Infections, Papillomavirus
Conditions
Keywords
Hong Kong, Human papillomavirus, Safety
Brief summary
This study will collect safety data of GlaxoSmithKline Biologicals' human papillomavirus (HPV) vaccine in healthy females of Chinese origin who are unable to receive all three doses of commercially available HPV vaccine before they are 25 years, and were placebo recipients in the primary study (NCT00306241).
Interventions
BIOLOGICALCervarix
Subjects will receive three doses of the HPV vaccine administered intramuscularly according to a 0, 1, 6 month vaccination schedule.
Sponsors
GlaxoSmithKline
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
25 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Subjects enrolled in the primary study (NCT00306241) who received the placebo (aluminium hydroxide \[Al(OH)3\]). * A female who is unable to receive all three doses of commercially available Cervarix before her 25th birthday. * Written informed consent obtained from the subject (prior to enrolment). * Healthy subjects as established by medical history and clinical examination before entering into the study. * Subjects must have a negative urine pregnancy test. * Subjects must be of non-childbearing potential or, if the subject is of childbearing potential, she must be abstinent (and if so, this must be documented in the source documents at each vaccination visit) or must be using adequate contraception for 30 days prior to vaccination and continue for two months after completion of the vaccination series.
Exclusion criteria
* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period. * 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 non-investigational product (pharmaceutical product or device). * Pregnant or breastfeeding. * Planning to become pregnant or likely to become pregnant (as determined by the investigator) or planning to discontinue contraceptive prevention during the study period and up to two months after the last vaccine dose. * History of allergic disease, suspected allergy or reactions likely to be exacerbated by any component of the study vaccine. * Hypersensitivity to latex (found in syringe-tip cap and plunger). * Known acute or chronic, clinically significant neurologic, haematological, hepatic or renal functional abnormality, as determined by previous physical examination or laboratory tests. * Cancer or autoimmune disease under treatment. * Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination. * Previous administration of an adjuvant that used in the HPV-16/18 vaccine. * Previous vaccination against HPV or planned administration of another HPV vaccine during the study. * Acute disease at the time of enrolment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects Reporting Any Serious Adverse Event (SAE) and SAE(s) With a Causal Relationship to Vaccination as Assessed by the Investigator. | During the entire study period (Day 0 up to the telephone contact at Month 12). | SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects. |
Countries
Hong Kong
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Cervarix Group Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly in the deltoid of the non-dominant arm according to a 0, 1, 6-month schedule. | 92 |
| Total | 92 |
Baseline characteristics
| Characteristic | Cervarix Group |
|---|---|
| Age, Continuous | 30.8 Years STANDARD_DEVIATION 4.14 |
| Sex: Female, Male Female | 92 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 | 3 / 92 |
Outcome results
Primary
Number of Subjects Reporting Any Serious Adverse Event (SAE) and SAE(s) With a Causal Relationship to Vaccination as Assessed by the Investigator.
SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.
Time frame: During the entire study period (Day 0 up to the telephone contact at Month 12).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cervarix Group | Number of Subjects Reporting Any Serious Adverse Event (SAE) and SAE(s) With a Causal Relationship to Vaccination as Assessed by the Investigator. | Any | 3 Subjects |
| Cervarix Group | Number of Subjects Reporting Any Serious Adverse Event (SAE) and SAE(s) With a Causal Relationship to Vaccination as Assessed by the Investigator. | Related | 0 Subjects |