HPV InfectionsPhase 4HPV CSP01NCT00956553
Reactogenicity Study of Cervarix and Gardasil in UK Adolescent Girls
A Phase 4 study testing Cervarix and Gardasil in people with HPV Infections, run by Public Health England at 3 sites in United Kingdom.
Trial summary
This is a phase IV study to evaluate the body's immune response of participants to the Cervarix and Gardasil vaccines against the Human Papilloma Virus (HPV) types associated with increased risk of cervical cancer. Read more about this study
- Who is it for?
- Ages 13 to 15 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- HPV Infections
- What is being tested?
- Cervarix and Gardasil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- Sep 2009to Sep 2013
- Phase
- Phase 4
- 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 13 to 15 years
- Women only
- Healthy volunteers accepted
- Child
Who may be able to join
- Aged between 13 and 15 years at the time of the first immunisation
- Female
- No contraindications to vaccination as specified in the "Green Book" - Immunisation Against Infectious Disease, HMSO.
- Written informed consent obtained from parent or guardian of subject
Who cannot join
- Pregnant or become pregnant during the course of the trial (no contraindications to vaccination for those taking the contraceptive pill).
- Breast-feeding mothers
- Allergic to vaccine components
Trial locations and contacts
3 sites in 1 country.
United Kingdom3 sites
Professor Elizabeth Miller
Gloucester
Public Health England
London, NW9 5HT
Public Health England
Stevenage, Hertfordshire
About this study
Official title: A Phase IV, Randomised Study to Evaluate the Immune Responses of UK Adolescent Girls Receiving CervarixTM or GardasilTM Human Papillomavirus Vaccines
This is a phase IV study to evaluate the body's immune response of participants to the Cervarix and Gardasil vaccines against the Human Papilloma Virus (HPV) types associated with increased risk of cervical cancer.
Read the detailed description
This study looks at possible cross reactivity between different HPV serotypes and both peripheral antibodies and mucosally-secreted antibodies.
- Conditions
- HPV Infections
- Being tested
- Cervarix, Gardasil
- Keywords
- HPV, Human Papilloma Virus, Cervical cancer vaccine
- Medical subject headings
- Papillomavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CervarixBiological
Three doses of Cervarix at month 0, 1 and 6.
GardasilBiological
Three doses of Gardasil at month 0, 1 and 6.
| Study group | Role | What they receive |
|---|---|---|
| Cervarix | Active comparator | Three doses of Cervarix at month 0, 1 and 6. Blood sample at month 0, 2, 7 and 12. Optional vaginal sponge sample at month 7. Receives: Biological: Cervarix |
| Gardasil | Active comparator | Three doses of Gardasil at month 0, 1 and 6. Blood sample at month 0, 2, 7 and 12. Optional vaginal sponge sample at month 7. Receives: Biological: Gardasil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurable antibody mediated neutralisation of HPV serotype 6, 11, 16, 18 and genetically related serotypes, especially 45
Measured: 18 months from enrollment
Secondary outcomes (1)
Determine differences in vaccine formulation and their impact on cross protection.
Measured: 24 months from enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2009 (estimated)
- Study startSep 2009
- Primary completionSep 2012
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for HPV InfectionsStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Public Health England
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00956553
- Sponsor's protocol ID
- HPV CSP01
- Acronym
- HPV CSP01
- Status last verified
- Aug 2018
- First submitted
- 10 Aug 2009
- Last updated
- 1 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Haskins-Coulter T, Southern J, Andrews N, Miller E. Reactogenicity of Cervarix and Gardasil human papillomavirus (HPV) vaccines in a randomized single blind trial in healthy UK adolescent females. Hum Vaccin Immunother. 2017 Jun 3;13(6):1-9. doi: 10.1080/21645515.2016.1277846. Epub 2017 Mar 20.
PubMed 28319456Bergman 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 41276263Godi A, Panwar K, Haque M, Cocuzza CE, Andrews N, Southern J, Turner P, Miller E, Beddows S. Durability of the neutralizing antibody response to vaccine and non-vaccine HPV types 7 years following immunization with either Cervarix(R) or Gardasil(R) vaccine. Vaccine. 2019 Apr 24;37(18):2455-2462. doi: 10.1016/j.vaccine.2019.03.052. Epub 2019 Mar 27.
PubMed 30926298Draper E, Bissett SL, Howell-Jones R, Waight P, Soldan K, Jit M, Andrews N, Miller E, Beddows S. A randomized, observer-blinded immunogenicity trial of Cervarix((R)) and Gardasil((R)) Human Papillomavirus vaccines in 12-15 year old girls. PLoS One. 2013 May 1;8(5):e61825. doi: 10.1371/journal.pone.0061825. Print 2013.
PubMed 23650505
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IV, Randomised Study to Evaluate the Immune Responses of UK Adolescent Girls Receiving CervarixTM or GardasilTM Human Papillomavirus Vaccines
- ClinicalTrials.gov ID
- NCT00956553
- Acronym / sponsor ID
- HPV CSP01 / HPV CSP01
- Conditions
- HPV Infections
- Keywords
- HPV, Human Papilloma Virus, Cervical cancer vaccine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Public Health EnglandOther government
- Study start
- Sep 2009
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 11 Aug 2009 (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.
This is a phase IV study to evaluate the body's immune response of participants to the Cervarix and Gardasil vaccines against the Human Papilloma Virus (HPV) types associated with increased risk of cervical cancer.
Detailed description
This study looks at possible cross reactivity between different HPV serotypes and both peripheral antibodies and mucosally-secreted antibodies.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cervarix | Active comparator | Biological: CervarixThree doses of Cervarix at month 0, 1 and 6. Blood sample at month 0, 2, 7 and 12. Optional vaginal sponge sample at month 7. |
| Gardasil | Active comparator | Biological: GardasilThree doses of Gardasil at month 0, 1 and 6. Blood sample at month 0, 2, 7 and 12. Optional vaginal sponge sample at month 7. |
Who may qualify
- Ages
- 13 to 15 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Aged between 13 and 15 years at the time of the first immunisation
- Female
- No contraindications to vaccination as specified in the "Green Book" - Immunisation Against Infectious Disease, HMSO.
- Written informed consent obtained from parent or guardian of subject
Key exclusion criteria (3 listed)
- Pregnant or become pregnant during the course of the trial (no contraindications to vaccination for those taking the contraceptive pill).
- Breast-feeding mothers
- Allergic to vaccine components
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 |
|---|---|---|
| CervarixThree doses of Cervarix at month 0, 1 and 6. | Biological | Cervarix |
| GardasilThree doses of Gardasil at month 0, 1 and 6. | Biological | Gardasil |
Primary outcome
Measurable antibody mediated neutralisation of HPV serotype 6, 11, 16, 18 and genetically related serotypes, especially 45
Time frame: 18 months from enrollment
1 secondary outcome
Determine differences in vaccine formulation and their impact on cross protection.
Time frame: 24 months from enrollment
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 1 Oct 2020.
- Results publication: PubMed 28319456Haskins-Coulter T, Southern J, Andrews N, Miller E. Reactogenicity of Cervarix and Gardasil human papillomavirus (HPV) vaccines in a randomized single blind trial in healthy UK adolescent females. Hum Vaccin Immunother. 2017 Jun 3;13(6):1-9. doi: 10.1080/21645515.2016.1277846. Epub 2017 Mar 20.
- 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.
- Derived from this study: PubMed 30926298Godi A, Panwar K, Haque M, Cocuzza CE, Andrews N, Southern J, Turner P, Miller E, Beddows S. Durability of the neutralizing antibody response to vaccine and non-vaccine HPV types 7 years following immunization with either Cervarix(R) or Gardasil(R) vaccine. Vaccine. 2019 Apr 24;37(18):2455-2462. doi: 10.1016/j.vaccine.2019.03.052. Epub 2019 Mar 27.
- Derived from this study: PubMed 23650505Draper E, Bissett SL, Howell-Jones R, Waight P, Soldan K, Jit M, Andrews N, Miller E, Beddows S. A randomized, observer-blinded immunogenicity trial of Cervarix((R)) and Gardasil((R)) Human Papillomavirus vaccines in 12-15 year old girls. PLoS One. 2013 May 1;8(5):e61825. doi: 10.1371/journal.pone.0061825. Print 2013.
- Published study resultsLink provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cervarix and Gardasil in people with HPV Infections, run by Public Health England at 3 sites in United Kingdom.
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 3 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 1 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United Kingdom. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Measurable antibody mediated neutralisation of HPV serotype 6, 11, 16, 18 and genetically related serotypes, especially 45 (time frame: 18 months from enrollment). 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 NCT00956553, which also lists 4 linked publications.
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 1 Oct 2020.