Immunogenicity and Safety Study of Proquad® and Infanrix® Hexa When Administered Concomitantly (V221-035)
Varicella, Measles, Mumps
About this trial
This is an interventional prevention trial for Varicella focused on measuring Mumps and Rubella, Haemophilus influenzae type b (Infanrix® hexa)
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Active Comparator
Active Comparator
ProQuad® + Infanrix® hexa
ProQuad®
Infanrix® hexa
Pediatric (12 to 23 months of age) participants received ProQuad® and Infanrix® hexa (booster dose) concomitantly on Visit 1 (Day 0). Blood samples were taken on Visit 1 and Visit 2 (Day 42).
Pediatric (12 to 23 months of age) participants received ProQuad® on Visit 1 (Day 0). Blood samples were taken on Visit 1 and Visit 2 (Day 42).
Pediatric (12 to 23 months of age) participants received Infanrix® hexa (booster dose) on Visit 1 (Day 0). Blood samples were taken on Visit 1 and Visit 2 (Day 42).