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OpenTrials
Completed

NCT Number: NCT01304498

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

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.

Completed

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Key information

Conditions

Human Papillomavirus

Age range

9 year–15 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

V503

Biological

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

Other names: 9vHPV vaccine

GARDASIL

Biological

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

Other names: qHPV vaccine

Primary outcomes

  1. 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 outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study 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)

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Feb 25, 2011
Registry last updated
Dec 14, 2018

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.

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