A Study to Evaluate the Immunogenicity, Safety and Tolerability of Quadrivalent Human Papillomavirus Vaccine (V501) in Chinese Girls Aged 9-19 Years and Young Women Aged 20-26 Years (V501-213)

December 23, 2024 updated by: Merck Sharp & Dohme LLC

A Phase 3 Open-Label Clinical Trial to Study the Immunogenicity, Safety and Tolerability of Recombinant Human Papillomavirus Quadrivalent (Types 6, 11, 16, 18) Vaccine (V501) in Chinese Girls Aged 9-19 Years and Young Women Aged 20-26 Years

This study is designed to evaluate the immunogenicity, safety, and tolerability of Gardasil® (quadrivalent human papillomavirus [qHPV] vaccine, V501) in Chinese girls aged 9-19 years and young women aged 20-26 years. The primary hypothesis of the study states that at 1 month postdose 3, a 3-dose regimen of V501 induces non-inferior geometric mean titers (GMTs) for serum anti-HPV 6, anti-HPV 11, anti-HPV 16, anti-HPV 18 in girls aged 9-19 years compared to young women aged 20-26 years.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The study consists of a Base Stage wherein Chinese girls aged 9-19 years and young women aged 20-26 years receive a 3-dose regimen of V501 and are followed up to 1 month postdose 3 (Month 7). Participants aged 9-19 years who received 3 doses of V501 in the Base Stage will be eligible to participate in the Extension Stage and will be followed up to Month 60. No study vaccine will be administered during the Extension Stage.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
766

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Yangchun, Guangdong, China, 529600
        • Yangchun Center For Disease Prevention And Control ( Site 0003)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

9 years to 26 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Not pregnant and 1) not a woman of childbearing potential (WOCBP), or 2) a WOCBP who has not had sex with males or has had sex with males and used effective contraception since the first day of participant's last menstrual period through Day 1 and understands and agrees that during the study she should not have sexual intercourse with males without effective contraception (the rhythm method, withdrawal, and emergency contraception are not acceptable methods per the protocol).
  • Participant and participant's parent or guardian (participants aged 9-17 years only) provided written informed consent/assent.
  • Provided a primary and alternative telephone for follow-up purposes.
  • Extension Stage: participant was enrolled in the 9-19 years old group, received 3 doses of V501 in the Base Stage, and participant and participant's legally acceptable representative (if applicable) provided written informed consent/assent for the study extension.

Exclusion Criteria:

  • History of severe allergic reaction that required medical intervention.
  • Allergic to any vaccine component, including aluminum, yeast, or Benzonase® (nuclease).
  • Known thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injections.
  • Currently immunocompromised or was diagnosed as having congenital or acquired immunodeficiency, human immunodeficiency virus (HIV) infection, lymphoma, leukemia, systemic lupus erythematosus (SLE), rheumatoid arthritis, juvenile rheumatoid arthritis (JRA), inflammatory bowel disease, or other autoimmune condition.
  • History of splenectomy.
  • Any condition which in the opinion of the investigator might interfere with the evaluation of the study objectives.
  • History of recent or ongoing alcohol or other drug abuse.
  • History of a positive test for HPV.
  • Any history of abnormal Pap test.
  • History of external genital wart, vulvar intraepithelial neoplasia (VIN), vaginal intraepithelial neoplasia (VaIN), vulvar cancer or vaginal cancer.
  • Undergone hysterectomy (either vaginal or total abdominal hysterectomy).
  • Receiving or has received in the year prior to Day 1 vaccination an excluded immunosuppressive therapy. A participant will be excluded if she is currently receiving steroid therapy, has recently received such therapy, or has received 2 or more courses of corticosteroids (orally or parenterally) lasting at least 1 week in duration in the year prior to Day 1 vaccination. Participants using inhaled, nasal or topical steroids are considered eligible for the study.
  • Received immune globulin product or blood-derived product within 6 months prior to Day 1 vaccination, or plans to receive any such product during the study.
  • Received a marketed HPV vaccine, or has participated in an HPV vaccine clinical trial and has received either active agent or placebo.
  • Received inactivated or recombinant vaccines within 14 days prior to Day 1 vaccination or receipt of live vaccines within 21 days prior to Day 1 vaccination.
  • Concurrently enrolled in a clinical study of investigational agents.
  • Had >4 lifetime sexual partners.
  • Unlikely to adhere to the study procedures, keep appointments, or is planning to permanently relocate from the area prior to the completion of the study or to leave for an extended period of time when study visits would need to be scheduled.
  • An immediate family member who is investigational site or sponsor staff directly involved with this study.
  • Extension Stage: reported overdose or received non-study HPV vaccine during the Base Stage.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Chinese Girls Aged 9 to 19 Years
Participants will receive V501 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6
Biological: V501
0.5 mL intramuscular injection in the deltoid muscle at Day 1, Month 2, and Month 6
Other Names:
  • (Gardasil®) human papillomavirus (types 6, 11, 16, 18) recombinant vaccine
  • qHPV
Active Comparator: Chinese Young Women Aged 20 to 26 Years
Participants will receive V501 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6
Biological: V501
0.5 mL intramuscular injection in the deltoid muscle at Day 1, Month 2, and Month 6
Other Names:
  • (Gardasil®) human papillomavirus (types 6, 11, 16, 18) recombinant vaccine
  • qHPV

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Base Stage: Geometric Mean Titers for Serum Anti-Human Papillomavirus (HPV) Types 6, 11, 16, and 18: Competitive Luminex Immunoassay (cLIA)
Time Frame: Month 7 (1 month postdose 3)
Serum antibody titers (Geometric mean titers) for HPV Types 6, 11, 16, and 18 were measured. Antibodies were measured using a Competitive Luminex Immunoassay (cLIA). Antibody titers were expressed as milli Merck Units/milliliter (mMU/mL).
Month 7 (1 month postdose 3)
Extension Stage: GMTs for Serum Anti-Human Papillomavirus (HPV) Types 6, 11, 16, and 18 at Month 12 Assessed by cLIA
Time Frame: Month 12 post-vaccination 1
Serum antibody titers (Geometric mean titers) for HPV Types 6, 11, 16, and 18 were measured. Antibodies were measured using a Competitive Luminex Immunoassay (cLIA). Antibody titers were expressed as (mMU/mL).
Month 12 post-vaccination 1
Extension Stage: GMTs for Serum Anti-Human Papillomavirus (HPV) Types 6, 11, 16, and 18 at Month 24 Assessed by cLIA
Time Frame: Month 24 post-vaccination 1
Serum antibody titers (Geometric mean titers) for HPV Types 6, 11, 16, and 18 were measured. Antibodies were measured using a Competitive Luminex Immunoassay (cLIA). Antibody titers were expressed as (mMU/mL).
Month 24 post-vaccination 1
Extension Stage: GMTs for Serum Anti-Human Papillomavirus (HPV) Types 6, 11, 16, and 18 at Month 36 Assessed by cLIA
Time Frame: Month 36 post-vaccination 1
Serum antibody titers (Geometric mean titers) for HPV Types 6, 11, 16, and 18 were measured. Antibodies were measured using a Competitive Luminex Immunoassay (cLIA). Antibody titers were expressed as (mMU/mL).
Month 36 post-vaccination 1
Extension Stage: GMTs for Serum Anti-Human Papillomavirus (HPV) Types 6, 11, 16, and 18 at Month 48 Assessed by cLIA
Time Frame: Month 48 post-vaccination 1
Serum antibody titers (Geometric mean titers) for HPV Types 6, 11, 16, and 18 were measured. Antibodies were measured using a Competitive Luminex Immunoassay (cLIA). Antibody titers were expressed as (mMU/mL).
Month 48 post-vaccination 1
Extension Stage: GMTs for Serum Anti-Human Papillomavirus (HPV) Types 6, 11, 16, and 18 at Month 60 Assessed by cLIA
Time Frame: Month 60 post-vaccination 1
Serum antibody titers (Geometric mean titers) for HPV virus-like particles (VLPs) Types 6, 11, 16, and 18 were measured. Antibodies were measured using a Competitive Luminex Immunoassay (cLIA). Antibody titers were expressed as (mMU/mL).
Month 60 post-vaccination 1
Extension Stage: Percentage of Participants With Seropositivity to HPV Types 6, 11, 16, and 18 at Month 12 Assessed by cLIA
Time Frame: Month 12 post-vaccination 1
The percentage of participants who are seropositive to each of HPV Types 6, 11, 16, and 18 were assessed. Antibodies were measured using cLIA.
Month 12 post-vaccination 1
Extension Stage: Percentage of Participants With Seropositivity to HPV Types 6, 11, 16, and 18 at Month 24 Assessed by cLIA
Time Frame: Month 24 post-vaccination 1
The percentage of participants who are seropositive to each of HPV Types 6, 11, 16, and 18 were assessed. Antibodies were measured using cLIA.
Month 24 post-vaccination 1
Extension Stage: Percentage of Participants With Seropositivity to HPV Types 6, 11, 16, and 18 at Month 36 Assessed by cLIA
Time Frame: Month 36 post-vaccination 1
The percentage of participants who are seropositive to each of HPV Types 6, 11, 16, and 18 were assessed. Antibodies were measured using cLIA.
Month 36 post-vaccination 1
Extension Stage: Percentage of Participants With Seropositivity to HPV Types 6, 11, 16, and 18 at Month 48 Assessed by cLIA
Time Frame: Month 48 post-vaccination 1
The percentage of participants who are seropositive to each of HPV Types 6, 11, 16, and 18 were assessed. Antibodies were measured using cLIA.
Month 48 post-vaccination 1
Extension Stage: Percentage of Participants With Seropositivity to HPV Types 6, 11, 16, and 18 at Month 60 Assessed by cLIA
Time Frame: Month 60 post-vaccination 1
The percentage of participants who are seropositive to each of HPV Types 6, 11, 16, and 18 were assessed. Antibodies were measured using cLIA.
Month 60 post-vaccination 1
Extension Stage: GMTs for Serum Anti-HPV Types 6, 11, 16, and 18 at Month 12 Assessed by Immunoglobulin G Luminex Immunoassay (IgG LIA)
Time Frame: Month 12 post-vaccination 1
Serum antibody titers (Geometric mean titers) for HPV Types 6, 11, 16, and 18 were measured. Antibodies were measured using IgG LIA. Antibody titers were expressed as (mMU/mL).
Month 12 post-vaccination 1
Extension Stage: GMTs for Serum Anti-HPV Types 6, 11, 16, and 18 at Month 24 Assessed by Immunoglobulin G Luminex Immunoassay (IgG LIA)
Time Frame: Month 24 post-vaccination 1
Serum antibody titers (Geometric mean titers) for HPV Types 6, 11, 16, and 18 were measured. Antibodies were measured using IgG LIA. Antibody titers were expressed as (mMU/mL).
Month 24 post-vaccination 1
Extension Stage: GMTs for Serum Anti-HPV Types 6, 11, 16, and 18 at Month 36 Assessed by Immunoglobulin G Luminex Immunoassay (IgG LIA)
Time Frame: Month 36 post-vaccination 1
Serum antibody titers (Geometric mean titers) for HPV Types 6, 11, 16, and 18 were measured. Antibodies were measured using IgG LIA. Antibody titers were expressed as (mMU/mL).
Month 36 post-vaccination 1
Extension Stage: GMTs for Serum Anti-HPV Types 6, 11, 16, and 18 at Month 48 Assessed by Immunoglobulin G Luminex Immunoassay (IgG LIA)
Time Frame: Month 48 post-vaccination 1
Serum antibody titers (Geometric mean titers) for HPV Types 6, 11, 16, and 18 were measured. Antibodies were measured using IgG LIA.
Month 48 post-vaccination 1
Extension Stage: GMTs for Serum Anti-HPV Types 6, 11, 16, and 18 at Month 60 Assessed by Immunoglobulin G Luminex Immunoassay (IgG LIA)
Time Frame: Month 60 post-vaccination 1
Serum antibody titers (Geometric mean titers) for HPV Types 6, 11, 16, and 18 were measured. Antibodies were measured using IgG LIA.
Month 60 post-vaccination 1
Extension Stage: Percentage of Participants With Seropositivity to HPV Types 6, 11, 16, and 18 at Month 12 Assessed by IgG LIA
Time Frame: Month 12 post-vaccination 1
The percentage of participants who are seropositive to each of HPV Types 6, 11, 16, and 18 were assessed. Antibodies were measured using IgG LIA.
Month 12 post-vaccination 1
Extension Stage: Percentage of Participants With Seropositivity to HPV Types 6, 11, 16, and 18 at Month 24 Assessed by IgG LIA
Time Frame: Month 24 post-vaccination 1
The percentage of participants who are seropositive to each of HPV Types 6, 11, 16, and 18 were assessed. Antibodies were measured using IgG LIA.
Month 24 post-vaccination 1
Extension Stage: Percentage of Participants With Seropositivity to HPV Types 6, 11, 16, and 18 at Month 36 Assessed by IgG LIA
Time Frame: Month 36 post-vaccination 1
The percentage of participants who are seropositive to each of HPV Types 6, 11, 16, and 18 were assessed. Antibodies were measured using IgG LIA.
Month 36 post-vaccination 1
Extension Stage: Percentage of Participants With Seropositivity to HPV Types 6, 11, 16, and 18 at Month 48 Assessed by IgG LIA
Time Frame: Month 48 post-vaccination 1
The percentage of participants who are seropositive to each of HPV Types 6, 11, 16, and 18 were assessed. Antibodies were measured using IgG LIA.
Month 48 post-vaccination 1
Extension Stage: Percentage of Participants With Seropositivity to HPV Types 6, 11, 16, and 18 at Month 60 Assessed by IgG LIA
Time Frame: Month 60 post-vaccination 1
The percentage of participants who are seropositive to each of HPV Types 6, 11, 16, and 18 were assessed. Antibodies were measured using IgG LIA.
Month 60 post-vaccination 1

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Base Stage: Percentage of Participants With Seroconversion for HPV Types 6, 11, 16, and 18: cLIA
Time Frame: Month 7 (1 month postdose 3)
Seroconversion is defined as changing serostatus from seronegative at Day 1 to seropositive at 1 month post dose 3. Antibodies were measured using a Competitive Luminex Immunoassay (cLIA). Antibody titers were expressed as milli Merck Units/milliliter (mMU/mL).
Month 7 (1 month postdose 3)
Base Stage: Geometric Mean Titers for Serum Anti-HPV Types 6, 11, 16, and 18: IgG LIA
Time Frame: Month 7 (1 month postdose 3)
Antibodies to HPV Types 6, 11, 16, and 18 were measured using an IgG LIA. Antibody titers were expressed as milli Merck Units/milliliter (mMU/mL).
Month 7 (1 month postdose 3)
Base Stage: Percentage of Participants With Seroconversion for HPV Types 6, 11, 16, and 18: IgG LIA
Time Frame: Month 7 (1 month postdose 3)
The percentage of participants who seroconverted to each of HPV Types 6, 11, 16, and 18 was assessed. Antibodies were measured using IgG LIA.
Month 7 (1 month postdose 3)
Base Stage: Percentage of Participants Who Experienced a Solicited Injection-site Adverse Event (AE)
Time Frame: Up to 15 days after any vaccination
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Solicited injection-site AEs included injection-site redness, swelling, induration, pain, and pruritus.
Up to 15 days after any vaccination
Base Stage: Percentage of Participants Participants Who Experienced a Solicited Systemic AE
Time Frame: Up to 15 days after any vaccination
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Solicited systemic AEs included hypersensitivity, headache, fatigue, vomiting, nausea, diarrhea, myalgia, pyrexia, and cough.
Up to 15 days after any vaccination
Base Stage: Percentage of Participants Who Experienced a Serious Adverse Event (SAE)
Time Frame: Up to Month 7 (1 month postdose 3)
An SAE is an AE that results in death, is life threatening, requires hospitalization or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, according to medical or scientific judgment, may jeopardize the participant or requires medical or surgical intervention to prevent one of the other outcomes listed in the above definition.
Up to Month 7 (1 month postdose 3)
Base Stage: Percentage of Participants Who Experienced an AE
Time Frame: Up to 31 days after any vaccination
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment
Up to 31 days after any vaccination
Base Stage: Maximum Axillary Temperature: Merck Sharp & Dohme (MSD) Criteria
Time Frame: Up to 5 days after any vaccination
In the global studies, fever is defined as an oral temperature of ≥37.8°C or 100.0°F, which is equivalent to axillary temperature of ≥37.2°C, while the definition of fever is axillary temperature of ≥37.1°C in Chinese criteria. To be compliant to Chinese criteria, axillary temperatures of ≥37.1°C was considered as a fever in this study. Body temperature readings assessed orally were converted to the axillary equivalent. The percentage of participants with a maximum axillary or converted axillary temperature was summarized by temperature range.
Up to 5 days after any vaccination
Extension Stage: Percentage of Participants Who Experienced an SAE
Time Frame: Month 7 up to Month 60
The percentage of participants with an SAE will be assessed. An SAE is an AE that results in death, is life threatening, requires hospitalization or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, according to medical or scientific judgment, may jeopardize the participant or requires medical or surgical intervention to prevent one of the other outcomes listed in the above definition.
Month 7 up to Month 60

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Merck Sharp & Dohme LLC

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Medical Director, Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 31, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 30, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 30, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 4, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 4, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 10, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 23, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • V501-213 (Other Identifier: MSD Protocol Number)
  • 2023-001144-29 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

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