Follow-up Study to Evaluate the Long-term Efficacy of the HPV Vaccine (580299) in Healthy Young Adult Women in Brazil

NCT00518336 | Completed Phase 2 Results

• 3 other identifiers: 109616 (Y7)109624109625
• Study Type: interventional
• Target: 433
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Infections, Papillomavirus

Outcome Measures

Primary Outcomes (3)

• Number of Subjects Presenting Cervical Infections With Human Papillomavirus (HPV) -16 and/or HPV-18

  Cervical HPV infection was defined as the first detection of an HPV type in a subject previously negative for that HPV type.

  Up to year 8

• Number of Subjects Presenting Cervical Infections With Human Papillomavirus (HPV) -16 and/or HPV-18

  Cervical HPV infection was defined as the first detection of an HPV type in a subject previously negative for that HPV type

  Up to year 9

• Number of Subjects Presenting Cervical Infections With Human Papillomavirus (HPV) -16 and /or HPV-18

  Cervical HPV infection was defined as the first detection of an HPV type in a subject previously negative for that HPV type.

  Up to year 7

Secondary Outcomes (76)

• Number of Subjects Presenting Cervical Infections With Any Oncogenic HPV Type

  Up to year 8

• Number of Subjects Presenting Cervical Infections With Individual Oncogenic Non-vaccine HPV Type

  Up to year 8

• Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 and/or HPV-18

  Up to year 8

• Number of Subjects With Persistent Infection (6-month Definition) With Any Oncogenic HPV Types

  Up to year 8

• Number of Subjects With Persistent Infection (6-month Definition) With Individual Oncogenic Non-vaccine HPV Types

  Up to year 8

Study Arms (2)

Cervarix Group

EXPERIMENTAL

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.

Procedure: Blood sampling; Procedure: Collection of cervical specimen; Biological: Cervarix

Placebo Group

PLACEBO COMPARATOR

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.

Procedure: Blood sampling; Procedure: Collection of cervical specimen

Interventions

Blood sampling PROCEDURE

Blood sampling at Visit 3, 5 and 7.

Cervarix Group; Placebo Group

Collection of cervical specimen PROCEDURE

Collection of cervical specimen at Visit2, 3, 4, 5, 6 and 7.

Cervarix Group; Placebo Group

Cervarix BIOLOGICAL

Three doses administered intramuscularly at 0, 1 and 6 months.

Cervarix Group

Eligibility Criteria

• Age: 15 Years - 25 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (5)

GSK Investigational Site

Curitiba, Paraná, 80069-900, Brazil

Location

GSK Investigational Site

Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

Location

GSK Investigational Site

São Paulo, São Paulo, 03015000, Brazil

Location

GSK Investigational Site

Campinas, 13083-970, Brazil

Location

GSK Investigational Site

Fortaleza, Brazil

Location

Related Publications (2)

• Naud 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 DERIVED

• Roteli-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 DERIVED

Related Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

MeSH Terms

Conditions

Papillomavirus Infections

Interventions

Blood Specimen Collection; human papillomavirus vaccine, L1 type 16, 18

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Limitations and Caveats

Interim analysis at Year 7 and Year 8 are superseded by the final analysis at Year 9.

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2007
• First Posted: August 20, 2007
• Study Start: November 1, 2007
• Primary Completion: July 1, 2008
• Study Completion: September 1, 2010
• Last Updated: December 9, 2016
• Results First Posted: October 25, 2011

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will share

Locations

BR (5)