Infections, PapillomavirusPhase 3NCT00290277
Evaluate the Immunogenicity & Safety of GSK Biologicals' HPV Vaccine in Female Subjects Aged 10-14 Years
A Phase 3 study testing HPV-16/18 L1/AS04 in people with Infections, Papillomavirus, run by GlaxoSmithKline at 8 sites in South Korea.
Trial 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 . Read more about this study
- Who is it for?
- Ages 10 to 14 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infections, Papillomavirus
- What is being tested?
- HPV-16/18 L1/AS04
- How many people
- 300 participants
- Where
- 8 sitesSouth Korea
- Study dates
- Nov 2005to Aug 2006
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 14 years
- Women only
- Healthy volunteers accepted
- Child
Who may be able to join
- A female subject between, and including, 10 and 14 years of age at the time of the first vaccination.
- Written informed assent from the subject and informed consent from the parent or guardian of the subject should be obtained prior to enrolment.
- Subjects must have a negative urine pregnancy test.
- Healthy subject before entering the study as established by medical history and clinical examination.
- Subject must be of non-childbearing potential.
Who cannot join
- Pregnant or breastfeeding.
- Previous vaccination against 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."
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
South Korea8 sites
GSK Investigational Site
Daegu, 700-712
GSK Investigational Site
Kwangju
GSK Investigational Site
Seoul, 110-744
GSK Investigational Site
Seoul, 133--792
GSK Investigational Site
Seoul, 135-710
GSK Investigational Site
Seoul, 135-720
GSK Investigational Site
Seoul, 137-701
GSK Investigational Site
Seoul, 138-736
About this study
Official title: Evaluate the Immunogenicity & Safety of GSK Biologicals' HPV-16/18 L1/AS04 Vaccine Administered Intramuscularly According to a 0,1,6 Mth Schedule in Healthy Female Subjects Aged 10-14 Yrs
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 evaluate the immunogenicity and the safety of the HPV vaccine in female subjects aged 10 - 14 years in Korea.
Read the detailed description
Study participants will receive either HPV or hepatitis A vaccine, study duration will last for 7 months and involve a total of 4 visits.
- Conditions
- Infections, Papillomavirus
- Being tested
- HPV-16/18 L1/AS04
- Medical subject headings
- Papillomavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HPV-16/18 L1/AS04Biological
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate antibody responses against HPV-16 and HPV-18 in all HPV vaccine recipients at Month 7.
Secondary outcomes (1)
To evaluate safety and reactogenicity throughout the study period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2006 (estimated)
- Study startNov 2005
- Study completionAug 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Infections, PapillomavirusStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00290277
- Sponsor's protocol ID
- 104951
- Status last verified
- Sep 2016
- First submitted
- 10 Feb 2006
- Last updated
- 28 Sep 2016
- Results posted
- No
- Individual data sharing
- Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Publications
Bergman H, Henschke N, Arevalo-Rodriguez I, Buckley BS, Crosbie EJ, Davies JC, Dwan K, Golder SP, Loke YK, Probyn K, Petkovic J, Villanueva G, Morrison J. Human papillomavirus (HPV) vaccination for the prevention of cervical cancer and other HPV-related diseases: a network meta-analysis. Cochrane Database Syst Rev. 2025 Nov 24;11(11):CD015364. doi: 10.1002/14651858.CD015364.pub2.
PubMed 41276263
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluate the Immunogenicity & Safety of GSK Biologicals' HPV-16/18 L1/AS04 Vaccine Administered Intramuscularly According to a 0,1,6 Mth Schedule in Healthy Female Subjects Aged 10-14 Yrs
- ClinicalTrials.gov ID
- NCT00290277
- Acronym / sponsor ID
- 104951
- Conditions
- Infections, Papillomavirus
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Nov 2005
- Study completion
- Aug 2006 (actual)
- First posted
- 13 Feb 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 evaluate the immunogenicity and the safety of the HPV vaccine in female subjects aged 10 - 14 years in Korea.
Detailed description
Study participants will receive either HPV or hepatitis A vaccine, study duration will last for 7 months and involve a total of 4 visits.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 10 to 14 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- A female subject between, and including, 10 and 14 years of age at the time of the first vaccination.
- Written informed assent from the subject and informed consent from the parent or guardian of the subject should be obtained prior to enrolment.
- Subjects must have a negative urine pregnancy test.
- Healthy subject before entering the study as established by medical history and clinical examination.
- Subject must be of non-childbearing potential.
Key exclusion criteria (4 listed)
- Pregnant or breastfeeding.
- Previous vaccination against 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."
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HPV-16/18 L1/AS04 | Biological | – |
Primary outcome
To evaluate antibody responses against HPV-16 and HPV-18 in all HPV vaccine recipients at Month 7.
1 secondary outcome
To evaluate safety and reactogenicity throughout the study period.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2016.
- Derived from this study: PubMed 41276263Bergman H, Henschke N, Arevalo-Rodriguez I, Buckley BS, Crosbie EJ, Davies JC, Dwan K, Golder SP, Loke YK, Probyn K, Petkovic J, Villanueva G, Morrison J. Human papillomavirus (HPV) vaccination for the prevention of cervical cancer and other HPV-related diseases: a network meta-analysis. Cochrane Database Syst Rev. 2025 Nov 24;11(11):CD015364. doi: 10.1002/14651858.CD015364.pub2.
- Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Related trials for Infections, Papillomavirus
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing HPV-16/18 L1/AS04 in people with Infections, Papillomavirus, run by GlaxoSmithKline at 8 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate antibody responses against HPV-16 and HPV-18 in all HPV vaccine recipients at Month 7.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00290277, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2016.