal Serogroups A, C, W & Y Measured by Serum Bactericidal Assay Using Human Complement (hSBA) After Vaccination With MenACYW Conjugate Vaccine in Study MEQ00066: Group 1 (Menomune-primed)

Timeframe: Day 30 (post-vaccination) in study MEQ00066

Trial details

NCT IDNCT04142242

SponsorSanofi Pasteur, a Sanofi Company

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2020-04-01

Results submitted2021-03-26

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