immunogenicity and safety study of proquad® and infanrix® hexa when administered concomitantly (v221-035)

Conditions: Varicella; Measles; Mumps; Rubella; Diphtheria; Tetanus; Pertussis; Poliomyelitis; Hepatitis B; Haemophilus Infections

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 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. secondary objectives: * 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.


Eligibility criteria:
inclusion criteria: * 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 criteria: * 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

Keywords: mumps and rubella haemophilus influenzae type b (infanrix® hexa)