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Human PapillomavirusPhase 3NCT01304498

Immunogenicity and Tolerability of V503 Versus GARDASIL (V503-009)

A Phase 3 study testing V503 and GARDASIL in people with Human Papillomavirus, 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

Primary objective: To demonstrate that administration of V503 induces non-inferior Geometric Mean Titers (GMTs) (for serum anti-HPV16 and anti-HPV18) compared to GARDASIL. Secondary objectives: To evaluate the tolerability of V503 in 9-15 year-old girls. Read more about this study

Who is it for?
Ages 9 to 15 years, women onlyHealthy volunteers can take part
Conditions the study is for
Human Papillomavirus
What is being tested?
V503 and GARDASIL
Could I receive a placebo?
No, everyone receives an active treatment
How many people
600 participants
Where
No sites listed yet
Study dates
23 Feb 2011to 20 Dec 2011
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 15 years
  • Women only
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Female from 9 to 15 years old.
  • Good physical health.

Who cannot join

  • Known allergy to any vaccine component.
  • History of severe allergic reaction.
  • Thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injections.
  • Pregnant subject.
  • Immunocompromised or immunodeficient subject.
  • Splenectomy.
Show all 10Show fewer
  • Receipt of medication / vaccine that may interfere with study assessment.
  • Fever
  • History of a positive test for HPV, prior receipt of HPV vaccine or prior participation to HPV trial.
  • Any condition that might interfere with study assessment.

About this study

Official title: A Randomized, Double-Blinded, Controlled With GARDASIL (Human Papillomavirus Vaccine [Types 6, 11, 16, 18] (Recombinant, Adsorbed)), Phase III Clinical Trial to Study the Immunogenicity and Tolerability of V503 (9-Valent Human Papillomavirus (HPV) Vaccine) in Preadolescent and Adolescent Girls (9- to 15-year-old)

Primary objective:

  • To demonstrate that administration of V503 induces non-inferior Geometric Mean Titers (GMTs) (for serum anti-HPV16 and anti-HPV18) compared to GARDASIL.

Secondary objectives:

  • To evaluate the tolerability of V503 in 9-15 year-old girls.
  • To summarize humoral immune response (anti-HPV 6, 11, 16, 18) induced by V503 or GARDASIL.
Being tested
V503, GARDASIL

What participants receive

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

  • V503Biological

    Also called 9vHPV vaccine

    9-valent HPV [Types 6, 11, 16, 18, 31, 33, 45, 52, and 58] L1 virus-like particle vaccine

  • GARDASILBiological

    Also called qHPV vaccine

    Quadrivalent HPV [Types 6, 11, 16, and 18] L1 virus-like particle vaccine

Study groups in NCT01304498
Study groupRoleWhat they receive
V503Experimental9-valent HPV [Types 6, 11, 16, 18, 31, 33, 45, 52, and 58] L1 virus-like particle vaccine, 0.5-mL intramuscular injection in 3 dose regimen at Day 1, Month 2, and Month 6
Receives: Biological: V503
GARDASILActive comparatorQuadrivalent HPV [Types 6, 11, 16, and 18] L1 virus-like particle vaccine, 0.5-mL intramuscular injection in 3 dose regimen at Day 1, Month 2, and Month 6
Receives: Biological: GARDASIL

What is being measured

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

  1. Geometric Mean Titers (GMTs) to HPV Types 16 and 18

    Serum antibodies to HPV types 16 and 18 were measured with a Competitive Luminex Immunoassay.

    Measured: 4 weeks postdose 3 (Month 7)

Secondary outcomes (7)

  1. GMTs to HPV Types 6 and 11

    Serum antibodies to HPV types 6 and 11 were measured with a Competitive Luminex Immunoassay.

    Measured: 4 weeks postdose 3 (Month 7)

  2. Percentage of Participants Who Are Seropositive for HPV Types 6/11/16/18

    Serum antibodies to HPV types were measured with a Competitive Luminex Immunoassay. The serostatus cutoffs (milli Merck Units/mL) for HPV types were as follows: HPV Type 6: ≥30; HPV Type 11: ≥16; HPV Type 16: ≥20; HPV Type 18: ≥24. The percentage of participants who were seropositive according to these cutoffs was assessed.

    Measured: 4 weeks postdose 3 (Month 7)

  3. Percentage of Participants With One or More Adverse Events

    An adverse event is defined as any unfavourable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, 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 study vaccine, is also an adverse event. The percentage of participants with one or more adverse events was assessed.

    Measured: Up to Month 7

  4. Percentage of Participants With One or More Injection-site Adverse Reactions

    The percentage of participants with one or more injection-site adverse reactions (solicited or unsolicited) was assessed.

    Measured: Up to 5 days after any vaccination

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

    The percentage of participants with one or more systemic adverse events was assessed.

    Measured: Up to 15 days after any vaccination

  6. Percentage of Participants With Maximum Oral Temperature ≥37.8°C

    The percentage of participants with maximum oral temperature ≥37.8°C was assessed.

    Measured: Up to 15 days after any vaccination

  7. Percentage of Participants With One or More Serious Adverse Events

    A serious adverse event is an adverse event 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 a cancer, or may jeopardize the participant and may require medical or surgical intervention. The percentage of participants with one or more serious adverse events was assessed.

    Measured: Up to Month 7

Timeline

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

  1. First posted25 Feb 2011 (estimated)
  2. Study start23 Feb 2011
  3. Primary completion20 Dec 2011
  4. Study completion20 Dec 2011

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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
600 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01304498
Sponsor's protocol ID
V503-009
Other IDs
GDS01C, 2010-023393-39
Status last verified
Nov 2018
First submitted
24 Feb 2011
Last updated
14 Dec 2018
Data monitoring committee
No
Individual data sharing
Yes: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Publications

  • Vesikari T, Brodszki N, van Damme P, Diez-Domingo J, Icardi G, Petersen LK, Tran C, Thomas S, Luxembourg A, Baudin M. A Randomized, Double-Blind, Phase III Study of the Immunogenicity and Safety of a 9-Valent Human Papillomavirus L1 Virus-Like Particle Vaccine (V503) Versus Gardasil(R) in 9-15-Year-Old Girls. Pediatr Infect Dis J. 2015 Sep;34(9):992-8. doi: 10.1097/INF.0000000000000773.

    PubMed 26090572

  • Moreira ED Jr, Block SL, Ferris D, Giuliano AR, Iversen OE, Joura EA, Kosalaraksa P, Schilling A, Van Damme P, Bornstein J, Bosch FX, Pils S, Cuzick J, Garland SM, Huh W, Kjaer SK, Qi H, Hyatt D, Martin J, Moeller E, Ritter M, Baudin M, Luxembourg A. Safety Profile of the 9-Valent HPV Vaccine: A Combined Analysis of 7 Phase III Clinical Trials. Pediatrics. 2016 Aug;138(2):e20154387. doi: 10.1542/peds.2015-4387. Epub 2016 Jul 15.

    PubMed 27422279

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing V503 and GARDASIL in people with Human Papillomavirus, 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 2 inclusion and 10 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 14 Dec 2018. 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. 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 22 Aug 2017). 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 Titers (GMTs) to HPV Types 16 and 18 (time frame: 4 weeks postdose 3 (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 NCT01304498, 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 14 Dec 2018.

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