HPV InfectionsPhase 3NCT00733122
Tolerability and Immunogenicity of Gardasil in Females Between 16 and 23 Years of Age in India (V501-034)
A Phase 3 study testing Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine in people with HPV Infections, run by Merck Sharp & Dohme LLC.
Trial summary
This study is designed to determine the tolerability and immunogenicity of a 3-dose regimen of Gardasil administered to healthy married females between 16 and 23 years of age, in India. 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
- HPV Infections
- What is being tested?
- Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2009to 1 Oct 2013
- 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 16 to 26 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Healthy Married Females Between 16 And 23 Years Of Age With Intact Uteri
- No Clinical Evidence Of Gross Purulent Cervicitis (Otherwise Postpone Until After Treatment Or Lack Of Laboratory Confirmation Of Treatable Cause
- Must Agree To Refrain From Sexual Activity (Including Vaginal And Anal Penetration And Any Genital Contact) For 48 Hours Prior To Any Scheduled Visit That Includes A Pelvic Examination In An Attempt To Avoid Detection Of Viral DNA Which Has Been Deposited In The Vagina Or On The Perineal/Perianal Area During Sexual Intercourse And Is Not The Result Of Ongoing Infection
- Not Pregnant Now (As Determined By A Serum Pregnancy Test Or Urine Pregnancy Test Sensitive To 25 IU/L hCG), And Must Agree To Use Effective Contraception Through Month 7 Of The Study
- Must Agree To Provide Study Personnel With A Primary Telephone Number As Well As An Alternate Telephone Number For Follow-Up Purposes.
- Individuals Who Have Had Sexual Intercourse In The 2 Weeks Prior To Enrollment Must Have Been Using Effective Contraception As Defined Above (Emergency Contraception Is Not Considered Effective Contraception For Enrollment Into The Study.)
Who cannot join
- Individuals Concurrently Enrolled In Clinical Studies Of Investigational Agents Or Studies Involving Collection Of Cervical/Genital Specimens
- Feverish Feeling Within 24 Hours Prior To The First Injection And No Temperature < 100°F Or < 37.8°C (Oral Or Oral Equivalent) At First Vaccination
- History Of Recent Or Ongoing Alcohol Or Other Drug Abuse. Alcohol Abusers Are Defined As Those Who Drink Despite Recurrent Social, Interpersonal, And Legal Problems As A Result Of Alcohol Use
- History Of Known Prior Vaccination With An Hpv Vaccine Subject Has Received Non-Replicating (Inactivated) Vaccine Within 14 Days Prior To The Day 1 Vaccination Or Has Received Replicating (Live Virus) Vaccine Within 21 Days Prior To The Day 1 Vaccination
- Individuals With Any Prior Abnormal Pap Test Showing Squamous Intraepithelial Lesion (Sil), Ascus, Asc-Us, Asc-H Individuals With A History Of Genital Warts
- Individuals Allergic To Any Vaccine Component, Including Aluminium, Yeast, Or Benzonase™ (Nuclease, Nycomed [Used To Remove Residual Nucleic Acids From This And Other Vaccines])
Show all 14Show fewer
- Individuals Who Have Received Any Immune Globulin Preparation Or Blood-Derived Products Within The 3 Months Prior To The First Injection, Or Plan To Receive Any Through The Completion Of The Study
- Individuals With A History Of Splenectomy, Known Immune Disorders (E.G., Systemic Lupus Erythematosus, Rheumatoid Arthritis), Or Receiving Immunosuppressives (E.G., Substances Or Treatments Known To Diminish Immune Response Such As Radiation Therapy, Administration Of Antimetabolites, Antilymphocytic Sera, Systemic Corticosteroids)
- Individuals Who Have Received Periodic Treatments With Immunosuppressives, Defined As At Least 3 Courses Of Systemic Corticosteroids Each Lasting At Least 1 Week In Duration For The Year Prior To Enrollment, Will Be Excluded. Subjects Using Topical Steroids (I.E., Inhaled Or Nasal) Will Be Eligible For Vaccination
- Individuals Who Are Immunocompromised Or Have Been Diagnosed As Having HIV Infection
- Individuals With Known Thrombocytopenia Or Any Coagulation Disorder That Would Contraindicate Intramuscular Injections
- Any Condition Which In The Opinion Of The Investigator Might Interfere With The Evaluation Of The Study Objectives
- Any Plans To Permanently Relocate From The Area Prior To The Completion Of The Study Or To Leave For An Extended Period Of Time When Study Visits Would Need To Be Scheduled
- Inability To Give Consent/Assent
About this study
Official title: Evaluation of Tolerability and Immunogenicity of GARDASIL in Healthy Females, Between 16 and 26 Years of Age, in India.
This study is designed to determine the tolerability and immunogenicity of a 3-dose regimen of Gardasil administered to healthy married females between 16 and 23 years of age, in India.
- Conditions
- HPV Infections
- Being tested
- Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant 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.
Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant VaccineBiological
Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine 0.5 mL of GARDASIL as intramuscular injections at the Day 1, Month 2, and Month 6 visits.
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | GARDASIL, Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine Receives: Biological: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of subjects who seroconvert to each of HPV 6, 11, 16, 18 at Week 4 Post dose 3 (Month 7), Month 24 and Month 36.
Measured: Week 4 Post dose 3 (Month 7), Month 24 and Month 36
Secondary outcomes (1)
The Geometric Mean Titers (GMTs)
Measured: Week 4 Post dose 3 (Month 7), Month 24 and Month 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2008 (estimated)
- Study start1 Oct 2009
- Primary completion1 Oct 2013 (estimated)
- Study completion1 Oct 2013 (estimated)
Why it stopped: Following the direction of the local (India) health authority, data specified in the protocol were not collected and study was cancelled.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HPV InfectionsStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 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
- NCT00733122
- Sponsor's protocol ID
- V501-034
- Other IDs
- 2008_016, CTRI/2009/091/000787
- Status last verified
- Feb 2025
- First submitted
- 8 Aug 2008
- Last updated
- 3 Mar 2025
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Tolerability and Immunogenicity of GARDASIL in Healthy Females, Between 16 and 26 Years of Age, in India.
- ClinicalTrials.gov ID
- NCT00733122
- Acronym / sponsor ID
- V501-034
- Conditions
- HPV Infections
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Following the direction of the local (India) health authority, data specified in the protocol were not collected and study was cancelled.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 1 Oct 2009 (actual)
- Primary completion
- 1 Oct 2013 (estimated)
- Study completion
- 1 Oct 2013 (estimated)
- First posted
- 12 Aug 2008 (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 study is designed to determine the tolerability and immunogenicity of a 3-dose regimen of Gardasil administered to healthy married females between 16 and 23 years of age, in India.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Biological: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant VaccineGARDASIL, Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine |
Who may qualify
- Ages
- 16 to 26 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Healthy Married Females Between 16 And 23 Years Of Age With Intact Uteri
- No Clinical Evidence Of Gross Purulent Cervicitis (Otherwise Postpone Until After Treatment Or Lack Of Laboratory Confirmation Of Treatable Cause
- Must Agree To Refrain From Sexual Activity (Including Vaginal And Anal Penetration And Any Genital Contact) For 48 Hours Prior To Any Scheduled Visit That Includes A Pelvic Examination In An Attempt To Avoid Detection Of Viral DNA Which Has Been Deposited In The Vagina Or On The Perineal/Perianal Area During Sexual Intercourse And Is Not The Result Of Ongoing Infection
- Not Pregnant Now (As Determined By A Serum Pregnancy Test Or Urine Pregnancy Test Sensitive To 25 IU/L hCG), And Must Agree To Use Effective Contraception Through Month 7 Of The Study
- Must Agree To Provide Study Personnel With A Primary Telephone Number As Well As An Alternate Telephone Number For Follow-Up Purposes.
Key exclusion criteria (14 listed)
- Individuals Concurrently Enrolled In Clinical Studies Of Investigational Agents Or Studies Involving Collection Of Cervical/Genital Specimens
- Feverish Feeling Within 24 Hours Prior To The First Injection And No Temperature < 100°F Or < 37.8°C (Oral Or Oral Equivalent) At First Vaccination
- History Of Recent Or Ongoing Alcohol Or Other Drug Abuse. Alcohol Abusers Are Defined As Those Who Drink Despite Recurrent Social, Interpersonal, And Legal Problems As A Result Of Alcohol Use
- History Of Known Prior Vaccination With An Hpv Vaccine Subject Has Received Non-Replicating (Inactivated) Vaccine Within 14 Days Prior To The Day 1 Vaccination Or Has Received Replicating (Live Virus) Vaccine Within 21 Days Prior To The Day 1 Vaccination
- Individuals With Any Prior Abnormal Pap Test Showing Squamous Intraepithelial Lesion (Sil), Ascus, Asc-Us, Asc-H Individuals With A History Of Genital Warts
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 |
|---|---|---|
| Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant VaccineQuadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine 0.5 mL of GARDASIL as intramuscular injections at the Day 1, Month 2, and Month 6 visits. | Biological | A |
Primary outcome
The percentage of subjects who seroconvert to each of HPV 6, 11, 16, 18 at Week 4 Post dose 3 (Month 7), Month 24 and Month 36.
Time frame: Week 4 Post dose 3 (Month 7), Month 24 and Month 36
1 secondary outcome
The Geometric Mean Titers (GMTs)
Time frame: Week 4 Post dose 3 (Month 7), Month 24 and Month 36
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2025.
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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 3 study testing Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine in people with HPV Infections, 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 6 inclusion and 14 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: withdrawn, as of the sponsor's last update on 3 Mar 2025. 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 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 was withdrawn before enrolling participants, so there are no results.
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?
The percentage of subjects who seroconvert to each of HPV 6, 11, 16, 18 at Week 4 Post dose 3 (Month 7), Month 24 and Month 36. (time frame: Week 4 Post dose 3 (Month 7), Month 24 and Month 36). 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 3 Mar 2025.