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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01304498
First Posted: February 25, 2011
Last Update Posted: August 22, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
  Purpose

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.

Condition Intervention Phase
Human Papillomavirus Biological: V503 Biological: GARDASIL Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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)

Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Geometric Mean Titers (GMTs) to HPV Types 16 and 18 [ Time Frame: 4 weeks postdose 3 (Month 7) ]
    Serum antibodies to HPV types 16 and 18 were measured with a Competitive Luminex Immunoassay.


Secondary Outcome Measures:
  • GMTs to HPV Types 6 and 11 [ Time Frame: 4 weeks postdose 3 (Month 7) ]
    Serum antibodies to HPV types 6 and 11 were measured with a Competitive Luminex Immunoassay.

  • Percentage of Participants Who Are Seropositive for HPV Types 6/11/16/18 [ Time Frame: 4 weeks postdose 3 (Month 7) ]
    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.

  • Percentage of Participants With One or More Adverse Events [ Time Frame: Up to Month 7 ]
    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.

  • Percentage of Participants With One or More Injection-site Adverse Reactions [ Time Frame: Up to 5 days after any vaccination ]
    The percentage of participants with one or more injection-site adverse reactions (solicited or unsolicited) was assessed.

  • Percentage of Participants With One or More Systemic Adverse Events [ Time Frame: Up to 15 days after any vaccination ]
    The percentage of participants with one or more systemic adverse events was assessed.

  • Percentage of Participants With Maximum Oral Temperature ≥37.8°C [ Time Frame: Up to 15 days after any vaccination ]
    The percentage of participants with maximum oral temperature ≥37.8°C was assessed.

  • Percentage of Participants With One or More Serious Adverse Events [ Time Frame: Up to Month 7 ]
    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.


Enrollment: 600
Study Start Date: February 1, 2011
Study Completion Date: December 20, 2011
Primary Completion Date: December 20, 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: V503
9-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
Biological: V503
9-valent HPV [Types 6, 11, 16, 18, 31, 33, 45, 52, and 58] L1 virus-like particle vaccine
Other Name: 9vHPV vaccine
Active Comparator: GARDASIL
Quadrivalent 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
Biological: GARDASIL
Quadrivalent HPV [Types 6, 11, 16, and 18] L1 virus-like particle vaccine
Other Name: qHPV vaccine

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   9 Years to 15 Years   (Child)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.
  • 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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01304498


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Director Merck Sharp & Dohme Corp.
  More Information

Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01304498     History of Changes
Other Study ID Numbers: V503-009
GDS01C ( Other Identifier: MCMVaccBV (SPMSD) Protocol Number )
2010-023393-39 ( EudraCT Number )
First Submitted: February 24, 2011
First Posted: February 25, 2011
Results First Submitted: July 24, 2017
Results First Posted: August 22, 2017
Last Update Posted: August 22, 2017
Last Verified: July 2017

Additional relevant MeSH terms:
Vaccines
Immunologic Factors
Physiological Effects of Drugs