Phase 3 N=1,054 Randomized Prevention

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

Papillomavirus Infections

Bottom Line

View on ClinicalTrials.gov: NCT01073293 ↗

Enrolled (actual)

1,054

Serious AEs

1.5%

Results posted

Dec 2014

Primary outcome: Primary: Geometric Mean Titers (GMTs) of the Antibody Response to Each of the Human Papillomavirus (HPV) Types Contained in V503 — 1637.9; 1725.0; 1170.3; 1212.6 milli Merck Units/mL — p=<0.001

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: V503 Vaccine (Biological); REPEVAX™ (Concomitant) (Biological); REPEVAX™ (Non-concomitant) (Biological)
Age: Pediatric · 11+ yrs
Sex: All
Sponsor: Merck Sharp & Dohme LLC
Primary completion: Jun 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Geometric Mean Titers (GMTs) of the Antibody Response to Each of the Human Papillomavirus (HPV) Types Contained in V503	1637.9; 1725.0; 1170.3; 1212.6; 6529.4; 6940.6	<0.001 sig
PRIMARY Percentage of Participants With a V503 Injection-site Adverse Experience	63.4; 62.8	—
PRIMARY Percentage of Participants With a Repevax™ Injection-site Adverse Experience	88.0; 84.6	—
PRIMARY Percentage of Participants With Maximum Temperature >=37.8 °C (>=100.0 °F) (Oral or Oral Equivalent)	8.8; 8.4	—
PRIMARY Percentage of Participants With a Systemic Adverse Experience	48.6; 48.6	—
PRIMARY Percentage of Participants Who Achieve Acceptable Titers of Anti-Diphtheria and Anti-Tetanus Antibody	99.8; 99.6; 99.6; 99.6	<0.001 sig
PRIMARY Geometric Mean Titers of Pertussis Antibody Responses	41.5; 43.8; 188.1; 190.6; 372.9; 398.2	<0.001 sig
PRIMARY Percentage of Participants Who Achieve Acceptable Titers of Anti-Poliovirus Antibody	99.6; 99.8; 99.6; 99.8; 100; 100	<0.001 sig
SECONDARY Percentage of Participants Who Seroconvert for Each of the HPV Types	99.8; 100.0; 100.0; 100.0; 100.0; 100.0	—

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.

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01073293). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.