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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-003666-13 | EudraCT Number | ||
| VAC89220HPX3002 | Other Identifier | Janssen Vaccines & Prevention B.V. | |
| HVTN 706 | Other Identifier | HIV Vaccine Trials Network (HVTN) |
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The purpose of this study is to evaluate the vaccine efficacy (VE) of a heterologous vaccine regimen utilizing Ad26.Mos4.HIV and aluminum phosphate-adjuvanted Clade C gp140 and Mosaic gp140 for the prevention of HIV-1 infection in HIV-1 seronegative cis-gender men and transgender individuals having sex with cis-gender men and/or transgender individuals.
Human immunodeficiency virus type 1 (HIV-1) is a retrovirus that, if left untreated, can progress to acquired immunodeficiency syndrome (AIDS), a condition in which the immune system is severely compromised, leading to life-threatening conditions. Ad26.Mos4.HIV is a tetravalent vaccine composed of Ad26.Mos1.Gag-Pol, Ad26.Mos2.Gag-Pol, Ad26.Mos1.Env, and Ad26.Mos2S.Env. Clade C and Mosaic gp140 HIV bivalent vaccine contains: Clade C gp140, HIV-1 Env gp140 of Clade C, Mosaic gp140, HIV-1 Env gp140, and aluminum phosphate adjuvant. Evidences showed that a combination of vaccination with Ad26.Mos.HIV followed by Ad26.Mos.HIV together with Clade C gp140 protein in aluminum phosphate adjuvant led to highest level of protection observed so far with this vaccine concept. Study comprises of a screening period of 45 days, a 12-month vaccination period and a follow-up period of at least 18 months after fourth vaccination (until Month 30) in participants who remain HIV-1 negative or up to 6 months after diagnosis of HIV-1 infection in participants who become HIV-1 infected. Participants who completed their Month 30 visit will be followed for HIV infection, medically-attended adverse event (MAAEs) and serious adverse events until the end of study (Month 30). Primary analysis of vaccine efficacy will evaluate the number of HIV-1 infections in the vaccine group compared to number of HIV-1 infections in the placebo group between Month 7 and Month X (with 24<=X<=30) in per-protocol population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group1:Ad26.Mos4.HIV,Clade C and Mosaic gp140 bivalent vaccine | Experimental | Participants will receive adenovirus serotype 26.Mosaic 4.human immunodeficiency virus (Ad26.Mos4.HIV) via intramuscular (IM) injection into the deltoid muscle at months 0 (Day 1) and 3 (preferably the deltoid of the non-dominant upper arm) and, Ad26.Mos4.HIV together with Clade C and Mosaic gp140 HIV bivalent vaccine IM into the deltoid muscle at Months 6 and 12 (different deltoid for each injection). |
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| Group 2: Placebo | Placebo Comparator | Participants will receive placebo into the deltoid muscle on Months 0 (Day 1), 3 (1 injection), 6 and 12 (2 injections). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ad26.Mos4.HIV | Biological | Participants will receive Ad26.Mos4.HIV via IM injection into the deltoid muscle at months 0 (Day 1), 3, 6 and 12. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Confirmed Human Immunodeficiency Virus (HIV)-1 Infections Diagnosed Between the Month 7 and Month 24 Visits (Per-protocol [PP] Set) | Number of participants with a confirmed HIV-1 infections diagnosed between the Month 7 and Month 24 visits (PP set) was reported. The data represents the cumulative incidence of HIV-1 infections. | From Month 7 up to Month 24 |
| Number of Participants With a Confirmed Human Immunodeficiency Virus (HIV)-1 Infections Diagnosed Between the Month 7 and Month 30 Visits (PP Set) | Number of participants with a confirmed HIV-1 infections diagnosed between the Month 7 and Month 30 visits (PP set) was reported. The data represents the cumulative incidence of HIV-1 infections. | From Month 7 up to Month 30 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Solicited Local Adverse Events (AEs) | Number of participants with solicited local AEs were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local AEs that included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, are used to assess the reactogenicity of the study vaccine and are pre-defined local (injection site) and which were noted by participants in their participant diary for 7 days post vaccination (day of vaccination and the subsequent 7 days). |
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Inclusion Criteria:
Exclusion Criteria:
Cis-gender men and transgender individuals who have sex with cis-gender men and/or transgender Individuals.
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Vaccines & Prevention B.V. Clinical Trial | Janssen Vaccines & Prevention B.V. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35222 | United States | ||
| Bridge HIV |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41314741 | Derived | Buchbinder SP, Spinosa Guzman S, Sanchez J, Willems W, Stieh DJ, van Duijn J, van Rosmalen MGM, Hendriks J, Nijs S, Lavreys L, Paez CA, Grinzstejn B, Hutter J, Mann P, Sierra Madero JG, Cahn P, Castagna A, Truyers C, Roels S, Gilbert PB, Carone M, Luedtke A, Corey L, Pau MG, Tomaka F; HVTN 706/HPX3002/Mosaico Study Team. Efficacy and safety of a mosaic HIV-1 vaccine regimen in men who have sex with men and transgender individuals (HVTN 706/HPX3002/Mosaico): a global, randomised, double-blind, placebo-controlled, phase 3 trial. Lancet HIV. 2025 Dec;12(12):e823-e835. doi: 10.1016/S2352-3018(25)00195-X. |
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The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency.
As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1: Ad26.Mos4.HIV + Clade C and Mosaic gp140 | Participants received adenovirus serotype 26.Mosaic 4.human immunodeficiency virus (Ad26.Mos4.HIV) 5*10^10 viral particles (vp) intramuscular (IM) injection into the deltoid muscle as a monotherapy at Months 0 (Day 1) and 3 (Day 84) (preferably the deltoid of the non-dominant upper arm) along with adjuvanted protein formulation consisting of Clade C protein 80 micrograms (mcg), Mosaic protein 75 mcg and adjuvanted aluminum phosphate 425 mcg, into the deltoid muscle at Months 6 (Day 168) and 12 (Day 364) (different deltoid for each injection). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 28, 2023 | Jul 4, 2024 |
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| Clade C and Mosaic gp140 HIV bivalent vaccine | Biological | Participants will receive Clade C and Mosaic gp140 HIV bivalent vaccine as IM injection into the deltoid muscle at Months 6 and 12. |
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| Placebo | Biological | Participants will receive matching placebo. |
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| Up to 7 days post each vaccination (dose) on Days 1 (up to Day 8), 84 (up to Day 91), 168 (up to Day 175), and 364 (up to 371) |
| Number of Participants With Solicited Systemic Adverse Events (AEs) | Number of participants with solicited systemic AEs were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited systemic events included events such as fatigue, headache, nausea, and myalgia, for which participants were specifically questioned and which were noted by participants in their participant diary for 7 days post vaccination (day of vaccination and the subsequent 7 days). | Up to 7 days after each vaccination (dose) on Days 1 (up to Day 8), 84 (up to Day 91), 168 (up to Day 175), and 364 (up to 371) |
| Number of Participants With Unsolicited Adverse Events (AEs) | Number of participants with unsolicited AEs were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Unsolicited AEs are all AEs for which the participants were not specifically questioned in the participant's diary. | Up to 28 days after each vaccination (dose) on Days 1 (up to Day 29), 84 (up to Day 112), 168 (up to Day 196), and 364 (up to 392) |
| Number of Participants With Adverse Events of Special Interest (AESIs) | Number of participants with AESIs were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Thrombotic events and/or thrombocytopenia (defined as platelet count below the lower limit of normal [LLN] range for the testing lab) were considered to be potential AESIs. | Up to 6 months after the last vaccination (up to Month 18) |
| Number of Participants With Medically-attended Adverse Events (MAAEs) | Number of participants with MAAEs were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. MAAEs are defined as AEs with medically-attended visits including hospital, emergency room, urgent care clinic, or other visits to or from medical personnel for any reason. | From Day 1 up to Month 40 |
| Number of Participants With Serious Adverse Events (SAEs) | Number of participants with SAEs were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; suspected transmission of any infectious agent via a medicinal product or medically important. | From Day 1 up to Month 40 |
| Number of Participants Who Discontinued the Study or Study Intervention Due to Adverse Events (AEs) | Number of participants who discontinued the study or study intervention due to AEs were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. | From Day 1 up to Month 40 |
| Number of Participants With a Confirmed Human Immunodeficiency Virus (HIV)-1 Infections Diagnosed Over Time (Modified Intent-to-Treat [mITT] Set) | Number of participants with a confirmed HIV-1 infections diagnosed over time (mITT set) were reported. The data represents the cumulative incidence of HIV-1 infections at specified intervals. | Month 0 to 24, Month 0 to 30, Month 0 to 40 |
| Number of Participants With a Confirmed Human Immunodeficiency Virus (HIV)-1 Infections Diagnosed Over Time (Modified Intent-to-Treat-2 [mITT-2] Set) | Number of participants with a confirmed HIV-1 infections diagnosed over time (mITT-2 set) were reported. The data represents the cumulative incidence of HIV-1 infections at specified intervals. | Month 7 to 24, Month 7 to 30, Month 7 to 40 |
| Number of Participants With Confirmed Human Immunodeficiency Virus (HIV)-1 Infections Diagnosed Over Time (Modified Intent-to-Treat-3 [mITT-3] Set) | Number of participants with confirmed HIV-1 infection diagnosed over time (mITT-3 set) were reported. The data represents the cumulative incidence of HIV-1 infections at specified intervals. | Month 7 to 24, Month 7 to 30, Month 7 to 40 |
| Number of Participants With Confirmed Human Immunodeficiency Virus (HIV)-1 Infections Diagnosed Over Time (Full Immunization Analysis Set [FIS]) | Number of participants with confirmed HIV-1 infection diagnosed over time (FIS set) were reported. The data represents the cumulative incidence of HIV-1 infections at specified intervals. | Month 13 to 24, Month 13 to 30, Month 13 to 40 |
| Number of Participants With Confirmed Human Immunodeficiency Virus (HIV)-1 Infections as Assessed by Demographic Characteristics: Age Groups | Number of participants with confirmed HIV-1 infection as assessed by demographic characteristics: age groups was reported. Age groups included 18-20, 21-24, 25-29, 30-34, 35-44, and greater than or equal to (>=) 45 years. The data represents the cumulative incidence of HIV-1 infections at specified intervals. | Month 7 to 24, Month 7 to 30, Month 7 to 40 |
| Number of Participants With Confirmed Human Immunodeficiency Virus (HIV)-1 Infections as Assessed by Demographic Characteristics: Region-Wise Enrollment | Number of participants with confirmed HIV-1 infections as assessed by demographic characteristics: region-wise enrollment was reported. Regions were Latin-America (Argentina, Brazil, Mexico, and Peru), North America (Puerto Rico and United States of America), and Europe (Italy, Poland, and Spain). The data represents the cumulative incidence of HIV-1 infections at specified intervals. | Month 7 to 24, Month 7 to 30, Month 7 to 40 |
| Number of Participants With an HIV-1 Infection by Adenovirus Serotype 26 (Ad26) at Baseline | Number of participants with an HIV-1 infection by Ad26 at baseline were reported. | Baseline (Day 1) |
| Geometric Mean Antibody Titers For Adenovirus Serotype 26 (Ad26) as Determined by Vector Neutralization Assay (VNA) | Geometric mean antibody titers for Ad26 as determined by VNA were reported. | From Day 1 up to Month 40 |
| Number of Participants With HIV-1 Infection by Pre/Post-exposure Prophylaxis (P[r]EP) Use | Number of participants with HIV-1 infection by P(r)EP use were reported. P(r)EP was assessed with a 4 item survey. Each item was measured on a scale ranging from 1 (strongly disagree) to 5 (strongly agree). Higher scores indicating higher levels of self-efficacy. If participant showed any evidence of P(r)EP use during the period based on questionnaire responses, concomitant medications or dried blood spot analysis, the response was "yes". The data represents the cumulative incidence of HIV-1 infections at specified intervals. | Month 7 to 24, Month 7 to 30, Month 7 to 40 |
| San Francisco |
| California |
| 94102 |
| United States |
| Whitman Walker Health | Washington D.C. | District of Columbia | 20816 | United States |
| University of Miami | Miami | Florida | 33136 | United States |
| Orlando Immunology Center | Orlando | Florida | 32803 | United States |
| Emory University Rollins School of Public Health - Ponce De Leon CRS | Atlanta | Georgia | 30322 | United States |
| The Hope Clinic at Emory University | Decatur | Georgia | 30030 | United States |
| University Of Illinois | Chicago | Illinois | 60612 | United States |
| New Orleans Adolescent Trials Unit CRS | New Orleans | Louisiana | 70112 | United States |
| Dana-Farber/Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
| Fenway Health | Boston | Massachusetts | 02215 | United States |
| Rutgers, The State University of New Jersey - The University Hospital/ACTG Network | Newark | New Jersey | 07103 | United States |
| Harlem Prevention Center CRS | New York | New York | 10027 | United States |
| Columbia University Medical Center | New York | New York | 10032 | United States |
| New York Blood Center | New York | New York | 10065 | United States |
| Strong Memorial Infectious Disease | Rochester | New York | 14642 | United States |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37212 | United States |
| Gordon E. Crofoot MD | Houston | Texas | 77098 | United States |
| Seattle Vaccine Trials Unit | Seattle | Washington | 98104 | United States |
| Helios Salud Sa | Buenos Aires | C1141ACG | Argentina |
| Fundacion Huesped | Ciudad Autonoma de Buenos Aire | C1202ABB | Argentina |
| Hospital J. M. Ramos Mejía | Ciudad de Buenos Aires | C1221Adc | Argentina |
| Instituto Caici Srl. | Rosario | S2000PBJ | Argentina |
| Universidade Federal De Minas Gerais - Hospital das Clínicas | Belo Horizonte | 30130-100 | Brazil |
| Centro Medico Sao Francisco | Curitiba | 80810-050 | Brazil |
| Fundacao de Medicina Tropical Doutor Heitor Vieira Dourado - FMT | Manaus | 69040-000 | Brazil |
| Fundacao Oswaldo Cruz | Rio de Janeiro | 21040-900 | Brazil |
| Municipio de Nova Iguacu - Hospital Geral de Nova Iguacu | Rio de Janeiro | 26030-380 | Brazil |
| Instituto de infectologia Emilio Ribas | São Paulo | 01246-900 | Brazil |
| Hospital Das Clinicas Da Faculdade De Medicina Da USP | São Paulo | 01246-903 | Brazil |
| Centro de Referencia E Treinamento Dst/Aids | São Paulo | 02141-000 | Brazil |
| Ospedale San Raffaele | Milan | 20127 | Italy |
| Azienda Ospedaliero-Universitaria Policlinico di Modena | Modena | 41124 | Italy |
| Istituto nazionale malattie infettive 'L. Spallanzani' | Roma | 00149 | Italy |
| Hospital Civil Fray Antonio Alcalde | Guadalajara | 44280 | Mexico |
| Inst. Nal. de Ciencias Med. Y Nutricion Salvador Zubiran | Mexico City | 14000 | Mexico |
| Unidad de Atención Medica e Investigacion en Salud (UNAMIS) | Mérida | 97000 | Mexico |
| Centro de Investigaciones Tecnologicas, Biomedica y medio ambientales (CITBM) | Callao | 07066 | Peru |
| Asociacion Civil Selva Amazonica (ACSA) | Iquitos | 16001 | Peru |
| Asociacion Civil Via Libre | Lima | 15001 | Peru |
| Asociacion Civil Impacta Salud y Educacion - Barranco | Lima - Barranco | Barranco 15063 | Peru |
| Asociacion Civil Impacta Salud y Educacion- San Miguel CRS | Lima - San Miguel | 15088 | Peru |
| Neutrum Lekarze M.Hlebowicz i Partnerzy spolka partnerska | Gdansk | 80-462 | Poland |
| Wroclawskie Centrum Zdrowia SPZOZ, Poradnia Profilaktyczno-Lecznicza | Wroclaw | 50-136 | Poland |
| Clinical Research Puerto Rico Inc | San Juan | 00909 | Puerto Rico |
| University of Puerto Rico | San Juan | 00936-5067 | Puerto Rico |
| Hosp. Univ. Germans Trias I Pujol | Badalona | 08916 | Spain |
| Hosp. Univ. Vall D Hebron | Barcelona | 08001 | Spain |
| Hosp Reina Sofia | Córdoba | 14004 | Spain |
| Hosp Univ Fund Jimenez Diaz | Madrid | 28015 | Spain |
| Hosp. Clinico San Carlos | Madrid | 28040 | Spain |
| Hosp. Gral. Univ. Valencia | Valencia | 46014 | Spain |
| FG001 | Group 2: Placebo | Participants received placebo into the deltoid muscle at Months 0 (Day 1), 3 (Day 84; 1 injection), 6 (Day 168) and 12 (Day 364; 2 injections). |
| Treated: Full Analysis Set (FAS) |
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| COMPLETED |
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| NOT COMPLETED |
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The full analysis set (FAS) set included all randomized participants who received at least one vaccine administration.
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1: Ad26.Mos4.HIV + Clade C and Mosaic gp140 | Participants received adenovirus serotype 26.Mosaic 4.human immunodeficiency virus (Ad26.Mos4.HIV) 5*10^10 viral particles (vp) intramuscular (IM) injection into the deltoid muscle as a monotherapy at Months 0 (Day 1) and 3 (Day 84) (preferably the deltoid of the non-dominant upper arm) along with adjuvanted protein formulation consisting of Clade C protein 80 micrograms (mcg), Mosaic protein 75 mcg and adjuvanted aluminum phosphate 425 mcg, into the deltoid muscle at Months 6 (Day 168) and 12 (Day 364) (different deltoid for each injection). |
| BG001 | Group 2: Placebo | Participants received placebo into the deltoid muscle at Months 0 (Day 1), 3 (Day 84; 1 injection), 6 (Day 168) and 12 (Day 364; 2 injections). |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex/Gender, Customized | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| 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 | |||||||||||||||||||||||
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| Primary | Number of Participants With Confirmed Human Immunodeficiency Virus (HIV)-1 Infections Diagnosed Between the Month 7 and Month 24 Visits (Per-protocol [PP] Set) | Number of participants with a confirmed HIV-1 infections diagnosed between the Month 7 and Month 24 visits (PP set) was reported. The data represents the cumulative incidence of HIV-1 infections. | The PP set included all participants in the full analysis set (FAS; all randomized participants who received at least one vaccine administration) population who had a negative HIV test 4 weeks post 3rd vaccination visit (that is, at the Month 7 Visit) and who received all planned vaccinations at the first three vaccination visits within the respective visit windows. | Posted | Count of Participants | Participants | From Month 7 up to Month 24 |
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| Primary | Number of Participants With a Confirmed Human Immunodeficiency Virus (HIV)-1 Infections Diagnosed Between the Month 7 and Month 30 Visits (PP Set) | Number of participants with a confirmed HIV-1 infections diagnosed between the Month 7 and Month 30 visits (PP set) was reported. The data represents the cumulative incidence of HIV-1 infections. | The PP set included all participants in the FAS (all randomized participants who received at least one vaccine administration) population who had a negative HIV test 4 weeks post 3rd vaccination visit (that is, at the Month 7 Visit) and who received all planned vaccinations at the first three vaccination visits within the respective visit windows. | Posted | Count of Participants | Participants | From Month 7 up to Month 30 |
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| Secondary | Number of Participants With Solicited Local Adverse Events (AEs) | Number of participants with solicited local AEs were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local AEs that included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, are used to assess the reactogenicity of the study vaccine and are pre-defined local (injection site) and which were noted by participants in their participant diary for 7 days post vaccination (day of vaccination and the subsequent 7 days). | The FAS set included all randomized participants who received at least one vaccine administration. Here, 'n' (number analyzed) is defined as participants analyzed at specified timepoints. | Posted | Count of Participants | Participants | Up to 7 days post each vaccination (dose) on Days 1 (up to Day 8), 84 (up to Day 91), 168 (up to Day 175), and 364 (up to 371) |
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| Secondary | Number of Participants With Solicited Systemic Adverse Events (AEs) | Number of participants with solicited systemic AEs were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited systemic events included events such as fatigue, headache, nausea, and myalgia, for which participants were specifically questioned and which were noted by participants in their participant diary for 7 days post vaccination (day of vaccination and the subsequent 7 days). | The FAS set included all randomized participants who received at least one vaccine administration. Here, 'n' (number analyzed) is defined as participants analyzed at specified timepoints. | Posted | Count of Participants | Participants | Up to 7 days after each vaccination (dose) on Days 1 (up to Day 8), 84 (up to Day 91), 168 (up to Day 175), and 364 (up to 371) |
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| Secondary | Number of Participants With Unsolicited Adverse Events (AEs) | Number of participants with unsolicited AEs were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Unsolicited AEs are all AEs for which the participants were not specifically questioned in the participant's diary. | The FAS set included all randomized participants who received at least one vaccine administration. Here, 'n' (number analyzed) is defined as participants analyzed at specified timepoints. | Posted | Count of Participants | Participants | Up to 28 days after each vaccination (dose) on Days 1 (up to Day 29), 84 (up to Day 112), 168 (up to Day 196), and 364 (up to 392) |
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| Secondary | Number of Participants With Adverse Events of Special Interest (AESIs) | Number of participants with AESIs were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Thrombotic events and/or thrombocytopenia (defined as platelet count below the lower limit of normal [LLN] range for the testing lab) were considered to be potential AESIs. | The FAS set included all randomized participants who received at least one vaccine administration. | Posted | Count of Participants | Participants | Up to 6 months after the last vaccination (up to Month 18) |
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| Secondary | Number of Participants With Medically-attended Adverse Events (MAAEs) | Number of participants with MAAEs were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. MAAEs are defined as AEs with medically-attended visits including hospital, emergency room, urgent care clinic, or other visits to or from medical personnel for any reason. | The FAS set included all randomized participants who received at least one vaccine administration. | Posted | Count of Participants | Participants | From Day 1 up to Month 40 |
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| Secondary | Number of Participants With Serious Adverse Events (SAEs) | Number of participants with SAEs were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; suspected transmission of any infectious agent via a medicinal product or medically important. | The FAS set included all randomized participants who received at least one vaccine administration. | Posted | Count of Participants | Participants | From Day 1 up to Month 40 |
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| Secondary | Number of Participants Who Discontinued the Study or Study Intervention Due to Adverse Events (AEs) | Number of participants who discontinued the study or study intervention due to AEs were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. | The FAS set included all randomized participants who received at least one vaccine administration. | Posted | Count of Participants | Participants | From Day 1 up to Month 40 |
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| Secondary | Number of Participants With a Confirmed Human Immunodeficiency Virus (HIV)-1 Infections Diagnosed Over Time (Modified Intent-to-Treat [mITT] Set) | Number of participants with a confirmed HIV-1 infections diagnosed over time (mITT set) were reported. The data represents the cumulative incidence of HIV-1 infections at specified intervals. | The mITT efficacy population included participants in the FAS who were HIV-1 uninfected at the date of the first vaccination. | Posted | Count of Participants | Participants | Month 0 to 24, Month 0 to 30, Month 0 to 40 |
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| Secondary | Number of Participants With a Confirmed Human Immunodeficiency Virus (HIV)-1 Infections Diagnosed Over Time (Modified Intent-to-Treat-2 [mITT-2] Set) | Number of participants with a confirmed HIV-1 infections diagnosed over time (mITT-2 set) were reported. The data represents the cumulative incidence of HIV-1 infections at specified intervals. | The mITT-2 efficacy population included participants in the FAS who had a negative HIV test 4 weeks post third vaccination visit (that is, at the Month 7 Visit). | Posted | Count of Participants | Participants | Month 7 to 24, Month 7 to 30, Month 7 to 40 |
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| Secondary | Number of Participants With Confirmed Human Immunodeficiency Virus (HIV)-1 Infections Diagnosed Over Time (Modified Intent-to-Treat-3 [mITT-3] Set) | Number of participants with confirmed HIV-1 infection diagnosed over time (mITT-3 set) were reported. The data represents the cumulative incidence of HIV-1 infections at specified intervals. | The mITT-3 efficacy population included participants in the FAS who had a negative HIV test 4 weeks post third vaccination visit (that is, at the Month 7 Visit) and who received all planned vaccinations at the first three vaccination visits regardless of the fact if the vaccinations were within the visit windows. | Posted | Count of Participants | Participants | Month 7 to 24, Month 7 to 30, Month 7 to 40 |
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| Secondary | Number of Participants With Confirmed Human Immunodeficiency Virus (HIV)-1 Infections Diagnosed Over Time (Full Immunization Analysis Set [FIS]) | Number of participants with confirmed HIV-1 infection diagnosed over time (FIS set) were reported. The data represents the cumulative incidence of HIV-1 infections at specified intervals. | The FIS included participants in the FAS who were HIV-1 uninfected 4 weeks after the fourth vaccination visit (that is, at Month 13 Visit) and who received all planned vaccinations within the respective visit windows. | Posted | Count of Participants | Participants | Month 13 to 24, Month 13 to 30, Month 13 to 40 |
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| Secondary | Number of Participants With Confirmed Human Immunodeficiency Virus (HIV)-1 Infections as Assessed by Demographic Characteristics: Age Groups | Number of participants with confirmed HIV-1 infection as assessed by demographic characteristics: age groups was reported. Age groups included 18-20, 21-24, 25-29, 30-34, 35-44, and greater than or equal to (>=) 45 years. The data represents the cumulative incidence of HIV-1 infections at specified intervals. | The PP set included all participants in the FAS (who received at least one vaccine administration) population who had a negative HIV test 4 weeks post third vaccination visit (that is, at Month 7 Visit) and who received all planned vaccinations at the first 3 vaccination visits within the respective visit windows. Here, 'n' (number analyzed) indicated participants analyzed at specified timepoints. | Posted | Count of Participants | Participants | Month 7 to 24, Month 7 to 30, Month 7 to 40 |
| |||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Confirmed Human Immunodeficiency Virus (HIV)-1 Infections as Assessed by Demographic Characteristics: Region-Wise Enrollment | Number of participants with confirmed HIV-1 infections as assessed by demographic characteristics: region-wise enrollment was reported. Regions were Latin-America (Argentina, Brazil, Mexico, and Peru), North America (Puerto Rico and United States of America), and Europe (Italy, Poland, and Spain). The data represents the cumulative incidence of HIV-1 infections at specified intervals. | The PP set included all participants in the FAS (who received at least one vaccine administration) population who had a negative HIV test 4 weeks post third vaccination visit (that is, at Month 7 Visit) and who received all planned vaccinations at the first 3 vaccination visits within the respective visit windows. Here, 'n' (number analyzed) indicated participants analyzed at specified timepoints. | Posted | Count of Participants | Participants | Month 7 to 24, Month 7 to 30, Month 7 to 40 |
| |||||||||||||||||||||||||||||||
| Secondary | Number of Participants With an HIV-1 Infection by Adenovirus Serotype 26 (Ad26) at Baseline | Number of participants with an HIV-1 infection by Ad26 at baseline were reported. | The immunogenicity analysis set included participants who acquired HIV-1 (case) and HIV-1 test negative (controls) that were selected for the case-control analysis. Here, 'N' (number of participants analyzed) indicates number of participants evaluable for this outcome measure. | Posted | Count of Participants | Participants | Baseline (Day 1) |
| |||||||||||||||||||||||||||||||
| Secondary | Geometric Mean Antibody Titers For Adenovirus Serotype 26 (Ad26) as Determined by Vector Neutralization Assay (VNA) | Geometric mean antibody titers for Ad26 as determined by VNA were reported. | The immunogenicity analysis set included participants who acquired HIV-1 (case) and HIV-1 test negative (controls) that were selected for the analysis. Here, 'N' (number of participants analyzed) indicates number of participants evaluable for this outcome measure. | Posted | Geometric Mean | 95% Confidence Interval | Titers | From Day 1 up to Month 40 |
| ||||||||||||||||||||||||||||||
| Secondary | Number of Participants With HIV-1 Infection by Pre/Post-exposure Prophylaxis (P[r]EP) Use | Number of participants with HIV-1 infection by P(r)EP use were reported. P(r)EP was assessed with a 4 item survey. Each item was measured on a scale ranging from 1 (strongly disagree) to 5 (strongly agree). Higher scores indicating higher levels of self-efficacy. If participant showed any evidence of P(r)EP use during the period based on questionnaire responses, concomitant medications or dried blood spot analysis, the response was "yes". The data represents the cumulative incidence of HIV-1 infections at specified intervals. | The PP set included all subjects in FAS (all randomized participants who received at least one vaccine) set who had a negative HIV test 4 weeks post 3rd vaccination visit (that is, at Month 7 Visit) and who received all planned vaccinations at the first three vaccination visits within respective visit windows. Here, 'N' (number of participants analyzed) is number of participants evaluable for this outcome measure and 'n' (number analyzed) indicated participants analyzed at specified timepoints. | Posted | Count of Participants | Participants | Month 7 to 24, Month 7 to 30, Month 7 to 40 |
|
Unsolicited AEs: 28 days after each vaccination (up to Day 392); Solicited AEs: 7 days after each vaccination (up to Day 371); All-cause mortality and SAE: From Day 1 up to Month 40
The full analysis set (FAS) set included all randomized participants who received at least one vaccine administration.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group 1: Ad26.Mos4.HIV + Clade C and Mosaic gp140 | Participants received adenovirus serotype 26.Mosaic 4.human immunodeficiency virus (Ad26.Mos4.HIV) 5*10^10 viral particles (vp) intramuscular (IM) injection into the deltoid muscle as a monotherapy at Months 0 (Day 1) and 3 (Day 84) (preferably the deltoid of the non-dominant upper arm) along with adjuvanted protein formulation consisting of Clade C protein 80 micrograms (mcg), Mosaic protein 75 mcg and adjuvanted aluminum phosphate 425 mcg, into the deltoid muscle at Months 6 (Day 168) and 12 (Day 364) (different deltoid for each injection). | 4 | 1,942 | 82 | 1,942 | 1,687 | 1,942 |
| EG001 | Group 2: Placebo | Participants received placebo into the deltoid muscle at Months 0 (Day 1), 3 (Day 84; 1 injection), 6 (Day 168) and 12 (Day 364; 2 injections). | 6 | 1,945 | 77 | 1,945 | 1,348 | 1,945 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 26.0 | Non-systematic Assessment |
| |
| Coagulopathy | Blood and lymphatic system disorders | MedDRA 26.0 | Non-systematic Assessment |
| |
| Lymphadenitis | Blood and lymphatic system disorders | MedDRA 26.0 | Non-systematic Assessment |
| |
| Angina Pectoris | Cardiac disorders | MedDRA 26.0 | Non-systematic Assessment |
| |
| Cardiac Arrest | Cardiac disorders | MedDRA 26.0 | Non-systematic Assessment |
| |
| Myocardial Infarction | Cardiac disorders | MedDRA 26.0 | Non-systematic Assessment |
| |
| Myocardial Ischaemia | Cardiac disorders | MedDRA 26.0 | Non-systematic Assessment |
| |
| Pericarditis | Cardiac disorders | MedDRA 26.0 | Non-systematic Assessment |
| |
| Alcoholic Pancreatitis | Gastrointestinal disorders | MedDRA 26.0 | Non-systematic Assessment |
| |
| Anal Fistula | Gastrointestinal disorders | MedDRA 26.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 26.0 | Non-systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA 26.0 | Non-systematic Assessment |
| |
| Ileal Perforation | Gastrointestinal disorders | MedDRA 26.0 | Non-systematic Assessment |
| |
| Incarcerated Umbilical Hernia | Gastrointestinal disorders | MedDRA 26.0 | Non-systematic Assessment |
| |
| Inguinal Hernia | Gastrointestinal disorders | MedDRA 26.0 | Non-systematic Assessment |
| |
| Intestinal Obstruction | Gastrointestinal disorders | MedDRA 26.0 | Non-systematic Assessment |
| |
| Intestinal Perforation | Gastrointestinal disorders | MedDRA 26.0 | Non-systematic Assessment |
| |
| Intussusception | Gastrointestinal disorders | MedDRA 26.0 | Non-systematic Assessment |
| |
| Oedematous Pancreatitis | Gastrointestinal disorders | MedDRA 26.0 | Non-systematic Assessment |
| |
| Death | General disorders | MedDRA 26.0 | Non-systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA 26.0 | Non-systematic Assessment |
| |
| Cholecystitis Acute | Hepatobiliary disorders | MedDRA 26.0 | Non-systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA 26.0 | Non-systematic Assessment |
| |
| Hepatitis | Hepatobiliary disorders | MedDRA 26.0 | Non-systematic Assessment |
| |
| Abdominal Sepsis | Infections and infestations | MedDRA 26.0 | Non-systematic Assessment |
| |
| Abscess Jaw | Infections and infestations | MedDRA 26.0 | Non-systematic Assessment |
| |
| Abscess Limb | Infections and infestations | MedDRA 26.0 | Non-systematic Assessment |
| |
| Acute HIV Infection | Infections and infestations | MedDRA 26.0 | Non-systematic Assessment |
| |
| Acute Hepatitis C | Infections and infestations | MedDRA 26.0 | Non-systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA 26.0 | Non-systematic Assessment |
| |
| Bacterial Colitis | Infections and infestations | MedDRA 26.0 | Non-systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 26.0 | Non-systematic Assessment |
| |
| COVID-19 Pneumonia | Infections and infestations | MedDRA 26.0 | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 26.0 | Non-systematic Assessment |
| |
| Complicated Appendicitis | Infections and infestations | MedDRA 26.0 | Non-systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA 26.0 | Non-systematic Assessment |
| |
| Dengue Fever | Infections and infestations | MedDRA 26.0 | Non-systematic Assessment |
| |
| Fournier's Gangrene | Infections and infestations | MedDRA 26.0 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 26.0 | Non-systematic Assessment |
| |
| Helicobacter Sepsis | Infections and infestations | MedDRA 26.0 | Non-systematic Assessment |
| |
| Hepatitis A | Infections and infestations | MedDRA 26.0 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 26.0 | Non-systematic Assessment |
| |
| Meningitis Tuberculous | Infections and infestations | MedDRA 26.0 | Non-systematic Assessment |
| |
| Meningitis Viral | Infections and infestations | MedDRA 26.0 | Non-systematic Assessment |
| |
| Monkeypox | Infections and infestations | MedDRA 26.0 | Non-systematic Assessment |
| |
| Neurosyphilis | Infections and infestations | MedDRA 26.0 | Non-systematic Assessment |
| |
| Osteomyelitis Chronic | Infections and infestations | MedDRA 26.0 | Non-systematic Assessment |
| |
| Peritonsillar Abscess | Infections and infestations | MedDRA 26.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 26.0 | Non-systematic Assessment |
| |
| Pulmonary Sepsis | Infections and infestations | MedDRA 26.0 | Non-systematic Assessment |
| |
| Pulmonary Tuberculosis | Infections and infestations | MedDRA 26.0 | Non-systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA 26.0 | Non-systematic Assessment |
| |
| Pyelonephritis Acute | Infections and infestations | MedDRA 26.0 | Non-systematic Assessment |
| |
| Septic Shock | Infections and infestations | MedDRA 26.0 | Non-systematic Assessment |
| |
| Soft Tissue Infection | Infections and infestations | MedDRA 26.0 | Non-systematic Assessment |
| |
| Subcutaneous Abscess | Infections and infestations | MedDRA 26.0 | Non-systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA 26.0 | Non-systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA 26.0 | Non-systematic Assessment |
| |
| Clavicle Fracture | Injury, poisoning and procedural complications | MedDRA 26.0 | Non-systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 26.0 | Non-systematic Assessment |
| |
| Craniocerebral Injury | Injury, poisoning and procedural complications | MedDRA 26.0 | Non-systematic Assessment |
| |
| Facial Bones Fracture | Injury, poisoning and procedural complications | MedDRA 26.0 | Non-systematic Assessment |
| |
| Femur Fracture | Injury, poisoning and procedural complications | MedDRA 26.0 | Non-systematic Assessment |
| |
| Foot Fracture | Injury, poisoning and procedural complications | MedDRA 26.0 | Non-systematic Assessment |
| |
| Hand Fracture | Injury, poisoning and procedural complications | MedDRA 26.0 | Non-systematic Assessment |
| |
| Humerus Fracture | Injury, poisoning and procedural complications | MedDRA 26.0 | Non-systematic Assessment |
| |
| Injury | Injury, poisoning and procedural complications | MedDRA 26.0 | Non-systematic Assessment |
| |
| Joint Dislocation | Injury, poisoning and procedural complications | MedDRA 26.0 | Non-systematic Assessment |
| |
| Joint Injury | Injury, poisoning and procedural complications | MedDRA 26.0 | Non-systematic Assessment |
| |
| Ligament Rupture | Injury, poisoning and procedural complications | MedDRA 26.0 | Non-systematic Assessment |
| |
| Lower Limb Fracture | Injury, poisoning and procedural complications | MedDRA 26.0 | Non-systematic Assessment |
| |
| Multiple Injuries | Injury, poisoning and procedural complications | MedDRA 26.0 | Non-systematic Assessment |
| |
| Pneumothorax Traumatic | Injury, poisoning and procedural complications | MedDRA 26.0 | Non-systematic Assessment |
| |
| Post-Traumatic Pain | Injury, poisoning and procedural complications | MedDRA 26.0 | Non-systematic Assessment |
| |
| Radius Fracture | Injury, poisoning and procedural complications | MedDRA 26.0 | Non-systematic Assessment |
| |
| Thermal Burn | Injury, poisoning and procedural complications | MedDRA 26.0 | Non-systematic Assessment |
| |
| Toxicity to Various Agents | Injury, poisoning and procedural complications | MedDRA 26.0 | Non-systematic Assessment |
| |
| Traumatic Fracture | Injury, poisoning and procedural complications | MedDRA 26.0 | Non-systematic Assessment |
| |
| Traumatic Intracranial Haemorrhage | Injury, poisoning and procedural complications | MedDRA 26.0 | Non-systematic Assessment |
| |
| Traumatic Lung Injury | Injury, poisoning and procedural complications | MedDRA 26.0 | Non-systematic Assessment |
| |
| Wrist Fracture | Injury, poisoning and procedural complications | MedDRA 26.0 | Non-systematic Assessment |
| |
| Blood Creatine Phosphokinase Increased | Investigations | MedDRA 26.0 | Non-systematic Assessment |
| |
| Diabetic Metabolic Decompensation | Metabolism and nutrition disorders | MedDRA 26.0 | Non-systematic Assessment |
| |
| Facial Asymmetry | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Non-systematic Assessment |
| |
| Intervertebral Disc Protrusion | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Non-systematic Assessment |
| |
| Muscular Weakness | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Non-systematic Assessment |
| |
| Rhabdomyolysis | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Non-systematic Assessment |
| |
| Bone Neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | Non-systematic Assessment |
| |
| Cholangiocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | Non-systematic Assessment |
| |
| Head and Neck Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | Non-systematic Assessment |
| |
| Non-Hodgkin's Lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | Non-systematic Assessment |
| |
| T-Cell Type Acute Leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | Non-systematic Assessment |
| |
| Testicular Seminoma (Pure) | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | Non-systematic Assessment |
| |
| Cerebral Haemorrhage | Nervous system disorders | MedDRA 26.0 | Non-systematic Assessment |
| |
| Nerve Compression | Nervous system disorders | MedDRA 26.0 | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 26.0 | Non-systematic Assessment |
| |
| Patient-Device Incompatibility | Product Issues | MedDRA 26.0 | Non-systematic Assessment |
| |
| Alcohol Withdrawal Syndrome | Psychiatric disorders | MedDRA 26.0 | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 26.0 | Non-systematic Assessment |
| |
| Behaviour Disorder | Psychiatric disorders | MedDRA 26.0 | Non-systematic Assessment |
| |
| Bipolar Disorder | Psychiatric disorders | MedDRA 26.0 | Non-systematic Assessment |
| |
| Completed Suicide | Psychiatric disorders | MedDRA 26.0 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 26.0 | Non-systematic Assessment |
| |
| Depression Suicidal | Psychiatric disorders | MedDRA 26.0 | Non-systematic Assessment |
| |
| Drug Abuse | Psychiatric disorders | MedDRA 26.0 | Non-systematic Assessment |
| |
| Drug Use Disorder | Psychiatric disorders | MedDRA 26.0 | Non-systematic Assessment |
| |
| Generalised Anxiety Disorder | Psychiatric disorders | MedDRA 26.0 | Non-systematic Assessment |
| |
| Intentional Self-Injury | Psychiatric disorders | MedDRA 26.0 | Non-systematic Assessment |
| |
| Mania | Psychiatric disorders | MedDRA 26.0 | Non-systematic Assessment |
| |
| Mental Disorder | Psychiatric disorders | MedDRA 26.0 | Non-systematic Assessment |
| |
| Suicidal Ideation | Psychiatric disorders | MedDRA 26.0 | Non-systematic Assessment |
| |
| Suicide Attempt | Psychiatric disorders | MedDRA 26.0 | Non-systematic Assessment |
| |
| Acute Kidney Injury | Renal and urinary disorders | MedDRA 26.0 | Non-systematic Assessment |
| |
| Calculus Urinary | Renal and urinary disorders | MedDRA 26.0 | Non-systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA 26.0 | Non-systematic Assessment |
| |
| Renal Failure | Renal and urinary disorders | MedDRA 26.0 | Non-systematic Assessment |
| |
| Urinary Tract Obstruction | Renal and urinary disorders | MedDRA 26.0 | Non-systematic Assessment |
| |
| Acute Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Non-systematic Assessment |
| |
| Asphyxia | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Non-systematic Assessment |
| |
| Nasal Septum Deviation | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Non-systematic Assessment |
| |
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Non-systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Non-systematic Assessment |
| |
| Pneumothorax Spontaneous | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Non-systematic Assessment |
| |
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Non-systematic Assessment |
| |
| Cellulite | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Non-systematic Assessment |
| |
| Nasal Septal Operation | Surgical and medical procedures | MedDRA 26.0 | Non-systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA 26.0 | Non-systematic Assessment |
| |
| Peripheral Venous Disease | Vascular disorders | MedDRA 26.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 26.0 | Non-systematic Assessment |
| |
| Nausea (Solicited) | Gastrointestinal disorders | MedDRA 26.0 | Non-systematic Assessment |
| |
| Vomiting (Solicited) | Gastrointestinal disorders | MedDRA 26.0 | Non-systematic Assessment |
| |
| Chills (Solicited) | General disorders | MedDRA 26.0 | Non-systematic Assessment |
| |
| Fatigue (Solicited) | General disorders | MedDRA 26.0 | Non-systematic Assessment |
| |
| Pyrexia (Solicited) | General disorders | MedDRA 26.0 | Non-systematic Assessment |
| |
| Vaccination Site Erythema (Solicited) | General disorders | MedDRA 26.0 | Non-systematic Assessment |
| |
| Vaccination Site Pain (Solicited) | General disorders | MedDRA 26.0 | Non-systematic Assessment |
| |
| Vaccination Site Swelling (Solicited) | General disorders | MedDRA 26.0 | Non-systematic Assessment |
| |
| Anal Chlamydia Infection | Infections and infestations | MedDRA 26.0 | Non-systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 26.0 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 26.0 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 26.0 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 26.0 | Non-systematic Assessment |
| |
| Oropharyngeal Gonococcal Infection | Infections and infestations | MedDRA 26.0 | Non-systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 26.0 | Non-systematic Assessment |
| |
| Proctitis Gonococcal | Infections and infestations | MedDRA 26.0 | Non-systematic Assessment |
| |
| Syphilis | Infections and infestations | MedDRA 26.0 | Non-systematic Assessment |
| |
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA 26.0 | Non-systematic Assessment |
| |
| Arthralgia (Solicited) | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Non-systematic Assessment |
| |
| Myalgia (Solicited) | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Non-systematic Assessment |
| |
| Headache (Solicited) | Nervous system disorders | MedDRA 26.0 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 26.0 | Non-systematic Assessment |
|
If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor and its partners for review at least 21 days before submission for publication or presentation. At the request of the sponsor and/or partners, such submission may be delayed up to 60 days. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days to allow for filing of a patent application.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Leader | Janssen Vaccines & Prevention B.V. | 844-434-4210 | ClinicalTrialDisclosure@its.jnj.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 5, 2024 | Jul 4, 2024 | SAP_001.pdf |
| Male (at birth) |
|
| Undifferentiated (at birth) |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Brazil |
|
| Italy |
|
| Mexico |
|
| Peru |
|
| Poland |
|
| Puerto Rico |
|
| Spain |
|
| United States |
|
|
|
| OG001 | Group 2: Placebo | Participants received placebo into the deltoid muscle at Months 0 (Day 1), 3 (Day 84; 1 injection), 6 (Day 168) and 12 (Day 364; 2 injections). |
|
|
| Group 2: Placebo |
Participants received placebo into the deltoid muscle at Months 0 (Day 1), 3 (Day 84; 1 injection), 6 (Day 168) and 12 (Day 364; 2 injections). |
|
|
Participants received placebo into the deltoid muscle at Months 0 (Day 1), 3 (Day 84; 1 injection), 6 (Day 168) and 12 (Day 364; 2 injections).
|
|
|
|
|
|
Participants received placebo into the deltoid muscle at Months 0 (Day 1), 3 (Day 84; 1 injection), 6 (Day 168) and 12 (Day 364; 2 injections). |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
|
|
|
|
| Group 2: Placebo |
Participants received placebo into the deltoid muscle at Months 0 (Day 1), 3 (Day 84; 1 injection), 6 (Day 168) and 12 (Day 364; 2 injections). |
|
|
| OG001 | Group 2: Placebo | Participants received placebo into the deltoid muscle at Months 0 (Day 1), 3 (Day 84; 1 injection), 6 (Day 168) and 12 (Day 364; 2 injections). |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| OG001 | Group 2: Placebo | Participants received placebo into the deltoid muscle at Months 0 (Day 1), 3 (Day 84; 1 injection), 6 (Day 168) and 12 (Day 364; 2 injections). |
|
|