Infections, PapillomavirusPhase 2NCT00518336

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

A Phase 2 study testing Blood sampling, Collection of cervical specimen and Cervarix in people with Infections, Papillomavirus, run by GlaxoSmithKline at 5 sites in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 15 to 25 years, women onlyHealthy volunteers can take part
Conditions the study is for: Infections, Papillomavirus
What is being tested?: Blood sampling, Collection of cervical specimen and Cervarix
Type of treatment: Injection or infusion, Surgery or procedure
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 433 participants
Where: 5 sitesBrazil
Study dates: Nov 2007to Sep 2010
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 15 to 25 years
Women only
Healthy volunteers accepted
Child, Adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

Brazil5 sites

GSK Investigational Site
Campinas, 13083-970
GSK Investigational Site
Curitiba, Paraná, 80069-900
GSK Investigational Site
Fortaleza
GSK Investigational Site
Porto Alegre, Rio Grande do Sul, 90035-903
GSK Investigational Site
São Paulo, São Paulo, 03015000

Other trials in Brazil

About this study

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

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.

Read the detailed description

In this extension study, women who were vaccinated in the primary study, and participated in the follow-up study, will be followed with visits every 6 months.

Conditions: Infections, Papillomavirus
Being tested: Blood sampling, Collection of cervical specimen, Cervarix
Medical subject headings: Papillomavirus Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Blood samplingProcedure or surgery
Blood sampling at Visit 3, 5 and 7.
Collection of cervical specimenProcedure or surgery
Collection of cervical specimen at Visit2, 3, 4, 5, 6 and 7.
CervarixBiological
Three doses administered intramuscularly at 0, 1 and 6 months.

Study groups in NCT00518336
Study group	Role	What they receive
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. Receives: 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. Receives: Procedure: Blood sampling; Procedure: Collection of cervical specimen

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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
Measured: 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.
Measured: Up to year 7

Secondary outcomes (76)

Number of Subjects Presenting Cervical Infections With Any Oncogenic HPV Type
Oncogenic HPV types included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.
Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had a normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at month 6 in the primary study.
Measured: Up to year 8
Number of Subjects Presenting Cervical Infections With Individual Oncogenic Non-vaccine HPV Type
Oncogenic types included HPV-31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.
Subjects with an event did not report the same event in the earlier studies and were DNA negative for the corresponding HPV type at month 6 in the primary study.
Measured: Up to year 8
Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 and/or HPV-18
Persistent cervical HPV infection (6-month definition) was defined as detection of the same HPV type in cervical specimens at 2 consecutive evaluations over a minimum of 5 months.
Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had a normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at month 6 in the primary study.
Measured: Up to year 8
Number of Subjects With Persistent Infection (6-month Definition) With Any Oncogenic HPV Types
Oncogenic HPV types included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.
Persistent cervical HPV infection (6-month definition) was defined as detection of the same HPV type in cervical specimens at 2 consecutive evaluations over a minimum of 5 months.
Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had a normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at month 6 in the primary study.
Measured: Up to year 8
Number of Subjects With Persistent Infection (6-month Definition) With Individual Oncogenic Non-vaccine HPV Types
Oncogenic HPV types included HPV-31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.
Persistent cervical HPV infection (6-month definition) was defined as detection of the same HPV type in cervical specimens at 2 consecutive evaluations over a minimum of 5 months.
Subjects with an event did not report the same event during the earlier studies. Subjects with an event were DNA negative for the corresponding HPV type at Month 6 in the primary study.
Measured: Up to year 8
Number of Subjects With Persistent Infection (12-month Definition) With HPV-16 and/or HPV-18
Persistent cervical HPV infection (12-month definition) was defined as detection of the same HPV type in cervical specimens at all consecutive evaluations over a minimum of 10 months.
Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had a normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at month 6 in the primary study.
Measured: Up to year 8
Number of Subjects With Persistent Infection (12-month Definition) With Any Oncogenic HPV Types
Oncogenic HPV types included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.
Persistent cervical HPV infection (12-month definition) was defined as detection of the same HPV type in cervical specimens at all consecutive evaluations over a minimum of 10 months.
Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had a normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at month 6 in the primary study.
Measured: Up to year 8
Number of Subjects With Persistent Infection (12-month Definition) With Individual Oncogenic Non-vaccine HPV Types
Individual oncogenic non-vaccine HPV types include HPV-31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.
Persistent cervical HPV infection (12-month definition) was defined as detection of the same HPV type in cervical specimens at all consecutive evaluations over a minimum of 10 months.
Subjects with an event did not report the same event in the earlier studies and were DNA negative for the corresponding HPV type at month 6 in the primary study.
Measured: Up to year 8
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
CIN1+ was defined as CIN (Cervical Intraepithelial Neoplasia) grades 1,2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer.
Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at Month 6 in the primary study.
Measured: Up to year 8
Number of Subjects With Histopathologically Confirmed CIN1+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen
CIN1+ was defined as CIN grades 1,2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer.
Oncogenic HPV types assessed included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.
Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at Month 6 in the primary study.
Measured: Up to year 8
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
CIN1+ was defined as CIN grades 1,2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer.
Oncogenic HPV types assessed included HPV-31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.
Subjects with an event did not report the same event in the earlier studies and were DNA negative for the corresponding HPV type at Month 6 in the primary study.
Measured: Up to year 8
Number of Subjects With Histopathologically-confirmed CIN2+ Associated With HPV-16 or HPV-18 Detected Within the Lesional Component of the Cervical Tissue Specimen
CIN2+ was defined as CIN grades 2 and 3, AIS and invasive cervical cancer.
Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at Month 6 in the primary study.
Measured: Up to year 8
Number of Subjects With Histopathologically Confirmed CIN2+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen
CIN2+ was defined as CIN grades 2 and 3, AIS and invasive cervical cancer.
Oncogenic HPV types assessed included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.
Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at Month 6 in the primary study.
Measured: Up to year 8
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
CIN2+ was defined as CIN grades 2 and 3, AIS and invasive cervical cancer.
Oncogenic HPV types assessed included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.
Subjects with an event did not report the same event in the earlier studies. and were DNA negative for the corresponding HPV type at Month 6 in the primary study.
Measured: Up to year 8
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
Abnormal cytology included atypical squamus cells of undetermined significance (ASC-US), low-grade squamous intraepithelial lesion (LSIL), high-grade squamous intraepithelial lesion (HSIL), atypical glandular cells (AGC), atypical squamus cells and cannot exclude HSIL (ASC-H).
Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at Month 6 in the primary study.
Measured: Up to year 8
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
Abnormal cytology included ASC-US, LSIL, HSIL, AGC, and ASC-H.
Oncogenic HPV types assessed included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.
Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at Month 6 in the primary study.
Measured: Up to year 8
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
Abnormal cytology included ASC-US, LSIL, HSIL, AGC and ASC-H.
Oncogenic HPV types assessed included HPV-31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.
Subjects with an event did not report the same event in the earlier studies and were DNA negative for the corresponding HPV type at month 6 in the primary study.
Measured: Up to year 8
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
Abnormal cytology included ASC-US, LSIL, HSIL, AGC and ASC-H.
Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at Month 6 in the primary study.
Measured: Up to year 8
Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With Oncogenic HPV Types Cervical Infection
Abnormal cytology included ASC-US, LSIL, HSIL, AGC, and ASC-H.
Oncogenic HPV types assessed included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.
Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at Month 6 in the primary study.
Measured: Up to year 8
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
Abnormal cytology included ASC-US, LSIL, HSIL, AGC and ASC-H.
Oncogenic HPV types assessed included HPV-31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.
Subjects with an event did not report the same event in the earlier studies and were DNA negative for the corresponding HPV type at month 6 in the primary study.
Measured: Up to year 8
Anti-HPV-16 and Anti-HPV-18 Enzyme-linked Immunosorbent Assay (ELISA) Titers in the Immunogenicity Cohort
Titers are given as Geometric Mean Titers (GMTs) expressed as ELISA Units per milliliter (EL.U/mL).
Measured: At Months 77-101
Anti-HPV-16 and Anti-HPV-18 Pseudovirion-based Neutralization Assay (PBNA) Titers in the Immunogenicity Subset
Data are expressed as Geometric Mean Titers (GMTs). The titer is the serum dilution giving a 50 percent reduction of the signal compared to a control without serum
Measured: At Months 77-101
Number of Subjects With New Onset Chronic Diseases (NOCD) up to Year 7
NOCDs include for example asthma, type I diabetes, allergies, ...
Measured: Up to year 7
Number of Subjects With NOCD up to Year 8
NOCDs included for example asthma, type I diabetes, allergies, ...
NOCDs which were not unblinded at the subject level at the time of the analysis are not presented and will be disclosed as soon as they become available.
Measured: Up to year 8
Number of Subjects With New Onset Autoimmune Disease (NOAD) up to Year 7
Measured: Up to year 7
Number of Subjects With NOAD up to Year 8
The values of NOADs are not yet corresponding to the values in each group. The cases are still blinded. They will be disclosed as soon as the results will be available.
Measured: Up to year 8
Number of Subjects With Medically Significant Conditions up to Year 7
Medically significant conditions include adverse events (AEs) prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.
Medically significant conditions which were not unblinded at the time of the analysis are not presented yet.
Measured: Up to year 7
Number of Subjects With Medically Significant Conditions up to Year 8
Medically significant conditions include adverse events (AEs) prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.
Medically significant conditions which were not unblinded at the time of the analysis are not presented yet.
Measured: up to year 8
Number of Subjects With Serious Adverse Events (SAEs) up to Year 7
SAEs assessed include medical occurrences that result in death, is life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject
Measured: Up to year 7
Number of Subjects With SAEs up to Year 8
SAEs assessed include medical occurrences that result in death, is life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject
Measured: up to year 8
Number of Subjects Presenting Cervical Infections With Any Oncogenic HPV Type.
Oncogenic HPV types included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.
Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had a normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at month 6 in the primary study.
Measured: Up to year 9
Number of Subjects Presenting Cervical Infections With Individual Oncogenic Non-vaccine HPV Type
Oncogenic types included HPV-31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.
Subjects with an event did not report the same event in the earlier studies and were DNA negative for the corresponding HPV type at month 6 in the primary study.
Measured: Up to year 9
Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 and/or HPV-18
Persistent cervical HPV infection (6-month definition) was defined as detection of the same HPV type in cervical specimens at 2 consecutive evaluations over a minimum of 5 months.
Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had a normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at month 6 in the primary study
Measured: Up to year 9
Number of Subjects With Persistent Infection (6-month Definition) With Any Oncogenic HPV Type
Oncogenic HPV types included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.
Persistent cervical HPV infection (6-month definition) was defined as detection of the same HPV type in cervical specimens at 2 consecutive evaluations over a minimum of 5 months.
Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had a normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at month 6 in the primary study.
Measured: Up to year 9
Number of Subjects With Persistent Infection (6-month Definition) With Individual Oncogenic Non-vaccine HPV Types
Oncogenic HPV types included HPV-31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.
Persistent cervical HPV infection (6-month definition) was defined as detection of the same HPV type in cervical specimens at 2 consecutive evaluations over a minimum of 5 months.
Subjects with an event did not report the same event during the earlier studies. Subjects with an event were DNA negative for the corresponding HPV type at Month 6 in the primary study.
Measured: Up to year 9
Number of Subjects With Persistent Infection (12-month Definition) With HPV-16 and/or HPV-18
Persistent cervical HPV infection (12-month definition) was defined as detection of the same HPV type in cervical specimens at all consecutive evaluations over a minimum of 10 months.
Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had a normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at month 6 in the primary study
Measured: Up to year 9
Number of Subjects With Persistent Infection (12-month Definition) With Any Oncogenic HPV Types
Oncogenic HPV types included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.
Persistent cervical HPV infection (12-month definition) was defined as detection of the same HPV type in cervical specimens at all consecutive evaluations over a minimum of 10 months.
Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had a normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at month 6 in the primary study.
Measured: Up to year 9
Number of Subjects With Persistent Infection (12-month Definition) With Individual Oncogenic Non-vaccine HPV Types
Individual oncogenic non-vaccine HPV types include HPV-31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.
Persistent cervical HPV infection (12-month definition) was defined as detection of the same HPV type in cervical specimens at all consecutive evaluations over a minimum of 10 months.
Subjects with an event did not report the same event in the earlier studies and were DNA negative for the corresponding HPV type at month 6 in the primary study
Measured: Up to year 9
Number of Subjects With Histopathologically-confirmed CIN1+ Associated With HPV-16 or HPV-18 Detected Within the Lesional Component of the Cervical Tissue Specimen
Cervical Intraepithelial Neoplasia (CIN1)+ was defined as CIN grades 1,2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer.
Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at Month 6 in the primary study.
Measured: Up to year 9
Number of Subjects With Histopathologically Confirmed CIN1+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen
CIN1+ was defined as CIN grades 1,2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer.
Oncogenic HPV types assessed included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.
Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at Month 6 in the primary study.
Measured: Up to year 9
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
CIN1+ was defined as CIN grades 1,2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer.
Oncogenic HPV types assessed included HPV-31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.
Subjects with an event did not report the same event in the earlier studies and were DNA negative for the corresponding HPV type at Month 6 in the primary study.
Measured: Up to year 9
Number of Subjects With Histopathologically-confirmed CIN2+ Associated With HPV-16 or HPV-18 Detected Within the Lesional Component of the Cervical Tissue Specimen
CIN2+ was defined as CIN grades 2 and 3, AIS and invasive cervical cancer.
Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at Month 6 in the primary study.
Measured: Up to year 9
Number of Subjects With Histopathologically Confirmed CIN2+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen
CIN2+ was defined as CIN grades 2 and 3, AIS and invasive cervical cancer.
Oncogenic HPV types assessed included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.
Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at Month 6 in the primary study.
Measured: Up to year 9
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
CIN2+ was defined as CIN grades 2 and 3, AIS and invasive cervical cancer.
Oncogenic HPV types assessed included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.
Subjects with an event did not report the same event in the earlier studies and were DNA negative for the corresponding HPV type at Month 6 in the primary study.
Measured: Up to year 9
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
Abnormal cytology included atypical squamus cells of undetermined significance (ASC-US), low-grade squamous intraepithelial lesion (LSIL), high-grade squamous intraepithelial lesion (HSIL), atypical glandular cells (AGC), atypical squamus cells and cannot exclude HSIL (ASC-H).
Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at Month 6 in the primary study
Measured: Up to year 9
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
Abnormal cytology included ASC-US, LSIL, HSIL, AGC, and ASC-H.
Oncogenic HPV types assessed included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.
Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at Month 6 in the primary study.
Measured: Up to year 9
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
Abnormal cytology included ASC-US, LSIL, HSIL, AGC and ASC-H.
Oncogenic HPV types assessed included HPV-31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.
Subjects with an event did not report the same event in the earlier studies and were DNA negative for the corresponding HPV type at month 6 in the primary study
Measured: Up to year 9
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
Abnormal cytology included ASC-US, LSIL, HSIL, AGC and ASC-H.
Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at Month 6 in the primary study.
Measured: Up to year 9
Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With Oncogenic HPV Types Cervical Infection
Abnormal cytology included ASC-US, LSIL, HSIL, AGC, and ASC-H.
Oncogenic HPV types assessed included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.
Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at Month 6 in the primary study.
Measured: Up to year 9
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
Abnormal cytology included ASC-US, LSIL, HSIL, AGC and ASC-H.
Oncogenic HPV types assessed included HPV-31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.
Subjects with an event did not report the same event in the earlier studies and were DNA negative for the corresponding HPV type at month 6 in the primary study.
Measured: Up to year 9
Anti-HPV-16 and Anti-HPV-18 Enzyme-linked Immunosorbent Assay (ELISA) Titers in the Immunogenicity Cohort
Titers are given as Geometric Mean Titers (GMTs) expressed as Enzyme-linked immunosorbent assay (ELISA) Units per milliliter (EL.U/mL).
The cut-off-vales assessed were >= 8 or 7 EL. U/mL for anti-HPV-16 and 18, respectively.
Measured: At Month 77 until year 9 (Month 113)
Anti-HPV-16 and Anti-HPV-18 Pseudovirion-based Neutralization Assay (PBNA) Titers in the Immunogenicity Subset
Data are expressed as Geometric Mean Titers (GMTs). The titer is the serum dilution giving a 50 percent reduction of the signal compared to a control without serum
Measured: At Month 77 until year 9 (Month 113)
Number of Subjects With New Onset Chronic Diseases (NOCD) up to Year 9
NOCDs include for example asthma, type I diabetes, allergies, ...
Measured: Up to year 9
Number of Subjects With New Onset Autoimmune Disease (NOAD) up to Year 9.
Measured: Up to year 9
Number of Subjects With Medically Signifant Conditions up to Year 9
Medically significant conditions include adverse events (AEs) prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.
Measured: Up to year 9
Number of Subjects With Serious Adverse Events (SAEs) up to Year 9.
SAEs assessed include medical occurrences that result in death, is life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject
Measured: up to year 9
Number of Subjects Presenting Cervical Infections With Any Oncogenic HPV Type.
Oncogenic HPV types included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.
Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had a normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at month 6 in the primary study.
Measured: Up to year 7
Number of Subjects Presenting Cervical Infections With Individual Oncogenic Non-vaccine HPV Type.
Oncogenic types included HPV-31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.
Subjects with an event did not report the same event in the earlier studies and were DNA negative for the corresponding HPV type at month 6 in the primary study.
Measured: Up to year 7
Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 and/or HPV-18
Persistent cervical HPV infection (6-month definition) was defined as detection of the same HPV type in cervical specimens at 2 consecutive evaluations over a minimum of 5 months.
Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had a normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at month 6 in the primary study
Measured: Up to year 7
Number of Subjects With Persistent Infection (6-month Definition) With Any Oncogenic HPV Type
Oncogenic HPV types included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.
Persistent cervical HPV infection (6-month definition) was defined as detection of the same HPV type in cervical specimens at 2 consecutive evaluations over a minimum of 5 months.
Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had a normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at month 6 in the primary study.
Measured: Up to year 7
Number of Subjects With Persistent Infection (6-month Definition) With Individual Oncogenic Non-vaccine HPV Types
Oncogenic HPV types included HPV-31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.
Persistent cervical HPV infection (6-month definition) was defined as detection of the same HPV type in cervical specimens at 2 consecutive evaluations over a minimum of 5 months.
Subjects with an event did not report the same event during the earlier studies. Subjects with an event were DNA negative for the corresponding HPV type at Month 6 in the primary study.
Measured: Up to year 7
Number of Subjects With Persistent Infection (12-month Definition) With HPV-16 and/or HPV-18
Persistent cervical HPV infection (12-month definition) was defined as detection of the same HPV type in cervical specimens at all consecutive evaluations over a minimum of 10 months.
Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had a normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at month 6 in the primary study.
Measured: Up to year 7
Number of Subjects With Persistent Infection (12-month Definition) With Any Oncogenic HPV Type
Oncogenic HPV types included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.
Persistent cervical HPV infection (12-month definition) was defined as detection of the same HPV type in cervical specimens at all consecutive evaluations over a minimum of 10 months.
Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had a normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at month 6 in the primary study.
Measured: Up to year 7
Number of Subjects With Persistent Infection (12-month Definition) With Individual Oncogenic Non-vaccine HPV Types
Individual oncogenic non-vaccine HPV types include HPV-31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.
Persistent cervical HPV infection (12-month definition) was defined as detection of the same HPV type in cervical specimens at all consecutive evaluations over a minimum of 10 months.
Subjects with an event did not report the same event in the earlier studies and were DNA negative for the corresponding HPV type at month 6 in the primary study.
Measured: Up to year 7
Number of Subjects With Histopathologically-confirmed CIN1+ Associated With HPV-16 or HPV-18 Detected Within the Lesional Component of the Cervical Tissue Specimen
CIN1+ was defined as CIN grades 1,2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer.
Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at Month 6 in the primary study.
Measured: Up to year 7
Number of Subjects With Histopathologically Confirmed CIN1+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen
CIN1+ was defined as CIN grades 1,2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer.
Oncogenic HPV types assessed included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.
Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at Month 6 in the primary study.
Measured: Up to year 7
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
CIN1+ was defined as CIN grades 1,2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer.
Oncogenic HPV types assessed included HPV-31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.
Subjects with an event did not report the same event in the earlier studies and were DNA negative for the corresponding HPV type at Month 6 in the primary study.
Measured: Up to year 7
Number of Subjects With Histopathologically-confirmed CIN2+ Associated With HPV-16 or HPV-18 Detected Within the Lesional Component of the Cervical Tissue Specimen
CIN2+ was defined as CIN grades 2 and 3, AIS and invasive cervical cancer.
Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at Month 6 in the primary study.
Measured: Up to year 7
Number of Subjects With Histopathologically Confirmed CIN2+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen
CIN2+ was defined as CIN grades 2 and 3, AIS and invasive cervical cancer.
Oncogenic HPV types assessed included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.
Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at Month 6 in the primary study.
Measured: Up to year 7
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
CIN2+ was defined as CIN grades 2 and 3, AIS and invasive cervical cancer.
Oncogenic HPV types assessed included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.
Subjects with an event did not report the same event in the earlier studies and were DNA negative for the corresponding HPV type at Month 6 in the primary study.
Measured: Up to year 7
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
Abnormal cytology included atypical squamus cells of undetermined significance (ASC-US), low-grade squamous intraepithelial lesion (LSIL), high-grade squamous intraepithelial lesion (HSIL), atypical glandular cells (AGC), atypical squamus cells and cannot exclude HSIL (ASC-H).
Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at Month 6 in the primary study.
Measured: Up to year 7
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
Abnormal cytology included ASC-US, LSIL, HSIL, AGC, and ASC-H.
Oncogenic HPV types assessed included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.
Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at Month 6 in the primary study.
Measured: Up to year 7
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
Abnormal cytology included ASC-US, LSIL, HSIL, AGC and ASC-H.
Oncogenic HPV types assessed included HPV-31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.
Subjects with an event did not report the same event in the earlier studies and were DNA negative for the corresponding HPV type at month 6 in the primary study.
Measured: Up to year 7
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
Abnormal cytology included ASC-US, LSIL, HSIL, AGC and ASC-H.
Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at Month 6 in the primary study.
Measured: Up to year 7
Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With Oncogenic HPV Types Cervical Infection
Abnormal cytology included ASC-US, LSIL, HSIL, AGC, and ASC-H.
Oncogenic HPV types assessed included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.
Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at Month 6 in the primary study.
Measured: Up to year 7
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
Abnormal cytology included ASC-US, LSIL, HSIL, AGC and ASC-H.
Oncogenic HPV types assessed included HPV-31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.
Subjects with an event did not report the same event in the earlier studies and were DNA negative for the corresponding HPV type at month 6 in the primary study.
Measured: Up to year 7

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2007Sep 2010

First posted20 Aug 2007 (estimated)
Study startNov 2007
Primary completionJul 2008
Study completionSep 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Infections, PapillomavirusStudies of the same condition, open and under way.
More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 433 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00518336
Sponsor's protocol ID: 109616 (Y7)
Other IDs: 109624, 109625
Status last verified: Oct 2016
First submitted: 17 Aug 2007
Last updated: 9 Dec 2016
Results posted: Yes, on ClinicalTrials.gov
Individual data sharing: Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Publications

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.
PubMed 25424918
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.
PubMed 22327492

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 9 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Follow-up Study to Evaluate the Long-term Efficacy of a HPV Vaccine (580299) in Healthy Young Adult Women in Brazil
ClinicalTrials.gov ID: NCT00518336
Acronym / sponsor ID: 109616 (Y7)
Conditions: Infections, Papillomavirus
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 433 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: Nov 2007
Primary completion: Jul 2008 (actual)
Study completion: Sep 2010 (actual)
First posted: 20 Aug 2007 (estimated)
Results: Posted 25 Oct 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Detailed description

In this extension study, women who were vaccinated in the primary study, and participated in the follow-up study, will be followed with visits every 6 months.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Cervarix Group	Experimental	Procedure: Blood sampling, Procedure: Collection of cervical specimen, Biological: CervarixYoung 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.
Placebo Group	Placebo comparator	Procedure: Blood sampling, Procedure: Collection of cervical specimenYoung 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.

Who may qualify

Ages: 15 to 25 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Child, Adult

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (3 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Blood samplingBlood sampling at Visit 3, 5 and 7.	Procedure or surgery	Cervarix Group, Placebo Group
Collection of cervical specimenCollection of cervical specimen at Visit2, 3, 4, 5, 6 and 7.	Procedure or surgery	Cervarix Group, Placebo Group
CervarixThree doses administered intramuscularly at 0, 1 and 6 months.	Biological	Cervarix Group

Primary outcome

Number of Subjects Presenting Cervical Infections With Human Papillomavirus (HPV) -16 and/or HPV-18
Time frame: Up to year 8
Cervical HPV infection was defined as the first detection of an HPV type in a subject previously negative for that HPV type.
Number of Subjects Presenting Cervical Infections With Human Papillomavirus (HPV) -16 and/or HPV-18
Time frame: Up to year 9
Cervical HPV infection was defined as the first detection of an HPV type in a subject previously negative for that HPV type
Number of Subjects Presenting Cervical Infections With Human Papillomavirus (HPV) -16 and /or HPV-18
Time frame: Up to year 7
Cervical HPV infection was defined as the first detection of an HPV type in a subject previously negative for that HPV type.

76 secondary outcomes

Number of Subjects Presenting Cervical Infections With Any Oncogenic HPV Type
Time frame: Up to year 8
Number of Subjects Presenting Cervical Infections With Individual Oncogenic Non-vaccine HPV Type
Time frame: Up to year 8
Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 and/or HPV-18
Time frame: Up to year 8
Number of Subjects With Persistent Infection (6-month Definition) With Any Oncogenic HPV Types
Time frame: Up to year 8
Number of Subjects With Persistent Infection (6-month Definition) With Individual Oncogenic Non-vaccine HPV Types
Time frame: Up to year 8
Number of Subjects With Persistent Infection (12-month Definition) With HPV-16 and/or HPV-18
Time frame: Up to year 8
Number of Subjects With Persistent Infection (12-month Definition) With Any Oncogenic HPV Types
Time frame: Up to year 8
Number of Subjects With Persistent Infection (12-month Definition) With Individual Oncogenic Non-vaccine HPV Types
Time frame: Up to year 8
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
Time frame: Up to year 8
Number of Subjects With Histopathologically Confirmed CIN1+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen
Time frame: Up to year 8
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
Time frame: Up to year 8
Number of Subjects With Histopathologically-confirmed CIN2+ Associated With HPV-16 or HPV-18 Detected Within the Lesional Component of the Cervical Tissue Specimen
Time frame: Up to year 8
Number of Subjects With Histopathologically Confirmed CIN2+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen
Time frame: Up to year 8
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
Time frame: Up to year 8
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
Time frame: Up to year 8
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
Time frame: Up to year 8
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
Time frame: Up to year 8
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
Time frame: Up to year 8
Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With Oncogenic HPV Types Cervical Infection
Time frame: Up to year 8
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
Time frame: Up to year 8
Anti-HPV-16 and Anti-HPV-18 Enzyme-linked Immunosorbent Assay (ELISA) Titers in the Immunogenicity Cohort
Time frame: At Months 77-101
Anti-HPV-16 and Anti-HPV-18 Pseudovirion-based Neutralization Assay (PBNA) Titers in the Immunogenicity Subset
Time frame: At Months 77-101
Number of Subjects With New Onset Chronic Diseases (NOCD) up to Year 7
Time frame: Up to year 7
Number of Subjects With NOCD up to Year 8
Time frame: Up to year 8
Number of Subjects With New Onset Autoimmune Disease (NOAD) up to Year 7
Time frame: Up to year 7
Number of Subjects With NOAD up to Year 8
Time frame: Up to year 8
Number of Subjects With Medically Significant Conditions up to Year 7
Time frame: Up to year 7
Number of Subjects With Medically Significant Conditions up to Year 8
Time frame: up to year 8
Number of Subjects With Serious Adverse Events (SAEs) up to Year 7
Time frame: Up to year 7
Number of Subjects With SAEs up to Year 8
Time frame: up to year 8
Number of Subjects Presenting Cervical Infections With Any Oncogenic HPV Type.
Time frame: Up to year 9
Number of Subjects Presenting Cervical Infections With Individual Oncogenic Non-vaccine HPV Type
Time frame: Up to year 9
Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 and/or HPV-18
Time frame: Up to year 9
Number of Subjects With Persistent Infection (6-month Definition) With Any Oncogenic HPV Type
Time frame: Up to year 9
Number of Subjects With Persistent Infection (6-month Definition) With Individual Oncogenic Non-vaccine HPV Types
Time frame: Up to year 9
Number of Subjects With Persistent Infection (12-month Definition) With HPV-16 and/or HPV-18
Time frame: Up to year 9
Number of Subjects With Persistent Infection (12-month Definition) With Any Oncogenic HPV Types
Time frame: Up to year 9
Number of Subjects With Persistent Infection (12-month Definition) With Individual Oncogenic Non-vaccine HPV Types
Time frame: Up to year 9
Number of Subjects With Histopathologically-confirmed CIN1+ Associated With HPV-16 or HPV-18 Detected Within the Lesional Component of the Cervical Tissue Specimen
Time frame: Up to year 9
Number of Subjects With Histopathologically Confirmed CIN1+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen
Time frame: Up to year 9

Results and safety

Results posted to the registry on 25 Oct 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cervarix Group	222	220
Placebo Group	211	208

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

Time frame: Up to year 8. Number. Unit: subjects

Measure	Cervarix Group n = 178	Placebo Group n = 139
HPV-16 (N=176;122)	0	5
HPV-18 (N=178;133)	0	4
HPV-16/18 (N=176;139)	0	5

Population analysed: According-To-Protocol (ATP) cohort for analysis of efficacy included all subjects for whom differential treatment effect on efficacy was likely (i.e. who met all eligibility criteria in the primary study (580299/001), the first follow-up (580299/007) and the current study), who complied with the protocol and for whom efficacy data were available.

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

Time frame: Up to year 9. Number. Unit: Subjects

Measure	Cervarix Group n = 179	Placebo Group n = 140
HPV-16 (N=179;133)	0	9
HPV-18 (N=177;140)	0	6
HPV-16/18 (N=177;122)	0	9

Population analysed: The According-To-Protocol (ATP) cohort for efficacy included all subjects for whom differential treatment effect on efficacy was likely (i.e. those meeting all eligibility criteria in the primary study (580299/001), the first follow-up (580299/007) and the current study), who complied with the protocol and for whom efficacy data were available.

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

Time frame: Up to year 7. Number. Unit: Subjects

Measure	Cervarix Group n = 171	Placebo Group n = 133
HPV-16 (N=171;128)	0	2
HPV-18 (N=169;133)	0	0
HPV-16/18 (N=169;117)	0	2

Population analysed: The According -To-Protocol (ATP) cohort for efficacy included all subjects for whom differential treatment effect on efficacy was likely (i.e. those meeting all eligibility criteria in the primary study (580299/001), the first follow-up (580299/007) and the current study), who complied with the protocol and for whom efficacy data were available.

76 secondary outcomes are reported in the full results.

Adverse events

Time frame: Serious adverse events: during the follow-up period up to Year 9.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cervarix Group	20 of 224 (8.9%)	0 of 0	Not reported
Placebo Group	11 of 213 (5.2%)	0 of 0	Not reported

Limitations and caveats (from the sponsor): Interim analysis at Year 7 and Year 8 are superseded by the final analysis at Year 9.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 25424918Naud 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.
Derived from this study: PubMed 22327492Roteli-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.
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

GSK Clinical Trials study director

GlaxoSmithKline

5 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Blood sampling, Collection of cervical specimen and Cervarix in people with Infections, Papillomavirus, run by GlaxoSmithKline at 5 sites in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Oct 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Subjects Presenting Cervical Infections With Human Papillomavirus (HPV) -16 and/or HPV-18 (time frame: Up to year 8). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00518336, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2016.