Overview

This trial is active, not recruiting.

Condition infections, papillomavirus
Treatments hpv gsk 580299 vaccine, placebo control
Phase phase 3
Sponsor GlaxoSmithKline
Start date October 2008
End date October 2013
Trial size 6051 participants
Trial identifier NCT00779766, 107638

Summary

This is a multicenter study in which women are planned to receive either the HPV vaccine or control. Study participation will last approximately 48 months and involves a total of eleven scheduled visits.

The Protocol Posting has been updated as the study will be extended by 2 additional years.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose prevention
Arm
(Experimental)
Subjects received 3 doses of Cervarix™ vaccine. Cervarix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
hpv gsk 580299 vaccine
Subjects were planned to receive three doses of the study vaccine administered intramuscularly according to a 0, 1, 6 month vaccination schedule.
(Placebo Comparator)
Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
placebo control
Subjects were planned to receive three doses of the placebo control administered intramuscularly according to a 0, 1, 6 month vaccination schedule.

Primary Outcomes

Measure
Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN1+) and/or Persistent Infection (6 Month+ Definition) Associated With Human Papillomavirus (HPV)-16 and/or HPV-18
time frame: up to Month 24

Secondary Outcomes

Measure
Number of Subjects With Incident Cervical Infection With HPV-16 and/or HPV-18
time frame: up to Month 24
Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With HPV-16 and/or HPV-18
time frame: up to Month 24
Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With HPV-16 and/or HPV-18
time frame: up to Month 24
Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type
time frame: up to Month 24
Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type
time frame: up to Month 24
Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type
time frame: up to Month 24
Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With HPV-16 and/or HPV-18 Cervical Infection
time frame: up to Month 24
Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type
time frame: up to Month 24
Number of Subjects With Histopathologically-confirmed CIN1+ Associated With HPV-16 and/or HPV-18 Cervical Infection
time frame: up to Month 24
Number of Subjects With Histopathologically-confirmed CIN2+ Associated With HPV-16 and/or HPV-18 Cervical Infection
time frame: up to Month 24
Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type
time frame: up to Month 24
Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type
time frame: up to Month 24
Number of Seroconverted Subjects for HPV-16 and HPV-18 Antibodies
time frame: at Months 0, 7, 12, 24, 36 and 48
Number of Subjects With HPV-16 Antibody Concentration Equal to or Above the Assay Cut-off Value, by Pre-vaccination Status
time frame: at Months 0 and 7
Number of Subjects With HPV-18 Antibody Concentration Equal to or Above the Assay Cut-off Value, by Pre-vaccination Status
time frame: at Months 0 and 7
Number of Subjects With HPV-18 Antibody Concentration Equal to or Above the Assay Cut-off Value, by Pre-vaccination Status
time frame: at Months 12, 24, 36 and 48
Titers for HPV-16/HPV-18 Antibodies, by Pre-vaccination Status
time frame: at Months 0 and 7
Titers for HPV-16/HPV-18 Antibodies, by Pre-vaccination Status
time frame: at Months 12, 24, 36 and 48
Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms
time frame: Within 7 days (Days 0-6) after vaccination
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms.
time frame: Within 7 days (Days 0-6) after vaccination
Number of Subjects With Medically Significant Conditions Regardless of Causal Relationship to Vaccination and Intensity.
time frame: up to Month 24
Number of Subjects With HPV-16 Antibody Concentration Equal to or Above the Assay Cut-off Value, by Pre-vaccination Status
time frame: at Months 12, 24, 36 and 48
Number of Subjects With Medically Significant Conditions Regardless of Causal Relationship to Vaccination and Intensity Overall and Stratified According to Month 0 HPV-16 or HPV-18 Serostatus and DNA Status.
time frame: Throughout the study period (up to Month 48)
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Unsolicited Adverse Events (AEs)
time frame: Within Days 0-29 after vaccination
Number of Subjects With Serious Adverse Events (SAEs)
time frame: up to Month 24
Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline
time frame: Within 7 days (Days 0-6) after vaccination
Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline
time frame: Within 7 days (Days 0-6) after vaccination
Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline
time frame: Within 7 days (Days 0-6) after vaccination
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline
time frame: Within 7 days (Days 0-6) after vaccination
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline
time frame: Within 7 days (Days 0-6) after vaccination
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline
time frame: Within 7 days (Days 0-6) after vaccination
Number of Subjects With Medically Significant Conditions Regardless of Causal Relationship to Vaccination and Intensity for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline.
time frame: up to Month 24
Number of Subjects With Medically Significant Conditions Regardless of Causal Relationship to Vaccination and Intensity for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline
time frame: up to Month 24
Number (%) of Subjects With Medically Significant Conditions Regardless of Causal Relationship to Vaccination and Intensity for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline
time frame: up to Month 24
Number of Subjects With Unsolicited Adverse Events for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline
time frame: Within Days 0-29 after vaccination
Number of Subjects With Unsolicited Adverse Events for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline
time frame: Within Days 0-29 after vaccination
Number of Subjects With Unsolicited Adverse Events for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline
time frame: Within Days 0-29 after vaccination
Number of Subjects With Any and Related to Vaccination Serious Adverse Events (SAEs) Overall and Stratified According to Month 0 HPV-16 or HPV-18 Serostatus and DNA Status.
time frame: Throughout the study period (up to Month 48).
Number of Subjects With Serious Adverse Events (SAEs) for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline
time frame: up to Month 24
Number of Subjects With Serious Adverse Events (SAEs) for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline
time frame: up to Month 24
Number of Subjects With Serious Adverse Events (SAEs) for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline
time frame: up to Month 24
Number of Subjects With Pregnancies and Their Outcomes Overall and Stratified According to Month 0 HPV-16 or HPV-18 Serostatus and DNA Status.
time frame: Throughout the study period (up to Month 48)
Number of Subjects With Pregnancies and Their Outcomes
time frame: up to Month 24
Number of Subjects With Pregnancies and Their Outcomes for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline
time frame: up to Month 24
Number of Subjects With Pregnancies and Their Outcomes Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline
time frame: up to Month 24
Number of Subjects With Pregnancies and Their Outcomes for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline
time frame: up to Month 24

Eligibility Criteria

Female participants from 18 years up to 25 years old.

Inclusion Criteria: - Healthy Chinese females between and including 18 and 25 years of age at the time of the first vaccination. - Subjects who the investigator believes that they can and will comply with the requirements of the protocol. - Written informed consent obtained from the subject prior to enrolment. - Healthy subjects as established by medical history and history-directed clinical examination before entering into the study. - Subjects must not be pregnant. Absence of pregnancy will be verified with a urine pregnancy test. - Subjects must be of non-childbearing potential, or if of childbearing potential, they must be abstinent or have practiced adequate contraception for 30 days prior to vaccination and agree to continue such precautions for 2 months after completion of the vaccination series. - Subject must have one single intact cervix. Exclusion Criteria: - Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines 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. - Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days before and 30 days after (i.e., Days 0-29) the first dose of vaccine. - Concurrently participating in another clinical study, at any time during the study period (up to Month 24), in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device). - A subject planning to become pregnant, likely to become pregnant (as determined by the investigator) or planning to discontinue contraceptive precautions during the study period and up to two months after the last vaccine dose. - Pregnant or breastfeeding. Subjects must be at least three months post-pregnancy and not breastfeeding to enter the study. - Previous vaccination against HPV or planned administration of any HPV vaccine other than that foreseen by the protocol during the study period. - Previous administration of components of the investigational vaccine. - History of chronic condition(s) requiring treatment such as cancer or autoimmune disease. - History of allergic disease, suspected allergy or reactions likely to be exacerbated by any component of the vaccine. - Hypersensitivity to latex. - Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination. - Acute disease at the time of enrolment. - Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period. - History of having had colposcopy or has planned a colposcopy to evaluate an abnormal cervical cytology (Pap smear) test.

Additional Information

Official title Efficacy, Immunogenicity and Safety of GlaxoSmithKline Biologicals' HPV GSK 580299 Vaccine in Healthy Chinese Female Subjects
Description This Protocol Posting has been updated following Protocol Amendment 2 28th March 2011.
Trial information was received from ClinicalTrials.gov and was last updated in April 2014.
Information provided to ClinicalTrials.gov by GlaxoSmithKline.