Infections, Papillomavirus
Conditions
Keywords
HPV vaccine, serious adverse events (SAEs), medically significant conditions, cervical neoplasia
Brief summary
This phase IIIb study is designed to assess the safety of GlaxoSmithKline Biological's HPV vaccine GSK580299 in female subjects who took part in the HPV-023 (NCT00518336) study and received a placebo in the HPV-001 (NCT00689741) study.
Interventions
BIOLOGICALCervarixTM (GSK580299)
Three intramuscular injections
Sponsors
GlaxoSmithKline
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
26 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Subjects who the investigator believes can and will comply with the requirements of the protocol. * A subject previously enrolled in Study HPV-023 (NCT00518336), who received placebo in Study HPV-001 (NCT00689741), and who is 26 years of age or older. * Written informed consent must be obtained from the subject prior to enrollment. * Free of obvious health problems as established by medical history and clinical examination before entering into the study. * Female subjects of non-childbearing potential may be enrolled in the study. * Female subjects of childbearing potential may be enrolled in the study, if the subject has practiced adequate contraception for 30 days prior to vaccination, and has a negative pregnancy test on the day of vaccination, and has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series.
Exclusion criteria
* Pregnant or breastfeeding: enrollment should be deferred to at least three months after delivery and after breastfeeding is ceased. * A woman planning to become pregnant, likely to become pregnant or planning to discontinue contraceptive precautions during the vaccination phase of the study, and up to two months after the last vaccine dose. * 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. * Previous vaccination against HPV or planned administration of another HPV vaccine during the study other than that foreseen in the protocol. * 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 of each dose of the vaccine, with the exception of administration of routine meningococcal, hepatitis B, hepatitis A, inactivated influenza, diphtheria/tetanus and/or diphtheria/tetanus-containing vaccine up to 8 days before each dose of study vaccine. Enrollment will be deferred until the subject is outside of specified window. * Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product. * Previous administration of vaccine components. * Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination. * Cancer or autoimmune disease under treatment. * History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine. * History of any neurological disorders or seizures. * Acute disease and/or fever at the time of enrollment. Enrollment will be deferred until condition is resolved. * Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests, which in the opinion of the investigator precludes administration of the study vaccine.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Serious Adverse Events (SAEs) | Throughout the study period (from Month 0 up to Month 12) | Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. |
| Number of Subjects With Potential Immune-mediated Disease (pIMDs) | Throughout the study period (from Month 0 up to Month 12) | — |
| Number of Subjects With Medically Significant Conditions (MSCs) | Throughout the study period (from Month 0 up to Month 12) | MSCs 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 Pregnant Subjects Reporting Pregnancy Outcomes | Throughout the study period (from Month 0 up to Month 12) | The pregnancy outcomes were based on reports from pregnant subjects in the study population. Pregnancy outcomes are pregnancies resulting in live births. |
Countries
Brazil
Participant flow
Pre-assignment details
During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms.
Participants by arm
| Arm | Count |
|---|---|
| Cervarix Group Subjects received 3 intramuscular injections of Cervarix™ vaccine according to a 0, 1, 6-month schedule. | 164 |
| Total | 164 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 5 |
| Overall Study | Pregnancy | 1 |
| Overall Study | Protocol Violation | 1 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Cervarix Group |
|---|---|
| Age, Continuous | 30.8 Years STANDARD_DEVIATION 2.9 |
| Sex: Female, Male Female | 164 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 1 / 164 |
Outcome results
Primary
Number of Pregnant Subjects Reporting Pregnancy Outcomes
The pregnancy outcomes were based on reports from pregnant subjects in the study population. Pregnancy outcomes are pregnancies resulting in live births.
Time frame: Throughout the study period (from Month 0 up to Month 12)
Population: The analysis was performed on the number of pregnant subjects participating in the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cervarix Group | Number of Pregnant Subjects Reporting Pregnancy Outcomes | 5 Subjects |
Primary
Number of Subjects With Medically Significant Conditions (MSCs)
MSCs 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: Throughout the study period (from Month 0 up to Month 12)
Population: The analysis was based on the Total Vaccinated cohort, which included all subjects with the study vaccine administered
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cervarix Group | Number of Subjects With Medically Significant Conditions (MSCs) | Any MSCs | 8 Subjects |
| Cervarix Group | Number of Subjects With Medically Significant Conditions (MSCs) | Grade 3 MSCs | 1 Subjects |
| Cervarix Group | Number of Subjects With Medically Significant Conditions (MSCs) | Vaccine-related MSCs | 0 Subjects |
Primary
Number of Subjects With Potential Immune-mediated Disease (pIMDs)
Time frame: Throughout the study period (from Month 0 up to Month 12)
Population: The analysis was based on the Total Vaccinated cohort, which included all subjects with the study vaccine administered
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cervarix Group | Number of Subjects With Potential Immune-mediated Disease (pIMDs) | Any pIMDs | 0 Subjects |
| Cervarix Group | Number of Subjects With Potential Immune-mediated Disease (pIMDs) | Grade 3 pIMDs | 0 Subjects |
| Cervarix Group | Number of Subjects With Potential Immune-mediated Disease (pIMDs) | Related pIMDs | 0 Subjects |
Primary
Number of Subjects With Serious Adverse Events (SAEs)
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Time frame: Throughout the study period (from Month 0 up to Month 12)
Population: The analysis was based on the Total Vaccinated cohort, which included all subjects with the study vaccine administered
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cervarix Group | Number of Subjects With Serious Adverse Events (SAEs) | Related SAEs | 0 Subjects |
| Cervarix Group | Number of Subjects With Serious Adverse Events (SAEs) | Any SAEs | 1 Subjects |
| Cervarix Group | Number of Subjects With Serious Adverse Events (SAEs) | Grade 3 SAEs | 1 Subjects |