A Study of Gardasil (V501) in Preadolescents and Adolescents (V501-018)
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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. |
ClinicalTrials.gov Identifier: NCT00092547 |
Recruitment Status :
Completed
First Posted : September 28, 2004
Results First Posted : May 4, 2010
Last Update Posted : February 20, 2018
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Sponsor:
Merck Sharp & Dohme LLC
Information provided by (Responsible Party):
Merck Sharp & Dohme LLC
- Study Details
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Prevention |
Conditions |
Human Papillomavirus Infections |
Interventions |
Biological: V501 Biological: Comparator: Placebo |
Enrollment | 1781 |
Participant Flow
Recruitment Details | 1781 participants were randomized to receive qHPV or Placebo in the Base Study. At month 30, participants who received Placebo in the Base Study were eligible to receive qHPV, and formed the Extension Group. Participants were to be followed for safety and efficacy for up to 10 years. |
Pre-assignment Details |
Arm/Group Title | qHPV Vaccine in Base Study | Placebo in Base Study | qHPV Vaccine in Extension Study |
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Represents participants who were randomized into the qHPV Group, who received three 0.5 mL intramuscular injections of V501 (qHPV) at Day 1, Month 2, and Month 6. | Represents participants who were randomized into the Placebo Group, who received three 0.5 mL intramuscular injections of placebo at Day 1, Month 2, and Month 6. | Represent participants originally enrolled into the Placebo Group who continued in the study to receive 0.5 mL intramuscular injections of V501 (qHPV) at Month 30, Month 32, and Month 36. |
Period Title: Base Vaccine Phase (Day 1 to Month 7) | |||
Started | 1184 | 597 | 0 |
Vaccinated | 1179 | 596 | 0 |
Completed | 1121 | 561 | 0 |
Not Completed | 63 | 36 | 0 |
Reason Not Completed | |||
Not Vaccinated | 5 | 1 | 0 |
Adverse Event | 4 | 1 | 0 |
Lost to Follow-up | 18 | 7 | 0 |
Withdrawal by Subject | 28 | 21 | 0 |
Moved | 3 | 1 | 0 |
per sponsor request: (noncompliant) | 0 | 1 | 0 |
Did not meet local regulations | 0 | 1 | 0 |
Refused Vaccination | 5 | 3 | 0 |
Period Title: Base Follow-up Phase (Month 7 to 18) | |||
Started | 1128 [1] | 565 [1] | 0 |
Completed | 1108 | 551 | 0 |
Not Completed | 20 | 14 | 0 |
Reason Not Completed | |||
Subject moved | 1 | 5 | 0 |
Withdrawal by Subject | 4 | 2 | 0 |
Lost to Follow-up | 13 | 7 | 0 |
Protocol Violation | 1 | 0 | 0 |
Physician Decision | 1 | 0 | 0 |
[1]
Includes participants continuing and who previously discontinued who re-entered the study
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Period Title: Base Follow-up Phase (Month 18 to 30) | |||
Started | 964 [1] | 490 [1] | 0 |
Completed | 956 | 485 | 0 |
Not Completed | 8 | 5 | 0 |
Reason Not Completed | |||
Subject moved | 4 | 2 | 0 |
Withdrawal by Subject | 1 | 3 | 0 |
Lost to Follow-up | 2 | 0 | 0 |
Protocol Violation | 1 | 0 | 0 |
[1]
Includes participants continuing and who previously discontinued who re-entered the study
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Period Title: Extension Vaccine Phase (Month 30 to 37) | |||
Started | 956 [1] | 0 | 485 [1] |
Vaccinated in Extension Study | 0 | 0 | 482 |
Completed | 933 | 0 | 469 |
Not Completed | 23 | 0 | 16 |
Reason Not Completed | |||
Subject moved | 3 | 0 | 0 |
Withdrawal by Subject | 6 | 0 | 9 |
Lost to Follow-up | 14 | 0 | 7 |
[1]
Includes participants continuing and who previously discontinued who re-entered the study
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Period Title: Long-term Follow-up (Month 42 Visit) | |||
Started | 612 [1] | 0 | 308 [1] |
Completed | 611 | 0 | 308 |
Not Completed | 1 | 0 | 0 |
Reason Not Completed | |||
Adverse Event | 1 | 0 | 0 |
[1]
Includes participants continuing and who previously discontinued who re-entered the study
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Period Title: Long-term Follow-up (Month 72 Visit) | |||
Started | 550 [1] | 0 | 276 [1] |
Completed | 550 | 0 | 276 |
Not Completed | 0 | 0 | 0 |
[1]
Includes participants continuing and who previously discontinued who re-entered the study
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Period Title: Long-term Follow-up (Month 96 Visit) | |||
Started | 508 [1] | 0 | 267 [1] |
Completed | 508 | 0 | 267 |
Not Completed | 0 | 0 | 0 |
[1]
Includes participants continuing and who previously discontinued who re-entered the study
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Period Title: Long-term Follow-up (Month 126 Visit) | |||
Started | 454 | 0 | 211 |
Completed | 454 | 0 | 211 |
Not Completed | 0 | 0 | 0 |
Baseline Characteristics
Arm/Group Title | qHPV Vaccine in Base Study | Placebo in Base Study | Total | |
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Represents participants who were randomized into the qHPV Group, who received three 0.5 mL intramuscular injections of V501 (qHPV) at Day 1, Month 2, and Month 6 | Represents participants who were randomized into the Placebo Group, who received three 0.5 mL intramuscular injections of placebo at Day 1, Month 2, and Month 6 | Total of all reporting groups | |
Overall Number of Baseline Participants | 1184 | 597 | 1781 | |
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[Not Specified]
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 1184 participants | 597 participants | 1781 participants | |
11.9 (1.9) | 11.8 (1.9) | 11.9 (1.9) | ||
Age, Customized
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 1184 participants | 597 participants | 1781 participants |
8 Years of Age and Under | 0 | 0 | 0 | |
9 to 16 Years of Age | 1184 | 597 | 1781 | |
17 Years of Age and Over | 0 | 0 | 0 | |
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 1184 participants | 597 participants | 1781 participants | |
Female |
616 52.0%
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322 53.9%
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938 52.7%
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Male |
568 48.0%
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275 46.1%
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843 47.3%
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Race/Ethnicity, Customized
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 1184 participants | 597 participants | 1781 participants |
Asian | 149 | 70 | 219 | |
Black | 50 | 21 | 71 | |
Hispanic American | 260 | 130 | 390 | |
Native American | 0 | 1 | 1 | |
White | 716 | 369 | 1085 | |
Other | 9 | 6 | 15 |
Outcome Measures
Adverse Events
Limitations and Caveats
The difference between the prior and final data is a minor change in the definition of the per-protocol immunogenicity population, which was applied down to the base study. Also, protocol violators were identified and excluded from the analysis.
More Information
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.
Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
Name/Title: | Senior Vice President, Global Clinical Development |
Organization: | Merck Sharp & Dohme Corp. |
Phone: | 1-800-672-6372 |
EMail: | ClinicalTrialsDisclosure@merck.com |
Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Merck Sharp & Dohme LLC |
ClinicalTrials.gov Identifier: | NCT00092547 |
Other Study ID Numbers: |
V501-018 2004_084 |
First Submitted: | September 23, 2004 |
First Posted: | September 28, 2004 |
Results First Submitted: | November 3, 2009 |
Results First Posted: | May 4, 2010 |
Last Update Posted: | February 20, 2018 |