Human Papillomavirus InfectionPhase 3NCT00988884

A Study of V503 Given Concomitantly With Menactra™ and Adacel™ in 11 to 15 Year Olds (V503-005)

A Phase 3 study testing V503, Comparator: Menactra™ (Concomitant) and Comparator: Adacel™ (Concomitant) in people with Human Papillomavirus Infection, 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

This study will evaluate the tolerability and immunogenicity of administration of the first dose of V503 at the same time as Menactra™ and Adacel™ versus administration of V503 one month prior to administration of Menactra™ and Adacel™. Read more about this study

Who is it for?: Ages 11 to 15 yearsHealthy volunteers can take part
Conditions the study is for: Human Papillomavirus Infection
What is being tested?: V503, Comparator: Menactra™ (Concomitant) and Comparator: Adacel™ (Concomitant)
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,241 participants
Where: No sites listed yet
Study dates: 21 Oct 2009to 22 Feb 2011
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 11 to 15 years
All sexes
Healthy volunteers accepted
Child

Who may be able to join

Subject is in good health
Subject's parent/legal guardian can read, understand, and complete the vaccine report card
Subject is not sexually active and does not plan on becoming sexually active during the study
Subject has received a documented full primary immunization series against diphtheria, tetanus, and pertussis (not in the last 5 years)

Who cannot join

Subject has a known allergy to any vaccine component of V503, Menactra™, or Adacel™
Subject has a condition that is a contraindication to vaccination with Menactra™ or Adacel™
Subject has any coagulation disorder
Female subject is pregnant
Subject is immunocompromised or immunodeficient
Subject has had a splenectomy

Show all 13Show fewer

Subject has received immunosuppressive therapies in the prior year
Subject has received any immune globulin product or blood-derived product in the last 3 months
Subject has received inactivated vaccines within 14 days or live vaccines within 21 days of the first study vaccination
Subject has received a marketed HPV vaccine or has participation in an HPV vaccine trial
Subject has received a meningococcal vaccine
Subject has a fever >= 100F within 24 hours of vaccination
Subject has a history of HPV

About this study

Official title: A Phase III Open-Label Clinical Trial to Study the Immunogenicity and Tolerability of V503 (A Multivalent Human Papillomavirus [HPV] L1 Virus-Like Particle [VLP] Vaccine) Given Concomitantly With Menactra™ and Adacel™ in Preadolescents and Adolescents (11 to 15 Year Olds)

Conditions: Human Papillomavirus Infection
Being tested: V503, Comparator: Menactra™ (Concomitant), Comparator: Adacel™ (Concomitant), Comparator: Menactra™ (Non-Concomitant), Comparator: Adacel™ (Non-concomitant)
Medical subject headings: Papillomavirus Infections

What participants receive

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

V503Biological
V503 (Multivalent HPV L1 VLP vaccine) given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm at Day 1, Month 2, and Month 6
Comparator: Menactra™ (Concomitant)Biological
Menactra™ given as a single 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm on Day 1.
Comparator: Adacel™ (Concomitant)Biological
Adacel™ given as a single 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm on Day 1.
Comparator: Menactra™ (Non-Concomitant)Biological
Menactra™ given as a single 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm at Month 1.
Comparator: Adacel™ (Non-concomitant)Biological
Adacel™ given as a single 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm at Month 1.

Study groups in NCT00988884
Study group	Role	What they receive
Concomitant Vaccination	Experimental	V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Menactra™ and Adacel™ each given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm on Day 1 Receives: Biological: V503; Biological: Comparator: Menactra™ (Concomitant); Biological: Comparator: Adacel™ (Concomitant)
Non-concomitant Vaccination	Experimental	V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Menactra™ and Adacel™ each given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm at Month 1 Receives: Biological: V503; Biological: Comparator: Menactra™ (Non-Concomitant); Biological: Comparator: Adacel™ (Non-concomitant)

What is being measured

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

Geometric Mean Titers (GMTs) of the Antibody Response to Each of the Human Papillomavirus (HPV) Types Contained in V503
Serum antibody titers to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 were evaluated using a competitive Luminex immunoassay. Titers are reported in milli Merck Units/mL.
Measured: 4 weeks following Month 6 vaccination
Percentage of Participants With >=4-fold Increase in Antibody Titers to Neisseria Meningitidis Serogroups
For the Concomitant Vaccination group, serum samples were collected at Day 1 (baseline) and 4 weeks after the Day 1 vaccination; for the Non-concomitant Vaccination group, serum samples were collected at Month 1 (baseline) and 4 weeks after the Month 1 vaccination. Bactericidal antibodies to Neisseria meningitidis serogroups A, C, Y, and W-135 were measured by incubating serial dilutions of serum with target N. meningitidis strains and complement, and enumerating the surviving bacteria after overnight incubation on blood agar plates. The serum bactericidal titer is reported as the reciprocal of the final serum dilution giving >50% killing in 60 minutes.
Measured: Baseline and 4 weeks following Day 1 (Concomitant) or Month 1 (Non-concomitant) vaccination
Percentage of Participants Who Achieve Acceptable Titers of Anti-Diphtheria and Anti-Tetanus Antibody
For the Concomitant Vaccination group, serum samples were collected 4 weeks after the Day 1 vaccination; for the Non-concomitant Vaccination group, serum samples were collected 4 weeks after the Month 1 vaccination. Titers of neutralizing antibody to diphtheria toxin were measured using a cell-based Diphtheria Micrometabolic Inhibition assay. The lower limit of quantitation of the assay was defined as 0.01 International Units (IU)/mL. Serum titers of neutralizing antibody to tetanus toxin were measured using an enzyme immunoassay. The lower limit of quantitation of the assay was defined as 0.04 IU/mL. Acceptable titers refer to the World Health Organization-defined protective titers of >=0.1 IU/mL.
Measured: 4 weeks following Day 1 or Month 1 vaccination
Geometric Mean Titers of Pertussis Antibody Responses
For the Concomitant Vaccination group, serum samples were collected 4 weeks after the Day 1 vaccination; for the Non-concomitant Vaccination group, serum samples were collected 4 weeks after the Month 1 vaccination. Titers of anti-pertussis toxin (PT), anti-filamentous hemagglutinin (FHA), anti-pertactin (PRN), and anti-fimbriae 2/3 (FM 2/3) antibodies were measured using enzyme-linked immunosorbent assays. The titers were expressed as Enzyme-linked Immunoassay Units (ELU)/mL.
Measured: 4 weeks following Day 1 or Month 1 vaccination
Percentage of Participants With a V503 Injection-site Adverse Experience
An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE. Only injection-site AEs in the arm that received V503 vaccination were reported for this endpoint.
Measured: Day 1 through Day 5 following Day 1 vaccination
Percentage of Participants With a Menactra™ or Adacel™ Injection-site Adverse Experience
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE. Only injection-site AEs in the arm that received Menactra™ and Adacel™ vaccination were reported for this endpoint. For the Concomitant Vaccination group, injection-site AEs are reported following Day 1 vaccination; for the Non-concomitant Vaccination group, injection-site AEs are reported following Month 1 vaccination.
Measured: Day 1 through Day 5 following Day 1 or Month 1 vaccination
Percentage of Participants With Maximum Temperature >=37.8 °C (>=100.0 °F) (Oral or Oral Equivalent)
For the Concomitant Vaccination group, temperatures were collected after the Day 1 vaccination and the Month 1 visit; for the Non-concomitant Vaccination group, temperatures were collected after the Day 1 vaccination and the Month 1 vaccination.
Measured: Up to 5 days following the Day 1 and Month 1 vaccination / visit

Secondary outcomes (2)

Percentage of Participants Who Seroconvert for Each of the HPV Types Contained in V503
Blood was drawn at Month 7 and assayed to determine whether or not a participant had achieved seroconversion for the HPV types. The lower limit of the titer (milli Merck U/mL) considered seropositive was as follows: HPV Type 6: >=30, HPV Type 11: >=16; HPV Type 16: >=20, HPV Type 18: >=24, HPV Type 31: >=10, HPV Type 33: >=8, HPV Type 45: >=8, HPV Type 52: >=8, and HPV Type 58: >=8.
Measured: Month 7
Geometric Mean Titers of the Antibody Response to Neisseria Meningitidis Serogroups Contained in Menactra™
Serum bactericidal antibodies to Neisseria meningitidis serogroups A, C, Y, and W-135 were measured by incubating serial dilutions of serum with target N. meningitidis strains and complement, and enumerating the surviving bacteria after overnight incubation on blood agar plates. The antibody titer is expressed as the reciprocal of the highest dilution that achieves >50% bacterial killing; a higher value represents a greater antibody response. For the Concomitant Vaccination group, serum samples were collected 4 weeks after Day 1 vaccination; for the Non-concomitant Vaccination group, serum samples were collected 4 weeks after Month 1 vaccination.
Measured: 4 weeks following Day 1 or Month 1 vaccination

Timeline

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

21 Oct 200922 Feb 2011

First posted2 Oct 2009 (estimated)
Study start21 Oct 2009
Primary completion22 Feb 2011
Study completion22 Feb 2011

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 (3)Papers the sponsor has linked to this study.
Other trials for Human Papillomavirus InfectionStudies 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: None (open label)
Enrolment: 1,241 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00988884
Sponsor's protocol ID: V503-005
Other IDs: V503-005
Status last verified: Nov 2018
First submitted: 1 Oct 2009
Last updated: 14 Dec 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: Yes: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Publications

Rodrigues S, Grenha A. Activation of Macrophages: Establishing a Role for Polysaccharides in Drug Delivery Strategies Envisaging Antibacterial Therapy. Curr Pharm Des. 2015;21(33):4869-87. doi: 10.2174/1381612821666150820103910.
PubMed 26290207
Schilling A, Parra MM, Gutierrez M, Restrepo J, Ucros S, Herrera T, Engel E, Huicho L, Shew M, Maansson R, Caldwell N, Luxembourg A, Ter Meulen AS. Coadministration of a 9-Valent Human Papillomavirus Vaccine With Meningococcal and Tdap Vaccines. Pediatrics. 2015 Sep;136(3):e563-72. doi: 10.1542/peds.2014-4199. Epub 2015 Aug 3.
PubMed 26240207
Moreira ED Jr, Block SL, Ferris D, Giuliano AR, Iversen OE, Joura EA, Kosalaraksa P, Schilling A, Van Damme P, Bornstein J, Bosch FX, Pils S, Cuzick J, Garland SM, Huh W, Kjaer SK, Qi H, Hyatt D, Martin J, Moeller E, Ritter M, Baudin M, Luxembourg A. Safety Profile of the 9-Valent HPV Vaccine: A Combined Analysis of 7 Phase III Clinical Trials. Pediatrics. 2016 Aug;138(2):e20154387. doi: 10.1542/peds.2015-4387. Epub 2016 Jul 15.
PubMed 27422279

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 Papillomavirus Infection trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase III Open-Label Clinical Trial to Study the Immunogenicity and Tolerability of V503 (A Multivalent Human Papillomavirus [HPV] L1 Virus-Like Particle [VLP] Vaccine) Given Concomitantly With Menactra™ and Adacel™ in Preadolescents and Adolescents (11 to 15 Year Olds)
ClinicalTrials.gov ID: NCT00988884
Acronym / sponsor ID: V503-005
Conditions: Human Papillomavirus Infection
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,241 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: 21 Oct 2009 (actual)
Primary completion: 22 Feb 2011 (actual)
Study completion: 22 Feb 2011 (actual)
First posted: 2 Oct 2009 (estimated)
Results: Posted 13 Jan 2015

Clinical summary

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

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Concomitant Vaccination	Experimental	Biological: V503, Biological: Comparator: Menactra™ (Concomitant), Biological: Comparator: Adacel™ (Concomitant)V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Menactra™ and Adacel™ each given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm on Day 1
Non-concomitant Vaccination	Experimental	Biological: V503, Biological: Comparator: Menactra™ (Non-Concomitant), Biological: Comparator: Adacel™ (Non-concomitant)V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Menactra™ and Adacel™ each given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm at Month 1

Who may qualify

Ages: 11 to 15 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (4 listed)

Subject is in good health
Subject's parent/legal guardian can read, understand, and complete the vaccine report card
Subject is not sexually active and does not plan on becoming sexually active during the study
Subject has received a documented full primary immunization series against diphtheria, tetanus, and pertussis (not in the last 5 years)

Key exclusion criteria (13 listed)

Subject has a known allergy to any vaccine component of V503, Menactra™, or Adacel™
Subject has a condition that is a contraindication to vaccination with Menactra™ or Adacel™
Subject has any coagulation disorder
Female subject is pregnant
Subject is immunocompromised or immunodeficient

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
V503V503 (Multivalent HPV L1 VLP vaccine) given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm at Day 1, Month 2, and Month 6	Biological	Concomitant Vaccination, Non-concomitant Vaccination
Comparator: Menactra™ (Concomitant)Menactra™ given as a single 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm on Day 1.	Biological	Concomitant Vaccination
Comparator: Adacel™ (Concomitant)Adacel™ given as a single 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm on Day 1.	Biological	Concomitant Vaccination
Comparator: Menactra™ (Non-Concomitant)Menactra™ given as a single 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm at Month 1.	Biological	Non-concomitant Vaccination
Comparator: Adacel™ (Non-concomitant)Adacel™ given as a single 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm at Month 1.	Biological	Non-concomitant Vaccination

Primary outcome

Geometric Mean Titers (GMTs) of the Antibody Response to Each of the Human Papillomavirus (HPV) Types Contained in V503
Time frame: 4 weeks following Month 6 vaccination
Serum antibody titers to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 were evaluated using a competitive Luminex immunoassay. Titers are reported in milli Merck Units/mL.
Percentage of Participants With >=4-fold Increase in Antibody Titers to Neisseria Meningitidis Serogroups
Time frame: Baseline and 4 weeks following Day 1 (Concomitant) or Month 1 (Non-concomitant) vaccination
For the Concomitant Vaccination group, serum samples were collected at Day 1 (baseline) and 4 weeks after the Day 1 vaccination; for the Non-concomitant Vaccination group, serum samples were collected at Month 1 (baseline) and 4 weeks after the Month 1 vaccination. Bactericidal antibodies to Neisseria meningitidis serogroups A, C, Y, and W-135 were measured by incubating serial dilutions of serum with target N. meningitidis strains and complement, and enumerating the surviving bacteria after overnight incubation on blood agar plates. The serum bactericidal titer is reported as the reciprocal of the final serum dilution giving >50% killing in 60 minutes.
Percentage of Participants Who Achieve Acceptable Titers of Anti-Diphtheria and Anti-Tetanus Antibody
Time frame: 4 weeks following Day 1 or Month 1 vaccination
For the Concomitant Vaccination group, serum samples were collected 4 weeks after the Day 1 vaccination; for the Non-concomitant Vaccination group, serum samples were collected 4 weeks after the Month 1 vaccination. Titers of neutralizing antibody to diphtheria toxin were measured using a cell-based Diphtheria Micrometabolic Inhibition assay. The lower limit of quantitation of the assay was defined as 0.01 International Units (IU)/mL. Serum titers of neutralizing antibody to tetanus toxin were measured using an enzyme immunoassay. The lower limit of quantitation of the assay was defined as 0.04 IU/mL. Acceptable titers refer to the World Health Organization-defined protective titers of >=0.1 IU/mL.
Geometric Mean Titers of Pertussis Antibody Responses
Time frame: 4 weeks following Day 1 or Month 1 vaccination
For the Concomitant Vaccination group, serum samples were collected 4 weeks after the Day 1 vaccination; for the Non-concomitant Vaccination group, serum samples were collected 4 weeks after the Month 1 vaccination. Titers of anti-pertussis toxin (PT), anti-filamentous hemagglutinin (FHA), anti-pertactin (PRN), and anti-fimbriae 2/3 (FM 2/3) antibodies were measured using enzyme-linked immunosorbent assays. The titers were expressed as Enzyme-linked Immunoassay Units (ELU)/mL.
Percentage of Participants With a V503 Injection-site Adverse Experience
Time frame: Day 1 through Day 5 following Day 1 vaccination
An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE. Only injection-site AEs in the arm that received V503 vaccination were reported for this endpoint.
Percentage of Participants With a Menactra™ or Adacel™ Injection-site Adverse Experience
Time frame: Day 1 through Day 5 following Day 1 or Month 1 vaccination
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE. Only injection-site AEs in the arm that received Menactra™ and Adacel™ vaccination were reported for this endpoint. For the Concomitant Vaccination group, injection-site AEs are reported following Day 1 vaccination; for the Non-concomitant Vaccination group, injection-site AEs are reported following Month 1 vaccination.
Percentage of Participants With Maximum Temperature >=37.8 °C (>=100.0 °F) (Oral or Oral Equivalent)
Time frame: Up to 5 days following the Day 1 and Month 1 vaccination / visit
For the Concomitant Vaccination group, temperatures were collected after the Day 1 vaccination and the Month 1 visit; for the Non-concomitant Vaccination group, temperatures were collected after the Day 1 vaccination and the Month 1 vaccination.

2 secondary outcomes

Percentage of Participants Who Seroconvert for Each of the HPV Types Contained in V503
Time frame: Month 7
Geometric Mean Titers of the Antibody Response to Neisseria Meningitidis Serogroups Contained in Menactra™
Time frame: 4 weeks following Day 1 or Month 1 vaccination

Results and safety

Results posted to the registry on 13 Jan 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Concomitant Vaccination	621	586
Non-concomitant Vaccination	620	584

Primary outcome: Geometric Mean Titers (GMTs) of the Antibody Response to Each of the Human Papillomavirus (HPV) Types Contained in V503

Time frame: 4 weeks following Month 6 vaccination. Geometric mean (Full Range). Unit: milli Merck Units/mL

Measure	Concomitant Vaccination n = 619	Non-concomitant Vaccination n = 618
Anti-HPV 6: n=501, 514	2198.7 (137.0 to 18555.0)	2260.7 (210.0 to 30594.0)
Anti-HPV 11: n=502, 514	1495.0 (64.0 to 13292.0)	1547.2 (109.0 to 30345.0)
Anti-HPV 16: n=513, 530	8882.6 (159.0 to 60653.0)	9027.6 (619.0 to 125497.0)
Anti-HPV 18: n=516, 535	2610.4 (35.0 to 49077.0)	2633.9 (79.0 to 45639.0)
Anti-HPV 31: n=514, 536	2439.4 (50.0 to 43734.0)	2334.3 (89.0 to 45636.0)
Anti-HPV 33: n=520, 537	1268.5 (25.0 to 34514.0)	1276.3 (52.0 to 21991.0)
Anti-HPV 45: n=523, 539	947.8 (8.0 to 15268.0)	863.8 (16.0 to 13822.0)
Anti-HPV 52: n=521, 538	1082.7 (26.0 to 10420.0)	1103.7 (50.0 to 20926.0)

Concomitant Vaccination vs Non-concomitant Vaccination: Fold difference in GMT: 0.97 (95% CI 0.88 to 1.08), p <0.001, ANOVA
Concomitant Vaccination vs Non-concomitant Vaccination: Fold difference in GMT: 0.97 (95% CI 0.87 to 1.07), p <0.001, ANOVA
Concomitant Vaccination vs Non-concomitant Vaccination: Fold difference in GMT: 0.98 (95% CI 0.89 to 1.09), p <0.001, ANOVA

Population analysed: The per-protocol population included participants who received all study vaccinations, were seronegative to HPV on Day 1, and had serum samples available for evaluation of the endpoint

Primary outcome: Percentage of Participants With >=4-fold Increase in Antibody Titers to Neisseria Meningitidis Serogroups

Time frame: Baseline and 4 weeks following Day 1 (Concomitant) or Month 1 (Non-concomitant) vaccination. Number. Unit: Percentage of participants

Measure	Concomitant Vaccination n = 619	Non-concomitant Vaccination n = 618
Serogroup A: n=590, 564	79.0	75.4
Serogroup C:n=590, 566	92.9	95.1
Serogroup Y: n=590, 566	91.5	89.4
Serogroup W-135: n=589, 566	95.6	97.7

Concomitant Vaccination vs Non-concomitant Vaccination: Difference in percentage: 3.8 (97.5% CI -1.7 to 9.3), p <0.001, Miettinen and Nurminen
Concomitant Vaccination vs Non-concomitant Vaccination: Difference in percentage: -2.1 (97.5% CI -5.4 to 1.1), p <0.001, Miettinen and Nurminen
Concomitant Vaccination vs Non-concomitant Vaccination: Difference in percentage: 2.1 (97.5% CI -1.8 to 6.1), p <0.001, Miettinen and Nurminen

Population analysed: The per-protocol population included participants who received study vaccination and had serum samples available for evaluation of the endpoint

Primary outcome: Percentage of Participants Who Achieve Acceptable Titers of Anti-Diphtheria and Anti-Tetanus Antibody

Time frame: 4 weeks following Day 1 or Month 1 vaccination. Number. Unit: Percentage of participants

Measure	Concomitant Vaccination n = 619	Non-concomitant Vaccination n = 618
Anti-diphtheria titer >=0.1 IU/mL: n=595, 566	100	100
Anti-tetanus titer >=0.1 IU/mL: n=594, 562	99.8	100

Concomitant Vaccination vs Non-concomitant Vaccination: Difference in percentage: 0.0 (97.5% CI -0.8 to 0.9), p <0.001, Miettinen and Nurminen
Concomitant Vaccination vs Non-concomitant Vaccination: Difference in percentage: -0.2 (97.5% CI -1.2 to 0.7), p <0.001, Miettinen and Nurminen

Population analysed: The per-protocol population included participants who received study vaccination and had serum samples available for evaluation of the endpoint

Primary outcome: Geometric Mean Titers of Pertussis Antibody Responses

Time frame: 4 weeks following Day 1 or Month 1 vaccination. Geometric mean (Full Range). Unit: ELU/mL

Measure	Concomitant Vaccination n = 619	Non-concomitant Vaccination n = 618
Anti-PT: n=595, 566	28.5 (2.5 to 1056.0)	35.7 (2.5 to 618.0)
Anti-FHA: n=595, 566	184.1 (5.0 to 3019.0)	201.4 (3.0 to 1547.0)
Anti-PRN: n=595, 566	328.4 (15.0 to 5093.0)	344.0 (19.0 to 3232.0)
Anti-FIM 2/3: n=595, 566	653.0 (2.5 to 73900.0)	681.4 (2.5 to 27520.0)

Concomitant Vaccination vs Non-concomitant Vaccination: Fold difference in GMT: 0.80 (97.5% CI 0.69 to 0.92), p = 0.003, ANOVA
Concomitant Vaccination vs Non-concomitant Vaccination: Fold difference in GMT: 0.91 (97.5% CI 0.83 to 1.01), p <0.001, ANOVA
Concomitant Vaccination vs Non-concomitant Vaccination: Fold difference in GMT: 0.95 (97.5% CI 0.84 to 1.08), p <0.001, ANOVA

Population analysed: The per-protocol population included participants who received study vaccination and had serum samples available for evaluation of the endpoint

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Serious adverse events: up to Month 7; Other adverse events: up to Day 15 following any vaccination. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Concomitant Vaccination	5 of 613 (0.8%)	543 of 613 (88.6%)	Not reported
Non-concomitant Vaccination	5 of 611 (0.8%)	518 of 611 (84.8%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 26290207Rodrigues S, Grenha A. Activation of Macrophages: Establishing a Role for Polysaccharides in Drug Delivery Strategies Envisaging Antibacterial Therapy. Curr Pharm Des. 2015;21(33):4869-87. doi: 10.2174/1381612821666150820103910.
Results publication: PubMed 26240207Schilling A, Parra MM, Gutierrez M, Restrepo J, Ucros S, Herrera T, Engel E, Huicho L, Shew M, Maansson R, Caldwell N, Luxembourg A, Ter Meulen AS. Coadministration of a 9-Valent Human Papillomavirus Vaccine With Meningococcal and Tdap Vaccines. Pediatrics. 2015 Sep;136(3):e563-72. doi: 10.1542/peds.2014-4199. Epub 2015 Aug 3.
Results publication: PubMed 27422279Moreira ED Jr, Block SL, Ferris D, Giuliano AR, Iversen OE, Joura EA, Kosalaraksa P, Schilling A, Van Damme P, Bornstein J, Bosch FX, Pils S, Cuzick J, Garland SM, Huh W, Kjaer SK, Qi H, Hyatt D, Martin J, Moeller E, Ritter M, Baudin M, Luxembourg A. Safety Profile of the 9-Valent HPV Vaccine: A Combined Analysis of 7 Phase III Clinical Trials. Pediatrics. 2016 Aug;138(2):e20154387. doi: 10.1542/peds.2015-4387. Epub 2016 Jul 15.
Individual participant dataSharing planned: Yes. http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Medical Monitor study director

Merck Sharp & Dohme LLC

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing V503, Comparator: Menactra™ (Concomitant) and Comparator: Adacel™ (Concomitant) in people with Human Papillomavirus Infection, 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 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Dec 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. 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 13 Jan 2015). 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) of the Antibody Response to Each of the Human Papillomavirus (HPV) Types Contained in V503 (time frame: 4 weeks following Month 6 vaccination). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00988884, which also lists 3 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 14 Dec 2018.