Clinical trial · Interventional

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

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)

NCT01073293CI-TRIAL-00035952completedPhase 3Results postedClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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.

Conditions

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Papillomavirus Infections	—	UNRESOLVED	—

Interventions

Interventions (3)

Intervention	Type	Mapped drug	Match
REPEVAX™ (Concomitant)	Biological	—	UNRESOLVED
REPEVAX™ (Non-concomitant)	Biological	—	UNRESOLVED
V503 Vaccine	Biological	—	UNRESOLVED

Design

Arms and outcomes

Arms (2)

type
EXPERIMENTAL
label
Concomitant Vaccination
description
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
interventionNames
1. Biological: V503 Vaccine
2. Biological: REPEVAX™ (Concomitant)
type
EXPERIMENTAL
label
Non-concomitant Vaccination
description
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
interventionNames
1. Biological: V503 Vaccine
2. Biological: REPEVAX™ (Non-concomitant)

Primary outcomes (8)

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 11 Years
Maximum age: 15 Years

Show eligibility criteria text

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

References

Publications (2)

RESULTKosalaraksa 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. PMID 25831420
RESULTMoreira 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. PMID 27422279