Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
Assessment method [1] 0 0
Anti-HPV-16/18 antibody titers are presented as Geometric Mean Titers (GMTs) and expressed in enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL). The immune response of the HPV-16/18 vaccine (as determined by anti-HPV-16/18 antibodies assessed by ELISA) in the HPV-060 study population was compared with the immune response obtained in study HPV-001 and its long-term follow-up studies HPV-007/HPV-023 at equivalent timepoints and with the immune response obtained after natural infection in subjects from study HPV-008. The immune response data for the efficacy studies HPV-001/HPV-007/HPV-023 can be found under the NCT record NCT00518336. The immune response data for the HPV-008 study can be found under the NCT record NCT00122681.
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
Assessment method [2] 0 0
Anti-HPV-16/18 antibody titers are presented as Geometric Mean Titers (GMTs) and expressed in EL.U/mL. The immune response of the HPV-16/18 vaccine (as determined by anti-HPV-16/18 antibodies assessed by ELISA) in the HPV-060 study population was compared with the immune response obtained in study HPV-001 and its long-term follow-up studies HPV-007/HPV-023 at equivalent timepoints and with the immune response obtained after natural infection in subjects from study HPV-008. The immune response data for the efficacy studies HPV-001/HPV-007/HPV-023 can be found under the NCT number NCT00518336. The immune response data for the HPV-008 study can be found under the NCT number NCT00122681.
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
Assessment method [3] 0 0
Seroconversion was defined as the appearance of anti-HPV-16 and anti- HPV-18 antibodies \[i.e. antibody titer greater than or equal to (=) the cut-off value\] in the serum of subjects seronegative before vaccination in the primary study HPV-014 (NCT00196937). Cut-off values were 8 EL.U/mL for anti-HPV-16 antibody titers and 7 EL.U/mL for anti-HPV-18 antibody titers.
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
Assessment method [4] 0 0
Seroconversion was defined as the appearance of anti-HPV-16 and anti-HPV-18 antibodies (i.e. antibody titer = the cut-off value) in the serum of subjects seronegative before vaccination in the primary study HPV-014 (NCT00196937). Cut-off values were 19 EL.U/mL for anti-HPV-16 antibody titers and 18 EL.U/mL for anti-HPV-18 antibody titers.
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
Assessment method [1] 0 0
Anti-HPV-16/18 titers in CVS samples are presented as GMTs and expressed in EL.U/mL.
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
Assessment method [2] 0 0
Anti-HPV-16/18 titers in CVS samples are presented as GMTs and expressed in EL.U/mL.
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
Assessment method [3] 0 0
IgG antibody titers in CVS samples are presented as GMTs and expressed in microgram per milliliter (µg/mL).
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
Assessment method [4] 0 0
Total IgG antibody titers in CVS samples are presented as GMTs and expressed in microgram per milliliter (µg/mL).
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
Assessment method [5] 0 0
Total IgG antibody titers are presented as GMTs and expressed in µg/mL.
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
Assessment method [6] 0 0
Total IgG antibody titers are presented as GMTs and expressed in µg/mL.
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
Assessment method [7] 0 0
Total IgG antibody titers are presented as GMTs and expressed in µg/mL.
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
Assessment method [8] 0 0
Total IgG antibody titers are presented as GMTs and expressed in µg/mL.
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
Assessment method [9] 0 0
SAEs assessed include medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or were a congenital anomaly/birth defect in the offspring of a study subject, or may have evolved into one of the outcomes listed above. Related SAE = SAE assessed by the investigator as causally related to the study vaccine administered in study HPV-014 (NCT00196937).
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
Assessment method [10] 0 0
SAEs assessed include medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or were a congenital anomaly/birth defect in the offspring of a study subject, or may have evolved into one of the outcomes listed above. Related SAE = SAE assessed by the investigator as causally related to the study vaccine administered in study HPV-014 (NCT00196937).
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
Assessment method [11] 0 0
SAEs assessed include medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or were a congenital anomaly/birth defect in the offspring of a study subject, or may have evolved into one of the outcomes listed above. Related SAE = SAE assessed by the investigator as causally related to the study vaccine administered in study HPV-014 (NCT00196937).
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
Assessment method [12] 0 0
SAEs assessed include medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or were a congenital anomaly/birth defect in the offspring of a study subject, or may have evolved into one of the outcomes listed above. Related SAE = SAE assessed by the investigator as causally related to the study vaccine administered in study HPV-014 (NCT00196937).
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
Assessment method [13] 0 0
SAEs assessed include medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or were a congenital anomaly/birth defect in the offspring of a study subject, or may have evolved into one of the outcomes listed above. Related SAE = SAE assessed by the investigator as causally related to the study vaccine administered in study HPV-014 (NCT00196937).
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
Assessment method [14] 0 0
SAEs assessed include medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or were a congenital anomaly/birth defect in the offspring of a study subject, or may have evolved into one of the outcomes listed above. Related SAE = SAE assessed by the investigator as causally related to the study vaccine administered in study HPV-014 (NCT00196937).
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
Assessment method [15] 0 0
SAEs assessed include medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or were a congenital anomaly/birth defect in the offspring of a study subject. Related SAE = SAE assessed by the investigator as causally related to the study vaccine administered in study HPV-014 (NCT00196937).
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
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT00947115