Human Papilloma Virus Vaccine Consistency and Non-inferiority Trial in Young Adult Women With GSK Bio HPV-16/18
This study has been completed.
Sponsor:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00169494
First received: September 12, 2005
Last updated: January 29, 2015
Last verified: January 2015
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
Human Papilloma virus (HPV) are viruses that cause a common infection 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 often goes away by itself, but if it does not go away (this is called persistent infection), it can lead in women over a long period of time to cancer of the cervix. If a woman is not infected by HPV, it is very unlikely that she will get cervical cancer. This study will evaluate the consistency of consecutive vaccine lots and the non-inferiority of modified manufacturing processes of GSK Biologicals HPV-16/18 vaccine and the vaccine safety, over 12 months, in young adolescents and women of 10-25 years of age at study start. Approximately 750 study subjects will receive different lots of the HPV vaccine administered intramuscularly according to a 0-1-6 month schedule.
| Condition | Intervention | Phase |
|---|---|---|
|
Infections, Papillomavirus |
Biological: HPV-16/18 L1/AS04 |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | Immunogenicity: 3 Consecutive Lots of GSK Biologicals' HPV-16/18 Vaccine Administered Intramuscularly at 0,1,6 Month Schedule in Healthy Females Aged 10-25 Years and Demonstrate Non-inferiority of Candidate HPV Vaccine Manufactured by Modified Production Process |
Further study details as provided by GlaxoSmithKline:
Primary Outcome Measures:
- Demonstration of lot-to-lot consistency in terms of immunogenicity of 3 lots of HPV-16/18 vaccine. [ Designated as safety issue: No ]
- Demonstration of non-inferiority in terms of immunogenicity of the HPV vaccine produced with a revised manufacturing process compared to the HPV vaccine produced with a previous manufacturing process [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Safety of HPV vaccine in entire study period. Immunogenicity bridge between pre-adolescent and adolescent population. [ Designated as safety issue: No ]
| Enrollment: | 770 |
| Study Start Date: | September 2004 |
| Study Completion Date: | July 2005 |
| Primary Completion Date: | July 2005 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 10 Years to 25 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- A woman between, and including, 10 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 have negative urine pregnancy test.
Exclusion Criteria:
- Pregnant or breastfeeding.
- 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).
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00169494
Please refer to this study by its ClinicalTrials.gov identifier: NCT00169494
Locations
| Denmark | |
| GSK Investigational Site | |
| Koebenhavn NV, Denmark, 2400 | |
| GSK Investigational Site | |
| Odense C, Denmark, 5000 | |
| Estonia | |
| GSK Investigational Site | |
| Tallinn, Estonia, 1162 | |
| GSK Investigational Site | |
| Tartu, Estonia, 50417 | |
| Finland | |
| GSK Investigational Site | |
| Seinajoki, Finland, 60100 | |
| GSK Investigational Site | |
| Tampere, Finland, 33200 | |
| Greece | |
| GSK Investigational Site | |
| Athens, Greece, 11527 | |
| GSK Investigational Site | |
| Athens, Greece, 11528 | |
| GSK Investigational Site | |
| Heraklion, Crete, Greece, 71110 | |
| GSK Investigational Site | |
| Thessaloniki, Greece, 54642 | |
| Netherlands | |
| GSK Investigational Site | |
| Rotterdam, Netherlands, 3015 GE | |
| GSK Investigational Site | |
| Rotterdam, Netherlands, 3011 EN | |
| Russian Federation | |
| GSK Investigational Site | |
| Kazan, Russian Federation, 420015 | |
| GSK Investigational Site | |
| Moscow, Russian Federation, 119991 | |
| GSK Investigational Site | |
| Moscow, Russian Federation, 115 478 | |
| GSK Investigational Site | |
| Smolensk, Russian Federation, 214018 | |
| GSK Investigational Site | |
| Volgograd, Russian Federation, 400130 | |
Sponsors and Collaborators
GlaxoSmithKline
Investigators
| Study Director: | GSK Clinical Trials | GlaxoSmithKline |
More Information
Additional Information:
No publications provided
| Responsible Party: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT00169494 History of Changes |
| Other Study ID Numbers: | 580299/012 |
| Study First Received: | September 12, 2005 |
| Last Updated: | January 29, 2015 |
| Health Authority: | Denmark: The Danish National Committee on Biomedical Research Ethics |
ClinicalTrials.gov processed this record on March 03, 2015