Evaluation of the Immune Responses of GSK Biologicals' HPV Vaccine Following Manufacturing Process Adaptation.
This study has been completed.
Sponsor:
GlaxoSmithKline
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00250276
First received: November 7, 2005
Last updated: February 2, 2012
Last verified: January 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Human Papillomavirus (HPV) Infection Cervical Neoplasia |
Biological: HPV-16/18 L1/AS04 |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Bio-equivalence Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
| 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) |
Resource links provided by NLM:
Further study details as provided by GlaxoSmithKline:
Primary Outcome Measures:
- "• Demonstration of lot-to-lot consistency in terms of immunogenicity between different lots of HPV-16/18 L1/AS04 vaccine.
- • Demonstration of non-inferiority in terms of immunogenicity of the adapted manufacturing process compared to the previous manufacturing process."
Secondary Outcome Measures:
- • Evaluation of safety and reactogenicity throughout the entire study.
| Enrollment: | 798 |
| Study Start Date: | October 2005 |
| Study Completion Date: | March 2007 |
| Primary Completion Date: | March 2007 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years to 25 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00250276
Locations
| Denmark | |
| GSK Investigational Site | |
| Hvidovre, Denmark, DK-2650 | |
| Lithuania | |
| GSK Investigational Site | |
| Klaipeda, Lithuania, LT-93200 | |
| GSK Investigational Site | |
| Vilnius, Lithuania, LT-07156 | |
| GSK Investigational Site | |
| Vilnius, Lithuania, LT-10207 | |
| Poland | |
| GSK Investigational Site | |
| Krakow, Poland, 31-501 | |
| GSK Investigational Site | |
| Poznan, Poland, 60-533 | |
| GSK Investigational Site | |
| Warszawa, Poland, 01-211 | |
Sponsors and Collaborators
GlaxoSmithKline
Investigators
| Study Director: | GSK Clinical Trials | GlaxoSmithKline |
More Information
Publications:
Descamps D et al. (2009) Safety of human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine for cervical cancer prevention: A pooled analysis of 11 clinical trials. Hum Vaccin. 5(5):51-59.
Rombo L et al. Tolerability of HPV-16/18 AS04-adjuvanted cervical cancer vaccine. Abstract presented at the European Research Organization on Genital Infection and Neoplasia (EUROGIN) International Multidisciplinary Conference. Nice, France, 12-15 November 2008.
| Responsible Party: | Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure |
| ClinicalTrials.gov Identifier: | NCT00250276 History of Changes |
| Other Study ID Numbers: | 104772 |
| Study First Received: | November 7, 2005 |
| Last Updated: | February 2, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Neoplasms |
ClinicalTrials.gov processed this record on June 18, 2013