ProQuad® rHA Safety

This study has been completed.
Sponsor:
Information provided by:
Sanofi Pasteur MSD
ClinicalTrials.gov Identifier:
NCT00560755
First received: November 19, 2007
Last updated: April 3, 2009
Last verified: April 2009
  Purpose

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


Condition Intervention Phase
Measles
Mumps
Rubella
Varicella
Biological: ProQuad® manufactured with rHA
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by Sanofi Pasteur MSD:

Primary Outcome Measures:
  • 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 Measures:
  • 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 ]

Estimated Enrollment: 3340
Study Start Date: October 2007
Study Completion Date: November 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Biological: ProQuad® manufactured with rHA
Measles-Mumps-Rubella-Varicella live vaccine

  Eligibility

Ages Eligible for Study:   12 Months to 22 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00560755

  Show 65 Study Locations
Sponsors and Collaborators
Sanofi Pasteur MSD
Investigators
Study Director: Anne FIQUET, MD Sanofi Pasteur MSD
  More Information

No publications provided by Sanofi Pasteur MSD

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Anne FIQUET MD, Sanofi Pasteur MSD
ClinicalTrials.gov Identifier: NCT00560755     History of Changes
Other Study ID Numbers: MRV01C
Study First Received: November 19, 2007
Last Updated: April 3, 2009
Health Authority: Germany: Paul-Ehrlich-Institut
Denmark: Danish Medicines Agency
Sweden: Medical Products Agency
The Netherlands: Ministry VWS (Ministerie van Volksgezondheid, Welzijn en Sport)
Greece: National Organization of Medicines
Spain: Spanish Agency of Medicines
Italy: The Italian Medicines Agency

Keywords provided by Sanofi Pasteur MSD:
Prevention of: measles, mumps, rubella and varicella

Additional relevant MeSH terms:
Chickenpox
Herpes Zoster
Measles
Mumps
Parotitis
Rubella
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Morbillivirus Infections
Paramyxoviridae Infections
Mononegavirales Infections
RNA Virus Infections
Rubulavirus Infections
Parotid Diseases
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases
Sialadenitis
Rubivirus Infections
Togaviridae Infections

ClinicalTrials.gov processed this record on July 29, 2014