Healthy Adult Female ParticipantsPhase 3NCT00090220

A Study to Evaluate the Safety, Immune Response, and Efficacy of Gardasil (V501, qHPV) in Mid-Adult Women (V501-019)

A Phase 3 study testing Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine in people with Healthy Adult Female Participants and Prevention, run by Merck Sharp & Dohme LLC.

Completed

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

Official record

Search all trials

Trial summary

This study was conducted to assess the safety, immunogenicity, efficacy and long-term effectiveness of a vaccine being evaluated for the prevention of human papillomavirus (HPV) infection and disease in mid-adult women. Read more about this study

Who is it for?: Ages 24 to 45 years, women onlyHealthy volunteers can take part
Conditions the study is for: Healthy Adult Female Participants, Prevention, Papillomavirus Infection
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?: Yes, some participants may receive a placebo
How many people: 3,819 participants
Where: No sites listed yet
Study dates: 16 Jun 2004to 12 Nov 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 24 to 45 years
Women only
Healthy volunteers accepted
Adult

Who may be able to join

No history of genital warts, vulvar intraepithelial neoplasia (VIN), or vaginal intraepithelial neoplasia (VaIN)
Not pregnant and agrees to use effective contraception through Month 7 of the study
Additional criteria applied

Who cannot join

Pregnant
Concurrently enrolled in a clinical study involving collection of cervical specimens
Previously received any HPV vaccine
History of severe allergic reaction that required medical intervention
Received any immune globulin or blood-derived products within 3 months prior to the first study injection
History of splenectomy, known immune disorders, or receiving immunosuppressives

Show all 12Show fewer

Immunocompromised or diagnosed with human immunodeficiency virus (HIV) infection
Known thrombocytopenia or any coagulation disorders that could contraindicate intramuscular injections
History of recent or ongoing alcohol or drug abuse
Prior treatment for genital warts, VIN, or VaIN
History of cervical disease (ie, surgical treatment for cervical lesions)
Hysterectomy

About this study

Official title: Safety, Immunogenicity, and Efficacy of Gardasil (V501 (Human Papilloma Virus [Types 6, 11, 16, 18] Recombinant Vaccine) in Mid-Adult Women - The FUTURE III (Females United to Unilaterally Reduce Endo/Ectocervical Cancer) Study

Read the detailed description

The Base study vaccination period (V501-019) encompassed Day 1 through Month 7, during which time participants received randomly assigned, blinded Gardasil™ (V501, qHPV vaccine) or placebo at Day 1, Month 2 and Month 6. The Base study follow-up period continued through approximately Month 48.

The base study was extended in protocol V501-019-10 (EXT1). Participants who received placebo and participants who received only 1 dose of qHPV vaccine in the Base Study were offered a complete, open-label, 3-dose qHPV vaccine regimen (administered at EXT1 Day 1, Month 2 and Month 6). Participants who received only 2 doses of qHPV vaccine in the base study were offered a single additional dose of qHPV vaccine (administered at EXT1 Day 1). Participants were followed to EXT1 Month 7.

A Long Term Follow-Up (LTFU) extension study V501-019-21 (EXT2) was added to observe the long term safety, effectiveness, and immunogenicity of qHPV vaccine in approximately 1,600 women who participated in the Base Study at sites in Colombia. Data were collected over a period of 6-10 years following participant's enrollment in the original Base Study.

Conditions: Healthy Adult Female Participants, Prevention, Papillomavirus Infection, Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18
Being tested: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine, 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.

Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant VaccineBiological
qHPV intramuscular injection in three 0.5 mL doses over 6 months in the Base Study or EXT1
Comparator: PlaceboBiological
Placebo intramuscular injection in three 0.5 mL doses over 6 months.

Study groups in NCT00090220
Study group	Role	What they receive
qHPV Vaccine in Base Study	Experimental	Participants received blinded qHPV vaccination at Day 1, Month 2, and Month 6 of the Base Study Receives: Biological: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine
Placebo in Base Study	Placebo comparator	Participants received blinded placebo at Day 1, Month 2, and Month 6 in the Base Study. They were eligible to receive open-label qHPV vaccine in Extension 1 Receives: Biological: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine; Biological: Comparator: Placebo

What is being measured

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

Incidence Rate of HPV 6/11/16/18 Related Persistent Infection, Genital Warts, VIN, VaIN, Vulvar Cancer, Vaginal Cancer, Cervical Dysplasia, Cervical AIS, and Cervical Cancer
The four HPV types were determined by polymerase chain reaction (PCR) testing. VIN = vulvar intraepithelial neoplasia; VaIN = vaginal intraepithelial neoplasia; AIS = adenocarcinoma in situ.
Measured: Up to 48 months (4 years) after the first dose of qHPV vaccine in the Base Study
Number of Participants With Vaccine- or Placebo-Related Serious Adverse Events (SAEs) in the Base Study
An adverse event (AE) is any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an adverse event. A serious adverse event (SAE) is an AE that results in death, is life threatening, results in persistent or significant disability or incapacity, results in or prolongs a hospitalization, is a congenital anomaly or birth defect, is a cancer, or is an overdose. Vaccine-related SAEs are those deemed by the investigator to be definitely, probably, or possibly related to study vaccine.
Measured: Up to Month 48 (up to 42 months after the third dose of qHPV vaccine in the Base Study)
Number of Participants With Vaccine-Related SAEs After Vaccine Administration
An adverse event (AE) is any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an adverse event. A serious adverse event (SAE) is an AE that results in death, is life threatening, results in persistent or significant disability or incapacity, results in or prolongs a hospitalization, is a congenital anomaly or birth defect, is a cancer, or is an overdose. Vaccine-related SAEs are those deemed by the investigator to be definitely, probably, or possibly related to study vaccine.
Measured: qHPV in Base Study: Up to Month 120; Placebo in Base Study: approximately Month 60 up to Month 120
Number of Participants With an SAE Resulting in Death After Vaccine Administration
An adverse event (AE) is any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an adverse event. A serious adverse event (SAE) is an AE that results in death, is life threatening, results in persistent or significant disability or incapacity, results in or prolongs a hospitalization, is a congenital anomaly or birth defect, is a cancer, or is an overdose.
Measured: qHPV in Base Study: Up to Month 120; Placebo in Base Study: approximately Month 60 up to Month 120
Cumulative Incidence of HPV 6/11/16/18-related Cervical Intraepithelial Neoplasia (CIN) or Condyloma: Day 1 to Year 4
The four HPV types were determined by PCR testing. Cumulative incidence probability is the probability of becoming an endpoint case at any time from Day 1 to Year 4, conditional on having been event-free at Day 1.
Measured: Up to Month 48 (up to 42 months after the third dose of qHPV vaccine in the Base Study)
Cumulative Incidence of HPV 6/11/16/18-related CIN or Condyloma: Year 4 to 8
The four HPV types were determined by PCR testing. Cumulative incidence probability is the probability of becoming an endpoint case at any time from Year 4 to Year 8, conditional on having been event-free from Day 1 to Year 4. The analysis windows were cut at the exact time points, e.g., Year 4. Visits and events which occurred after Year 4 due to visit window or follow-up investigations are included in the Year 4 to Year 8 time interval.
Measured: From 48 to 96 months (4 to 8 years) after the first dose of qHPV vaccine in the Base Study
Cumulative Incidence of HPV 6/11/16/18-related CIN or Condyloma: Year 6 to 10
The four HPV types were determined by PCR testing. Cumulative incidence probability is the probability of becoming an endpoint case at any time from Year 6 to Year 10, conditional on having been event-free from Day 1 to Year 6.
Measured: From 72 to 120 months (6 to 10 years) after the first dose of qHPV vaccine in the Base Study
Incidence Rate of HPV 6/11/16/18-related CIN or Condyloma (Secondary Analysis): Day 1 to Year 4
The four HPV types were determined by PCR testing.
Measured: Up to Month 48 (up to 42 months after the third dose of qHPV vaccine in the Base Study)
Incidence Rate of HPV 6/11/16/18-related CIN or Condyloma (Secondary Analysis): Year 4 to 8
The four HPV types were determined by PCR testing. The analysis windows were cut at the exact time points, e.g., Year 4. Visits and events which occurred after Year 4 due to visit window or follow-up investigations are included in the Year 4 to Year 8 time interval.
Measured: From 48 to 96 months (4 to 8 years) after the first dose of qHPV vaccine in the Base Study
Incidence Rate of HPV 6/11/16/18-related CIN or Condyloma (Secondary Analysis): Year 6 to 10
The four HPV types were determined by PCR testing.
Measured: From 72 to 120 months (6 to 10 years) after the first dose of qHPV vaccine in the Base Study
Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 1 Month Postdose 3 in the Base Study
Serum antibodies to the HPV Types were determined by Competitive Luminex Immunoassay (cLIA). Geometric Mean Titers (GMT) are reported in milli-Merck Units/mL (mMU/mL). This Outcome Measure evaluated age-specific immunogenicity responses, and applied only to participants who received qHPV in the Base Study.
Measured: Month 7 (1 month after the third dose of qHPV vaccine in the Base Study)
Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 6 Months Postdose 3 in the Base Study
Serum antibodies to the HPV Types were determined by Competitive Luminex Immunoassay (cLIA). Geometric Mean Titers (GMT) are reported in milli-Merck Units/mL (mMU/mL). This Outcome Measure evaluated age-specific immunogenicity responses, and applied only to participants who received qHPV in the Base Study.
Measured: Month 12 (6 months after the third dose of qHPV vaccine in the Base Study)
Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 18 Months Postdose 3 in the Base Study
Serum antibodies to the HPV Types were determined by Competitive Luminex Immunoassay (cLIA). Geometric Mean Titers (GMT) are reported in milli-Merck Units/mL (mMU/mL). This Outcome Measure evaluated age-specific immunogenicity responses, and applied only to participants who received qHPV in the Base Study.
Measured: Month 24 (18 months after the third dose of qHPV vaccine in the Base Study)
Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 30 Months Postdose 3 in the Base Study
Serum antibodies to the HPV Types were determined by Competitive Luminex Immunoassay (cLIA). Geometric Mean Titers (GMT) are reported in milli-Merck Units/mL (mMU/mL). This Outcome Measure evaluated age-specific immunogenicity responses, and applied only to participants who received qHPV in the Base Study.
Measured: Month 36 (30 months after the third dose of qHPV vaccine in the Base Study)
Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 42 Months Postdose 3 in the Base Study
Serum antibodies to the HPV Types were determined by Competitive Luminex Immunoassay (cLIA). Geometric Mean Titers (GMT) are reported in milli-Merck Units/mL (mMU/mL). This Outcome Measure evaluated age-specific immunogenicity responses, and applied only to participants who received qHPV in the Base Study.
Measured: Month 48 (42 months after the third dose of qHPV vaccine in the Base Study)
Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 66 Months Postdose 3 in the Base Study
Serum antibodies to the HPV Types were determined by Competitive Luminex Immunoassay (cLIA). Geometric Mean Titers (GMT) are reported in milli-Merck Units/mL (mMU/mL). This Outcome Measure evaluated age-specific immunogenicity responses, and applied only to participants who received qHPV in the Base Study.
Measured: Month 72 (66 months after the third dose of qHPV vaccine in the Base Study)
Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 90 Months Postdose 3 in the Base Study
Serum antibodies to the HPV Types were determined by Competitive Luminex Immunoassay (cLIA). Geometric Mean Titers (GMT) are reported in milli-Merck Units/mL (mMU/mL). This Outcome Measure evaluated age-specific immunogenicity responses, and applied only to participants who received qHPV in the Base Study.
Measured: Month 96 (90 months after the third dose of qHPV vaccine in the Base Study)
Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 114 Months Postdose 3 in the Base Study
Serum antibodies to the HPV Types were determined by Competitive Luminex Immunoassay (cLIA). Geometric Mean Titers (GMT) are reported in milli-Merck Units/mL (mMU/mL). This Outcome Measure evaluated age-specific immunogenicity responses, and applied only to participants who received qHPV in the Base Study.
Measured: Month 120 (114 months after the third dose of qHPV vaccine in the Base Study)
Percentage of Participants Seropositive for Anti-HPV Antibody at 1 Month Postdose 3 in the Base Study
Serum antibodies to HPV Types 6, 11, 16, and 18 were determined by Competitive Luminex Immunoassay (cLIA). The seropositive thresholds (in mMU/mL) were >20 for Type 6, >16 for Type 11, >20 for Type 16, and >24 for Type 18. This Outcome Measure evaluated age-specific immunogenicity responses, and applied only to participants who received qHPV in the Base Study.
Measured: Month 7 (1 month after the third dose of qHPV vaccine in the Base Study)
Percentage of Participants Seropositive for Anti-HPV Antibody at 6 Months Postdose 3 in the Base Study
Serum antibodies to HPV Types 6, 11, 16, and 18 were determined by Competitive Luminex Immunoassay (cLIA). The seropositive thresholds (in mMU/mL) were >20 for Type 6, >16 for Type 11, >20 for Type 16, and >24 for Type 18. This Outcome Measure evaluated age-specific immunogenicity responses, and applied only to participants who received qHPV in the Base Study.
Measured: Month 12 (6 months after the third dose of qHPV vaccine in the Base Study)
Percentage of Participants Seropositive for Anti-HPV Antibody at 18 Months Postdose 3 in the Base Study
Serum antibodies to HPV Types 6, 11, 16, and 18 were determined by Competitive Luminex Immunoassay (cLIA). The seropositive thresholds (in mMU/mL) were >20 for Type 6, >16 for Type 11, >20 for Type 16, and >24 for Type 18. This Outcome Measure evaluated age-specific immunogenicity responses, and applied only to participants who received qHPV in the Base Study.
Measured: Month 24 (18 months after the third dose of qHPV vaccine in the Base Study)
Percentage of Participants Seropositive for Anti-HPV Antibody at 30 Months Postdose 3 in the Base Study
Serum antibodies to HPV Types 6, 11, 16, and 18 were determined by Competitive Luminex Immunoassay (cLIA). The seropositive thresholds (in mMU/mL) were >20 for Type 6, >16 for Type 11, >20 for Type 16, and >24 for Type 18. This Outcome Measure evaluated age-specific immunogenicity responses, and applied only to participants who received qHPV in the Base Study.
Measured: Month 36 (30 months after the third dose of qHPV vaccine in the Base Study)
Percentage of Participants Seropositive for Anti-HPV Antibody at 42 Months Postdose 3 in the Base Study
Serum antibodies to HPV Types 6, 11, 16, and 18 were determined by Competitive Luminex Immunoassay (cLIA). The seropositive thresholds (in mMU/mL) were >20 for Type 6, >16 for Type 11, >20 for Type 16, and >24 for Type 18. This Outcome Measure evaluated age-specific immunogenicity responses, and applied only to participants who received qHPV in the Base Study.
Measured: Month 48 (42 months after the third dose of qHPV vaccine in the Base Study)
Percentage of Participants Seropositive for Anti-HPV Antibody at 66 Months Postdose 3 in the Base Study
Serum antibodies to HPV Types 6, 11, 16, and 18 were determined by Competitive Luminex Immunoassay (cLIA). The seropositive thresholds (in mMU/mL) were >20 for Type 6, >16 for Type 11, >20 for Type 16, and >24 for Type 18. This Outcome Measure evaluated age-specific immunogenicity responses, and applied only to participants who received qHPV in the Base Study.
Measured: Month 72 (66 months after the third dose of qHPV vaccine in the Base Study)
Percentage of Participants Seropositive for Anti-HPV Antibody at 90 Months Postdose 3 in the Base Study
Serum antibodies to HPV Types 6, 11, 16, and 18 were determined by Competitive Luminex Immunoassay (cLIA). The seropositive thresholds (in mMU/mL) were >20 for Type 6, >16 for Type 11, >20 for Type 16, and >24 for Type 18. This Outcome Measure evaluated age-specific immunogenicity responses, and applied only to participants who received qHPV in the Base Study.
Measured: Month 96 (96 months after the third dose of qHPV vaccine in the Base Study)
Percentage of Participants Seropositive for Anti-HPV Antibody at 114 Months Postdose 3 in the Base Study
Serum antibodies to HPV Types 6, 11, 16, and 18 were determined by Competitive Luminex Immunoassay (cLIA). The seropositive thresholds (in mMU/mL) were >20 for Type 6, >16 for Type 11, >20 for Type 16, and >24 for Type 18. This Outcome Measure evaluated age-specific immunogenicity responses, and applied only to participants who received qHPV in the Base Study.
Measured: Month 120 (114 months after the third dose of qHPV vaccine in the Base Study)

Secondary outcomes (8)

Incidence Rate of HPV 6/11 Related Persistent Infection, Genital Warts, VIN, VaIN, Vulvar Cancer, Vaginal Cancer, Cervical Dysplasia, Cervical AIS, and Cervical Cancer
HPV 6/11: The two types of HPV (types 6/11) were determined by PCR testing
Measured: Up to Month 48 (up to 42 months after the third dose of qHPV vaccine in the Base Study)
Cumulative Incidence of HPV 6/11-related Condyloma: Day 1 to Year 4
The four HPV types were determined by PCR testing. Cumulative incidence probability is the probability of becoming an endpoint case at any time from Day 1 to Year 4 conditional on having been event-free at Day 1.
Measured: Up to 48 months (4 years) after the first dose of qHPV vaccine or placebo in the Base Study
Cumulative Incidence of HPV 6/11-related Condyloma: Year 4 to Year 8
The four HPV types were determined by PCR testing. Cumulative incidence probability is the probability of becoming an endpoint case at any time from Year 4 to Year 8 conditional on having been event-free from Day 1 to Year 4. The analysis windows were cut at the exact time points, e.g., Year 4. Visits and events which occurred after Year 4 due to visit window or follow-up investigations are included in the Year 4 to Year 8 time interval.
Measured: From 48 to 96 months (4 to 8 years) after the first dose of qHPV vaccine in the Base Study
Cumulative Incidence of HPV 6/11-related Condyloma: Year 6 to Year 10
The four HPV types were determined by PCR testing. Cumulative incidence probability is the probability of becoming an endpoint case at any time from Year 6 to Year 10 conditional on having been event-free from Day 1 to Year 6.
Measured: From 72 to 120 months (6 to 10 years) after the first dose of qHPV vaccine in the Base Study
Incidence Rate of HPV 6/11-related Condyloma (Secondary Analysis): Day 1 to Year 4
The four HPV types were determined by PCR testing.
Measured: Up to 48 months (4 years) after the first dose of qHPV vaccine or placebo in the Base Study
Incidence Rate of HPV 6/11-related Condyloma (Secondary Analysis): Year 4 to Year 8
The four HPV types were determined by PCR testing. The analysis windows were cut at the exact time points, e.g., Year 4. Visits and events which occurred after Year 4 due to visit window or follow-up investigations are included in the Year 4 to Year 8 time interval.
Measured: From 48 to 96 months (4 to 8 years) after the first dose of qHPV vaccine in the Base Study
Incidence Rate of HPV 6/11-related Condyloma (Secondary Analysis): Year 6 to Year 10
The four HPV types were determined by PCR testing. Cumulative incidence probability is the probability of becoming an endpoint case at any time from Year 6 to Year 10 conditional on having been event-free from Day 1 to Year 6.
Measured: From 72 to 120 months (6 to 10 years) after the first dose of qHPV vaccine in the Base Study
Incidence Rate of HPV 31/33/35/52/58 Related Persistent Infection, Genital Warts, VIN, VaIN, Vulvar Cancer, Vaginal Cancer, Cervical Dysplasia, Cervical AIS, and Cervical Cancer
This outcome measure was not analyzed because of diminished interest by experts in composite efficacy endpoints associated with these HPV types
Measured: Up to Month 48 (up to 42 months after the third dose of qHPV vaccine in the Base Study)

Timeline

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

16 Jun 200412 Nov 2015

First posted27 Aug 2004 (estimated)
Study start16 Jun 2004
Primary completion21 May 2009
Study completion12 Nov 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 (8)Papers the sponsor has linked to this study.
Other trials for Healthy Adult Female ParticipantsStudies 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: 3,819 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00090220
Sponsor's protocol ID: V501-019
Other IDs: 2004_013
Status last verified: Mar 2017
First submitted: 25 Aug 2004
Last updated: 21 Apr 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: Yes: http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final\_Updated%20July\_9\_2014.pdf http://engagezone.msd.com/ds\_documentation.php

Publications

Munoz N, Manalastas R Jr, Pitisuttithum P, Tresukosol D, Monsonego J, Ault K, Clavel C, Luna J, Myers E, Hood S, Bautista O, Bryan J, Taddeo FJ, Esser MT, Vuocolo S, Haupt RM, Barr E, Saah A. Safety, immunogenicity, and efficacy of quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine in women aged 24-45 years: a randomised, double-blind trial. Lancet. 2009 Jun 6;373(9679):1949-57. doi: 10.1016/S0140-6736(09)60691-7. Epub 2009 Jun 1.
PubMed 19493565
Velicer C, Zhu X, Vuocolo S, Liaw KL, Saah A. Prevalence and incidence of HPV genital infection in women. Sex Transm Dis. 2009 Nov;36(11):696-703. doi: 10.1097/OLQ.0b013e3181ad25ff.
PubMed 19652630
Castellsague X, Munoz N, Pitisuttithum P, Ferris D, Monsonego J, Ault K, Luna J, Myers E, Mallary S, Bautista OM, Bryan J, Vuocolo S, Haupt RM, Saah A. End-of-study safety, immunogenicity, and efficacy of quadrivalent HPV (types 6, 11, 16, 18) recombinant vaccine in adult women 24-45 years of age. Br J Cancer. 2011 Jun 28;105(1):28-37. doi: 10.1038/bjc.2011.185. Epub 2011 May 31.
PubMed 21629249
Luna J, Plata M, Gonzalez M, Correa A, Maldonado I, Nossa C, Radley D, Vuocolo S, Haupt RM, Saah A. Long-term follow-up observation of the safety, immunogenicity, and effectiveness of Gardasil in adult women. PLoS One. 2013 Dec 31;8(12):e83431. doi: 10.1371/journal.pone.0083431. eCollection 2013.
PubMed 24391768
Matys K, Mallary S, Bautista O, Vuocolo S, Manalastas R, Pitisuttithum P, Saah A. Mother-infant transfer of anti-human papillomavirus (HPV) antibodies following vaccination with the quadrivalent HPV (type 6/11/16/18) virus-like particle vaccine. Clin Vaccine Immunol. 2012 Jun;19(6):881-5. doi: 10.1128/CVI.00002-12. Epub 2012 Apr 18.
PubMed 22518014
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
Doshi P, Bourgeois F, Hong K, Jones M, Lee H, Shamseer L, Spence O, Jefferson T. Adjuvant-containing control arms in pivotal quadrivalent human papillomavirus vaccine trials: restoration of previously unpublished methodology. BMJ Evid Based Med. 2020 Dec;25(6):213-219. doi: 10.1136/bmjebm-2019-111331. Epub 2020 Mar 17.
PubMed 32184277
Castellsague X, Ault KA, Bosch FX, Brown D, Cuzick J, Ferris DG, Joura EA, Garland SM, Giuliano AR, Hernandez-Avila M, Huh W, Iversen OE, Kjaer SK, Luna J, Monsonego J, Munoz N, Myers E, Paavonen J, Pitisuttihum P, Steben M, Wheeler CM, Perez G, Saah A, Luxembourg A, Sings HL, Velicer C. Human papillomavirus detection in cervical neoplasia attributed to 12 high-risk human papillomavirus genotypes by region. Papillomavirus Res. 2016 Dec;2:61-69. doi: 10.1016/j.pvr.2016.03.002. Epub 2016 Mar 14.
PubMed 29074187

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

Recruiting
Methylation Analyses for Gynaecological Research Through Home-based Self-sampling
Healthy Adult Participants, Gynecological Disease
Recruiting
Pharmacokinetic (PK) Study of Phytochemicals in Whole Grains (WGs)- Brown Rice
Healthy Adult Males, Healthy Adult Females
Not yet recruiting
Investigating Sex Differences in Mitochondrial Function and Leg Blood Flow During Exercise
Healthy Adult Male, Healthy Adult Females
Enrolling by invitationObservational study
CArdiovascular Phenotyping in Recreationally Active Saudi Women
Healthy Active Females, Healthy Adult Female Participants
RecruitingPhase 1
A Study of Navlimetostat (BMS-986504) Drug Interactions and Food Effect in Healthy Participants
Healthy Female Adults

All Healthy Adult Female Participants trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Safety, Immunogenicity, and Efficacy of Gardasil (V501 (Human Papilloma Virus [Types 6, 11, 16, 18] Recombinant Vaccine) in Mid-Adult Women - The FUTURE III (Females United to Unilaterally Reduce Endo/Ectocervical Cancer) Study
ClinicalTrials.gov ID: NCT00090220
Acronym / sponsor ID: V501-019
Conditions: Healthy Adult Female Participants, Prevention, Papillomavirus Infection, Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 3,819 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: 16 Jun 2004 (actual)
Primary completion: 21 May 2009 (actual)
Study completion: 12 Nov 2015 (actual)
First posted: 27 Aug 2004 (estimated)
Results: Posted 1 Feb 2010

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
qHPV Vaccine in Base Study	Experimental	Biological: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant VaccineParticipants received blinded qHPV vaccination at Day 1, Month 2, and Month 6 of the Base Study
Placebo in Base Study	Placebo comparator	Biological: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine, Biological: Comparator: PlaceboParticipants received blinded placebo at Day 1, Month 2, and Month 6 in the Base Study. They were eligible to receive open-label qHPV vaccine in Extension 1

Who may qualify

Ages: 24 to 45 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (3 listed)

No history of genital warts, vulvar intraepithelial neoplasia (VIN), or vaginal intraepithelial neoplasia (VaIN)
Not pregnant and agrees to use effective contraception through Month 7 of the study
Additional criteria applied

Key exclusion criteria (12 listed)

Pregnant
Concurrently enrolled in a clinical study involving collection of cervical specimens
Previously received any HPV vaccine
History of severe allergic reaction that required medical intervention
Received any immune globulin or blood-derived products within 3 months prior to the first study injection

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 VaccineqHPV intramuscular injection in three 0.5 mL doses over 6 months in the Base Study or EXT1	Biological	Placebo in Base Study, qHPV Vaccine in Base Study
Comparator: PlaceboPlacebo intramuscular injection in three 0.5 mL doses over 6 months.	Biological	Placebo in Base Study

Primary outcome

Incidence Rate of HPV 6/11/16/18 Related Persistent Infection, Genital Warts, VIN, VaIN, Vulvar Cancer, Vaginal Cancer, Cervical Dysplasia, Cervical AIS, and Cervical Cancer
Time frame: Up to 48 months (4 years) after the first dose of qHPV vaccine in the Base Study
The four HPV types were determined by polymerase chain reaction (PCR) testing. VIN = vulvar intraepithelial neoplasia; VaIN = vaginal intraepithelial neoplasia; AIS = adenocarcinoma in situ.
Number of Participants With Vaccine- or Placebo-Related Serious Adverse Events (SAEs) in the Base Study
Time frame: Up to Month 48 (up to 42 months after the third dose of qHPV vaccine in the Base Study)
An adverse event (AE) is any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an adverse event. A serious adverse event (SAE) is an AE that results in death, is life threatening, results in persistent or significant disability or incapacity, results in or prolongs a hospitalization, is a congenital anomaly or birth defect, is a cancer, or is an overdose. Vaccine-related SAEs are those deemed by the investigator to be definitely, probably, or possibly related to study vaccine.
Number of Participants With Vaccine-Related SAEs After Vaccine Administration
Time frame: qHPV in Base Study: Up to Month 120; Placebo in Base Study: approximately Month 60 up to Month 120
An adverse event (AE) is any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an adverse event. A serious adverse event (SAE) is an AE that results in death, is life threatening, results in persistent or significant disability or incapacity, results in or prolongs a hospitalization, is a congenital anomaly or birth defect, is a cancer, or is an overdose. Vaccine-related SAEs are those deemed by the investigator to be definitely, probably, or possibly related to study vaccine.
Number of Participants With an SAE Resulting in Death After Vaccine Administration
Time frame: qHPV in Base Study: Up to Month 120; Placebo in Base Study: approximately Month 60 up to Month 120
An adverse event (AE) is any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an adverse event. A serious adverse event (SAE) is an AE that results in death, is life threatening, results in persistent or significant disability or incapacity, results in or prolongs a hospitalization, is a congenital anomaly or birth defect, is a cancer, or is an overdose.
Cumulative Incidence of HPV 6/11/16/18-related Cervical Intraepithelial Neoplasia (CIN) or Condyloma: Day 1 to Year 4
Time frame: Up to Month 48 (up to 42 months after the third dose of qHPV vaccine in the Base Study)
The four HPV types were determined by PCR testing. Cumulative incidence probability is the probability of becoming an endpoint case at any time from Day 1 to Year 4, conditional on having been event-free at Day 1.
Cumulative Incidence of HPV 6/11/16/18-related CIN or Condyloma: Year 4 to 8
Time frame: From 48 to 96 months (4 to 8 years) after the first dose of qHPV vaccine in the Base Study
The four HPV types were determined by PCR testing. Cumulative incidence probability is the probability of becoming an endpoint case at any time from Year 4 to Year 8, conditional on having been event-free from Day 1 to Year 4. The analysis windows were cut at the exact time points, e.g., Year 4. Visits and events which occurred after Year 4 due to visit window or follow-up investigations are included in the Year 4 to Year 8 time interval.
Cumulative Incidence of HPV 6/11/16/18-related CIN or Condyloma: Year 6 to 10
Time frame: From 72 to 120 months (6 to 10 years) after the first dose of qHPV vaccine in the Base Study
The four HPV types were determined by PCR testing. Cumulative incidence probability is the probability of becoming an endpoint case at any time from Year 6 to Year 10, conditional on having been event-free from Day 1 to Year 6.
Incidence Rate of HPV 6/11/16/18-related CIN or Condyloma (Secondary Analysis): Day 1 to Year 4
Time frame: Up to Month 48 (up to 42 months after the third dose of qHPV vaccine in the Base Study)
The four HPV types were determined by PCR testing.
Incidence Rate of HPV 6/11/16/18-related CIN or Condyloma (Secondary Analysis): Year 4 to 8
Time frame: From 48 to 96 months (4 to 8 years) after the first dose of qHPV vaccine in the Base Study
The four HPV types were determined by PCR testing. The analysis windows were cut at the exact time points, e.g., Year 4. Visits and events which occurred after Year 4 due to visit window or follow-up investigations are included in the Year 4 to Year 8 time interval.
Incidence Rate of HPV 6/11/16/18-related CIN or Condyloma (Secondary Analysis): Year 6 to 10
Time frame: From 72 to 120 months (6 to 10 years) after the first dose of qHPV vaccine in the Base Study
The four HPV types were determined by PCR testing.
Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 1 Month Postdose 3 in the Base Study
Time frame: Month 7 (1 month after the third dose of qHPV vaccine in the Base Study)
Serum antibodies to the HPV Types were determined by Competitive Luminex Immunoassay (cLIA). Geometric Mean Titers (GMT) are reported in milli-Merck Units/mL (mMU/mL). This Outcome Measure evaluated age-specific immunogenicity responses, and applied only to participants who received qHPV in the Base Study.
Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 6 Months Postdose 3 in the Base Study
Time frame: Month 12 (6 months after the third dose of qHPV vaccine in the Base Study)
Serum antibodies to the HPV Types were determined by Competitive Luminex Immunoassay (cLIA). Geometric Mean Titers (GMT) are reported in milli-Merck Units/mL (mMU/mL). This Outcome Measure evaluated age-specific immunogenicity responses, and applied only to participants who received qHPV in the Base Study.
Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 18 Months Postdose 3 in the Base Study
Time frame: Month 24 (18 months after the third dose of qHPV vaccine in the Base Study)
Serum antibodies to the HPV Types were determined by Competitive Luminex Immunoassay (cLIA). Geometric Mean Titers (GMT) are reported in milli-Merck Units/mL (mMU/mL). This Outcome Measure evaluated age-specific immunogenicity responses, and applied only to participants who received qHPV in the Base Study.
Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 30 Months Postdose 3 in the Base Study
Time frame: Month 36 (30 months after the third dose of qHPV vaccine in the Base Study)
Serum antibodies to the HPV Types were determined by Competitive Luminex Immunoassay (cLIA). Geometric Mean Titers (GMT) are reported in milli-Merck Units/mL (mMU/mL). This Outcome Measure evaluated age-specific immunogenicity responses, and applied only to participants who received qHPV in the Base Study.
Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 42 Months Postdose 3 in the Base Study
Time frame: Month 48 (42 months after the third dose of qHPV vaccine in the Base Study)
Serum antibodies to the HPV Types were determined by Competitive Luminex Immunoassay (cLIA). Geometric Mean Titers (GMT) are reported in milli-Merck Units/mL (mMU/mL). This Outcome Measure evaluated age-specific immunogenicity responses, and applied only to participants who received qHPV in the Base Study.
Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 66 Months Postdose 3 in the Base Study
Time frame: Month 72 (66 months after the third dose of qHPV vaccine in the Base Study)
Serum antibodies to the HPV Types were determined by Competitive Luminex Immunoassay (cLIA). Geometric Mean Titers (GMT) are reported in milli-Merck Units/mL (mMU/mL). This Outcome Measure evaluated age-specific immunogenicity responses, and applied only to participants who received qHPV in the Base Study.
Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 90 Months Postdose 3 in the Base Study
Time frame: Month 96 (90 months after the third dose of qHPV vaccine in the Base Study)
Serum antibodies to the HPV Types were determined by Competitive Luminex Immunoassay (cLIA). Geometric Mean Titers (GMT) are reported in milli-Merck Units/mL (mMU/mL). This Outcome Measure evaluated age-specific immunogenicity responses, and applied only to participants who received qHPV in the Base Study.
Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 114 Months Postdose 3 in the Base Study
Time frame: Month 120 (114 months after the third dose of qHPV vaccine in the Base Study)
Serum antibodies to the HPV Types were determined by Competitive Luminex Immunoassay (cLIA). Geometric Mean Titers (GMT) are reported in milli-Merck Units/mL (mMU/mL). This Outcome Measure evaluated age-specific immunogenicity responses, and applied only to participants who received qHPV in the Base Study.
Percentage of Participants Seropositive for Anti-HPV Antibody at 1 Month Postdose 3 in the Base Study
Time frame: Month 7 (1 month after the third dose of qHPV vaccine in the Base Study)
Serum antibodies to HPV Types 6, 11, 16, and 18 were determined by Competitive Luminex Immunoassay (cLIA). The seropositive thresholds (in mMU/mL) were >20 for Type 6, >16 for Type 11, >20 for Type 16, and >24 for Type 18. This Outcome Measure evaluated age-specific immunogenicity responses, and applied only to participants who received qHPV in the Base Study.
Percentage of Participants Seropositive for Anti-HPV Antibody at 6 Months Postdose 3 in the Base Study
Time frame: Month 12 (6 months after the third dose of qHPV vaccine in the Base Study)
Serum antibodies to HPV Types 6, 11, 16, and 18 were determined by Competitive Luminex Immunoassay (cLIA). The seropositive thresholds (in mMU/mL) were >20 for Type 6, >16 for Type 11, >20 for Type 16, and >24 for Type 18. This Outcome Measure evaluated age-specific immunogenicity responses, and applied only to participants who received qHPV in the Base Study.
Percentage of Participants Seropositive for Anti-HPV Antibody at 18 Months Postdose 3 in the Base Study
Time frame: Month 24 (18 months after the third dose of qHPV vaccine in the Base Study)
Serum antibodies to HPV Types 6, 11, 16, and 18 were determined by Competitive Luminex Immunoassay (cLIA). The seropositive thresholds (in mMU/mL) were >20 for Type 6, >16 for Type 11, >20 for Type 16, and >24 for Type 18. This Outcome Measure evaluated age-specific immunogenicity responses, and applied only to participants who received qHPV in the Base Study.
Percentage of Participants Seropositive for Anti-HPV Antibody at 30 Months Postdose 3 in the Base Study
Time frame: Month 36 (30 months after the third dose of qHPV vaccine in the Base Study)
Serum antibodies to HPV Types 6, 11, 16, and 18 were determined by Competitive Luminex Immunoassay (cLIA). The seropositive thresholds (in mMU/mL) were >20 for Type 6, >16 for Type 11, >20 for Type 16, and >24 for Type 18. This Outcome Measure evaluated age-specific immunogenicity responses, and applied only to participants who received qHPV in the Base Study.
Percentage of Participants Seropositive for Anti-HPV Antibody at 42 Months Postdose 3 in the Base Study
Time frame: Month 48 (42 months after the third dose of qHPV vaccine in the Base Study)
Serum antibodies to HPV Types 6, 11, 16, and 18 were determined by Competitive Luminex Immunoassay (cLIA). The seropositive thresholds (in mMU/mL) were >20 for Type 6, >16 for Type 11, >20 for Type 16, and >24 for Type 18. This Outcome Measure evaluated age-specific immunogenicity responses, and applied only to participants who received qHPV in the Base Study.
Percentage of Participants Seropositive for Anti-HPV Antibody at 66 Months Postdose 3 in the Base Study
Time frame: Month 72 (66 months after the third dose of qHPV vaccine in the Base Study)
Serum antibodies to HPV Types 6, 11, 16, and 18 were determined by Competitive Luminex Immunoassay (cLIA). The seropositive thresholds (in mMU/mL) were >20 for Type 6, >16 for Type 11, >20 for Type 16, and >24 for Type 18. This Outcome Measure evaluated age-specific immunogenicity responses, and applied only to participants who received qHPV in the Base Study.
Percentage of Participants Seropositive for Anti-HPV Antibody at 90 Months Postdose 3 in the Base Study
Time frame: Month 96 (96 months after the third dose of qHPV vaccine in the Base Study)
Serum antibodies to HPV Types 6, 11, 16, and 18 were determined by Competitive Luminex Immunoassay (cLIA). The seropositive thresholds (in mMU/mL) were >20 for Type 6, >16 for Type 11, >20 for Type 16, and >24 for Type 18. This Outcome Measure evaluated age-specific immunogenicity responses, and applied only to participants who received qHPV in the Base Study.
Percentage of Participants Seropositive for Anti-HPV Antibody at 114 Months Postdose 3 in the Base Study
Time frame: Month 120 (114 months after the third dose of qHPV vaccine in the Base Study)
Serum antibodies to HPV Types 6, 11, 16, and 18 were determined by Competitive Luminex Immunoassay (cLIA). The seropositive thresholds (in mMU/mL) were >20 for Type 6, >16 for Type 11, >20 for Type 16, and >24 for Type 18. This Outcome Measure evaluated age-specific immunogenicity responses, and applied only to participants who received qHPV in the Base Study.

8 secondary outcomes

Incidence Rate of HPV 6/11 Related Persistent Infection, Genital Warts, VIN, VaIN, Vulvar Cancer, Vaginal Cancer, Cervical Dysplasia, Cervical AIS, and Cervical Cancer
Time frame: Up to Month 48 (up to 42 months after the third dose of qHPV vaccine in the Base Study)
Cumulative Incidence of HPV 6/11-related Condyloma: Day 1 to Year 4
Time frame: Up to 48 months (4 years) after the first dose of qHPV vaccine or placebo in the Base Study
Cumulative Incidence of HPV 6/11-related Condyloma: Year 4 to Year 8
Time frame: From 48 to 96 months (4 to 8 years) after the first dose of qHPV vaccine in the Base Study
Cumulative Incidence of HPV 6/11-related Condyloma: Year 6 to Year 10
Time frame: From 72 to 120 months (6 to 10 years) after the first dose of qHPV vaccine in the Base Study
Incidence Rate of HPV 6/11-related Condyloma (Secondary Analysis): Day 1 to Year 4
Time frame: Up to 48 months (4 years) after the first dose of qHPV vaccine or placebo in the Base Study
Incidence Rate of HPV 6/11-related Condyloma (Secondary Analysis): Year 4 to Year 8
Time frame: From 48 to 96 months (4 to 8 years) after the first dose of qHPV vaccine in the Base Study
Incidence Rate of HPV 6/11-related Condyloma (Secondary Analysis): Year 6 to Year 10
Time frame: From 72 to 120 months (6 to 10 years) after the first dose of qHPV vaccine in the Base Study
Incidence Rate of HPV 31/33/35/52/58 Related Persistent Infection, Genital Warts, VIN, VaIN, Vulvar Cancer, Vaginal Cancer, Cervical Dysplasia, Cervical AIS, and Cervical Cancer
Time frame: Up to Month 48 (up to 42 months after the third dose of qHPV vaccine in the Base Study)

Results and safety

Results posted to the registry on 1 Feb 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	1,911	1,847
Placebo in Base Study	1,908	1,845
Placebo in Base Study: EXT1	0	0
Incomplete qHPV Regimen in Base Study: EXT1	0	0
qHPV Vaccine in Base Study: LTFU (EXT2)	0	0
Placebo in Base Study and qHPV Vaccine in EXT1: LTFU (EXT2)	0	0

Primary outcome: Incidence Rate of HPV 6/11/16/18 Related Persistent Infection, Genital Warts, VIN, VaIN, Vulvar Cancer, Vaginal Cancer, Cervical Dysplasia, Cervical AIS, and Cervical Cancer

Time frame: Up to 48 months (4 years) after the first dose of qHPV vaccine in the Base Study. Number. Unit: Incidence per 100 person-years

Measure	qHPV in Base Study n = 1601	Placebo in Base Study n = 1599
Value	0.2	1.7

qHPV in Base Study vs Placebo in Base Study: Percent Relative Risk Reduction: 88.7 (95% CI 78.1 to 94.8)

Population analysed: Participants who had no major protocol violations, received all 3 vaccinations, were seronegative to the relevant HPV type at Day 1 and PCR negative to the relevant HPV type Day 1 through Month 7, and provided follow-up data after Month 7

Primary outcome: Number of Participants With Vaccine- or Placebo-Related Serious Adverse Events (SAEs) in the Base Study

Time frame: Up to Month 48 (up to 42 months after the third dose of qHPV vaccine in the Base Study). Number. Unit: Participants

Measure	qHPV in Base Study n = 1890	Placebo in Base Study n = 1888
Value	0	0

Population analysed: Participants who received \>=1 qHPV vaccination or placebo injection in the Base Study and had safety follow-up

Primary outcome: Number of Participants With Vaccine-Related SAEs After Vaccine Administration

Time frame: qHPV in Base Study: Up to Month 120; Placebo in Base Study: approximately Month 60 up to Month 120. Number. Unit: Participants

Measure	qHPV in Base Study n = 1890	Placebo in Base Study n = 1327
Value	0	1

Population analysed: Participants who received \>=1 qHPV vaccination in the Base Study or EXT1 and had safety follow-up

Primary outcome: Number of Participants With an SAE Resulting in Death After Vaccine Administration

Time frame: qHPV in Base Study: Up to Month 120; Placebo in Base Study: approximately Month 60 up to Month 120. Number. Unit: Participants

Measure	qHPV in Base Study: All Participants n = 1890	Base Study: Placebo n = 1327
Value	8	4

Population analysed: Participants who received \>=1 qHPV vaccination in the Base Study or EXT1 and had safety follow-up

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: Base study: all AEs Day 1 to approximately Month 48; EXT1: SAEs only approximately Month 60 to Month 67; LTFU (EXT2): SAEs only approximately Month 72 to Month 120. Other AEs were not solicited in EXT1 or LTFU (EXT2).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
qHPV Vaccine: Base Study	15 of 1,890 (0.8%)	1,565 of 1,890 (82.8%)	Not reported
Placebo: Base Study	17 of 1,888 (0.9%)	1,390 of 1,888 (73.6%)	Not reported
qHPV Vaccine: EXT1	6 of 1,327 (0.5%)	2 of 1,327 (0.2%)	Not reported
Long-term Follow-up: EXT2	6 of 1,336 (0.4%)	0 of 1,336 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 19493565Munoz N, Manalastas R Jr, Pitisuttithum P, Tresukosol D, Monsonego J, Ault K, Clavel C, Luna J, Myers E, Hood S, Bautista O, Bryan J, Taddeo FJ, Esser MT, Vuocolo S, Haupt RM, Barr E, Saah A. Safety, immunogenicity, and efficacy of quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine in women aged 24-45 years: a randomised, double-blind trial. Lancet. 2009 Jun 6;373(9679):1949-57. doi: 10.1016/S0140-6736(09)60691-7. Epub 2009 Jun 1.
Results publication: PubMed 19652630Velicer C, Zhu X, Vuocolo S, Liaw KL, Saah A. Prevalence and incidence of HPV genital infection in women. Sex Transm Dis. 2009 Nov;36(11):696-703. doi: 10.1097/OLQ.0b013e3181ad25ff.
Results publication: PubMed 21629249Castellsague X, Munoz N, Pitisuttithum P, Ferris D, Monsonego J, Ault K, Luna J, Myers E, Mallary S, Bautista OM, Bryan J, Vuocolo S, Haupt RM, Saah A. End-of-study safety, immunogenicity, and efficacy of quadrivalent HPV (types 6, 11, 16, 18) recombinant vaccine in adult women 24-45 years of age. Br J Cancer. 2011 Jun 28;105(1):28-37. doi: 10.1038/bjc.2011.185. Epub 2011 May 31.
Results publication: PubMed 24391768Luna J, Plata M, Gonzalez M, Correa A, Maldonado I, Nossa C, Radley D, Vuocolo S, Haupt RM, Saah A. Long-term follow-up observation of the safety, immunogenicity, and effectiveness of Gardasil in adult women. PLoS One. 2013 Dec 31;8(12):e83431. doi: 10.1371/journal.pone.0083431. eCollection 2013.
Results publication: PubMed 22518014Matys K, Mallary S, Bautista O, Vuocolo S, Manalastas R, Pitisuttithum P, Saah A. Mother-infant transfer of anti-human papillomavirus (HPV) antibodies following vaccination with the quadrivalent HPV (type 6/11/16/18) virus-like particle vaccine. Clin Vaccine Immunol. 2012 Jun;19(6):881-5. doi: 10.1128/CVI.00002-12. Epub 2012 Apr 18.
Results publication: 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.
Derived from this study: PubMed 32184277Doshi P, Bourgeois F, Hong K, Jones M, Lee H, Shamseer L, Spence O, Jefferson T. Adjuvant-containing control arms in pivotal quadrivalent human papillomavirus vaccine trials: restoration of previously unpublished methodology. BMJ Evid Based Med. 2020 Dec;25(6):213-219. doi: 10.1136/bmjebm-2019-111331. Epub 2020 Mar 17.
Derived from this study: PubMed 29074187Castellsague X, Ault KA, Bosch FX, Brown D, Cuzick J, Ferris DG, Joura EA, Garland SM, Giuliano AR, Hernandez-Avila M, Huh W, Iversen OE, Kjaer SK, Luna J, Monsonego J, Munoz N, Myers E, Paavonen J, Pitisuttihum P, Steben M, Wheeler CM, Perez G, Saah A, Luxembourg A, Sings HL, Velicer C. Human papillomavirus detection in cervical neoplasia attributed to 12 high-risk human papillomavirus genotypes by region. Papillomavirus Res. 2016 Dec;2:61-69. doi: 10.1016/j.pvr.2016.03.002. Epub 2016 Mar 14.
Individual participant dataSharing planned: Yes. http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf http://engagezone.msd.com/ds_documentation.php

Related trials for Healthy Adult Female Participants

Recruiting
Methylation Analyses for Gynaecological Research Through Home-based Self-sampling
Healthy Adult Participants, Gynecological Disease
Recruiting
Pharmacokinetic (PK) Study of Phytochemicals in Whole Grains (WGs)- Brown Rice
Healthy Adult Males, Healthy Adult Females
Not yet recruiting
Investigating Sex Differences in Mitochondrial Function and Leg Blood Flow During Exercise
Healthy Adult Male, Healthy Adult Females
Enrolling by invitationObservational study
CArdiovascular Phenotyping in Recreationally Active Saudi Women
Healthy Active Females, Healthy Adult Female Participants
RecruitingPhase 1
A Study of Navlimetostat (BMS-986504) Drug Interactions and Food Effect in Healthy Participants
Healthy Female Adults

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 Healthy Adult Female Participants and Prevention, 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 12 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 21 Apr 2017. 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 1 Feb 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?

Incidence Rate of HPV 6/11/16/18 Related Persistent Infection, Genital Warts, VIN, VaIN, Vulvar Cancer, Vaginal Cancer, Cervical Dysplasia, Cervical AIS, and Cervical Cancer (time frame: Up to 48 months (4 years) after the first dose of qHPV vaccine in the Base Study). The study lists 26 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 NCT00090220, which also lists 8 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 21 Apr 2017; AzTrials last refreshed its copy on 31 Oct 2026.