Trials Sponsors Conditions Drugs Pricing

Conditions

Human Papillomavirus (HPV) Vaccine

Outcome Measures

Primary Outcomes (1)

To assess the occurrence of serious adverse events (SAEs) throughout the study
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.
7 months

Interventions

HPV-16/18 L1 VLP AS04 vaccineBiological

Representation: 0.5ml monodose vials Administration: intramuscular Schedule: 0, 1, 6 month

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Eligibility Criteria

Age25 Years - 40 Years

Sexfemale

Healthy VolunteersYes

Age GroupsAdult (18-64)

You may qualify if:

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:

Sponsors & Collaborators

National Institute for Control of Vaccine and Biologicals
Governmentlead

Study Sites (1)

Thi Son commune health center and Ngoc Son Commune Health Center

Hà Nam, 084, Vietnam

RECRUITING

son hoa hoang, medicine doctorCONTACT84(4)5595167 hoanghoason2005@yahoo.com.vn

MeSH Terms

Conditions

Papillomavirus Infections

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, ViralSexually Transmitted DiseasesCommunicable DiseasesInfectionsDNA Virus InfectionsVirus DiseasesTumor Virus InfectionsGenital DiseasesUrogenital DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

Son Hoa Hoang, Medicine Doctor
National Institute for Control of Vaccine and Biologicals
PRINCIPAL INVESTIGATOR

Central Study Contacts

Son Hoa Hoang, Medicine Doctor

CONTACT

84(4)5595167 hoanghoason2005@yahoo.com.vn

Study Design

Study Type: interventional
Phase: not applicable
Allocation: NON RANDOMIZED
Masking: NONE
Purpose: PREVENTION
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER GOV

Study Record Dates

First Submitted

December 11, 2007

First Posted

December 12, 2007

Study Start

November 2007

Date type not reported

This date has not been verified as actual or estimated.

Study Completion

June 2008

Estimated (date passed)

You may not qualify if:

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.
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.

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations