Human Papilloma Virus Vaccine Consistency and Non-inferiority Trial in Young Adult Women With GSK Bio HPV-16/18
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ClinicalTrials.gov Identifier: NCT00169494 |
Recruitment Status :
Completed
First Posted : September 15, 2005
Last Update Posted : September 12, 2016
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Infections, Papillomavirus | Biological: HPV-16/18 L1/AS04 | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 770 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (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 |
Study Start Date : | September 2004 |
Actual Primary Completion Date : | July 2005 |
Actual Study Completion Date : | July 2005 |
- 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
- Safety of HPV vaccine in entire study period. Immunogenicity bridge between pre-adolescent and adolescent population.

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Ages Eligible for Study: | 10 Years to 25 Years (Child, Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
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).

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00169494
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 |
Study Director: | GSK Clinical Trials | GlaxoSmithKline |
Study Data/Documents: Informed Consent Form

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

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

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

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 |
Other Study ID Numbers: |
580299/012 |
First Posted: | September 15, 2005 Key Record Dates |
Last Update Posted: | September 12, 2016 |
Last Verified: | September 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. |