Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine in Adults 56 Years and Older
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| ClinicalTrials.gov Identifier: NCT02842866 |
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Recruitment Status :
Completed
First Posted : July 25, 2016
Results First Posted : February 18, 2020
Last Update Posted : April 5, 2022
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Sponsor:
Sanofi Pasteur, a Sanofi Company
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
- Study Details
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| Study Type | Interventional |
|---|---|
| Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Prevention |
| Conditions |
Meningitis Meningococcal Meningitis Meningococcal Infections |
| Interventions |
Biological: Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine Biological: Meningococcal Polysaccharide Vaccine, Groups A, C, Y, and W-135 Combined |
| Enrollment | 907 |
Participant Flow
| Recruitment Details | Study was conducted from 15-July-2016 to 13-February-2017 at 35 sites in the United States and Puerto Rico. |
| Pre-assignment Details | Total 907 participants were enrolled in the study, out of which 906 were randomized. 1 participant was not randomized to either of the 2 treatment groups; this participant was not vaccinated and did not provide blood samples, therefore not counted in any analysis. |
| Arm/Group Title | Group 1: MenACYW Conjugate Vaccine | Group 2: Menomune® Vaccine |
|---|---|---|
 Arm/Group Description |
Healthy, adult participants aged greater than equal to (≥) 56 years received a single dose of Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid (MenACYW) Conjugate Vaccine on Day 0. | Healthy, adult participants aged ≥56 years received a single dose of Meningococcal Polysaccharide Serogroups A, C, Y, and W-135 Combined (Menomune®) Vaccine on Day 0. |
| Period Title: Overall Study | ||
| Started [1] | 451 | 455 |
| Vaccinated | 448 | 453 |
| Completed | 444 | 452 |
| Not Completed | 7 | 3 |
| Reason Not Completed | ||
| Serious Adverse Event | 0 | 1 |
| Protocol Violation | 4 | 2 |
| Lost to Follow-up | 2 | 0 |
| Withdrawal by Subject | 1 | 0 |
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[1]
Randomized
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Baseline Characteristics
| Arm/Group Title | Group 1: MenACYW Conjugate Vaccine | Group 2: Menomune® Vaccine | Total | |
|---|---|---|---|---|
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Arm/Group Description |
Healthy, adult participants aged ≥56 years received a single dose of MenACYW Conjugate vaccine on Day 0. | Healthy, adult participants aged ≥56 years received a single dose of Menomune®- A/C/Y/W-135 Vaccine on Day 0. | Total of all reporting groups | |
| Overall Number of Baseline Participants | 451 | 455 | 906 | |
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Baseline Analysis Population Description |
Analysis was performed on all randomized participants.
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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| Number Analyzed | 451 participants | 455 participants | 906 participants | |
| 66.9 (7.51) | 67.3 (7.53) | 67.1 (7.52) | ||
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 451 participants | 455 participants | 906 participants | |
| Female |
259 57.4%
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261 57.4%
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520 57.4%
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| Male |
192 42.6%
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194 42.6%
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386 42.6%
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 451 participants | 455 participants | 906 participants | |
| American Indian or Alaska Native |
2 0.4%
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2 0.4%
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4 0.4%
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| Asian |
5 1.1%
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1 0.2%
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6 0.7%
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| Native Hawaiian or Other Pacific Islander |
0 0.0%
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1 0.2%
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1 0.1%
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| Black or African American |
54 12.0%
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47 10.3%
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101 11.1%
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| White |
389 86.3%
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404 88.8%
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793 87.5%
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| More than one race |
0 0.0%
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0 0.0%
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0 0.0%
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| Unknown or Not Reported |
1 0.2%
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0 0.0%
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1 0.1%
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
| Name/Title: | Trial Transparency Team |
| Organization: | Sanofi Pasteur |
| Phone: | 800-633-1610 ext 1# |
| EMail: | Contact-US@sanofi.com |
| Responsible Party: | Sanofi ( Sanofi Pasteur, a Sanofi Company ) |
| ClinicalTrials.gov Identifier: | NCT02842866 |
| Other Study ID Numbers: |
MET49 |
| First Submitted: | July 15, 2016 |
| First Posted: | July 25, 2016 |
| Results First Submitted: | February 5, 2020 |
| Results First Posted: | February 18, 2020 |
| Last Update Posted: | April 5, 2022 |