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A Study to Evaluate Different Dose Levels of Ad26.COV2.S in Healthy Adolescents From 12 to 17 Years Inclusive (HORIZON 2)

Primary Purpose

Coronavirus Disease-2019 (COVID-19) Prevention

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

Ad26.COV2.S

About this trial

This is an interventional prevention trial for Coronavirus Disease-2019 (COVID-19) Prevention

Eligibility Criteria

12 Years - 17 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Participant's age is 12 to 17 years of age at the time of first vaccination
Participant must be healthy, in the investigator's clinical judgement, as confirmed by medical history, physical examination, and vital signs performed at screening, and must not have comorbidities related to an increased risk of severe coronavirus disease-2019 (COVID-19)
Participant agrees to not donate bone marrow, blood, and blood products from the first study vaccine administration until 3 months after receiving the last dose of study vaccine
Participant and/or parent(s)/legal guardian(s) are available and willing to participate for the duration of the study visits and follow-up
Each participant or participant's parent(s)/legal guardian(s) must have access to a consistent means of contact either by telephone contact or email/computer

Exclusion Criteria:

Participant has a history of malignancy, bone marrow transplant, or solid organ transplant within 5 years before screening
Participant has a known or suspected allergy, history of anaphylaxis, or other serious adverse reactions, related to vaccines or their excipients (including specifically the excipients of the study vaccine)
Use of systemic corticosteroids at an immunosuppressive dose (treatment duration more than 14 days for one course or recurrent use) within 6 months before administration of study vaccine and during the study
Participants with a history of illness or with an ongoing illness that, in the opinion of the investigator, may pose additional risk to the participant if he/she participates in the study
Any serious, chronic, or progressive disease (example: diabetes, cardiac disease, hepatic disease, progressive neurological disease or seizure disorder; autoimmune disease, acquired immunodeficiency syndrome [AIDS] infection, blood dyscrasias, bleeding diathesis, signs of cardiac or renal failure, or severe malnutrition)

Sites / Locations

CIPREC
Hospital de Ninos de Cordoba
Hospital del Niño Jesús
Universidade Federal De Minas Gerais - Hospital das Clínicas
Santa Casa de Misericordia de Belo Horizonte
Hospital das Clínicas da Faculdade de Medicina de RPUSP - HCRP
CPQuali Pesquisa Clinica LTDA ME
Sri ramchandra Medical College & Research Institute
JSS Hospital
Supe Heart And Diabetes Hospital and Research Center
BAPS Pramukhswami Hospital
CAIMED Investigacion en salud S.A de C.V.
Hospital Universitario 'Dr. Jose Eleuterio Gonzalez'
Ndlovu Elandsdoorn Site
Shandukani Research Centre
Setshaba Research Centre
Perinatal HIV Research Unit, Chris Hani Baragwanath Hospital
University of Witwatersrand - Helen Joseph Hospital - Themba Lethu Hiv Research Centre

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Arm Label

Group 1: Ad26.COV2.S Dose Level 1 (Lower Volume): 1-Dose Regimen

Group 2: Ad26.COV2.S Dose Level 2: 1-Dose Regimen

Group 3: Ad26.COV2.S Dose Level 3: 1-Dose Regimen

Group 4: Ad26.COV2.S Dose Level 1: 2-Dose Regimen

Group 5: Ad26.COV2.S Dose Level 2: 2-Dose Regimen

Group 6: Ad26.COV2.S Dose Level 3: 2-Dose Regimen

Arm Description

Participants will receive 1-dose of Ad26.COV2.S at dose level 1 on Day 1 and placebo on Day 57. Participants will be unblinded to the primary vaccination regimen at 6 months after the first vaccination. Participants will receive booster vaccination at dose level 1 on Day 184.

Participants will receive 1-dose of Ad26.COV2.S at dose level 2 on Day 1 and placebo on Day 57. Participants will be unblinded to the primary vaccination regimen at 6 months after the first vaccination. Participants will receive booster vaccination at dose level 1 on Day 184.

Participants will receive 1-dose of Ad26.COV2.S at dose level 3 on Day 1 and placebo on Day 57. Participants will be unblinded to the primary vaccination regimen at 6 months after the first vaccination. Participants will receive booster vaccination at dose level 1 on Day 184.

Participants will receive 2-dose of Ad26.COV2.S at dose level 1 on Day 1 and 57. Participants will be unblinded to the primary vaccination regimen at 6 months after the first vaccination.

Participants will receive 2-doses of Ad26.COV2.S at dose level 2 on Day 1 and Day 57. Participants will be unblinded to the primary vaccination regimen at 6 months after the first vaccination.

Participants will receive 2-doses of Ad26.COV2.S at dose level 3 on Day 1 and Day 57. Participants will be unblinded to the primary vaccination regimen at 6 months after the first vaccination.

Outcomes

Primary Outcome Measures

Groups 1, 2, 3, 4, 5 and 6: Number of Participants with Solicited Local Adverse Events (AEs) 7 Days Post-dose 1

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 are pre-defined local (at the injection site) AEs for which participants are specifically asked and which are noted by participants in their reactogenicity diary for 7 days post each vaccination. Solicited local AEs are: injection site pain/tenderness, erythema, swelling at the vaccination site.

Groups 1, 2, 3, 4, 5 and 6: Number of Participants with Solicited Local Adverse Events (AEs) 7 Days Post-dose 2

Groups 1, 2, 3, 4, 5 and 6: Number of Participants with Solicited Systemic AEs 7 Days Post-dose 1

Participants will be instructed on how to note signs and symptoms in the diary on a daily basis for 7 days post-vaccination (day of vaccination and the subsequent 7 days) for the following solicited systemic AEs: fatigue, headache, nausea, and myalgia.

Groups 1, 2, 3, 4, 5 and 6: Number of Participants with Solicited Systemic AEs 7 Days Post-dose 2

Participants will be instructed on how to note signs and symptoms in the diary on a daily basis for 7 days post-vaccination (Day of vaccination and the subsequent 7 days) for following solicited systemic AEs: fatigue, headache, nausea, and myalgia.

Groups 1, 2, 3, 4, 5 and 6: Number of Participants with Unsolicited AEs 28 Days Post-dose 1

Unsolicited AEs are all AEs for which the participant is not specifically questioned in the participant's reactogenicity diary.

Groups 1, 2, 3, 4, 5 and 6: Number of Participants with Unsolicited AEs 28 Days Post-dose 2

Unsolicited AEs are all AEs for which the participant is not specifically questioned in the participant's reactogenicity diary.

Groups 1, 2, 3, 4, 5 and 6: Number of Participants with Medically-attended Adverse Events (MAAEs)

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. Routine study visits will not be considered medically-attended visits. New onset of chronic diseases will be collected as part of the MAAEs.

Groups 1, 2, 3, 4, 5 and 6: Number of Participants with MAAEs

Groups 1, 2 and 3: Number of Participants with MAAEs Leading to Discontinuation

Groups 4, 5 and 6: Number of Participants with MAAEs Leading to Discontinuation

Groups 1, 2 and 3: Number of Participants with Serious Adverse Events (SAEs)

SAE is any untoward medical occurrence that at any dose results in any of the following outcomes: 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.

Groups 4, 5 and 6: Number of Participants with SAEs

Groups 1, 2 and 3: Number of Participants with Adverse Events of Special Interest (AESI) (Including Multisystem Inflammatory Syndrome in Children [MIS-C])

Number of participants with AESI (including MIS-C) will be reported. Thrombosis with thrombocytopenia syndrome (TTS) and MIS-C are considered to be AESIs.

Groups 4, 5 and 6: Number of Participants with AESI (Including MIS-C)

Number of participants with AESI (including MIS-C) will be reported. Thrombosis with TTS and MIS-C are considered to be AESIs.

Groups 1, 2, 3, 4, 5 and 6: Serological Response to Vaccination Measured by Spike-enzyme-linked Immunosorbent Assay (S-ELISA) or Equivalent Assay 28 Days Post-dose 1

Serological response to vaccination will be measured by S-ELISA (ELISA Units/mL [EU/mL]) or equivalent assay 28 days post-dose 1.

Groups 1, 2, 3, 4, 5 and 6: Serological Response to Vaccination Measured by S-ELISA or Equivalent Assay 14 Days Post-dose 2

Serological response to vaccination will be measured by S-ELISA (ELISA Units/mL [EU/mL]) or equivalent assay 14 days post-dose 2.

Groups 1, 2, 3, 4, 5 and 6: Serological Response to Vaccination Measured by Virus Neutralization Assay (VNA) Titers 28 Days Post-dose 1

Serological response to vaccination will be measured by VNA titers 28 days post-dose 1.

Groups 1, 2, 3, 4, 5 and 6: Serological Response to Vaccination Measured by VNA Titers 14 Days Post-dose 2

Serological response to vaccination will be measured by VNA titers 14 days post-dose 2.

Secondary Outcome Measures

Groups 1, 2, 3, 4, 5 and 6: Serological Response to Vaccination Measured by Binding Antibody Titers to Severe Acute Respiratory Syndrome Coronavirus(-2) (SARS-CoV-2) or individual SARS-CoV-2 S Proteins as Assessed by ELISA (or Equivalent Assay).

Serological response to vaccination measured by binding antibody titers to SARS-CoV-2 or individual SARS-CoV-2 S proteins as assessed by ELISA (or equivalent assay) will be reported.

Groups 1, 2, 3, 4, 5 and 6: Serological Response to Vaccination Measured by Neutralizing Antibody Titers to SARS-CoV-2

Serological response to vaccination measured by neutralizing antibody titers to SARS-CoV-2 (VNA) will be reported.

Groups 1, 2 and 3: Number of Participants with Solicited Local AEs for 7 Days Post-booster Vaccination

Solicited local AEs are pre-defined local (at the injection site) AEs for which participants are specifically asked and which are noted by participants in their reactogenicity diary for 7 days post booster vaccination. Solicited local AEs are: injection site pain/tenderness, erythema, swelling at the vaccination.

Groups 1, 2 and 3: Number of Participants with Solicited Systemic AEs for 7 Days Post-booster Vaccination

Participants will be instructed on how to note signs and symptoms in the diary on a daily basis for 7 days post-booster vaccination (day of vaccination and the subsequent 7 days) for the following solicited systemic AEs: fatigue, headache, nausea, and myalgia.

Groups 1, 2 and 3: Number of Participants with Unsolicited AEs for 28 Days Post-booster Vaccination

Unsolicited AEs are all AEs for which the participant is not specifically questioned in the participant's reactogenicity diary.

Groups 1, 2 and 3: Number of Participants with MAAEs Until 6 Months Post-booster Vaccination

Groups 1, 2 and 3: Serological Response to Post-booster Vaccination Measured by Binding (S-ELISA and/or Equivalent Assay) Antibody Titers

Serological response to vaccination measured by binding (S-ELISA and/or equivalent assay) antibody titers will be reported.

Groups 1, 2 and 3: Serological Response to Post-booster Vaccination Measured by Neutralizing (VNA) Antibody Titers

Serological response to vaccination measured by neutralizing (VNA) antibody titers will be reported.

Full Information

NCT ID

NCT05007080

First Posted

August 9, 2021

Last Updated

October 11, 2023

Sponsor

Janssen Vaccines & Prevention B.V.

1. Study Identification

Unique Protocol Identification Number

NCT05007080

Brief Title

A Study to Evaluate Different Dose Levels of Ad26.COV2.S in Healthy Adolescents From 12 to 17 Years Inclusive

Acronym

HORIZON 2

Official Title

A Randomized, Observer-blind, Phase 2 Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of Different Dose Levels of Ad26.COV2.S Administered as a One- or Two-dose Regimen in Healthy Adolescents From 12 to 17 Years Inclusive

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Completed

Study Start Date

September 27, 2021 (Actual)

Primary Completion Date

August 14, 2023 (Actual)

Study Completion Date

August 14, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Janssen Vaccines & Prevention B.V.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The primary purpose of this study is to assess the safety, reactogenicity, and humoral immune response of Ad26.COV2.S administered intramuscularly (IM) as a 1-dose schedule or as a 2-dose schedule (56-day interval) in adolescents.

Detailed Description

Available safety, immunogenicity and efficacy data from the Ad26.COV2.S vaccine development program supports initiating evaluation of Ad26.COV2.S in the pediatric population. Ad26.COV2.S will be evaluated in the pediatric population through a dose-confirmation approach. Ad26.COV2.S (also known as Ad26COVS1, VAC31518, JNJ-78436735) is a monovalent vaccine composed of a recombinant, replication-incompetent human adenovirus type 26 (Ad26) vector, constructed to encode the severe acute respiratory syndrome coronavirus(-2) (SARS-CoV-2) spike (S) protein, stabilized in its prefusion conformation. The study duration from screening until the last follow-up visit will be, excluding the 28-day screening phase, 8 months (Groups 4-6) to 12 months (Groups 1-3), consisting of 12-month study duration comprising a study period (6-months) including vaccination with a 1 active dose and a placebo vaccination (56-day interval), followed by a booster vaccination at 6 months and follow-up (safety and immunogenicity) until at least 6 months after booster vaccination (Groups 1-3) and 8 month study duration comprising 2 active doses (56-day interval) and follow-up (safety and immunogenicity) until at least 6 months after second vaccination (Groups 4-6). Assessments like immunogenicity (such as humoral and cellular immune responses), safety and reactogenicity (such as adverse events [AEs] monitoring) will be performed in this study. Other safety assessments include vital signs measurements (heart rate, supine systolic and diastolic blood pressure, respiratory rate, and body temperature) and physical examinations. The overall study duration from enrolment of the first participant until study completion is expected to be up to 1 year 11 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Coronavirus Disease-2019 (COVID-19) Prevention

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

304 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group 1: Ad26.COV2.S Dose Level 1 (Lower Volume): 1-Dose Regimen

Arm Type

Experimental

Arm Description

Arm Title

Group 2: Ad26.COV2.S Dose Level 2: 1-Dose Regimen

Arm Type

Experimental

Arm Description

Arm Title

Group 3: Ad26.COV2.S Dose Level 3: 1-Dose Regimen

Arm Type

Experimental

Arm Description

Arm Title

Group 4: Ad26.COV2.S Dose Level 1: 2-Dose Regimen

Arm Type

Experimental

Arm Description

Participants will receive 2-dose of Ad26.COV2.S at dose level 1 on Day 1 and 57. Participants will be unblinded to the primary vaccination regimen at 6 months after the first vaccination.

Arm Title

Group 5: Ad26.COV2.S Dose Level 2: 2-Dose Regimen

Arm Type

Experimental

Arm Description

Participants will receive 2-doses of Ad26.COV2.S at dose level 2 on Day 1 and Day 57. Participants will be unblinded to the primary vaccination regimen at 6 months after the first vaccination.

Arm Title

Group 6: Ad26.COV2.S Dose Level 3: 2-Dose Regimen

Arm Type

Experimental

Arm Description

Participants will receive 2-doses of Ad26.COV2.S at dose level 3 on Day 1 and Day 57. Participants will be unblinded to the primary vaccination regimen at 6 months after the first vaccination.

Intervention Type

Biological

Intervention Name(s)

Ad26.COV2.S

Other Intervention Name(s)

Ad26COVS1, VAC31518, JNJ-78436735

Intervention Description

Ad26.COV2.S will be administered as intramuscular (IM) injection.

Primary Outcome Measure Information:

Title

Groups 1, 2, 3, 4, 5 and 6: Number of Participants with Solicited Local Adverse Events (AEs) 7 Days Post-dose 1

Description

Time Frame

7 days post-dose 1 (Day 8)

Title

Groups 1, 2, 3, 4, 5 and 6: Number of Participants with Solicited Local Adverse Events (AEs) 7 Days Post-dose 2

Description

Time Frame

7 days post-dose 2 (Day 64)

Title

Groups 1, 2, 3, 4, 5 and 6: Number of Participants with Solicited Systemic AEs 7 Days Post-dose 1

Description

Time Frame

7 days post-dose 1 (Day 8)

Title

Groups 1, 2, 3, 4, 5 and 6: Number of Participants with Solicited Systemic AEs 7 Days Post-dose 2

Description

Time Frame

7 days post-dose 2 (Day 64)

Title

Groups 1, 2, 3, 4, 5 and 6: Number of Participants with Unsolicited AEs 28 Days Post-dose 1

Description

Unsolicited AEs are all AEs for which the participant is not specifically questioned in the participant's reactogenicity diary.

Time Frame

28 days post-dose 1 (Day 29)

Title

Groups 1, 2, 3, 4, 5 and 6: Number of Participants with Unsolicited AEs 28 Days Post-dose 2

Description

Unsolicited AEs are all AEs for which the participant is not specifically questioned in the participant's reactogenicity diary.

Time Frame

28 days post-dose 2 (Day 85)

Title

Groups 1, 2, 3, 4, 5 and 6: Number of Participants with Medically-attended Adverse Events (MAAEs)

Description

Time Frame

From the first vaccination until 6 months post-dose 1 (Up to Day 184)

Title

Groups 1, 2, 3, 4, 5 and 6: Number of Participants with MAAEs

Description

Time Frame

From the first vaccination until 6 months post-dose 2 (Up to Day 240)

Title

Groups 1, 2 and 3: Number of Participants with MAAEs Leading to Discontinuation

Description

Time Frame

Up to Day 366 (6 months after booster vaccination on Day 184)

Title

Groups 4, 5 and 6: Number of Participants with MAAEs Leading to Discontinuation

Description

Time Frame

Up to Day 240 (6 months after second vaccination on Day 57)

Title

Groups 1, 2 and 3: Number of Participants with Serious Adverse Events (SAEs)

Description

Time Frame

Up to Day 366 (6 months after booster vaccination on Day 184)

Title

Groups 4, 5 and 6: Number of Participants with SAEs

Description

Time Frame

Up to Day 240 (6 months after second vaccination on Day 57)

Title

Groups 1, 2 and 3: Number of Participants with Adverse Events of Special Interest (AESI) (Including Multisystem Inflammatory Syndrome in Children [MIS-C])

Description

Number of participants with AESI (including MIS-C) will be reported. Thrombosis with thrombocytopenia syndrome (TTS) and MIS-C are considered to be AESIs.

Time Frame

Up to Day 366 (6 months after booster vaccination on Day 184)

Title

Groups 4, 5 and 6: Number of Participants with AESI (Including MIS-C)

Description

Number of participants with AESI (including MIS-C) will be reported. Thrombosis with TTS and MIS-C are considered to be AESIs.

Time Frame

Up to Day 240 (6 months after second vaccination on Day 57)

Title

Groups 1, 2, 3, 4, 5 and 6: Serological Response to Vaccination Measured by Spike-enzyme-linked Immunosorbent Assay (S-ELISA) or Equivalent Assay 28 Days Post-dose 1

Description

Serological response to vaccination will be measured by S-ELISA (ELISA Units/mL [EU/mL]) or equivalent assay 28 days post-dose 1.

Time Frame

28 days post-dose 1 (Day 29)

Title

Groups 1, 2, 3, 4, 5 and 6: Serological Response to Vaccination Measured by S-ELISA or Equivalent Assay 14 Days Post-dose 2

Description

Serological response to vaccination will be measured by S-ELISA (ELISA Units/mL [EU/mL]) or equivalent assay 14 days post-dose 2.

Time Frame

14 days post-dose 2 (Day 71)

Title

Groups 1, 2, 3, 4, 5 and 6: Serological Response to Vaccination Measured by Virus Neutralization Assay (VNA) Titers 28 Days Post-dose 1

Description

Serological response to vaccination will be measured by VNA titers 28 days post-dose 1.

Time Frame

28 days post-dose 1 (Day 29)

Title

Groups 1, 2, 3, 4, 5 and 6: Serological Response to Vaccination Measured by VNA Titers 14 Days Post-dose 2

Description

Serological response to vaccination will be measured by VNA titers 14 days post-dose 2.

Time Frame

14 days post-dose 2 (Day 71)

Secondary Outcome Measure Information:

Title

Description

Serological response to vaccination measured by binding antibody titers to SARS-CoV-2 or individual SARS-CoV-2 S proteins as assessed by ELISA (or equivalent assay) will be reported.

Time Frame

Groups 1-3: Days 1, 29, 57, 71, 184, 198, and 366; Groups 4-6: Days 1, 29, 57, 71 and 240

Title

Groups 1, 2, 3, 4, 5 and 6: Serological Response to Vaccination Measured by Neutralizing Antibody Titers to SARS-CoV-2

Description

Serological response to vaccination measured by neutralizing antibody titers to SARS-CoV-2 (VNA) will be reported.

Time Frame

Groups 1-3: Days 1, 29, 57, 71, 184, 198 and 366; Groups 4-6: Days 1, 29, 57, 71 and 240

Title

Groups 1, 2 and 3: Number of Participants with Solicited Local AEs for 7 Days Post-booster Vaccination

Description

Time Frame

Up to Day 191 (7 days after booster vaccination on Day 184)

Title

Groups 1, 2 and 3: Number of Participants with Solicited Systemic AEs for 7 Days Post-booster Vaccination

Description

Time Frame

Up to Day 191 (7 days after booster vaccination on Day 184)

Title

Groups 1, 2 and 3: Number of Participants with Unsolicited AEs for 28 Days Post-booster Vaccination

Description

Unsolicited AEs are all AEs for which the participant is not specifically questioned in the participant's reactogenicity diary.

Time Frame

Up to Day 212 (28 days after booster Vaccination on Day 184)

Title

Groups 1, 2 and 3: Number of Participants with MAAEs Until 6 Months Post-booster Vaccination

Description

Time Frame

Up to Day 366 (6 months after booster vaccination on Day 184)

Title

Groups 1, 2 and 3: Serological Response to Post-booster Vaccination Measured by Binding (S-ELISA and/or Equivalent Assay) Antibody Titers

Description

Serological response to vaccination measured by binding (S-ELISA and/or equivalent assay) antibody titers will be reported.

Time Frame

Days 184, 198 and 366

Title

Groups 1, 2 and 3: Serological Response to Post-booster Vaccination Measured by Neutralizing (VNA) Antibody Titers

Description

Serological response to vaccination measured by neutralizing (VNA) antibody titers will be reported.

Time Frame

Days 184, 198 and 366

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Maximum Age & Unit of Time

17 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Participant's age is 12 to 17 years of age at the time of first vaccination Participant must be healthy, in the investigator's clinical judgement, as confirmed by medical history, physical examination, and vital signs performed at screening, and must not have comorbidities related to an increased risk of severe coronavirus disease-2019 (COVID-19) Participant agrees to not donate bone marrow, blood, and blood products from the first study vaccine administration until 3 months after receiving the last dose of study vaccine Participant and/or parent(s)/legal guardian(s) are available and willing to participate for the duration of the study visits and follow-up Each participant or participant's parent(s)/legal guardian(s) must have access to a consistent means of contact either by telephone contact or email/computer Exclusion Criteria: Participant has a history of malignancy, bone marrow transplant, or solid organ transplant within 5 years before screening Participant has a known or suspected allergy, history of anaphylaxis, or other serious adverse reactions, related to vaccines or their excipients (including specifically the excipients of the study vaccine) Use of systemic corticosteroids at an immunosuppressive dose (treatment duration more than 14 days for one course or recurrent use) within 6 months before administration of study vaccine and during the study Participants with a history of illness or with an ongoing illness that, in the opinion of the investigator, may pose additional risk to the participant if he/she participates in the study Any serious, chronic, or progressive disease (example: diabetes, cardiac disease, hepatic disease, progressive neurological disease or seizure disorder; autoimmune disease, acquired immunodeficiency syndrome [AIDS] infection, blood dyscrasias, bleeding diathesis, signs of cardiac or renal failure, or severe malnutrition)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Janssen Vaccines & Prevention B.V. Clinical Trial

Organizational Affiliation

Janssen Vaccines & Prevention B.V.

Official's Role

Study Director

Facility Information:

Facility Name

CIPREC

City

Buenos Aires

ZIP/Postal Code

C1119ACN

Country

Argentina

Facility Name

Hospital de Ninos de Cordoba

City

Córdoba

ZIP/Postal Code

5000

Country

Argentina

Facility Name

Hospital del Niño Jesús

City

San Miguel de Tucumán

ZIP/Postal Code

4000

Country

Argentina

Facility Name

Universidade Federal De Minas Gerais - Hospital das Clínicas

City

Belo Horizonte

ZIP/Postal Code

30130-100

Country

Brazil

Facility Name

Santa Casa de Misericordia de Belo Horizonte

City

Belo Horizonte

ZIP/Postal Code

30150-221

Country

Brazil

Facility Name

Hospital das Clínicas da Faculdade de Medicina de RPUSP - HCRP

City

Ribeirão Preto

ZIP/Postal Code

14051-140

Country

Brazil

Facility Name

CPQuali Pesquisa Clinica LTDA ME

City

São Paulo

ZIP/Postal Code

01228-000

Country

Brazil

Facility Name

Sri ramchandra Medical College & Research Institute

City

Chennai

ZIP/Postal Code

600116

Country

India

Facility Name

JSS Hospital

City

Mysore

ZIP/Postal Code

570004

Country

India

Facility Name

Supe Heart And Diabetes Hospital and Research Center

City

Nashik

ZIP/Postal Code

0422002

Country

India

Facility Name

BAPS Pramukhswami Hospital

City

Surat

ZIP/Postal Code

395009

Country

India

Facility Name

CAIMED Investigacion en salud S.A de C.V.

City

Ciudad de Mexico

ZIP/Postal Code

06760

Country

Mexico

Facility Name

Hospital Universitario 'Dr. Jose Eleuterio Gonzalez'

City

Monterrey

ZIP/Postal Code

64460

Country

Mexico

Facility Name

Ndlovu Elandsdoorn Site

City

Dennilton

ZIP/Postal Code

0485

Country

South Africa

Facility Name

Shandukani Research Centre

City

Johannesburg

ZIP/Postal Code

2001

Country

South Africa

Facility Name

Setshaba Research Centre

City

Soshanguve

ZIP/Postal Code

152

Country

South Africa

Facility Name

Perinatal HIV Research Unit, Chris Hani Baragwanath Hospital

City

Soweto

ZIP/Postal Code

1864

Country

South Africa

Facility Name

University of Witwatersrand - Helen Joseph Hospital - Themba Lethu Hiv Research Centre

City

Westdene Johannesburg Gauteng

ZIP/Postal Code

2092

Country

South Africa

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

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

IPD Sharing URL

https://www.janssen.com/clinical-trials/transparency

Learn more about this trial

A Study to Evaluate Different Dose Levels of Ad26.COV2.S in Healthy Adolescents From 12 to 17 Years Inclusive

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