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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: September 9, 2016
Last verified: September 2016
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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 Intervention Model: Parallel Assignment Masking: Double Blind (Participant, Care Provider, 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.
- 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
Secondary Outcome Measures:
- Safety of HPV vaccine in entire study period. Immunogenicity bridge between pre-adolescent and adolescent population.
| 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 (Child, Adult) |
| Sexes 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
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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, 3011 EN | |
| GSK Investigational Site | |
| Rotterdam, Netherlands, 3015 GE | |
| Russian Federation | |
| GSK Investigational Site | |
| Kazan, Russian Federation, 420015 | |
| GSK Investigational Site | |
| Moscow, Russian Federation, 115 478 | |
| GSK Investigational Site | |
| Moscow, Russian Federation, 119991 | |
| 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:
Study Data/Documents: Informed Consent Form
Identifier: 580299/012
For additional information about this study please refer to the GSK Clinical Study Register
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification
Identifier: 580299/012
For additional information about this study please refer to the GSK Clinical Study Register
For additional information about this study please refer to the GSK Clinical Study Register
Annotated Case Report Form
Identifier: 580299/012
For additional information about this study please refer to the GSK Clinical Study Register
For additional information about this study please refer to the GSK Clinical Study Register
Clinical Study Report
Identifier: 580299/012
For additional information about this study please refer to the GSK Clinical Study Register
For additional information about this study please refer to the GSK Clinical Study Register
Statistical Analysis Plan
Identifier: 580299/012
For additional information about this study please refer to the GSK Clinical Study Register
For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol
Identifier: 580299/012
For additional information about this study please refer to the GSK Clinical Study Register
For additional information about this study please refer to the GSK Clinical Study Register
Individual Participant Data Set
Identifier: 580299/012
For additional information about this study please refer to the GSK Clinical Study Register. The results of this study 580299/012 are summarised with studies 107476 (M18), 107477 (M24), and 107479 (M36) on the GSK Clinical Study Register.
For additional information about this study please refer to the GSK Clinical Study Register. The results of this study 580299/012 are summarised with studies 107476 (M18), 107477 (M24), and 107479 (M36) on the GSK Clinical Study Register.
| Responsible Party: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT00169494 History of Changes |
| Other Study ID Numbers: |
580299/012 |
| Study First Received: | September 12, 2005 |
| Last Updated: | September 9, 2016 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site. |
ClinicalTrials.gov processed this record on July 21, 2017