Clinical trial NCT00231413: Human Papilloma Virus Vaccine Immunogenicity and Safety Trial in Young Adult Women With GSK Bio's Novel HPV Vaccine.
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Infections, Papillomavirus
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2005-10-04
Enrollment: 383
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.


Eligibility criteria: Inclusion Criteria:

* A woman between, and including, 18 and 25 years of age at the time of the first vaccination
* Written informed consent from the subject prior to enrolment
* Subject must be free of obvious health problems
* Subject must be of non-childbearing potential and have had no more than 6 lifetime sexual partners

Exclusion Criteria:

* Pregnant or breastfeeding
* A woman planning to become pregnant or planning to discontinue contraceptive precautions during approximately the first nine months of the study (Month 0-8)
* Known acute or chronic, clinically significant pulmonary, cardiovascular, neurologic, hepatic or renal functional abnormality
* History of chronic condition(s) requiring treatment such as cancer, chronic hepatitis or kidney disease(s), diabetes, or autoimmune disease
* Previous vaccination against human papillomavirus (HPV)

Primary outcomes:
measure: Number of Seroconverted Subjects for Anti-Human Papillomavirus (Anti-HPV)-16 at Month 7
timeFrame: At Month 7
measure: Number of Seroconverted Subjects for Anti-HPV-18 at Month 7
timeFrame: At Month 7
measure: Anti-HPV-16 Antibody Titers Assessed by ELISA at Month 7
timeFrame: At Month 7
measure: Anti-HPV-18 Antibody Titers Assessed by ELISA at Month 7
timeFrame: At Month 7
Secondary outcomes:
measure: Number of Seroconverted Subjects for Anti-HPV-16 at Month 2
timeFrame: At Month 2
measure: Number of Seroconverted Subjects for Anti-HPV-18 at Month 2
timeFrame: At Month 2
measure: Anti-HPV-16 Antibody Titers Assessed by ELISA at Month 2
timeFrame: At Month 2
measure: Anti-HPV-18 Antibody Titers Assessed by ELISA at Month 2
timeFrame: At Month 2
measure: Number of Seroconverted Subjects for Anti-HPV-31 at Months 2 and 7
timeFrame: At Month 2 and Month 7
measure: Number of Seroconverted Subjects for Anti-HPV-45 at Months 2 and 7
timeFrame: At Month 2 and Month 7
measure: Anti-HPV-31 Antibody Titers Assessed by ELISA at Months 2 and 7
timeFrame: At Month 2 and Month 7
measure: Anti-HPV-45 Antibody Titers Assessed by ELISA at Months 2 and 7
timeFrame: At Month 2 and Month 7
measure: Number of Subjects With Any and Grade 3 Solicited Local Symptoms
timeFrame: During the 7 day post-vaccination period following each dose and across doses
measure: Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
timeFrame: During the 7 day post-vaccination period following each dose and across doses
measure: Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
timeFrame: During the 30-day post-vaccination period
measure: Number of Subjects With Any Serious Adverse Events (SAEs)
timeFrame: From Day 0 to Month 7
measure: Number of Subjects With Any SAEs During the Extended Safety Follow-up
timeFrame: From Day 0 to Month 12
measure: Number of Subjects Reporting Pregnancies and Outcomes of Reported Pregnancies
timeFrame: From Day 0 to Month 12
measure: Number of Subjects Reporting New Onset of Chronic Diseases (NOCDs)
timeFrame: From Day 0 up to Month 12
measure: Number of Subjects Reporting Medically Significant Conditions
timeFrame: From Day 0 up to Month 12
measure: Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
timeFrame: At Month 2 and Month 7
Other outcomes:
Locations:
city: Aurora
country: United States
facility: GSK Investigational Site
state: Colorado
city: Golden
country: United States
facility: GSK Investigational Site
state: Colorado
city: Kingston
country: United States
facility: GSK Investigational Site
state: Rhode Island
city: Salt Lake City
country: United States
facility: GSK Investigational Site
state: Utah
city: Salt Lake City
country: United States
facility: GSK Investigational Site
state: Utah
city: Bruxelles
country: Belgium
facility: GSK Investigational Site
city: Gent
country: Belgium
facility: GSK Investigational Site
city: Leuven
country: Belgium
facility: GSK Investigational Site
city: Liège
country: Belgium
facility: GSK Investigational Site
city: Roeselare
country: Belgium
facility: GSK Investigational Site
city: Wilrijk
country: Belgium
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Van Damme P, Leroux-Roels G, Simon P, Foidart JM, Donders G, Hoppenbrouwers K, Levin M, Tibaldi F, Poncelet S, Moris P, Dessy F, Giannini SL, Descamps D, Dubin G. Effects of varying antigens and adjuvant systems on the immunogenicity and safety of investigational tetravalent human oncogenic papillomavirus vaccines: results from two randomized trials. Vaccine. 2014 Jun 17;32(29):3694-705. doi: 10.1016/j.vaccine.2014.03.040. Epub 2014 Mar 25.