Clinical trial · Interventional
Follow-up Study to Evaluate the Long-term Efficacy of the HPV Vaccine (580299) in Healthy Young Adult Women in Brazil
Follow-up Study to Evaluate the Long-term Efficacy of a HPV Vaccine (580299) in Healthy Young Adult Women in Brazil
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Infections, Papillomavirus | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blood sampling | Procedure | — | UNRESOLVED |
| Cervarix | Biological | — | UNRESOLVED |
| Collection of cervical specimen | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Cervarix Group
- description
- Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
- interventionNames
- Procedure: Blood sampling
- Procedure: Collection of cervical specimen
- Biological: Cervarix
- type
- PLACEBO_COMPARATOR
- label
- Placebo Group
- description
- Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
- interventionNames
- Procedure: Blood sampling
- Procedure: Collection of cervical specimen
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 15 Years
- Maximum age
- 25 Years
Show eligibility criteria text
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.
References
Publications (2)
- DERIVEDNaud PS, Roteli-Martins CM, De Carvalho NS, Teixeira JC, de Borba PC, Sanchez N, Zahaf T, Catteau G, Geeraerts B, Descamps D. Sustained efficacy, immunogenicity, and safety of the HPV-16/18 AS04-adjuvanted vaccine: final analysis of a long-term follow-up study up to 9.4 years post-vaccination. Hum Vaccin Immunother. 2014;10(8):2147-62. doi: 10.4161/hv.29532. PMID 25424918
- DERIVEDRoteli-Martins CM, Naud P, De Borba P, Teixeira JC, De Carvalho NS, Zahaf T, Sanchez N, Geeraerts B, Descamps D. Sustained immunogenicity and efficacy of the HPV-16/18 AS04-adjuvanted vaccine: up to 8.4 years of follow-up. Hum Vaccin Immunother. 2012 Mar;8(3):390-7. doi: 10.4161/hv.18865. Epub 2012 Feb 13. PMID 22327492