Infections, Papillomavirus
Conditions
Brief summary
Human papillomavirus infection has clearly been recognized as the cause of cervical cancer. Indeed, the infection of the cervix by certain oncogenic types of HPV, if not cleared , can lead over time to cervical cancer in women . This study will evaluate the immunogenicity and the safety of the HPV vaccine in female subjects aged 10 - 14 years in Korea.
Detailed description
Study participants will receive either HPV or hepatitis A vaccine, study duration will last for 7 months and involve a total of 4 visits.
Interventions
BIOLOGICALHPV-16/18 L1/AS04
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE
Eligibility
Sex/Gender
FEMALE
Age
10 Years to 14 Years
Healthy volunteers
Yes
Inclusion criteria
* A female subject between, and including, 10 and 14 years of age at the time of the first vaccination. * Written informed assent from the subject and informed consent from the parent or guardian of the subject should be obtained prior to enrolment. * Subjects must have a negative urine pregnancy test. * Healthy subject before entering the study as established by medical history and clinical examination. * Subject must be of non-childbearing potential.
Exclusion criteria
* Pregnant or breastfeeding. * Previous vaccination against HPV. * Known acute or chronic, clinically significant neurologic, hepatic or renal functional abnormality * History of chronic condition(s) requiring treatment such as cancer, chronic hepatic or kidney disease(s), diabetes, or autoimmune disease.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate antibody responses against HPV-16 and HPV-18 in all HPV vaccine recipients at Month 7. | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate safety and reactogenicity throughout the study period. | — |
Countries
South Korea
Outcome results
None listed