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NCT04708041 · ClinicalTrials.gov registry record · Phase 3

Safety and Immunogenicity of Extended 2-dose Regimens of 9-valent Human Papillomavirus (9vHPV) Vaccine (V503-069)

A Phase 3 study of Papillomavirus Infections, sponsored by Merck Sharp & Dohme.

Active
Registry status
Phase 3
Development phase
700
Enrollment target
20
Study locations

NCT04708041 is a Phase 3 study of Papillomavirus Infections that is active but no longer recruiting, run by Merck Sharp & Dohme. The registered enrollment target is 700 participants, below the 1,327-participant average among 5 other Papillomavirus Infections trials with a reported enrollment target (47% lower). The trial reports 20 study locations across 11 states.

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The verdict

NCT04708041, a Phase 3 study of Papillomavirus Infections, is active but no longer recruiting, sponsored by Merck Sharp & Dohme.

ACTIVE NOT RECRUITING
Registry status
Phase 3
Development phase
700 participants
Enrollment target
20
Study locations

Study Summary

This is a 96-month safety and immunogenicity study conducted in boys and girls 9 to 14 years of age and in young women 16 to 26 years of age. From this study, the goal is to establish that the investigational extended 2-dose regimens (0, 12 months; 0, 24 months; 0, 36 months; and 0, 60 months) studied in boys and girls 9 to 14 years of age are generally safe and immunogenic, with an antibody response that is not inferior to that observed in young women 16 to 26 years of age who receive the standard 3-dose regimen of 9-valent human papillomavirus (9vHPV) vaccine at 0, 2, and 6 months (i.e., the population and dose regimen used to establish 9vHPV vaccine efficacy).

Conditions Studied

Interventions

  • BIOLOGICAL 9vHPV vaccine

Study Locations (20)

California

  • Kaiser Permanente Daly City ( Site 0044) - Daly City
  • Kaiser Permanente Oakland ( Site 0020) - Oakland
  • Kaiser Permanente Roseville ( Site 0047) - Roseville
  • Kaiser Permanente Sacramento ( Site 0043) - Sacramento
  • Kaiser Permanente South Sacramento ( Site 0045) - Sacramento
  • Kaiser Permanente San Jose ( Site 0046) - San Jose
  • Kaiser Permanente Santa Clara ( Site 0042) - Santa Clara
  • Encompass Clinical Research ( Site 0022) - Spring Valley

South Carolina

  • Tribe Clinical Research, LLC ( Site 0010) - Greenville
  • Coastal Carolina Research Center ( Site 0032) - North Charleston

Texas

  • Coastal Bend Clinical Research ( Site 0025) - Corpus Christi
  • University of Texas Medical Branch-Sealy Institute for Vaccine Sciences Clinical Trials Program ( Si - Galveston

Florida

  • Advanced Research for Health Improvement, LLC-Pediatrics ( Site 0007) - Naples

Washington

  • MultiCare Rockwood Cheney Clinic ( Site 0038) - Cheney

Antioquia

  • Fundación Centro de Investigación Clínica CIC ( Site 0157) - Medellín

Cundinamarca

  • Centro de Atención e Investigación Médica SAS - CAIMED CHIA ( Site 0151) - Chía

Mexico City

  • CAIMED México ( Site 0207) - Mexico City

Trial Details

FieldValue
Enrollment Target 700 participants
Start Date 2021-03-15
Est. Completion 2029-10-23
Phase Phase 3

Sponsor

Merck Sharp & Dohme

558 total trials

What the Registry Record Tells You About NCT04708041

The ClinicalTrials.gov registry entry for NCT04708041 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 700 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,327-participant average among 5 other Papillomavirus Infections trials with a reported enrollment target (47% lower). The listed sponsor is Merck Sharp & Dohme, which has 558 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Papillomavirus Infections appearing as the primary indexed condition, and to 1 intervention - of which 9vHPV vaccine is the first listed.

NCT04708041 reports 20 study locations spanning 11 distinct geographic areas - top geographies include California, South Carolina, Texas.

Frequently Asked Questions

What is clinical trial NCT04708041 about?

NCT04708041 is a clinical study titled "Safety and Immunogenicity of Extended 2-dose Regimens of 9-valent Human Papillomavirus (9vHPV) Vaccine (V503-069)". This is a 96-month safety and immunogenicity study conducted in boys and girls 9 to 14 years of age and in young women 16 to 26 years of age. From this study, the goal is to establish that the investigational extended 2-dose regimens (0, 12 months; 0, 24 months; 0, 36 months; and 0, 60 months) studi...

What is the current status of trial NCT04708041?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 700 participants. The study started on 2021-03-15. Estimated completion is 2029-10-23.

What conditions does trial NCT04708041 study?

This clinical trial studies the following conditions: Papillomavirus Infections.

What interventions are being tested in trial NCT04708041?

The interventions under investigation include: 9vHPV vaccine (BIOLOGICAL).

Who is sponsoring clinical trial NCT04708041?

This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04708041 being conducted?

This trial has 20 study locations across California, Florida, South Carolina, Texas, Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.