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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00937950




Registration number
NCT00937950
Ethics application status
Date submitted
2/07/2009
Date registered
13/07/2009
Date last updated
29/10/2019

Titles & IDs
Public title
Gynaecological Follow-up of a Subset of 580299/008 (NCT00122681) Study Subjects
Scientific title
Gynaecological Follow-up of a Subset of 580299/008 Study Subjects
Secondary ID [1] 0 0
2008-008124-33
Secondary ID [2] 0 0
112024
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 - Gynaecological follow-up

Other: HPV-052 study subjects Group - The study group consisted of a subset of HPV-008 (NCT00122681) study subjects (15-25 years old at first study vaccination), who at their last study visit (Visit 10, Month 48) in HPV-008 (NCT00122681) study displayed normal cervical cytology, but were tested positive for oncogenic HPV infection, or were pregnant and hence no cervical sample could be collected at their HPV-008 (NCT00122681) concluding visit.


Other interventions: Gynaecological follow-up
Subjects received a gynaecological follow-up with cytology and oncogenic HPV DNA testing every 12 months, for up to four years in this gynaecological follow-up study (HPV-052 EXT 008). No vaccine was administered in this extension study. Subjects received 3 doses of Cervarix/Havrix vaccine, administered intramuscularly, according to a 0, 1, 6-month vaccination schedule in the HPV-008 (NCT00122681) primary study.

Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Subjects With HPV DNA in Cervical Samples by Hybrid Capture 2 Test (HCII) - Subjects who presented oncogenic HPV DNA in cervical samples by HPV DNA testing. The presence of oncogenic HPV infection was determined by the Hybrid Capture 2 (HCII) test, which detects HPV DNA types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59 and 68.
Missing = For some of the subjects whose result was indicated as quantity not sufficient (QNS).
Timepoint [1] 0 0
At Months 12, 24, 36, 48
Primary outcome [2] 0 0
Number of Subjects With Colposcopy Referral and Colposcopy Adequacy - Subjects with normal cervical cytology, who were found to be oncogenic HPV DNA positive in two subsequent tests, were referred to colposcopy. The result of the subjects' last HPV-008 study visit was taken into account at Visit 1. Subjects with a single cervical cytology reading of = atypical squamous cells of undetermined significance (ASC-US) positive for oncogenic HPV DNA were referred for colposcopy. Subjects with a single cervical cytology reading of = low grade squamous intraepithelial lesion (LSIL) were referred to colposcopy, irrespective of their oncogenic HPV DNA test result.
Timepoint [2] 0 0
At Months 12, 24, 36, 48
Primary outcome [3] 0 0
Number of Subjects With Cytological Abnormalities in Cervical Samples by ThinPrep PapTest - Subjects who presented normal, ASC-US (Atypical Squamous Cell of Undetermined Significance), LSIL (Low-grade Squamous Intraepithelial Lesions), HSIL (High-grade Squamous Intraepithelial Lesions), AGC (Atypical Glandular Cells), ASC-H (Atypical Squamous Cells cannot exclude HSIL) cervical cytology.
Cervical cytology examination was performed using the ThinPrep PapTest. Note: One subject may have presented with different cytology results at the yearly visit throughout the maximum 4-year follow-up period and therefore may be counted in more than one result category in the analysis.
Timepoint [3] 0 0
At Months 12, 24, 36, 48
Primary outcome [4] 0 0
Number of Subjects With Cervical Biopsy Results at Month 12 - Subjects with negative and positive cervical biopsy results for only CIN1, only CIN2, only CIN3, CIN1 and CIN2, CIN1 and CIN3, CIN2 and CIN3, CIN1 and CIN2 and CIN3, AIS, Invasive malignancy, other.
CIN = Cervical intraepithelial neoplasia. CIN1/CIN2/CIN3 = Cervical intraepithelial neoplasia grade 1/grade 2/grade 3.
Note: Only CIN1/Only CIN2/Only CIN3 categories contain the subject who has only CIN1/CIN2/CIN3, but not the combinations.
Timepoint [4] 0 0
At Month 12
Primary outcome [5] 0 0
Number of Subjects With Cervical Biopsy Results at Month 24 - Subjects with negative and positive cervical biopsy results for only CIN1, only CIN2, only CIN3, CIN1 and CIN2, CIN1 and CIN3, CIN2 and CIN3, CIN1 and CIN2 and CIN3, AIS, Invasive malignancy, other.
CIN = Cervical intraepithelial neoplasia. CIN1/CIN2/CIN3 = Cervical intraepithelial neoplasia grade 1/grade 2/grade 3.
Note: Only CIN1/Only CIN2/Only CIN3 categories contain the subject who has only CIN1/CIN2/CIN3, but not the combinations.
Timepoint [5] 0 0
At Month 24
Primary outcome [6] 0 0
Number of Subjects With Cervical Biopsy Results at Month 36 - Subjects with negative and positive cervical biopsy results for only CIN1, only CIN2, only CIN3, CIN1 and CIN2, CIN1 and CIN3, CIN2 and CIN3, CIN1 and CIN2 and CIN3, AIS, Invasive malignancy, other.
CIN = Cervical intraepithelial neoplasia. CIN1/CIN2/CIN3 = Cervical intraepithelial neoplasia grade 1/grade 2/grade 3.
Note: Only CIN1/Only CIN2/Only CIN3 categories contain the subject who has only CIN1/CIN2/CIN3, but not the combinations.
Timepoint [6] 0 0
At Month 36
Primary outcome [7] 0 0
Number of Subjects With Cervical Biopsy Results at Month 48 - Subjects with negative and positive cervical biopsy results for only CIN1, only CIN2, only CIN3, CIN1 and CIN2, CIN1 and CIN3, CIN2 and CIN3, CIN1 and CIN2 and CIN3, AIS, Invasive malignancy, other.
CIN = Cervical intraepithelial neoplasia. CIN1/CIN2/CIN3 = Cervical intraepithelial neoplasia grade 1/grade 2/grade 3.
Note: Only CIN1/Only CIN2/Only CIN3 categories contain the subject who has only CIN1/CIN2/CIN3, but not the combinations.
Timepoint [7] 0 0
At Month 48
Primary outcome [8] 0 0
Number of Subjects With Treatment Referrals by Treatment Type at Month 12 - If a high-grade lesion was detected, the subject was to be referred to treatment according to local medical practice. Any further management following local cervical therapy for cervical lesions was to be handled according to local medical practice within the local health care system. The subject's participation in the study concluded after treatment.
The treatment types included the following: Loop excision of cervix, Loop cone of cervix, Cold knife cone of cervix, Laser excision, other.
Timepoint [8] 0 0
At Month 12
Primary outcome [9] 0 0
Number of Subjects With Treatment Referrals by Treatment Type at Month 24 - If a high-grade lesion was detected, the subject was to be referred to treatment according to local medical practice. Any further management following local cervical therapy for cervical lesions was to be handled according to local medical practice within the local health care system. The subject's participation in the study concluded after treatment.
The treatment types included the following: Loop excision of cervix, Loop cone of cervix, Cold knife cone of cervix, Laser excision, other.
Timepoint [9] 0 0
At Month 24
Primary outcome [10] 0 0
Number of Subjects With Treatment Referrals by Treatment Type at Month 36 - If a high-grade lesion was detected, the subject was to be referred to treatment according to local medical practice. Any further management following local cervical therapy for cervical lesions was to be handled according to local medical practice within the local health care system. The subject's participation in the study concluded after treatment.
The treatment types included the following: Loop excision of cervix, Loop cone of cervix, Cold knife cone of cervix, Laser excision, other.
Timepoint [10] 0 0
At Month 36
Primary outcome [11] 0 0
Number of Subjects With Treatment Referrals by Treatment Type at Month 48 - If a high-grade lesion was detected, the subject was to be referred to treatment according to local medical practice. Any further management following local cervical therapy for cervical lesions was to be handled according to local medical practice within the local health care system. The subject's participation in the study concluded after treatment.
The treatment types included the following: Loop excision of cervix, Loop cone of cervix, Cold knife cone of cervix, Laser excision, other.
Timepoint [11] 0 0
At Month 48
Primary outcome [12] 0 0
Number of Subjects With Adverse Events (AEs) or Serious Adverse Events (SAEs) Leading to Withdrawal - An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.
Timepoint [12] 0 0
From Month 12 [i.e. 12 months after the last visit in HPV-008 (NCT00122681) primary study) up to Month 48 [i.e. 48 months after the last visit in HPV-008 (NCT00122681) primary study]
Primary outcome [13] 0 0
Number of Subjects With Any Fatal SAEs, With Any SAEs Assessed as Possibly Related to Study Participation or to a Concurrent GSK Medication. - SAEs assessed include medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity.
Timepoint [13] 0 0
From Month 12 [i.e. 12 months after the last visit in HPV-008 (NCT00122681) primary study) up to Month 48 [i.e. 48 months after the last visit in HPV-008 (NCT00122681) primary study]

Eligibility
Key inclusion criteria
- Written informed consent obtained from the subject prior to enrolment.

- Subjects who the investigator believes that they can and will comply with the
requirements of the protocol should be enrolled in the study.

- A subject previously enrolled in the study NCT00122681 and who fulfils either of the
following criteria:

- displayed normal cervical cytology but tested positive for oncogenic HPV
infection at her last NCT00122681 study visit (Visit 10, Month 48).

or

- was pregnant at her last visit of the NCT00122681 study (Visit 10, Month 48) so that no
cervical sample could be collected at that visit.
Minimum age
18 Years
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
- A subject who displayed normal cervical cytology and who was negative for oncogenic
HPV infection at her last NCT00122681 study visit (Visit 10, Month 48).

- A subject who had a cervical lesion at her last NCT00122681 study visit (Visit 10,
Month 48) or who had a cervical lesion that required treatment at the NCT00122681 exit
colposcopy.

- A subject for whom the cervical cytology results from the last NCT00122681 study visit
(Visit 10, Month 48) were unavailable for reasons other than pregnancy.

If at the time of enrolment the subject experiences heavy bleeding (menstruation or other)
or heavy vaginal discharge, or is pregnant, the pelvic exam cannot be performed. The
subject's first study visit will be deferred until condition is resolved according to
investigator's medical judgment.

Study design
Purpose of the study
Prevention
Allocation to intervention
N/A
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
Single group
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,TAS,VIC,WA
Recruitment hospital [1] 0 0
GSK Investigational Site - Westmead
Recruitment hospital [2] 0 0
GSK Investigational Site - Hobart
Recruitment hospital [3] 0 0
GSK Investigational Site - Carlton
Recruitment hospital [4] 0 0
GSK Investigational Site - Parkville
Recruitment hospital [5] 0 0
GSK Investigational Site - Perth
Recruitment postcode(s) [1] 0 0
2145 - Westmead
Recruitment postcode(s) [2] 0 0
- Hobart
Recruitment postcode(s) [3] 0 0
3053 - Carlton
Recruitment postcode(s) [4] 0 0
3052 - Parkville
Recruitment postcode(s) [5] 0 0
- Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Florida
Country [2] 0 0
United States of America
State/province [2] 0 0
Hawaii
Country [3] 0 0
United States of America
State/province [3] 0 0
Iowa
Country [4] 0 0
United States of America
State/province [4] 0 0
Kansas
Country [5] 0 0
United States of America
State/province [5] 0 0
Kentucky
Country [6] 0 0
United States of America
State/province [6] 0 0
Nebraska
Country [7] 0 0
United States of America
State/province [7] 0 0
New Mexico
Country [8] 0 0
United States of America
State/province [8] 0 0
New York
Country [9] 0 0
United States of America
State/province [9] 0 0
North Carolina
Country [10] 0 0
United States of America
State/province [10] 0 0
Oklahoma
Country [11] 0 0
United States of America
State/province [11] 0 0
Oregon
Country [12] 0 0
United States of America
State/province [12] 0 0
Pennsylvania
Country [13] 0 0
United States of America
State/province [13] 0 0
Washington
Country [14] 0 0
Belgium
State/province [14] 0 0
Brussels
Country [15] 0 0
Belgium
State/province [15] 0 0
Edegem
Country [16] 0 0
Belgium
State/province [16] 0 0
Leuven
Country [17] 0 0
Brazil
State/province [17] 0 0
Rio Grande Do Sul
Country [18] 0 0
Brazil
State/province [18] 0 0
Campinas
Country [19] 0 0
Brazil
State/province [19] 0 0
Curitiba
Country [20] 0 0
Canada
State/province [20] 0 0
Alberta
Country [21] 0 0
Canada
State/province [21] 0 0
British Columbia
Country [22] 0 0
Canada
State/province [22] 0 0
Nova Scotia
Country [23] 0 0
Canada
State/province [23] 0 0
Quebec
Country [24] 0 0
Finland
State/province [24] 0 0
Helsinki
Country [25] 0 0
Finland
State/province [25] 0 0
Jyvaskyla
Country [26] 0 0
Finland
State/province [26] 0 0
Kotka
Country [27] 0 0
Finland
State/province [27] 0 0
Kouvola
Country [28] 0 0
Finland
State/province [28] 0 0
Kuopio
Country [29] 0 0
Finland
State/province [29] 0 0
Lahti
Country [30] 0 0
Finland
State/province [30] 0 0
Lappeenranta
Country [31] 0 0
Finland
State/province [31] 0 0
Mikkeli
Country [32] 0 0
Finland
State/province [32] 0 0
Oulu
Country [33] 0 0
Finland
State/province [33] 0 0
Pori
Country [34] 0 0
Finland
State/province [34] 0 0
Rauma
Country [35] 0 0
Finland
State/province [35] 0 0
Seinajoki
Country [36] 0 0
Finland
State/province [36] 0 0
Tampere
Country [37] 0 0
Finland
State/province [37] 0 0
Turku
Country [38] 0 0
Finland
State/province [38] 0 0
Vaasa
Country [39] 0 0
Germany
State/province [39] 0 0
Baden-Wuerttemberg
Country [40] 0 0
Germany
State/province [40] 0 0
Bayern
Country [41] 0 0
Germany
State/province [41] 0 0
Hessen
Country [42] 0 0
Germany
State/province [42] 0 0
Niedersachsen
Country [43] 0 0
Germany
State/province [43] 0 0
Rheinland-Pfalz
Country [44] 0 0
Germany
State/province [44] 0 0
Sachsen
Country [45] 0 0
Germany
State/province [45] 0 0
Thueringen
Country [46] 0 0
Germany
State/province [46] 0 0
Berlin
Country [47] 0 0
Germany
State/province [47] 0 0
Hamburg
Country [48] 0 0
Italy
State/province [48] 0 0
Emilia-Romagna
Country [49] 0 0
Philippines
State/province [49] 0 0
Cavite
Country [50] 0 0
Philippines
State/province [50] 0 0
Laguna
Country [51] 0 0
Philippines
State/province [51] 0 0
Las Pinas City
Country [52] 0 0
Philippines
State/province [52] 0 0
Los Banos, Laguna
Country [53] 0 0
Philippines
State/province [53] 0 0
Makati City
Country [54] 0 0
Philippines
State/province [54] 0 0
Manila
Country [55] 0 0
Spain
State/province [55] 0 0
Barcelona
Country [56] 0 0
Spain
State/province [56] 0 0
L'Hospitalet de Llobregat
Country [57] 0 0
Spain
State/province [57] 0 0
Madrid
Country [58] 0 0
Spain
State/province [58] 0 0
Móstoles/Madrid
Country [59] 0 0
Taiwan
State/province [59] 0 0
Taipei
Country [60] 0 0
Thailand
State/province [60] 0 0
Bangkok
Country [61] 0 0
United Kingdom
State/province [61] 0 0
Aberdeen
Country [62] 0 0
United Kingdom
State/province [62] 0 0
London
Country [63] 0 0
United Kingdom
State/province [63] 0 0
Manchester

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

Ethics approval
Ethics application status

Summary
Brief summary
This study is designed to provide up to four years of annual oncogenic HPV DNA testing and
cervical cytology examination for NCT00122681 study subjects who displayed normal cervical
cytology but tested positive for oncogenic HPV infection at their last NCT00122681 study
visit (Visit 10, Month 48).

This follow-up study will also be offered to subjects who were pregnant at their last
NCT00122681 study visit (Visit 10, Month 48) so that no cervical sample could be collected at
that visit.

The objectives & outcome measures of the primary phase (study 008/580299) are presented in a
separate protocol posting (NCT00122681).
Trial website
https://clinicaltrials.gov/show/NCT00937950
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

Summary results
Other publications