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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)


Phase 3
11 Years
15 Years
Not Enrolling
Both
Papillomavirus Infections

Thank you

Trial Information

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 amendment is to update the definitions of adverse event relationship to study vaccine.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

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

Outcome Time Frame:

4 weeks post-dose 3 of V503

Safety Issue:

No

Authority:

Belgium: Federal Agency for Medicines and Health Products, FAMHP

Study ID:

V503-007

NCT ID:

NCT01073293

Start Date:

April 2010

Completion Date:

June 2011

Related Keywords:

  • Papillomavirus Infections
  • Papillomavirus Infections

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