Last updated: 11/07/2018 05:23:06

Extension study of the efficacy of the GSK 580299 vaccine in Japanese women vaccinated in the primary NCT00316693 study

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GSK study ID
112949
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Clinicaltrials.gov ID
NCT00929526
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EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Long-term extension study of the efficacy of the 580299 vaccine in the prevention of HPV-16 and/or HPV-18 associated cervical intraepithelial neoplasia (CIN) in Japanese women vaccinated in the primary vaccination study NCT00316693
Trial description: This extension study is conducted to assess the efficacy of the GSK 580299 vaccine against cervical intraepithelial neoplasia (CIN) lesions, cervical cancer and cytological abnormalities associated with human papillomavirus (HPV)-16 and/or HPV-18 or other oncogenic HPV types for an additional two years. All subjects who participated in the primary vaccination study NCT00316693 and who confirmed their interest in participating in a long term follow up study will therefore be invited to be followed for up to 48 months after administration of the first dose of vaccine. In addition, safety and persistence of the humoral immune response will be evaluated in this study.
This protocol posting deals with objectives & outcome measures of the extension phase at Months 36 and 48. The objectives & outcome measures of the primary phase are presented in a separate protocol posting (NCT number = NCT00316693).
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:

Number of subjects reporting histopathologically confirmed Cervical Intraepithelial Neoplasia (CIN)1+ cases associated with HPV16 and/or HPV18 detected within the lesional component of the cervical tissue specimen.

Timeframe: From Month 0 up to Month 12

Secondary outcomes:

Number of subjects reporting cytological abnormalities and lesions associated with HPV-16 and/or HPV-18.

Timeframe: From Month 0 up to Month 12

Number of subjects reporting cytologically confirmed abnormalities and lesions concurrently associated with any oncogenic HPV types.

Timeframe: From Month 0 up to Month 12

Number of subjects reporting CIN1+ associated with any oncogenic HPV types detected within the lesional component of the cervical tissue specimen.

Timeframe: From Month 0 up to Month 12

Number of subjects reporting incident cervical infection associated with HPV-16 and/or 18.

Timeframe: From Month 0 up to Month 12

Number of subjects reporting incident cervical infection with any oncogenic HPV types.

Timeframe: From Month 0 up to Month 12

Number of subjects reporting persistent long-term cervical infection (12-month definition) with HPV-16 and/or 18.

Timeframe: From Month 0 up to Month 12

Number of subjects reporting persistent long-term cervical infection (12-month definition) with any oncogenic HPV-types.

Timeframe: From Month 0 up to Month 12

Number of subjects with HPV-16 and HPV-18 antibodies titers equal to or above the assay cut-off values.

Timeframe: At Month 0 and at Month 12

HPV-16 and HPV-18 antibody titers

Timeframe: At Month 0 and at Month 12

Number of subjects reporting serious adverse events (SAEs).

Timeframe: During the follow-up period from last study visit at Month 24 in the primary vaccination study NCT00316693 until the end of this follow-up study at Month 12

Number of subjects with new onset of chronic diseases (NOCDs) regardless of causal relationship to vaccination and intensity.

Timeframe: During the follow-up period from last study visit at Month 24 in the primary vaccination study NCT00316693 until the end of this follow-up study at Month 12

Number of subjects with new onset of autoimmune diseases (NOADs) regardless of causal relationship to vaccination and intensity.

Timeframe: During the follow-up period from last study visit at Month 24 in the primary vaccination study NCT00316693 until the end of this follow-up study at Month 12

Number of subjects with medically significant conditions (MSCs).

Timeframe: During the follow-up period from last study visit at Month 24 in the primary vaccination study NCT00316693 until the end of this follow-up study at Month 12

Number of subjects with pregnancies and pregnancy outcomes.

Timeframe: During the follow-up period from last study visit at Month 24 in the primary vaccination study NCT00316693 until the end of this follow-up study at Month 12 (Month 48 Ext- NCT00316693).

Interventions:
Procedure/surgery: Liquid-based cytology (LBC) sampling
Procedure/surgery: Blood sampling
Enrollment:
752
Observational study model:
Not applicable
Primary completion date:
2011-21-02
Time perspective:
Not applicable
Clinical publications:
Konno R et al. (2014) Efficacy of the human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine against cervical intraepithelial neoplasia and cervical infection in young Japanese women: Open follow-up of a randomized clinical trial up to 4 years post-vaccination. Hum Vaccin Immunother. 10(7). [Epub ahead of print]
Medical condition
Infections, Papillomavirus
Product
SB580299
Collaborators
Not applicable
Study date(s)
June 2009 to February 2011
Type
Interventional
Phase
3

Participation criteria

Sex
Female
Age
20 - 25 years
Accepts healthy volunteers
Yes
  • Subjects who the investigator believes that they can and will comply with the requirements of the protocol;
  • Written informed consent obtained from the subject prior to enrolment in the extension study;
  • Use of any HPV vaccine other than the one administered in the NCT00316693 study;
  • Use of any investigational or non-registered product other than the study vaccine since last NCT00316693 study visit, or planned use during the study period;
Inclusion and exclusion criteria
Inclusion criteria:

    Subjects who the investigator believes that they can and will comply with the requirements of the protocol;

    • Written informed consent obtained from the subject prior to enrolment in the extension study;
    • A subject previously vaccinated in the NCT00316693 study.
    • Subjects who showed, at the last NCT00316693 study visit (at Month 24) willingness to participate in this extension study.
Exclusion criteria:

    Use of any HPV vaccine other than the one administered in the NCT00316693 study;

    • Use of any investigational or non-registered product other than the study vaccine since last NCT00316693 study visit, or planned use during the study period;
    • 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;
    • Subjects who were diagnosed high grade or missing cytology at Month 0 in the NCT00316693 study;
    • Pregnant females and females who were pregnant less than 3 months ago.

Trial location(s)

Location
Status
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Location
GSK Investigational Site
Fukui, Japan, 910-0858
Status
Study Complete
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Location
GSK Investigational Site
Tokyo, Japan, 189-0014
Status
Study Complete
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Location
GSK Investigational Site
Tokyo, Japan, 173-0005
Status
Study Complete
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Location
GSK Investigational Site
Miyazaki, Japan, 889-1692
Status
Study Complete
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Location
GSK Investigational Site
Hiroshima, Japan, 733-0813
Status
Study Complete
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Location
GSK Investigational Site
Tokyo, Japan, 102-0083
Status
Study Complete
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Location
GSK Investigational Site
Aomori, Japan, 036-8003
Status
Study Complete
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Location
GSK Investigational Site
Kagoshima, Japan, 890-0055
Status
Study Complete
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Location
GSK Investigational Site
Kagoshima, Japan, 892-0824
Status
Study Complete
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Location
GSK Investigational Site
Tokyo, Japan, 183-0056
Status
Study Complete
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Location
GSK Investigational Site
Hiroshima, Japan, 734-0036
Status
Study Complete
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Location
GSK Investigational Site
Tokyo, Japan, 160-0017
Status
Study Complete
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Location
GSK Investigational Site
Osaka, Japan, 530-0013
Status
Study Complete
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Study documents

Clinical study report
Available language(s): English
Download document(s)
Scientific result summary
Available language(s): English
Download document(s)

If you wish to request for full study report, please contact - [email protected]

Results overview

Results posted on ClinicalTrials.gov

Recruitment status
Completed
Actual primary completion date
2011-21-02
Actual study completion date
2011-21-02

Plain language summaries

Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

Additional information about the trial

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