Human Papilloma VirusPhase 1NCT00851643

Broad Spectrum HPV Vaccine Dose Escalation Study (V502-002)

A Phase 1 study testing Octavalent HPV with 15 mcg IMX / AAHS, Octavalent HPV with 30 mcg IMX / AAHS and Octavalent HPV with 60 mcg IMX / AAHS in people with Human Papilloma Virus and Cervical Cancer, 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

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Trial summary

Who is it for?: Ages 18 to 24 years, women onlyHealthy volunteers can take part
Conditions the study is for: Human Papilloma Virus, Cervical Cancer, Vulvar Cancer
What is being tested?: Octavalent HPV with 15 mcg IMX / AAHS, Octavalent HPV with 30 mcg IMX / AAHS and Octavalent HPV with 60 mcg IMX / AAHS
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 158 participants
Where: No sites listed yet
Study dates: Apr 2006to Nov 2009
Phase: Phase 1
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 18 to 24 years
Women only
Healthy volunteers accepted
Adult

Who may be able to join

Participant is in good physical health
Participant has had a lifetime history of 0 to 4 sexual partners
Females between 18-to-24 years

Who cannot join

Participant has a history of abnormal Pap test
Participant has a history of positive test for HPV
Participant has a history of recent or ongoing alcohol or drug abuse
Participant is immunocompromised or has an autoimmune condition
Participant has received immunosuppressive therapy within a year of screening
Participant has previously received an HPV vaccine

Show all 10Show fewer

Participant is pregnant
Participant has a history of external genital/vaginal warts
Participant is currently enrolled in a clinical trial
Participant has a history of a severe allergic reaction that required medical attention

About this study

Official title: A Randomized, Double-Blind, Multicenter, Biphasic, Controlled With GARDASIL™ Dose-Escalation Study of Octavalent Human Papillomavirus (HPV) L1 Virus-Like Particle (VLP) Vaccine Adjuvanted With Amorphous Aluminum Hydroxyphosphate Sulfate (AAHS) and ISCOMATRIX™ (IMX)

This study will examine the safety and tolerability of octavalent Human Papillomavirus (HPV) L1 Virus-Like Particle (VLP) vaccine formulated with amorphous aluminum hydroxysulfate (AAHS) and ISCOMATRIX™ (IMX). Reviews of safety and tolerability will be used to select the dose(s) of IMX for further studies of the octavalent HPV L1 VLP vaccine.

Read the detailed description

The study was performed in 2 staggered phases, Phase A and Phase B. In Phase A, participants were randomized to qHPV, Octavalent HPV with 15 mcg IMX/AAHS, or Octavalent HPV with 30 mcg IMX/AAHS. After the safety for Phase A was reviewed, Phase B was initiated. In Phase B, participants were randomized to qHPV, Octavalent HPV with 60 mcg IMX/AAHS or Octavalent HPV with 120 mcg IMX/AAHS.

Conditions: Human Papilloma Virus, Cervical Cancer, Vulvar Cancer, Vaginal Cancer, Genital Warts
Being tested: Octavalent HPV with 15 mcg IMX / AAHS, Octavalent HPV with 30 mcg IMX / AAHS, Octavalent HPV with 60 mcg IMX / AAHS, Octavalent HPV with 120 mcg IMX / AAHS, Comparator: Quadrivalent HPV Vaccine (qHPV), (GARDASIL™)
Medical subject headings: Uterine Cervical Neoplasms, Vulvar Neoplasms, Vaginal Neoplasms, Condylomata Acuminata

What participants receive

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

Octavalent HPV with 15 mcg IMX / AAHSBiological
Also called V502
0.5-mL intramuscular injection administered at Day 1, Month 2 and Month 6
Octavalent HPV with 30 mcg IMX / AAHSBiological
Also called V502
0.5-mL intramuscular injection administered at Day 1, Month 2 and Month 6
Octavalent HPV with 60 mcg IMX / AAHSBiological
Also called V502
0.5-mL intramuscular injection administered at Day 1, Month 2 and Month 6
Octavalent HPV with 120 mcg IMX / AAHSBiological
Also called V502
0.5-mL intramuscular injection administered at Day 1, Month 2 and Month 6
Comparator: Quadrivalent HPV Vaccine (qHPV), (GARDASIL™)Biological
Also called V502-002
0.5-mL intramuscular injection administered at Day 1, Month 2 and Month 6

Study groups in NCT00851643
Study group	Role	What they receive
qHPV (GARDASIL™) - Phase A Control	Active comparator	Quadrivalent Human Papillomavirus (qHPV) (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL™). This is the control for the Octavalent HPV with 15 mcg ISCOMATRIX™ (IMX) / Aluminum Hydroxyphosphate Sulfate (AAHS) and Octavalent HPV with 30 mcg IMX / AAHS during Phase A. Receives: Biological: Comparator: Quadrivalent HPV Vaccine (qHPV), (GARDASIL™)
Octavalent HPV with 15 mcg IMX / AAHS	Experimental	Octavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 Virus-Like Particle (VLP) Vaccine Adjuvanted With 281 mcg AAHS and 15 mcg IMX. Receives: Biological: Octavalent HPV with 15 mcg IMX / AAHS
Octavalent HPV with 30 mcg IMX / AAHS	Experimental	Octavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 VLP Vaccine Adjuvanted With 281 mcg AAHS and 30 mcg IMX. Receives: Biological: Octavalent HPV with 30 mcg IMX / AAHS
qHPV (GARDASIL™) - Phase B Control	Active comparator	Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL™). This is the control for the Octavalent HPV with 60 mcg IMX / AAHS and Octavalent HPV with 120 mcg IMX / AAHS during Phase B. Receives: Biological: Comparator: Quadrivalent HPV Vaccine (qHPV), (GARDASIL™)
Octavalent HPV with 60 mcg IMX / AAHS	Experimental	Octavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 VLP Vaccine Adjuvanted With 281 mcg AAHS and 60 mcg IMX. Receives: Biological: Octavalent HPV with 60 mcg IMX / AAHS
Octavalent HPV with 120 mcg IMX / AAHS	Experimental	Octavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 VLP Vaccine Adjuvanted With 281 mcg AAHS and 120 mcg IMX. Receives: Biological: Octavalent HPV with 120 mcg IMX / AAHS

What is being measured

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

Geometric Mean Titers (GMTs) to Each of the HPV Types Contained in the Vaccine for Phase A
The quadrivalent HPV (GARDASIL™) vaccine has types 6, 11, 16, 18, and the octavalent HPV has types 6, 11, 16, 18, 31, 45, 52, and 58. Serum antibody titres to the HPV type were obtained using a competitive Luminex immunoassay (cLIA) after vaccination with GARDASIL™ or the octavalent HPV vaccine. GMTs were calculated and are reported as the antibody concentration in milli-Merck Units per milliliter (mMU/mL) of neutralizing monoclonal antibody equivalent.
Measured: 4 weeks postdose 3 (Phase A)
Geometric Mean Titers (GMTs) to Each of the HPV Types Contained in the Vaccine for Phase B
The quadrivalent HPV (GARDASIL™) vaccine has types 6, 11, 16, 18, and the octavalent HPV has types 6, 11, 16, 18, 31, 45, 52, and 58. Serum antibody titres to the HPV type were obtained using cLIA after vaccination with GARDASIL™ or the octavalent HPV vaccine. GMTs were calculated and are reported as the antibody concentration in milli-Merck Units per milliliter (mMU/mL) of neutralizing monoclonal antibody equivalent.
Measured: 4 weeks postdose 3 (Phase B)
Number of Participants Who Seroconverted to Each of the HPV Types Contained in the Vaccine During Phase A
A vaccinated participant was considered seropositive for a given HPV type if her serum antibody titer by cLIA for the HPV type was greater than the serostatus cutoff. The serostatus cutoffs for HPV Types 6, 11, 16, 18, 31, 45, 52, and 58 were 20, 20, 20, 20, 16, 16, 20, and 16 mMU/mL, respectively.
Measured: 4 weeks postdose 3 (Phase A)
Number of Participants Who Seroconverted to Each of the HPV Types Contained in the Vaccine During Phase B
A vaccinated participant was considered seropositive for a given HPV type if her serum antibody titer by cLIA for the HPV type was greater than the serostatus cutoff. The serostatus cutoffs for HPV Types 6, 11, 16, 18, 31, 45, 52, and 58 were 20, 20, 20, 20, 16, 16, 20, and 16 mMU/mL, respectively.
Measured: 4 weeks postdose 3 (Phase B)

Timeline

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

Apr 2006Nov 2009

First posted26 Feb 2009 (estimated)
Study startApr 2006
Primary completionDec 2007
Study completionNov 2009

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.
Other trials for Human Papilloma VirusStudies 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 1
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 158 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00851643
Sponsor's protocol ID: V502-002
Other IDs: 2009_552
Status last verified: Feb 2016
First submitted: 24 Feb 2009
Last updated: 3 Feb 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

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

Not yet recruitingPhase 1/2
Clinical Trial to Assess the Safety, Tolerability, Reactogenicity, and Immunogenicity of a 10 Valent Human Papillomavirus Virus (10vHPV) Vaccine
Human Papillomavirus Infection
Active, not recruitingPhase 4
Comparing Immune Response of 2 vs 3 HPV Doses (27-45 Years Old)
Immunization, HPV Infection
Not yet recruitingPhase 2
Combination Bevacizumab and PRGN-2012 in Adults With Recurrent Respiratory Papillomatosis (RRP)
Respiratory Recurrent Papillomatosis (RRP), Human Papillomavirus (HPV)
RecruitingPhase 2
A Study of the Preliminary Efficacy of DARE-HPV to Treat High-risk Persistent Human Papillomavirus (hrHPV)
Human Papilloma Virus (HPV), High-risk Human Papillomavirus Infection
RecruitingPhase 2
A Single Arm Phase II Trial in p16-positive Oropharynx Cancer of Selective Dose De-escalation of nodAl VolumEs at Minimal Risk and Primary Site Disease (SAVED)
Head and Neck Cancer, Head and Neck Squamous Cell Cancer

All Human Papilloma Virus trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-Blind, Multicenter, Biphasic, Controlled With GARDASIL™ Dose-Escalation Study of Octavalent Human Papillomavirus (HPV) L1 Virus-Like Particle (VLP) Vaccine Adjuvanted With Amorphous Aluminum Hydroxyphosphate Sulfate (AAHS) and ISCOMATRIX™ (IMX)
ClinicalTrials.gov ID: NCT00851643
Acronym / sponsor ID: V502-002
Conditions: Human Papilloma Virus, Cervical Cancer, Vulvar Cancer, Vaginal Cancer, Genital Warts
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 158 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: Apr 2006
Primary completion: Dec 2007 (actual)
Study completion: Nov 2009 (actual)
First posted: 26 Feb 2009 (estimated)
Results: Posted 21 Jun 2011

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: 6

Arm	Type	Receives
qHPV (GARDASIL™) - Phase A Control	Active comparator	Biological: Comparator: Quadrivalent HPV Vaccine (qHPV), (GARDASIL™)Quadrivalent Human Papillomavirus (qHPV) (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL™). This is the control for the Octavalent HPV with 15 mcg ISCOMATRIX™ (IMX) / Aluminum Hydroxyphosphate Sulfate (AAHS) and Octavalent HPV with 30 mcg IMX / AAHS during Phase A.
Octavalent HPV with 15 mcg IMX / AAHS	Experimental	Biological: Octavalent HPV with 15 mcg IMX / AAHSOctavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 Virus-Like Particle (VLP) Vaccine Adjuvanted With 281 mcg AAHS and 15 mcg IMX.
Octavalent HPV with 30 mcg IMX / AAHS	Experimental	Biological: Octavalent HPV with 30 mcg IMX / AAHSOctavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 VLP Vaccine Adjuvanted With 281 mcg AAHS and 30 mcg IMX.
qHPV (GARDASIL™) - Phase B Control	Active comparator	Biological: Comparator: Quadrivalent HPV Vaccine (qHPV), (GARDASIL™)Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL™). This is the control for the Octavalent HPV with 60 mcg IMX / AAHS and Octavalent HPV with 120 mcg IMX / AAHS during Phase B.
Octavalent HPV with 60 mcg IMX / AAHS	Experimental	Biological: Octavalent HPV with 60 mcg IMX / AAHSOctavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 VLP Vaccine Adjuvanted With 281 mcg AAHS and 60 mcg IMX.
Octavalent HPV with 120 mcg IMX / AAHS	Experimental	Biological: Octavalent HPV with 120 mcg IMX / AAHSOctavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 VLP Vaccine Adjuvanted With 281 mcg AAHS and 120 mcg IMX.

Who may qualify

Ages: 18 to 24 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (3 listed)

Participant is in good physical health
Participant has had a lifetime history of 0 to 4 sexual partners
Females between 18-to-24 years

Key exclusion criteria (10 listed)

Participant has a history of abnormal Pap test
Participant has a history of positive test for HPV
Participant has a history of recent or ongoing alcohol or drug abuse
Participant is immunocompromised or has an autoimmune condition
Participant has received immunosuppressive therapy within a year of screening

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
Octavalent HPV with 15 mcg IMX / AAHSAlso: V5020.5-mL intramuscular injection administered at Day 1, Month 2 and Month 6	Biological	Octavalent HPV with 15 mcg IMX / AAHS
Octavalent HPV with 30 mcg IMX / AAHSAlso: V5020.5-mL intramuscular injection administered at Day 1, Month 2 and Month 6	Biological	Octavalent HPV with 30 mcg IMX / AAHS
Octavalent HPV with 60 mcg IMX / AAHSAlso: V5020.5-mL intramuscular injection administered at Day 1, Month 2 and Month 6	Biological	Octavalent HPV with 60 mcg IMX / AAHS
Octavalent HPV with 120 mcg IMX / AAHSAlso: V5020.5-mL intramuscular injection administered at Day 1, Month 2 and Month 6	Biological	Octavalent HPV with 120 mcg IMX / AAHS
Comparator: Quadrivalent HPV Vaccine (qHPV), (GARDASIL™)Also: V502-0020.5-mL intramuscular injection administered at Day 1, Month 2 and Month 6	Biological	qHPV (GARDASIL™) - Phase A Control, qHPV (GARDASIL™) - Phase B Control

Primary outcome

Geometric Mean Titers (GMTs) to Each of the HPV Types Contained in the Vaccine for Phase A
Time frame: 4 weeks postdose 3 (Phase A)
The quadrivalent HPV (GARDASIL™) vaccine has types 6, 11, 16, 18, and the octavalent HPV has types 6, 11, 16, 18, 31, 45, 52, and 58. Serum antibody titres to the HPV type were obtained using a competitive Luminex immunoassay (cLIA) after vaccination with GARDASIL™ or the octavalent HPV vaccine. GMTs were calculated and are reported as the antibody concentration in milli-Merck Units per milliliter (mMU/mL) of neutralizing monoclonal antibody equivalent.
Geometric Mean Titers (GMTs) to Each of the HPV Types Contained in the Vaccine for Phase B
Time frame: 4 weeks postdose 3 (Phase B)
The quadrivalent HPV (GARDASIL™) vaccine has types 6, 11, 16, 18, and the octavalent HPV has types 6, 11, 16, 18, 31, 45, 52, and 58. Serum antibody titres to the HPV type were obtained using cLIA after vaccination with GARDASIL™ or the octavalent HPV vaccine. GMTs were calculated and are reported as the antibody concentration in milli-Merck Units per milliliter (mMU/mL) of neutralizing monoclonal antibody equivalent.
Number of Participants Who Seroconverted to Each of the HPV Types Contained in the Vaccine During Phase A
Time frame: 4 weeks postdose 3 (Phase A)
A vaccinated participant was considered seropositive for a given HPV type if her serum antibody titer by cLIA for the HPV type was greater than the serostatus cutoff. The serostatus cutoffs for HPV Types 6, 11, 16, 18, 31, 45, 52, and 58 were 20, 20, 20, 20, 16, 16, 20, and 16 mMU/mL, respectively.
Number of Participants Who Seroconverted to Each of the HPV Types Contained in the Vaccine During Phase B
Time frame: 4 weeks postdose 3 (Phase B)
A vaccinated participant was considered seropositive for a given HPV type if her serum antibody titer by cLIA for the HPV type was greater than the serostatus cutoff. The serostatus cutoffs for HPV Types 6, 11, 16, 18, 31, 45, 52, and 58 were 20, 20, 20, 20, 16, 16, 20, and 16 mMU/mL, respectively.

Results and safety

Results posted to the registry on 21 Jun 2011, 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 (GARDASIL™) - Phase A Control	15	14
Octavalent HPV With 15 mcg IMX / AAHS	30	30
Octavalent HPV With 30 mcg IMX / AAHS	30	30
qHPV (GARDASIL™) - Phase B Control	15	15
Octavalent HPV With 60 mcg IMX / AAHS	30	30
Octavalent HPV With 120 mcg IMX / AAHS	30	29

Primary outcome: Geometric Mean Titers (GMTs) to Each of the HPV Types Contained in the Vaccine for Phase A

Time frame: 4 weeks postdose 3 (Phase A). Geometric mean (95% Confidence Interval). Unit: mMU/mL

Measure	qHPV (GARDASIL™) - Phase A Control n = 15	Octavalent HPV With 15 mcg IMX / AAHS n = 30	Octavalent HPV With 30 mcg IMX / AAHS n = 30
Anti-HPV 6 (N=11, N=21, N=22)	1273.3 (704.9 to 2300.1)	2203.0 (1658.9 to 2925.6)	4784.7 (3741.5 to 6118.8)
Anti-HPV 11 (N=11, N=21, N=22)	1991.6 (1096.3 to 3618.2)	2564.3 (1940.8 to 3388.3)	3921.6 (2964.4 to 5188.0)
Anti-HPV 16 (N=11, N=23, N=24)	2381.9 (1558.5 to 3640.4)	3961.8 (2982.6 to 5262.4)	7484.4 (5493.9 to 10196.1)
Anti-HPV 18 (N=11, N=24, N=24)	568.7 (284.8 to 1135.7)	1375.7 (966.4 to 1958.2)	2315.3 (1453.4 to 3688.3)
Anti-HPV 31(N=11, N=24, N=23)	24.3 (NA to 79.1)	2037.5 (1502.4 to 2763.0)	4782.3 (3282.4 to 6967.5)
Anti-HPV 45 (N=11, N=26, N=25)	10.8 (NA to 52.7)	1042.8 (760.8 to 1429.1)	2116.5 (1329.7 to 3368.8)
Anti-HPV 52 (N=9, N=23, N=25)	NA (NA to NA)	2531.1 (1798.6 to 3561.9)	4292.0 (2997.7 to 6145.2)
Anti-HPV 58 (N=10, N=24, N=22)	17.7 (NA to 86.1)	1759.2 (1276.5 to 2424.4)	3146.4 (2335.4 to 4428.8)

Population analysed: Per Protocol Immunogenicity (PPI) population: participants who were not protocol violators, received all 3 vaccinations within acceptable day ranges, were seronegative at Day 1 and polymerase chain reaction (PCR)-negative Day 1 through Month 7 for the relevant HPV type(s), had a valid Month 7 serology result collected in the appropriate day range.

Primary outcome: Geometric Mean Titers (GMTs) to Each of the HPV Types Contained in the Vaccine for Phase B

Time frame: 4 weeks postdose 3 (Phase B). Geometric mean (95% Confidence Interval). Unit: mMU/mL

Measure	qHPV (GARDASIL™) - Phase B Control n = 15	Octavalent HPV With 60 mcg IMX / AAHS n = 30	Octavalent HPV With 120 mcg IMX / AAHS n = 30
Anti-HPV Type 6 (N=10, N=19, N=23)	2350.9 (1581.6 to 3494.2)	6006.0 (3991.6 to 9037.0)	4484.8 (2791.7 to 7204.7)
Anti-HPV Type 11 (N=10, N=19, N=23)	3762.2 (2422.0 to 5844.1)	6514.2 (4520.8 to 9386.8)	6609.3 (5028.2 to 8687.5)
Anti-HPV Type 16 (N=7, N=19, N=20)	2783.6 (973.2 to 7961.8)	12947.5 (8856.5 to 18928.3)	10105.9 (6570.9 to 15542.6)
Anti-HPV Type 18 (N=10, N=19, N=25)	948.2 (403.7 to 2227.1)	5090.0 (3467.5 to 7471.7)	4070.9 (3135.2 to 5285.9)
Anti-HPV Type 31 (N=11, N=22, N=24)	36.9 (15.5 to 88.2)	7779.0 (4876.7 to 12408.5)	5487.3 (3683.0 to 8175.6)
Anti-HPV Type 45 (N=11, N=20, N=24)	4.7 (NA to 10.9)	3974.8 (2680.5 to 5894.0)	4696.4 (3499.6 to 6302.5)
Anti-HPV Type 52 (N=10, N=20, N=23)	NA (NA to NA)	5714.9 (3962.4 to 8242.6)	6624.6 (4919.9 to 8919.9)
Anti-HPV Type 58 (N=9, N=21, N=24)	9.6 (NA to 28.1)	4961.8 (3170.1 to 7766.1)	5191.2 (4036.3 to 6676.5)

Population analysed: PPI population: All participants who were not protocol violators, received all 3 vaccinations within acceptable day ranges, were seronegative at Day 1 and PCR-negative Day 1 through Month 7 for the relevant HPV type(s), and had a valid Month 7 serology result collected in the appropriate day range.

Primary outcome: Number of Participants Who Seroconverted to Each of the HPV Types Contained in the Vaccine During Phase A

Time frame: 4 weeks postdose 3 (Phase A). Number. Unit: Participants

Measure	qHPV (GARDASIL™) - Phase A Control n = 15	Octavalent HPV With 15 mcg IMX / AAHS n = 30	Octavalent HPV With 30 mcg IMX / AAHS n = 30
Anti-HPV 6 (N=11, N=21, N=22)	11	21	22
Anti-HPV 11 (N=11, N=21, N=22)	11	21	22
Anti-HPV 16 (N=11, N=23, N=24)	11	23	24
Anti-HPV 18 (N=11, N=24, N=24)	11	24	24
Anti-HPV 31 (N=11, N=24, N=23)	6	24	23
Anti-HPV 45 (N=11, N=26, N=25)	4	26	25
Anti-HPV 52 (N=9, N=23, N=25)	0	23	25
Anti-HPV 58 (N=10, N=24, N=22)	3	24	22

Primary outcome: Number of Participants Who Seroconverted to Each of the HPV Types Contained in the Vaccine During Phase B

Time frame: 4 weeks postdose 3 (Phase B). Number. Unit: Participants

Measure	qHPV (GARDASIL™) - Phase B Control n = 15	Octavalent HPV With 60 mcg IMX / AAHS n = 30	Octavalent HPV With 120 mcg IMX / AAHS n = 30
Anti-HPV 6 (N=10, N=19, N=23)	10	19	23
Anti-HPV 11 (N=10, N=19, N=23)	10	19	23
Anti-HPV 16 (N=7, N=19, N=20)	7	19	20
Anti-HPV 18 (N=10, N=19, N=25)	10	19	25
Anti-HPV 31 (N=11, N=22, N=24)	9	22	24
Anti-HPV 45 (N=11, N=20, N=24)	2	20	24
Anti-HPV 52 (N=10, N=20, N=23)	0	20	23
Anti-HPV 58 (N=9, N=21, N=24)	2	21	24

Adverse events

Time frame: All injection site adverse events (AEs) for 5 days following vaccination, all non-injection site AEs for 14 calendar days following vaccination, and all laboratory AEs that occurred at any time during the study are included.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
qHPV (GARDASIL™) - Phase A and Phase B Controls	0 of 30 (0%)	30 of 30 (100%)	Not reported
Octavalent HPV With 15 mcg IMX / AAHS	0 of 30 (0%)	30 of 30 (100%)	Not reported
Octavalent HPV With 30 mcg IMX / AAHS	0 of 30 (0%)	30 of 30 (100%)	Not reported
Octavalent HPV With 60 mcg IMX / AAHS	0 of 30 (0%)	30 of 30 (100%)	Not reported
Octavalent With 120 mcg IMX / AAHS	0 of 30 (0%)	30 of 30 (100%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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?

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 10 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 3 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 21 Jun 2011). 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?

Geometric Mean Titers (GMTs) to Each of the HPV Types Contained in the Vaccine for Phase A (time frame: 4 weeks postdose 3 (Phase A)). The study lists 4 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 NCT00851643.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2016.