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Safety Study of GlaxoSmithKline (GSK) Biologicals' Human Papillomavirus (HPV) Vaccine in Healthy Vietnamese Women According to a 0, 1, 6 Month Schedule (HPV-022 PRI)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2007 by National Institute for Control of Vaccine and Biologicals.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Institute for Control of Vaccine and Biologicals
ClinicalTrials.gov Identifier:
NCT00572000
First received: December 11, 2007
Last updated: NA
Last verified: October 2007
History: No changes posted
  Purpose

The purpose of this study is to assess the occurrence of serious adverse events (SAEs) as well as evaluate the occurrence of solicited local and solicited general symptoms and the occurrence of medically significant conditions reported throughout the study period.


Condition Intervention
Human Papillomavirus (HPV) Vaccine
Biological: HPV-16/18 L1 VLP AS04 vaccine

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Safety Study of GlaxoSmithKline (GSK) Biologicals' Human Papillomavirus (HPV) Vaccine in Healthy Vietnamese Women According to a 0, 1, 6 Month Schedule

Resource links provided by NLM:


Further study details as provided by National Institute for Control of Vaccine and Biologicals:

Primary Outcome Measures:
  • To assess the occurrence of serious adverse events (SAEs) throughout the study [ Time Frame: 7 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To evaluate the occurrence of solicited local and solicited general symptoms and the occurrence of unsolicited symptoms as well as the occurrence of medically significant conditions. [ Time Frame: 7 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 222
Study Start Date: November 2007
Estimated Study Completion Date: June 2008
Intervention Details:
    Biological: HPV-16/18 L1 VLP AS04 vaccine
    Representation: 0.5ml monodose vials Administration: intramuscular Schedule: 0, 1, 6 month
  Eligibility

Ages Eligible for Study:   25 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects who the investigator believes that they can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for vaccination visits and for the follow-up visit) should be enrolled in the study.

    • The female subject should be:

      • married
      • of Vietnamese origin, residing in Vietnam, and
      • between, and including, 25 to 40 years of age at the time of the first vaccination.
    • Written informed consent obtained from the subject (prior to enrolment).
    • Healthy subjects as established by medical history and clinical examination before entering into the study.
    • Subjects must have a negative urine pregnancy test.
    • Subjects of childbearing potential (i.e. active menstrual cycle) at the time of study entry:

      • must not be pregnant
      • and must be abstinent (and if so, this must be documented in the source documents at each vaccination visit)
      • or must be using adequate contraceptive precautions (i.e. intrauterine contraceptive device, oral contraceptives, diaphragm or condom in combination with contraceptive jelly, cream or foam, progestogen-only implantable cutaneous hormonal patch or injectable contraceptives) for 30 days prior to vaccination and must agree to continue such precautions for one month after completion of the vaccination series.

Exclusion Criteria:

  • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period and up to one month after the last vaccine dose.

    • Subjects who have delivered recently or breastfeeding women must have completed a period of at least 3 months post-pregnancy and should not be breast-feeding in order to be enrolled in the study.

Planning to become pregnant or likely to become pregnant (as determined by the investigator) or planning to discontinue contraceptive precautions during the study period.

  • Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs on 14 consecutive days within six months prior to the first vaccine dose and up to one month after the last dose of the vaccine. (For corticosteroids, this will mean prednisone, or equivalent, ≥ 0.5 mg/kg/day. Inhaled and topical steroids are allowed).
  • Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days before (Days - 1 to - 30) and 30 days (i.e. Days 0 - 29) after the first dose of vaccine. However, the administration of tetanus toxoid vaccine up to 8 days before the first dose of study vaccine is allowed. Enrolment will be deferred until the subject is outside of specified window.
  • Previous vaccination against HPV or planned administration of any HPV vaccine other than that foreseen by the study protocol during the study period.
  • Any medically diagnosed or suspected immunodeficient condition such as human immunodeficiency virus (HIV) infection based on medical history and physical examination (no laboratory testing required).
  • History of allergic disease, suspected allergy or reactions likely to be exacerbated by any component of the study vaccines, e.g. AS04, aluminium, MPL.
  • Hypersensitivity to latex (found in syringe-tip cap and plunger).
  • Known acute or chronic, clinically significant system conditions, e.g. neurologic,pulmonary, cardiovascular, hepatic, renal functional abnormality or psychiatric disorders, as determined by medical history, physical examination or previous laboratory tests.
  • History of chronic condition(s) requiring treatment such as cancer, chronic hepatic or kidney disease(s), diabetes, or autoimmune disease. This exclusion criterion should be understood as exclusion of subjects having significant medical conditions (such as cancer, autoimmune diseases) currently under treatment.
  • Acute disease at the time of enrolment. Acute disease is defined as the presence of a moderate or severe illness with or without fever. Enrolment will be deferred until condition is resolved. All vaccines can be administered to persons with a minor illness such as diarrhoea, mild upper respiratory infection with or without low-grade febrile illness, i.e. oral/ axillary temperature < 37.5 °C (99.5 °F).
  • A subject with body temperature (i.e. fever) > 37.5 °C (99.5 °F).
  • Drug and/or alcohol abuse.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00572000

Contacts
Contact: Son Hoa Hoang, Medicine Doctor 84(4)5595167 hoanghoason2005@yahoo.com.vn

Locations
Vietnam
Thi Son commune health center and Ngoc Son Commune Health Center Recruiting
Ha nam, Vietnam, 084
Contact: son hoa hoang, medicine doctor    84(4)5595167    hoanghoason2005@yahoo.com.vn   
Sponsors and Collaborators
National Institute for Control of Vaccine and Biologicals
Investigators
Principal Investigator: Son Hoa Hoang, Medicine Doctor National Institute for Control of Vaccine and Biologicals
Principal Investigator: son hoa hoang, Medicine Doctor National Institute for Control of Vaccine and Biologicals
  More Information

No publications provided

Responsible Party: National Institute for Control of Vaccine and Biologicals
ClinicalTrials.gov Identifier: NCT00572000     History of Changes
Other Study ID Numbers: 111040 (HPV-022 PRI)
Study First Received: December 11, 2007
Last Updated: December 11, 2007
Health Authority: Vietnam: Ministry of Health
United States: Federal Government

ClinicalTrials.gov processed this record on November 19, 2014