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Papillomavirus InfectionsPhase 3NCT00496626

An Immunogenicity and Safety Study of Gardasil® in Chinese Subjects (V501-030)(COMPLETED)

A Phase 3 study testing Quadrivalent Human Papillomavirus (HPV, Types 6, 11, 16, 18) Recombinant Vaccine (Gardasil®) in people with Papillomavirus Infections, run by Merck Sharp & Dohme LLC.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a China registration study. A randomized, double-blind, placebo-controlled immunogenicity and safety study in Chinese female participants aged 9 to 45 years and male participants aged 9 to 15 years. Read more about this study

Who is it for?
Ages 9 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Papillomavirus Infections
What is being tested?
Quadrivalent Human Papillomavirus (HPV, Types 6, 11, 16, 18) Recombinant Vaccine (Gardasil®)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
600 participants
Where
No sites listed yet
Study dates
20 Jul 2008to 28 Feb 2009
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 9 to 45 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • Healthy female participants aged 9-45 years old and male participants aged 9-15 years old
  • Participants agrees to provide study personnel with a primary telephone number as well as an alternate telephone number for follow-up purposes
  • Not pregnant now (as demonstrated by a negative urine beta-Human Chorionic Gonadotropin (beta-HCG) test) for post-pubertal female participants

Who cannot join

None listed.

About this study

Official title: An Immunogenicity and Safety Study of Quadrivalent HPV (Types 6, 11, 16, 18) Virus-Like Particle (VLP) Vaccine in Chinese Female Subjects Aged 9 to 45 Years and Male Subjects Aged 9 to 15 Years

This is a China registration study. A randomized, double-blind, placebo-controlled immunogenicity and safety study in Chinese female participants aged 9 to 45 years and male participants aged 9 to 15 years. Approximately 600 participants will be randomized in a 1:1 ratio to receive either vaccine or aluminum-containing placebo. Each participant received one injection at each visit at Day 1, Month 2, and Month 6. Vaccine or placebo was given as a 0.5-mL intramuscular injection. Serum will be collected from all participants to evaluate immune response against anti-Human Papillomavirus (HPV) 6/11/16/18 with Luminex Assay. At Month 2, Month 6, Month 7, subjects will be evaluated for any new medical condition or health concerns and Serious Adverse Experiences throughout the study. The primary objective is to evaluate the vaccine-induced serum anti-HPV 6, 11, 16 and 18 antibody titers following 3-dose regimen of Gardasil® compared with placebo.

Being tested
Quadrivalent Human Papillomavirus (HPV, Types 6, 11, 16, 18) Recombinant Vaccine (Gardasil®), Comparator: Placebo
Keywords
HPV infections
Medical subject headings
Papillomavirus Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Quadrivalent Human Papillomavirus (HPV, Types 6, 11, 16, 18) Recombinant Vaccine (Gardasil®)Biological

    Also called V501, Gardasil®

    Human Papillomavirus (Type 6, 11, 16, 18) Recombinant Vaccine (Gardasil®), 0.5mL, 3 Dose of intramuscular injection at Day 1, Month 2 and Month 6

  • Comparator: PlaceboBiological

    aluminum-contained, 0.5mL, 3 Dose of intramuscular injection at Day 1, Month 2 and Month 6

Study groups in NCT00496626
Study groupRoleWhat they receive
1ExperimentalV501 (Gardasil®)
Receives: Biological: Quadrivalent Human Papillomavirus (HPV, Types 6, 11, 16, 18) Recombinant Vaccine (Gardasil®)
2Placebo comparatorPlacebo
Receives: Biological: Comparator: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Geometric Mean Titer (GMT) of Anti-HPV 6, 11, 16 , 18 at Day 1 and Month 7 (1 Month After Completion of Administration of a 6-month 3-dose Regimen of Vaccines)

    Measured GMT of anti-HPV 6, 11, 16 and 18 at Day 1 and Month 7 (1 month after completion of administration of a 6-month 3-dose regimen of vaccines). GMT at Day 1 was used to define per-protocol population. Antibody titers were tested with Luminex array.

    The numeric values for the Day 1 (Vaccine and Placebo groups) and the Month 7 (Placebo groups) are the threshold of detection for the Luminex array assays. The reported values are all below the lower limit of qualification, ((less than) <7, <8, <11, <10 respectively)

    Measured: Collect blood sample for anti-HPV 6, 11, 16, 18 titers testing at Day 1 prior to vaccination, and Month 7

Secondary outcomes (2)

  1. Number of Participants Who Were Seronegative at Baseline and Developed Seropositive at Month 7

    Anti-HPV 6, 11, 16, 18 Seroconversion Rate, i.e., the Number of participants who were seronegative at baseline and developed seropositive at Month 7. Seroconversion for HPV 6, 11, 16, and 18 is defined as achieving an anti-HPV cLIA level of at least 20, 16, 20 and 24 mMU/mL, respectively.

    Seroconversion rate = (number of participants with seronegative at baseline and developed seropositive at Month 7)/(number of participants with seronegative at baseline regardless relevant HPV serum status at Month 7). Measure serum anti-HPV 6, 11, 16, 18 titers at Day 1 prior to vaccination and at Month 7

    Measured: Collect blood sample for anti-HPV 6, 11, 16, 18 titers testing at Day 1 prior to vaccination and Month 7

  2. Serious Adverse Experiences and Systemic Adverse Experiences Occurring Within 14 Days After Each Vaccination, and Injection-site Complaints Occurring Day 1 Through Day 5 After Each Vaccination

    All adverse experiences were collected through 14 days following each vaccination. All participants were requested to record injection-site adverse experiences and monitor the participant's temperature daily on the Vaccination Report Card for Day 1 thereafter for 4 additional calendar days, and record all systemic adverse experiences that occur during the 14-day period after each injection.

    Measured: For serious adverse experiences and systemic adverse experiences: 14 days follow-up after each dose of vaccination; For injection-site adverse experiences: 5 days follow-up after each dose of vaccination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jul 2007 (estimated)
  2. Study start20 Jul 2008
  3. Primary completion28 Feb 2009
  4. Study completion28 Feb 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
600 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00496626
Sponsor's protocol ID
V501-030
Other IDs
2007_021
Status last verified
Mar 2017
First submitted
3 Jul 2007
Last updated
17 Apr 2017
Individual data sharing
Yes: http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final\_Updated%20July\_9\_2014.pdf http://engagezone.msd.com/ds\_documentation.php

Publications

  • Li R, Li Y, Radley D, Liu Y, Huang T, Sings HL, Zhang L, Wang W, Zhong X, Saah AJ. Safety and immunogenicity of a vaccine targeting human papillomavirus types 6, 11, 16 and 18: a randomized, double-blind, placebo-controlled trial in Chinese males and females. Vaccine. 2012 Jun 13;30(28):4284-91. doi: 10.1016/j.vaccine.2012.02.079. Epub 2012 Mar 18.

    PubMed 22433961

  • Bergman H, Henschke N, Arevalo-Rodriguez I, Buckley BS, Crosbie EJ, Davies JC, Dwan K, Golder SP, Loke YK, Probyn K, Petkovic J, Villanueva G, Morrison J. Human papillomavirus (HPV) vaccination for the prevention of cervical cancer and other HPV-related diseases: a network meta-analysis. Cochrane Database Syst Rev. 2025 Nov 24;11(11):CD015364. doi: 10.1002/14651858.CD015364.pub2.

    PubMed 41276263

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Quadrivalent Human Papillomavirus (HPV, Types 6, 11, 16, 18) Recombinant Vaccine (Gardasil®) in people with Papillomavirus Infections, run by Merck Sharp & Dohme LLC.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Jul 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Geometric Mean Titer (GMT) of Anti-HPV 6, 11, 16 , 18 at Day 1 and Month 7 (1 Month After Completion of Administration of a 6-month 3-dose Regimen of Vaccines) (time frame: Collect blood sample for anti-HPV 6, 11, 16, 18 titers testing at Day 1 prior to vaccination, and Month 7). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00496626, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2017.

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