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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00572000
• Date of registration: 11/12/2007
• Primary sponsor: National Institute for Control of Vaccine and Biologicals
• Public title: 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
• Scientific title: Safety Study of GlaxoSmithKline (GSK) Biologicals' Human Papillomavirus (HPV) Vaccine in Healthy Vietnamese Women According to a 0, 1, 6 Month Schedule
• Date of first enrolment: November 2007
• Target sample size: 222
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT00572000
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Countries of recruitment

Vietnam

Contacts

• Name: son hoa hoang, medicine doctor

• Name: Son Hoa Hoang, Medicine Doctor

• Name: Son Hoa Hoang, Medicine Doctor
• Affiliation: National Institute for Control of Vaccine and Biologicals

Key inclusion & exclusion 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.



Age minimum: 25 Years
Age maximum: 40 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Human Papillomavirus (HPV) Vaccine

Intervention(s)

Biological: HPV-16/18 L1 VLP AS04 vaccine

Primary Outcome(s)

To assess the occurrence of serious adverse events (SAEs) throughout the study [Time Frame: 7 months]

Secondary Outcome(s)

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]

Secondary ID(s)

111040 (HPV-022 PRI)

Source(s) of Monetary Support

Please refer to primary and secondary sponsors