Infections, PapillomavirusPhase 3NCT00169494
Human Papilloma Virus Vaccine Consistency and Non-inferiority Trial in Young Adult Women With GSK Bio HPV-16/18
A Phase 3 study testing HPV-16/18 L1/AS04 in people with Infections, Papillomavirus, run by GlaxoSmithKline at 17 sites in 6 countries.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 10 to 25 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
- 770 participants
- Where
- 17 sitesin 6 countries
- Study dates
- Sep 2004to Jul 2005
- 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 25 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
17 sites in 6 countries.
17 sites in 6 countries
Russia5 sites
GSK Investigational Site
Kazan', 420015
GSK Investigational Site
Moscow, 115 478
GSK Investigational Site
Moscow, 119991
GSK Investigational Site
Smolensk, 214018
GSK Investigational Site
Volgograd, 400130
Greece4 sites
GSK Investigational Site
Athens, 11527
GSK Investigational Site
Athens, 11528
GSK Investigational Site
Heraklion, Crete, 71110
GSK Investigational Site
Thessaloniki, 54642
Denmark2 sites
GSK Investigational Site
Koebenhavn NV, 2400
GSK Investigational Site
Odense C, 5000
Estonia2 sites
GSK Investigational Site
Tallinn, 1162
GSK Investigational Site
Tartu, 50417
Finland2 sites
GSK Investigational Site
Seinäjoki, 60100
GSK Investigational Site
Tampere, 33200
Netherlands2 sites
GSK Investigational Site
Rotterdam, 3011 EN
GSK Investigational Site
Rotterdam, 3015 GE
About this study
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
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.
- 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.
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 outcomes (1)
Safety of HPV vaccine in entire study period. Immunogenicity bridge between pre-adolescent and adolescent population.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startSep 2004
- Primary completionJul 2005
- Study completionJul 2005
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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 770 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
- NCT00169494
- Sponsor's protocol ID
- 580299/012
- Status last verified
- Sep 2016
- First submitted
- 12 Sep 2005
- Last updated
- 12 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
Lehtinen M, Lagheden C, Luostarinen T, Eriksson T, Apter D, Bly A, Gray P, Harjula K, Heikkila K, Hokkanen M, Karttunen H, Kuortti M, Nieminen P, Nummela M, Paavonen J, Palmroth J, Petaja T, Pukkala E, Soderlund-Strand A, Veivo U, Dillner J. Human papillomavirus vaccine efficacy against invasive, HPV-positive cancers: population-based follow-up of a cluster-randomised trial. BMJ Open. 2021 Dec 30;11(12):e050669. doi: 10.1136/bmjopen-2021-050669.
PubMed 35149535
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00169494
- Acronym / sponsor ID
- 580299/012
- Conditions
- Infections, Papillomavirus
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 770 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Sep 2004
- Primary completion
- Jul 2005 (actual)
- Study completion
- Jul 2005 (actual)
- First posted
- 15 Sep 2005 (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 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
Who may qualify
- Ages
- 10 to 25 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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).
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
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
1 secondary outcome
Safety of HPV vaccine in entire study period. Immunogenicity bridge between pre-adolescent and adolescent population.
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 12 Sep 2016.
- Derived from this study: PubMed 35149535Lehtinen M, Lagheden C, Luostarinen T, Eriksson T, Apter D, Bly A, Gray P, Harjula K, Heikkila K, Hokkanen M, Karttunen H, Kuortti M, Nieminen P, Nummela M, Paavonen J, Palmroth J, Petaja T, Pukkala E, Soderlund-Strand A, Veivo U, Dillner J. Human papillomavirus vaccine efficacy against invasive, HPV-positive cancers: population-based follow-up of a cluster-randomised trial. BMJ Open. 2021 Dec 30;11(12):e050669. doi: 10.1136/bmjopen-2021-050669.
- Month 18 FULink provided by the sponsor.
- Month 24 FULink provided by the sponsor.
- Month 36 FULink provided by the sponsor.
- Month 48 FULink 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.
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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
17 sites in 6 countries: 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 17 sites in 6 countries.
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 4 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 12 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 17 sites in Russia, Greece, Denmark, Estonia, Finland and 1 more country. 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?
Demonstration of lot-to-lot consistency in terms of immunogenicity of 3 lots of HPV-16/18 vaccine.. The study lists 2 primary outcomes in all. 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 NCT00169494, 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 12 Sep 2016.