Phase 2
Completed N=433
Follow-up Study to Evaluate the Long-term Efficacy of the HPV Vaccine (580299) in Healthy Young Adult Women in Brazil
Infections, Papillomavirus
Source: ClinicalTrials.gov NCT00518336 ↗
Enrolled (actual)
433
Serious AEs
7.1%
Results posted
Oct 2011
Primary outcomePrimary: Number of Subjects Presenting Cervical Infections With Human Papillomavirus (HPV) -16 and/or HPV-18 — 0; 5; 0; 4 subjects
Summary
Infection with human papillomavirus (HPV) has been clearly established as the central cause of cervical cancer. This Phase IIb study is designed to evaluate the the long-term efficacy, safety and immunogenicity of the 580299 HPV vaccine (CervarixTM) in a Brazilian cohort of women vaccinated in the phase IIb, blinded, primary study 580299/001 (NCT00689741) and having participated in follow-up study 580299/007 (NCT00120848). Only subjects who participated in the primary & follow-up study will be enrolled in this long-term follow-up study. Subjects were aged 15-25 years at the time of entry into the primary study.
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects Presenting Cervical Infections With Human Papillomavirus (HPV) -16 and/or HPV-18 |
0; 9; 0; 6; 0; 9 | — |
| PRIMARY Number of Subjects Presenting Cervical Infections With Human Papillomavirus (HPV) -16 and /or HPV-18 |
0; 2; 0; 0; 0; 2 | — |
| SECONDARY Number of Subjects Presenting Cervical Infections With Any Oncogenic HPV Type |
32; 39; 32; 36 | — |
| SECONDARY Number of Subjects Presenting Cervical Infections With Individual Oncogenic Non-vaccine HPV Type |
4; 5; 2; 4; 4; 9 | — |
| SECONDARY Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 and/or HPV-18 |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Subjects With Persistent Infection (6-month Definition) With Any Oncogenic HPV Types |
15; 17; 15; 17 | — |
| SECONDARY Number of Subjects With Persistent Infection (6-month Definition) With Individual Oncogenic Non-vaccine HPV Types |
0; 2; 0; 0; 1; 1 | — |
| SECONDARY Number of Subjects With Persistent Infection (12-month Definition) With HPV-16 and/or HPV-18 |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Subjects With Persistent Infection (12-month Definition) With Any Oncogenic HPV Types |
13; 10; 13; 8 | — |
| SECONDARY Number of Subjects With Persistent Infection (12-month Definition) With Individual Oncogenic Non-vaccine HPV Types |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 or HPV-18 Detected Within the Lesional Component of the Cervical Tissue Specimen |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Subjects With Histopathologically Confirmed CIN1+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen |
0; 0; 0; 0 | — |
| SECONDARY Number of Subjects With Histopathologically Confirmed CIN1+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Subjects With Histopathologically-confirmed CIN2+ Associated With HPV-16 or HPV-18 Detected Within the Lesional Component of the Cervical Tissue Specimen |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Subjects With Histopathologically Confirmed CIN2+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen |
0; 0; 0; 0 | — |
| SECONDARY Number of Subjects With Histopathologically Confirmed CIN2+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undetermined Significance (ASC-US) Associated With an HPV 16 and/or HPV-18 Cervical Infection |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undetermined Significance (ASC-US) Associated With Oncogenic HPV Types Cervical Infection |
3; 8; 3; 8 | — |
| SECONDARY Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undetermined Significance (ASC-US) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection |
0; 1; 0; 0; 0; 1 | — |
| SECONDARY Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With an HPV 16 and/or HPV-18 Cervical Infection |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With Oncogenic HPV Types Cervical Infection |
2; 6; 2; 6 | — |
| SECONDARY Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection |
0; 1; 0; 0; 0; 0 | — |
| SECONDARY Anti-HPV-16 and Anti-HPV-18 Enzyme-linked Immunosorbent Assay (ELISA) Titers in the Immunogenicity Cohort |
374.9; 5.2; 383.4; 5.2; 346.3; 5.4 | — |
| SECONDARY Anti-HPV-16 and Anti-HPV-18 Pseudovirion-based Neutralization Assay (PBNA) Titers in the Immunogenicity Subset |
1616.1; 20.0; 1990.7; 20.0; 1385.0; 20.0 | — |
| SECONDARY Number of Subjects With New Onset Chronic Diseases (NOCD) up to Year 7 |
0; 0 | — |
| SECONDARY Number of Subjects With NOCD up to Year 8 |
5; 2 | — |
| SECONDARY Number of Subjects With New Onset Autoimmune Disease (NOAD) up to Year 7 |
0; 0 | — |
| SECONDARY Number of Subjects With NOAD up to Year 8 |
2; 2 | — |
| SECONDARY Number of Subjects With Medically Significant Conditions up to Year 7 |
18; 13 | — |
| SECONDARY Number of Subjects With Medically Significant Conditions up to Year 8 |
40; 24 | — |
| SECONDARY Number of Subjects With Serious Adverse Events (SAEs) up to Year 7 |
4; 5 | — |
| SECONDARY Number of Subjects With SAEs up to Year 8 |
10; 7 | — |
| SECONDARY Number of Subjects Presenting Cervical Infections With Any Oncogenic HPV Type. |
22; 16; 22; 14 | — |
| SECONDARY Number of Subjects With Persistent Infection (6-month Definition) With Any Oncogenic HPV Type |
5; 4; 5; 4 | — |
| SECONDARY Number of Subjects With Histopathologically-confirmed CIN1+ Associated With HPV-16 or HPV-18 Detected Within the Lesional Component of the Cervical Tissue Specimen |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undertermined Significance (ASC-US) Associated With an HPV 16 and/or HPV-18 Cervical Infection |
0; 3; 0; 1; 0; 2 | — |
| SECONDARY Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undertermined Significance (ASC-US) Associated With Oncogenic HPV Types Cervical Infection |
15; 25; 15; 25 | — |
| SECONDARY Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undertermined Significance (ASC-US) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection |
1; 5; 0; 2; 1; 3 | — |
| SECONDARY Number of Subjects With New Onset Chronic Diseases (NOCD) up to Year 9 |
6; 3; 2; 1; 1; 0 | — |
| SECONDARY Number of Subjects With New Onset Autoimmune Disease (NOAD) up to Year 9. |
4; 1; 2; 1; 1; 0 | — |
| SECONDARY Number of Subjects With Medically Signifant Conditions up to Year 9 |
60; 38; 5; 2; 5; 2 | — |
| SECONDARY Number of Subjects With Serious Adverse Events (SAEs) up to Year 9. |
20; 11 | — |
| SECONDARY Number of Subjects Presenting Cervical Infections With Individual Oncogenic Non-vaccine HPV Type. |
1; 1; 0; 1; 3; 3 | — |
| SECONDARY Number of Subjects With Persistent Infection (12-month Definition) With Any Oncogenic HPV Type |
0; 0; 0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study.
- Subjects who participated in study 580299-007.
- Written informed consent obtained from the subject prior to enrollment.
Exclusion Criteria
- Use or planned use of any investigational or non-registered product other than the study vaccine.
- Decoding of the subject's 580299-001 treatment allocation to either the subject or the investigator.
- Administration or planned administration of any other HPV vaccine, other than the vaccine administered in study 580299-001.
Data sourced from ClinicalTrials.gov (NCT00518336). 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.