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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
History of Changes

November 19, 2007
April 3, 2009
October 2007
November 2008   (final data collection date for 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 ]
  • Solicited injection-site adverse reactions (erythema, swelling, pain) [ Time Frame: from day 0 to day 4 following second dose ]
  • Unsolicited injection-site adverse reactions, Numeric values of temperature, Systemic Adverse Event [ Time Frame: Day 0 to Day 28 following second dose ]
  • Serious Adverse Events [ Time Frame: from Day 0 to next visit (or last visit in case of premature discontinuation) ]
Complete list of historical versions of study NCT00560755 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Solicited injection-site adverse reactions (erythema, swelling, pain) [ Time Frame: From Day 0 to Day 4 following first dose ]
  • Unsolicited injection-site adverse reactions, Numeric values of temperature, Systemic Adverse Event [ Time Frame: From Day 0 to Day 28 following first dose ]
Not Provided
Not Provided
 
ProQuad® rHA Safety
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

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
Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Measles
  • Mumps
  • Rubella
  • Varicella
Biological: ProQuad® manufactured with rHA
Measles-Mumps-Rubella-Varicella live vaccine
Experimental: 1
Intervention: Biological: ProQuad® manufactured with rHA
Rüger G, Gabutti G, Rümke H, Rombo L, Bernaola E, Diez-Domingo J, Martinon-Torres F, Høgh B, Konstantopoulos A, Fiquet A, Thomas S, Eymin C, Baudin M. Safety of a 2-dose regimen of a combined measles, mumps, rubella and varicella live vaccine manufactured with recombinant human albumin. Pediatr Infect Dis J. 2012 Nov;31(11):1166-72. doi: 10.1097/INF.0b013e318267fd8b.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
3340
November 2008
November 2008   (final data collection date for primary outcome measure)

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
Both
12 Months to 22 Months
Yes
Contact information is only displayed when the study is recruiting subjects
Denmark,   Germany,   Greece,   Italy,   Netherlands,   Spain,   Sweden
 
NCT00560755
MRV01C
No
Anne FIQUET MD, Sanofi Pasteur MSD
Sanofi Pasteur MSD
Not Provided
Study Director: Anne FIQUET, MD Sanofi Pasteur MSD
Sanofi Pasteur MSD
April 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP