Back to resultsFollow-up Study to Evaluate the Safety and Immunogenicity of a HPV Vaccine (580299) in North America
Primary Purpose
Infections, Papillomavirus
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Cervarix™
Sponsored by
About this trial
This is an interventional prevention trial for Infections, Papillomavirus focused on measuring HPV vaccine, Cervical cancer, Human papillomavirus infection
Eligibility Criteria
Inclusion Criteria:
- A subject whom the investigator believes that she can and will comply with the requirements of the protocol
- Must have received three doses of study vaccine or placebo control in study 580299/001.
- Must have completed study 580299/007.
- Written informed consent must be obtained from the subject prior to enrollment in the study.
- Healthy subjects, as established by medical history and history-directed clinical examination before entering into the study.
- Subject must have a negative urine pregnancy test.
- Subject must be at least three months post-termination of a pregnancy.
- Subject must be of non-childbearing potential,or subjects are required to be abstinent or use adequate contraceptive precautions for 30 days prior to vaccination. Subjects are also required to agree to continue such precautions for two months after completion of the vaccination series.
Exclusion Criteria:
- Pregnant or breastfeeding.
- A woman planning to become pregnant or planning to discontinue contraceptive precautions during the study until approximately 2 months after the last vaccination.
- Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose or planned administration during the study period.
- Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days of each dose of vaccine. Administration of some routine vaccines up to 8 days before each dose of study vaccine is allowed.
- Previous vaccination against HPV, or planned administration of any HPV vaccine other than that foreseen by the study protocol during the study period.
- previous administration of components of the investigational vaccine outside of protocol 580299/001.
- Any medically diagnosed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination
- History of allergic disease, suspected allergy or reactions likely to be exacerbated by any component of the study vaccines,
- Hypersensitivity to latex
- Acute or chronic, clinically significant pulmonary, cardiovascular, neurologic, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
- Cancer or autoimmune disease under treatment.
- Administration of immunoglobulins and/or any blood products within the three months (90 days) preceding enrollment or planned administration during the study period.
- Acute disease at the time of enrollment. All vaccines can be administered to persons with a minor illness
- Heavy bleeding or heavy vaginal discharge in which a pelvic exam cannot be performed.
Sites / Locations
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Cervarix™ 4-Dose Group
Cervarix™ 3-Dose Group
Arm Description
Subjects who had received 3 doses of Cervarix™ in study 580299/001 (NCT00689741), received a 4th dose of Cervarix™ on Day 0 in the current study.
Subjects who had received 3 doses of placebo in study 580299/001 (NCT00689741), received 3 doses of Cervarix™ (Day 0, Month 1 and Month 6) in the current study.
Outcomes
Primary Outcome Measures
Number of Subjects With Anti-human Papilloma Virus-16 (Anti-HPV-16) and Anti-HPV-18 Antibody Titers Greater Than or Equal to Pre-defined Cut-off Values
Cut-off values assessed include 8 Enzyme-linked immunosorbent assay units per milliliter (EL.U/mL) for anti-HPV-16 antibodies and 7 EL.U/mL for anti-HPV-18 antibodies.
Anti-HPV-16 and Anti-HPV-18 Antibody Titers
Titers are given as geometric mean titers (GMTs) calculated on all subjects.
Secondary Outcome Measures
Number of Subjects With Anti-HPV-16 and Anti-HPV-18 Greater Than or Equal to Pre-defined Cut-off Values
Cut-off values assessed include 8 EL.U/mL for anti-HPV-16 antibodies and 7 EL.U/mL for anti-HPV-18 antibodies.
Anti-HPV-16 and Anti-HPV-18 Antibody Titers
Titers are given as GMTs calculated on all subjects.
Number of Subjects With Antibody Titers Against Other Oncogenic HPV Types (HPV-31 & HPV-45) Greater Than or Equal to 59 EL.U/mL
Anti-HPV-31 and Anti-HPV-45 Antibody Titers
Titers are given as geometric mean titers (GMTs) calculated on all subjects.
Number of Subjects With Cluster of Differentiation 4 (CD4) T Cell-mediated Immune Responses Specific to Defined Oncogenic HPV Types
CD4 T cell-mediated immune responses against the antigens HPV-16, HPV-18, HPV-31 and HPV-45 were analyzed for cells expressing at least 2 of the following immune markers: CD40 Ligand, Interleukin-2, Tumor Necrosis Factor alpha or Interferon-gamma.
An immune response is defined as 500 or more antigen-specific CD4 T-cells per million CD4 T-cells.
Number of Subjects With Cluster of Differentiation 8 (CD8) T Cell-mediated Immune Responses Specific to Defined Oncogenic HPV Types
CD8 T cell-mediated immune responses against the antigens HPV-16, HPV-18, HPV-31 and HPV-45 were analyzed for cells expressing at least 2 of the following immune markers: CD40 Ligand, Interleukin-2, Tumor Necrosis Factor alpha or Interferon-gamma.
An immune response is defined as 200 or more antigen-specific CD8 T-cells per million CD8 T-cells.
Number of Subjects With B Cell-mediated Immune Responses Specific to Defined Oncogenic HPV Types
B-cell-mediated immune responses against the antigens HPV-16, HPV-18, HPV-31 and HPV-45 were measured by Enzyme-linked immunosorbent spot (ELISPOT) assay.
A memory B-cell immune response was defined as presence of any antigen-specific memory B-cells per million B-cells.
Number of Subjects Seropositive for Anti-HPV-16 and Anti-HPV-18 Antibodies in Cervico-vaginal Secretion Samples
Seropositivity was defined as the detection of antibody titers above the limit of quantification by Enzyme-Linked Immunosorbant Assay. Defining a cut-off is technically not possible for this assay.
Analyses were done in all collected samples from the evaluable subjects who provided cervical samples, with < 200 erythrocytes per microliter.
Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies in Cervico-vaginal Secretion Samples
Titers are given as Geometric Mean Titers (GMTs) expressed as Enzyme-linked Immunosorbent Assay Units Per Milliliter (EL.U/mL).
Analyses were done in all collected samples from the evaluable subjects who provided cervical samples with < 200 erythrocytes per microliter.
Number of Subjects Reporting Solicited Local Symptoms
Solicited local symptoms assessed include pain, redness and swelling at the injection site.
Solicited symptoms reported after the 4th vaccine dose in the 4-dose Group and across the 3 doses administered during this study in the 3-dose Group are disclosed.
Number of Subjects Reporting Solicited General Symptoms
Solicited general symptoms assessed include arthralgia, fatigue, fever, gastrointestinal discomfort, headache, myalgia, rash and urticaria.
Solicited symptoms reported after the 4th vaccine dose in the 4-dose Group and across the 3 doses administered during this study in the 3-dose Group are disclosed.
Number of Subjects Reporting Unsolicited Adverse Events (AE)
An unsolicited adverse event is defined as any adverse event (AE) reported in addition to those solicited during the clinical study. Also any "solicited" symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event.
AEs reported after the 4th vaccine dose in the 4-dose Group and after the 3 doses administered in this study in the 3-dose Group are disclosed.
Outcome of Any Reported Pregnancies
Information on any subject who became pregnant while participating in this study was collected. The outcomes of the pregnancies are reported below.
Number of Subjects With New Onset of Chronic Diseases (NOCDs), New Onset of Autoimmune Diseases (NOADs) and Medically Significant Conditions (MSCs)
NOCDs include autoimmune disorders, asthma, type I diabetes, allergies. MSC include 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.
Number of Subjects Reporting Serious Adverse Events (SAEs)
SAEs assessed include medical occurrences that result in death, are 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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00546078
Brief Title
Follow-up Study to Evaluate the Safety and Immunogenicity of a HPV Vaccine (580299) in North America
Official Title
Safety and Immunogenicity Study of an Additional Dose of HPV Vaccine (580299) in Young, Adult Women in North America.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
January 14, 2008 (undefined)
Primary Completion Date
December 22, 2008 (Actual)
Study Completion Date
December 1, 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
4. Oversight
5. Study Description
Brief Summary
Infection with human papillomavirus (HPV) has been clearly established as the central cause of cervical cancer. This study will further evaluate induction of immune memory and anamnestic responses in women who previously took part in the primary study (580299/001) and follow-up study (580299/007). Subjects were aged 15-25 yrs at the time of entry into the primary study and participation in the follow-up study lasted approximately 6 years. In the primary and follow-up studies, subjects were protected against HPV-16 and HPV-18 endpoints and had sustained antibody responses to both vaccine types over at least 5.5 years of follow-up. All subjects from North American study sites that completed the follow-up study will be invited to take part in the current study. The study will evaluate the safety and immunogenicity of a dose of GSK Biologicals HPV vaccine (580299) in women who had been immunologically primed in the primary study.
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infections, Papillomavirus
Keywords
HPV vaccine, Cervical cancer, Human papillomavirus infection
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
116 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cervarix™ 4-Dose Group
Arm Type
Experimental
Arm Description
Subjects who had received 3 doses of Cervarix™ in study 580299/001 (NCT00689741), received a 4th dose of Cervarix™ on Day 0 in the current study.
Arm Title
Cervarix™ 3-Dose Group
Arm Type
Experimental
Arm Description
Subjects who had received 3 doses of placebo in study 580299/001 (NCT00689741), received 3 doses of Cervarix™ (Day 0, Month 1 and Month 6) in the current study.
Intervention Type
Biological
Intervention Name(s)
Cervarix™
Other Intervention Name(s)
GSK Biologicals' HPV Vaccine GSK580299
Intervention Description
Intramuscular injection, one or three doses
Primary Outcome Measure Information:
Title
Number of Subjects With Anti-human Papilloma Virus-16 (Anti-HPV-16) and Anti-HPV-18 Antibody Titers Greater Than or Equal to Pre-defined Cut-off Values
Description
Cut-off values assessed include 8 Enzyme-linked immunosorbent assay units per milliliter (EL.U/mL) for anti-HPV-16 antibodies and 7 EL.U/mL for anti-HPV-18 antibodies.
Time Frame
At Day 7 and Month 1 (Day 30)
Title
Anti-HPV-16 and Anti-HPV-18 Antibody Titers
Description
Titers are given as geometric mean titers (GMTs) calculated on all subjects.
Time Frame
At Day 7 and at Month 1 (Day 30)
Secondary Outcome Measure Information:
Title
Number of Subjects With Anti-HPV-16 and Anti-HPV-18 Greater Than or Equal to Pre-defined Cut-off Values
Description
Cut-off values assessed include 8 EL.U/mL for anti-HPV-16 antibodies and 7 EL.U/mL for anti-HPV-18 antibodies.
Time Frame
At Month 7 and Month 18
Title
Anti-HPV-16 and Anti-HPV-18 Antibody Titers
Description
Titers are given as GMTs calculated on all subjects.
Time Frame
At Month 7 and Month 18
Title
Number of Subjects With Antibody Titers Against Other Oncogenic HPV Types (HPV-31 & HPV-45) Greater Than or Equal to 59 EL.U/mL
Time Frame
Day 0, Month 1 (Day 30), Month 7 and Month 18
Title
Anti-HPV-31 and Anti-HPV-45 Antibody Titers
Description
Titers are given as geometric mean titers (GMTs) calculated on all subjects.
Time Frame
Day 7, Month 1 (Day 30), Month 7 and Month 18
Title
Number of Subjects With Cluster of Differentiation 4 (CD4) T Cell-mediated Immune Responses Specific to Defined Oncogenic HPV Types
Description
CD4 T cell-mediated immune responses against the antigens HPV-16, HPV-18, HPV-31 and HPV-45 were analyzed for cells expressing at least 2 of the following immune markers: CD40 Ligand, Interleukin-2, Tumor Necrosis Factor alpha or Interferon-gamma.
An immune response is defined as 500 or more antigen-specific CD4 T-cells per million CD4 T-cells.
Time Frame
Day 0, Month 1 [Day 30], Month 7 and Month 18
Title
Number of Subjects With Cluster of Differentiation 8 (CD8) T Cell-mediated Immune Responses Specific to Defined Oncogenic HPV Types
Description
CD8 T cell-mediated immune responses against the antigens HPV-16, HPV-18, HPV-31 and HPV-45 were analyzed for cells expressing at least 2 of the following immune markers: CD40 Ligand, Interleukin-2, Tumor Necrosis Factor alpha or Interferon-gamma.
An immune response is defined as 200 or more antigen-specific CD8 T-cells per million CD8 T-cells.
Time Frame
Day 0, Month 1 [Day 30], Month 7 and Month 18
Title
Number of Subjects With B Cell-mediated Immune Responses Specific to Defined Oncogenic HPV Types
Description
B-cell-mediated immune responses against the antigens HPV-16, HPV-18, HPV-31 and HPV-45 were measured by Enzyme-linked immunosorbent spot (ELISPOT) assay.
A memory B-cell immune response was defined as presence of any antigen-specific memory B-cells per million B-cells.
Time Frame
Day 0, Month 1 [Day 30], Month 7 and Month 18
Title
Number of Subjects Seropositive for Anti-HPV-16 and Anti-HPV-18 Antibodies in Cervico-vaginal Secretion Samples
Description
Seropositivity was defined as the detection of antibody titers above the limit of quantification by Enzyme-Linked Immunosorbant Assay. Defining a cut-off is technically not possible for this assay.
Analyses were done in all collected samples from the evaluable subjects who provided cervical samples, with < 200 erythrocytes per microliter.
Time Frame
Day 0, Month 1 (Day 30), Month 7 and Month 18
Title
Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies in Cervico-vaginal Secretion Samples
Description
Titers are given as Geometric Mean Titers (GMTs) expressed as Enzyme-linked Immunosorbent Assay Units Per Milliliter (EL.U/mL).
Analyses were done in all collected samples from the evaluable subjects who provided cervical samples with < 200 erythrocytes per microliter.
Time Frame
Day 0, Month 1 (Day 30), Month 7 and Month 18
Title
Number of Subjects Reporting Solicited Local Symptoms
Description
Solicited local symptoms assessed include pain, redness and swelling at the injection site.
Solicited symptoms reported after the 4th vaccine dose in the 4-dose Group and across the 3 doses administered during this study in the 3-dose Group are disclosed.
Time Frame
Within 7 days after vaccination
Title
Number of Subjects Reporting Solicited General Symptoms
Description
Solicited general symptoms assessed include arthralgia, fatigue, fever, gastrointestinal discomfort, headache, myalgia, rash and urticaria.
Solicited symptoms reported after the 4th vaccine dose in the 4-dose Group and across the 3 doses administered during this study in the 3-dose Group are disclosed.
Time Frame
Within 7 days of vaccination
Title
Number of Subjects Reporting Unsolicited Adverse Events (AE)
Description
An unsolicited adverse event is defined as any adverse event (AE) reported in addition to those solicited during the clinical study. Also any "solicited" symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event.
AEs reported after the 4th vaccine dose in the 4-dose Group and after the 3 doses administered in this study in the 3-dose Group are disclosed.
Time Frame
Within 30 days of vaccination
Title
Outcome of Any Reported Pregnancies
Description
Information on any subject who became pregnant while participating in this study was collected. The outcomes of the pregnancies are reported below.
Time Frame
From Day 0 up to Month 18
Title
Number of Subjects With New Onset of Chronic Diseases (NOCDs), New Onset of Autoimmune Diseases (NOADs) and Medically Significant Conditions (MSCs)
Description
NOCDs include autoimmune disorders, asthma, type I diabetes, allergies. MSC include 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.
Time Frame
From Day 0 up to Month 18
Title
Number of Subjects Reporting Serious Adverse Events (SAEs)
Description
SAEs assessed include medical occurrences that result in death, are 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.
Time Frame
From Day 0 up to Month 18
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
A subject whom the investigator believes that she can and will comply with the requirements of the protocol
Must have received three doses of study vaccine or placebo control in study 580299/001.
Must have completed study 580299/007.
Written informed consent must be obtained from the subject prior to enrollment in the study.
Healthy subjects, as established by medical history and history-directed clinical examination before entering into the study.
Subject must have a negative urine pregnancy test.
Subject must be at least three months post-termination of a pregnancy.
Subject must be of non-childbearing potential,or subjects are required to be abstinent or use adequate contraceptive precautions for 30 days prior to vaccination. Subjects are also required to agree to continue such precautions for two months after completion of the vaccination series.
Exclusion Criteria:
Pregnant or breastfeeding.
A woman planning to become pregnant or planning to discontinue contraceptive precautions during the study until approximately 2 months after the last vaccination.
Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period.
Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose or planned administration during the study period.
Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days of each dose of vaccine. Administration of some routine vaccines up to 8 days before each dose of study vaccine is allowed.
Previous vaccination against HPV, or planned administration of any HPV vaccine other than that foreseen by the study protocol during the study period.
previous administration of components of the investigational vaccine outside of protocol 580299/001.
Any medically diagnosed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination
History of allergic disease, suspected allergy or reactions likely to be exacerbated by any component of the study vaccines,
Hypersensitivity to latex
Acute or chronic, clinically significant pulmonary, cardiovascular, neurologic, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
Cancer or autoimmune disease under treatment.
Administration of immunoglobulins and/or any blood products within the three months (90 days) preceding enrollment or planned administration during the study period.
Acute disease at the time of enrollment. All vaccines can be administered to persons with a minor illness
Heavy bleeding or heavy vaginal discharge in which a pelvic exam cannot be performed.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
San Francisco
State/Province
California
ZIP/Postal Code
94118
Country
United States
Facility Name
GSK Investigational Site
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912-3500
Country
United States
Facility Name
GSK Investigational Site
City
Bardstown
State/Province
Kentucky
ZIP/Postal Code
40004
Country
United States
Facility Name
GSK Investigational Site
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
GSK Investigational Site
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131
Country
United States
Facility Name
GSK Investigational Site
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
GSK Investigational Site
City
Grove City
State/Province
Pennsylvania
ZIP/Postal Code
16127
Country
United States
Facility Name
GSK Investigational Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
GSK Investigational Site
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15241
Country
United States
Facility Name
GSK Investigational Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78205
Country
United States
Facility Name
GSK Investigational Site
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84109
Country
United States
Facility Name
GSK Investigational Site
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Facility Name
GSK Investigational Site
City
Marshfield
State/Province
Wisconsin
ZIP/Postal Code
54449
Country
United States
Facility Name
GSK Investigational Site
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2C8
Country
Canada
Facility Name
GSK Investigational Site
City
Langley
State/Province
British Columbia
ZIP/Postal Code
V3A 4H9
Country
Canada
Facility Name
GSK Investigational Site
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3E 0J9
Country
Canada
Facility Name
GSK Investigational Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Citations:
PubMed Identifier
23063422
Citation
Moscicki AB, Wheeler CM, Romanowski B, Hedrick J, Gall S, Ferris D, Poncelet S, Zahaf T, Moris P, Geeraerts B, Descamps D, Schuind A. Immune responses elicited by a fourth dose of the HPV-16/18 AS04-adjuvanted vaccine in previously vaccinated adult women. Vaccine. 2012 Dec 17;31(1):234-41. doi: 10.1016/j.vaccine.2012.09.037. Epub 2012 Oct 11.
Results Reference
background
Citation
Moscicki B et al. Anamnestic response elicited by a fourth dose of the HPV-16/18 ASO4-adjuvanted vaccine in young women. Abstract presented at European Research Organization on Genital Infection and Neoplasia 2010 (EUROGIN). Monte Carlo, Monaco, 17-20 February 2010.
Results Reference
background
Citation
Moscicki B et al. Anamnestic response to non-vaccine types elicited by a fourth dose of the HPV-16/18 ASO4-adjuvanted vaccine in young women. Abstract presented at European Research Organization on Genital Infection and Neoplasia 2010 (EUROGIN). Monte Carlo, Monaco, 17-20 February 2010.
Results Reference
background
Links:
URL
https://www.clinicalstudydatarequest.com
Description
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
Available IPD and Supporting Information:
Available IPD/Information Type
Individual Participant Data Set
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
109628
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Dataset Specification
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
109628
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Clinical Study Report
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
109628
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Annotated Case Report Form
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
109628
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Informed Consent Form
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
109628
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Study Protocol
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
109628
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Statistical Analysis Plan
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
109628
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Learn more about this trial
Follow-up Study to Evaluate the Safety and Immunogenicity of a HPV Vaccine (580299) in North America
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