NCT00231413

Human Papilloma Virus Vaccine Immunogenicity and Safety Trial in Young Adult Women With GSK Bio's Novel HPV Vaccine.

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)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 383 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: Female
• Age: 18 Years – 25 Years
• Healthy volunteers: Accepted

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.

Conditions

• Infections, Papillomavirus

Interventions

Type	Name	Description
BIOLOGICAL	HPV 16/18 L1 AS04	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.
BIOLOGICAL	HPV-16/18/31/45 L1 AS04 Formulation 1	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.
BIOLOGICAL	HPV-16/18/31/45 L1 AS04 Formulation 2	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.
BIOLOGICAL	HPV-16/18/31/45 L1 AS04 Formulation 3	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.
BIOLOGICAL	HPV-16/18/31/45 L1 AS04 Formulation 4	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.
BIOLOGICAL	HPV-16/18/31/45 L1 AS04 Formulation 5	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.
BIOLOGICAL	HPV-16/18/31/45 L1 AS04 Formulation 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.

Timeline

• Start date: 2005-03-04
• Primary completion: 2006-03-27
• Completion: 2006-03-27
• First posted: 2005-10-04
• Last updated: 2019-12-12
• Results posted: 2019-12-12

Locations

11 sites across 2 countries: United States, Belgium