Clinical trial NCT00250276: Evaluation of the Immune Responses of GSK Biologicals' HPV Vaccine Following Manufacturing Process Adaptation.
Official title: Assess Lot-to-lot Consistency of GSK Biologicals' HPV-16/18 L1/AS04 Vaccine Following Manufacturing Adjustments Administered Intramuscularly According to a 0,1,6-mth Schedule in Healthy Female Subjects (18-25 y)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Infections, Papillomavirus
Papillomavirus Vaccines
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2005-11-08
Enrollment: 798
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 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 compare the immune response induced by different lots of the HPV-16/18 L1/AS04 vaccine, following adjustments to the manufacturing process.


Eligibility criteria: Inclusion Criteria:

* A female subject between, and including, 18 and 25 years of age at the time of the first vaccination.
* Written informed consent obtained from the subject prior to enrolment.
* Subject must have a negative urine pregnancy test.
* Healthy subject before entering the study entry as established by medical history and physical examination.
* Subject must be of non-childbearing potential.

Exclusion Criteria:

* pregnant or breastfeeding subject.
* previous vaccination against human papillomavirus (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.

Primary outcomes:
measure: Number of Seroconverted (SCR) Subjects for Anti-Human Papillomavirus Type 16 (Anti-HPV-16) and Anti-Human Papillomavirus Type 18 (Anti-HPV-18)
timeFrame: At Month 7
measure: Number of Seropositive Subjects for Anti-HPV-16 and Anti-HPV-18
timeFrame: At Month 7
Secondary outcomes:
measure: Number of SCR Subjects for Anti-HPV-16 and Anti-HPV-18
timeFrame: At Month 2
measure: Number of Seropositive Subjects for Anti-HPV-16 and Anti-HPV-18
timeFrame: At Month 2
measure: Number of Subjects With Any and Grade 3 Solicited Local Symptoms
timeFrame: During the 7-days (Day 0-6) post-vaccination
measure: Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
timeFrame: During the 7-days (Day 0-6) post-vaccination
measure: Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
timeFrame: During the 7-days (Day 0-6) post-vaccination
measure: Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
timeFrame: During the 7-days (Day 0-6) post-vaccination
measure: Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
timeFrame: During the 7-days (Day 0-6) post-vaccination
measure: Number of Subjects With New Onset Chronic Diseases (NOCDs)
timeFrame: From Month 0 to Month 7
measure: Number of Subjects With Medically Significant Adverse Events (MSAEs)
timeFrame: From Month 0 to Month 7
measure: Number of Subjects With (NOCDs)
timeFrame: From Month 0 to Month 12
measure: Number of Subjects With MSAEs
timeFrame: From Month 0 to Month 12
measure: Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
timeFrame: Within 30 days (Day 0-29) post vaccination
measure: Number of Subjects With Serious Adverse Events (SAEs)
timeFrame: From Month 0 to Month 7
measure: Number of Subjects With Serious Adverse Events (SAEs)
timeFrame: From Month 0 to Month 12
Other outcomes:
Locations:
city: Hvidovre
country: Denmark
facility: GSK Investigational Site
city: Kaunas
country: Lithuania
facility: GSK Investigational Site
city: Klaipeda
country: Lithuania
facility: GSK Investigational Site
city: Vilnius
country: Lithuania
facility: GSK Investigational Site
city: Vilnius
country: Lithuania
facility: GSK Investigational Site
city: Krakow
country: Poland
facility: GSK Investigational Site
city: Poznan
country: Poland
facility: GSK Investigational Site
city: Warszawa
country: Poland
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Descamps D, Hardt K, Spiessens B, Izurieta P, Verstraeten T, Breuer T, Dubin G. Safety of human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine for cervical cancer prevention: a pooled analysis of 11 clinical trials. Hum Vaccin. 2009 May;5(5):332-40. doi: 10.4161/hv.5.5.7211. Epub 2009 May 20.