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A Study of V503 in Preadolescents and Adolescents (V503-002 EXT1 EXT2)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Merck
ClinicalTrials.gov Identifier:
NCT00943722
First received: July 21, 2009
Last updated: May 22, 2013
Last verified: May 2013
History of Changes
  Purpose

This study will evaluate the immunogenicity and tolerability of V503 in preadolescent and adolescent subjects between 9 and 15 years old and demonstrate the consistency of the manufactured vaccine through assessment of 3 different final manufacturing process lots of V503.


Condition Intervention Phase
Cervical Cancers
Vulvar Cancer
Vaginal Cancer
Genital Lesions
PAP Test Abnormalities
HPV Infections
 Biological: V503
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Phase III Clinical Trial to Study the Immunogenicity, Tolerability, and Manufacturing Consistency of V503 (A Multivalent Human Papillomavirus [HPV] L1 Virus-Like Particle [VLP] Vaccine) in Preadolescents and Adolescents (9 to 15 Year Olds) With a Comparison to Young Women (16 to 26 Year Olds)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:
  • Number of subjects with injection site adverse experiences [ Time Frame: Day 1 to 5 post-vaccination ] [ Designated as safety issue: Yes ]
  • Number of subjects with elevated temperature [ Time Frame: Day 1 to 5 post-vaccination ] [ Designated as safety issue: Yes ]
  • Number of subjects with systemic adverse experiences [ Time Frame: Day 1 to 15 post-vaccination ] [ Designated as safety issue: Yes ]
  • Geometric mean titers (GMTs) to each of the HPV types contained in the vaccine [ Time Frame: 4 weeks post dose 3 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Seroconversion percentages to each of the HPV types contained in the vaccine [ Time Frame: 4 weeks post dose 3 ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Geometric mean titers (GMTs) to each of the HPV types contained in the vaccine at 6, 18, and 30 months post dose 3 [ Time Frame: Up to 30 months post dose 3 ] [ Designated as safety issue: No ]
  • Seroconversion percentages to each of the HPV types contained in the vaccine at 6, 18, and 30 months post dose 3 [ Time Frame: Up to 30 months post dose 3 ] [ Designated as safety issue: No ]
  • Geometric mean titers (GMTs) to each of the HPV types contained in the vaccine at 60, 84, and 120 months post dose 3 [ Time Frame: Up to 120 months post dose 3 ] [ Designated as safety issue: No ]
  • Seroconversion percentages to each of the HPV types contained in the vaccine at 60, 84, and 120 months post dose 3 [ Time Frame: Up to 120 months post dose 3 ] [ Designated as safety issue: No ]
  • Number of participants with vaccine-related serious adverse events (SAEs) or death [ Time Frame: Up to 30 months post dose 3 ] [ Designated as safety issue: Yes ]
  • Number of participants with vaccine-related serious adverse events (SAEs) or death [ Time Frame: Up to 120 months post dose 3 ] [ Designated as safety issue: Yes ]

Enrollment: 3074
Study Start Date: August 2009
Estimated Study Completion Date: June 2020
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Boys 9 to 15 years old: V503 Lot 1 Biological: V503
Multivalent HPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing lot 1, 2, or 3.
Experimental: Young women 16 to 26 years old: V503 Lot 1 Biological: V503
Multivalent HPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing lot 1, 2, or 3.
Experimental: Girls 9 to 15 years old: V503 Lot 1 Biological: V503
Multivalent HPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing lot 1, 2, or 3.
Experimental: Girls 9 to 15 years old: V503 Lot 2 Biological: V503
Multivalent HPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing lot 1, 2, or 3.
Experimental: Girls 9 to 15 years old: V503 Lot 3 Biological: V503
Multivalent HPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing lot 1, 2, or 3.

Detailed Description:

The base study V503-002 is a 12-month study that is collecting safety and immunogenicity information for six months following the subjects' third dose of study vaccine and is expected to conclude in 2011.

An optional extension study (V503-002 EXT1) will collect safety and immunogenicity information through Month 36. No study vaccine will be administered in the extension study. Subjects enrolled in the 16- to 26-year-old cohort in the base study will not be included in EXT1.

An optional second extension study (V503-002 EXT2) will collect long-term safety and immunogenicity information through approximately 10 years. No study vaccine will be administered in the extension study. Subjects enrolled in the 16- to 26-year-old cohort in the base study will not be included in EXT2.

  Eligibility

Ages Eligible for Study:   9 Years to 26 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Boys and Girls Age 9 to 15:

  • Participant has not had sexual intercourse prior to the study and does not plan to become sexually active during the study period Day 1 to Month 7

Women Age 16 to 26:

  • Participant has never had Pap testing or has had only normal results
  • Participant has had 0 to 4 sexual partners at the time of enrollment

Exclusion Criteria:

Boys and Girls Age 9 to 15:

  • History of allergic reaction that required medical intervention
  • Currently enrolled in any other clinical study
  • Participant is pregnant
  • Participant is immunocompromised or has taken immunosuppressants in the last year
  • Participant has received a marketed HPV vaccine or participated in an HPV vaccine clinical trial
  • Participant has a history of positive test for HPV

Women Age 16 to 26:

  • History of allergic reaction that required medical intervention
  • Currently enrolled in any other clinical study
  • Participant is pregnant
  • Participant is immunocompromised or has taken immunosuppressants in the last year
  • Participant has received a marketed HPV vaccine or participated in an HPV vaccine clinical trial
  • Participant has a history of positive test for HPV
  • Participant has a history of abnormal cervical biopsy result
  • Participant has a history of external genital lesions
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck
ClinicalTrials.gov Identifier: NCT00943722     History of Changes
Other Study ID Numbers: V503-002, 2009_611
Study First Received: July 21, 2009
Last Updated: May 22, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Vaginal Neoplasms
Vulvar Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
 Neoplasms
Vulvar Diseases
Congenital Abnormalities
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Vaginal Diseases

ClinicalTrials.gov processed this record on June 18, 2013