Immunogenicity and Safety Study of Proquad® and Infanrix® Hexa When Administered Concomitantly
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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 antibody response rates to measles, mumps, rubella, varicella, hepatitis B and Haemophilus influenzae type b; or to the 3 pertussis antibody titres measured at 42 days following vaccination.
To describe the antibody titres and the antibody response rates to measles, mumps, rubella, varicella, diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and Haemophilus influenzae type b as measured at 42 days following vaccination by an Infanrix® hexa primary series schedule and all data are pooled.
To evaluate the safety profile of ProQuad® when administered concomitantly with a booster dose of Infanrix® hexa by an Infanrix® hexa primary series schedule and all data are pooled.
An Open, Randomised, Comparative, Multicentre Study of the Immunogenicity and Safety of Concomitant Versus Separate Administration of a Combined Measles, Mumps, Rubella and Varicella Live Vaccine (ProQuad®) and a Booster Dose of Infanrix® Hexa in Healthy Children 12 to 23 Months of Age
Study Start Date
Primary Completion Date
Study Completion Date
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Ages Eligible for Study:
12 Months to 23 Months (Child)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Healthy subjects 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.
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