HumanPhase 3NCT00092547

A Study of Gardasil (V501) in Preadolescents and Adolescents (V501-018)

A Phase 3 study testing V501 in people with Human and Papillomavirus Infections, run by Merck Sharp & Dohme LLC.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This study is to evaluate the safety, tolerability, and immune response of an investigational vaccine in preadolescent and adolescent boys and girls for the prevention of Human Papilloma Virus (HPV). Read more about this study

Who is it for?: Ages 9 to 15 yearsHealthy volunteers can take part
Conditions the study is for: Human, Papillomavirus Infections
What is being tested?: V501
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 1,781 participants
Where: No sites listed yet
Study dates: 8 Oct 2003to 1 Jun 2015
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 15 years
All sexes
Healthy volunteers accepted
Child

Who may be able to join

Healthy adolescents and preadolescents with no prior sexual history

Who cannot join

Subjects with compromised immune system or have a history of severe allergic reaction

About this study

Official title: A Safety and Immunogenicity Study of Quadrivalent HPV (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) Vaccine in Preadolescents and Adolescents (Base Study). A Long Term Immunogenicity, Safety, and Effectiveness Study of GARDASIL (Human Papillomavirus [Types 6, 11, 16, 18] Recombinant Vaccine) Among Adolescents Who Received GARDASIL at 9-18 Years of Age (Extension Study).

This study is to evaluate the safety, tolerability, and immune response of an investigational vaccine in preadolescent and adolescent boys and girls for the prevention of Human Papilloma Virus (HPV).

Read the detailed description

The original base protocol (V501-018)(NCT00092547) was extended in amendments V501-018-05 and -06 to provide 37 months of follow-up. Additionally, subjects in the Placebo Group during the base study were given 3 doses of open-label GARDASIL™ (V501) at Months 30, 32, and 36.

The study was extended again in amendment V501-018-10(NCT00092547), titled "A Long Term Immunogenicity, Safety, and Effectiveness Study of GARDASIL (Human Papillomavirus [Types 6, 11, 16, 18] Recombinant Vaccine) Among Adolescents Who Received GARDASIL at 9-18 Years of Age" to allow a follow-up period to Month 126.

Conditions: Human, Papillomavirus Infections
Being tested: V501, Comparator: Placebo
Medical subject headings: Papillomavirus Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

V501Biological
Also called GARDASIL™
0.5 mL intramuscular injection of V501
Comparator: PlaceboBiological
0.5 mL intramuscular injection of placebo

Study groups in NCT00092547
Study group	Role	What they receive
qHPV Vaccine in Base Study	Experimental	Represents participants who were randomized into the qHPV Group, who received three 0.5 mL intramuscular injections of V501 (qHPV) at Day 1, Month 2, and Month 6. Receives: Biological: V501
Placebo in Base Study	Placebo comparator	Represents participants who were randomized into the Placebo Group, who received three 0.5 mL intramuscular injections of placebo at Day 1, Month 2, and Month 6. Receives: Biological: Comparator: Placebo
qHPV Vaccine in Extension Study	Experimental	Represents participants originally enrolled into the Placebo Group who continued in the study to receive 0.5 mL intramuscular injections of V501 (qHPV) at Month 30, Month 32, and Month 36. Receives: Biological: V501

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants Reporting Serious Adverse Experiences (SAEs) Through Month 18
Tolerability as assessed by the number of participants with clinical adverse experiences through Month 18. A serious adverse event is any adverse event that results in death, is life threatening, results in a persistent or significant disability/incapacity, results in hospitalization or prolongs an existing hospitalization, is a congenital anomaly/birth defect, is a cancer, is an overdose, or is considered an "other important medical event" based on medical judgment.
Measured: Up to Month 18
Number of Participants Reporting SAEs From Month 18 Through Month 37
Tolerability as assessed by the number of participants with clinical adverse experiences from Month 18 through Month 37
Measured: Month 18 to Month 37
Number of Participants Reporting Other (Non-serious) AEs Through Month 18
Tolerability as assessed by the number of participants with clinical adverse experiences through Month 18
Measured: Up to Month 18: Injection site AEs were collected from Days 1-5 and other non-serious AEs from Days 1-15 after any vaccination
Percentage of Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 72
A participant is considered seropositive for a given HPV type if he or she has a cLIA titer at or above the serostatus cutoff for that HPV type. Serostatus cutoffs are ≥ 20 mMU/mL for HPV 6 and 16, ≥ 16 mMU/mL for HPV 11, and ≥ 24 mMU/mL for HPV 18.
Measured: Month 72 (66 Months Post-dose 3 for the Original qHPV Vaccine Cohort and 36 months Post-dose 3 for the Extension Group)
Geometric Mean Titers (GMTs) for Anti-HPV 6, 11, 16, and 18 at Month 72
Measured: Month 72 (66 Months Post-dose 3 for the Original qHPV Vaccine Cohort and 36 months Post-dose 3 for the Extension Group)
Geometric Mean Titers for Anti-HPV 6, 11, 16, and 18 at Month 96
Measured: Month 96 (90 Months Post-dose 3 for Original qHPV Vaccine Group and 60 Months Post-dose 3 for Extension Group)
Percentage of Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 96
A participant is considered seropositive for a given HPV type if he or she has a cLIA titer at or above the serostatus cutoff for that HPV type. Serostatus cutoffs are ≥ 20 mMU/mL for HPV 6 and 16, ≥ 16 mMU/mL for HPV 11, and ≥ 24 mMU/mL for HPV 18.
Measured: Month 96 (90 Months Post-dose 3 for Original qHPV Vaccine Cohort and 60 Months Post-dose 3 for Extension Group)
Geometric Mean Titers for Anti-HPV 6, 11, 16, and 18 at Month 126
Measured: Month 126 (120 Months Post-dose 3 for Original qHPV Vaccine Cohort and 90 Months Post-dose 3 for Extension Group)
Percentage of Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 126
A participant is considered seropositive for a given HPV type if he or she has a cLIA titer at or above the serostatus cutoff for that HPV type. Serostatus cutoffs are ≥ 20 mMU/mL for HPV 6 and 16, ≥ 16 mMU/mL for HPV 11, and ≥ 24 mMU/mL for HPV 18.
Measured: Month 126 (120 Months Post-dose 3 for Original qHPV Vaccine Cohort and 90 Months Post-dose 3 for Extension Group)
Number of Participants Reporting SAEs Related to Study Vaccine or to a Study Procedure in the Long-term Follow-up
A serious adverse event is any adverse event that results in death, is life threatening, results in a persistent or significant disability/incapacity, results in hospitalization or prolongs an existing hospitalization, is a congenital anomaly/birth defect, is a cancer, is an overdose, or is considered an "other important medical event" based on medical judgment. SAEs considered by the investigator to be possibly, probably, or definitely related to study vaccine or a study procedure were reported.
Measured: Month 37 to Month 126

Secondary outcomes (14)

Percentage of Original qHPV Vaccine Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 1 Postdose 3 (Month 7)
A participant is considered seropositive for a given HPV type if he or she has a cLIA titer at or above the serostatus cutoff for that HPV type. Serostatus cutoffs are ≥ 20 mMU/mL for HPV 6 and 16, ≥ 16 mMU/mL for HPV 11, and ≥ 24 mMU/mL for HPV 18.
Measured: Month 7 (1 Month Postdose 3)
Percentage of Original qHPV Vaccine Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 12 Postdose 3 (Month 18).
A participant is considered seropositive for a given HPV type if he or she has a cLIA titer at or above the serostatus cutoff for that HPV type. Serostatus cutoffs are ≥ 20 mMU/mL for HPV 6 and 16, ≥ 16 mMU/mL for HPV 11, and ≥ 24 mMU/mL for HPV 18.
Measured: Month 18 (12 Months Post-dose 3)
Percentage of Original qHPV Vaccine Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 18 Postdose 3 (Month 24)
A participant is considered seropositive for a given HPV type if he or she has a cLIA titer at or above the serostatus cutoff for that HPV type. Serostatus cutoffs are ≥ 20 mMU/mL for HPV 6 and 16, ≥ 16 mMU/mL for HPV 11, and ≥ 24 mMU/mL for HPV 18.
Measured: Month 24 (18 Months Post-dose 3)
Percentage of Original qHPV Vaccine Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 24 Postdose 3 (Month 30)
A participant is considered seropositive for a given HPV type if he or she has a cLIA titer at or above the serostatus cutoff for that HPV type. Serostatus cutoffs are ≥ 20 mMU/mL for HPV 6 and 16, ≥ 16 mMU/mL for HPV 11, and ≥ 24 mMU/mL for HPV 18.
Measured: Month 30 (24 Months Post-dose 3)
Percentage of Original qHPV Vaccine Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 31 Postdose 3 (Month 37).
A participant is considered seropositive for a given HPV type if he or she has a cLIA titer at or above the serostatus cutoff for that HPV type. Serostatus cutoffs are ≥ 20 mMU/mL for HPV 6 and 16, ≥ 16 mMU/mL for HPV 11, and ≥ 24 mMU/mL for HPV 18.
Measured: Month 37 (31 Months Post-dose 3)
Percentage of Participants in the Extension Group Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 1 Postdose 3 of qHPV (Month 37)
A participant is considered seropositive for a given HPV type if he or she has a cLIA titer at or above the serostatus cutoff for that HPV type. Serostatus cutoffs are ≥ 20 mMU/mL for HPV 6 and 16, ≥ 16 mMU/mL for HPV 11, and ≥ 24 mMU/mL for HPV 18.
Measured: Month 37 (1 Month Post-dose 3 of qHPV)
Geometric Mean Titers of Original qHPV Vaccine Cohort for Anti-HPV 6, 11, 16, and 18 at Month 1 Postdose 3 of qHPV Vaccine (Month 7)
Measured: Month 7 (1 Month Post-dose 3)
Geometric Mean Titers of Original qHPV Vaccine Cohort for Anti-HPV 6, 11, 16, and 18 at Month 12 Postdose 3 of qHPV Vaccine (Month 18)
Measured: Month 18 (Month 12 Post-dose 3)
Geometric Mean Titers of Original qHPV Vaccine Cohort for Anti-HPV 6, 11, 16, and 18 at Month 18 Postdose 3 of qHPV Vaccine (Month 24)
Measured: Month 24 (18 Months Post-dose 3)
Geometric Mean Titers of Original qHPV Vaccine Cohort for Anti-HPV 6, 11, 16, and 18 at Month 24 Postdose 3 of qHPV Vaccine (Month 30)
Measured: Month 30 (24 Months Post-dose 3)
Geometric Mean Titers of Original qHPV Vaccine Cohort for Anti-HPV 6, 11, 16, and 18 at Month 31 Postdose 3 of qHPV Vaccine (Month 37)
Measured: Month 37 (31 Months Post-dose 3)
Geometric Mean Titers in the Extension Group for Anti-HPV 6, 11, 16, and 18 at Month 1 Postdose 3 of qHPV Vaccine (Month 37)
Measured: Month 37 (1 Month Post-dose 3 of qHPV)
Combined Incidence of HPV 6/11/16/18-related Persistent Infection and HPV 6/11/16/18-related CIN, AIS, VIN, VaIN, Genital Warts, and Cervical/Vaginal/Vulvar Cancer in Females
The HPV types were determined by polymerase chain reaction (PCR) testing. The combined incidence of HPV 6/11/16/18-related persistent infection and HPV 6/11/16/18-related cervical intraepithelial neoplasia (CIN), adenocarcinoma in situ (AIS), vulvar intraepithelial neoplasia (VIN), vaginal intraepithelial neoplasia (VaIN), genital warts, and cervical/Vaginal/vulvar cancer was assessed in female participants.
Measured: Up to Month 126
Combined Incidence of HPV 6/11/16/18-related Persistent Infection and HPV 6/11/16/18-related PIN, Genital Warts, and Penile/Perineal/Perianal Cancer in Males
The HPV types were determined by PCR testing. Combined incidence of HPV 6/11/16/18-related persistent infection and HPV 6/11/16/18-related penile/perineal/perianal intraepithelial neoplasia (PIN), genital warts, and penile/perineal/perianal cancer was assessed in male participants.
Measured: Up to Month 126

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 Oct 20031 Jun 2015

First posted28 Sep 2004 (estimated)
Study start8 Oct 2003
Primary completion3 Nov 2005
Study completion1 Jun 2015

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 (5)Papers the sponsor has linked to this study.
Other trials for HumanStudies 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: Double blind
Who is masked: Participant, Investigator
Enrolment: 1,781 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00092547
Sponsor's protocol ID: V501-018
Other IDs: 2004_084
Status last verified: Jan 2018
First submitted: 23 Sep 2004
Last updated: 20 Feb 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Reisinger KS, Block SL, Lazcano-Ponce E, Samakoses R, Esser MT, Erick J, Puchalski D, Giacoletti KE, Sings HL, Lukac S, Alvarez FB, Barr E. Safety and persistent immunogenicity of a quadrivalent human papillomavirus types 6, 11, 16, 18 L1 virus-like particle vaccine in preadolescents and adolescents: a randomized controlled trial. Pediatr Infect Dis J. 2007 Mar;26(3):201-9. doi: 10.1097/01.inf.0000253970.29190.5a.
PubMed 17484215
Perez G, Lazcano-Ponce E, Hernandez-Avila M, Garcia PJ, Munoz N, Villa LL, Bryan J, Taddeo FJ, Lu S, Esser MT, Vuocolo S, Sattler C, Barr E. Safety, immunogenicity, and efficacy of quadrivalent human papillomavirus (types 6, 11, 16, 18) L1 virus-like-particle vaccine in Latin American women. Int J Cancer. 2008 Mar 15;122(6):1311-8. doi: 10.1002/ijc.23260.
PubMed 18000825
Ferris D, Samakoses R, Block SL, Lazcano-Ponce E, Restrepo JA, Reisinger KS, Mehlsen J, Chatterjee A, Iversen OE, Sings HL, Shou Q, Sausser TA, Saah A. Long-term study of a quadrivalent human papillomavirus vaccine. Pediatrics. 2014 Sep;134(3):e657-65. doi: 10.1542/peds.2013-4144. Epub 2014 Aug 18.
PubMed 25136050
Ferris DG, Samakoses R, Block SL, Lazcano-Ponce E, Restrepo JA, Mehlsen J, Chatterjee A, Iversen OE, Joshi A, Chu JL, Krick AL, Saah A, Das R. 4-Valent Human Papillomavirus (4vHPV) Vaccine in Preadolescents and Adolescents After 10 Years. Pediatrics. 2017 Dec;140(6):e20163947. doi: 10.1542/peds.2016-3947.
PubMed 29167376
Garland SM, Ault KA, Gall SA, Paavonen J, Sings HL, Ciprero KL, Saah A, Marino D, Ryan D, Radley D, Zhou H, Haupt RM, Garner EIO; Quadrivalent Human Papillomavirus Vaccine Phase III Investigators. Pregnancy and infant outcomes in the clinical trials of a human papillomavirus type 6/11/16/18 vaccine: a combined analysis of five randomized controlled trials. Obstet Gynecol. 2009 Dec;114(6):1179-1188. doi: 10.1097/AOG.0b013e3181c2ca21.
PubMed 19935017

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Effectiveness and Clinical Outcomes of Long-term Bulevirtide Monotherapy in Patients With HDV-related Compensated Cirrhosis
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Healthy Volunteers - Male and Female

All Human trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Safety and Immunogenicity Study of Quadrivalent HPV (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) Vaccine in Preadolescents and Adolescents (Base Study). A Long Term Immunogenicity, Safety, and Effectiveness Study of GARDASIL (Human Papillomavirus [Types 6, 11, 16, 18] Recombinant Vaccine) Among Adolescents Who Received GARDASIL at 9-18 Years of Age (Extension Study).
ClinicalTrials.gov ID: NCT00092547
Acronym / sponsor ID: V501-018
Conditions: Human, Papillomavirus Infections
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,781 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: 8 Oct 2003 (actual)
Primary completion: 3 Nov 2005 (actual)
Study completion: 1 Jun 2015 (actual)
First posted: 28 Sep 2004 (estimated)
Results: Posted 4 May 2010

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 to evaluate the safety, tolerability, and immune response of an investigational vaccine in preadolescent and adolescent boys and girls for the prevention of Human Papilloma Virus (HPV).

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
qHPV Vaccine in Base Study	Experimental	Biological: V501Represents participants who were randomized into the qHPV Group, who received three 0.5 mL intramuscular injections of V501 (qHPV) at Day 1, Month 2, and Month 6.
Placebo in Base Study	Placebo comparator	Biological: Comparator: PlaceboRepresents participants who were randomized into the Placebo Group, who received three 0.5 mL intramuscular injections of placebo at Day 1, Month 2, and Month 6.
qHPV Vaccine in Extension Study	Experimental	Biological: V501Represents participants originally enrolled into the Placebo Group who continued in the study to receive 0.5 mL intramuscular injections of V501 (qHPV) at Month 30, Month 32, and Month 36.

Who may qualify

Ages: 9 to 15 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (1 listed)

Healthy adolescents and preadolescents with no prior sexual history

Key exclusion criteria (1 listed)

Subjects with compromised immune system or have a history of severe allergic reaction

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
V501Also: GARDASIL™0.5 mL intramuscular injection of V501	Biological	qHPV Vaccine in Base Study, qHPV Vaccine in Extension Study
Comparator: Placebo0.5 mL intramuscular injection of placebo	Biological	Placebo in Base Study

Primary outcome

Number of Participants Reporting Serious Adverse Experiences (SAEs) Through Month 18
Time frame: Up to Month 18
Tolerability as assessed by the number of participants with clinical adverse experiences through Month 18. A serious adverse event is any adverse event that results in death, is life threatening, results in a persistent or significant disability/incapacity, results in hospitalization or prolongs an existing hospitalization, is a congenital anomaly/birth defect, is a cancer, is an overdose, or is considered an "other important medical event" based on medical judgment.
Number of Participants Reporting SAEs From Month 18 Through Month 37
Time frame: Month 18 to Month 37
Tolerability as assessed by the number of participants with clinical adverse experiences from Month 18 through Month 37
Number of Participants Reporting Other (Non-serious) AEs Through Month 18
Time frame: Up to Month 18: Injection site AEs were collected from Days 1-5 and other non-serious AEs from Days 1-15 after any vaccination
Tolerability as assessed by the number of participants with clinical adverse experiences through Month 18
Percentage of Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 72
Time frame: Month 72 (66 Months Post-dose 3 for the Original qHPV Vaccine Cohort and 36 months Post-dose 3 for the Extension Group)
A participant is considered seropositive for a given HPV type if he or she has a cLIA titer at or above the serostatus cutoff for that HPV type. Serostatus cutoffs are ≥ 20 mMU/mL for HPV 6 and 16, ≥ 16 mMU/mL for HPV 11, and ≥ 24 mMU/mL for HPV 18.
Geometric Mean Titers (GMTs) for Anti-HPV 6, 11, 16, and 18 at Month 72
Time frame: Month 72 (66 Months Post-dose 3 for the Original qHPV Vaccine Cohort and 36 months Post-dose 3 for the Extension Group)
Geometric Mean Titers for Anti-HPV 6, 11, 16, and 18 at Month 96
Time frame: Month 96 (90 Months Post-dose 3 for Original qHPV Vaccine Group and 60 Months Post-dose 3 for Extension Group)
Percentage of Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 96
Time frame: Month 96 (90 Months Post-dose 3 for Original qHPV Vaccine Cohort and 60 Months Post-dose 3 for Extension Group)
A participant is considered seropositive for a given HPV type if he or she has a cLIA titer at or above the serostatus cutoff for that HPV type. Serostatus cutoffs are ≥ 20 mMU/mL for HPV 6 and 16, ≥ 16 mMU/mL for HPV 11, and ≥ 24 mMU/mL for HPV 18.
Geometric Mean Titers for Anti-HPV 6, 11, 16, and 18 at Month 126
Time frame: Month 126 (120 Months Post-dose 3 for Original qHPV Vaccine Cohort and 90 Months Post-dose 3 for Extension Group)
Percentage of Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 126
Time frame: Month 126 (120 Months Post-dose 3 for Original qHPV Vaccine Cohort and 90 Months Post-dose 3 for Extension Group)
A participant is considered seropositive for a given HPV type if he or she has a cLIA titer at or above the serostatus cutoff for that HPV type. Serostatus cutoffs are ≥ 20 mMU/mL for HPV 6 and 16, ≥ 16 mMU/mL for HPV 11, and ≥ 24 mMU/mL for HPV 18.
Number of Participants Reporting SAEs Related to Study Vaccine or to a Study Procedure in the Long-term Follow-up
Time frame: Month 37 to Month 126
A serious adverse event is any adverse event that results in death, is life threatening, results in a persistent or significant disability/incapacity, results in hospitalization or prolongs an existing hospitalization, is a congenital anomaly/birth defect, is a cancer, is an overdose, or is considered an "other important medical event" based on medical judgment. SAEs considered by the investigator to be possibly, probably, or definitely related to study vaccine or a study procedure were reported.

14 secondary outcomes

Percentage of Original qHPV Vaccine Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 1 Postdose 3 (Month 7)
Time frame: Month 7 (1 Month Postdose 3)
Percentage of Original qHPV Vaccine Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 12 Postdose 3 (Month 18).
Time frame: Month 18 (12 Months Post-dose 3)
Percentage of Original qHPV Vaccine Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 18 Postdose 3 (Month 24)
Time frame: Month 24 (18 Months Post-dose 3)
Percentage of Original qHPV Vaccine Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 24 Postdose 3 (Month 30)
Time frame: Month 30 (24 Months Post-dose 3)
Percentage of Original qHPV Vaccine Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 31 Postdose 3 (Month 37).
Time frame: Month 37 (31 Months Post-dose 3)
Percentage of Participants in the Extension Group Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 1 Postdose 3 of qHPV (Month 37)
Time frame: Month 37 (1 Month Post-dose 3 of qHPV)
Geometric Mean Titers of Original qHPV Vaccine Cohort for Anti-HPV 6, 11, 16, and 18 at Month 1 Postdose 3 of qHPV Vaccine (Month 7)
Time frame: Month 7 (1 Month Post-dose 3)
Geometric Mean Titers of Original qHPV Vaccine Cohort for Anti-HPV 6, 11, 16, and 18 at Month 12 Postdose 3 of qHPV Vaccine (Month 18)
Time frame: Month 18 (Month 12 Post-dose 3)
Geometric Mean Titers of Original qHPV Vaccine Cohort for Anti-HPV 6, 11, 16, and 18 at Month 18 Postdose 3 of qHPV Vaccine (Month 24)
Time frame: Month 24 (18 Months Post-dose 3)
Geometric Mean Titers of Original qHPV Vaccine Cohort for Anti-HPV 6, 11, 16, and 18 at Month 24 Postdose 3 of qHPV Vaccine (Month 30)
Time frame: Month 30 (24 Months Post-dose 3)
Geometric Mean Titers of Original qHPV Vaccine Cohort for Anti-HPV 6, 11, 16, and 18 at Month 31 Postdose 3 of qHPV Vaccine (Month 37)
Time frame: Month 37 (31 Months Post-dose 3)
Geometric Mean Titers in the Extension Group for Anti-HPV 6, 11, 16, and 18 at Month 1 Postdose 3 of qHPV Vaccine (Month 37)
Time frame: Month 37 (1 Month Post-dose 3 of qHPV)
Combined Incidence of HPV 6/11/16/18-related Persistent Infection and HPV 6/11/16/18-related CIN, AIS, VIN, VaIN, Genital Warts, and Cervical/Vaginal/Vulvar Cancer in Females
Time frame: Up to Month 126
Combined Incidence of HPV 6/11/16/18-related Persistent Infection and HPV 6/11/16/18-related PIN, Genital Warts, and Penile/Perineal/Perianal Cancer in Males
Time frame: Up to Month 126

Results and safety

Results posted to the registry on 4 May 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
qHPV Vaccine in Base Study	1,184	1,121
Placebo in Base Study	597	561
qHPV Vaccine in Extension Study	0	0

Primary outcome: Number of Participants Reporting Serious Adverse Experiences (SAEs) Through Month 18

Time frame: Up to Month 18. Number. Unit: participants

Measure	qHPV Vaccine in Base Study n = 1165	Placebo in Base Study n = 584
Value	6	0

Population analysed: All participants who were vaccinated according to actual treatment received (qHPV or placebo) and had safety follow-up.

Primary outcome: Number of Participants Reporting SAEs From Month 18 Through Month 37

Time frame: Month 18 to Month 37. Number. Unit: participants

Measure	qHPV Vaccine in Base Study n = 923	qHPV Vaccine in Extension Study n = 477
Value	0	3

Population analysed: All participants who were vaccinated according to actual treatment received (qHPV or placebo) and had safety follow-up.

Primary outcome: Number of Participants Reporting Other (Non-serious) AEs Through Month 18

Time frame: Up to Month 18: Injection site AEs were collected from Days 1-5 and other non-serious AEs from Days 1-15 after any vaccination. Number. Unit: participants

Measure	qHPV Vaccine in Base Study n = 1165	Placebo in Base Study n = 584
Value	918	340

Population analysed: All participants who were vaccinated according to actual treatment received (qHPV or placebo) and had safety follow-up.

Primary outcome: Percentage of Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 72

Time frame: Month 72 (66 Months Post-dose 3 for the Original qHPV Vaccine Cohort and 36 months Post-dose 3 for the Extension Group). Number (95% Confidence Interval). Unit: Percentage of participants

Measure	qHPV Vaccine in Base Study n = 550	qHPV Vaccine in Extension Study n = 276
Type 6: n=475, 151	93.3 (90.6 to 95.3)	91.4 (85.7 to 95.3)
Type 11: n=475, 151	96.0 (93.8 to 97.6)	96.7 (92.4 to 98.9)
Type 16: n=473, 154	97.9 (96.1 to 99.0)	97.4 (93.5 to 99.3)
Type 18: n=477, 160	74.4 (70.3 to 78.3)	79.4 (72.3 to 85.4)

Population analysed: Per-protocol population: participants without protocol violations who received all 3 vaccinations, were seronegative to the respective HPV type at Day 1 (for the Base Vaccination group), or Month 30 (for the Extension Group), and had a valid serology result at the specified time for assessment.

14 secondary outcomes are reported in the full results.

Adverse events

Time frame: Day 1 to Month 30 and Month 30 to Month 126. Other adverse events reported at 4% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
qHPV Vaccine in Base: Vaccine Phase and Follow-up	6 of 1,165 (0.5%)	918 of 1,165 (78.8%)	Not reported
Placebo in Base: Vaccine Phase and Follow-up	0 of 584 (0%)	344 of 584 (58.9%)	Not reported
qHPV Vaccine in Base: Extension and Long-term Follow-up	2 of 932 (0.2%)	0 of 932 (0%)	Not reported
qHPV Vaccine in Extension: Extension and Long-term Follow-up	3 of 481 (0.6%)	3 of 481 (0.6%)	Not reported

Limitations and caveats (from the sponsor): The difference between the prior and final data is a minor change in the definition of the per-protocol immunogenicity population, which was applied down to the base study. Also, protocol violators were identified and excluded from the analysis.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 17484215Reisinger KS, Block SL, Lazcano-Ponce E, Samakoses R, Esser MT, Erick J, Puchalski D, Giacoletti KE, Sings HL, Lukac S, Alvarez FB, Barr E. Safety and persistent immunogenicity of a quadrivalent human papillomavirus types 6, 11, 16, 18 L1 virus-like particle vaccine in preadolescents and adolescents: a randomized controlled trial. Pediatr Infect Dis J. 2007 Mar;26(3):201-9. doi: 10.1097/01.inf.0000253970.29190.5a.
Background: PubMed 18000825Perez G, Lazcano-Ponce E, Hernandez-Avila M, Garcia PJ, Munoz N, Villa LL, Bryan J, Taddeo FJ, Lu S, Esser MT, Vuocolo S, Sattler C, Barr E. Safety, immunogenicity, and efficacy of quadrivalent human papillomavirus (types 6, 11, 16, 18) L1 virus-like-particle vaccine in Latin American women. Int J Cancer. 2008 Mar 15;122(6):1311-8. doi: 10.1002/ijc.23260.
Results publication: PubMed 25136050Ferris D, Samakoses R, Block SL, Lazcano-Ponce E, Restrepo JA, Reisinger KS, Mehlsen J, Chatterjee A, Iversen OE, Sings HL, Shou Q, Sausser TA, Saah A. Long-term study of a quadrivalent human papillomavirus vaccine. Pediatrics. 2014 Sep;134(3):e657-65. doi: 10.1542/peds.2013-4144. Epub 2014 Aug 18.
Results publication: PubMed 29167376Ferris DG, Samakoses R, Block SL, Lazcano-Ponce E, Restrepo JA, Mehlsen J, Chatterjee A, Iversen OE, Joshi A, Chu JL, Krick AL, Saah A, Das R. 4-Valent Human Papillomavirus (4vHPV) Vaccine in Preadolescents and Adolescents After 10 Years. Pediatrics. 2017 Dec;140(6):e20163947. doi: 10.1542/peds.2016-3947.
Derived from this study: PubMed 19935017Garland SM, Ault KA, Gall SA, Paavonen J, Sings HL, Ciprero KL, Saah A, Marino D, Ryan D, Radley D, Zhou H, Haupt RM, Garner EIO; Quadrivalent Human Papillomavirus Vaccine Phase III Investigators. Pregnancy and infant outcomes in the clinical trials of a human papillomavirus type 6/11/16/18 vaccine: a combined analysis of five randomized controlled trials. Obstet Gynecol. 2009 Dec;114(6):1179-1188. doi: 10.1097/AOG.0b013e3181c2ca21.

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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 V501 in people with Human and 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 1 inclusion and 1 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 20 Feb 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 4 May 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?

Number of Participants Reporting Serious Adverse Experiences (SAEs) Through Month 18 (time frame: Up to Month 18). The study lists 10 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 NCT00092547, which also lists 5 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 20 Feb 2018.