Comparative Study of Immunogenicity and Safety of a 2-Dose Regimen of ProQuad® Manufactured With rHA - Full Text View

Sponsored by:	Sanofi Pasteur MSD
Information provided by:	Sanofi Pasteur MSD
ClinicalTrials.gov Identifier:	NCT00566527

Purpose

Primary objectives:
- To demonstrate that a 2-dose regimen of ProQuad® rHA administered at a 3-month interval to healthy children of 11 months of age at the time of Dose 1 is as immunogenic as in healthy children of 12 months of age at the time of Dose 1.
- To demonstrate that a 2-dose regimen of ProQuad® rHA administered at a 3-month interval to healthy children of 9 months of age at the time of Dose 1 is as immunogenic as in healthy children of 12 months of age at the time of Dose 1.
- To demonstrate that a 2-dose regimen of ProQuad® rHA administered at a 3-month interval to healthy children of 11 months of age and 9 months of age at the time of Dose 1 is well-tolerated compared to children of 12 months of age at the time of Dose 1.
Secondary objectives
- To describe the antibody titres to measles, mumps, rubella and varicella at Day 42 following Dose 1 and Dose 2 of ProQuad® rHA administered to healthy children from 9 months of age.
- To evaluate the safety profile of Dose 1 and Dose 2 of ProQuad® rHA administered to healthy children from 9 months of age.

Condition	Intervention	Phase
Measles Mumps Rubella Varicella	Biological: ProQuad® manufactured with recombinant Human Albumine	Phase III

MedlinePlus related topics: Chickenpox Measles Mumps Rubella Shingles

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title:	An Open-Label, Randomised, Comparative, Multi-Centre Study of the Immunogenicity and Safety of a 2-Dose Regimen of ProQuad® Manufactured With rHA Administered to Healthy Children From 9 Months of Age

Further study details as provided by Sanofi Pasteur MSD:

Primary Outcome Measures:

antibody response rates to measles, mumps, rubella and varicella measured at Day 42 following Dose 2 [ Time Frame: 42 days ] [ Designated as safety issue: No ]
From Day 0 to Day 4 following each dose, the rates of subjects with solicited injection-site adverse reactions (injection site erythema; injection site swelling; injection site pain) [ Time Frame: from day 0 to day 4 ] [ Designated as safety issue: Yes ]
Unsolicited injection-site adverse reactions starting from Day 5 to Day 28; Systemic adverse events and rectal (or rectal equivalent) temperature ≥ 39.4°C starting from Day 0 to Day 28 [ Time Frame: from D0 to Day 28 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

The GMTs to measles, mumps, rubella and varicella; the rate of subjects with varicella antibody titres <1.25 gpELISA units/mL in subjects with baseline varicella antibody titre <1.25 gpELISA units/mL. [ Time Frame: 42 days post dose 2 ] [ Designated as safety issue: No ]
antibody response rates for measles, mumps, rubella (MMR) and varicella; GMTs to MMR and varicella; rate of subjects with varicella antibody titres >1.25 gpELISA U/mL in subjects with varicella antibody titre <1.25 gpELISA U/mL. [ Time Frame: 42 days post dose 1 ] [ Designated as safety issue: No ]
Intensity, onset, duration and relationship (for systemic adverse events only) of events; Specific description for rashes; Rectal temperature ≥38.0°C [ Time Frame: Post dose 1 and post dose 2 ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	1260
Study Start Date:	November 2007
Estimated Study Completion Date:	March 2009
Primary Completion Date:	April 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Dose 1 at 9 months of age, Dose 2 at 12 months of age.	Biological: ProQuad® manufactured with recombinant Human Albumine 2-dose regimen of ProQuad® (0.5 mL per dose) given at a 3-month interval
2: Experimental Dose 1 at 11 months of age, Dose 2 at 14 months of age.	Biological: ProQuad® manufactured with recombinant Human Albumine 2-dose regimen of ProQuad® (0.5 mL per dose) given at a 3-month interval
3: Active Comparator Dose 1 at 12 months of age, Dose 2 at 15 months of age.	Biological: ProQuad® manufactured with recombinant Human Albumine 2-dose regimen of ProQuad® (0.5 mL per dose) given at a 3-month interval

Eligibility

Criteria

Inclusion Criteria:

Healthy subject of either gender of 9 months of age
Negative clinical history of measles, mumps, rubella, varicella or zoster
Informed consent form signed by both parents or legal representative
Parent(s) or legal representative able to attend all the scheduled visits with the subject and to understand and comply with the study procedures

Exclusion Criteria:

Febrile illness in the previous 3 days
Prior vaccination with a measles, mumps, rubella and/or varicella vaccine either alone or in any combination
Exposure to measles, mumps, rubella, varicella and/or zoster in the previous 30 days
Tuberculin test done in the previous 2 days
Severe chronic disease
Known active tuberculosis
Known personal history of encephalopathy, seizure disorder or progressive, evolving or unstable neurological condition
Hereditary problems of fructose intolerance
Prior known sensitivity or allergy to any component of the vaccine
Known blood dyscrasias, leukemia, lymphomas of any type, or other malignant neoplasms affecting the bone marrow or lymphatic systems
Humoral or cellular immunodeficiency,
Immunosuppressive therapy at high doses during at least 14 days in the previous 30 days
Family history of congenital or hereditary immunodeficiency
Receipt of immunoglobulins or blood-derived products in the previous 150 days
Receipt of an inactivated vaccine in the previous 14 days
Receipt of a live non-study vaccine in the previous 28 days

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00566527

Sponsors and Collaborators

Sanofi Pasteur MSD

Investigators

Study Director:

Emilio LEDESMA, MD

SPMSD

More Information

Responsible Party:	Sanofi Pasteur MSD ( Emilio LEDESMA MD )
Study ID Numbers:	MRV02C
Study First Received:	November 29, 2007
Last Updated:	July 1, 2008
ClinicalTrials.gov Identifier:	NCT00566527
Health Authority:	France: Afssaps - French Health Products Safety Agency; Finland: National Agency for Medicines; Germany: Paul-Ehrlich-Institut

Study placed in the following topic categories:

Virus Diseases
Herpes Zoster
Measles
Chickenpox
DNA Virus Infections

Chicken pox
Healthy
Rubella
Mumps
Herpesviridae Infections

ClinicalTrials.gov processed this record on January 16, 2009