Human Papillomavirus (HPV) VaccineHPV-022 PRINCT00572000
Safety Study of GlaxoSmithKline (GSK) Biologicals' Human Papillomavirus (HPV) Vaccine in Healthy Vietnamese Women According to a 0, 1, 6 Month Schedule
A study testing HPV-16/18 L1 VLP AS04 vaccine in people with Human Papillomavirus (HPV) Vaccine, run by National Institute for Control of Vaccine and Biologicals at 1 site in Vietnam.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 25 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Human Papillomavirus (HPV) Vaccine
- What is being tested?
- HPV-16/18 L1 VLP AS04 vaccine
- Type of treatment
- Vaccines, Injection or infusion
- How many people
- 222 participants
- Where
- 1 siteVietnam
- Study dates
- Nov 2007to Jun 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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).
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
Vietnam1 site, 1 recruiting
- Recruiting
Thi Son commune health center and Ngoc Son Commune Health Center
Hà Nam, 084
son hoa hoang, medicine doctor, 84(4)5595167, hoanghoason2005@yahoo.com.vn
About this study
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.
- Conditions
- Human Papillomavirus (HPV) Vaccine
- Being tested
- HPV-16/18 L1 VLP AS04 vaccine
- Medical subject headings
- Papillomavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HPV-16/18 L1 VLP AS04 vaccineBiological
Representation: 0.5ml monodose vials Administration: intramuscular Schedule: 0, 1, 6 month
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the occurrence of serious adverse events (SAEs) throughout the study
Measured: 7 months
Secondary outcomes (1)
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.
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2007 (estimated)
- Study startNov 2007
- Study completionJun 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Papillomavirus (HPV) VaccineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 222 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institute for Control of Vaccine and Biologicals
- Sponsor type
- Other government
- Investigators
- Son Hoa Hoang, Medicine Doctor, Principal investigator, National Institute for Control of Vaccine and Biologicals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00572000
- Sponsor's protocol ID
- 111040 (HPV-022 PRI)
- Acronym
- HPV-022 PRI
- Status last verified
- Oct 2007
- First submitted
- 11 Dec 2007
- Last updated
- 12 Dec 2007
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety Study of GlaxoSmithKline (GSK) Biologicals' Human Papillomavirus (HPV) Vaccine in Healthy Vietnamese Women According to a 0, 1, 6 Month Schedule
- ClinicalTrials.gov ID
- NCT00572000
- Acronym / sponsor ID
- HPV-022 PRI / 111040 (HPV-022 PRI)
- Conditions
- Human Papillomavirus (HPV) Vaccine
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 222 participants (estimated)
- Lead sponsor
- National Institute for Control of Vaccine and BiologicalsOther government
- Study start
- Nov 2007
- Study completion
- Jun 2008 (estimated)
- First posted
- 12 Dec 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 25 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- 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.
- married
- of Vietnamese origin, residing in Vietnam, and
- between, and including, 25 to 40 years of age at the time of the first vaccination.
- must not be pregnant
Key exclusion criteria (14 listed)
- 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.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HPV-16/18 L1 VLP AS04 vaccineRepresentation: 0.5ml monodose vials Administration: intramuscular Schedule: 0, 1, 6 month | Biological | – |
Primary outcome
To assess the occurrence of serious adverse events (SAEs) throughout the study
Time frame: 7 months
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Son Hoa Hoang, Medicine Doctor principal investigator
National Institute for Control of Vaccine and Biologicals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HPV-16/18 L1 VLP AS04 vaccine in people with Human Papillomavirus (HPV) Vaccine, run by National Institute for Control of Vaccine and Biologicals at 1 site in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Dec 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Son Hoa Hoang, Medicine Doctor (84(4)5595167, hoanghoason2005@yahoo.com.vn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the occurrence of serious adverse events (SAEs) throughout the study (time frame: 7 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2007.