Safety and Efficacy of GSK Neisseria Gonorrhoeae GMMA (Ng... | NCT05630859 | Trialant
NCT05630859
Sponsor
GlaxoSmithKline
Status
Completed
Last Update Posted
Jun 16, 2026Actual
Enrollment
1,009Actual
Phase
Phase 1Phase 2
Conditions
Sexually Transmitted Diseases
Interventions
NgG 12.5 µg investigational vaccine
NgG 25 µg investigational vaccine
NgG 50 µg investigational vaccine
Placebo
Countries
United States
Brazil
France
Germany
Philippines
South Africa
Spain
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT05630859
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
216156
Secondary IDs
ID
Type
Description
Link
2022-500883-37-00
Other Identifier
EU CT number
Brief Title
Safety and Efficacy of GSK Neisseria Gonorrhoeae GMMA (NgG) Investigational Vaccine When Administered to Healthy Adults 18 to 50 Years of Age
Official Title
A Phase 1/2, Observer-blind, Randomized, Placebo-controlled Multi-country Study to Assess Safety and Efficacy of GSK Neisseria Gonorrhoeae GMMA (NgG) Investigational Vaccine When Administered to Healthy Adults 18 to 50 Years of Age
Acronym
Not provided
Organization
GlaxoSmithKlineINDUSTRY
Status Module
Record Verification Date
May 2026
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Nov 28, 2022Actual
Primary Completion Date
May 22, 2025Actual
Completion Date
May 22, 2025Actual
First Submitted Date
Nov 25, 2022
First Submission Date that Met QC Criteria
Nov 25, 2022
First Posted Date
Nov 30, 2022Actual
Results Waived
Not provided
Results First Submitted Date
May 19, 2026
Results First Submitted that Met QC Criteria
May 19, 2026
Results First Posted Date
Jun 16, 2026Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
May 19, 2026
Last Update Posted Date
Jun 16, 2026Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
GlaxoSmithKlineINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
No
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The aim of this first time in human proof of concept (FTiH-PoC) study was to evaluate safety and reactogenicity, to demonstrate efficacy and to explore immunogenicity of GlaxoSmithKline's (GSK) Neisseria gonorrhoeae generalized modules for membrane antigens (GMMA) (NgG) investigational vaccine compared to placebo (saline).
Detailed Description
The study included the following parts:
Phase 1 - Dose-escalation safety lead-in in healthy participants.
Phase 2 - Efficacy PoC in healthy participants considered at risk for gonorrhea.
The doses to be tested for efficacy would be selected based on the safety evaluation performed during the dose-escalation safety lead-in: in case more than one dose would show tolerability, the highest tolerated dose (HTD) and the dose below the highest tolerated (i.e., 2 doses) would be advanced in the efficacy PoC part of the study and compared versus placebo. In case only the lowest dose shows adequate tolerability, this would be the only dose tested in the PoC versus placebo.
Conditions Module
Conditions
Sexually Transmitted Diseases
Keywords
Neisseria gonorrhoeae
Safety
Efficacy
Sexually transmitted infection
Healthy adults 18 to 50 years of age
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
1,009Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Phase 1: Neisseria gonorrhoeae GMMA (NgG) 12.5 micrograms (µg) Group
Experimental
Participants received 2 doses of NgG 12.5 µg investigational vaccine on Day 1 and Day 61.
Biological: NgG 12.5 µg investigational vaccine
Phase 1: NgG 25 µg Group
Experimental
Participants received 2 doses of NgG 25 µg investigational vaccine on Day 1 and Day 61.
Biological: NgG 25 µg investigational vaccine
Phase 1: NgG 50 µg Group
Experimental
Participants received 2 doses of NgG 50 µg investigational vaccine on Day 1 and Day 61.
Biological: NgG 50 µg investigational vaccine
Phase 1: Placebo Group
Placebo Comparator
Participants received 2 doses of placebo on Day 1 and Day 61.
Combination Product: Placebo
Phase 2: NgG Highest tolerated dose (HTD; 50 µg) Group
Experimental
Participants received 2 doses of NgG HTD (50 µg) investigational vaccine on Day 1 and Day 61. The HTD was selected based on the safety evaluation performed in Phase 1.
Interventions
Name
Type
Description
Arm Group Labels
Other Names
NgG 12.5 µg investigational vaccine
Biological
2 doses of NgG 12.5 µg investigational vaccine administered intramuscularly.
Phase 1: Neisseria gonorrhoeae GMMA (NgG) 12.5 micrograms (µg) Group
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Phase 1: Number of Participants Reporting Any Solicited Administration Site Events
Assessed solicited administration site events included injection site pain, erythema (redness), and swelling. Any = occurrence of the event regardless of intensity grade.
From Day 1 to Day 7
Phase 1: Number of Participants Reporting Any Solicited Administration Site Events
Assessed solicited administration site events included injection site pain, erythema (redness), and swelling. Any = occurrence of the event regardless of intensity grade.
From Day 61 to Day 67
Phase 1: Number of Participants Reporting Any Solicited Systemic Events
Assessed solicited systemic events included headache, fatigue (tiredness), myalgia (muscle pain), arthralgia (joint pain), and fever (pyrexia). Fever is defined as body temperature >=38ºC; preferred location for measuring the temperature is oral cavity. Any = occurrence of the event regardless of intensity grade.
From Day 1 to Day 7
Phase 1: Number of Participants Reporting Any Solicited Systemic Events
Assessed solicited systemic events included headache, fatigue (tiredness), myalgia (muscle pain), arthralgia (joint pain), and fever (pyrexia). Fever is defined as body temperature >=38ºC; preferred location for measuring the temperature is oral cavity. Any = occurrence of the event regardless of intensity grade.
From Day 61 to Day 67
Phase 1: Number of Participants Reporting Any Unsolicited Adverse Events (AEs)
An unsolicited AE is an AE that is either not included in the list of solicited events or can be included in the list of solicited events but with an onset outside the specified period of follow-up for solicited events. Unsolicited AEs include both serious and non-serious AEs. Any = occurrence of the event regardless of intensity grade.
Secondary Outcomes
Measure
Description
Time Frame
Phase 2: Incidence Rates of Confirmed Gonorrhea Cases With and Without Chlamydia Trachomatis Co-infection
Confirmed gonorrhea cases by positive NAAT with and without chlamydia trachomatis co-infection at the pharyngeal and/or anorectal and/or urogenital location are reported. The incidence rate (y/PT) of confirmed gonorrhea cases with and without Chlamydia Trachomatis co-infection, expressed in terms of 100 person-years, was calculated as the number of confirmed gonorrhea cases with and without Chlamydia Trachomatis co-infection (y) in a group, over the sum of individual person-times at risk (PT) in the same group, and multiplied by 100.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Inclusion criteria for the dose-escalation safety lead-in part
Participants, who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
Written or witnessed/thumb printed informed consent obtained from the participant prior to performance of any study-specific procedure.
Healthy participants as established by medical history, clinical examination, and laboratory assessment.
A participant between and including 18 and 50 years of age at the time of informed consent.
Female participants of non-childbearing potential may be enrolled in the study.
Female participants of childbearing potential may be enrolled in the study if the participant:
has practiced adequate contraception for 1 month prior to study intervention administration, and
has a negative pregnancy test on the day of study intervention administration, and
has agreed to continue adequate contraception during the entire treatment period and for 1 month after completion of the study intervention administration series.
Inclusion criteria for the efficacy PoC part
Participants, who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
Written or witnessed/thumb printed informed consent obtained from the participant prior to performance of any study-specific procedure.
Healthy participants as established by:
For the 2 intensive safety monitoring subsets (i.e., first 30 HIV negative subjects per group followed by first 8 HIV positive subjects per group): medical history, clinical examination, and laboratory assessment.
For all the remaining participants: medical history, clinical examination.
At risk for gonococcus infections based on sexual behavioral characteristics: this may include men having sex with men, pre-exposure prophylaxis for HIV users, individuals who engage in transactional sex participants with current or past STI diagnosis, participants at time of STI screening or seeking other STI services.
A participant between and including 18 and 50 years of age at the time of informed consent. Transgender men and women, and other gender non-conforming people who identify themselves as neither men nor women may be enrolled into the study, based on their risk factors. For the purpose of this study, they will be followed up according to their biological sex (sex at birth), sexual orientation, and genital/sexual anatomy
Participants of non-childbearing potential may be enrolled in the study. This includes transmen that have not undergone gender affirming surgery of their genitals.
Participants of childbearing potential may be enrolled in the study if the participant:
has practiced adequate contraception for 1 month prior to study intervention administration, and
has a negative pregnancy test on the day of study intervention administration, and
has agreed to continue adequate contraception during the entire treatment period and for 1 month after completion of the study intervention administration series.
Exclusion criteria:
Medical conditions Dose-escalation safety lead-in part
Any clinically significant biochemical laboratory abnormality.
Any other clinical condition as determined by the investigator, that may increase participant's risk due to study participation.
History of any reaction/hypersensitivity likely to be exacerbated by any component of the study intervention.
Confirmed or suspected immunosuppressive/immunodeficient condition, based on medical history and physical examination.
Hypersensitivity to latex.
Acute/chronic clinically significant pulmonary, cardiovascular, hepatic/renal functional abnormality, as determined by physical examination/laboratory tests.
Uncontrolled neurological disorders or seizures.
History of invasive meningococcal disease. Efficacy PoC part: HIV negative intensive safety monitoring, HIV negative full enrollment and for all remaining participants
Persons under guardianship or trusteeship.
Persons deprived of liberty.
Gonococcal infection identified within 14 days prior to randomization.
Any other clinical condition as determined by the investigator, that may increase participant's risk due to study participation.
History of severe allergic reactions and/anaphylaxis, or any reaction or hypersensitivity likely to be exacerbated by any component of the study intervention(s).
Bleeding diathesis / any other condition that would contraindicate intramuscular administration.
Confirmed or suspected immunosuppressive/immunodeficient condition, based on medical history and physical examination.
Known seropositivity for HIV infection, regardless of viremia and CD4 cell count
Hypersensitivity to latex.
Acute/chronic clinically significant pulmonary, cardiovascular, hepatic/renal functional abnormality, as determined by physical examination/laboratory tests.
Recurrent history/uncontrolled neurological disorders or seizures.
History of invasive meningococcal disease.
The exclusion criteria depicted above, and the following exclusions criterion applies only for the HIV positive participants (intensive safety monitoring subset and full enrollment of HIV positive participants):
Seropositivity for HIV infection if:
CD4 cell count < 350 cells/mm3 in the last 6 months
viral load > 50cp/ml in the last 6 months
participant is not on antiretroviral therapy (ART) for > 3 months or has switched from a different ART in the last 3 months.
For both Intensive safety monitoring subset (first 30 HIV negative subjects per group and first 8 HIV positive subjects per group) these criteria apply:
Any clinically significant hematological/biochemical laboratory abnormality.
Prior/Concomitant therapy Applicable for both the dose-escalation safety lead-in part and the PoC part
Use of any investigational/non-registered product other than the study intervention(s) within 30 days before the first dose/planned use during the study period.
Previous and planned vaccination with an OMV based Neisseria meningitidis group B vaccine (e.g., Bexsero, MeNZB vaccine or MenBvac at any time prior to first dose and during the entire study period.
Planned administration/administration of a vaccine not specified in study protocol within 15 days before the first dose and ending 15 days after the last dose of vaccine administration.
Administration of long-acting immune-modifying drugs during the period starting 6 months prior to the first dose of study intervention/planned administration at any time during the study period.
Administration of immunoglobulins /any blood products/plasma derivatives during the period starting 3 months before the administration of the first dose of study intervention/planned administration during the study period.
Chronic administration (more than 14 days in total) of immunosuppressants/other immune-modifying drugs during the period starting 3 months prior to the first study intervention dose(s). For corticosteroids, this will mean prednisone equivalent ≥20 mg/day for adult participants/ ≥0.5 mg/kg/day. Inhaled and topical steroids are allowed.
The following criterion applies only for the PoC part:
• Chronic/long-term use of systemic antibiotics with an activity against Neisseria gonorrhoeae.
Prior/Concurrent clinical study experience applicable for both dose-escalation safety lead-in part and the PoC part Concurrently participating in another clinical study, at any time during the study period, in which the participant has been/will be exposed to an investigational/a non-investigational intervention.
Other exclusions applicable for both dose-escalation safety leading part and the PoC part
Pregnant/lactating female.
Female planning to become pregnant/to discontinue contraceptive precautions before 1 month after completion of the study intervention administration series.
Any study personnel/their immediate dependents, family/household members.
Lifestyle consideration that may interfere with the conduct of the study/pose additional risks to the rights and wellbeing of participants.
Accepts Healthy Volunteers
Yes
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
50 Years
Standard Ages
Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Not provided
Locations
Facility
Status
City
State
ZIP
Country
Contacts
GSK Investigational Site
Washington D.C.
District of Columbia
20009
United States
GSK Investigational Site
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
Plan to Share IPD
Yes
Description
IPD for this study will be made available via the Clinical Study Data Request site.
Types
Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame
IPD will be made available within 6 months of publishing the results of the primary endpoints, a key secondary endpoints and safety data of the study.
Access Criteria
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
URL
Not provided
Results Section
Participant Flow Module
Pre-assignment Details
Phase 1 Placebo group: Enrollment in the Phase 1 portion of the study proceeded stepwise to allow three increasing dosages of the candidate vaccine to be tested against placebo. In this record we present the pooled Phase 1 placebo analysis group, which includes all participants who received placebo during Phase 1.
Recruitment Details
A total of 1009 participants were included in the enrolled set, out of which only 1004 were included in the exposed set and started the study. The study was conducted in 2 phases: Phase 1 was the Dose-escalation safety lead-in (SLI) phase and Phase 2 was the Efficacy Proof of Concept (PoC) phase.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Phase 1: Neisseria Gonorrhoeae GMMA (NgG) 12.5 Micrograms (µg) Group
Participants received 2 doses of NgG 12.5 µg investigational vaccine on Day 1 and Day 61.
Participants received 2 doses of NgG bHTD (25 µg) investigational vaccine on Day 1 and Day 61. The bHTD is selected based on the safety evaluation performed in Phase 1.
Biological: NgG 25 µg investigational vaccine
Phase 2: Placebo Group
Placebo Comparator
Participants received 2 doses of placebo on Day 1 and Day 61.
Combination Product: Placebo
NgG 25 µg investigational vaccine
Biological
2 doses of NgG 25 µg investigational vaccine administered intramuscularly.
Phase 1: NgG 25 µg Group
Phase 2: NgG dose below HTD (bHTD; 25 µg) Group
NgG 50 µg investigational vaccine
Biological
2 doses of NgG 50 µg investigational vaccine administered intramuscularly.
Phase 1: NgG 50 µg Group
Phase 2: NgG Highest tolerated dose (HTD; 50 µg) Group
Placebo
Combination Product
2 doses of placebo administered intramuscularly.
Phase 1: Placebo Group
Phase 2: Placebo Group
Sodium chloride (NaCl)
From Day 1 to Day 30
Phase 1: Number of Participants Reporting Any Unsolicited AEs
An unsolicited AE is an AE that is either not included in the list of solicited events or can be included in the list of solicited events but with an onset outside the specified period of follow-up for solicited events. Unsolicited AEs include both serious and non-serious AEs. Any = occurrence of the event regardless of intensity grade.
From Day 61 to Day 90
Phase 1: Number of Participants Reporting Any Serious Adverse Events (SAEs) and AEs Leading to Withdrawal
An SAE is defined as any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant, abnormal pregnancy outcome or any other situation as determined by the investigator. An AE is any untoward medical occurrence (an unfavourable/unintended sign - including an abnormal laboratory finding), symptom, or disease (new or exacerbated) in a clinical study participant that is temporally associated with the study intervention. The AE may or may not be considered related to the study intervention. A participant is considered to have withdrawn from the study if no new study procedure has been performed or no new information has been collected for them since the date of withdrawal/last contact. Any = occurrence of the event regardless of intensity grade.
From Day 1 after the first dose to Day 241
Phase 1: Number of Participants With Change From Baseline in Haematological and Biochemical Laboratory Values
The safety laboratory data included haematological parameters [hemoglobin, lymphocytes, platelets, neutrophils, and white blood cells (WBC)] and biochemical parameters (Alanine Aminotransferase [ALT], Aspartate Aminotransferase [AST], Blood Urea Nitrogen and Creatinine). Categories reported when comparing Day 1 (baseline) and Day 8 haematological and biochemical laboratory results are defined as follows: <parameter>, <range at baseline>, <range at timing> (e.g. ALT, Within, Within). Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.
At Day 8 compared to baseline (Day 1)
Phase 1: Number of Participants With Change From Baseline in Haematological and Biochemical Laboratory Values
The safety laboratory data included haematological parameters (hemoglobin, lymphocytes, platelets, neutrophils, and WBC) and biochemical parameters (ALT, AST, Blood Urea Nitrogen and Creatinine). Categories reported when comparing Day 61 (baseline) and Day 68 hematological and biochemical laboratory results are defined as follows: <parameter>, <range at baseline>, <range at timing> (e.g. ALT, Within, Within). Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter. Unknown = No results are available for the corresponding laboratory parameter at the specific timepoint.
At Day 68 compared to baseline (Day 61)
Phase 2: Incidence Rate of Confirmed Gonorrhea Cases
Incidence of first confirmed gonorrhea cases by positive Nucleic Acid Amplification Test (NAAT) at the anorectal and/or urogenital location were evaluated. The incidence rate (y/PT) of confirmed gonorrhea cases, expressed in terms of 100 person-years, was calculated as the number of confirmed gonorrhea cases (y) in a group, over the sum of individual person-times at risk (PT) in the same group, and multiplied by 100.
From 1 month post-Dose 2 (Day 91) to 13 months post-Dose 2 (Day 451)
Phase 2: Number of Participants Reporting Any Solicited Administration Site Events
Assessed solicited administration site events included injection site pain, erythema (redness), and swelling. Any = occurrence of the event regardless of intensity grade.
From Day 1 to Day 7
Phase 2: Number of Participants Reporting Any Solicited Administration Site Events
Assessed solicited administration site events included injection site pain, erythema (redness), and swelling. Any = occurrence of the event regardless of intensity grade.
From Day 61 to Day 67
Phase 2: Number of Participants Reporting Any Solicited Systemic Events
Assessed solicited systemic events included headache, fatigue (tiredness), myalgia (muscle pain), arthralgia (joint pain), and fever (pyrexia). Fever is defined as body temperature >=38ºC; preferred location for measuring the temperature is oral cavity. Any = occurrence of the event regardless of intensity grade.
From Day 1 to Day 7
Phase 2: Number of Participants Reporting Any Solicited Systemic Events
Assessed solicited systemic events included headache, fatigue (tiredness), myalgia (muscle pain), arthralgia (joint pain), and fever (pyrexia). Fever is defined as body temperature >=38ºC; preferred location for measuring the temperature is oral. Any = occurrence of the event regardless of intensity grade.
From Day 61 to Day 67
Phase 2: Number of Participants Reporting Any Unsolicited AEs
An unsolicited AE is an AE that is either not included in the list of solicited events or can be included in the list of solicited events but with an onset outside the specified period of follow-up for solicited events. Unsolicited AEs include both serious and non-serious AEs. Any = occurrence of the event regardless of intensity grade.
From Day 1 to Day 30
Phase 2: Number of Participants Reporting Any Unsolicited AEs
An unsolicited AE is an AE that is either not included in the list of solicited events or can be included in the list of solicited events but with an onset outside the specified period of follow-up for solicited events. Unsolicited AEs include both serious and non-serious AEs. Any = occurrence of the event regardless of intensity grade.
From Day 61 to Day 90
Phase 2: Number of Participants Reporting Any SAEs and AEs Leading to Withdrawal
An SAE is defined as any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant, abnormal pregnancy outcome or any other situation as determined by the investigator. An AE is any untoward medical occurrence (an unfavourable/unintended sign - including an abnormal laboratory finding), symptom, or disease (new or exacerbated) in a clinical study participant that is temporally associated with the study intervention. The AE may or may not be considered related to the study intervention. A participant is considered to have withdrawn from the study if no new study procedure has been performed or no new information has been collected for them since the date of withdrawal/last contact. Any = occurrence of the event regardless of intensity grade.
From Day 1 after the first dose to Day 451
Phase 2: Number of Participants With Change From Baseline in Haematological and Biochemical Laboratory Values in HIV Negative (HIV-) Subset
The safety laboratory data included haematological parameters (hemoglobin, lymphocytes, platelets, neutrophils, and WBC) and biochemical parameters (ALT, AST, Blood Urea Nitrogen and Creatinine). Categories reported when comparing Day 1 (baseline) and Day 8 hematological and biochemical laboratory results are defined as follows: <parameter>, <range at baseline>, <range at timing> (e.g. ALT, Within, Within). Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.
At Day 8 compared to baseline (Day 1)
Phase 2: Number of Participants With Change From Baseline in Haematological and Biochemical Laboratory Values for HIV Positive (HIV+) Subset
The safety laboratory data included haematological parameters (hemoglobin, absolute lymphocyte count, platelets, absolute neutrophil count, and WBC) and biochemical parameters (ALT, AST, Blood Urea Nitrogen and Creatinine). Categories reported when comparing Day 1 (baseline) and Day 8 hematological and biochemical laboratory results are defined as follows: <parameter>, <range at baseline>, <range at timing> (e.g. ALT, Within, Within). Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter. Unknown = No results are available for the corresponding laboratory parameter at the specific timepoint.
At Day 8 compared to baseline (Day 1)
Phase 2: Number of Participants With Change From Baseline in Haematological and Biochemical Laboratory Values for HIV- Subset
The safety laboratory data included haematological parameters (hemoglobin, lymphocytes, platelets, neutrophils, and WBC) and biochemical parameters (ALT, AST, Blood Urea Nitrogen and Creatinine). Categories reported when comparing Day 61 (baseline) and Day 68 haematological and biochemical laboratory results are defined as follows: <parameter>, <range at baseline>, <range at timing> (e.g. ALT, Within, Within). Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter. Unknown = No results are available for the corresponding laboratory parameter at the specific timepoint.
At Day 68 compared to baseline (Day 61)
Phase 2: Number of Participants With Change From Baseline in Haematological and Biochemical Laboratory Values HIV+ Subset
The safety laboratory data included haematological parameters (hemoglobin, absolute lymphocyte count, platelets, absolute neutrophil count, and WBC) and biochemical parameters (ALT, AST, Blood Urea Nitrogen and Creatinine). Categories reported when comparing Day 61 (baseline) and Day 68 hematological and biochemical laboratory results are defined as follows: <parameter>, <range at baseline>, <range at timing> (e.g. ALT, Within, Within). Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter. Unknown = No results are available for the corresponding laboratory parameter at the specific timepoint.
At Day 68 compared to baseline (Day 61)
From 1 month post-Dose 2 (Day 91) to 13 months post-Dose 2 (Day 451)
Phase 2: Incidence Rates of Symptomatic and Confirmed Gonorrhea Cases
Symptomatic gonorrhea cases which were later confirmed gonorrhea cases are reported. Symptomatic gonorrhea cases are defined as participants with symptoms suggestive of gonorrhea at the infected anatomical site which were later confirmed by a positive NAAT at the anorectal and/or urogenital location. The incidence rate (y/PT) of confirmed gonorrhea cases, expressed in terms of 100 person-years, was calculated as the number of confirmed gonorrhea cases (y) in a group, over the sum of individual person-times at risk (PT) in the same group, and multiplied by 100.
From 1 month post-Dose 2 (Day 91) to 13 months post-Dose 2 (Day 451)
Participants received 2 doses of NgG 25 µg investigational vaccine on Day 1 and Day 61.
FG002
Phase 1: NgG 50 µg Group
Participants received 2 doses of NgG 50 µg investigational vaccine on Day 1 and Day 61.
FG003
Phase 1: Placebo Group
Participants received 2 doses of placebo on Day 1 and Day 61.
FG004
Phase 2: NgG Highest Tolerated Dose (HTD; 50 µg) Group
Participants received 2 doses of NgG HTD (50 µg) investigational vaccine on Day 1 and Day 61. The HTD was selected based on the safety evaluation performed in Phase 1.
FG005
Phase 2: NgG Dose Below HTD (bHTD; 25 µg) Group
Participants received 2 doses of NgG bHTD (25 µg) investigational vaccine on Day 1 and Day 61. The bHTD is selected based on the safety evaluation performed in Phase 1.
FG006
Phase 2: Placebo Group
Participants received 2 doses of placebo on Day 1 and Day 61.
FG0006 subjects
FG0016 subjects
FG0026 subjects
FG0036 subjects
FG004329 subjects
FG005327 subjects
FG006324 subjects
COMPLETED
FG0006 subjects
FG0016 subjects
FG0026 subjects
FG0035 subjects
FG004311 subjects
FG005304 subjects
FG006304 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG00418 subjects
FG00523 subjects
FG00620 subjects
Type
Comment
Reasons
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG0046 subjects
FG0057 subjects
FG0068 subjects
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Migrated / Moved from the study area
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Other
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Phase 1: Neisseria Gonorrhoeae GMMA (NgG) 12.5 Micrograms (µg) Group
Participants received 2 doses of NgG 12.5 µg investigational vaccine on Day 1 and Day 61.
BG001
Phase 1: NgG 25 µg Group
Participants received 2 doses of NgG 25 µg investigational vaccine on Day 1 and Day 61.
BG002
Phase 1: NgG 50 µg Group
Participants received 2 doses of NgG 50 µg investigational vaccine on Day 1 and Day 61.
BG003
Phase 1: Placebo Group
Participants received 2 doses of placebo on Day 1 and Day 61.
BG004
Phase 2: NgG Highest Tolerated Dose (HTD; 50 µg) Group
Participants received 2 doses of NgG HTD (50 µg) investigational vaccine on Day 1 and Day 61. The HTD was selected based on the safety evaluation performed in Phase 1.
BG005
Phase 2: NgG Dose Below HTD (bHTD; 25 µg) Group
Participants received 2 doses of NgG bHTD (25 µg) investigational vaccine on Day 1 and Day 61. The bHTD is selected based on the safety evaluation performed in Phase 1.
BG006
Phase 2: Placebo Group
Participants received 2 doses of placebo on Day 1 and Day 61.
BG007
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0006
BG0016
BG0026
BG0036
BG004329
BG005327
BG006324
BG0071004
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
YEARS
Title
Denominators
Categories
Title
Measurements
BG00037.2± 9.9
BG00139.0± 5.5
BG00241.3± 8.3
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0003
BG0013
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Black or African American
BG0002
BG0013
BG002
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
Primary
Phase 1: Number of Participants Reporting Any Solicited Administration Site Events
Assessed solicited administration site events included injection site pain, erythema (redness), and swelling. Any = occurrence of the event regardless of intensity grade.
Analysis was performed on the Solicited Safety Set which includes all participants who received at least one dose of the study intervention and had solicited safety data available at the specified duration. Only participants from Phase 1 groups with solicited administration site events data available for the specified analysis at the specified duration were included in this outcome measure.
Posted
Count of Participants
Participants
From Day 1 to Day 7
ID
Title
Description
OG000
Phase 1: Neisseria Gonorrhoeae GMMA (NgG) 12.5 Micrograms (µg) Group
Participants received 2 doses of NgG 12.5 µg investigational vaccine on Day 1 and Day 61.
OG001
Phase 1: NgG 25 µg Group
Participants received 2 doses of NgG 25 µg investigational vaccine on Day 1 and Day 61.
OG002
Phase 1: NgG 50 µg Group
Participants received 2 doses of NgG 50 µg investigational vaccine on Day 1 and Day 61.
OG003
Phase 1: Placebo Group
Participants received 2 doses of placebo on Day 1 and Day 61.
Units
Counts
Participants
OG0006
OG0016
OG0026
OG003
Title
Denominators
Categories
Pain
Title
Measurements
OG0004
OG0014
OG0025
OG003
Primary
Phase 1: Number of Participants Reporting Any Solicited Administration Site Events
Assessed solicited administration site events included injection site pain, erythema (redness), and swelling. Any = occurrence of the event regardless of intensity grade.
Analysis was performed on the Solicited Safety Set. Only participants from Phase 1 groups with solicited administration site events data available for the specified analysis at the specified duration were included in this outcome measure.
Posted
Count of Participants
Participants
From Day 61 to Day 67
ID
Title
Description
OG000
Phase 1: Neisseria Gonorrhoeae GMMA (NgG) 12.5 Micrograms (µg) Group
Participants received 2 doses of NgG 12.5 µg investigational vaccine on Day 1 and Day 61.
OG001
Phase 1: NgG 25 µg Group
Participants received 2 doses of NgG 25 µg investigational vaccine on Day 1 and Day 61.
OG002
Phase 1: NgG 50 µg Group
Participants received 2 doses of NgG 50 µg investigational vaccine on Day 1 and Day 61.
OG003
Phase 1: Placebo Group
Primary
Phase 1: Number of Participants Reporting Any Solicited Systemic Events
Assessed solicited systemic events included headache, fatigue (tiredness), myalgia (muscle pain), arthralgia (joint pain), and fever (pyrexia). Fever is defined as body temperature >=38ºC; preferred location for measuring the temperature is oral cavity. Any = occurrence of the event regardless of intensity grade.
Analysis was performed on the Solicited Safety Set. Only participants from Phase 1 groups with solicited systemic events data available for the specified analysis at the specified duration were included in this outcome measure.
Posted
Count of Participants
Participants
From Day 1 to Day 7
ID
Title
Description
OG000
Phase 1: Neisseria Gonorrhoeae GMMA (NgG) 12.5 Micrograms (µg) Group
Participants received 2 doses of NgG 12.5 µg investigational vaccine on Day 1 and Day 61.
OG001
Phase 1: NgG 25 µg Group
Participants received 2 doses of NgG 25 µg investigational vaccine on Day 1 and Day 61.
OG002
Phase 1: NgG 50 µg Group
Participants received 2 doses of NgG 50 µg investigational vaccine on Day 1 and Day 61.
Primary
Phase 1: Number of Participants Reporting Any Solicited Systemic Events
Assessed solicited systemic events included headache, fatigue (tiredness), myalgia (muscle pain), arthralgia (joint pain), and fever (pyrexia). Fever is defined as body temperature >=38ºC; preferred location for measuring the temperature is oral cavity. Any = occurrence of the event regardless of intensity grade.
Analysis was performed on the Solicited Safety Set. Only participants from Phase 1 groups with solicited systemic events data available for the specified analysis at the specified duration were included in this outcome measure.
Posted
Count of Participants
Participants
From Day 61 to Day 67
ID
Title
Description
OG000
Phase 1: Neisseria Gonorrhoeae GMMA (NgG) 12.5 Micrograms (µg) Group
Participants received 2 doses of NgG 12.5 µg investigational vaccine on Day 1 and Day 61.
OG001
Phase 1: NgG 25 µg Group
Participants received 2 doses of NgG 25 µg investigational vaccine on Day 1 and Day 61.
OG002
Phase 1: NgG 50 µg Group
Participants received 2 doses of NgG 50 µg investigational vaccine on Day 1 and Day 61.
Primary
Phase 1: Number of Participants Reporting Any Unsolicited Adverse Events (AEs)
An unsolicited AE is an AE that is either not included in the list of solicited events or can be included in the list of solicited events but with an onset outside the specified period of follow-up for solicited events. Unsolicited AEs include both serious and non-serious AEs. Any = occurrence of the event regardless of intensity grade.
Analysis was performed on the Unsolicited Safety Set which includes all participants who received at least one dose of the study intervention and had unsolicited safety data available at the specified duration. Only participants from Phase 1 groups with unsolicited AEs data available for the specified analysis at the specified duration were included in this outcome measure.
Posted
Count of Participants
Participants
From Day 1 to Day 30
ID
Title
Description
OG000
Phase 1: Neisseria Gonorrhoeae GMMA (NgG) 12.5 Micrograms (µg) Group
Participants received 2 doses of NgG 12.5 µg investigational vaccine on Day 1 and Day 61.
OG001
Phase 1: NgG 25 µg Group
Participants received 2 doses of NgG 25 µg investigational vaccine on Day 1 and Day 61.
OG002
Phase 1: NgG 50 µg Group
Primary
Phase 1: Number of Participants Reporting Any Unsolicited AEs
An unsolicited AE is an AE that is either not included in the list of solicited events or can be included in the list of solicited events but with an onset outside the specified period of follow-up for solicited events. Unsolicited AEs include both serious and non-serious AEs. Any = occurrence of the event regardless of intensity grade.
Analysis was performed on the Unsolicited Safety Set. Only participants from Phase 1 groups with unsolicited AEs data available for the specified analysis at the specified duration were included in this outcome measure.
Posted
Count of Participants
Participants
From Day 61 to Day 90
ID
Title
Description
OG000
Phase 1: Neisseria Gonorrhoeae GMMA (NgG) 12.5 Micrograms (µg) Group
Participants received 2 doses of NgG 12.5 µg investigational vaccine on Day 1 and Day 61.
OG001
Phase 1: NgG 25 µg Group
Participants received 2 doses of NgG 25 µg investigational vaccine on Day 1 and Day 61.
OG002
Phase 1: NgG 50 µg Group
Participants received 2 doses of NgG 50 µg investigational vaccine on Day 1 and Day 61.
Primary
Phase 1: Number of Participants Reporting Any Serious Adverse Events (SAEs) and AEs Leading to Withdrawal
An SAE is defined as any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant, abnormal pregnancy outcome or any other situation as determined by the investigator. An AE is any untoward medical occurrence (an unfavourable/unintended sign - including an abnormal laboratory finding), symptom, or disease (new or exacerbated) in a clinical study participant that is temporally associated with the study intervention. The AE may or may not be considered related to the study intervention. A participant is considered to have withdrawn from the study if no new study procedure has been performed or no new information has been collected for them since the date of withdrawal/last contact. Any = occurrence of the event regardless of intensity grade.
Analysis was performed on the Exposed set which includes all participants who received at least one dose of the study intervention and had post-vaccination data available at the specified duration. Only participants from Phase 1 groups with SAEs and AEs leading to withdrawal data available for the specified analysis at the specified duration were included in this outcome measure.
Posted
Count of Participants
Participants
From Day 1 after the first dose to Day 241
ID
Title
Description
OG000
Phase 1: Neisseria Gonorrhoeae GMMA (NgG) 12.5 Micrograms (µg) Group
Participants received 2 doses of NgG 12.5 µg investigational vaccine on Day 1 and Day 61.
Primary
Phase 1: Number of Participants With Change From Baseline in Haematological and Biochemical Laboratory Values
The safety laboratory data included haematological parameters [hemoglobin, lymphocytes, platelets, neutrophils, and white blood cells (WBC)] and biochemical parameters (Alanine Aminotransferase [ALT], Aspartate Aminotransferase [AST], Blood Urea Nitrogen and Creatinine). Categories reported when comparing Day 1 (baseline) and Day 8 haematological and biochemical laboratory results are defined as follows: <parameter>, <range at baseline>, <range at timing> (e.g. ALT, Within, Within). Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.
Analysis was performed on the Exposed set. Only participants from Phase 1 groups with haematological and biochemical laboratory parameters data available for the specified analysis at the specified timepoint were included in this outcome measure.
Posted
Count of Participants
Participants
At Day 8 compared to baseline (Day 1)
ID
Title
Description
OG000
Phase 1: Neisseria Gonorrhoeae GMMA (NgG) 12.5 Micrograms (µg) Group
Participants received 2 doses of NgG 12.5 µg investigational vaccine on Day 1 and Day 61.
OG001
Phase 1: NgG 25 µg Group
Primary
Phase 1: Number of Participants With Change From Baseline in Haematological and Biochemical Laboratory Values
The safety laboratory data included haematological parameters (hemoglobin, lymphocytes, platelets, neutrophils, and WBC) and biochemical parameters (ALT, AST, Blood Urea Nitrogen and Creatinine). Categories reported when comparing Day 61 (baseline) and Day 68 hematological and biochemical laboratory results are defined as follows: <parameter>, <range at baseline>, <range at timing> (e.g. ALT, Within, Within). Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter. Unknown = No results are available for the corresponding laboratory parameter at the specific timepoint.
Analysis was performed on the Exposed set. Only participants from Phase 1 groups with haematological and biochemical laboratory parameters data available for the specified analysis at the specified timepoint were included in this outcome measure.
Posted
Count of Participants
Participants
At Day 68 compared to baseline (Day 61)
ID
Title
Description
OG000
Phase 1: Neisseria Gonorrhoeae GMMA (NgG) 12.5 Micrograms (µg) Group
Participants received 2 doses of NgG 12.5 µg investigational vaccine on Day 1 and Day 61.
OG001
Phase 1: NgG 25 µg Group
Primary
Phase 2: Incidence Rate of Confirmed Gonorrhea Cases
Incidence of first confirmed gonorrhea cases by positive Nucleic Acid Amplification Test (NAAT) at the anorectal and/or urogenital location were evaluated. The incidence rate (y/PT) of confirmed gonorrhea cases, expressed in terms of 100 person-years, was calculated as the number of confirmed gonorrhea cases (y) in a group, over the sum of individual person-times at risk (PT) in the same group, and multiplied by 100.
Analysis was performed on the Modified Full Analysis Efficacy Set (mFAS) which includes all participants who received full study intervention (2 doses) and had post-vaccination efficacy data available at the specified duration. Only participants from Phase 2 groups with confirmed gonorrhea cases data available for the specified analysis at the specified duration were included in this outcome measure.
Posted
Number
Cases per 100 person-years
From 1 month post-Dose 2 (Day 91) to 13 months post-Dose 2 (Day 451)
ID
Title
Description
OG000
Phase 2: NgG Highest Tolerated Dose (HTD; 50 µg) Group
Participants received 2 doses of NgG HTD (50 µg) investigational vaccine on Day 1 and Day 61. The HTD was selected based on the safety evaluation performed in Phase 1.
OG001
Phase 2: NgG Dose Below HTD (bHTD; 25 µg) Group
Participants received 2 doses of NgG bHTD (25 µg) investigational vaccine on Day 1 and Day 61. The bHTD is selected based on the safety evaluation performed in Phase 1.
Primary
Phase 2: Number of Participants Reporting Any Solicited Administration Site Events
Assessed solicited administration site events included injection site pain, erythema (redness), and swelling. Any = occurrence of the event regardless of intensity grade.
Analysis was performed on the Solicited Safety Set. Only participants from Phase 2 groups with solicited administration site events data available for the specified analysis at the specified duration were included in this outcome measure.
Posted
Count of Participants
Participants
From Day 1 to Day 7
ID
Title
Description
OG000
Phase 2: NgG Highest Tolerated Dose (HTD; 50 µg) Group
Participants received 2 doses of NgG HTD (50 µg) investigational vaccine on Day 1 and Day 61. The HTD was selected based on the safety evaluation performed in Phase 1.
OG001
Phase 2: NgG Dose Below HTD (bHTD; 25 µg) Group
Participants received 2 doses of NgG bHTD (25 µg) investigational vaccine on Day 1 and Day 61. The bHTD is selected based on the safety evaluation performed in Phase 1.
OG002
Phase 2: Placebo Group
Participants received 2 doses of placebo on Day 1 and Day 61.
Primary
Phase 2: Number of Participants Reporting Any Solicited Administration Site Events
Assessed solicited administration site events included injection site pain, erythema (redness), and swelling. Any = occurrence of the event regardless of intensity grade.
Analysis was performed on the Solicited Safety Set. Only participants from Phase 2 groups with solicited administration site events data available for the specified analysis at the specified duration were included in this outcome measure.
Posted
Count of Participants
Participants
From Day 61 to Day 67
ID
Title
Description
OG000
Phase 2: NgG Highest Tolerated Dose (HTD; 50 µg) Group
Participants received 2 doses of NgG HTD (50 µg) investigational vaccine on Day 1 and Day 61. The HTD was selected based on the safety evaluation performed in Phase 1.
OG001
Phase 2: NgG Dose Below HTD (bHTD; 25 µg) Group
Participants received 2 doses of NgG bHTD (25 µg) investigational vaccine on Day 1 and Day 61. The bHTD is selected based on the safety evaluation performed in Phase 1.
OG002
Phase 2: Placebo Group
Participants received 2 doses of placebo on Day 1 and Day 61.
Primary
Phase 2: Number of Participants Reporting Any Solicited Systemic Events
Assessed solicited systemic events included headache, fatigue (tiredness), myalgia (muscle pain), arthralgia (joint pain), and fever (pyrexia). Fever is defined as body temperature >=38ºC; preferred location for measuring the temperature is oral cavity. Any = occurrence of the event regardless of intensity grade.
Analysis was performed on the Solicited Safety Set. Only participants from Phase 2 groups with solicited systemic events data available for the specified analysis at the specified duration were included in this outcome measure.
Posted
Count of Participants
Participants
From Day 1 to Day 7
ID
Title
Description
OG000
Phase 2: NgG Highest Tolerated Dose (HTD; 50 µg) Group
Participants received 2 doses of NgG HTD (50 µg) investigational vaccine on Day 1 and Day 61. The HTD was selected based on the safety evaluation performed in Phase 1.
OG001
Phase 2: NgG Dose Below HTD (bHTD; 25 µg) Group
Participants received 2 doses of NgG bHTD (25 µg) investigational vaccine on Day 1 and Day 61. The bHTD is selected based on the safety evaluation performed in Phase 1.
OG002
Phase 2: Placebo Group
Participants received 2 doses of placebo on Day 1 and Day 61.
Primary
Phase 2: Number of Participants Reporting Any Solicited Systemic Events
Assessed solicited systemic events included headache, fatigue (tiredness), myalgia (muscle pain), arthralgia (joint pain), and fever (pyrexia). Fever is defined as body temperature >=38ºC; preferred location for measuring the temperature is oral. Any = occurrence of the event regardless of intensity grade.
Analysis was performed on the Solicited Safety Set. Only participants from Phase 2 groups with solicited systemic events data available for the specified analysis at the specified duration were included in this outcome measure.
Posted
Count of Participants
Participants
From Day 61 to Day 67
ID
Title
Description
OG000
Phase 2: NgG Highest Tolerated Dose (HTD; 50 µg) Group
Participants received 2 doses of NgG HTD (50 µg) investigational vaccine on Day 1 and Day 61. The HTD was selected based on the safety evaluation performed in Phase 1.
OG001
Phase 2: NgG Dose Below HTD (bHTD; 25 µg) Group
Participants received 2 doses of NgG bHTD (25 µg) investigational vaccine on Day 1 and Day 61. The bHTD is selected based on the safety evaluation performed in Phase 1.
OG002
Phase 2: Placebo Group
Participants received 2 doses of placebo on Day 1 and Day 61.
Primary
Phase 2: Number of Participants Reporting Any Unsolicited AEs
An unsolicited AE is an AE that is either not included in the list of solicited events or can be included in the list of solicited events but with an onset outside the specified period of follow-up for solicited events. Unsolicited AEs include both serious and non-serious AEs. Any = occurrence of the event regardless of intensity grade.
Analysis was performed on the Unsolicited Safety Set. Only participants from Phase 2 groups with unsolicited AEs data available for the specified analysis at the specified duration were included in this outcome measure.
Posted
Count of Participants
Participants
From Day 1 to Day 30
ID
Title
Description
OG000
Phase 2: NgG Highest Tolerated Dose (HTD; 50 µg) Group
Participants received 2 doses of NgG HTD (50 µg) investigational vaccine on Day 1 and Day 61. The HTD was selected based on the safety evaluation performed in Phase 1.
OG001
Phase 2: NgG Dose Below HTD (bHTD; 25 µg) Group
Participants received 2 doses of NgG bHTD (25 µg) investigational vaccine on Day 1 and Day 61. The bHTD is selected based on the safety evaluation performed in Phase 1.
OG002
Phase 2: Placebo Group
Primary
Phase 2: Number of Participants Reporting Any Unsolicited AEs
An unsolicited AE is an AE that is either not included in the list of solicited events or can be included in the list of solicited events but with an onset outside the specified period of follow-up for solicited events. Unsolicited AEs include both serious and non-serious AEs. Any = occurrence of the event regardless of intensity grade.
Analysis was performed on the Unsolicited Safety Set. Only participants from Phase 2 groups with unsolicited AEs data available for the specified analysis at the specified duration were included in this outcome measure.
Posted
Count of Participants
Participants
From Day 61 to Day 90
ID
Title
Description
OG000
Phase 2: NgG Highest Tolerated Dose (HTD; 50 µg) Group
Participants received 2 doses of NgG HTD (50 µg) investigational vaccine on Day 1 and Day 61. The HTD was selected based on the safety evaluation performed in Phase 1.
OG001
Phase 2: NgG Dose Below HTD (bHTD; 25 µg) Group
Participants received 2 doses of NgG bHTD (25 µg) investigational vaccine on Day 1 and Day 61. The bHTD is selected based on the safety evaluation performed in Phase 1.
OG002
Phase 2: Placebo Group
Primary
Phase 2: Number of Participants Reporting Any SAEs and AEs Leading to Withdrawal
An SAE is defined as any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant, abnormal pregnancy outcome or any other situation as determined by the investigator. An AE is any untoward medical occurrence (an unfavourable/unintended sign - including an abnormal laboratory finding), symptom, or disease (new or exacerbated) in a clinical study participant that is temporally associated with the study intervention. The AE may or may not be considered related to the study intervention. A participant is considered to have withdrawn from the study if no new study procedure has been performed or no new information has been collected for them since the date of withdrawal/last contact. Any = occurrence of the event regardless of intensity grade.
Analysis was performed on the Exposed set. Only participants from Phase 2 groups with SAEs and AEs leading to withdrawal data available for the specified analysis at the specified duration were included in this outcome measure.
Posted
Count of Participants
Participants
From Day 1 after the first dose to Day 451
ID
Title
Description
OG000
Phase 2: NgG Highest Tolerated Dose (HTD; 50 µg) Group
Participants received 2 doses of NgG HTD (50 µg) investigational vaccine on Day 1 and Day 61. The HTD was selected based on the safety evaluation performed in Phase 1.
Primary
Phase 2: Number of Participants With Change From Baseline in Haematological and Biochemical Laboratory Values in HIV Negative (HIV-) Subset
The safety laboratory data included haematological parameters (hemoglobin, lymphocytes, platelets, neutrophils, and WBC) and biochemical parameters (ALT, AST, Blood Urea Nitrogen and Creatinine). Categories reported when comparing Day 1 (baseline) and Day 8 hematological and biochemical laboratory results are defined as follows: <parameter>, <range at baseline>, <range at timing> (e.g. ALT, Within, Within). Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.
Analysis was performed on the HIV negative subset of the Exposed set which includes all HIV negative participants who received at least one dose of the study intervention and had post-vaccination data available at the specified timepoint. Only participants from Phase 2 groups with haematological and biochemical parameters data available for the specified analysis at the specified timepoint were included in this outcome measure.
Posted
Count of Participants
Participants
At Day 8 compared to baseline (Day 1)
ID
Title
Description
OG000
Phase 2: NgG Highest Tolerated Dose (HTD; 50 µg) Group
Participants received 2 doses of NgG HTD (50 µg) investigational vaccine on Day 1 and Day 61. The HTD was selected based on the safety evaluation performed in Phase 1.
Primary
Phase 2: Number of Participants With Change From Baseline in Haematological and Biochemical Laboratory Values for HIV Positive (HIV+) Subset
The safety laboratory data included haematological parameters (hemoglobin, absolute lymphocyte count, platelets, absolute neutrophil count, and WBC) and biochemical parameters (ALT, AST, Blood Urea Nitrogen and Creatinine). Categories reported when comparing Day 1 (baseline) and Day 8 hematological and biochemical laboratory results are defined as follows: <parameter>, <range at baseline>, <range at timing> (e.g. ALT, Within, Within). Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter. Unknown = No results are available for the corresponding laboratory parameter at the specific timepoint.
Analysis was performed on the HIV positive subset of the Exposed set which includes all HIV positive participants who received at least one dose of the study intervention and had post-vaccination data available at the specified timepoint. Only participants from Phase 2 groups with haematological and biochemical parameters data available for the specified analysis at the specified timepoint were included in this outcome measure.
Posted
Count of Participants
Participants
At Day 8 compared to baseline (Day 1)
ID
Title
Description
OG000
Phase 2: NgG Highest Tolerated Dose (HTD; 50 µg) Group
Participants received 2 doses of NgG HTD (50 µg) investigational vaccine on Day 1 and Day 61. The HTD was selected based on the safety evaluation performed in Phase 1.
Primary
Phase 2: Number of Participants With Change From Baseline in Haematological and Biochemical Laboratory Values for HIV- Subset
The safety laboratory data included haematological parameters (hemoglobin, lymphocytes, platelets, neutrophils, and WBC) and biochemical parameters (ALT, AST, Blood Urea Nitrogen and Creatinine). Categories reported when comparing Day 61 (baseline) and Day 68 haematological and biochemical laboratory results are defined as follows: <parameter>, <range at baseline>, <range at timing> (e.g. ALT, Within, Within). Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter. Unknown = No results are available for the corresponding laboratory parameter at the specific timepoint.
Analysis was performed on the HIV negative subset of the Exposed set which includes all HIV negative participants who received at least one dose of the study intervention and had post-vaccination data available at the specified timepoint. Only participants from Phase 2 groups with haematological and biochemical parameters data available for the specified analysis at the specified timepoint were included in this outcome measure.
Posted
Count of Participants
Participants
At Day 68 compared to baseline (Day 61)
ID
Title
Description
OG000
Phase 2: NgG Highest Tolerated Dose (HTD; 50 µg) Group
Participants received 2 doses of NgG HTD (50 µg) investigational vaccine on Day 1 and Day 61. The HTD was selected based on the safety evaluation performed in Phase 1.
Secondary
Phase 2: Incidence Rates of Confirmed Gonorrhea Cases With and Without Chlamydia Trachomatis Co-infection
Confirmed gonorrhea cases by positive NAAT with and without chlamydia trachomatis co-infection at the pharyngeal and/or anorectal and/or urogenital location are reported. The incidence rate (y/PT) of confirmed gonorrhea cases with and without Chlamydia Trachomatis co-infection, expressed in terms of 100 person-years, was calculated as the number of confirmed gonorrhea cases with and without Chlamydia Trachomatis co-infection (y) in a group, over the sum of individual person-times at risk (PT) in the same group, and multiplied by 100.
Analysis was performed on the mFAS. Only participants from Phase 2 groups with confirmed gonorrhea cases with and without Chlamydia Trachomatis data available for the specified analysis at the specified duration were included in this outcome measure.
Posted
Number
Cases per 100 person-years
From 1 month post-Dose 2 (Day 91) to 13 months post-Dose 2 (Day 451)
ID
Title
Description
OG000
Phase 2: NgG Highest Tolerated Dose (HTD; 50 µg) Group
Participants received 2 doses of NgG HTD (50 µg) investigational vaccine on Day 1 and Day 61. The HTD was selected based on the safety evaluation performed in Phase 1.
OG001
Phase 2: NgG Dose Below HTD (bHTD; 25 µg) Group
Participants received 2 doses of NgG bHTD (25 µg) investigational vaccine on Day 1 and Day 61. The bHTD is selected based on the safety evaluation performed in Phase 1.
Secondary
Phase 2: Incidence Rates of Symptomatic and Confirmed Gonorrhea Cases
Symptomatic gonorrhea cases which were later confirmed gonorrhea cases are reported. Symptomatic gonorrhea cases are defined as participants with symptoms suggestive of gonorrhea at the infected anatomical site which were later confirmed by a positive NAAT at the anorectal and/or urogenital location. The incidence rate (y/PT) of confirmed gonorrhea cases, expressed in terms of 100 person-years, was calculated as the number of confirmed gonorrhea cases (y) in a group, over the sum of individual person-times at risk (PT) in the same group, and multiplied by 100.
Analysis was performed on the mFAS. Only participants from Phase 2 groups with symptomatic and confirmed gonorrhea cases data available for the specified analysis at the specified duration were included in this outcome measure.
Posted
Number
Cases per 100 person-years
From 1 month post-Dose 2 (Day 91) to 13 months post-Dose 2 (Day 451)
ID
Title
Description
OG000
Phase 2: NgG Highest Tolerated Dose (HTD; 50 µg) Group
Participants received 2 doses of NgG HTD (50 µg) investigational vaccine on Day 1 and Day 61. The HTD was selected based on the safety evaluation performed in Phase 1.
OG001
Phase 2: NgG Dose Below HTD (bHTD; 25 µg) Group
Participants received 2 doses of NgG bHTD (25 µg) investigational vaccine on Day 1 and Day 61. The bHTD is selected based on the safety evaluation performed in Phase 1.
Primary
Phase 2: Number of Participants With Change From Baseline in Haematological and Biochemical Laboratory Values HIV+ Subset
The safety laboratory data included haematological parameters (hemoglobin, absolute lymphocyte count, platelets, absolute neutrophil count, and WBC) and biochemical parameters (ALT, AST, Blood Urea Nitrogen and Creatinine). Categories reported when comparing Day 61 (baseline) and Day 68 hematological and biochemical laboratory results are defined as follows: <parameter>, <range at baseline>, <range at timing> (e.g. ALT, Within, Within). Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter. Unknown = No results are available for the corresponding laboratory parameter at the specific timepoint.
Analysis was performed on the HIV positive subset of the Exposed set which includes all HIV positive participants who received at least one dose of the study intervention and had post-vaccination data available at the specified timepoint. Only participants from Phase 2 groups with haematological and biochemical parameters data available for the specified analysis at the specified timepoint were included in this outcome measure.
Posted
Count of Participants
Participants
At Day 68 compared to baseline (Day 61)
ID
Title
Description
OG000
Phase 2: NgG Highest Tolerated Dose (HTD; 50 µg) Group
Participants received 2 doses of NgG HTD (50 µg) investigational vaccine on Day 1 and Day 61. The HTD was selected based on the safety evaluation performed in Phase 1.
Time Frame
Solicited AEs: From Day 1 to Day 7 and from Day 61 to Day 67 in both phases. Unsolicited AEs: From Day 1 to Day 30 and from Day 61 to Day 90 in both phases. All-cause mortality, SAEs, AEs leading to withdrawal: From Day 1 to Day 241 in Phase 1 and from Day 1 to Day 451 in Phase 2.
Description
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set which includes all participants who received at least 1 dose of the study intervention.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Phase 1: Neisseria Gonorrhoeae GMMA (NgG) 12.5 Micrograms (µg) Group
Participants received 2 doses of NgG 12.5 µg investigational vaccine on Day 1 and Day 61.
0
6
0
6
5
6
EG001
Phase 1: NgG 25 µg Group
Participants received 2 doses of NgG 25 µg investigational vaccine on Day 1 and Day 61.
0
6
0
6
4
6
EG002
Phase 1: NgG 50 µg Group
Participants received 2 doses of NgG 50 µg investigational vaccine on Day 1 and Day 61.
0
6
0
6
6
6
EG003
Phase 1: Placebo Group
Participants received 2 doses of placebo on Day 1 and Day 61.
0
6
0
6
5
6
EG004
Phase 2: NgG Highest Tolerated Dose (HTD; 50 µg) Group
Participants received 2 doses of NgG HTD (50 µg) investigational vaccine on Day 1 and Day 61. The HTD was selected based on the safety evaluation performed in Phase 1.
0
329
3
329
303
329
EG005
Phase 2: NgG Dose Below HTD (bHTD; 25 µg) Group
Participants received 2 doses of NgG bHTD (25 µg) investigational vaccine on Day 1 and Day 61. The bHTD is selected based on the safety evaluation performed in Phase 1.
0
327
11
327
305
327
EG006
Phase 2: Placebo Group
Participants received 2 doses of placebo on Day 1 and Day 61.
0
324
3
324
232
324
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Lymphadenopathy
Blood and lymphatic system disorders
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0041 events1 affected329 at risk
EG0050 events0 affected327 at risk
EG0060 events0 affected324 at risk
Atrial fibrillation
Cardiac disorders
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Anal fistula
Gastrointestinal disorders
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Food poisoning
Gastrointestinal disorders
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Cholecystitis
Hepatobiliary disorders
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Abscess limb
Infections and infestations
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Appendicitis
Infections and infestations
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Foot fracture
Injury, poisoning and procedural complications
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Joint injury
Injury, poisoning and procedural complications
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Overdose
Injury, poisoning and procedural complications
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Toxicity to various agents
Injury, poisoning and procedural complications
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Nose deformity
Musculoskeletal and connective tissue disorders
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Syncope
Nervous system disorders
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Burnout syndrome
Psychiatric disorders
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Conversion disorder
Psychiatric disorders
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Major depression
Psychiatric disorders
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Renal failure
Renal and urinary disorders
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Haematoma
Vascular disorders
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected329 at risk
EG0051 events1 affected327 at risk
EG0062 events2 affected324 at risk
Lymphadenitis
Blood and lymphatic system disorders
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Lymphadenopathy
Blood and lymphatic system disorders
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Bradycardia
Cardiac disorders
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Supraventricular extrasystoles
Cardiac disorders
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Tachycardia
Cardiac disorders
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Deafness unilateral
Ear and labyrinth disorders
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Ear pain
Ear and labyrinth disorders
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Hypothyroidism
Endocrine disorders
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Thyroid disorder
Endocrine disorders
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Chalazion
Eye disorders
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Conjunctivitis allergic
Eye disorders
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Eye pain
Eye disorders
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Periorbital swelling
Eye disorders
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Vision blurred
Eye disorders
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Abdominal pain
Gastrointestinal disorders
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Anal fissure
Gastrointestinal disorders
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Anal skin tags
Gastrointestinal disorders
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Aphthous ulcer
Gastrointestinal disorders
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Cannabinoid hyperemesis syndrome
Gastrointestinal disorders
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Constipation
Gastrointestinal disorders
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Dental caries
Gastrointestinal disorders
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Diarrhoea
Gastrointestinal disorders
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Dyspepsia
Gastrointestinal disorders
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Enteritis
Gastrointestinal disorders
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Haemorrhoidal haemorrhage
Gastrointestinal disorders
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Irritable bowel syndrome
Gastrointestinal disorders
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Nausea
Gastrointestinal disorders
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Odynophagia
Gastrointestinal disorders
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Oral disorder
Gastrointestinal disorders
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Paraesthesia oral
Gastrointestinal disorders
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Stomatitis
Gastrointestinal disorders
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Tooth impacted
Gastrointestinal disorders
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Toothache
Gastrointestinal disorders
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Vomiting
Gastrointestinal disorders
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Administration site erythema
General disorders
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected6 at risk
EG003
Administration site pain
General disorders
v28.0
Systematic Assessment
EG0007 events4 affected6 at risk
EG0018 events4 affected6 at risk
EG00211 events6 affected6 at risk
EG003
Administration site swelling
General disorders
v28.0
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected6 at risk
EG003
Chills
General disorders
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Fatigue
General disorders
v28.0
Systematic Assessment
EG0003 events3 affected6 at risk
EG0011 events1 affected6 at risk
EG0022 events2 affected6 at risk
EG003
Hyperthermia
General disorders
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Influenza like illness
General disorders
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Injection site discharge
General disorders
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Injection site haematoma
General disorders
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Injection site pain
General disorders
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Injection site pruritus
General disorders
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected6 at risk
EG003
Injection site rash
General disorders
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected6 at risk
EG003
Pyrexia
General disorders
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Hypertransaminasaemia
Hepatobiliary disorders
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Anal abscess
Infections and infestations
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Anal chlamydia infection
Infections and infestations
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Anorectal herpes
Infections and infestations
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Bacterial ureteritis
Infections and infestations
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Balanitis candida
Infections and infestations
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Body tinea
Infections and infestations
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Bronchitis
Infections and infestations
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Bronchitis viral
Infections and infestations
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
COVID-19
Infections and infestations
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Campylobacter infection
Infections and infestations
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Chlamydial infection
Infections and infestations
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Conjunctivitis
Infections and infestations
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Conjunctivitis viral
Infections and infestations
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Diarrhoea infectious
Infections and infestations
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Ear infection
Infections and infestations
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Enterobiasis
Infections and infestations
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Fungal foot infection
Infections and infestations
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Fungal infection
Infections and infestations
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Fungal skin infection
Infections and infestations
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Gastroenteritis
Infections and infestations
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Gastroenteritis viral
Infections and infestations
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Gastrointestinal infection
Infections and infestations
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Genital herpes
Infections and infestations
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Genitourinary chlamydia infection
Infections and infestations
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Gingivitis
Infections and infestations
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
HIV infection
Infections and infestations
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Helicobacter infection
Infections and infestations
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Herpes simplex
Infections and infestations
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Herpes simplex anorectal
Infections and infestations
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Herpes virus infection
Infections and infestations
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Hordeolum
Infections and infestations
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Influenza
Infections and infestations
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Lice infestation
Infections and infestations
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Lower respiratory tract infection
Infections and infestations
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Monkeypox
Infections and infestations
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Mycoplasma genitalium infection
Infections and infestations
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Mycoplasma infection
Infections and infestations
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Nasopharyngitis
Infections and infestations
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Onychomycosis
Infections and infestations
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Oral herpes
Infections and infestations
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Pharyngitis
Infections and infestations
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Proctitis chlamydial
Infections and infestations
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Proctitis herpes
Infections and infestations
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Pulpitis dental
Infections and infestations
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Respiratory tract infection
Infections and infestations
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Respiratory tract infection viral
Infections and infestations
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Rhinitis
Infections and infestations
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Scabies
Infections and infestations
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Secondary syphilis
Infections and infestations
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Shigella infection
Infections and infestations
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Sinusitis
Infections and infestations
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Skin infection
Infections and infestations
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Syphilis
Infections and infestations
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Tonsillitis
Infections and infestations
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Tooth infection
Infections and infestations
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Upper respiratory tract infection
Infections and infestations
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Urethritis
Infections and infestations
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Urethritis chlamydial
Infections and infestations
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Urethritis mycoplasmal
Infections and infestations
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Urinary tract infection
Infections and infestations
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Viral infection
Infections and infestations
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Viral upper respiratory tract infection
Infections and infestations
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Vulvovaginal candidiasis
Infections and infestations
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Ankle fracture
Injury, poisoning and procedural complications
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Arthropod bite
Injury, poisoning and procedural complications
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Contusion
Injury, poisoning and procedural complications
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Eye contusion
Injury, poisoning and procedural complications
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Face injury
Injury, poisoning and procedural complications
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Ligament injury
Injury, poisoning and procedural complications
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Ligament sprain
Injury, poisoning and procedural complications
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Meniscus injury
Injury, poisoning and procedural complications
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Muscle rupture
Injury, poisoning and procedural complications
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Procedural pain
Injury, poisoning and procedural complications
v28.0
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Skin abrasion
Injury, poisoning and procedural complications
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Skin laceration
Injury, poisoning and procedural complications
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Aspartate aminotransferase increased
Investigations
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Blood HIV RNA increased
Investigations
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Neutrophil count decreased
Investigations
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
White blood cell count decreased
Investigations
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
White blood cell count increased
Investigations
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Gout
Metabolism and nutrition disorders
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0022 events2 affected6 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Bursitis
Musculoskeletal and connective tissue disorders
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Exostosis
Musculoskeletal and connective tissue disorders
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Joint swelling
Musculoskeletal and connective tissue disorders
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Muscle contracture
Musculoskeletal and connective tissue disorders
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
v28.0
Systematic Assessment
EG0004 events3 affected6 at risk
EG0013 events2 affected6 at risk
EG0025 events4 affected6 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Anogenital warts
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Dizziness
Nervous system disorders
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Electric shock sensation
Nervous system disorders
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Headache
Nervous system disorders
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected6 at risk
EG0021 events1 affected6 at risk
EG003
Migraine with aura
Nervous system disorders
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Paraesthesia
Nervous system disorders
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Syncope
Nervous system disorders
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Tension headache
Nervous system disorders
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Adjustment disorder
Psychiatric disorders
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Anxiety
Psychiatric disorders
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Attention deficit hyperactivity disorder
Psychiatric disorders
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Depression
Psychiatric disorders
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Insomnia
Psychiatric disorders
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Mixed anxiety and depressive disorder
Psychiatric disorders
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Sleep disorder
Psychiatric disorders
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Stress
Psychiatric disorders
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Dysuria
Renal and urinary disorders
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Renal colic
Renal and urinary disorders
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Balanoposthitis
Reproductive system and breast disorders
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Bartholin's cyst
Reproductive system and breast disorders
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Erectile dysfunction
Reproductive system and breast disorders
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Haematospermia
Reproductive system and breast disorders
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Intermenstrual bleeding
Reproductive system and breast disorders
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Menstruation irregular
Reproductive system and breast disorders
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Penile dermatitis
Reproductive system and breast disorders
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Testicular mass
Reproductive system and breast disorders
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Vaginal discharge
Reproductive system and breast disorders
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Catarrh
Respiratory, thoracic and mediastinal disorders
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Nasal pruritus
Respiratory, thoracic and mediastinal disorders
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Nasal septum deviation
Respiratory, thoracic and mediastinal disorders
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Productive cough
Respiratory, thoracic and mediastinal disorders
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Pulmonary congestion
Respiratory, thoracic and mediastinal disorders
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Rhinitis allergic
Respiratory, thoracic and mediastinal disorders
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Androgenetic alopecia
Skin and subcutaneous tissue disorders
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Blister
Skin and subcutaneous tissue disorders
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Dermatitis
Skin and subcutaneous tissue disorders
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Dermatitis contact
Skin and subcutaneous tissue disorders
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Intertrigo
Skin and subcutaneous tissue disorders
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Photosensitivity reaction
Skin and subcutaneous tissue disorders
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
v28.0
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Rash vesicular
Skin and subcutaneous tissue disorders
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Hypertension
Vascular disorders
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Venous thrombosis
Vascular disorders
v28.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single site data not precede the primary publication of the entire clinical trial.
Participants received 2 doses of placebo on Day 1 and Day 61.
Units
Counts
Participants
OG0006
OG0016
OG0026
OG0034
Title
Denominators
Categories
Pain
Title
Measurements
OG0003
OG0014
OG0026
OG0031
Erythema
Title
Measurements
OG0000
OG0010
OG0020
OG003
Swelling
Title
Measurements
OG0000
OG0010
OG0020
OG003
OG003
Phase 1: Placebo Group
Participants received 2 doses of placebo on Day 1 and Day 61.
Units
Counts
Participants
OG0006
OG0016
OG0026
OG0036
Title
Denominators
Categories
Headache
Title
Measurements
OG0000
OG0011
OG0020
OG0032
Fatigue
Title
Measurements
OG0002
OG0010
OG0021
OG003
Myalgia
Title
Measurements
OG0002
OG0011
OG0024
OG003
Arthralgia
Title
Measurements
OG0000
OG0010
OG0022
OG003
Fever
Title
Measurements
OG0000
OG0010
OG0020
OG003
OG003
Phase 1: Placebo Group
Participants received 2 doses of placebo on Day 1 and Day 61.
Units
Counts
Participants
OG0006
OG0016
OG0026
OG0034
Title
Denominators
Categories
Headache
Title
Measurements
OG0000
OG0010
OG0021
OG0031
Fatigue
Title
Measurements
OG0001
OG0011
OG0021
OG003
Myalgia
Title
Measurements
OG0002
OG0012
OG0021
OG003
Arthralgia
Title
Measurements
OG0000
OG0010
OG0020
OG003
Fever
Title
Measurements
OG0000
OG0010
OG0020
OG003
Participants received 2 doses of NgG 50 µg investigational vaccine on Day 1 and Day 61.
OG003
Phase 1: Placebo Group
Participants received 2 doses of placebo on Day 1 and Day 61.
Units
Counts
Participants
OG0006
OG0016
OG0026
OG0036
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0022
OG0031
OG003
Phase 1: Placebo Group
Participants received 2 doses of placebo on Day 1 and Day 61.
Units
Counts
Participants
OG0006
OG0016
OG0026
OG0034
Title
Denominators
Categories
Title
Measurements
OG0002
OG0010
OG0020
OG0030
OG001
Phase 1: NgG 25 µg Group
Participants received 2 doses of NgG 25 µg investigational vaccine on Day 1 and Day 61.
OG002
Phase 1: NgG 50 µg Group
Participants received 2 doses of NgG 50 µg investigational vaccine on Day 1 and Day 61.
OG003
Phase 1: Placebo Group
Participants received 2 doses of placebo on Day 1 and Day 61.
Units
Counts
Participants
OG0006
OG0016
OG0026
OG0036
Title
Denominators
Categories
SAEs
Title
Measurements
OG0000
OG0010
OG0020
OG0030
AEs leading to withdrawal
Title
Measurements
OG0000
OG0010
OG0020
OG003
Participants received 2 doses of NgG 25 µg investigational vaccine on Day 1 and Day 61.
OG002
Phase 1: NgG 50 µg Group
Participants received 2 doses of NgG 50 µg investigational vaccine on Day 1 and Day 61.
OG003
Phase 1: Placebo Group
Participants received 2 doses of placebo on Day 1 and Day 61.
Units
Counts
Participants
OG0006
OG0016
OG0026
OG0036
Title
Denominators
Categories
ALT, Within, Within
Title
Measurements
OG0005
OG0016
OG0026
OG0036
ALT, Above, Within
Title
Measurements
OG0001
OG0010
OG0020
OG003
AST, Within, Within
Title
Measurements
OG0006
OG0015
OG0026
OG003
AST, Within, Above
Title
Measurements
OG0000
OG0011
OG0020
OG003
Blood Urea Nitrogen, Below, Below
Title
Measurements
OG0000
OG0010
OG0021
OG003
Blood Urea Nitrogen, Within, Within
Title
Measurements
OG0006
OG0016
OG0025
OG003
Creatinine, Within, Within
Title
Measurements
OG0006
OG0014
OG0026
OG003
Creatinine, Above, Above
Title
Measurements
OG0000
OG0012
OG0020
OG003
Hemoglobin, Within, Below
Title
Measurements
OG0000
OG0011
OG0020
OG003
Hemoglobin, Within, Within
Title
Measurements
OG0006
OG0015
OG0026
OG003
Hemoglobin, Above, Within
Title
Measurements
OG0000
OG0010
OG0020
OG003
Lymphocytes, Within, Within
Title
Measurements
OG0006
OG0016
OG0026
OG003
Neutrophils, Within, Within
Title
Measurements
OG0006
OG0016
OG0026
OG003
Platelets, Within, Within
Title
Measurements
OG0005
OG0015
OG0026
OG003
Platelets, Within, Above
Title
Measurements
OG0000
OG0011
OG0020
OG003
Platelets, Above, Above
Title
Measurements
OG0001
OG0010
OG0020
OG003
WBC, Within, Within
Title
Measurements
OG0005
OG0016
OG0026
OG003
WBC, Above, Above
Title
Measurements
OG0001
OG0010
OG0020
OG003
Participants received 2 doses of NgG 25 µg investigational vaccine on Day 1 and Day 61.
OG002
Phase 1: NgG 50 µg Group
Participants received 2 doses of NgG 50 µg investigational vaccine on Day 1 and Day 61.
OG003
Phase 1: Placebo Group
Participants received 2 doses of placebo on Day 1 and Day 61.
Units
Counts
Participants
OG0006
OG0016
OG0026
OG0035
Title
Denominators
Categories
ALT, Within, Unknown
Title
Measurements
OG0000
OG0010
OG0021
OG0030
ALT, Within, Below
Title
Measurements
OG0001
OG0010
OG0020
OG003
ALT, Within, Within
Title
Measurements
OG0004
OG0016
OG0025
OG003
ALT, Above, Within
Title
Measurements
OG0001
OG0010
OG0020
OG003
AST, Within, Unknown
Title
Measurements
OG0000
OG0010
OG0021
OG003
AST, Within, Within
Title
Measurements
OG0006
OG0016
OG0025
OG003
Blood Urea Nitrogen, Within, Unknown
Title
Measurements
OG0000
OG0010
OG0021
OG003
Blood Urea Nitrogen, Within, Within
Title
Measurements
OG0006
OG0016
OG0025
OG003
Creatinine, Within, Unknown
Title
Measurements
OG0000
OG0010
OG0021
OG003
Creatinine, Within, Within
Title
Measurements
OG0006
OG0013
OG0025
OG003
Creatinine, Within, Above
Title
Measurements
OG0000
OG0011
OG0020
OG003
Creatinine, Above, Within
Title
Measurements
OG0000
OG0010
OG0020
OG003
Creatinine, Above, Above
Title
Measurements
OG0000
OG0012
OG0020
OG003
Hemoglobin, Unknown, Within
Title
Measurements
OG0000
OG0011
OG0020
OG003
Hemoglobin, Within, Unknown
Title
Measurements
OG0000
OG0011
OG0021
OG003
Hemoglobin, Within, Within
Title
Measurements
OG0006
OG0014
OG0025
OG003
Hemoglobin, Within, Above
Title
Measurements
OG0000
OG0010
OG0020
OG003
Lymphocytes, Unknown, Within
Title
Measurements
OG0000
OG0011
OG0020
OG003
Lymphocytes, Within, Unknown
Title
Measurements
OG0000
OG0011
OG0021
OG003
Lymphocytes, Within, Within
Title
Measurements
OG0006
OG0014
OG0025
OG003
Neutrophils, Unknown, Within
Title
Measurements
OG0000
OG0011
OG0020
OG003
Neutrophils, Within, Unknown
Title
Measurements
OG0000
OG0011
OG0021
OG003
Neutrophils, Within, Within
Title
Measurements
OG0005
OG0014
OG0025
OG003
Neutrophils, Above, Within
Title
Measurements
OG0001
OG0010
OG0020
OG003
Platelets, Unknown, Within
Title
Measurements
OG0000
OG0011
OG0020
OG003
Platelets, Within, Unknown
Title
Measurements
OG0000
OG0011
OG0021
OG003
Platelets, Within, Within
Title
Measurements
OG0005
OG0014
OG0025
OG003
Platelets, Above, Above
Title
Measurements
OG0001
OG0010
OG0020
OG003
WBC, Unknown, Within
Title
Measurements
OG0000
OG0011
OG0020
OG003
WBC, Within, Unknown
Title
Measurements
OG0000
OG0011
OG0021
OG003
WBC, Within, Below
Title
Measurements
OG0000
OG0010
OG0020
OG003
WBC, Within, Within
Title
Measurements
OG0005
OG0014
OG0025
OG003
WBC, Above, Within
Title
Measurements
OG0001
OG0010
OG0020
OG003
OG002
Phase 2: Placebo Group
Participants received 2 doses of placebo on Day 1 and Day 61.
Units
Counts
Participants
OG000319
OG001318
OG002316
Title
Denominators
Categories
Title
Measurements
OG00026.94
OG00126.64
OG00229.90
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
To demonstrate vaccine efficacy (VE) in the prevention of gonorrhea cases between Phase 2: NgG HTD group and Phase 2: placebo group
VE
9.89
2-Sided
85
-16.69
30.46
VE= [(1 - Incidence Rate Ratio (IRR)) x 100]. IRR=the ratio between incidence rate (IR) of confirmed gonorrhea cases in the investigational group (HTD) compared to the placebo group.
Other
Efficacy was to be demonstrated if the lower limit of the 2-sided 85% confidence interval (CI) for the VE is above 0 between the Phase 2: NgG Highest tolerated dose (HTD) group compared to the Phase 2: Placebo group.
OG001
OG002
To demonstrate VE in the prevention of gonorrhea cases between Phase 2: NgG below HTD (bHTD) group and Phase 2: placebo group
VE
10.90
2-Sided
85
-15.63
31.40
VE= [(1 - IRR) x 100]. IRR=the ratio between IR of confirmed gonorrhea cases in the investigational group (bHTD) compared to the placebo group.
Other
The statistical analyses performed for the bHTD group were descriptive. Formal statistical testing was not performed as the primary efficacy hypothesis for the HTD group could not be rejected.
Units
Counts
Participants
OG000327
OG001325
OG002320
Title
Denominators
Categories
Pain
Title
Measurements
OG000274
OG001274
OG00250
Erythema
Title
Measurements
OG00048
OG00141
OG0024
Swelling
Title
Measurements
OG00045
OG00136
OG0022
Units
Counts
Participants
OG000302
OG001303
OG002286
Title
Denominators
Categories
Pain
Title
Measurements
OG000247
OG001240
OG00241
Erythema
Title
Measurements
OG00043
OG00133
OG0022
Swelling
Title
Measurements
OG00040
OG00141
OG0020
Units
Counts
Participants
OG000327
OG001325
OG002320
Title
Denominators
Categories
Headache
Title
Measurements
OG000113
OG001108
OG00288
Fatigue
Title
Measurements
OG000180
OG001171
OG002111
Myalgia
Title
Measurements
OG000187
OG001185
OG00247
Arthralgia
Title
Measurements
OG00060
OG00157
OG00220
Fever
Title
Measurements
OG00010
OG00112
OG0027
Units
Counts
Participants
OG000302
OG001303
OG002286
Title
Denominators
Categories
Headache
Title
Measurements
OG00088
OG00183
OG00253
Fatigue
Title
Measurements
OG000161
OG001155
OG00275
Myalgia
Title
Measurements
OG000163
OG001147
OG00220
Arthralgia
Title
Measurements
OG00052
OG00144
OG00212
Fever
Title
Measurements
OG00013
OG00117
OG0029
Participants received 2 doses of placebo on Day 1 and Day 61.
Units
Counts
Participants
OG000329
OG001327
OG002324
Title
Denominators
Categories
Title
Measurements
OG00069
OG00166
OG00267
Participants received 2 doses of placebo on Day 1 and Day 61.
Units
Counts
Participants
OG000322
OG001318
OG002318
Title
Denominators
Categories
Title
Measurements
OG00069
OG00173
OG00264
OG001
Phase 2: NgG Dose Below HTD (bHTD; 25 µg) Group
Participants received 2 doses of NgG bHTD (25 µg) investigational vaccine on Day 1 and Day 61. The bHTD is selected based on the safety evaluation performed in Phase 1.
OG002
Phase 2: Placebo Group
Participants received 2 doses of placebo on Day 1 and Day 61.
Units
Counts
Participants
OG000329
OG001327
OG002324
Title
Denominators
Categories
SAEs
Title
Measurements
OG0003
OG00111
OG0023
AEs leading to withdrawal
Title
Measurements
OG0000
OG0010
OG0020
OG001
Phase 2: NgG Dose Below HTD (bHTD; 25 µg) Group
Participants received 2 doses of NgG bHTD (25 µg) investigational vaccine on Day 1 and Day 61. The bHTD is selected based on the safety evaluation performed in Phase 1.
OG002
Phase 2: Placebo Group
Participants received 2 doses of placebo on Day 1 and Day 61.
Units
Counts
Participants
OG00030
OG00130
OG00230
Title
Denominators
Categories
ALT, Below, Below
Title
Measurements
OG0000
OG0011
OG0020
ALT, Within, Within
Title
Measurements
OG00027
OG00126
OG00229
ALT, Above, Within
Title
Measurements
OG0001
OG0010
OG0020
ALT, Within, Above
Title
Measurements
OG0002
OG0011
OG0021
ALT, Above, Above
Title
Measurements
OG0000
OG0012
OG0020
AST, Below, Below
Title
Measurements
OG0000
OG0011
OG0020
AST, Within, Below
Title
Measurements
OG0001
OG0010
OG0020
AST, Within, Within
Title
Measurements
OG00025
OG00127
OG00230
AST, Above, Within
Title
Measurements
OG0000
OG0012
OG0020
AST, Within, Above
Title
Measurements
OG0003
OG0010
OG0020
AST, Above, Above
Title
Measurements
OG0001
OG0010
OG0020
Blood Urea Nitrogen, Below, Below
Title
Measurements
OG0000
OG0011
OG0020
Blood Urea Nitrogen, Within, Below
Title
Measurements
OG0001
OG0010
OG0020
Blood Urea Nitrogen, Below, Within
Title
Measurements
OG0001
OG0010
OG0021
Blood Urea Nitrogen, Within, Within
Title
Measurements
OG00027
OG00129
OG00229
Blood Urea Nitrogen, Within, Above
Title
Measurements
OG0001
OG0010
OG0020
Hemoglobin, Below, Below
Title
Measurements
OG0004
OG0015
OG0022
Hemoglobin, Within, Below
Title
Measurements
OG0000
OG0012
OG0022
Hemoglobin, Below, Within
Title
Measurements
OG0001
OG0010
OG0021
Hemoglobin, Within, Within
Title
Measurements
OG00024
OG00123
OG00225
Hemoglobin, Below, Above
Title
Measurements
OG0001
OG0010
OG0020
Lymphocytes, Within, Within
Title
Measurements
OG00029
OG00130
OG00230
Lymphocytes, Within, Above
Title
Measurements
OG0001
OG0010
OG0020
Neutrophils, Below, Below
Title
Measurements
OG0003
OG0013
OG0021
Neutrophils, Within, Below
Title
Measurements
OG0000
OG0014
OG0020
Neutrophils, Below, Within
Title
Measurements
OG0002
OG0011
OG0022
Neutrophils, Within, Within
Title
Measurements
OG00024
OG00122
OG00227
Neutrophils, Within, Above
Title
Measurements
OG0001
OG0010
OG0020
Platelets, Below, Within
Title
Measurements
OG0000
OG0012
OG0020
Platelets, Within, Within
Title
Measurements
OG00030
OG00128
OG00229
Platelets, Above, Within
Title
Measurements
OG0000
OG0010
OG0021
WBC, Below, Below
Title
Measurements
OG0003
OG0012
OG0021
WBC, Within, Below
Title
Measurements
OG0003
OG0014
OG0023
WBC, Below, Within
Title
Measurements
OG0001
OG0012
OG0020
WBC, Within, Within
Title
Measurements
OG00021
OG00122
OG00226
WBC, Within, Above
Title
Measurements
OG0002
OG0010
OG0020
Creatinine, Below, Below
Title
Measurements
OG0000
OG0011
OG0020
Creatinine, Below, Within
Title
Measurements
OG0001
OG0010
OG0021
Creatinine, Within, Below
Title
Measurements
OG0000
OG0011
OG0022
Creatinine, Within, Within
Title
Measurements
OG00029
OG00128
OG00224
Creatinine, Within, Above
Title
Measurements
OG0000
OG0010
OG0021
Creatinine, Above, Within
Title
Measurements
OG0000
OG0010
OG0022
OG001
Phase 2: NgG Dose Below HTD (bHTD; 25 µg) Group
Participants received 2 doses of NgG bHTD (25 µg) investigational vaccine on Day 1 and Day 61. The bHTD is selected based on the safety evaluation performed in Phase 1.
OG002
Phase 2: Placebo Group
Participants received 2 doses of placebo on Day 1 and Day 61.
Units
Counts
Participants
OG0008
OG0018
OG0027
Title
Denominators
Categories
ALT, Within, Within
ParticipantsOG0008
ParticipantsOG0018
ParticipantsOG0026
Title
Measurements
OG0007
OG0018
OG0025
ALT, Above, Within
ParticipantsOG0008
ParticipantsOG0018
ParticipantsOG0026
Title
Measurements
OG000
ALT, Within, Above
ParticipantsOG0008
ParticipantsOG0018
ParticipantsOG0026
Title
Measurements
OG000
AST, Within, Within
ParticipantsOG0008
ParticipantsOG0018
ParticipantsOG0026
Title
Measurements
OG000
AST, Above, Within
ParticipantsOG0008
ParticipantsOG0018
ParticipantsOG0026
Title
Measurements
OG000
Blood Urea Nitrogen, Within, Below
ParticipantsOG0008
ParticipantsOG0018
ParticipantsOG0026
Title
Measurements
OG000
Blood Urea Nitrogen, Within, Within
ParticipantsOG0008
ParticipantsOG0018
ParticipantsOG0026
Title
Measurements
OG000
Blood Urea Nitrogen, Above, Within
ParticipantsOG0008
ParticipantsOG0018
ParticipantsOG0026
Title
Measurements
OG000
Blood Urea Nitrogen, Within, Above
ParticipantsOG0008
ParticipantsOG0018
ParticipantsOG0026
Title
Measurements
OG000
Creatinine, Within, Below
ParticipantsOG0008
ParticipantsOG0018
ParticipantsOG0026
Title
Measurements
OG000
Creatinine, Within, Within
ParticipantsOG0008
ParticipantsOG0018
ParticipantsOG0026
Title
Measurements
OG000
Creatinine, Above, Within
ParticipantsOG0008
ParticipantsOG0018
ParticipantsOG0026
Title
Measurements
OG000
Creatinine, Above, Above
ParticipantsOG0008
ParticipantsOG0018
ParticipantsOG0026
Title
Measurements
OG000
Absolute Lymphocyte Count, Unknown, Unknown
ParticipantsOG0008
ParticipantsOG0018
ParticipantsOG0027
Title
Measurements
OG000
Absolute Lymphocyte Count, Within, Within
ParticipantsOG0008
ParticipantsOG0018
ParticipantsOG0027
Title
Measurements
OG000
Absolute Lymphocyte Count, Within, Above
ParticipantsOG0008
ParticipantsOG0018
ParticipantsOG0027
Title
Measurements
OG000
Absolute Neutrophil Count, Unknown, Unknown
ParticipantsOG0008
ParticipantsOG0018
ParticipantsOG0027
Title
Measurements
OG000
Absolute Neutrophil Count, Within, Below
ParticipantsOG0008
ParticipantsOG0018
ParticipantsOG0027
Title
Measurements
OG000
Absolute Neutrophil Count, Within, Within
ParticipantsOG0008
ParticipantsOG0018
ParticipantsOG0027
Title
Measurements
OG000
Hemoglobin, Below, Below
ParticipantsOG0008
ParticipantsOG0018
ParticipantsOG0027
Title
Measurements
OG000
Hemoglobin, Unknown, Within
ParticipantsOG0008
ParticipantsOG0018
ParticipantsOG0027
Title
Measurements
OG000
Hemoglobin, Below, Within
ParticipantsOG0008
ParticipantsOG0018
ParticipantsOG0027
Title
Measurements
OG000
Hemoglobin, Within, Within
ParticipantsOG0008
ParticipantsOG0018
ParticipantsOG0027
Title
Measurements
OG000
Hemoglobin, Within, Above
ParticipantsOG0008
ParticipantsOG0018
ParticipantsOG0027
Title
Measurements
OG000
Platelets, Unknown, Within
ParticipantsOG0008
ParticipantsOG0018
ParticipantsOG0027
Title
Measurements
OG000
Platelets, Within, Within
ParticipantsOG0008
ParticipantsOG0018
ParticipantsOG0027
Title
Measurements
OG000
Platelets, Within, Above
ParticipantsOG0008
ParticipantsOG0018
ParticipantsOG0027
Title
Measurements
OG000
WBC, Within, Below
ParticipantsOG0008
ParticipantsOG0018
ParticipantsOG0027
Title
Measurements
OG000
WBC, Unknown, Within
ParticipantsOG0008
ParticipantsOG0018
ParticipantsOG0027
Title
Measurements
OG000
WBC, Within, Within
ParticipantsOG0008
ParticipantsOG0018
ParticipantsOG0027
Title
Measurements
OG000
OG001
Phase 2: NgG Dose Below HTD (bHTD; 25 µg) Group
Participants received 2 doses of NgG bHTD (25 µg) investigational vaccine on Day 1 and Day 61. The bHTD is selected based on the safety evaluation performed in Phase 1.
OG002
Phase 2: Placebo Group
Participants received 2 doses of placebo on Day 1 and Day 61.
Units
Counts
Participants
OG00028
OG00129
OG00230
Title
Denominators
Categories
ALT, Above, Unknown
ParticipantsOG00028
ParticipantsOG00128
ParticipantsOG00230
Title
Measurements
OG0001
OG0010
OG0020
ALT, Below, Below
ParticipantsOG00028
ParticipantsOG00128
ParticipantsOG00230
Title
Measurements
OG000
ALT, Unknown, Within
ParticipantsOG00028
ParticipantsOG00128
ParticipantsOG00230
Title
Measurements
OG000
ALT, Within, Within
ParticipantsOG00028
ParticipantsOG00128
ParticipantsOG00230
Title
Measurements
OG000
ALT, Above, Within
ParticipantsOG00028
ParticipantsOG00128
ParticipantsOG00230
Title
Measurements
OG000
ALT, Within, Above
ParticipantsOG00028
ParticipantsOG00128
ParticipantsOG00230
Title
Measurements
OG000
AST, Within, Unknown
ParticipantsOG00028
ParticipantsOG00128
ParticipantsOG00230
Title
Measurements
OG000
AST, Below, Below
ParticipantsOG00028
ParticipantsOG00128
ParticipantsOG00230
Title
Measurements
OG000
AST, Unknown, Within
ParticipantsOG00028
ParticipantsOG00128
ParticipantsOG00230
Title
Measurements
OG000
AST, Below, Within
ParticipantsOG00028
ParticipantsOG00128
ParticipantsOG00230
Title
Measurements
OG000
AST, Within, Within
ParticipantsOG00028
ParticipantsOG00128
ParticipantsOG00230
Title
Measurements
OG000
AST, Above, Within
ParticipantsOG00028
ParticipantsOG00128
ParticipantsOG00230
Title
Measurements
OG000
AST, Within, Above
ParticipantsOG00028
ParticipantsOG00128
ParticipantsOG00230
Title
Measurements
OG000
Blood Urea Nitrogen, Below, Below
ParticipantsOG00028
ParticipantsOG00128
ParticipantsOG00230
Title
Measurements
OG000
Blood Urea Nitrogen, Unknown, Within
ParticipantsOG00028
ParticipantsOG00128
ParticipantsOG00230
Title
Measurements
OG000
Blood Urea Nitrogen, Below, Within
ParticipantsOG00028
ParticipantsOG00128
ParticipantsOG00230
Title
Measurements
OG000
Blood Urea Nitrogen, Within, Within
ParticipantsOG00028
ParticipantsOG00128
ParticipantsOG00230
Title
Measurements
OG000
Creatinine, Unknown, Below
ParticipantsOG00028
ParticipantsOG00128
ParticipantsOG00230
Title
Measurements
OG000
Creatinine, Unknown, Within
ParticipantsOG00028
ParticipantsOG00128
ParticipantsOG00230
Title
Measurements
OG000
Creatinine, Below, Below
ParticipantsOG00028
ParticipantsOG00128
ParticipantsOG00230
Title
Measurements
OG000
Creatinine, Below, Within
ParticipantsOG00028
ParticipantsOG00128
ParticipantsOG00230
Title
Measurements
OG000
Creatinine, Within, Within
ParticipantsOG00028
ParticipantsOG00128
ParticipantsOG00230
Title
Measurements
OG000
Creatinine, Above, Within
ParticipantsOG00028
ParticipantsOG00128
ParticipantsOG00230
Title
Measurements
OG000
Creatinine, Above, Above
ParticipantsOG00028
ParticipantsOG00128
ParticipantsOG00230
Title
Measurements
OG000
Hemoglobin, Unknown, Below
ParticipantsOG00028
ParticipantsOG00129
ParticipantsOG00230
Title
Measurements
OG000
Hemoglobin, Below, Below
ParticipantsOG00028
ParticipantsOG00129
ParticipantsOG00230
Title
Measurements
OG000
Hemoglobin, Within, Below
ParticipantsOG00028
ParticipantsOG00129
ParticipantsOG00230
Title
Measurements
OG000
Hemoglobin, Unknown, Within
ParticipantsOG00028
ParticipantsOG00129
ParticipantsOG00230
Title
Measurements
OG000
Hemoglobin, Within, Within
ParticipantsOG00028
ParticipantsOG00129
ParticipantsOG00230
Title
Measurements
OG000
Hemoglobin, Above, Within
ParticipantsOG00028
ParticipantsOG00129
ParticipantsOG00230
Title
Measurements
OG000
Hemoglobin, Within, Above
ParticipantsOG00028
ParticipantsOG00129
ParticipantsOG00230
Title
Measurements
OG000
Lymphocytes, Unknown, Within
ParticipantsOG00028
ParticipantsOG00129
ParticipantsOG00230
Title
Measurements
OG000
Lymphocytes, Below, Within
ParticipantsOG00028
ParticipantsOG00129
ParticipantsOG00230
Title
Measurements
OG000
Lymphocytes, Within, Within
ParticipantsOG00028
ParticipantsOG00129
ParticipantsOG00230
Title
Measurements
OG000
Lymphocytes, Above, Within
ParticipantsOG00028
ParticipantsOG00129
ParticipantsOG00230
Title
Measurements
OG000
Lymphocytes, Within, Above
ParticipantsOG00028
ParticipantsOG00129
ParticipantsOG00230
Title
Measurements
OG000
Neutrophils, Below, Below
ParticipantsOG00028
ParticipantsOG00129
ParticipantsOG00230
Title
Measurements
OG000
Neutrophils, Within, Below
ParticipantsOG00028
ParticipantsOG00129
ParticipantsOG00230
Title
Measurements
OG000
Neutrophils, Unknown, Within
ParticipantsOG00028
ParticipantsOG00129
ParticipantsOG00230
Title
Measurements
OG000
Neutrophils, Below, Within
ParticipantsOG00028
ParticipantsOG00129
ParticipantsOG00230
Title
Measurements
OG000
Neutrophils, Within, Within
ParticipantsOG00028
ParticipantsOG00129
ParticipantsOG00230
Title
Measurements
OG000
Neutrophils, Above, Within
ParticipantsOG00028
ParticipantsOG00129
ParticipantsOG00230
Title
Measurements
OG000
Neutrophils, Above, Above
ParticipantsOG00028
ParticipantsOG00129
ParticipantsOG00230
Title
Measurements
OG000
Platelets, Unknown, Within
ParticipantsOG00028
ParticipantsOG00129
ParticipantsOG00230
Title
Measurements
OG000
Platelets, Below, Within
ParticipantsOG00028
ParticipantsOG00129
ParticipantsOG00230
Title
Measurements
OG000
Platelets, Within, Within
ParticipantsOG00028
ParticipantsOG00129
ParticipantsOG00230
Title
Measurements
OG000
Platelets, Within, Above
ParticipantsOG00028
ParticipantsOG00129
ParticipantsOG00230
Title
Measurements
OG000
WBC, Unknown, Below
ParticipantsOG00028
ParticipantsOG00129
ParticipantsOG00230
Title
Measurements
OG000
WBC, Below, Below
ParticipantsOG00028
ParticipantsOG00129
ParticipantsOG00230
Title
Measurements
OG000
WBC, Within, Below
ParticipantsOG00028
ParticipantsOG00129
ParticipantsOG00230
Title
Measurements
OG000
WBC, Unknown, Within
ParticipantsOG00028
ParticipantsOG00129
ParticipantsOG00230
Title
Measurements
OG000
WBC, Below, Within
ParticipantsOG00028
ParticipantsOG00129
ParticipantsOG00230
Title
Measurements
OG000
WBC, Within, Within
ParticipantsOG00028
ParticipantsOG00129
ParticipantsOG00230
Title
Measurements
OG000
WBC, Above, Above
ParticipantsOG00028
ParticipantsOG00129
ParticipantsOG00230
Title
Measurements
OG000
OG002
Phase 2: Placebo Group
Participants received 2 doses of placebo on Day 1 and Day 61.
Units
Counts
Participants
OG000319
OG001318
OG002316
Title
Denominators
Categories
Gonorrhea with co-infection
Title
Measurements
OG0003.46
OG0014.76
OG0025.67
Gonorrhea without co-infection
Title
Measurements
OG00037.60
OG00132.02
OG00237.54
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
To demonstrate VE in prevention of gonorrhea cases with Chlamydia Trachomatis co-infection between Phase 2: NgG HTD group and Phase 2: placebo group.
VE
39.07
2-Sided
85
-26.55
71.62
VE= [(1 - IRR) x 100]. IRR=the ratio between IR of confirmed gonorrhea cases with Chlamydia trachomatis co-infection in the investigational group (HTD) compared to the placebo group.
Other
The statistical analyses performed for this study objective were descriptive and no success criteria were defined for this statistical analysis.
OG001
OG002
To demonstrate VE in prevention of gonorrhea cases with Chlamydia Trachomatis co-infection between phase 2: NgG bHTD group and phase 2: placebo groups.
VE
16.12
2-Sided
85
-63.71
57.42
VE= [(1 - IRR) x 100]. IRR=the ratio between IR of confirmed gonorrhea cases with Chlamydia trachomatis co-infection in the investigational group (bHTD) compared to the placebo group.
Other
The statistical analyses performed for this study objective were descriptive and no success criteria were defined for this statistical analysis.
OG000
OG002
To demonstrate VE in prevention of gonorrhea cases without Chlamydia trachomatis co-infection between phase 2: NgG HTD group and phase 2: placebo groups.
VE
-0.17
2-Sided
85
-26.12
20.44
VE= [(1 - IRR) x 100]. IRR=the ratio between IR of confirmed gonorrhea cases without Chlamydia trachomatis co-infection in the investigational group (HTD) compared to the placebo group.
Other
The statistical analyses performed for this study objective were descriptive and no success criteria were defined for this statistical analysis.
OG001
OG002
To demonstrate VE in prevention of gonorrhea cases without Chlamydia trachomatis co-infection between phase 2: NgG bHTD group and phase 2: placebo groups.
VE
14.70
2-Sided
85
-8.47
32.98
VE= [(1 - IRR) x 100]. IRR=the ratio between IR of confirmed gonorrhea cases without Chlamydia trachomatis co-infection in the investigational group (bHTD) compared to the placebo group.
Other
The statistical analyses performed for this study objective were descriptive and no success criteria were defined for this statistical analysis.
OG002
Phase 2: Placebo Group
Participants received 2 doses of placebo on Day 1 and Day 61.
Units
Counts
Participants
OG000319
OG001318
OG002316
Title
Denominators
Categories
Title
Measurements
OG0008.54
OG0019.55
OG0025.88
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
To demonstrate VE in prevention of symptomatic and confirmed gonorrhea cases between phase 2: NgG HTD group and phase 2: placebo groups.
VE
-45.28
2-Sided
85
-146.1
13.25
VE= [(1 - IRR) x 100]. IRR=the ratio between IR of symptomatic and confirmed gonorrhea cases in the investigational group (HTD) compared to the placebo group.
Other
The statistical analyses performed for this study objective were descriptive and no success criteria were defined for this statistical analysis.
OG001
OG002
To demonstrate VE in prevention of symptomatic and confirmed gonorrhea cases between phase 2: NgG bHTD group and phase 2: placebo groups.
VE
-62.42
2-Sided
85
-172.8
1.99
VE= [(1 - IRR) x 100]. IRR=the ratio between IR of symptomatic and confirmed gonorrhea cases in the investigational group (bHTD) compared to the placebo group.
Other
The statistical analyses performed for this study objective were descriptive and no success criteria were defined for this statistical analysis.
OG001
Phase 2: NgG Dose Below HTD (bHTD; 25 µg) Group
Participants received 2 doses of NgG bHTD (25 µg) investigational vaccine on Day 1 and Day 61. The bHTD is selected based on the safety evaluation performed in Phase 1.
OG002
Phase 2: Placebo Group
Participants received 2 doses of placebo on Day 1 and Day 61.