Papillomavirus InfectionsPhase 3NCT01245764
GARDASIL™ Study in Healthy Females Between 9 and 26 Years of Age in Sub-Saharan Africa (V501-046)
A Phase 3 study testing Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL™) in people with Papillomavirus Infections, run by Merck Sharp & Dohme LLC.
Trial summary
The study is designed to determine the safety, tolerability and immunogenicity of a 3-dose regimen of GARDASIL™ administered to healthy females between 9 and 26 years of age, in Sub-Saharan Africa. Read more about this study
- Who is it for?
- Ages 9 to 26 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Papillomavirus Infections
- What is being tested?
- Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL™)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 250 participants
- Where
- No sites listed yet
- Study dates
- 21 Mar 2011to 15 Apr 2013
- 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 9 to 26 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Healthy subjects who are native to and living in a participating Sub-Saharan African country.
- Subject agrees to provide study personnel with a primary telephone number as well as an alternate telephone number for follow-up purposes. If potential subject does not have a telephone number, the subject must provide an address at which he or she may be contacted.
- Post-pubertal female subjects must not be pregnant
- Subjects who are sexually active must agree to use effective contraception or remain abstinent through Month 7 of the study.
- Subjects who have not yet had sexual intercourse must either agree to remain abstinent through Month 7 of the study, or if they become sexually active during the vaccination phase of the study, to use effective contraception through Month 7.
- Subjects who have had sexual intercourse in the two weeks prior to enrollment must have been using effective contraception as defined above. (Emergency contraception is not considered effective contraception for enrollment in the study.)
Who cannot join
- Subject is pregnant as determined by a positive pregnancy test
- Subject has had a temperature ≥ 37.8 °C or ≥ 100 °F within 24 hours prior to the first injection.
- Subject is currently enrolled in another clinical study of an investigational agent or agents.
- Subject has a history of known prior vaccination with a HPV vaccine, or was previously enrolled in an HPV vaccine study and received either active agent or placebo.
- Subject has received any inactivated vaccine within 14 days prior to enrollment or any live vaccine within 21 days prior to enrollment.
- Subject has a history of severe allergic reaction to any agent (e.g., swelling of the mouth and throat, difficulty breathing, hypotension, or shock) that required medical intervention.
Show all 19Show fewer
- Subject has known allergy to any vaccine component, including aluminum, yeast or BENZONASE™ (nuclease, Nycomed™ [used to remove residual nucleic acids from this and other vaccines]).
- Subject has received any immune globulin preparation or blood-derived products within the 6 months prior to the first injection, or plans to receive any such products during the course of the study.
- Subject has a history of splenectomy, known autoimmune disorder (e.g., systemic lupus erythematosus, rheumatoid arthritis), or is 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.
- Subject is immunocompromised or has been diagnosed as having Human Immunodeficiency Virus (HIV) infection
- Subject has known thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injections.
- Subject has known sickle cell anemia disease, active malaria or active tuberculosis.
- Subject has any condition which in the opinion of the investigator might interfere with the evaluation of the study objectives.
- Subject has a history of recent or ongoing alcohol or other drug abuse.
- Female subject has a prior history of abnormal Pap test showing squamous intraepithelial lesion (SIL), atypical squamous cells of undetermined significance (ASC-US), atypical squamous cells, cannot rule out a high grade lesion (ASC-H), or biopsy showing cervical intraepithelial neoplasia (CIN) or worse.
- Subject has any prior history (or at Day 1) of genital warts or treatment for genital warts.
- Subject with >4 lifetime sexual partners.
- Subject has undergone hysterectomy with removal of the cervix.
- Subject 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.
About this study
Official title: Evaluation of Safety and Immunogenicity of GARDASIL™ in Healthy Females Between 9 and 26 Years of Age in SubSaharan Africa
The study is designed to determine the safety, tolerability and immunogenicity of a 3-dose regimen of GARDASIL™ administered to healthy females between 9 and 26 years of age, in Sub-Saharan Africa. Data from the current study are needed in order to complement existing extensive safety data from the GARDASIL™ clinical trials program, and confirm that GARDASIL™ may be administered safely and will induce immune responses in populations from and living in Sub-Saharan Africa, as GARDASIL™ has not previously been studied in this region of the world.
Read the detailed description
In Phase A of the study, healthy females between 9 and 12 years of age will be randomized (4:1) to receive the 3-dose regimen of GARDASIL™ or placebo, and those between 13 and 26 years old will receive GARDASIL™. In Phase B of the study, participants who received placebo in Phase A will have the option to receive the 3-dose regimen of GARDASIL™.
- Conditions
- Papillomavirus Infections
- Being tested
- Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL™), Placebo
- Keywords
- Cervical cancer, vulvar cancer, vaginal cancer, genital warts, human papillomavirus
- Medical subject headings
- Papillomavirus Infections, Uterine Cervical Neoplasms, Vulvar Neoplasms, Vaginal Neoplasms, Condylomata Acuminata
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 Vaccine (GARDASIL™)Biological
PlaceboBiological
| Study group | Role | What they receive |
|---|---|---|
| GARDASIL™ 9 to 12 Years Old | Experimental | GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A. Participants will not continue to study Phase B. Receives: Biological: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL™) |
| GARDASIL™ 13 to 15 Years Old | Experimental | GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A. Participants will not continue to study Phase B. Receives: Biological: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL™) |
| GARDASIL™ 16 to 26 Years Old | Experimental | GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A. Participants will not continue to study Phase B. Receives: Biological: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL™) |
| Placebo 9 to 12 Years Old | Placebo comparator | Placebo to GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A. After database lock and unblinding for study Phase A, participants will have the option to receive GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase B. Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Seroconvert to Human Papillomavirus (HPV) Type 6
Seroconversion was defined as achieving an anti-HPV Type 6 competitive Luminex Immunoassay (cLIA) level of >=20 milli Merck U/mL. The dilution-corrected limit of detection for the Type 6 cLIA was 4.2 milli Merck U/mL.
Measured: Month 7 (1 month postdose 3 in study Phase A)
Number of Participants Who Seroconvert to HPV Type 11
Seroconversion was defined as achieving an anti-HPV Type 11 cLIA level of >=16 milli Merck U/mL. The dilution-corrected limit of detection for the Type 11 cLIA was 3.9 milli Merck U/mL.
Measured: Month 7 (1 month postdose 3 in study Phase A)
Number of Participants Who Seroconvert to HPV Type 16
Seroconversion was defined as achieving an anti-HPV Type 16 cLIA level of >=20 milli Merck U/mL. The dilution-corrected limit of detection for the Type 16 cLIA was 9.7 milli Merck U/mL.
Measured: Month 7 (1 month postdose 3 in study Phase A)
Number of Participants Who Seroconvert to HPV Type 18
Seroconversion was defined as achieving an anti-HPV Type 18 cLIA level of >=24 milli Merck U/mL. The dilution-corrected limit of detection for the Type 18 cLIA was 5.8 milli Merck U/mL.
Measured: Month 7 (1 month postdose 3 in study Phase A)
Number of Participants With Injection-site Adverse Experiences
Participants were prompted to report injection-site experiences of pain, erythema, or swelling and were also asked to report any other injection-site adverse experiences
Measured: Up to Day 5 after any vaccination in study Phase A
Number of Participants With Elevated Temperature (Oral Temperature >=100 °F)
Measured: Up to Day 5 after any vaccination in study Phase A
Number of Participants With Serious Adverse Experiences
A serious adverse experience is any adverse experience that results in death, is life threatening, results in persistent or significant disability/incapacity, results in or prolongs existing inpatient hospitalization, is a congenital anomaly/birth defect, is a cancer, is an overdose, or is another important medical event that may jeopardize the participant and may require medical or surgical intervention
Measured: From the time of informed consent is signed through the last study visit (up to 19 months)
Secondary outcomes (4)
Geometric Mean Titer (GMT) of Anti-HPV Type 6 Antibody
Anti-HPV Type 6 antibodies were measured by cLIA. The seropositive cut-off threshold for this assay is defined as 20 milli Merck U/mL.
Measured: Month 7 (1 month postdose 3 in study Phase A)
GMT of Anti-HPV Type 11 Antibody
Anti-HPV Type 11 antibodies were measured by cLIA. The seropositive cut-off threshold for this assay is defined as 16 milli Merck U/mL.
Measured: Month 7 (1 month postdose 3 in study Phase A)
GMT of Anti-HPV Type 16 Antibody
Anti-HPV Type 16 antibodies were measured by cLIA. The seropositive cut-off threshold for this assay is defined as 20 milli Merck U/mL.
Measured: Month 7 (1 month postdose 3 in study Phase A)
GMT of Anti-HPV Type 18 Antibody
Anti-HPV Type 18 antibodies were measured by cLIA. The seropositive cut-off threshold for this assay is defined as 24 milli Merck U/mL.
Measured: Month 7 (1 month postdose 3 in study Phase A)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2010 (estimated)
- Study start21 Mar 2011
- Primary completion15 Apr 2013
- Study completion15 Apr 2013
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Papillomavirus 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01245764
- Sponsor's protocol ID
- V501-046
- Status last verified
- Oct 2018
- First submitted
- 19 Nov 2010
- Last updated
- 14 Nov 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
Publications
Mugo N, Ansah NA, Marino D, Saah A, Garner EI. Evaluation of safety and immunogenicity of a quadrivalent human papillomavirus vaccine in healthy females between 9 and 26 years of age in Sub-Saharan Africa. Hum Vaccin Immunother. 2015;11(6):1323-30. doi: 10.1080/21645515.2015.1008877.
PubMed 25912475
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Safety and Immunogenicity of GARDASIL™ in Healthy Females Between 9 and 26 Years of Age in SubSaharan Africa
- ClinicalTrials.gov ID
- NCT01245764
- Acronym / sponsor ID
- V501-046
- Conditions
- Papillomavirus Infections
- Keywords
- Cervical cancer, vulvar cancer, vaginal cancer, genital warts, human papillomavirus
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 21 Mar 2011 (actual)
- Primary completion
- 15 Apr 2013 (actual)
- Study completion
- 15 Apr 2013 (actual)
- First posted
- 22 Nov 2010 (estimated)
- Results
- Posted 3 Jun 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is designed to determine the safety, tolerability and immunogenicity of a 3-dose regimen of GARDASIL™ administered to healthy females between 9 and 26 years of age, in Sub-Saharan Africa. Data from the current study are needed in order to complement existing extensive safety data from the GARDASIL™ clinical trials program, and confirm that GARDASIL™ may be administered safely and will induce immune responses in populations from and living in Sub-Saharan Africa, as GARDASIL™ has not previously been studied in this region of the world.
Detailed description
In Phase A of the study, healthy females between 9 and 12 years of age will be randomized (4:1) to receive the 3-dose regimen of GARDASIL™ or placebo, and those between 13 and 26 years old will receive GARDASIL™. In Phase B of the study, participants who received placebo in Phase A will have the option to receive the 3-dose regimen of GARDASIL™.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| GARDASIL™ 9 to 12 Years Old | Experimental | Biological: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL™)GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A. Participants will not continue to study Phase B. |
| GARDASIL™ 13 to 15 Years Old | Experimental | Biological: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL™)GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A. Participants will not continue to study Phase B. |
| GARDASIL™ 16 to 26 Years Old | Experimental | Biological: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL™)GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A. Participants will not continue to study Phase B. |
| Placebo 9 to 12 Years Old | Placebo comparator | Biological: PlaceboPlacebo to GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A. After database lock and unblinding for study Phase A, participants will have the option to receive GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase B. |
Who may qualify
- Ages
- 9 to 26 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Healthy subjects who are native to and living in a participating Sub-Saharan African country.
- Subject agrees to provide study personnel with a primary telephone number as well as an alternate telephone number for follow-up purposes. If potential subject does not have a telephone number, the subject must provide an address at which he or she may be contacted.
- Post-pubertal female subjects must not be pregnant
- Subjects who are sexually active must agree to use effective contraception or remain abstinent through Month 7 of the study.
- Subjects who have not yet had sexual intercourse must either agree to remain abstinent through Month 7 of the study, or if they become sexually active during the vaccination phase of the study, to use effective contraception through Month 7.
Key exclusion criteria (19 listed)
- Subject is pregnant as determined by a positive pregnancy test
- Subject has had a temperature ≥ 37.8 °C or ≥ 100 °F within 24 hours prior to the first injection.
- Subject is currently enrolled in another clinical study of an investigational agent or agents.
- Subject has a history of known prior vaccination with a HPV vaccine, or was previously enrolled in an HPV vaccine study and received either active agent or placebo.
- Subject has received any inactivated vaccine within 14 days prior to enrollment or any live vaccine within 21 days prior to enrollment.
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 Vaccine (GARDASIL™) | Biological | GARDASIL™ 13 to 15 Years Old, GARDASIL™ 16 to 26 Years Old, GARDASIL™ 9 to 12 Years Old |
| Placebo | Biological | Placebo 9 to 12 Years Old |
Primary outcome
Number of Participants Who Seroconvert to Human Papillomavirus (HPV) Type 6
Time frame: Month 7 (1 month postdose 3 in study Phase A)
Seroconversion was defined as achieving an anti-HPV Type 6 competitive Luminex Immunoassay (cLIA) level of >=20 milli Merck U/mL. The dilution-corrected limit of detection for the Type 6 cLIA was 4.2 milli Merck U/mL.
Number of Participants Who Seroconvert to HPV Type 11
Time frame: Month 7 (1 month postdose 3 in study Phase A)
Seroconversion was defined as achieving an anti-HPV Type 11 cLIA level of >=16 milli Merck U/mL. The dilution-corrected limit of detection for the Type 11 cLIA was 3.9 milli Merck U/mL.
Number of Participants Who Seroconvert to HPV Type 16
Time frame: Month 7 (1 month postdose 3 in study Phase A)
Seroconversion was defined as achieving an anti-HPV Type 16 cLIA level of >=20 milli Merck U/mL. The dilution-corrected limit of detection for the Type 16 cLIA was 9.7 milli Merck U/mL.
Number of Participants Who Seroconvert to HPV Type 18
Time frame: Month 7 (1 month postdose 3 in study Phase A)
Seroconversion was defined as achieving an anti-HPV Type 18 cLIA level of >=24 milli Merck U/mL. The dilution-corrected limit of detection for the Type 18 cLIA was 5.8 milli Merck U/mL.
Number of Participants With Injection-site Adverse Experiences
Time frame: Up to Day 5 after any vaccination in study Phase A
Participants were prompted to report injection-site experiences of pain, erythema, or swelling and were also asked to report any other injection-site adverse experiences
Number of Participants With Elevated Temperature (Oral Temperature >=100 °F)
Time frame: Up to Day 5 after any vaccination in study Phase A
Number of Participants With Serious Adverse Experiences
Time frame: From the time of informed consent is signed through the last study visit (up to 19 months)
A serious adverse experience is any adverse experience that results in death, is life threatening, results in persistent or significant disability/incapacity, results in or prolongs existing inpatient hospitalization, is a congenital anomaly/birth defect, is a cancer, is an overdose, or is another important medical event that may jeopardize the participant and may require medical or surgical intervention
4 secondary outcomes
Geometric Mean Titer (GMT) of Anti-HPV Type 6 Antibody
Time frame: Month 7 (1 month postdose 3 in study Phase A)
GMT of Anti-HPV Type 11 Antibody
Time frame: Month 7 (1 month postdose 3 in study Phase A)
GMT of Anti-HPV Type 16 Antibody
Time frame: Month 7 (1 month postdose 3 in study Phase A)
GMT of Anti-HPV Type 18 Antibody
Time frame: Month 7 (1 month postdose 3 in study Phase A)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 25912475Mugo N, Ansah NA, Marino D, Saah A, Garner EI. Evaluation of safety and immunogenicity of a quadrivalent human papillomavirus vaccine in healthy females between 9 and 26 years of age in Sub-Saharan Africa. Hum Vaccin Immunother. 2015;11(6):1323-30. doi: 10.1080/21645515.2015.1008877.
- Individual participant dataSharing planned: Yes. https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
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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.
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 (GARDASIL™) in people with Papillomavirus 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 19 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 14 Nov 2018. 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. Some participants in this study may receive a placebo. 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 3 Jun 2014). 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?
Number of Participants Who Seroconvert to Human Papillomavirus (HPV) Type 6 (time frame: Month 7 (1 month postdose 3 in study Phase A)). The study lists 7 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 NCT01245764, 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 14 Nov 2018; AzTrials last refreshed its copy on 8 Nov 2026.