Status:
COMPLETED
Immunogenicity and Safety Study of Proquad® and Infanrix® Hexa When Administered Concomitantly (V221-035)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Varicella
Measles
Eligibility:
All Genders
12-23 years
Phase:
PHASE3
Brief Summary
Primary Objective: * To demonstrate that ProQuad® can be administered concomitantly with a booster dose of Infanrix® hexa to healthy children 12 to 23 months of age without impairing either the antib...
Eligibility Criteria
Inclusion
- Healthy participants of either gender
- Aged 12 to 23 months
- No clinical history of measles, mumps, rubella, varicella and zoster
- For Italy: Primary vaccination with the combined diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and Haemophilus influenzae type b vaccine Infanrix® hexa as a 2-dose schedule, with receipt of the second dose ≥ 6 months prior to inclusion
- For Germany: Primary vaccination with the combined diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and Haemophilus influenzae type b vaccine Infanrix® hexa as a 3-dose schedule, with receipt of the third dose ≥ 6 months prior to inclusion
- Consent form signed by parent(s) according to local regulations or by the legal representative properly informed about the study
- Parent(s)/legal representative able to understand the protocol requirements and to fill in the Diary Card.
Exclusion
- Prior receipt of measles, mumps, rubella and/or varicella vaccine either alone or in any combination
- Any recent (\<= 30 days) exposure to measles, mumps, rubella, varicella and/or zoster
- Receipt of any other diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and/or Haemophilus influenzae type b containing vaccine (either alone or in any combination) than Infanrix® hexa
- Any recent (\<= 3 days) history of febrile illness
- Any severe chronic disease
- Active untreated tuberculosis
- Known personal history of encephalopathy, seizure disorder or progressive, evolving or unstable neurological condition
- Any known blood dyscrasia, leukemia, lymphomas of any type, or other malignant neoplasms affecting the haematopoietic or lymphatic systems
- Any severe thrombocytopenia or any other coagulation disorder that would contraindicate intramuscular injection
- Prior known sensitivity/allergy to any component of the vaccines including neomycin, sorbitol or gelatin
- Any immune impairment or humoral/cellular deficiency, neoplastic disease or depressed immunity
- Any recent (\<= 2 days) tuberculin test or scheduled tuberculin test through Visit 2
- Any previous (\<= 150 days) receipt of immune serum globulin or any blood-derived products or scheduled to be administered through Visit 2
- Any recent (\<= 30 days) receipt of an inactivated or a live non-study vaccine or scheduled non-study vaccination through Visit 2
- Any medical condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives
- Any recent (≤30 days) participation or scheduled participation in any other clinical trial through Visit 2
Key Trial Info
Start Date :
January 12 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 27 2008
Estimated Enrollment :
955 Patients enrolled
Trial Details
Trial ID
NCT00432042
Start Date
January 12 2007
End Date
March 27 2008
Last Update
March 19 2018
Active Locations (50)
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1
Alsfeld, Germany
2
Bad Saulgau, Germany
3
Bad Säckingen, Germany
4
Bad Sobernheim, Germany