Papillomavirus Type 16/18 InfectionPhase 3NCT00337818
Human Papillomavirus (HPV) Vaccine Consistency and Non-inferiority Trial in Young Adult Women
A Phase 3 study testing Cervarix™ in people with Papillomavirus Type 16/18 Infection and Cervical Intraepithelial Neoplasia, run by GlaxoSmithKline at 1 site in Estonia.
Trial summary
The study will be extended for subjects who received all three doses of vaccine in Finland, Denmark and Estonia to determine long-term safety and immunogenicity of the HPV-16/18 vaccine. Human Papilloma virus (HPV) are viruses that cause a common infection of the skin and genitals in men and women. 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
- Papillomavirus Type 16/18 Infection, Cervical Intraepithelial Neoplasia
- What is being tested?
- Cervarix™
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 770 participants
- Where
- 1 siteEstonia
- Study dates
- Jun 2006to Jan 2009
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 female who enrolled in the HPV-012 (NCT00337818) study in Denmark, Estonia and Finland, received three doses of vaccine and completed Visit 4 (Month 7).
- Written informed consent obtained from the subject prior to enrolment (for subjects below the legal age of consent, written informed consent must be obtained from a parent or legally acceptable representative (LAR) and, in addition, the subject must sign and personally date a written informed assent).
Who cannot join
- Use of any investigational or non-registered product (drug or vaccine) or planned use during the study period.
- Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
- Chronic administration of immunosuppressants or other immune-modifying drugs occurring less than three months prior to blood sampling.
- Administration of immunoglobulins and/or any blood products within the three months preceding blood sampling.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Long-term, Open, Follow-up of the Immunogenicity and Safety of GlaxoSmithKline Biologicals' HPV-16/18 L1/AS04 Vaccine in Healthy Female Subjects Vaccinated Either Pre- or Post-menarche in the Primary Study
The study will be extended for subjects who received all three doses of vaccine in Finland, Denmark and Estonia to determine long-term safety and immunogenicity of the HPV-16/18 vaccine. 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 GlaxoSmithKline 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.
Read the detailed description
Approximately 750 study subjects received different lots of the HPV vaccine administered intramuscularly according to a 0-1-6 month schedule.
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
- Being tested
- Cervarix™
- Keywords
- Non-inferiority, Immunogenicity, HPV Vaccine Consistency
- Medical subject headings
- Uterine Cervical Dysplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cervarix™Biological
Three doses of vaccine according to a 0, 1, 6 month schedule (during the primary study)
| Study group | Role | What they receive |
|---|---|---|
| Cervarix New Process | Experimental | Subjects aged 15 to 25 years received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus [HPV]) produced with the new manufacturing process. Receives: Biological: Cervarix™ |
| Cervarix Old Process Group | Experimental | Subjects aged 15 to 25 years who received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus [HPV]) produced with the old manufacturing process. Receives: Biological: Cervarix™ |
| Cervarix Young/Lot 1 Group | Experimental | Subjects aged 10 to 14 years, who received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus [HPV]) produced with the new manufacturing process (Lot 1). Receives: Biological: Cervarix™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies
Titers are given as Geometric Mean Titers (GMTs) expressed as Enzyme-linked Immunosorbent Assay Units Per Milliliter (EL.U/mL).
*Data for Month 18 outcome variables were incorporated into the Month 24 analyses.
Measured: At months 18*, 24, 36 and 48
Secondary outcomes (4)
Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies in Cervical Samples
Titers are given as Geometric Mean Titers (GMTs) expressed as EL.U/mL.
Measured: At months 24, 36, and 48
Titers of Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibodies in Blood Samples
Titers are given as Geometric Mean Titers (GMTs) expressed as EL.U/mL.
Measured: At Months 24, 36 and 48
Number of Subjects Reporting Pregnancies, New Onset Chronic Diseases (NOCDs) and Other Medically Significant Conditions (MSCs)
NOCDs assessed include e.g. autoimmune disorders, asthma, type I diabetes. MSCs assessed include adverse events prompting emergency room or physician visits that are not related to common diseases or serious adverse events (SAEs) that are not related to common diseases.
Measured: Throughout the study period (up to Month 48)
Number of Subjects Reporting SAEs
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
Measured: Throughout the study period (up to Month 48)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2006 (estimated)
- Study startJun 2006
- Primary completionJun 2006
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Papillomavirus Type 16/18 InfectionStudies 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
- None (open label)
- 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
- NCT00337818
- Sponsor's protocol ID
- 107476 (M18)
- Other IDs
- 107477, 107479, 107481
- Status last verified
- May 2017
- First submitted
- 15 Jun 2006
- Last updated
- 30 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Long-term, Open, Follow-up of the Immunogenicity and Safety of GlaxoSmithKline Biologicals' HPV-16/18 L1/AS04 Vaccine in Healthy Female Subjects Vaccinated Either Pre- or Post-menarche in the Primary Study
- ClinicalTrials.gov ID
- NCT00337818
- Acronym / sponsor ID
- 107476 (M18)
- Keywords
- Non-inferiority, Immunogenicity, HPV Vaccine Consistency
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 770 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Jun 2006
- Primary completion
- Jun 2006 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 16 Jun 2006 (estimated)
- Results
- Posted 2 Mar 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study will be extended for subjects who received all three doses of vaccine in Finland, Denmark and Estonia to determine long-term safety and immunogenicity of the HPV-16/18 vaccine. 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 GlaxoSmithKline 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.
Detailed description
Approximately 750 study subjects received different lots of the HPV vaccine administered intramuscularly according to a 0-1-6 month schedule.
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cervarix New Process | Experimental | Biological: Cervarix™Subjects aged 15 to 25 years received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus [HPV]) produced with the new manufacturing process. |
| Cervarix Old Process Group | Experimental | Biological: Cervarix™Subjects aged 15 to 25 years who received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus [HPV]) produced with the old manufacturing process. |
| Cervarix Young/Lot 1 Group | Experimental | Biological: Cervarix™Subjects aged 10 to 14 years, who received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus [HPV]) produced with the new manufacturing process (Lot 1). |
Who may qualify
- Ages
- 10 to 25 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- A female who enrolled in the HPV-012 (NCT00337818) study in Denmark, Estonia and Finland, received three doses of vaccine and completed Visit 4 (Month 7).
- Written informed consent obtained from the subject prior to enrolment (for subjects below the legal age of consent, written informed consent must be obtained from a parent or legally acceptable representative (LAR) and, in addition, the subject must sign and personally date a written informed assent).
Key exclusion criteria (4 listed)
- Use of any investigational or non-registered product (drug or vaccine) or planned use during the study period.
- Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
- Chronic administration of immunosuppressants or other immune-modifying drugs occurring less than three months prior to blood sampling.
- Administration of immunoglobulins and/or any blood products within the three months preceding blood sampling.
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 |
|---|---|---|
| Cervarix™Three doses of vaccine according to a 0, 1, 6 month schedule (during the primary study) | Biological | Cervarix New Process, Cervarix Old Process Group, Cervarix Young/Lot 1 Group |
Primary outcome
Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies
Time frame: At months 18*, 24, 36 and 48
Titers are given as Geometric Mean Titers (GMTs) expressed as Enzyme-linked Immunosorbent Assay Units Per Milliliter (EL.U/mL). *Data for Month 18 outcome variables were incorporated into the Month 24 analyses.
4 secondary outcomes
Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies in Cervical Samples
Time frame: At months 24, 36, and 48
Titers of Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibodies in Blood Samples
Time frame: At Months 24, 36 and 48
Number of Subjects Reporting Pregnancies, New Onset Chronic Diseases (NOCDs) and Other Medically Significant Conditions (MSCs)
Time frame: Throughout the study period (up to Month 48)
Number of Subjects Reporting SAEs
Time frame: Throughout the study period (up to Month 48)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Primary StudyLink provided by the sponsor.
Related trials for Papillomavirus Type 16/18 Infection
Active, not recruitingPhase 3
Efficacy Against Oral Persistent Infection, Immunogenicity and Safety of the 9-valent Human Papillomavirus Vaccine (9vHPV) in Men Aged 20-45 Years (V503-049)
Papillomavirus Infections
Active, not recruitingObservational study
Extended Follow Up of Young Women in Costa Rica Who Received Vaccine for Human Papillomavirus Types 16 and 18 and Unvaccinated Controls
Anal Carcinoma, Cervical Carcinoma
RecruitingPhase 1/2
A Phase I/IIa Clinical Trial to Investigate BVAC-E6E7 in Subjects With HPV Positive HNSCC.
Head and Neck Squamous Cell Carcinoma (HNSCC), HPV (Human Papillomavirus)-Associated Carcinoma
Not yet recruitingPhase 1/2
Evaluation of the Safety, Tolerability, Immunogenicity and Preliminary Efficacy of BBM-C101 Injection in Patients With Cervical High-Grade Squamous Intraepithelial Lesion(HSIL)
High-grade Squamous Intraepithelial Lesions of the Cervix Associated With Human Papillomavirus (HPV) Type 16 and/or HPV Type 18 Infection
RecruitingPhase 4
Lot-to-Lot Consistency Clinical Trial of Recombinant Human Papillomavirus 9-valent (Types 6/11/16/18/31/33/45/52/58) Vaccine (Escherichia Coli)
Infection by Human Papilloma Virus
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cervarix™ in people with Papillomavirus Type 16/18 Infection and Cervical Intraepithelial Neoplasia, run by GlaxoSmithKline at 1 site in Estonia.
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 2 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 30 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Estonia. 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?
Yes. Results are posted in the registry (first posted 2 Mar 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies (time frame: At months 18*, 24, 36 and 48). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 May 2017.