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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from 1 month to 13 months post-dose 2
Awards & highlights
Study Summary
This trial will test a vaccine to protect against gonorrhea, evaluating safety, effectiveness and how well it works with the body.
Who is the study for?
Healthy adults aged 18 to 50, including transgender and gender non-conforming individuals based on biological sex and sexual behavior risk factors for gonorrhea. Participants must be willing to follow the study protocol, use contraception if of childbearing potential, have a negative pregnancy test before receiving the vaccine, and not have any significant health issues or hypersensitivities that could interfere with the trial.Check my eligibility
What is being tested?
The trial is testing various doses of GSK's NgG investigational vaccine against placebo in preventing gonorrhea. It aims to assess safety (how well it's tolerated), reactogenicity (immediate reaction after vaccination), efficacy (how effective it is at preventing disease), and immunogenicity (the immune response it triggers).See study design
What are the potential side effects?
Potential side effects may include allergic reactions to components of the vaccine, immediate post-vaccination reactions like soreness or fever, as well as other unspecified risks typically associated with vaccines which will be monitored throughout the study.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from 1 month to 13 months post-dose 2
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from 1 month to 13 months post-dose 2
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence rates of confirmed gonorrhea cases in study Phase 2 [Efficacy Proof of Concept (PoC)]
Percentage of participants reporting AEs leading to withdrawal in study Phase 1 (Dose-escalation safety lead-in)
Percentage of participants reporting AEs leading to withdrawal in study Phase 2 (Efficacy PoC)
+11 moreSecondary outcome measures
Incidence rates of confirmed gonorrhea cases with and without co-infection with a different sexually-transmitted disease causing bacterium in study Phase 2 (Efficacy PoC)
Incidence rates of gonorrhea in study Phase 2 (Efficacy PoC)
Incidence rates of other gonococcal infection with positive Ng in study Phase 2 (Efficacy PoC)
Trial Design
9Treatment groups
Experimental Treatment
Placebo Group
Group I: Phase 2: 4b dose below HTD GroupExperimental Treatment1 Intervention
Participants randomized to the 4b dose below HTD Group receive 2 doses of NgG dose below the highest tolerated dose selected from Phase 1.
Group II: Phase 2: 4a HTD GroupExperimental Treatment1 Intervention
Participants randomized to the 4a highest tolerated dose (HTD) Group receive 2 doses of NgG highest tolerated dose selected from Phase 1.
Group III: Phase 1:1a Low dose GroupExperimental Treatment1 Intervention
Participants randomized to the 1a Low dose Group receive 2 doses of NgG low dose investigational vaccine.
Group IV: Phase 1: 3a High dose GroupExperimental Treatment1 Intervention
Participants randomized to the 3a High dose Group receive 2 doses of NgG high dose investigational vaccine.
Group V: Phase 1: 2a Medium dose GroupExperimental Treatment1 Intervention
Participants randomized to the 2a Medium dose Group receive 2 doses of NgG medium dose investigational vaccine.
Group VI: Phase 1:1b Placebo GroupPlacebo Group1 Intervention
Participants randomized to the 1b Placebo Group receive 2 doses of placebo.
Group VII: Phase 1: 2b Placebo GroupPlacebo Group1 Intervention
Participants randomized to the 2b Placebo Group receive 2 doses of placebo.
Group VIII: Phase 1: 3b Placebo GroupPlacebo Group1 Intervention
Participants randomized to the 3b Placebo Group receive 2 doses of placebo.
Group IX: Phase 2: 4c Placebo GroupPlacebo Group1 Intervention
Participants randomized to the 4c Placebo Group receive 2 doses of placebo.
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Who is running the clinical trial?
GlaxoSmithKlineLead Sponsor
4,753 Previous Clinical Trials
8,068,684 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had a serious infection called meningococcal disease before.I have been on long-term antibiotics for infections like gonorrhea.I have a condition that weakens my immune system.I am at risk for gonorrhea due to my sexual behavior or history.I do not have serious lung, heart, liver, or kidney problems.I am under guardianship or trusteeship.I do not have a bleeding disorder that prevents me from getting shots in my muscles.I have received or will receive a group B meningitis vaccine.I plan to avoid pregnancy until at least one month after the study treatment ends.I am between 18 and 50 years old.I am transgender or non-binary and will be followed in the study based on my sex at birth.I am a woman who cannot become pregnant.I will not receive any vaccines not listed in the study 15 days before or after the trial vaccine.I haven't taken immunosuppressants for more than 14 days in the last 3 months.I am not pregnant, have used birth control for a month, and will continue during the study.I have uncontrolled seizures or neurological disorders.I haven't received blood products or immunoglobulins in the last 3 months.I haven't taken long-acting immune drugs in the last 6 months.
Research Study Groups:
This trial has the following groups:- Group 1: Phase 2: 4b dose below HTD Group
- Group 2: Phase 1:1a Low dose Group
- Group 3: Phase 1:1b Placebo Group
- Group 4: Phase 1: 2a Medium dose Group
- Group 5: Phase 1: 2b Placebo Group
- Group 6: Phase 1: 3a High dose Group
- Group 7: Phase 1: 3b Placebo Group
- Group 8: Phase 2: 4a HTD Group
- Group 9: Phase 2: 4c Placebo Group
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any age restrictions for participation in this clinical trial?
"Eligibility for this trial is restricted to individuals between the ages of 18 and 50. Following a different set of criteria, there are 22 trials in place that cater exclusively to minors while 34 others focus on participants over 65 years old."
Answered by AI
Is there still room for enrollees in this research endeavor?
"Per the information available on clinicaltrials.gov, this medical trial is not recruiting any further participants at present; it was first listed as open to enrollment on November 28th 2022 and last updated on November 25th 2022. However, there are 61 similar trials actively looking for patients right now."
Answered by AI
Who meets the eligibility criteria for this trial's participation?
"This clinical trial is currently recruiting 774 individuals aged between 18 and 50 who have contracted a sexually transmitted disease, with the following prerequisites: all participants must be able to demonstrate commitment to the protocol; they must provide valid consent prior to any study-specific procedure being carried out; healthy status as established by medical history, physical examination and laboratory evaluation results; female non-childbearing potential (pre-menarche, bilateral tubal ligation/occlusion, hysterectomy or post menopause); one month of adequate contraception before intervention administration date; negative pregnancy test on day of intervention administration date; continued use of effective"
Answered by AI
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