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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01073293
First received: February 19, 2010
Last updated: January 12, 2015
Last verified: January 2015
  Purpose

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.


Condition Intervention Phase
Papillomavirus Infections
Biological: V503 Vaccine
Biological: REPEVAX™ (Concomitant)
Biological: REPEVAX™ (Non-concomitant)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
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)

Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants With a V503 Injection-site Adverse Experience [ Time Frame: Day 1 through Day 5 following Day 1 vaccination ] [ Designated as safety issue: Yes ]
    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.

  • Percentage of Participants With a Repevax™ Injection-site Adverse Experience [ Time Frame: Day 1 through Day 5 following Day 1 (Concomitant) or Month 1 (Non-concomitant) vaccination ] [ Designated as safety issue: Yes ]
    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.

  • 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 ] [ Designated as safety issue: Yes ]
    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.

  • Percentage of Participants With a Systemic Adverse Experience [ Time Frame: Up to 15 days following the Day 1 and Month 1 vaccination / visit ] [ Designated as safety issue: Yes ]
    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.

  • Percentage of Participants Who Achieve Acceptable Titers of Anti-Diphtheria and Anti-Tetanus Antibody [ Time Frame: 4 weeks following Day 1 (Concomitant) or Month 1 (Non-concomitant) vaccination ] [ Designated as safety issue: No ]
    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.

  • Geometric Mean Titers of Pertussis Antibody Responses [ Time Frame: 4 weeks following Day 1 (Concomitant) or Month 1 (Non-concomitant) vaccination ] [ Designated as safety issue: No ]
    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).

  • Percentage of Participants Who Achieve Acceptable Titers of Anti-Poliovirus Antibody [ Time Frame: 4 weeks following Day 1 (Concomitant) or Month 1 (Non-concomitant) vaccination ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Percentage of Participants Who Seroconvert for Each of the HPV Types [ Time Frame: Month 7 ] [ Designated as safety issue: No ]
    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.


Enrollment: 1054
Study Start Date: April 2010
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Concomitant Vaccination
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 Repevax™ given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm on Day 1
Biological: V503 Vaccine
V503 (Multivalent HPV L1 VLP vaccine) given as a 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6
Biological: REPEVAX™ (Concomitant)
REPEVAX™ given as a single 0.5 mL intramuscular injection at Day 1
Experimental: Non-concomitant Vaccination
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 Repevax™ given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm at Month 1
Biological: V503 Vaccine
V503 (Multivalent HPV L1 VLP vaccine) given as a 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6
Biological: REPEVAX™ (Non-concomitant)
REPEVAX™ given as a single 0.5 mL intramuscular injection at Month 1

  Eligibility

Ages Eligible for Study:   11 Years to 15 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

  • 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.

Exclusion Criteria:

  • 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
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01073293

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Director Merck Sharp & Dohme Corp.
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01073293     History of Changes
Other Study ID Numbers: V503-007, 2010_512
Study First Received: February 19, 2010
Results First Received: December 12, 2014
Last Updated: January 12, 2015
Health Authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP

Additional relevant MeSH terms:
Papillomavirus Infections
DNA Virus Infections
Tumor Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on April 23, 2015