Back to resultsA Study of Three Different Doses of VAC52416 (ExPEC10V) in Adults Aged 60 to 85 Years in Stable Health
Primary Purpose
Extraintestinal Pathogenic Escherichia Coli Prevention
Status
Active
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
ExPEC10V
ExPEC4V
Prevnar 13
Placebo
Sponsored by
About this trial
This is an interventional other trial for Extraintestinal Pathogenic Escherichia Coli Prevention
Eligibility Criteria
Inclusion Criteria:
- Must have a body mass index (BMI) of greater than (>) 18.5 or less than 40 kilogram per meter square (kg/m^2)
- Before randomization, a woman must be: postmenopausal - A postmenopausal state is defined as no menses for 12 months without an alternative medical cause; or not intending to conceive by any methods
- Must be healthy or medically stable
- Must sign an informed consent form (ICF) indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study
- Willing and able to adhere to the lifestyle restrictions specified in this protocol
- Agrees not to donate blood until 12 weeks after receiving the study vaccine
Exclusion Criteria:
- Acute illness (this does not include minor illnesses such as diarrhea or mild upper respiratory tract infection) or temperature greater than equal to >=38.0 degree Celsius (100.4 degree Fahrenheit) within 24 hours prior to the administration of study vaccine, or, applicable for Cohort 2 only, an ongoing or suspected symptomatic urinary tract infection (UTI); enrollment at a later date is permitted (provided the screening window of 28 days is respected)
- History of malignancy within 5 years before screening (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy, which is considered cured with minimal risk of recurrence)
- Known allergies, hypersensitivity, or intolerance to ExPEC10V or its excipients
- Applicable for Cohort 1 only: known allergy or history of anaphylaxis or other serious adverse reactions to vaccines or vaccine products (including any of the constituents of the active control vaccines)
- Contraindication to intramuscular (IM) injections and blood draws example, bleeding disorders
- Abnormal function of the immune system
- Has had major psychiatric illness and/or drug substance or alcohol abuse in the past 12 months
Sites / Locations
- Optimal Research
- Optimal Research
- Qps-Mra, Llc
- Optimal Research
- Synexus Clinical Research US, Inc
- Johnson County Clin-Trials
- Synexus Clinical Research US, Inc
- Synexus Clinical Research US, Inc
- Rochester Clinical Research, Inc
- Synexus Clinical Research US, Inc
- Synexus Clinical Research US, Inc
- Coastal Carolina Research Center
- Anima
- ATC Pharma
- Clinical Pharmacology Unit
- CHU Nantes
- Hopital Cochin
- APHP - Hopital Bichat - Claude Bernard
- CHU Lyon Sud
- Chu Rennes - Hopital Pontchaillou
- CHRU Tours Hôpital Bretonneau
- EB Flevo Research
- PRA Health Sciences
- Hosp. Del Mar
- Hosp. Reina Sofia
- Hosp. Univ. de La Princesa
- Hosp. Univ. La Paz
- Hosp. Univ. Marques de Valdecilla
- Hosp. Virgen Macarena
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
Cohort 1: ExPEC10V (Low Dose)
Cohort 1: ExPEC10V (Medium dose)
Cohort 1: ExPEC10V (High dose)
Cohort 1: ExPEC4V
Cohort 1: Prevnar 13
Cohort 2: ExPEC10V
Cohort 2: Placebo
Arm Description
Participants will be randomized to receive a single intramuscular (IM) injection of low dose ExPEC10V on Day 1.
Participants will be randomized to receive a single IM injection of medium dose ExPEC10V on Day 1.
Participants will be randomized to receive a single IM injection of high dose ExPEC10V on Day 1.
Participants will be randomized to receive a single IM injection of ExPEC4V on Day 1.
Participants will be randomized to receive a single IM injection of Prevnar 13 on Day 1.
Participants will be randomized to receive a single IM injection of selected dose of ExPEC10V on Day 1. The ExPEC10V dose used in Cohort 2 will be based on the primary analysis (Day 30) results of Cohort 1.
Participants will be randomized to receive a single IM injection of matching placebo on Day 1.
Outcomes
Primary Outcome Measures
Cohort 1 and Cohort 2: Number of Participants with Solicited Local and Systemic Adverse Events (AEs) Collected for 14 days post-Vaccination
Number of participants with solicited local and systemic AEs will be reported. Solicited local AEs (pain/tenderness, erythema, and swelling at the injection site) and solicited systemic AEs (oral body temperature, headache, fatigue, nausea, and myalgia) will be noted in the participant diary for 14 days post-vaccination.
Cohort 1 and Cohort 2: Number of Participants with Unsolicited Adverse Events From the Administration of Study Vaccine until 29 Days post-Vaccination
Number of participants with unsolicited AEs will be reported. An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. Unsolicited adverse events are all adverse events for which the participant is not specifically questioned in the participant ediary.
Cohort 1 and Cohort 2: Number of Participants with Serious Adverse Events (SAE's) from the Administration of the Study Vaccine until Day 181
Number of participants with SAEs will be reported. An SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life threatening experience, is a congenital anomaly/birth defect, is suspected transmission of any infectious agent via a medicinal product, is medically important, and may jeopardize participant or may require medical or surgical intervention to prevent one of the outcomes listed above.
Cohort 1: Antibody Titers for ExPEC10V as Determined by Multiplex Electrochemiluminescent (ECL)-based Immunoassay on Day 15
Antibody titers for ExPEC10V will be determined by multiplex ECL-based immunoassay.
Cohort 1: Antibody Titers for ExPEC10V as Determined by Multiplex Opsonophagocytic Assay (MOPA) on Day 15
Antibody titers for ExPEC10V will be determined by MOPA.
Cohort 2: Antibody Titers for ExPEC10V as Determined by Multiplex ECL-based Immunoassay on Day 30
Antibody titers for ExPEC10V will be determined by multiplex ECL-based immunoassay.
Cohort 2: Antibody Titers for ExPEC10V as Determined by MOPA on Day 30
Antibody titers for ExPEC10V will be determined by MOPA.
Secondary Outcome Measures
Cohort 1: Antibody Titers for ExPEC10V as Determined by Multiplex ECL-based Immunoassay and MOPA to find Correlation Between Multiplex ECL-based Immunoassay and MOPA
Antibody titers for ExPEC10V as determined by multiplex ECL-based immunoassay and MOPA to find correlation between multiplex ECL-based immunoassay and MOPA
Cohort 1: Antibody Titers for ExPEC10V as Determined by Multiplex ECL-based Immunoassay on Days 30, 181, 366, 731, 1096, 1461, and 1826
Antibody titers for ExPEC10V will be determined by multiplex ECL-based immunoassay.
Cohort 1: Antibody Titers for ExPEC10V as Determined by MOPA on Days 30, 181, 366, 731, 1096, 1461, and 1826
Antibody titers for ExPEC10V will be determined by MOPA.
Cohort 2: Antibody Titers for ExPEC10V as Determined by Multiplex ECL-based Immunoassay and MOPA to find Correlation Between Multiplex ECL-based Immunoassay and MOPA
Antibody titers for ExPEC10V as determined by multiplex ECL-based immunoassay and MOPA to find correlation between multiplex ECL-based immunoassay and MOPA
Cohort 2: Antibody Titers for ExPEC10V as Determined by Multiplex ECL-based Immunoassay on Days 15, 181, and 366
Antibody titers for ExPEC10V will be determined by multiplex ECL-based immunoassay.
Cohort 2: Antibody Titers for ExPEC10V as Determined by MOPA on Days 181, and 366
Antibody titers for ExPEC10V will be determined by MOPA.
Cohort 1 and Cohort 2: Number of Participants with Serious Adverse Events Related to the Study Intervention or Study Procedures From Day 182 Until the end of the Study
Number of participants with SAEs related to the study intervention or study procedures will be reported. An SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life threatening experience, is a congenital anomaly/birth defect, is suspected transmission of any infectious agent via a medicinal product, is medically important, and may jeopardize participant or may require medical or surgical intervention to prevent one of the outcomes listed above.
Full Information
NCT ID
NCT03819049
First Posted
January 25, 2019
Last Updated
October 10, 2023
Sponsor
Janssen Research & Development, LLC
1. Study Identification
Unique Protocol Identification Number
NCT03819049
Brief Title
A Study of Three Different Doses of VAC52416 (ExPEC10V) in Adults Aged 60 to 85 Years in Stable Health
Official Title
A Randomized, Observer-blind, First-in-Human Phase 1/2a Study to Evaluate the Safety, Reactogenicity and Immunogenicity of Three Different Doses of VAC52416 (ExPEC10V) in Adults Aged 60 to 85 Years in Stable Health
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 6, 2019 (Actual)
Primary Completion Date
June 8, 2021 (Actual)
Study Completion Date
December 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen Research & Development, LLC
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to assess the safety, reactogenicity, and immunogenicity of 3 different doses of ExPEC10V and to select the optimal dose for further clinical development (Cohort 1). Cohort 2 is aimed to expand the dataset supporting the short- and long-term safety and immunogenicity of the optimal dose of ExPEC10V, selected from the primary analysis results of Cohort 1. Cohort 2 will include participants in stable health with a history of urinary tract infection (UTI) in the past 5 years and will be included in the study to support the plan for late stage development of ExPEC vaccine.
Detailed Description
ExPEC10V (JNJ-69968054) is a 10-valent vaccine candidate in development for prevention of invasive extraintestinal pathogenic Escherichia coli (ExPEC) disease (IED) in adults 60 years of age and older. ExPEC10V consists of O-antigen polysaccharides (PSs) of the ExPEC serotypes O1A, O2, O4, O6A, O8, O15, O16, O18A, O25B and O75 separately bioconjugate to the carrier protein, a genetically detoxified form of exotoxin A (EPA) derived from Pseudomonas aeruginosa. Since, mechanism of action of conjugate vaccines in prevention of invasive disease is not expected to be affected by antibiotic resistance mechanisms, ExPEC10V vaccine may provide protection against IED caused by drug resistant and susceptible ExPEC serotypes. The study consists of two cohorts. Cohort 1 is comprised of three periods: a screening period (28 days), an observer-blind follow-up period (181 days) with vaccination on Day 1, and an open-label long term follow up (LTFU) period (from Day 182 until 5 years [Day 1826] post-vaccination). Cohort 2 is also comprised of three periods: a screening period (28 days), a double-blind follow-up period (181 days) with vaccination on Day 1, and a double-blind LTFU period (from Day 182 until 1 years [Day 366] post-vaccination). The end of Cohort 1 is considered as the Year 5 visit (Day 1826) for the last participant. The end of Cohort 2 is considered as the Year 1 visit (Day 366) for the last participant. Key immunogenicity assessments will include the assessment of ExPEC10V and ExPEC4V serotype-specific total immunoglobulin G antibody levels elicited by the vaccine and ExPEC10V and ExPEC4V serotype-specific functional antibodies. Key safety assessments include solicited local and systemic AEs, unsolicited AEs, SAEs, physical examinations, vital sign measurements, and, for Cohort 1 only, clinical laboratory tests. The total duration of the study is up to 5 years.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Extraintestinal Pathogenic Escherichia Coli Prevention
7. Study Design
Primary Purpose
Other
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
836 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cohort 1: ExPEC10V (Low Dose)
Arm Type
Experimental
Arm Description
Participants will be randomized to receive a single intramuscular (IM) injection of low dose ExPEC10V on Day 1.
Arm Title
Cohort 1: ExPEC10V (Medium dose)
Arm Type
Experimental
Arm Description
Participants will be randomized to receive a single IM injection of medium dose ExPEC10V on Day 1.
Arm Title
Cohort 1: ExPEC10V (High dose)
Arm Type
Experimental
Arm Description
Participants will be randomized to receive a single IM injection of high dose ExPEC10V on Day 1.
Arm Title
Cohort 1: ExPEC4V
Arm Type
Experimental
Arm Description
Participants will be randomized to receive a single IM injection of ExPEC4V on Day 1.
Arm Title
Cohort 1: Prevnar 13
Arm Type
Experimental
Arm Description
Participants will be randomized to receive a single IM injection of Prevnar 13 on Day 1.
Arm Title
Cohort 2: ExPEC10V
Arm Type
Experimental
Arm Description
Participants will be randomized to receive a single IM injection of selected dose of ExPEC10V on Day 1. The ExPEC10V dose used in Cohort 2 will be based on the primary analysis (Day 30) results of Cohort 1.
Arm Title
Cohort 2: Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will be randomized to receive a single IM injection of matching placebo on Day 1.
Intervention Type
Biological
Intervention Name(s)
ExPEC10V
Other Intervention Name(s)
VAC52416
Intervention Description
Participants will receive a single IM injection of ExPEC10V (1 of 3 doses [low or medium or high]) in Cohort 1 and ExPEC10V selected dose (based on the primary analysis results of Cohort 1) in Cohort 2 on Day 1.
Intervention Type
Biological
Intervention Name(s)
ExPEC4V
Other Intervention Name(s)
JNJ-63871860
Intervention Description
Participants will receive a single IM injection of ExPEC4V on Day 1.
Intervention Type
Biological
Intervention Name(s)
Prevnar 13
Intervention Description
Participants will receive a single IM injection of Prevnar 13 on Day 1.
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
Participants will receive single IM injection of matching placebo on Day 1.
Primary Outcome Measure Information:
Title
Cohort 1 and Cohort 2: Number of Participants with Solicited Local and Systemic Adverse Events (AEs) Collected for 14 days post-Vaccination
Description
Number of participants with solicited local and systemic AEs will be reported. Solicited local AEs (pain/tenderness, erythema, and swelling at the injection site) and solicited systemic AEs (oral body temperature, headache, fatigue, nausea, and myalgia) will be noted in the participant diary for 14 days post-vaccination.
Time Frame
From Day 1 to Day 15
Title
Cohort 1 and Cohort 2: Number of Participants with Unsolicited Adverse Events From the Administration of Study Vaccine until 29 Days post-Vaccination
Description
Number of participants with unsolicited AEs will be reported. An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. Unsolicited adverse events are all adverse events for which the participant is not specifically questioned in the participant ediary.
Time Frame
From Day 1 to Day 30
Title
Cohort 1 and Cohort 2: Number of Participants with Serious Adverse Events (SAE's) from the Administration of the Study Vaccine until Day 181
Description
Number of participants with SAEs will be reported. An SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life threatening experience, is a congenital anomaly/birth defect, is suspected transmission of any infectious agent via a medicinal product, is medically important, and may jeopardize participant or may require medical or surgical intervention to prevent one of the outcomes listed above.
Time Frame
Up to Day 181
Title
Cohort 1: Antibody Titers for ExPEC10V as Determined by Multiplex Electrochemiluminescent (ECL)-based Immunoassay on Day 15
Description
Antibody titers for ExPEC10V will be determined by multiplex ECL-based immunoassay.
Time Frame
On Day 15
Title
Cohort 1: Antibody Titers for ExPEC10V as Determined by Multiplex Opsonophagocytic Assay (MOPA) on Day 15
Description
Antibody titers for ExPEC10V will be determined by MOPA.
Time Frame
On Day 15
Title
Cohort 2: Antibody Titers for ExPEC10V as Determined by Multiplex ECL-based Immunoassay on Day 30
Description
Antibody titers for ExPEC10V will be determined by multiplex ECL-based immunoassay.
Time Frame
On Day 30
Title
Cohort 2: Antibody Titers for ExPEC10V as Determined by MOPA on Day 30
Description
Antibody titers for ExPEC10V will be determined by MOPA.
Time Frame
On Day 30
Secondary Outcome Measure Information:
Title
Cohort 1: Antibody Titers for ExPEC10V as Determined by Multiplex ECL-based Immunoassay and MOPA to find Correlation Between Multiplex ECL-based Immunoassay and MOPA
Description
Antibody titers for ExPEC10V as determined by multiplex ECL-based immunoassay and MOPA to find correlation between multiplex ECL-based immunoassay and MOPA
Time Frame
Day 15
Title
Cohort 1: Antibody Titers for ExPEC10V as Determined by Multiplex ECL-based Immunoassay on Days 30, 181, 366, 731, 1096, 1461, and 1826
Description
Antibody titers for ExPEC10V will be determined by multiplex ECL-based immunoassay.
Time Frame
On Days 30, 181, 366, 731, 1096, 1461, and 1826
Title
Cohort 1: Antibody Titers for ExPEC10V as Determined by MOPA on Days 30, 181, 366, 731, 1096, 1461, and 1826
Description
Antibody titers for ExPEC10V will be determined by MOPA.
Time Frame
On Days 30, 181, 366, 731, 1096, 1461, and 1826
Title
Cohort 2: Antibody Titers for ExPEC10V as Determined by Multiplex ECL-based Immunoassay and MOPA to find Correlation Between Multiplex ECL-based Immunoassay and MOPA
Description
Antibody titers for ExPEC10V as determined by multiplex ECL-based immunoassay and MOPA to find correlation between multiplex ECL-based immunoassay and MOPA
Time Frame
Day 30
Title
Cohort 2: Antibody Titers for ExPEC10V as Determined by Multiplex ECL-based Immunoassay on Days 15, 181, and 366
Description
Antibody titers for ExPEC10V will be determined by multiplex ECL-based immunoassay.
Time Frame
On Days 15, 181, and 366
Title
Cohort 2: Antibody Titers for ExPEC10V as Determined by MOPA on Days 181, and 366
Description
Antibody titers for ExPEC10V will be determined by MOPA.
Time Frame
On Days 181, and 366
Title
Cohort 1 and Cohort 2: Number of Participants with Serious Adverse Events Related to the Study Intervention or Study Procedures From Day 182 Until the end of the Study
Description
Number of participants with SAEs related to the study intervention or study procedures will be reported. An SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life threatening experience, is a congenital anomaly/birth defect, is suspected transmission of any infectious agent via a medicinal product, is medically important, and may jeopardize participant or may require medical or surgical intervention to prevent one of the outcomes listed above.
Time Frame
Cohort 1: Day 1826 and Cohort 2: Day 366
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Must have a body mass index (BMI) of greater than (>) 18.5 or less than 40 kilogram per meter square (kg/m^2)
Before randomization, a woman must be: postmenopausal - A postmenopausal state is defined as no menses for 12 months without an alternative medical cause; or not intending to conceive by any methods
Must be healthy or medically stable
Must sign an informed consent form (ICF) indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study
Willing and able to adhere to the lifestyle restrictions specified in this protocol
Agrees not to donate blood until 12 weeks after receiving the study vaccine
Exclusion Criteria:
Acute illness (this does not include minor illnesses such as diarrhea or mild upper respiratory tract infection) or temperature greater than equal to >=38.0 degree Celsius (100.4 degree Fahrenheit) within 24 hours prior to the administration of study vaccine, or, applicable for Cohort 2 only, an ongoing or suspected symptomatic urinary tract infection (UTI); enrollment at a later date is permitted (provided the screening window of 28 days is respected)
History of malignancy within 5 years before screening (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy, which is considered cured with minimal risk of recurrence)
Known allergies, hypersensitivity, or intolerance to ExPEC10V or its excipients
Applicable for Cohort 1 only: known allergy or history of anaphylaxis or other serious adverse reactions to vaccines or vaccine products (including any of the constituents of the active control vaccines)
Contraindication to intramuscular (IM) injections and blood draws example, bleeding disorders
Abnormal function of the immune system
Has had major psychiatric illness and/or drug substance or alcohol abuse in the past 12 months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen Research & Development, LLC Clinical Trial
Organizational Affiliation
Janssen Research & Development, LLC
Official's Role
Study Director
Facility Information:
Facility Name
Optimal Research
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35802
Country
United States
Facility Name
Optimal Research
City
Melbourne
State/Province
Florida
ZIP/Postal Code
32934
Country
United States
Facility Name
Qps-Mra, Llc
City
Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
Optimal Research
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61614
Country
United States
Facility Name
Synexus Clinical Research US, Inc
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47714
Country
United States
Facility Name
Johnson County Clin-Trials
City
Lenexa
State/Province
Kansas
ZIP/Postal Code
66219
Country
United States
Facility Name
Synexus Clinical Research US, Inc
City
Richfield
State/Province
Minnesota
ZIP/Postal Code
55432
Country
United States
Facility Name
Synexus Clinical Research US, Inc
City
Manhattan
State/Province
New York
ZIP/Postal Code
10017
Country
United States
Facility Name
Rochester Clinical Research, Inc
City
Rochester
State/Province
New York
ZIP/Postal Code
14609
Country
United States
Facility Name
Synexus Clinical Research US, Inc
City
Akron
State/Province
Ohio
ZIP/Postal Code
44311
Country
United States
Facility Name
Synexus Clinical Research US, Inc
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43212
Country
United States
Facility Name
Coastal Carolina Research Center
City
North Charleston
State/Province
South Carolina
ZIP/Postal Code
29405
Country
United States
Facility Name
Anima
City
Alken
ZIP/Postal Code
3570
Country
Belgium
Facility Name
ATC Pharma
City
Luik
ZIP/Postal Code
4000
Country
Belgium
Facility Name
Clinical Pharmacology Unit
City
Merksem
ZIP/Postal Code
2170
Country
Belgium
Facility Name
CHU Nantes
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
Hopital Cochin
City
Paris
ZIP/Postal Code
75014
Country
France
Facility Name
APHP - Hopital Bichat - Claude Bernard
City
Paris
ZIP/Postal Code
75018
Country
France
Facility Name
CHU Lyon Sud
City
Pierre Benite
ZIP/Postal Code
69495
Country
France
Facility Name
Chu Rennes - Hopital Pontchaillou
City
Rennes
ZIP/Postal Code
35000
Country
France
Facility Name
CHRU Tours Hôpital Bretonneau
City
Tours
ZIP/Postal Code
37000
Country
France
Facility Name
EB Flevo Research
City
Almere
ZIP/Postal Code
1311 RL
Country
Netherlands
Facility Name
PRA Health Sciences
City
Groningen
ZIP/Postal Code
NZ 9728
Country
Netherlands
Facility Name
Hosp. Del Mar
City
Barcelona
ZIP/Postal Code
8003
Country
Spain
Facility Name
Hosp. Reina Sofia
City
Córdoba
ZIP/Postal Code
14004
Country
Spain
Facility Name
Hosp. Univ. de La Princesa
City
Madrid
ZIP/Postal Code
28006
Country
Spain
Facility Name
Hosp. Univ. La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Hosp. Univ. Marques de Valdecilla
City
Santander
ZIP/Postal Code
39008
Country
Spain
Facility Name
Hosp. Virgen Macarena
City
Sevilla
ZIP/Postal Code
41009
Country
Spain
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 of Three Different Doses of VAC52416 (ExPEC10V) in Adults Aged 60 to 85 Years in Stable Health
We'll reach out to this number within 24 hrs