AzTrials
AzTrials

Papillomavirus InfectionsPhase 3NCT01073293

A Study of V503 Vaccine Given Concomitantly With REPEVAX™ in 11 to 15 Year Olds (V503-007)

A Phase 3 study testing V503 Vaccine, REPEVAX™ (Concomitant) and REPEVAX™ (Non-concomitant) in people with Papillomavirus Infections, run by Merck Sharp & Dohme LLC.

Completed

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

Official record
Search all trials

Trial summary

This study will evaluate whether co-administration of the first dose of V503 and REPEVAX™ is well tolerated and causes a non-inferior immune response when compared to administration of REPEVAX™ one month following the first dose of V503. Read more about this study

Who is it for?
Ages 11 to 15 yearsHealthy volunteers can take part
Conditions the study is for
Papillomavirus Infections
What is being tested?
V503 Vaccine, REPEVAX™ (Concomitant) and REPEVAX™ (Non-concomitant)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,054 participants
Where
No sites listed yet
Study dates
22 Apr 2010to 16 Jun 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

  • Participant is in good health
  • Participant's parent/legal guardian can read, understand, and complete the vaccination report card
  • Participant is not sexually active and does not plan on becoming sexually active during the study
  • Participant has received a documented full primary immunization series against diphtheria, tetanus, pertussis, and poliovirus (inactivated and/or oral poliovirus), but not in the last 5 years. There must be a 5-year interval from a prior vaccination containing any one of these vaccine antigens.

Who cannot join

  • Participant has a known allergy to any vaccine component of V503 or REPEVAX™
  • Participant has had a severe reaction affecting the brain (e.g., evolving encephalopathy) within 7 days after a previous dose of a pertussis-containing vaccine
  • Participant has had a progressive severe illness affecting the brain after a previous dose of tetanus, diphtheria, poliovirus or a component pertussis combination (acellular and whole cell) vaccine
  • Participant ever had Guillain-Barré syndrome or brachial neuritis following a previous dose of a tetanus-containing vaccine
  • Participant has a condition that is a contraindication to vaccination as indicated in the most up to date package inserts of REPEVAX™
  • Participant has a history of severe allergic reaction that required medical intervention
Show all 23Show fewer
  • Participant has hemophilia, thrombocytopenia, is receiving anticoagulation therapy and/or has any coagulation disorder that would contraindicate intramuscular injections
  • Participant is concurrently enrolled in clinical studies of investigational agents
  • Female participant is pregnant
  • Participant has donated blood within 1 week prior to first study vaccination, or intends to donate during the study
  • Participant is immunocompromised, immunodeficient, or has an autoimmune condition
  • Participant has had a splenectomy
  • Participant has received immunosuppressive therapies in the prior year
  • Participant has received immune globulin product or blood-derived product in the last 3 months
  • Participant has received inactivated vaccine(s) within 14 days or live vaccine(s) within 21 days of first study vaccination
  • Participant has received a marketed HPV vaccine or has participated in an HPV vaccine trial
  • Participant has received a tetanus, diphtheria, pertussis, or poliovirus (inactivated and/or oral poliovirus) vaccination within the last 5 years
  • Participant has a fever ≥100°F within 24 hours of vaccination
  • Participant has any history or current condition, therapy, lab abnormality, or other circumstance such that it is not in the best interest of the participant to participate
  • Participant and parent/legal guardian are unable to give assent/consent
  • Participant is unlikely to adhere to the study procedures or is planning to relocate during the study
  • Participant has recent history of illicit drug or alcohol abuse
  • Participant 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 REPEVAX™ in Preadolescents and Adolescents (11 to 15 Year Olds)

This study will evaluate whether co-administration of the first dose of V503 and REPEVAX™ is well tolerated and causes a non-inferior immune response when compared to administration of REPEVAX™ one month following the first dose of V503.

Being tested
V503 Vaccine, REPEVAX™ (Concomitant), REPEVAX™ (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.

  • V503 VaccineBiological

    V503 (Multivalent HPV L1 VLP vaccine) given as a 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6

  • REPEVAX™ (Concomitant)Biological

    REPEVAX™ given as a single 0.5 mL intramuscular injection at Day 1

  • REPEVAX™ (Non-concomitant)Biological

    REPEVAX™ given as a single 0.5 mL intramuscular injection at Month 1

Study groups in NCT01073293
Study groupRoleWhat they receive
Concomitant VaccinationExperimentalV503 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 Repevax™ given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm on Day 1
Receives: Biological: V503 Vaccine; Biological: REPEVAX™ (Concomitant)
Non-concomitant VaccinationExperimentalV503 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 Repevax™ given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm at Month 1
Receives: Biological: V503 Vaccine; Biological: REPEVAX™ (Non-concomitant)

What is being measured

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

  1. Geometric Mean Titers (GMTs) of the Antibody Response to Each of the Human Papillomavirus (HPV) Types Contained in V503

    Serum antibody titers for HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58 were measured using a competitive Luminex immunoassay. Titers are reported in milli Merck Units/mL.

    Measured: 4 weeks following Month 6 vaccination

  2. 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 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

  3. Percentage of Participants With a Repevax™ Injection-site Adverse Experience

    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. 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 vaccine is also an AE. Only injection-site AEs in the arm that received Repevax™ vaccination were reported for this endpoint.

    Measured: Day 1 through Day 5 following Day 1 (Concomitant) or Month 1 (Non-concomitant) vaccination

  4. 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

  5. Percentage of Participants With a Systemic Adverse Experience

    For the Concomitant Vaccination group, systemic AEs were collected after the Day 1 vaccination and the Month 1 visit; for the Non-concomitant Vaccination group, systemic AEs were collected after the Day 1 vaccination and the Month 1 vaccination. An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body that is 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 vaccine is also an adverse experience. A systemic AE was an AE that was not associated with the injection site.

    Measured: Up to 15 days following the Day 1 and Month 1 vaccination / visit

  6. 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. Serum titers of neutralizing antibody to tetanus toxin were measured using an enzyme immunoassay. The lower limits of quantitation of the assays was 0.01 International Units (IU)/mL and 0.04 IU/mL, respectively. Acceptable titers refer to the World Health Organization-defined protective titer of >=0.1 IU/mL.

    Measured: 4 weeks following Day 1 (Concomitant) or Month 1 (Non-concomitant) vaccination

  7. 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. Titers are expressed as enzyme-linked immunoassay units/mL (ELU/mL).

    Measured: 4 weeks following Day 1 (Concomitant) or Month 1 (Non-concomitant) vaccination

  8. Percentage of Participants Who Achieve Acceptable Titers of Anti-Poliovirus 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 poliovirus type 1, 2, and 3 were measured using a microneutralization assay. Serial dilutions of sera were incubated with type-specific standard poliovirus and sensitive cells. Neutralization of the virus was measured by cell staining. Acceptable titers were defined as neutralization at >=1:8 dilution of serum.

    Measured: 4 weeks following Day 1 (Concomitant) or Month 1 (Non-concomitant) vaccination

Secondary outcomes (1)

  1. Percentage of Participants Who Seroconvert for Each of the HPV Types

    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

Timeline

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

  1. First posted23 Feb 2010 (estimated)
  2. Study start22 Apr 2010
  3. Primary completion16 Jun 2011
  4. Study completion16 Jun 2011

Resources

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
1,054 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01073293
Sponsor's protocol ID
V503-007
Other IDs
2010_512
Status last verified
Oct 2018
First submitted
19 Feb 2010
Last updated
27 Nov 2018
Data monitoring committee
Yes
Individual data sharing
Yes: https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf

Publications

  • Kosalaraksa P, Mehlsen J, Vesikari T, Forsten A, Helm K, Van Damme P, Joura EA, Ciprero K, Maansson R, Luxembourg A, Sobanjo-ter Meulen A. An open-label, randomized study of a 9-valent human papillomavirus vaccine given concomitantly with diphtheria, tetanus, pertussis and poliomyelitis vaccines to healthy adolescents 11-15 years of age. Pediatr Infect Dis J. 2015 Jun;34(6):627-34. doi: 10.1097/INF.0000000000000694.

    PubMed 25831420

  • 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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing V503 Vaccine, REPEVAX™ (Concomitant) and REPEVAX™ (Non-concomitant) in people with Papillomavirus Infections, run by Merck Sharp & Dohme LLC.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 23 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 27 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. 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 22 Dec 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 8 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 NCT01073293, which also lists 2 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 27 Nov 2018.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in