ProQuad® rHA Safety - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

ProQuad® rHA Safety

Official Title ^†

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

Brief Summary

Primary 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 objectives: To describe the safety profile of a first dose of ProQuad® manufactured with rHA when administered to children in their second year of life

Detailed Description

Study Phase

Phase III

Study Type ^†

Interventional

Study Design ^†

Prevention, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study

Primary Outcome Measure ^†

Solicited injection-site adverse reactions (erythema, swelling, pain) [ Time Frame: from day 0 to day 4 following second dose ] [ Designated as safety issue: Yes ]
Unsolicited injection-site adverse reactions, Numeric values of temperature, Systemic Adverse Event [ Time Frame: Day 0 to Day 28 following second dose ] [ Designated as safety issue: Yes ]
Serious Adverse Events [ Time Frame: from Day 0 to next visit (or last visit in case of premature discontinuation) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measure ^†

Solicited injection-site adverse reactions (erythema, swelling, pain) [ Time Frame: From Day 0 to Day 4 following first dose ] [ Designated as safety issue: Yes ]
Unsolicited injection-site adverse reactions, Numeric values of temperature, Systemic Adverse Event [ Time Frame: From Day 0 to Day 28 following first dose ] [ Designated as safety issue: Yes ]

Condition ^†

Measles
Mumps
Rubella
Varicella

Intervention ^†

Biological: ProQuad® manufactured with rHA

MEDLINE PMIDs

Links

Recruitment Information Fields

Recruitment Status ^†

Completed

Enrollment ^†

3340

Start Date ^†

October 2007

Completion Date

November 2008

Eligibility Criteria ^†

Inclusion Criteria:

Healthy subject of either gender,
Age from 12 to 22 months,
Negative clinical history of infection with measles, mumps, rubella, varicella or zoster,
Informed consent form signed by the parent(s) or by legal representative
Parent(s) or legal representative able to attend all schedule visits with the subject and to understand and comply with the study procedures

Exclusion Criteria:

Recent (≤ 3 days) history of febrile illness
Prior receipt of measles, mumps, rubella and/or varicella vaccination, either alone or in any combination
Recent (≤ 30 days) exposure to measles, mumps, rubella, varicella or zoster
Prior known sensitivity/allergy to any component of the vaccine
Severe chronic disease,
Blood dyscrasias, leukaemia, lymphomas of any type, or other malignant neoplasms affecting the haematopoietic and lymphatic system
Any severe thrombocytopenia or any other coagulation disorder that would contraindicate intramuscular injection
Humoral or cellular immunodeficiency,
Current immunosuppressive therapy
Family history of congenital or hereditary immunodeficiency
Hereditary problems of fructose intolerance
Known personal history of encephalopathy, seizure disorder or progressive, evolving or unstable neurological condition,
Known active tuberculosis
Recent (≤ 2 days) tuberculin test or scheduled tuberculin test through Visit 3
Receipt of immunoglobulins or blood-derived products in the past 150 days
Receipt of an inactivated vaccine in the past 14 days
Receipt of a live vaccine in the past 28 days

Gender

Both

Ages

12 Months to 22 Months

Accepts Healthy Volunteers

Yes

Contacts ^††

Location Countries ^†

Denmark, Germany, Greece, Italy, Netherlands, Spain, Sweden

Administrative Information Fields

NCT ID ^†

NCT00560755

Organization ID

MRV01C

Secondary IDs ^††

Study Sponsor ^†

Sanofi Pasteur MSD

Collaborators ^††

Investigators ^†

Study Director:

Emilio LEDESMA, MD

Sanofi Pasteur MSD

Information Provided By

Sanofi Pasteur MSD

Verification Date

December 2008

First Received Date ^†

November 19, 2007

Last Updated Date

December 1, 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.