Phase 3
N=471
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
Meningococcal Infection (Healthy Volunteers)
Bottom Line
View on ClinicalTrials.gov: NCT04142242 ↗Enrolled (actual)
471
Serious AEs
1.1%
Results posted
Apr 2021
Primary outcome: Primary: 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) — 60.8; 55.0; 49.2; 49.2 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 (Biological); Blood sample (Other)
- Age
- Adult, Older Adult · 59+ yrs
- Sex
- All
- Sponsor
- Sanofi Pasteur, a Sanofi Company
- Primary completion
- Apr 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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) |
60.8; 55.0; 49.2; 49.2 | — |
| SECONDARY Stage I: Percentage of Participants With Vaccine Seroresponse for Meningococcal Serogroups A, C, W, and Y Measured by hSBA After Vaccination With MenACYW Conjugate Vaccine in Study MEQ00066: Group 2 (MenACYW Conjugate Vaccine-primed Participants) |
79.3; 93.1; 90.3; 92.4 | — |
| SECONDARY Stage I: Percentage of Participants With Vaccine Seroresponse for Meningococcal Serogroups A, C, W, and Y Measured by hSBA at Day 6 After Vaccination With MenACYW Conjugate Vaccine in Study MEQ00066: Groups 1 and 2 |
8.1; 36.2; 8.1; 77.6; 6.5; 70.7 | — |
| SECONDARY Stage I: Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, W, and Y Measured by hSBA Before and After Vaccination With MenACYW Conjugate Vaccine in Study MEQ00066 (Groups 1 to 4) |
11.6; 11.8; 11.6; 12.2; 57.6; 144 | — |
| SECONDARY Stage I: Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, W, and Y Measured by hSBA: Groups 5 and 6 |
9.64; 9.00; 7.58; 11.9; 4.95; 11.9 | — |
| SECONDARY Stage I: Percentage of Participants With Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, W, and Y Measured by hSBA After Primary Vaccination With Menomune Vaccine or MenACYW Conjugate Vaccine: Groups 1 to 6 |
86.2; 89.1; 85.8; 87.9; 84.6; 81.4 | — |
| SECONDARY Stage II: Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, W, and Y Measured by hSBA After Primary Vaccination With Menomune Vaccine or MenACYW Conjugate Vaccine: Groups 3 and 4 |
8.72; 15.6; 3.78; 7.25; 4.62; 7.07 | — |
| SECONDARY Stage II: Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, W, and Y Measured by rSBA After Primary Vaccination With Menomune Vaccine or MenACYW Conjugate Vaccine: Groups 3 and 4 |
24.0; 40.0; 13.8; 64.0; 9.79; 25.0 | — |
| SECONDARY Stage II: Percentage of Participants With Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W Measured by hSBA After Primary Vaccination With Menomune Vaccine or MenACYW Conjugate Vaccine: Groups 3 and 4 |
79.2; 89.3; 58.3; 78.6; 50.0; 64.3 | — |
| SECONDARY Stage II: Percentage of Participants With Antibody Titers >=1:8 and >=1:128 Against Meningococcal Serogroups A, C, Y, and W Measured by rSBA After Primary Vaccination With Menomune Vaccine or MenACYW Conjugate Vaccine: Groups 3 and 4 |
45.8; 53.6; 41.7; 50.0; 45.8; 75.0 | — |
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.
Eligibility Criteria
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 (28 days) preceding the study vaccination or planned receipt of any vaccine during the active phase of the present study except for influenza vaccination, which might be received at least 2 weeks before or after study vaccine. This exception includes monovalent pandemic influenza vaccines and multivalent influenza vaccines.
- Receipt or planned receipt of any meningococcal vaccine since receipt of a single dose of MenACYW Conjugate vaccine or Menomune vaccine in Study MET49 or Study MET44.
- Receipt of immune globulins, blood, or blood-derived products in the 3 months prior to either enrollment or MenACYW Conjugate vaccination in the current study.
- 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 prior either to enrollment or MenACYW conjugate vaccination in the current study).
- History of meningococcal infection, confirmed either clinically, serologically, or microbiologically.
- At high risk for meningococcal infection during the study (specifically, but not limited to, participants with persistent complement deficiency, with anatomic or functional asplenia, or participants travelling 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 vaccine used in the study or to a vaccine containing any of the same substances (excluding participants in Group 5 and Group 6).
- Verbal report of thrombocytopenia, contraindicating IM vaccination, in the Investigator's opinion (excluding participants in Group 5 and Group 6).
- Personal history of Guillain-Barré Syndrome (GBS) (excluding participants in Group 5 and Group 6).
- Personal history of an Arthus-like reaction after vaccination with a tetanus toxoid-containing vaccine within at least 10 years of the proposed study vaccination (excluding participants in Group 5 and Group 6).
- Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion (excluding participants in Group 5 and Group 6), contraindicating IM vaccination in the Investigator's opinion.
- 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 compl
Data sourced from ClinicalTrials.gov (NCT04142242). 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.