Cervical CancerPhase 2NCT00520598
Broad Spectrum HPV (Human Papillomavirus) Vaccine in 16 to 26 Year Old Women (V505-001)
A Phase 2 study testing Comparator: V505 formulation 1, Comparator: V505 formulation 2 and Comparator: V505 formulation 3 in people with Cervical Cancer and Vulvar Cancer, run by Merck Sharp & Dohme LLC.
Trial summary
The purpose of this study is to evaluate the safety and immunogenicity of V505 in comparison to GARDASIL (TM) Read more about this study
- Who is it for?
- Ages 16 to 26 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cervical Cancer, Vulvar Cancer, Vaginal Cancer
- What is being tested?
- Comparator: V505 formulation 1, Comparator: V505 formulation 2 and Comparator: V505 formulation 3
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 511 participants
- Where
- No sites listed yet
- Study dates
- Oct 2007to May 2011
- Phase
- Phase 2
- 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 16 to 26 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Female between 16 to 26 years old
- Has never had Pap testing or have only had normal Pap test results
- Lifetime history of 0 to 4 sexual partners
Who cannot join
- History of an abnormal cervical biopsy result; History of a positive test for HPV; History of external genital/vaginal warts; Currently a user of any illegal drugs or an alcohol abuser
- History of severe allergic reaction that required medical attention
- Are pregnant
- Received a marketed HPV vaccine
- Currently enrolled in a clinical trial
- Currently has (or has a history of) certain medical conditions or is currently taking or has taken certain medications (details will be discussed at time of consent)
About this study
Official title: A Phase IIa Randomized, Double-Blind Controlled With Gardasil, Clinical Trial to Study theTolerability and Immunogenicity of V505 (a Multivalent Human Papilloma Virus [HPV] L1 Virus Like Particle [VLP] Vaccine) in Healthy 16 to 26 Year Old Women
The purpose of this study is to evaluate the safety and immunogenicity of V505 in comparison to GARDASIL (TM)
- Conditions
- Cervical Cancer, Vulvar Cancer, Vaginal Cancer, Genital Warts, Human Papillomavirus Infection
- Being tested
- Comparator: V505 formulation 1, Comparator: V505 formulation 2, Comparator: V505 formulation 3, Comparator: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant, Comparator: Placebo (unspecified)
- Medical subject headings
- Uterine Cervical Neoplasms, Vulvar Neoplasms, Vaginal Neoplasms, Condylomata Acuminata, Papillomavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comparator: V505 formulation 1Biological
0.5 ml injection of V505 formulation 1 as 3 dose regimen at Day 1, Month 2 and Month 6.
Comparator: V505 formulation 2Drug
0.5 ml injection of V505 formulation 2 as 3 dose regimen at Day 1, Month 2 and Month 6.
Comparator: V505 formulation 2Drug
0.5 ml injection of V505 formulation 2 as 2 dose regimen at Day 1 and Month 6.
Comparator: V505 formulation 3Biological
0.5 ml injection of V505 formulation 3 as 2 dose regimen at Day 1 and Month 6.
Comparator: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) RecombinantBiological
0.5 ml injection of Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine as 3 dose regimen at Day 1, Month 2 and Month 6.
Comparator: Placebo (unspecified)Biological
0.5 ml injection of placebo to V505 as a 1 dose regimen at Month 2.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Arm 1: 0.5 ml injection of Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine as 3 dose regimen. Receives: Biological: Comparator: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant |
| 2 | Experimental | Arm 2: 0.5 ml injection of V505 formulation 1 as 3 dose regimen. Receives: Biological: Comparator: V505 formulation 1 |
| 3 | Experimental | Arm 3: 0.5 ml injection of V505 formulation 2 as 3 dose regimen Receives: Drug: Comparator: V505 formulation 2 |
| 4 | Experimental | Arm 4: 0.5 ml injection of V505 formulation 2 as 2 dose regimen and 1 Pbo injection Receives: Drug: Comparator: V505 formulation 2; Biological: Comparator: Placebo (unspecified) |
| 5 | Experimental | Arm 5: 0.5 ml injection of V505 formulation 3 as 2 dose regimen and 1 Pbo injection Receives: Biological: Comparator: V505 formulation 3; Biological: Comparator: Placebo (unspecified) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Geometric mean titers (GMTs) to HPV types contained in the vaccines administered in a 3-dose regimen
Measured: 4 weeks post dose 3
Secondary outcomes (1)
Geometric mean titers (GMTs) to HPV types contained in the vaccines administered in a 2-dose regimen
Measured: 4 weeks post dose 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2007 (estimated)
- Study startOct 2007
- Primary completionMay 2011
- Study completionMay 2011
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 Cervical CancerStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 511 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00520598
- Sponsor's protocol ID
- V505-001
- Other IDs
- 2007_567
- Status last verified
- Nov 2015
- First submitted
- 22 Aug 2007
- Last updated
- 26 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
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 26 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIa Randomized, Double-Blind Controlled With Gardasil, Clinical Trial to Study theTolerability and Immunogenicity of V505 (a Multivalent Human Papilloma Virus [HPV] L1 Virus Like Particle [VLP] Vaccine) in Healthy 16 to 26 Year Old Women
- ClinicalTrials.gov ID
- NCT00520598
- Acronym / sponsor ID
- V505-001
- Conditions
- Cervical Cancer, Vulvar Cancer, Vaginal Cancer, Genital Warts, Human Papillomavirus Infection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 511 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Oct 2007
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 24 Aug 2007 (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.
The purpose of this study is to evaluate the safety and immunogenicity of V505 in comparison to GARDASIL (TM)
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Biological: Comparator: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) RecombinantArm 1: 0.5 ml injection of Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine as 3 dose regimen. |
| 2 | Experimental | Biological: Comparator: V505 formulation 1Arm 2: 0.5 ml injection of V505 formulation 1 as 3 dose regimen. |
| 3 | Experimental | Drug: Comparator: V505 formulation 2Arm 3: 0.5 ml injection of V505 formulation 2 as 3 dose regimen |
| 4 | Experimental | Drug: Comparator: V505 formulation 2, Biological: Comparator: Placebo (unspecified)Arm 4: 0.5 ml injection of V505 formulation 2 as 2 dose regimen and 1 Pbo injection |
| 5 | Experimental | Biological: Comparator: V505 formulation 3, Biological: Comparator: Placebo (unspecified)Arm 5: 0.5 ml injection of V505 formulation 3 as 2 dose regimen and 1 Pbo injection |
Who may qualify
- Ages
- 16 to 26 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Female between 16 to 26 years old
- Has never had Pap testing or have only had normal Pap test results
- Lifetime history of 0 to 4 sexual partners
Key exclusion criteria (6 listed)
- History of an abnormal cervical biopsy result; History of a positive test for HPV; History of external genital/vaginal warts; Currently a user of any illegal drugs or an alcohol abuser
- History of severe allergic reaction that required medical attention
- Are pregnant
- Received a marketed HPV vaccine
- Currently enrolled in a clinical trial
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 |
|---|---|---|
| Comparator: V505 formulation 10.5 ml injection of V505 formulation 1 as 3 dose regimen at Day 1, Month 2 and Month 6. | Biological | 2 |
| Comparator: V505 formulation 20.5 ml injection of V505 formulation 2 as 3 dose regimen at Day 1, Month 2 and Month 6. | Drug | 3 |
| Comparator: V505 formulation 20.5 ml injection of V505 formulation 2 as 2 dose regimen at Day 1 and Month 6. | Drug | 4 |
| Comparator: V505 formulation 30.5 ml injection of V505 formulation 3 as 2 dose regimen at Day 1 and Month 6. | Biological | 5 |
| Comparator: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant0.5 ml injection of Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine as 3 dose regimen at Day 1, Month 2 and Month 6. | Biological | 1 |
| Comparator: Placebo (unspecified)0.5 ml injection of placebo to V505 as a 1 dose regimen at Month 2. | Biological | 4, 5 |
Primary outcome
Geometric mean titers (GMTs) to HPV types contained in the vaccines administered in a 3-dose regimen
Time frame: 4 weeks post dose 3
1 secondary outcome
Geometric mean titers (GMTs) to HPV types contained in the vaccines administered in a 2-dose regimen
Time frame: 4 weeks post dose 2
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 26 Nov 2015.
- 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.
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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.
Medical Monitor study director
Merck Sharp & Dohme LLC
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Comparator: V505 formulation 1, Comparator: V505 formulation 2 and Comparator: V505 formulation 3 in people with Cervical Cancer and Vulvar Cancer, run by Merck Sharp & Dohme LLC.
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 3 inclusion and 6 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 26 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Geometric mean titers (GMTs) to HPV types contained in the vaccines administered in a 3-dose regimen (time frame: 4 weeks post dose 3). 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 NCT00520598, 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 26 Nov 2015.