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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/NCT00316706




Registration number
NCT00316706
Ethics application status
Date submitted
19/04/2006
Date registered
21/04/2006
Date last updated
18/09/2012

Titles & IDs
Public title
Human Papilloma Virus (HPV) Vaccine Trial in Young Adolescent Women With GlaxoSmithKline Biologicals' (GSK Bio) HPV-16/18 Vaccine
Scientific title
A Long-term, Open Follow-up of the Immunogenicity and Safety of GSK Biologicals' HPV Vaccine (580299) in Healthy Female Subjects Vaccinated in Study HPV-013
Secondary ID [1] 0 0
104902
Secondary ID [2] 0 0
104896 (month 18 FU)
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cervical Intraepithelial Neoplasia 0 0
Papillomavirus Infection 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - GSK Biologicals' HPV-16/18 Vaccine (Cervarix™)
Other interventions - Havrix™

Experimental: Cervarix Group - Subjects received 3 doses of GSK Biologicals' HPV-16/18 Vaccine (Cervarix™) during the primary study (NCT00196924). Subjects from this group continued the long-term follow-up study until Month 48.

Active Comparator: Havrix Group - Subjects received 3 doses of Havrix™ (hepatitis A vaccine [HAV]) during the primary study (NCT00196924). Subjects from the this group completed the study at Month 24.


Other interventions: GSK Biologicals' HPV-16/18 Vaccine (Cervarix™)
Three doses of vaccine administrerd intramuscularly according to 0, 1, 6 month schedule

Other interventions: Havrix™
Three doses of vaccine administrerd intramuscularly according to 0, 1, 6 month schedule.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies
Timepoint [1] 0 0
At 18, 24, 36 and 48 months
Secondary outcome [1] 0 0
Titers of Anti-3-O-desacyl-4'-Monophosphoryl Lipid A (Anti-MPL) Antibodies During the Initial 2 Years Follow-up
Timepoint [1] 0 0
At Months 18 and 24
Secondary outcome [2] 0 0
Titers of Anti-3-O-desacyl 4'-Monophosphoryl Lipid A (Anti-MPL) Antibodies During the Last 2 Years Follow-up
Timepoint [2] 0 0
At Month 36 and 48
Secondary outcome [3] 0 0
Number of Subjects Reporting Pregnancies, Serious Adverse Events (SAEs), New Onset Chronic Diseases (NOCDs), and Conditions Prompting Emergency Room (ER) Visits or Physician Visits That Are Not Related to Common Diseases During the First 2 Years Follow-up
Timepoint [3] 0 0
From Month 18 to Month 24
Secondary outcome [4] 0 0
Number of Subjects Reporting Pregnancies, Serious Adverse Events (SAEs), New Onset Chronic Diseases (NOCDs), and Conditions Prompting Emergency Room During the Last 2 Years Follow-up
Timepoint [4] 0 0
From Month 24 to Month 48

Eligibility
Key inclusion criteria
- A female who enrolled in the immunological subset of the 580299-013 study, received
the three doses of vaccine/control according to the treatment allocation and completed
the 580299-013 study.

- Written informed assent obtained from the subject and written informed consent
obtained from a parent or legally acceptable representative of the subject.
Minimum age
10 Years
Maximum age
14 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Concurrently participating in another clinical study, at any time during the study
period, in which the subject has been or will be exposed to an investigational or a
non-investigational product (pharmaceutical product or device).

- Use of any investigational or non-registered product (drug or vaccine) or planned use
during the study period.

- Chronic administration of immunosuppressants or other immune-modifying drugs occurring
less than 3 months prior to blood sampling.

- Administration of immunoglobulins and/or any blood products within the 3 months
preceding blood sampling.

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised 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
Open (masking not used)
Who is / are masked / blinded?



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
1/10/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/01/2009
Sample size
Target
Accrual to date
Final
1245
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Colombia
State/province [1] 0 0
Bogota
Country [2] 0 0
Germany
State/province [2] 0 0
Baden-Wuerttemberg
Country [3] 0 0
Germany
State/province [3] 0 0
Bayern
Country [4] 0 0
Germany
State/province [4] 0 0
Mecklenburg-Vorpommern
Country [5] 0 0
Germany
State/province [5] 0 0
Niedersachsen
Country [6] 0 0
Germany
State/province [6] 0 0
Nordrhein-Westfalen
Country [7] 0 0
Germany
State/province [7] 0 0
Rheinland-Pfalz
Country [8] 0 0
Germany
State/province [8] 0 0
Schleswig-Holstein
Country [9] 0 0
Germany
State/province [9] 0 0
Thueringen
Country [10] 0 0
Germany
State/province [10] 0 0
Berlin
Country [11] 0 0
Germany
State/province [11] 0 0
Hamburg
Country [12] 0 0
Honduras
State/province [12] 0 0
Comayaguela
Country [13] 0 0
Panama
State/province [13] 0 0
Panamá
Country [14] 0 0
Taiwan
State/province [14] 0 0
Taipei
Country [15] 0 0
Taiwan
State/province [15] 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
This protocol posting deals with objectives & outcome measures of the extension phase up to
Month 48. The objective of the extension study is to evaluate the long-term immunogenicity of
the HPV 16/18 L1 VLP AS04 vaccine (for all subjects in the HPV Vaccine Group) by
enzyme-linked immunosorbent assay (ELISA). The objectives & outcome measures of the primary
phase are presented in a separate protocol posting (NCT00196924).

The long-term follow-up study will be blinded until the primary study is unblinded and will
be open for all visits subsequent to unblinding of primary study HPV-013 (NCT00196924).
During the open phase, only subjects who received the HPV-16/18 VLP/AS04 vaccine during the
primary study will continue their participation in the follow-up study until Month 48.
Subjects in the Control group (Havrix®) will attend one further visit as their last study
visit.

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep
2007.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00316706
Trial related presentations / publications
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

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