Meningococcal Infection (Healthy Volunteers) Clinical Trial
Official title:
Safety and Immunogenicity of a Single Dose of MenACYW Conjugate Vaccine at Least 3 Years Following Initial Vaccination With Either Menomune® Vaccine or MenACYW Conjugate Vaccine in Older Adults
| Verified date | November 2023 |
| Source | Sanofi |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 471 |
| Est. completion date | May 25, 2022 |
| Est. primary completion date | April 1, 2020 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 59 Years and older |
| Eligibility | 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 completion. - Moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination or febrile illness (temperature >= 100.4°F). A prospective participant should not be included in the study or receive study vaccination 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 was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial. |
| Country | Name | City | State |
|---|---|---|---|
| Puerto Rico | Investigational Site Number 6300001 | San Juan | |
| United States | Investigational Site Number 8400018 | Anderson | South Carolina |
| United States | Investigational Site Number 8400026 | Chandler | Arizona |
| United States | Investigational Site Number 8400004 | Charlottesville | Virginia |
| United States | Investigational Site Number 8400005 | Cincinnati | Ohio |
| United States | Investigational Site Number 8400035 | Cincinnati | Ohio |
| United States | Investigational Site Number 8400038 | Clearwater | Florida |
| United States | Investigational Site Number 8400011 | Columbus | Ohio |
| United States | Investigational Site Number 8400024 | Dallas | Texas |
| United States | Investigational Site Number 8400023 | DeLand | Florida |
| United States | Investigational Site Number 8400010 | Elkridge | Maryland |
| United States | Investigational Site Number 8400019 | Endwell | New York |
| United States | Investigational Site Number 8400013 | Fargo | North Dakota |
| United States | Investigational Site Number 8400021 | Greensboro | North Carolina |
| United States | Investigational Site Number 8400007 | Jacksonville | Florida |
| United States | Investigational Site Number 8400015 | Jacksonville | Florida |
| United States | Investigational Site Number 8400016 | Metairie | Louisiana |
| United States | Investigational Site Number 8400034 | Mount Pleasant | South Carolina |
| United States | Investigational Site Number 8400036 | Mount Pleasant | South Carolina |
| United States | Investigational Site Number 8400001 | Murray | Utah |
| United States | Investigational Site Number 8400027 | Newton | Kansas |
| United States | Investigational Site Number 8400022 | Ponte Vedra | Florida |
| United States | Investigational Site Number 8400032 | Port Orange | Florida |
| United States | Investigational Site Number 8400012 | Raleigh | North Carolina |
| United States | Investigational Site Number 8400031 | Richfield | Minnesota |
| United States | Investigational Site Number 8400030 | Saint Louis | Missouri |
| United States | Investigational Site Number 8400002 | Salt Lake City | Utah |
| United States | Investigational Site Number 8400003 | San Diego | California |
| United States | Investigational Site Number 8400014 | Uniontown | Pennsylvania |
| United States | Investigational Site Number 8400028 | Waterbury | Connecticut |
| United States | Investigational Site Number 8400025 | West Jordan | Utah |
| United States | Investigational Site Number 8400020 | West Palm Beach | Florida |
| United States | Investigational Site Number 8400017 | Wichita | Kansas |
| United States | Investigational Site Number 8400033 | Winston-Salem | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| Sanofi Pasteur, a Sanofi Company |
United States, Puerto Rico,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| 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) | Antibody titers against meningococcal serogroups A, C, W, and Y were measured by hSBA. The hSBA vaccine seroresponse was defined as a post-vaccination hSBA titer greater than or equal to (>=) 1:16 for participants with pre-vaccination hSBA titer less than (<) 1:8, or a >= 4-fold increase in hSBA titer from pre-vaccination to post-vaccination for participants with pre-vaccination hSBA titer >= 1:8. | Day 30 (post-vaccination) in study MEQ00066 | |
| 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) | Antibody titers against meningococcal serogroups A, C, W, and Y were measured by hSBA. The hSBA vaccine seroresponse was defined as a post-vaccination hSBA titer >= 1:16 for participants with pre-vaccination hSBA titer < 1:8, or a >= 4-fold increase in hSBA titer from pre-vaccination to post-vaccination for participants with pre-vaccination hSBA titer >= 1:8. | Day 30 (post-vaccination) in study MEQ00066 | |
| 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 | Antibody titers against meningococcal serogroups A, C, W, and Y were measured by hSBA. The hSBA vaccine seroresponse was defined as a post-vaccination hSBA titer >= 1:16 for participants with pre-vaccination hSBA titer < 1:8, or a >= 4-fold increase in hSBA titer from pre-vaccination to post-vaccination for participants with pre-vaccination hSBA titer >= 1:8. | Day 6 (post-vaccination) in study MEQ00066 | |
| 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) | GMTs of antibodies against meningococcal serogroups A, C, W, and Y 135 were measured by hSBA. Titers are expressed in terms of 1/dilution. At Baseline, Group 1 was equivalent to Group 3 (both groups were Menomune-primed in MET49) and Group 2 was equivalent to Group 4 (both groups were MenACYW Conjugate Vaccine-primed in MET49), therefore it was planned to collect and present pooled data of Groups 1 and 3 and Groups 2 and 4 for Day 0 (pre-vaccination) in this outcome measure. Here, "0" in the number analyzed field for Day 30 signifies that data were not planned to be collected and analyzed for Groups 3 and 4 participants as pre-specified in the protocol. | Day 0 (pre-vaccination) and Day 30 (post-vaccination) in study MEQ00066 | |
| Secondary | Stage I: Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, W, and Y Measured by hSBA: Groups 5 and 6 | GMTs of antibodies against meningococcal serogroups A, C, W, and Y were measured by hSBA. Titers were expressed in terms of 1/dilution. | Day 0 (pre-vaccination in MEQ00066) | |
| 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 | Antibody titers against meningococcal serogroups A, C, W, and Y were measured by hSBA. | Day 0 (pre-vaccination) in study MEQ00066 | |
| 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 | GMTs of antibodies against meningococcal serogroups A, C, W, and Y were measured by hSBA. Titers were expressed in terms of 1/dilution. | 5 years post primary vaccination (with Menomune or MenACYW Conjugate vaccine) in study MET49 | |
| 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 | GMTs of antibodies against meningococcal serogroups A, C, W, and Y were measured by rSBA. Titers were expressed in terms of 1/dilution. | 5 years post primary vaccination (with Menomune or MenACYW Conjugate vaccine) in study MET49 | |
| 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 | Antibody titers against meningococcal serogroups A, C, W, and Y were measured by hSBA. | 5 years post primary vaccination (with Menomune or MenACYW Conjugate vaccine) in study MET49 | |
| 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 | Antibody titers against meningococcal serogroups A, C, W, and Y were measured by rSBA. | 5 years post primary vaccination (with Menomune or MenACYW Conjugate vaccine) in study MET49 |