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Safety and Protective Effect Study of GSK Biologicals' Human Papillomavirus (Types 16, 18) Vaccine, Adsorbed (GSK580299) in Healthy Female Subjects From the HPV-039 Study

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ClinicalTrials.gov Identifier: NCT03629886
Recruitment Status : Active, not recruiting
First Posted : August 14, 2018
Last Update Posted : May 21, 2019
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Brief Summary:

This study has been designed to enable all subjects who received placebo in the HPV-039 study (NCT00779766), to also receive GSK Biologicals' Human Papillomavirus (Types 16, 18) Vaccine, Adsorbed. Safety data in terms of serious adverse events (SAEs), any adverse events (AEs)/SAEs leading to premature discontinuation of the study, potential immune mediated diseases (pIMDs) and pregnancies (and their outcomes) will be collected during the study period.

In addition, this study will assess the long term protective effect of the vaccine, in an exploratory manner, in terms of rates of HPV-related (vaccine type) incident cervical infection up to approximately 10 years after vaccination in subjects who participated in HPV-039 study (NCT00779766).


Condition or disease Intervention/treatment Phase
Cervical Intraepithelial Neoplasia Biological: Cervarix Phase 4

Detailed Description:
Treatment allocation depends on the randomization in the previous study i.e. only the subjects from the control group of HPV-039 study will receive HPV vaccination in the current study. Subjects who previously received the Human Papillomavirus (Types 16, 18) Vaccine, Adsorbed in HPV-039 study will not receive vaccination in this study.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 6051 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Safety and Protective Effect Study of GSK Biologicals' Human Papillomavirus (Types 16, 18) Vaccine, Adsorbed (GSK580299) in Healthy Female Subjects From the HPV-039 Study
Actual Study Start Date : August 22, 2018
Estimated Primary Completion Date : March 8, 2020
Estimated Study Completion Date : March 8, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Vaccinated-HPV-039 Group
Healthy Chinese female subjects, who previously received Cervarix vaccine in HPV-039 study (NCT00779766), will undergo cervical sample collection in the current study.
Experimental: Cervarix Group
Healthy Chinese female subjects, above 26 years of age at study entry, who previously received control vaccine in HPV-039 study (NCT00779766), will undergo cervical sample collection before vaccination and will receive Cervarix vaccine in the current study.
Biological: Cervarix
Three doses of Human Papillomavirus (Types 16, 18) Vaccine, Adsorbed (20 µg HPV-16, 20 µg HPV-18) administered intramuscularly in the deltoid region of the upper arm, according to a 0, 1, 6-month schedule.




Primary Outcome Measures :
  1. Number of subjects with serious adverse events (SAEs) related to the study vaccine [ Time Frame: Throughout the study (From Day 1 to Month 12) ]
    An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect in the offspring of a study subject.


Secondary Outcome Measures :
  1. Number of subjects with potentially Immune Mediated Diseases (pIMDs) [ Time Frame: Throughout the study (From Day 1 to Month 12) ]
    pIMDs are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.

  2. Number of subjects reporting pregnancies and outcomes of reported pregnancies [ Time Frame: Throughout the study (From Day 1 to Month 12) ]
    Pregnancies and pregnancy outcomes are recorded and reported in electronic reports. Any adverse pregnancy outcome or complication or elective termination of a pregnancy for medical reasons is recorded and reported as an AE or a SAE. Assessed pregnancy outcomes are: Live infant NO apparent congenital anomaly; Live infant congenital anomaly; Elective termination NO apparent congenital anomaly; Elective termination congenital anomaly; Ectopic pregnancy; Spontaneous abortion NO apparent congenital anomaly; Stillbirth NO apparent congenital anomaly; Stillbirth congenital anomaly; Lost to follow up; Pregnancy ongoing.

  3. Number of subjects with SAEs [ Time Frame: Throughout the study (From Day 1 to Month 12) ]
    An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect in the offspring of a study subject.

  4. Number of subjects with any adverse events (AEs)/SAEs leading to premature discontinuation from the study [ Time Frame: Throughout the study (From Day 1 to Month 12) ]

    An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.

    An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e. lack of efficacy), abuse or misuse.

    An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect in the offspring of a study subject.

    Any is defined as the occurrence of any unsolicited AE/SAE regardless of intensity grade or relation to vaccination.


  5. Number of subjects with SAEs related to study participation [ Time Frame: Throughout the study (From Day 1 to Month 12) ]
    An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect in the offspring of a study subject.

  6. Number of subjects with incident cervical infection associated with HPV-16 and/or HPV-18 [ Time Frame: At Day 1 [approximately up to 10 years after vaccination in HPV-039 study (NCT00779766)] ]
    Cervical infection caused by Human Papillomavirus (HPV) Types 16 and 18 is assessed by detecting HPV Deoxyribonucleic acid (DNA) using Polymerase Chain Reaction (PCR).

  7. Number of subjects with incident cervical infection associated with any oncogenic HPV type [ Time Frame: At Day 1 [approximately up to 10 years after vaccination in study HPV-039 (NCT00779766)] ]
    Cervical infection caused by HPV-16, -18, -31, -33, -35, -39, -45, -51, -52, -56, -58, -59, -66 and -68 or combination of oncogenic HPV types is assessed by detecting HPV DNA using PCR.



Information from the National Library of Medicine

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Ages Eligible for Study:   26 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
  • Written informed consent obtained from the subject prior to performing any study specific procedure.
  • Subjects previously enrolled in the HPV-039 study.
  • Subjects with negative pregnancy test at Visit 1.

Additional inclusion criteria for subjects of HPV group undergoing vaccination ONLY:

  • Healthy subjects as established by medical history and clinical examination before entering into the study.
  • Female subjects of non-childbearing potential may be enrolled in the study.

    • Non-childbearing potential is defined as pre-menarche, current bilateral tubal ligation or occlusion, hysterectomy, bilateral ovariectomy or post-menopause.
  • Female subjects of childbearing potential may be enrolled in the study, if the subject:

    • has practiced adequate contraception for 30 days prior to vaccination, and
    • has a negative pregnancy test on the day of vaccination, and
    • has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series.

Exclusion Criteria:

  • Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational vaccine/product (pharmaceutical product or device).
  • Previous vaccination against HPV outside of study HPV-039.

Additional exclusion criteria for subjects of HPV group undergoing vaccination ONLY:

  • Use of any investigational or non-registered product other than the study vaccine during the period starting 30 days before the first dose of study vaccine, or planned use during the study period.
  • Any medical condition that in the judgment of the investigator would make intramuscular injection unsafe.
  • Chronic administration of immunosuppressants or other immune-modifying drugs during the period starting six months prior to the first vaccine dose. For corticosteroids, this will mean prednisone. Inhaled and topical steroids are allowed.
  • Planned administration/administration of a vaccine/product not foreseen by the study protocol in the period starting 30 days before and after each dose of vaccine administration, with the exception of administration of routine vaccines e.g. meningococcal, hepatitis B, hepatitis A, inactivated influenza up to eight days before and after each dose of study vaccine. Enrolment will be deferred until the subject is outside of the specified window.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
  • History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine.
  • Previous administration of MPL or AS04 adjuvant.
  • Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
  • Cancer or autoimmune disease under treatment.
  • Hypersensitivity to latex.
  • Acute disease and/or fever at the time of enrolment.

    • Fever is defined as temperature ≥37.0°C. The preferred location for measuring temperature in this study will be the axilla.
    • Subjects with a minor illness without fever may be enrolled at the discretion of the investigator.
  • Pregnant or breastfeeding. Subjects must be at least three months post-pregnancy and not breastfeeding to enter the study.
  • Females planning to become pregnant or planning to discontinue contraceptive precautions during the vaccination phase of the study, i.e. up to two months after the last vaccine dose.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03629886


Locations
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China, Jiangsu
GSK Investigational Site
Jintan, Jiangsu, China, 213200
GSK Investigational Site
Lianshui, Jiangsu, China
GSK Investigational Site
Xuzhou, Jiangsu, China, 221006
GSK Investigational Site
Yancheng, Jiangsu, China, 224500
Sponsors and Collaborators
GlaxoSmithKline
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline

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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT03629886     History of Changes
Other Study ID Numbers: 205779
First Posted: August 14, 2018    Key Record Dates
Last Update Posted: May 21, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by GlaxoSmithKline:
Adults
Human Papillomavirus (HPV)
Cervical cancer
Safety

Additional relevant MeSH terms:
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Carcinoma in Situ
Cervical Intraepithelial Neoplasia
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Vaccines
Immunologic Factors
Physiological Effects of Drugs