An Open-label, Multi-centre Study of the Safety of a 2-dose Regimen of a Combined Measles, Mumps, Rubella and Varicella Live Vaccine (ProQuad®) Manufactured with Recombinant Human Albumin (rHA) when administered to Children in their Second Year of Life

Conditions: Combined Measles, Mumps, Rubella and Varicella Live Vaccine
MedDRA version: 9.1Level: LLTClassification code 10000639Term: Active immunisation
MedDRA version: 9.1Level: LLTClassification code 10039242Term: Routine childhood immunisation
MedDRA version: 9.1Level: LLTClassification code 10036897Term: Prophylactic vaccination

Registration Number: EUCTR2007-002438-12-SE

Lead Sponsor: Sanofi Pasteur MSD S.N.C.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 3340

Inclusion Criteria

Subject will be included in the study if he / she meets all the following criteria:
1. Healthy subject of either gender
2. Age from 12 to 22 months (from the 12 month birthday to one day prior to the
23rd month birthday),
3. Negative clinical history of infection with measles, mumps, rubella, varicella or
zoster,
4. Informed consent form signed by the parent(s) or by legal representative
according to the local regulations
5. Parent(s) or legal representative able to attend all schedule visits with the
subject and to understand and comply with the study procedures (i.e. able to
read and write).

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

If any of the following criteria are met, subject must not be included in the study:
1. Recent (= 3 days) history of febrile illness (defined as rectal temperature = 38.0°C)
2. Prior receipt of measles, mumps, rubella and/or varicella vaccination, either alone
or in any combination
3. Recent (= 30 days) exposure to measles, mumps, rubella, varicella 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
•contact with a newborn whose mother had onset of varicella 5 days or less
before delivery or within 48 hours after delivery,
4. Prior known sensitivity/allergy to any component of the vaccine including
neomycin, sorbitol or gelatin, or true allergy to egg proteins (anaphylactic or
anaphylactoid reaction after ingesting eggs)
5. Severe chronic disease,
6. Blood dyscrasias, leukaemia, lymphomas of any type, or other malignant
neoplasms affecting the haematopoietic and lymphatic system
7. Any severe thrombocytopenia or any other coagulation disorder that would
contraindicate intramuscular injection
8. Humoral or cellular (primary or acquired) immunodeficiency, including
hypogammaglobulinemia and dysgammaglobulinemia and AIDS, or symptomatic
HIV infection
9. Current immunosuppressive therapy (including systemic corticosteroids given daily
or on alternate days at =20 mg/day prednisone equivalent during =14
days within the past 30 days)
10. Family history of congenital or hereditary immunodeficiency
11. Hereditary problems of fructose intolerance
12. Known personal history of encephalopathy, seizure disorder or progressive,
evolving or unstable neurological condition,
13. Known active tuberculosis
14. Recent (= 2 days) tuberculin test or scheduled tuberculin test through Visit 3
15. Receipt of immunoglobulins or blood-derived products in the past 150 days
16. Receipt of an inactivated vaccine in the past 14 days
17. Receipt of a live vaccine in the past 28 days
18. Any medical condition which, in the opinion of the investigator, might interfere
with the evaluation of the study objectives.
19. Participation to another clinical study in the past 30 days

There are also a list of temporary contra-indications and a list of definite contra-indications to the further vaccination. See study protocol page 20 for the detailed lists.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To describe the safety profile of a second dose of ProQuad® manufactured with rHA when administered to children in their second year of life;Secondary Objective: To describe the safety profile of a first dose of ProQuad® manufactured with rHA when administered to children in their second year of life;Primary end point(s): Primary Evaluation criteria: <br>The primary safety criteria will describe the safety profile of a second dose of ProQuad® manufactured with rHA when administered to children in their second year of life.<br>

Secondary Outcome Measures

Name	Time	Method

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