Safety and Efficacy Study of Meningococcal Group B Vaccine rMenB+OMV NZ (Bexsero) to Prevent Gonococcal Infection
|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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04350138|
Recruitment Status : Recruiting
First Posted : April 16, 2020
Last Update Posted : June 21, 2022
|Condition or disease||Intervention/treatment||Phase|
|Gonococcal Infection||Biological: Meningococcal Group B Vaccine Other: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||2200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||A Phase II Randomized, Observer-Blind, Placebo-Controlled Study, to Assess the Efficacy of Meningococcal Group B Vaccine rMenB+OMV NZ (Bexsero) in Preventing Gonococcal Infection|
|Actual Study Start Date :||December 29, 2020|
|Estimated Primary Completion Date :||August 1, 2023|
|Estimated Study Completion Date :||August 1, 2023|
Experimental: Group 1
Bexsero vaccine will be administered as an intramuscular injection in 1 mL single-dose prefilled syringe in two doses with a two-month apart (at enrollment/Visit 1 and Visit 3). N=1100.
Biological: Meningococcal Group B Vaccine
A combination vaccine consisting of rMenB and OMV NZ.
Placebo Comparator: Group 2
Placebo will be administered as an intramuscular injection in single-dose prefilled syringe in two doses with a two-month apart (at enrollment/Visit 1 and Visit 3). N=1100.
150mM sodium chloride (0.9% saline solution).
- Number of participants diagnosed with urogenital or anorectal gonococcal infection post second vaccination [ Time Frame: Day 91 to Day 451 ]Confirmed by Nucleic Acid Amplification Test (NAAT).
- Number of participants diagnosed with urogenital, anorectal, or pharyngeal gonococcal infection post second vaccination [ Time Frame: Day 91 to Day 451 ]Confirmed by Nucleic Acid Amplification Test (NAAT).
- Proportion of participants that experience at least one adverse event (AE) that results in withdrawal from study [ Time Frame: Day 1 to Day 451 ]Disease or medical condition, or new clinical finding(s) for which continued participation, in the opinion of the investigator might compromise the safety of the participant, interfere with the participant's successful completion of this study, or interfere with the evaluation of study endpoints.
- Proportion of participants that experience at least one adverse event of special interest (AESI) [ Time Frame: Day 1 to Day 451 ]Adverse Event of Special Interest (AESI) are specific to the protocol: Arthritis, Potential immune-mediated diseases (pIMD).
- Proportion of participants that experience at least one serious adverse event (SAE) [ Time Frame: Day 1 to Day 451 ]
- Proportion of participants with at least one medically attended adverse event (MAAE) [ Time Frame: Day 1 to Day 451 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04350138
|Contact: Jeanne M. Marrazzoemail@example.com|
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|Birmingham, Alabama, United States, 35294|
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