Phase 2
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
Bottom Line
View on ClinicalTrials.gov: NCT00518336 ↗Enrolled (actual)
433
Serious AEs
7.1%
Results posted
Oct 2011
Primary outcome: Primary: Number of Subjects Presenting Cervical Infections With Human Papillomavirus (HPV) -16 and/or HPV-18 — 0; 5; 0; 4 subjects
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Blood sampling (Procedure); Collection of cervical specimen (Procedure); Cervarix (Biological)
- Age
- Pediatric, Adult · 15+ yrs
- Sex
- Female
- Sponsor
- GlaxoSmithKline
- Primary completion
- Jul 2008
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; 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 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 Type |
5; 4; 5; 4 | — |
| 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 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 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 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 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 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 Any Oncogenic HPV Type. |
22; 16; 22; 14 | — |
| 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 (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 Type |
5; 4; 5; 4 | — |
| 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 Type |
0; 0; 0; 0 | — |
| 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 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 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 | — |
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.
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.