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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00196924




Registration number
NCT00196924
Ethics application status
Date submitted
13/09/2005
Date registered
20/09/2005
Date last updated
23/03/2017

Titles & IDs
Public title
Human Papilloma Virus Vaccine Safety and Immunogenicity Trial in Young Adolescent Women With GSK Bio HPV-16/18.
Scientific title
Evaluate the Safety and Immunogenicity of GSK Biologicals' HPV-16/18 Vaccine Administered Intramuscularly According to a 0,1,6 Month Schedule in Healthy Female Subjects (10 - 14 Years)
Secondary ID [1] 0 0
580299/013
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Infections, Papillomavirus 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - HPV-16/18 L1/AS04

Other interventions: HPV-16/18 L1/AS04
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Demonstration of safety of the HPV vaccine compared to the control (occurrence of SAEs) up to month 7.
Timepoint [1] 0 0
Secondary outcome [1] 0 0
Safety of HPV vaccine in entire study period. Vaccine immunogenicity.
Timepoint [1] 0 0

Eligibility
Key inclusion criteria
A woman between, and including, 10 and 14 years of age at the time of the first
vaccination.

Written informed consent from the subject prior to enrolment. Subject must be free of
obvious health problems. Subject must have negative urine pregnancy test.
Minimum age
10 Years
Maximum age
14 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Pregnant or breastfeeding. Known acute or chronic, clinically significant pulmonary,
cardiovascular, neurologic, hepatic or renal functional abnormality.

History of chronic condition(s) requiring treatment such as cancer, chronic hepatitis or
kidney disease(s), diabetes, or autoimmune disease.

Previous vaccination against human papillomavirus (HPV).

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/2004
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2006
Sample size
Target
Accrual to date
Final
2067
Recruitment in Australia
Recruitment state(s)
SA,WA
Recruitment hospital [1] 0 0
GSK Investigational Site - North Adelaide
Recruitment hospital [2] 0 0
GSK Investigational Site - Perth
Recruitment postcode(s) [1] 0 0
5006 - North Adelaide
Recruitment postcode(s) [2] 0 0
- Perth
Recruitment outside Australia
Country [1] 0 0
Colombia
State/province [1] 0 0
Bogota
Country [2] 0 0
Czech Republic
State/province [2] 0 0
Hradec kralove
Country [3] 0 0
Czech Republic
State/province [3] 0 0
Pardubice
Country [4] 0 0
France
State/province [4] 0 0
Aubevoye
Country [5] 0 0
France
State/province [5] 0 0
Broglie
Country [6] 0 0
France
State/province [6] 0 0
Evreux
Country [7] 0 0
France
State/province [7] 0 0
Luynes
Country [8] 0 0
France
State/province [8] 0 0
Nantes
Country [9] 0 0
France
State/province [9] 0 0
Nogent le Roi
Country [10] 0 0
France
State/province [10] 0 0
Paris
Country [11] 0 0
France
State/province [11] 0 0
Pont De L Arche
Country [12] 0 0
France
State/province [12] 0 0
Saint Sebastien de Morsent
Country [13] 0 0
France
State/province [13] 0 0
Tours
Country [14] 0 0
France
State/province [14] 0 0
Verneuil sur Avre
Country [15] 0 0
Germany
State/province [15] 0 0
Baden-Wuerttemberg
Country [16] 0 0
Germany
State/province [16] 0 0
Bayern
Country [17] 0 0
Germany
State/province [17] 0 0
Mecklenburg-Vorpommern
Country [18] 0 0
Germany
State/province [18] 0 0
Niedersachsen
Country [19] 0 0
Germany
State/province [19] 0 0
Nordrhein-Westfalen
Country [20] 0 0
Germany
State/province [20] 0 0
Rheinland-Pfalz
Country [21] 0 0
Germany
State/province [21] 0 0
Schleswig-Holstein
Country [22] 0 0
Germany
State/province [22] 0 0
Thueringen
Country [23] 0 0
Germany
State/province [23] 0 0
Berlin
Country [24] 0 0
Germany
State/province [24] 0 0
Hamburg
Country [25] 0 0
Honduras
State/province [25] 0 0
Comayaguela
Country [26] 0 0
Korea, Republic of
State/province [26] 0 0
Seoul
Country [27] 0 0
Norway
State/province [27] 0 0
Bergen
Country [28] 0 0
Norway
State/province [28] 0 0
Oslo
Country [29] 0 0
Panama
State/province [29] 0 0
Ciudad de Panama - La Chorrera
Country [30] 0 0
Spain
State/province [30] 0 0
Alcora/Castellón
Country [31] 0 0
Spain
State/province [31] 0 0
Alquerías del Niño Perdido (Castellón)
Country [32] 0 0
Spain
State/province [32] 0 0
Barcelona
Country [33] 0 0
Spain
State/province [33] 0 0
Castellon
Country [34] 0 0
Spain
State/province [34] 0 0
Madrid
Country [35] 0 0
Spain
State/province [35] 0 0
Valencia
Country [36] 0 0
Sweden
State/province [36] 0 0
Eskilstuna
Country [37] 0 0
Sweden
State/province [37] 0 0
Linköping
Country [38] 0 0
Sweden
State/province [38] 0 0
Örebro
Country [39] 0 0
Taiwan
State/province [39] 0 0
Taipei
Country [40] 0 0
Taiwan
State/province [40] 0 0
Tao Yuan County

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
GlaxoSmithKline
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Human Papilloma virus (HPV) are viruses that cause a common infection of the skin and
genitals in men and women. Several types of HPV infection are transmitted by sexual activity
and, in women, can infect the cervix (part of the uterus or womb). This infection often goes
away by itself, but if it does not go away (this is called persistent infection), it can lead
in women over a long period of time to cancer of the cervix. If a woman is not infected by
HPV, it is very unlikely that she will get cervical cancer. This study will evaluate the
safety and immunogenicity of GSK Biologicals HPV-16/18 vaccine over 12 months, in pre-teen
and adolescent women of 10-14 years of age at study start. Approximately 2000 study subjects
will receive the HPV vaccine or a control vaccine (hepatitis A vaccine) administered
intramuscularly according to a 0-1-6 month schedule.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00196924
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
GSK Clinical Trials
Address 0 0
GlaxoSmithKline
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries