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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1217-2058 | Other Identifier | UTN |
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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.
Study duration per participant in Group 1 and Group 2 was approximately 30 days including: 1 day of screening and vaccination, a phone call and a safety-follow up/end of study visit at Day 8 and Day 30 after vaccine administration, respectively.
Study duration per participant in Group 3 and 4 was approximately 2 years and 30 days including: 1 day of screening, 1 day of vaccination 2 years later, a phone call and a safety-follow up/end of study visit at Day 8 and Day 30 after vaccine administration, respectively.
Study duration per participant in Group 5 and 6 was 1 day.
Safety assessment includes solicited reactions within 7 days after vaccination, unsolicited adverse events (AEs), serious adverse events (SAEs) and adverse event of special interest (AESI)s throughout the study "active phase" (i.e., 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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: MenACYW Conjugate Vaccine (MET 49 - Menomune-primed Participants) | Experimental | Participants who received a single dose of Menomune vaccine in a previous study MET49, provided a blood sample for assessment of antibody persistence (at enrollment [Day 0]) followed by a single intramuscular (IM) dose of MenACYW Conjugate vaccine, at Day 0, during Stage I in the present study (MEQ00066). |
|
| Group 2: MenACYW Conjugate Vaccine (MET49 - MenACYW Conjugate Vaccine-primed Participants) | Experimental | Participants who received a single dose of MenACYW Conjugate vaccine in a previous study MET49, provided a blood sample for assessment of antibody persistence (at enrollment [Day 0]) followed by a single IM dose of MenACYW Conjugate vaccine at Day 0, during Stage I in the present study (MEQ00066). |
|
| Group 3: MenACYW Conjugate Vaccine (MET49: Menomune-primed Participants) | Experimental | Participants who received a single dose of Menomune vaccine in a previous study MET49, provided a blood sample for assessment of antibody persistence at enrollment (Day 0) during Stage I in the present study (MEQ00066), followed by receiving a single IM dose of MenACYW Conjugate vaccine at Stage II in the present study (MEQ00066). |
|
| Group 4: MenACYW Conjugate Vaccine (MET49: MenACYW-primed Participants) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Meningococcal Polysaccharide (serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine | Biological | Pharmaceutical form: Solution for injection; Route of administration: Intramuscular |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion criteria:
Exclusion criteria:
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.
The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Sciences & Operations | Sanofi Pasteur, a Sanofi Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational Site Number 8400026 | Chandler | Arizona | 85225 | United States | ||
| Investigational Site Number 8400003 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39555800 | Derived | Robertson CA, Jacqmein J, Selmani A, Galarza K, Oster P. Immune persistence and booster response of a quadrivalent meningococcal conjugate vaccine (MenACYW-TT) 5 years after primary vaccination of adults at >/=56 years of age. Hum Vaccin Immunother. 2024 Dec 31;20(1):2426868. doi: 10.1080/21645515.2024.2426868. Epub 2024 Nov 18. | |
| 36632042 |
| Label | URL |
|---|---|
| MEQ00066 Plain Language Results Summary | View source |
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Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
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Study consisted of two stages: Stage I and Stage II. In Stage I, Groups 1 and 2 participants alone received vaccination and Groups 3 and 4 received no vaccination and only provided blood sample for antibody persistence. Groups 3 and 4 participants continued into Stage II and received vaccination in Stage II of the current study.
Study participants were enrolled from 04-October-2019 to 02-March-2020 at 34 sites in the United States. A total of 471 participants who received Menomune vaccine or Meningococcal Polysaccharide (Serogroups A, C, Y, and W 135) Tetanus Toxoid (MenACYW) Conjugate vaccine in Study MET49 (NCT02842866) or Study MET44 (NCT01732627) were enrolled and randomized/assigned to a study group in the present study (MEQ00066).
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1: MenACYW Conjugate Vaccine (MET 49 - Menomune-primed Participants) | Participants who received a single dose of Menomune vaccine in a previous study MET49, provided a blood sample for assessment of antibody persistence (at enrollment [Day 0]) followed by a single intramuscular (IM) dose of MenACYW Conjugate vaccine, at Day 0, during Stage I in the present study (MEQ00066). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Stage I |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 11, 2020 | Mar 26, 2021 |
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Participants who received a single dose of MenACYW Conjugate vaccine in a previous study MET49, provided a blood sample for assessment of antibody persistence at enrollment (Day 0) during Stage I in the present study (MEQ00066), followed by receiving a single IM dose of MenACYW Conjugate vaccine at Stage II in the present study (MEQ00066). |
|
| Group 5: Menomune-primed Participants (MET44) | Other | Participants who received a single dose of Menomune vaccine in a previous study MET44, provided a blood sample for assessment of antibody persistence at enrollment (Day 0) during Stage I in the present study (MEQ00066). These participants did not receive any vaccination in the present study (MEQ00066). |
|
| Group 6: MenACYW Conjugate Vaccine-primed Participants (MET44) | Other | Participants who received a single dose of MenACYW Conjugate vaccine in a previous study MET44, provided a blood sample for assessment of antibody persistence at enrollment (Day 0) during Stage I in the present study (MEQ00066). These participants did not receive any vaccination in the present study (MEQ00066). |
|
|
| Blood sample | Other | Blood sample for assessment of antibody persistence. |
|
| Day 30 (post-vaccination) in study MEQ00066 |
| 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 |
| 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 |
| 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) |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| San Diego |
| California |
| 92123-1881 |
| United States |
| Investigational Site Number 8400028 | Waterbury | Connecticut | 06708 | United States |
| Investigational Site Number 8400038 | Clearwater | Florida | 33756 | United States |
| Investigational Site Number 8400023 | DeLand | Florida | 32720 | United States |
| Investigational Site Number 8400007 | Jacksonville | Florida | 32205 | United States |
| Investigational Site Number 8400015 | Jacksonville | Florida | 32216 | United States |
| Investigational Site Number 8400022 | Ponte Vedra | Florida | 32081 | United States |
| Investigational Site Number 8400032 | Port Orange | Florida | 32127 | United States |
| Investigational Site Number 8400020 | West Palm Beach | Florida | 33409 | United States |
| Investigational Site Number 8400027 | Newton | Kansas | 67114 | United States |
| Investigational Site Number 8400017 | Wichita | Kansas | 67205 | United States |
| Investigational Site Number 8400016 | Metairie | Louisiana | 70006 | United States |
| Investigational Site Number 8400010 | Elkridge | Maryland | 21075 | United States |
| Investigational Site Number 8400031 | Richfield | Minnesota | 55423 | United States |
| Investigational Site Number 8400030 | St Louis | Missouri | 63141 | United States |
| Investigational Site Number 8400019 | Endwell | New York | 13760 | United States |
| Investigational Site Number 8400021 | Greensboro | North Carolina | 27408 | United States |
| Investigational Site Number 8400012 | Raleigh | North Carolina | 27612 | United States |
| Investigational Site Number 8400033 | Winston-Salem | North Carolina | 27103 | United States |
| Investigational Site Number 8400013 | Fargo | North Dakota | 58104 | United States |
| Investigational Site Number 8400035 | Cincinnati | Ohio | 45241 | United States |
| Investigational Site Number 8400005 | Cincinnati | Ohio | 45246 | United States |
| Investigational Site Number 8400011 | Columbus | Ohio | 43212 | United States |
| Investigational Site Number 8400014 | Uniontown | Pennsylvania | 15401 | United States |
| Investigational Site Number 8400018 | Anderson | South Carolina | 29621 | United States |
| Investigational Site Number 8400034 | Mt. Pleasant | South Carolina | 29464 | United States |
| Investigational Site Number 8400036 | Mt. Pleasant | South Carolina | 29464 | United States |
| Investigational Site Number 8400024 | Dallas | Texas | 75231 | United States |
| Investigational Site Number 8400001 | Murray | Utah | 84123 | United States |
| Investigational Site Number 8400002 | Salt Lake City | Utah | 84107 | United States |
| Investigational Site Number 8400025 | West Jordan | Utah | 84088-8865 | United States |
| Investigational Site Number 8400004 | Charlottesville | Virginia | 22911 | United States |
| Investigational Site Number 6300001 | San Juan | 00981 | Puerto Rico |
| Robertson CA, Jacqmein J, Selmani A, Galarza K, Oster P. Immunogenicity and safety of a quadrivalent meningococcal conjugate vaccine (MenACYW-TT) administered as a booster to adults aged >/=59 years: A phase III randomized study. Hum Vaccin Immunother. 2023 Dec 31;19(1):2160600. doi: 10.1080/21645515.2022.2160600. Epub 2023 Jan 11. |
| FG001 | Group 2: MenACYW Conjugate Vaccine (MET49 - MenACYW Conjugate Vaccine-primed Participants) | Participants who received a single dose of MenACYW Conjugate vaccine in a previous study MET49, provided a blood sample for assessment of antibody persistence (at enrollment [Day 0]) followed by a single IM dose of MenACYW Conjugate vaccine at Day 0, during Stage I in the present study (MEQ00066). |
| FG002 | Group 3: MenACYW Conjugate Vaccine (MET49: Menomune-primed Participants) | Participants who received a single dose of Menomune vaccine in a previous study MET49, provided a blood sample for assessment of antibody persistence at enrollment (Day 0) during Stage I in the present study (MEQ00066), followed by receiving a single IM dose of MenACYW Conjugate vaccine at Stage II in the present study (MEQ00066). |
| FG003 | Group 4: MenACYW Conjugate Vaccine (MET49: MenACYW-primed Participants) | Participants who received a single dose of MenACYW Conjugate vaccine in a previous study MET49, provided a blood sample for assessment of antibody persistence at enrollment (Day 0) during Stage I in the present study (MEQ00066), followed by receiving a single IM dose of MenACYW Conjugate vaccine at Stage II in the present study (MEQ00066). |
| FG004 | Group 5: Menomune-primed Participants (MET44) | Participants who received a single dose of Menomune vaccine in a previous study MET44, provided a blood sample for assessment of antibody persistence at enrollment (Day 0) during Stage I in the present study (MEQ00066). These participants did not receive any vaccination in the present study (MEQ00066). |
| FG005 | Group 6: MenACYW Conjugate Vaccine-primed Participants (MET44) | Participants who received a single dose of MenACYW Conjugate vaccine in a previous study MET44, provided a blood sample for assessment of antibody persistence at enrollment (Day 0) during Stage I in the present study (MEQ00066). These participants did not receive any vaccination in the present study (MEQ00066). |
| Vaccinated |
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| Stage I Full Analysis Set (FAS) | Participants who had a valid serology result for at least 1 serogroup from a pre-vaccination blood sample. |
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| Safety Analysis Set (SafAS) | Participants of Groups 1 and 2 who had received study MEQ00066 vaccine and had available safety data, were analyzed according to the actually received vaccine. |
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| COMPLETED |
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| NOT COMPLETED |
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| Stage II |
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Analysis was performed on all enrolled participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1: MenACYW Conjugate Vaccine (MET 49 - Menomune-primed Participants) | Participants who received a single dose of Menomune vaccine in a previous study MET49, provided a blood sample for assessment of antibody persistence (at enrollment [Day 0]) followed by a single IM dose of MenACYW Conjugate vaccine, at Day 0, during Stage I in the present study (MEQ00066). |
| BG001 | Group 2: MenACYW Conjugate Vaccine (MET49 - MenACYW Conjugate Vaccine-primed Participants) | Participants who received a single dose of MenACYW Conjugate vaccine in a previous study MET49, provided a blood sample for assessment of antibody persistence (at enrollment [Day 0]) followed by a single IM dose of MenACYW Conjugate vaccine at Day 0, during Stage I in the present study (MEQ00066). |
| BG002 | Group 3: MenACYW Conjugate Vaccine (MET49: Menomune-primed Participants) | Participants who received a single dose of Menomune vaccine in a previous study MET49, provided a blood sample for assessment of antibody persistence at enrollment (Day 0) during Stage I in the present study (MEQ00066), followed by receiving a single IM dose of MenACYW Conjugate vaccine at Stage II in the present study (MEQ00066). |
| BG003 | Group 4: MenACYW Conjugate Vaccine (MET49: MenACYW-primed Participants) | Participants who received a single dose of MenACYW Conjugate vaccine in a previous study MET49, provided a blood sample for assessment of antibody persistence at enrollment (Day 0), during Stage I in the present study (MEQ00066), followed by receiving a single IM dose of MenACYW Conjugate vaccine at Stage II in the present study (MEQ00066). |
| BG004 | Group 5: Menomune-primed Participants (MET44) | Participants who received a single dose of Menomune vaccine in a previous study MET44, provided a blood sample for assessment of antibody persistence at enrollment (Day 0) during Stage I in the present study (MEQ00066). These participants did not receive any vaccination in the present study (MEQ00066). |
| BG005 | Group 6: MenACYW Conjugate Vaccine-primed Participants (MET44) | Participants who received a single dose of MenACYW Conjugate vaccine in a previous study MET44, provided a blood sample for assessment of antibody persistence at enrollment (Day 0) during Stage I in the present study (MEQ00066). These participants did not receive any vaccination in the present study (MEQ00066). |
| BG006 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||
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| 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. | Stage I Day 30 Per-Protocol Analysis Set (PPAS) population: participants of Groups 1 and 2 who received 1 dose of vaccine in MEQ00066 and had valid serology result for at least 1 serogroup from a blood sample provided 30 days (+14) post-vaccination with no relevant protocol deviations. 'Number analyzed'=participants with available data for each specified category. For this outcome measure, data were not planned to be collected and analyzed for Groups 3, 4, 5 and 6 as pre-specified in protocol. | Posted | Number | 95% Confidence Interval | percentage of participants | Day 30 (post-vaccination) in study MEQ00066 |
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| 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. | Analysis was performed on Stage I Day 30 PPAS population. For this outcome measure, data were not planned to be collected and analyzed for Groups 3, 4, 5 and 6 as pre-specified in the protocol. | Posted | Number | 95% Confidence Interval | percentage of participants | Day 30 (post-vaccination) in study MEQ00066 |
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| 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. | Analysis was performed on Stage I Day 6 PPAS which included participants of Groups 1 and 2 who had received the study MEQ00066 vaccine and had a valid serology result for at least 1 serogroup from a blood sample provided 6 days (window, 5 to 7) post-vaccination with no relevant protocol deviations. For this outcome measure, data were not planned to be collected and analyzed for Groups 3, 4, 5 and 6 as pre-specified in the protocol. | Posted | Number | 95% Confidence Interval | percentage of participants | Day 6 (post-vaccination) in study MEQ00066 |
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| 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. | Analysis was performed on the Stage I Full Analysis Set (FAS) population for persistence which included Groups 1, 2, 3, 4, 5 and 6 participants who had a valid serology result for at least 1 serogroup from a pre-vaccination blood sample. Here, 'number analyzed' = participants with available data for each specified category. | Posted | Geometric Mean | 95% Confidence Interval | titers | Day 0 (pre-vaccination) and Day 30 (post-vaccination) in study MEQ00066 |
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| 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. | Analysis was performed on Stage I FAS population. | Posted | Geometric Mean | 95% Confidence Interval | titers | Day 0 (pre-vaccination in MEQ00066) |
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| 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. | Analysis was performed on Stage I FAS population. 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. | Posted | Number | 95% Confidence Interval | percentage of participants | Day 0 (pre-vaccination) in study MEQ00066 |
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| 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. | Analysis was performed on Stage II FAS for persistence that included participants in Groups 3 and 4 who had a valid serology result for at least 1 serogroup from pre-vaccination blood sample (5-year antibody persistence). Data for this outcome measure was not planned to be collected and analyzed for Groups 1, 2, 5 and 6 as pre-specified in the protocol. | Posted | Geometric Mean | 95% Confidence Interval | titers | 5 years post primary vaccination (with Menomune or MenACYW Conjugate vaccine) in study MET49 |
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| 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. | Analysis was performed on Stage II FAS for persistence. Data for this outcome measure was not planned to be collected and analyzed for Groups 1, 2, 5 and 6 as pre-specified in the protocol. | Posted | Geometric Mean | 95% Confidence Interval | titers | 5 years post primary vaccination (with Menomune or MenACYW Conjugate vaccine) in study MET49 |
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| 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. | Analysis was performed on Stage II FAS for persistence. Data for this outcome measure was not planned to be collected and analyzed for Groups 1, 2, 5 and 6 as pre-specified in the protocol. | Posted | Number | 95% Confidence Interval | percentage of participants | 5 years post primary vaccination (with Menomune or MenACYW Conjugate vaccine) in study MET49 |
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| 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. | Analysis was performed on Stage II FAS for persistence. Data for this outcome measure was not planned to be collected and analyzed for Groups 1, 2, 5 and 6 as pre-specified in the protocol. | Posted | Number | 95% Confidence Interval | percentage of participants | 5 years post primary vaccination (with Menomune or MenACYW Conjugate vaccine) in study MET49 |
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Unsolicited adverse event (AE) data were collected from Day 0 (pre-vaccination) up to Day 30 (post-vaccination). The solicited reactions (SR) were collected within 7 days post-vaccination. Serious AEs data were collected throughout the study (i.e., up to 30 days post-vaccination for Groups 1 and 2; and 2 years post-vaccination for Groups 3 and 4 in the current study)
Analysis performed on SafAS population. Safety data were planned to be collected and reported for participants revaccinated with MenACYW conjugate vaccine (i.e., participants in Groups 1 and 2 during Stage I, and participants in Groups 3 and 4 during Stage II). Since participants in Groups 5 and 6 were not vaccinated in MEQ00066 as pre-specified in the protocol, safety data were not planned to be collected and reported for Groups 5 and 6.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Stage I - Group 1: MenACYW Conjugate Vaccine (MET 49 - Menomune-primed Participants) | Participants who received a single dose of Menomune vaccine in a previous study MET49, provided a blood sample for assessment of antibody persistence (at enrollment [Day 0]) followed by a single IM dose of MenACYW Conjugate vaccine, at Day 0, during Stage I in the present study (MEQ00066). | 0 | 151 | 2 | 151 | 55 | 151 |
| EG001 | Stage I - Group 2: MenACYW Conjugate Vaccine (MET49 - MenACYW Conjugate Vaccine-primed Participants) | Participants who received a single dose of MenACYW Conjugate vaccine in a previous study MET49, provided a blood sample for assessment of antibody persistence (at enrollment [Day 0]) followed by a single IM dose of MenACYW Conjugate vaccine at Day 0, during Stage I in the present study (MEQ00066). | 0 | 162 | 1 | 162 | 62 | 162 |
| EG002 | Stage II - Group 3: MenACYW Conjugate Vaccine (MET49: Menomune-primed Participants) | Participants who received a single dose of Menomune vaccine in a previous study MET49, provided a blood sample for assessment of antibody persistence at enrollment (Day 0) during Stage I in the present study (MEQ00066), followed by receiving a single IM dose of MenACYW Conjugate vaccine at Stage II in the present study (MEQ00066). | 0 | 27 | 0 | 27 | 10 | 27 |
| EG003 | Stage II - Group 4: MenACYW Conjugate Vaccine (MET49: MenACYW-primed Participants) | Participants who received a single dose of MenACYW Conjugate vaccine in a previous study MET49, provided a blood sample for assessment of antibody persistence at enrollment (Day 0, Stage I) in the present study (MEQ00066), followed by receiving a single IM dose of MenACYW Conjugate vaccine at Stage II in the present study (MEQ00066). | 0 | 25 | 1 | 25 | 5 | 25 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diverticulitis | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
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| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
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| Epithelioid Mesothelioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.0 | Systematic Assessment |
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| Transient Ischaemic Attack | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection Site Erythema | General disorders | MedDRA 25.0 | Systematic Assessment |
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| Injection Site Pain | General disorders | MedDRA 25.0 | Systematic Assessment |
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| Malaise | General disorders | MedDRA 25.0 | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
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The Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable participant matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Trial Transparency Team | Sanofi Pasteur | 800-633-1610 | 6# | Contact-US@sanofi.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 30, 2020 | Mar 26, 2021 | SAP_001.pdf |
| ID | Term |
|---|---|
| D008589 | Meningococcal Infections |
| ID | Term |
|---|---|
| D016870 | Neisseriaceae Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
Not provided
Not provided
| Lost to Follow-up |
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| Withdrawal by Subject |
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| Male |
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| Asian |
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| Black or African American |
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| Native American or Alaska Native |
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| Mixed Origin |
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| Not Reported |
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| Serogroup W |
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| Serogroup Y |
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Participants who received a single dose of MenACYW Conjugate vaccine in a previous study MET49, provided a blood sample for assessment of antibody persistence (at enrollment [Day 0]) followed by a single IM dose of MenACYW Conjugate vaccine at Day 0, during Stage I in the present study (MEQ00066). |
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| OG001 | Group 2: MenACYW Conjugate Vaccine (MET49 - MenACYW Conjugate Vaccine-primed Participants) | Participants who received a single dose of MenACYW Conjugate vaccine in a previous study MET49, provided a blood sample for assessment of antibody persistence (at enrollment [Day 0]) followed by a single IM dose of MenACYW Conjugate vaccine at Day 0, during Stage I in the present study (MEQ00066). |
| OG002 | Pooled Groups 1 and 3: MenACYW Conjugate Vaccine (MET49: Menomune-primed Participants) | Included all participants of Groups 1 and 3 who received a single dose of Menomune vaccine in a previous study MET49. Participants in each group provided a blood sample for assessment of antibody persistence at enrollment (Day 0) in the present study (MEQ00066). In addition, Group 1 participants received a single IM dose of MenACYW Conjugate vaccine at Day 0 in the present study (MEQ00066). |
| OG003 | Pooled Groups 2 and 4: MenACYW Conjugate Vaccine (MET49: MenACYW-primed Participants) | Included all participants of Groups 2 and 4 who received a single dose of MenACYW Conjugate vaccine in a previous study MET49. Participants in each group provided a blood sample for assessment of antibody persistence at enrollment (Day 0) in the present study (MEQ00066). In addition, Group 2 participants received a single IM dose of MenACYW Conjugate vaccine at Day 0 in the present study (MEQ00066). |
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| Participants |
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| OG002 | Pooled Groups 1 and 3: MenACYW Conjugate Vaccine (MET49: Menomune-primed Participants) | Included all participants of Groups 1 and 3 who received a single dose of Menomune vaccine in a previous study MET49. Participants in each group provided a blood sample for assessment of antibody persistence at enrollment (Day 0) in the present study (MEQ00066). In addition, Group 1 participants received a single IM dose of MenACYW Conjugate vaccine at Day 0 in the present study (MEQ00066). |
| OG003 | Pooled Groups 2 and 4: MenACYW Conjugate Vaccine (MET49: MenACYW-primed Participants) | Included all participants of Groups 2 and 4 who received a single dose of MenACYW Conjugate vaccine in a previous study MET49. Participants in each group provided a blood sample for assessment of antibody persistence at enrollment (Day 0) in the present study (MEQ00066). In addition, Group 2 participants received a single IM dose of MenACYW Conjugate vaccine at Day 0 in the present study (MEQ00066). |
| OG004 | Group 5: Menomune-primed Participants (MET44) | Participants who received a single dose of Menomune vaccine in a previous study MET44, provided a blood sample for assessment of antibody persistence at enrollment (Day 0) during Stage I in the present study (MEQ00066). These participants did not receive any vaccination in the present study (MEQ00066). |
| OG005 | Group 6: MenACYW Conjugate Vaccine-primed Participants (MET44) | Participants who received a single dose of MenACYW Conjugate vaccine in a previous study MET44, provided a blood sample for assessment of antibody persistence at enrollment (Day 0) during Stage I in the present study (MEQ00066). These participants did not receive any vaccination in the present study (MEQ00066). |
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