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OpenTrials
Completed

NCT Number: NCT03158220

Immunogenicity and Tolerability of Broad Spectrum Human Papillomavirus (HPV) Vaccine in Adult and Young Adult Women (V503-004)

This study will assess the safety and immunogenicity of GARDASIL®9 (V503) in 16- to 45-year-old women. The primary hypothesis of the study states that anti-HPV 16, 18, 31, 33, 45, 52, and 58 geometric mean titers (GMTs) at 4 weeks postdose 3 are non-inferior in adult women as compared with GMTs in young adult women.

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Key information

Conditions

Cervical Cancer Communicable Diseases Condylomata Acuminata DNA Virus Infections Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Genital Warts Human Papillomavirus Infection Infections Neoplasms Neoplasms by Site Papillomavirus Infections Pathologic Processes Pathological Conditions, Signs and Symptoms 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 Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms Vaginal Cancer Vaginal Diseases Vaginal Neoplasms Virus Diseases Vulvar Cancer Vulvar Diseases Vulvar Neoplasms Warts

Age range

16 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Universitatsklinik fuer Frauenheilkunde und Geburtshilfe ( Site 0002), Graz, Austria

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Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • good physical health

Exclusion criteria

  • history of an abnormal Pap (Papanicolaou) test or abnormal cervical biopsy results
  • history of HPV-related condition
  • history of known prior vaccination with an HPV vaccine
  • pregnant
  • user of recreational or illicit drugs
  • history of severe allergic reaction, including known allergy to any vaccine component
  • immunocompromised
  • history of certain medications or is currently taking or has taken certain medications (details will be discussed at the time of consent)
  • has thrombocytopenia or other coagulation disorder
  • concurrently enrolled in a clinical study of investigational agent

Treatment and study plan

V503

Biological

V503 vaccination, 0.5 mL in a 3-dose regimen administered on Day 1, Month 2, and Month 6

Other names: GARDASIL®9 (HPV 9-valent vaccine [recombinant, adsorbed]); HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58

Primary outcomes

  1. Anti-HPV Geometric Mean Titers (GMTs) for Each Anti-HPV Type

    Time frame: 4 weeks post vaccination 3 (Month 7)

    Antibodies to the HPV types contained in V503 were measured using a competitive luminex immunoassay. Antibody titers were expressed as milli Merck units/mL (mMU/mL). Statistical comparisons between arms was performed for the HPV types considered oncogenic (HPV Types 16/18/31/33/45/52/58).

Secondary outcomes

  1. Percentage of Participants That Experienced at Least 1 Adverse Event (AE)

    Time frame: Up to 1 month post vaccination 3 (up to 7 months)

    An AE is any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. The percentage of participants with 1 or more AEs was assessed.

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

    Time frame: Up to 1 month post vaccination 3 (up to 7 months)

    An adverse event is any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an adverse event. The percentage of participants who discontinued the study vaccine due to an adverse event regardless of study completion status was assessed.

  3. Percentage of Participants With at Least 1 Solicited Injection-site Adverse Event

    Time frame: Up to 5 days post any vaccination

    Participants were asked to record any injection-site reactions prompted in the Vaccination Report Card, i.e., injection-site tenderness, swelling, or redness, occurring after each study vaccination (solicited injection-site reactions). The percentage of participants with 1 or more solicited injection-site AE was assessed.

  4. Percentage of Participants That Reported at Least 1 Systemic Adverse Event

    Time frame: Up to 15 days post any vaccination

    An AE is defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with study vaccine. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or a protocol-specified procedure, whether or not considered related to the study vaccine or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the study vaccine or protocol-specified procedure is also an AE. Systemic AEs are those not categorized as injection-site AEs. The percentage of participants that reported at least 1 systemic AE was assessed

  5. Percentage of Participants With Elevated Temperature (Fever)

    Time frame: Up to 5 days post any vaccination

    Participants were asked to record oral body temperature in the Vaccination Report Card. The percentage of participants with elevated temperature (≥37.8°C or 100.0°F) was assessed.

  6. Percentage of Participants Who Seroconverted to Each of the Anti-HPV Types

    Time frame: 4 weeks post vaccination 3 (Month 7)

    Antibodies to the HPV types contained in V503 were measured using a competitive luminex immunoassay. The percentage of participants who were seronegative on Day 1 and have anti-HPV titer greater or equal to the type-specific serostatus cutoff at 4 weeks postdose 3 was assessed.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

An Open-Label Phase III Clinical Trial to Study the Immunogenicity and Tolerability of GARDASIL®9 (A Multivalent Human Papillomavirus [HPV] L1 Virus-Like Particle [VLP] Vaccine) in Adult Women (27- to 45-Year-Olds) Compared to Young Adult Women (16 to 26 Year Olds)

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
May 18, 2017
Registry last updated
Nov 21, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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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