ProQuad® Intramuscular vs Subcutaneous

This study has been completed.
Sponsor:
Information provided by:
Sanofi Pasteur MSD
ClinicalTrials.gov Identifier:
NCT00402831
First received: November 21, 2006
Last updated: April 3, 2009
Last verified: April 2009
  Purpose

Primary objective:

To demonstrate that two doses of ProQuad® administered by IM route are as immunogenic as two doses of ProQuad® administered by SC route to healthy children 12 to 18 months of age in terms of antibody response rates to measles, mumps, rubella and to varicella at 42 days following the second dose of ProQuad®

Secondary objectives:

  • To describe the antibody response rates to measles, mumps, rubella and varicella measured 30 days following the first dose of ProQuad® administered by IM or SC route,
  • To describe the antibody titres to measles, mumps, rubella and varicella at 30 days following the first dose and at 42 days following the second dose of ProQuad® both administered by IM or SC route,
  • To describe the safety profile of two doses of ProQuad® both administered by IM or SC route.

Condition Intervention Phase
Measles
Mumps
Rubella
Varicella
Biological: ProQuad® (prevention of measles, mumps, rubella and varicella)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: An Open, Randomised, Comparative, Multicentre Study of the Immunogenicity and Safety of ProQuad® When Administered by Intramuscular (IM) Route or Subcutaneous (SC) Route to Healthy Children Aged 12 to 18 Months

Resource links provided by NLM:


Further study details as provided by Sanofi Pasteur MSD:

Enrollment: 405
Study Start Date: October 2006
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Intramuscular
Biological: ProQuad® (prevention of measles, mumps, rubella and varicella)
route
Active Comparator: 2
Subcutaneous
Biological: ProQuad® (prevention of measles, mumps, rubella and varicella)
route

  Eligibility

Ages Eligible for Study:   12 Months to 18 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy subject of either gender,
  • Age 12 to 18 months,
  • Negative clinical history of measles, mumps, rubella, varicella and zoster,
  • Consent form signed by both holders of the parental authority or by the legal representative
  • Holder(s) of the the parental authority / legal representative able to understand the protocol requirements and to fill in the Diary Card.

Exclusion Criteria:

  • Prior receipt of measles, mumps, rubella and/or varicella vaccine either alone or in any combination,
  • Any recent (<=30 days) exposure to measles, mumps, rubella, varicella and/or zoster
  • Any recent (<= 3 days) history of febrile illness
  • Any severe chronic disease,
  • Active untreated tuberculosis,
  • Known personal history of seizure disorder,
  • Any known blood dyscrasias, leukemia, lymphomas of any type, or other malignant neoplasms affecting the haematopoietic and lymphatic systems,
  • Any severe thrombocytopenia or any other coagulation disorder that would contraindicate intramuscular injection,
  • Any immune impairment or humoral/cellular deficiency, neoplastic disease or depressed immunity,
  • Any previous (<= 150 days) receipt of immune globulin or any blood-derived product or scheduled to be administered through Visit 3,
  • Any recent (<= 7 days) tuberculin test or scheduled tuberculin test through Visit 3,
  • Any recent (<= 30 days) receipt of an inactivated or a live vaccine or scheduled vaccination through Visit 3,
  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: NCT00402831

Locations
France
Aix les Bains, France
Ancenis, France
Antibes Juan les Pins, France
Cannes, France
Cannes la Bocca, France
Chambéry, France
Darnetal, France
Dijon, France
Draguignan, France
Dunkerque, France
Ecully, France
Essey-les-Nancy, France
Fréjus, France
Illkirch, France
Le Havre, France
Les Sables d'Olonne, France
Lyon, France
Nice, France
Oullins, France
Rouen, France
St Laurent du Var, France
St Priest, France
St Priest en Jarez, France
St Raphaël, France
Strasbourg, France
Vaulx en Velin, France
Vence, France
Sponsors and Collaborators
Sanofi Pasteur MSD
Investigators
Study Director: Anne FIQUET, MD SPMSD
  More Information

No publications provided

Responsible Party: Anne FIQUET MD, Sanofi Pasteur MSD
ClinicalTrials.gov Identifier: NCT00402831     History of Changes
Other Study ID Numbers: F05-MMRV-304
Study First Received: November 21, 2006
Last Updated: April 3, 2009
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

ClinicalTrials.gov processed this record on September 16, 2014