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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/NCT00947115




Registration number
NCT00947115
Ethics application status
Date submitted
16/07/2009
Date registered
27/07/2009
Date last updated
30/10/2020

Titles & IDs
Public title
Evaluation of Long-term Immunogenicity and Safety of a Human Papillomavirus (HPV) Vaccine in Healthy Female Subjects
Scientific title
Follow-up Study to Evaluate the Long-term Immunogenicity and Safety of GlaxoSmithKline Biologicals' HPV (580299) Vaccine in Healthy Female Subjects
Secondary ID [1] 0 0
2009-011357-41
Secondary ID [2] 0 0
112772
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
Treatment: Surgery - Blood sampling
Treatment: Surgery - Cervico-vaginal secretion (CVS) samples

Experimental: Cervarix 15-25 years group - Women, aged 15 to 25 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study HPV-014 (NCT00196937).

Experimental: Cervarix 26-45 years group - Women, aged 26 to 45 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study HPV-014 (NCT00196937).

Experimental: Cervarix 46-55 years group - Women, aged 46 to 55 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study HPV-014 (NCT00196937).


Treatment: Surgery: Blood sampling
Blood samples were collected at Years 5, 6, 7, 8, 9 and 10.

Treatment: Surgery: Cervico-vaginal secretion (CVS) samples
CVS samples were collected at Years 5, 6, 7, 8, 9 and 10 in subjects who volunteered for this procedure.
Intervention code [1] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Anti-Human Papillomavirus (Anti-HPV)-16/18 Antibody Titers in Serum at Years 5, 6 and 7
Timepoint [1] 0 0
At Years 5, 6 and 7
Primary outcome [2] 0 0
Anti-HPV-16/18 Antibody Titers in Serum at Years 8, 9 and 10
Timepoint [2] 0 0
At Years 8, 9 and 10
Primary outcome [3] 0 0
Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 Antibodies at Years 5, 6 and 7
Timepoint [3] 0 0
At Years 5, 6 and 7
Primary outcome [4] 0 0
Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 Antibodies at Years 8, 9 and 10
Timepoint [4] 0 0
At Years 8, 9 and 10
Secondary outcome [1] 0 0
Anti-HPV-16/18 Secretion Antibody Titers in Cervico-vaginal Secretion (CVS) Samples at Years 5 and 6 in a Subset of Subjects
Timepoint [1] 0 0
At Year 5 and Year 6
Secondary outcome [2] 0 0
Anti-HPV-16/18 Secretion Antibody Titers in CVS Samples at Years 7, 8, 9 and 10 in a Subset of Subjects
Timepoint [2] 0 0
At Years 7, 8, 9 and 10
Secondary outcome [3] 0 0
Total Immunoglobulin G (IgG) Secretion Antibody Titers in CVS Samples at Years 5 and 6 in a Subset of Subjects
Timepoint [3] 0 0
At Year 5 and Year 6
Secondary outcome [4] 0 0
Total IgG Secretion Antibody Titers in CVS Samples at Years 7, 8, 9, and 10 in a Subset of Subjects
Timepoint [4] 0 0
At Years 7, 8, 9 and 10
Secondary outcome [5] 0 0
Total IgG Antibody Titers in Serum at Years 5, 6 and 7 Based on the ATP Cohort for Immunogenicity
Timepoint [5] 0 0
At Years 5, 6 and 7
Secondary outcome [6] 0 0
Total IgG Antibody Titers in Serum at Years 8, 9 and 10 Based on the ATP Cohort for Immunogenicity
Timepoint [6] 0 0
At Years 8, 9 and 10
Secondary outcome [7] 0 0
Total IgG Antibody Titers in Serum at Years 5, 6 and 7 Based on the TVC
Timepoint [7] 0 0
At Years 5, 6 and 7
Secondary outcome [8] 0 0
Total IgG Antibody Titers in Serum at Years 8, 9 and 10 Based on the TVC
Timepoint [8] 0 0
At Years 8, 9 and 10
Secondary outcome [9] 0 0
Number of Subjects With Any Fatal or Vaccine-related SAEs (Including SAEs Related to Study Procedures and GlaxoSmithKline Biologicals' Concomitant Medication) From Year 4 in Primary Study HPV-014 (NCT00196937) to Year 5 in the Present Study
Timepoint [9] 0 0
From Year 4 in primary study HPV-014 (NCT00196937) up to Year 5 in present HPV-060 study
Secondary outcome [10] 0 0
Number of Subjects With Any Fatal or Vaccine-related SAEs (Including SAEs Related to Study Procedures and GlaxoSmithKline Biologicals' Concomitant Medication) From Year 5 to Year 6
Timepoint [10] 0 0
From Year 5 up to Year 6
Secondary outcome [11] 0 0
Number of Subjects With Any Fatal or Vaccine-related SAEs (Including SAEs Related to Study Procedures and GlaxoSmithKline Biologicals' Concomitant Medication) From Year 6 to Year 7
Timepoint [11] 0 0
From Year 6 up to Year 7
Secondary outcome [12] 0 0
Number of Subjects With Any Fatal or Vaccine-related SAEs (Including SAEs Related to Study Procedures and GlaxoSmithKline Biologicals' Concomitant Medication) From Year 7 to Year 8
Timepoint [12] 0 0
From Year 7 up to Year 8
Secondary outcome [13] 0 0
Number of Subjects With Any Fatal or Vaccine-related SAEs (Including SAEs Related to Study Procedures and GlaxoSmithKline Biologicals' Concomitant Medication) From Year 8 to Year 9
Timepoint [13] 0 0
From Year 8 up to Year 9
Secondary outcome [14] 0 0
Number of Subjects With Any Fatal or Vaccine-related SAEs (Including SAEs Related to Study Procedures and GlaxoSmithKline Biologicals' Concomitant Medication) From Year 9 to Year 10
Timepoint [14] 0 0
From Year 9 up to Year 10
Secondary outcome [15] 0 0
Number of Subjects With Any Fatal or Vaccine-related SAEs (Including SAEs Related to Study Procedures and GlaxoSmithKline Biologicals' Concomitant Medication) From Year 0 to Year 10
Timepoint [15] 0 0
From Year 0 up to Year 10

Eligibility
Key inclusion criteria
- Subjects who the investigator believed that they could and would comply with the
requirements of the protocol.

- A female who had been enrolled in NCT00196937 study and received three doses of
HPV-16/18 vaccine.

- Written informed consent obtained from the subject.
Minimum age
20 Years
Maximum age
60 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Use of any investigational or non-registered product (drug or vaccine) or planned use
during the study period.

- Chronic administration (defined as more than 14 consecutive days) of
immunosuppressants or other immune-modifying drugs occurring less than three months
prior to blood sampling.

- 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).

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

- Administration or planned administration of any HPV vaccine, other than the three
doses of HPV-16/18 vaccine administered in NCT00196937 study.

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
22/09/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
3/02/2015
Sample size
Target
Accrual to date
Final
525
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Germany
State/province [1] 0 0
Bayern
Country [2] 0 0
Germany
State/province [2] 0 0
Berlin
Country [3] 0 0
Poland
State/province [3] 0 0
Bydgoszcz
Country [4] 0 0
Poland
State/province [4] 0 0
Poznan

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

Ethics approval
Ethics application status

Summary
Brief summary
Infection with human papillomavirus (HPV) has been clearly established as the necessary cause
of cervical cancer. This study is designed to evaluate the long-term immunogenicity and
safety of the GSK Biologicals' 580299 HPV vaccine up to 10 years after administration of the
first dose of HPV vaccine (Month 0) in primary study NCT00196937. This protocol posting deals
with objectives & outcome measures of the extension phase from Year 5 to Year 10. The
objectives & outcome measures of the primary phase and extension phase up to year 4 are
presented in a separate protocol posting (NCT00196937).
Trial website
https://clinicaltrials.gov/ct2/show/NCT00947115
Trial related presentations / publications
Schwarz T, Spaczynski M, Kaufmann A, Wysocki J, Galaj A, Schulze K, Suryakiran P, Thomas F, Descamps D. Persistence of immune responses to the HPV-16/18 AS04-adjuvanted vaccine in women aged 15-55 years and first-time modelling of antibody responses in mature women: results from an open-label 6-year follow-up study. BJOG. 2015 Jan;122(1):107-18. doi: 10.1111/1471-0528.13070. Epub 2014 Sep 11.
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