At a glance
ClinicalIndex Comparison Record- ✓Woman aged 18-25 years at first vaccination
- ✓Non-childbearing potential with no more than 6 lifetime sexual partners
- ✓Free of obvious health problems
- ✕Pregnant or breastfeeding
- ✕Planning pregnancy or discontinuing contraception during first 9 months (Month 0-8) of study
- ✕Known acute or chronic clinically significant pulmonary, cardiovascular, neurologic, hepatic, or renal functional abnormality
- ✕History of chronic conditions requiring treatment: cancer, chronic hepatitis, kidney disease, diabetes, or autoimmune disease
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Dose-range Study to Assess the Safety and Immunogenicity of a Novel HPV Vaccine When Administered Intramuscularly According to a 3-dose Schedule (0,1,6-month) in Healthy Adult Females (18-25 Years of Age)
In Brief
A Phase 2 clinical trial evaluating HPV 16/18 L1 AS04, HPV-16/18/31/45 L1 AS04 Formulation 1, and 5 other interventions for Infections, Papillomavirus. Completed, enrolled 383 participants across 11 sites in 2 countries.
Detailed Summary
Human Papilloma viruses (HPV) are viruses that cause infections of the skin and genitals in men and women. Several types of HPV infection are transmitted by sexual activity and, in women, can infect the cervix (part of the uterus or womb). This infection, if it persists, can lead over a long period of time to cancer of the cervix in women. In collaboration with MedImmune Inc., GlaxoSmithKline Biologicals has developed a HPV vaccine against the oncogenic types HPV-16 and HPV-18 formulated with the adjuvant AS04. GSK Biologicals is also evaluating novel HPV vaccine formulations.This study will evaluate the immunogenicity and safety of a novel GSK Biologicals HPV vaccine in women 18-25 years of age at study start. Approximately 376 study subjects will receive the novel HPV vaccine or the control vaccine administered intramuscularly according to a 0-1-6 month schedule.
Study Details
Timeline
Interventions
3 doses of 0.6 mL supplied as a liquid in individual pre-filled syringes administered intramuscularly in the deltoid muscle of the non-dominant arm, at Day 0, Month 1 and Month 6.
3 doses of 0.6 mL supplied as a liquid in individual pre-filled syringes administered intramuscularly in the deltoid muscle of the non-dominant arm, at Day 0, Month 1 and Month 6.
3 doses of 0.6 mL supplied as a liquid in individual pre-filled syringes administered intramuscularly in the deltoid muscle of the non-dominant arm, at Day 0, Month 1 and Month 6.
3 doses of 0.6 mL supplied as a liquid in individual pre-filled syringes administered intramuscularly in the deltoid muscle of the non-dominant arm, at Day 0, Month 1 and Month 6.
3 doses of 0.6 mL supplied as a liquid in individual pre-filled syringes administered intramuscularly in the deltoid muscle of the non-dominant arm, at Day 0, Month 1 and Month 6.
3 doses of 0.6 mL supplied as a liquid in individual pre-filled syringes administered intramuscularly in the deltoid muscle of the non-dominant arm, at Day 0, Month 1 and Month 6.
3 doses of 0.6 mL supplied as a liquid in individual pre-filled syringes administered intramuscularly in the deltoid muscle of the non-dominant arm, at Day 0, Month 1 and Month 6.