Extension Study of the Efficacy of the GSK 580299 Vaccine in Japanese Women Vaccinated in the Primary NCT00316693 Study
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
1 other identifier
interventional
752
1 country
13
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jun 2009
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2009
CompletedFirst Submitted
Initial submission to the registry
June 26, 2009
CompletedFirst Posted
Study publicly available on registry
June 29, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2011
CompletedResults Posted
Study results publicly available
October 15, 2012
CompletedOctober 20, 2016
September 1, 2016
1.7 years
June 26, 2009
February 16, 2012
September 9, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Low-grade cervical lesions and higher lesions are defined as CIN1+, i.e. CIN grade 1 (CIN1), CIN grade 2 (CIN2), CIN grade 3 (CIN3), adenocarcinoma in situ (AIS) or invasive cervical cancer (ICC). Detection of vaccine oncogenic Human papillomavirus (HPV) types 16 or 18 was made by polymerase chain reaction (PCR). For single type: Subjects Deoxyribonucleic acid (DNA) negative at Month 0 and Month 6 and seronegative at Month 0 for the corresponding HPV type. For combined types: Subjects DNA negative at Month 0 and Month 6 and seronegative at Month 0 for at least one HPV type.
From Month 0 up to Month 12
Secondary Outcomes (14)
Number of Subjects Reporting Cytological Abnormalities and Lesions Associated With HPV-16 and/or HPV-18.
From Month 0 up to Month 12
Number of Subjects Reporting Cytologically Confirmed Abnormalities and Lesions Concurrently Associated With Any Oncogenic HPV Types.
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.
From Month 0 up to Month 12
Number of Subjects Reporting Incident Cervical Infection Associated With HPV-16 and/or 18.
From Month 0 up to Month 12
Number of Subjects Reporting Incident Cervical Infection With Any Oncogenic HPV Types.
From Month 0 up to Month 12
- +9 more secondary outcomes
Study Arms (2)
Cervarix Group
EXPERIMENTALsubjects received 3 doses of Cervarix™ vaccine in primary vaccination study NCT00316693.
Aimmugen Group
PLACEBO COMPARATORsubjects received 3 doses of Aimmugen ™ vaccine in primary vaccination study NCT00316693.
Interventions
LBC samples will be collected at Months 36 and 48 for cytology and HPV DNA testing (by PCR)
Blood samples will be collected at Months 36 and 48 for antibody determination
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (13)
GSK Investigational Site
Aomori, 036-8003, Japan
GSK Investigational Site
Fukui, 910-0858, Japan
GSK Investigational Site
Hiroshima, 733-0813, Japan
GSK Investigational Site
Hiroshima, 734-0036, Japan
GSK Investigational Site
Kagoshima, 890-0055, Japan
GSK Investigational Site
Kagoshima, 892-0824, Japan
GSK Investigational Site
Miyazaki, 889-1692, Japan
GSK Investigational Site
Osaka, 530-0013, Japan
GSK Investigational Site
Tokyo, 102-0083, Japan
GSK Investigational Site
Tokyo, 160-0017, Japan
GSK Investigational Site
Tokyo, 173-0005, Japan
GSK Investigational Site
Tokyo, 183-0056, Japan
GSK Investigational Site
Tokyo, 189-0014, Japan
Related Publications (2)
Chen J, Gopala K, Akarsh PK, Struyf F, Rosillon D. Prevalence and Incidence of Human Papillomavirus (HPV) Infection Before and After Pregnancy: Pooled Analysis of the Control Arms of Efficacy Trials of HPV-16/18 AS04-Adjuvanted Vaccine. Open Forum Infect Dis. 2019 Dec 4;6(12):ofz486. doi: 10.1093/ofid/ofz486. eCollection 2019 Dec.
PMID: 31824976DERIVEDKonno R, Yoshikawa H, Okutani M, Quint W, V Suryakiran P, Lin L, Struyf F. Efficacy of the human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine against cervical intraepithelial neoplasia and cervical infection in young Japanese women. Hum Vaccin Immunother. 2014;10(7):1781-94. doi: 10.4161/hv.28712.
PMID: 25424783DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- GSK Response Center
- Organization
- GlaxoSmithKline
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 26, 2009
First Posted
June 29, 2009
Study Start
June 1, 2009
Primary Completion
February 1, 2011
Study Completion
February 1, 2011
Last Updated
October 20, 2016
Results First Posted
October 15, 2012
Record last verified: 2016-09
Data Sharing
- IPD Sharing
- Will share
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.