Phase 3
Completed N=752
Extension Study of the Efficacy of the GSK 580299 Vaccine in Japanese Women Vaccinated in the Primary NCT00316693 Study
Infections, Papillomavirus
Source: ClinicalTrials.gov NCT00929526 ↗
Enrolled (actual)
752
Serious AEs
3.6%
Results posted
Oct 2012
Primary outcomePrimary: 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. — 0; 5; 0; 5 Subjects
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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. |
0; 5; 0; 5; 0; 0 | — |
| SECONDARY Number of Subjects Reporting Cytological Abnormalities and Lesions Associated With HPV-16 and/or HPV-18. |
3; 11; 2; 10; 1; 2 | — |
| SECONDARY Number of Subjects Reporting Cytologically Confirmed Abnormalities and Lesions Concurrently Associated With Any Oncogenic HPV Types. |
33; 45 | — |
| SECONDARY Number of Subjects Reporting CIN1+ Associated With Any Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen. |
8; 22 | — |
| SECONDARY Number of Subjects Reporting Incident Cervical Infection Associated With HPV-16 and/or 18. |
7; 28; 3; 16; 5; 13 | — |
| SECONDARY Number of Subjects Reporting Incident Cervical Infection With Any Oncogenic HPV Types. |
87; 98 | — |
| SECONDARY Number of Subjects Reporting Persistent Long-term Cervical Infection (12-month Definition) With HPV-16 and/or 18. |
0; 9; 0; 6; 0; 4 | — |
| SECONDARY Number of Subjects Reporting Persistent Long-term Cervical Infection (12-month Definition) With Any Oncogenic HPV-types. |
19; 31 | — |
| SECONDARY Number of Subjects With HPV-16 and HPV-18 Antibodies Titers Equal to or Above the Assay Cut-off Values. |
282; 291; 281; 290 | — |
| SECONDARY HPV-16 and HPV-18 Antibody Titers |
1409.9; 1294.8; 572.3; 470.9 | — |
| SECONDARY Number of Subjects Reporting Serious Adverse Events (SAEs). |
11; 16 | — |
| SECONDARY Number of Subjects With New Onset of Chronic Diseases (NOCDs) Regardless of Causal Relationship to Vaccination and Intensity. |
2; 2 | — |
| SECONDARY Number of Subjects With New Onset of Autoimmune Diseases (NOADs) Regardless of Causal Relationship to Vaccination and Intensity. |
2; 1 | — |
| SECONDARY Number of Subjects With Medically Significant Conditions (MSCs). |
11; 15 | — |
| SECONDARY Number of Subjects With Pregnancies and Pregnancy Outcomes. |
28; 30; 0; 1; 4; 3 | — |
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT00929526). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.