Immunogenicity and Safety of a Booster Dose of an Investigational Quadrivalent Meningococcal Conjugate Vaccine
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02752906 |
Recruitment Status :
Completed
First Posted : April 27, 2016
Results First Posted : June 5, 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 )
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); 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 (Groups A, C, Y and W 135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine |
Enrollment | 810 |
Participant Flow
Recruitment Details | Study participants were enrolled in 30 centers from 15 April 2016 to 02 August 2016. |
Pre-assignment Details | A total of 810 participants who met all of the inclusion criteria and none of the exclusion criteria were enrolled and randomized in the study. |
Arm/Group Title | MenACYW Conjugate Vaccine | Menactra ® |
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Healthy, meningococcal vaccine-primed adolescents (greater than or equal to [>=] 15 to less than [<] 18 years) or adults (>= 18 years) received a single dose of a Meningococcal Polysaccharide (Serogroups A, C, Y and W) Tetanus Toxoid (MenACYW) Conjugate vaccine on Day 0. | Healthy, meningococcal-vaccine-primed adolescents (>= 15 to < 18 years) or adults (>= 18 years) received a single dose of Meningococcal (Groups A, C, Y and W 135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (Menactra ®) vaccine on Day 0. |
Period Title: Overall Study | ||
Started | 403 | 407 |
Vaccinated | 402 | 407 |
Completed | 396 | 402 |
Not Completed | 7 | 5 |
Reason Not Completed | ||
Protocol Violation | 2 | 1 |
Withdrawal by Subject | 2 | 2 |
Lost to Follow-up | 3 | 2 |
Baseline Characteristics
Arm/Group Title | MenACYW Conjugate Vaccine | Menactra ® | Total | |
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Healthy, meningococcal vaccine-primed adolescents (>= 15 to < 18 years) or adults (>= 18 years) received a single dose of a MenACYW Conjugate vaccine on Day 0. | Healthy, meningococcal-vaccine-primed adolescents (>= 15 to < 18 years) or adults (>= 18 years) received a single dose of Menactra ® vaccine on Day 0. | Total of all reporting groups | |
Overall Number of Baseline Participants | 403 | 407 | 810 | |
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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 | 403 participants | 407 participants | 810 participants | |
20.0 (5.96) | 19.9 (5.59) | 20.0 (5.77) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 403 participants | 407 participants | 810 participants | |
Female |
207 51.4%
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200 49.1%
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407 50.2%
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Male |
196 48.6%
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207 50.9%
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403 49.8%
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 403 participants | 407 participants | 810 participants | |
American Indian or Alaska Native |
1 0.2%
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0 0.0%
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1 0.1%
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Asian |
11 2.7%
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3 0.7%
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14 1.7%
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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 |
40 9.9%
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46 11.3%
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86 10.6%
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White |
342 84.9%
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340 83.5%
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682 84.2%
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More than one race |
8 2.0%
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17 4.2%
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25 3.1%
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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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Region of Enrollment
Measure Type: Count of Participants Unit of measure: Participants |
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United States | Number Analyzed | 403 participants | 407 participants | 810 participants |
403 100.0%
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407 100.0%
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810 100.0%
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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 Inc. |
Phone: | 800-633-1610 ext 1# |
EMail: | Contact-US@sanofi.com |
Responsible Party: | Sanofi ( Sanofi Pasteur, a Sanofi Company ) |
ClinicalTrials.gov Identifier: | NCT02752906 |
Other Study ID Numbers: |
MET56 U1111-1161-2710 ( Other Identifier: WHO ) 2018-001470-18 ( EudraCT Number ) |
First Submitted: | April 22, 2016 |
First Posted: | April 27, 2016 |
Results First Submitted: | May 19, 2020 |
Results First Posted: | June 5, 2020 |
Last Update Posted: | April 5, 2022 |