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 - X06-MMRV-302

• Conditions: Vaccine against moulds, meals, rubella and varicella administered concomitantly with a booster dose of vaccine against difteria, tetanus, pertussis, hepatitis b, polyomielitis, haemophilus type B,; MedDRA version: 6.1Level: HLGTClassification code 10047438

• Registration Number: EUCTR2006-004129-27-IT
• Lead Sponsor: CASA MADRE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-01-05
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 960

Inclusion Criteria

1. Healthy subject of either gender,2. Age from 12 to 23 months from the 12th month birthday to 1 day prior to the 24th month birthday ,3. Negative clinical history of measles, mumps, rubella, varicella and zoster,4. 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 8805; 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 8805; 6 months prior to inclusion,5. Consent form signed by parent s according to local regulations or by the legal representative properly informed about the study,6. Parent s / legal representative able to understand the protocol requirements and to fill in the Diary Card.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Prior receipt of measles, mumps, rubella and/or varicella vaccine either alone or in any combination,2. Any recent 30 days exposure to measles, mumps, rubella, varicella and/or zoster involving continuous household contact, or playmate contact generally 1 hour of play indoors , or hospital contact in same 2- to 4-bed room or adjacent beds in a large ward or face-to-face contact with an infectious staff member or subject , or in the case of varicella, contact with a newborn whose mother had onset of varicella 5 days or less before delivery or within 48 hours after delivery,3. 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,4. Any recent 3 days history of febrile illness rectal temperature 38.0 C ,5. Any severe chronic disease,6. Active untreated tuberculosis,7. Known personal history of encephalopathy, seizure disorder or progressive, evolving or unstable neurological condition, 8. Any known blood dyscrasia, leukemia, lymphomas of any type, or other malignant neoplasms affecting the haematopoietic or lymphatic systems,9. Any severe thrombocytopenia or any other coagulation disorder that would contraindicate intramuscular injection,10. Prior known sensitivity/allergy to any component of the vaccines including neomycin, sorbitol or gelatin,11. Any immune impairment or humoral/cellular deficiency, neoplastic disease or depressed immunity including those resulting from corticosteroid any long-term 14 days administration of systemic corticosteroid therapy given daily or on alternate days at high doses 2 mg/kg/day prednisone equivalent or 20 mg/day if weight more than 10kg within the previous 30 days or other immunosuppressive therapy,12. Any recent 2 days tuberculin test or scheduled tuberculin test through Visit 2,13. Any previous 150 days receipt of immune serum globulin or any blood-derived products or scheduled to be administered through Visit 2,14. Any recent 30 days receipt of an inactivated or a live non-study vaccine or scheduled non-study vaccination through Visit 2,15. Any medical condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives, 16. Any recent 30 days participation or scheduled participation in any other clinical trial through Visit 2.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified