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Completed

NCT Number: NCT01651949

Multivalent HPV (Human Papillomavirus) Vaccine Study in 16- to 26-Year Old Men and Women (V503-003)

This study is designed to evaluate the immunogenicity and tolerability of 9vHPV (9-valent HPV vaccine, V503) in 16- to 26-year old men and women. The overall goal is to bridge 9vHPV efficacy findings in young women to young men based on the demonstration of similar immunogenicity and safety profiles. The primary hypothesis is that 9vHPV induces antibody responses at 4 weeks postdose 3 in heterosexual males that are non-inferior to antibody responses in young women.

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Key information

Conditions

Genital Warts Anal Cancer Anal Intraepithelial Neoplasia Anus Diseases Anus Neoplasms Colorectal Neoplasms Communicable Diseases Condylomata Acuminata DNA Virus Infections Digestive System Diseases Digestive System Neoplasms Disease Attributes Gastrointestinal Diseases Gastrointestinal Neoplasms Genital Diseases Infections Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Papillomavirus Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Rectal Diseases Rectal Neoplasms Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Skin Diseases Skin Diseases, Infectious Skin Diseases, Viral Skin and Connective Tissue Diseases Tumor Virus Infections Urogenital Diseases Virus Diseases Warts

Age range

16 year–26 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

Study participants will be administered a 3-dose regimen of 9vHPV. They will be assessed for immunogenicity 1 month following completion of vaccination. All participants will be followed for safety for a total of 12 months.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Good physical health
  • Has never had Papanicolaou testing (Pap, cervical or anal) or has only had normal Pap test results
  • Other inclusion criteria will be discussed with the investigator

Exclusion criteria

  • History of severe allergic reaction that required medical intervention
  • Currently enrolled in a clinical trial
  • If participant is female, pregnant
  • Currently immunocompromised or having received immunosuppressive therapy in the last year
  • Positive test for HPV
  • History of HPV-related external genital lesions or HPV-related anal lesions or anal cancer
  • If participant is female, history of abnormal cervical biopsy results
  • Other exclusion criteria will be discussed with the investigator

Treatment and study plan

9vHPV Vaccine

Biological

9vHPV, V503 (9-valent HPV [Types 6, 11, 16, 18, 31, 33, 45, 52, and 58] L1 virus-like particle vaccine), 0.5 mL injection in 3-dose regimen

Primary outcomes

  1. Geometric Mean Titers (GMTs) to the HPV Types Contained in the 9vHPV Vaccine

    Time frame: Four weeks post vaccination 3 (Month 7)

    Serum antibodies to HPV types 6/11/16/18/31/33/45/52/58 were measured with a Competitive Luminex Immunoassay. Titers are reported in milli Merck Units/mL

  2. Percentage of Participants With One or More Injection-site Adverse Experiences Prompted on the Vaccination Report Card

    Time frame: Up to 5 days after any vaccination

    An adverse experience (AE) is defined as any unfavorable 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 AE. Injection-site AEs prompted on the Vaccination Report Card (VRC) were erythema, pain, and swelling. Participants were instructed to use the Vaccination Report Card to record AEs daily after each study vaccination.

  3. Percentage of Participants With Elevated Oral Body Temperature (>=37.8° C, >=100° F)

    Time frame: Up to 5 days after any vaccination

    Participants were instructed by the investigator to use the Vaccination Report Card to document evening oral temperature daily after each study vaccination

  4. Percentage of Participants With an Adverse Event

    Time frame: Up to Month 12

    An AE is defined as any unfavorable 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 AE.

  5. Percentage of Participants Who Had Study Vaccine Discontinued Due to an Adverse Event

    Time frame: Up to Month 12

    An AE is defined as any unfavorable 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 AE.

Secondary outcomes

  1. Percentage of Participants With Seroconversion to the HPV Types Contained in the 9vHPV Vaccine

    Time frame: Four weeks post vaccination 3 (Month 7)

    Serum antibodies to HPV types were measured with a Competitive Luminex Immunoassay. The serostatus cutoffs (milli Merck U/mL) for HPV types were as follows: HPV Type 6: ≥30; HPV Type 11: ≥16; HPV Type 16: ≥20; HPV Type 18: ≥24; HPV Type 31: ≥10; HPV Types 33, 45, 52, and 58: ≥8.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

A Phase III Clinical Trial to Study the Tolerability and Immunogenicity of 9vHPV (V503), a Multivalent Human Papillomavirus (HPV) L1 Virus-Like Particle (VLP) Vaccine, in 16- to 26-Year-Old Men and 16- to 26-Year-Old Women

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Jul 27, 2012
Registry last updated
Nov 27, 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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