Skip to main content
OpenTrials
Completed

NCT Number: NCT00834106

Prevention of Human Papillomavirus (HPV) in 20 to 45 Year Old Chinese Women (V501-041)

A study to test the safety and effectiveness of Quadrivalent HPV (types 6, 11, 16, 18) L1 VLP vaccine against combined incidence of HPV 6/11/16/18-related persistent infection and vaccine type-specific genital disease among Chinese females between the ages of 20 and 45.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

HPV Infections Communicable Diseases DNA Virus Infections Disease Attributes Genital Diseases Infections Papillomavirus Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Tumor Virus Infections Urogenital Diseases Virus Diseases

Age range

20 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

About this study

The Base Study V501-041 duration was 30 months. The study was extended to further evaluate the efficacy of Quadrivalent HPV (Type 6, 11, 16, 18) L1 VLP (qHPV) vaccine against Cervical Intraepithelial Neoplasia Grade 2 (CIN 2), CIN 3, Adenocarcinoma In Situ (AIS), and/or cervical cancer. The efficacy was followed through the Month 78 visit, and the close-out visit was conducted at approximately Month 90 with only safety data collected

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy women between the ages of 20 and 45
  • Have used effective contraception for 2 weeks prior to starting in the study
  • Does not have a temperature within 24 hours before the first injection

Exclusion criteria

  • Prior history of genital warts
  • More than 4 lifetime sexual partners
  • Have undergone hysterectomy
  • Have active cervical disease or history of cervical disease

Treatment and study plan

quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine

Biological

Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine injection at Day 1, Month 2, and Month 6.

Other names: Gardasil ™, V501

Comparator: placebo (unspecified)

Biological

Aluminum-containing Vaccine placebo injection at Day 1, Month 2, and Month 6.

Primary outcomes

  1. Base Study: Combined Incidence of 6-Month Persistent Infection, Cervical Intraepithelial Neoplasia (CIN+), and External Genital Lesions Related to Human Papillomavirus (HPV) Type 6, 11, 16, or 18 in 20 to 45 Year Old Participants (Test of Hypothesis)

    Time frame: From Day 1 until >=25 cases accumulate, up to Month 30

    The endpoint included pathology panel consensus diagnosis of 6-month persistent infection, CIN+ (including CIN grade 1, 2, or 3, cervical adenocarcinoma in situ (AIS), and cervical cancer), or external genital lesions related to HPV Types 6, 11, 16, or 18 detected by polymerase chain reaction (PCR) in an adjacent section from the same tissue block.

  2. Base Study: Combined Incidence of 6-Month Persistent Infection, CIN+, and External Genital Lesions Related to Human Papillomavirus (HPV) Type 6, 11, 16, or 18 in 20 to 26 Years Old Participants (Test of Hypothesis)

    Time frame: From Day 1 until >=17 cases accumulate, up to Month 30

    The endpoint included pathology panel consensus diagnosis of 6-month persistent infection, CIN+ (including CIN grade 1, 2, or 3, cervical adenocarcinoma in situ (AIS), and cervical cancer), or external genital lesions related to HPV Types 6, 11, 16, or 18 detected by PCR in an adjacent section from the same tissue block.

  3. Entire Study: Combined Incidence of CIN2+ Related to HPV Types 16 or 18 in 20 to 45 Year Old Participants (End of Study Test of Hypothesis)

    Time frame: Up to Month 78

    The endpoint included pathology panel consensus diagnosis of CIN2+ (including CIN grade 2 or 3, AIS, and cervical cancer) related to HPV Types 16 or 18 detected by PCR in an adjacent section from the same tissue block.

  4. Base Study: Percentage of Participants With One or More Solicited Injection-site Adverse Events

    Time frame: Up to 15 days after any vaccination

    An adverse event (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the sponsor's product, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the sponsor's product, is also an AE. Injection-site AEs were prompted on the Vaccination Report Card (VRC), which was completed by the participant for 15 days after each vaccination.

  5. Base Study: Percentage of Participants With One or More Systemic Adverse Events

    Time frame: Up to 15 days after any vaccination

    An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the sponsor's product, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the sponsor's product, is also an AE.

  6. Base Study: Percentage of Participants Discontinued From Study Vaccination Due to an Adverse Event

    Time frame: Up to 6 months

    An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the sponsor's product, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the sponsor's product, is also an AE.

  7. Entire Study: Percentage of Participants With One or More Vaccine-related Serious Adverse Events

    Time frame: Up to approximately 90 months

    A serious adverse event (SAE) is an AE that results in death, is life threatening, results in persistent or significant disability or incapacity, results in or prolongs a hospitalization, is a congenital anomaly or birth defect, is an overdose or, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention. Related SAEs were those deemed possibly, probably, or definitely related to study vaccine or a study procedure.

  8. Entire Study: Percentage of Participants Who Died

    Time frame: Up to approximately 90 months

    The percentage of participants who died on study due to any cause, whether or not related to the investigational product, were reported for each arm

Secondary outcomes

  1. Entire Study: Combined Incidence of 12-Month Persistent Infection, CIN+, and External Genital Lesions Related to Human Papillomavirus (HPV) Type 6, 11, 16, or 18 in 20 to 45 Year Old Participants (End of Study Update)

    Time frame: Up to 78 months

    The endpoint included pathology panel consensus diagnosis of 12-month persistent infection, CIN+ (including CIN grade 1, 2, or 3, cervical adenocarcinoma in situ (AIS), and cervical cancer), or external genital lesions related to HPV Types 6, 11, 16, or 18 detected by PCR in an adjacent section from the same tissue block.

  2. Entire Study: Combined Incidence of 12-Month Persistent Infection, CIN+, and External Genital Lesions Related to Human Papillomavirus (HPV) Type 6, 11, 16, or 18 in 20 to 26 Year Old Participants (End of Study Update)

    Time frame: Up to 78 months

    The endpoint included pathology panel consensus diagnosis of 12-month persistent infection, CIN+ (including CIN grade 1, 2, or 3, cervical adenocarcinoma in situ (AIS), and cervical cancer), or external genital lesions related to HPV Types 6, 11, 16, or 18 detected by PCR in an adjacent section from the same tissue block.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

A Randomized, Placebo-Controlled, Double-Blind Study of Quadrivalent HPV (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) Vaccine to Investigate the Safety, and Efficacy in Chinese 20 - to 45-Years-Old Women

Important dates

Study start
2008
Primary completion
2012
Study completion
2016
First posted
Feb 3, 2009
Registry last updated
Feb 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.