Immunogenicity and Safety of Concomitant Administration of MMR™ rHA and VARIVAX® by Intramuscular Versus Subcutaneous Route

This study has been completed.
Sponsor:
Information provided by:
Sanofi Pasteur MSD
ClinicalTrials.gov Identifier:
NCT00432523
First received: February 7, 2007
Last updated: April 3, 2009
Last verified: April 2009
  Purpose

Primary objective:

To compare if, when given concomitantly with VARIVAX® by the same route at 12-18 months of age using separate injection sites, a single dose of M-M-RTMII administered by IM route is as immunogenic as a single dose of M-M-RTMII administered by SC route in terms of response rates to measles, mumps and rubella at 42 days following the vaccination.

AND/OR

To compare if, when given concomitantly with M-M-RTMII by the same route at 12-18 months of age using separate injection sites, a single dose of VARIVAX® administered by IM route is as immunogenic as a single dose of VARIVAX® administered by SC route in terms of response rate to varicella at 42 days following the vaccination

Secondary objectives:

  • To summarise the antibody titres to measles, mumps, rubella and varicella at 42 days following the vaccination in children immunised with M-M-R™II and VARIVAX® administered concomitantly at two separate injection sites by the same route IM or SC,
  • To evaluate the safety profiles of M-M-R™II and VARIVAX® administered concomitantly at two separate injection sites by the same route IM or SC.

Condition Intervention Phase
Measles
Mumps
Varicella
Biological: M-M-R™II manufactured with recombinant Human Albumin (rHA) and VARIVAX®
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: An Open, Randomised, Comparative, Multicentre Study of the Immunogenicity and Safety of M-M-R™II Manufactured With Recombinant Human Albumin (rHA) and VARIVAX® When Administered Concomitantly by Intramuscular (IM) Route or Subcutaneous (SC) Route at Two Separate Injection Sites in Healthy Subjects 12 to 18 Months of Age

Resource links provided by NLM:


Further study details as provided by Sanofi Pasteur MSD:

Estimated Enrollment: 752
Study Start Date: January 2005
Estimated Study Completion Date: July 2006
Primary Completion Date: July 2006 (Final data collection date for primary outcome measure)
  Eligibility

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

Inclusion Criteria:

  1. Healthy subject of either gender,
  2. Age 12 to 18 months ,
  3. Consent form signed by both parent(s) or by the legal representative properly informed about the study,
  4. Parent(s) / legal representative able to understand the protocol requirements and to fill in the Diary Card.

Exclusion Criteria:

  1. Prior receipt of measles, mumps, rubella or varicella vaccine either alone or in combination vaccine,
  2. Known or suspected clinical history of infection with measles, mumps, rubella, varicella or zoster,
  3. Any recent (≤30 days) exposure to measles, mumps or rubella,
  4. Any recent (≤30 days) exposure to varicella or zoster involving:
  5. Any recent (≤3 days) history of febrile illness
  6. Any severe chronic disease,
  7. Active untreated tuberculosis,
  8. Known personal history of seizures,
  9. Any known blood dyscrasia, leukemia, lymphomas of any type, or other malignant neoplasms affecting the bone marrow or lymphatic systems,
  10. Any severe thrombocytopenia or any other coagulation disorder that would contraindicate intramuscular injection,
  11. Any immune impairment or humoral/cellular deficiency, neoplastic disease or depressed
  12. Any recent tuberculin test (≤7 days) or scheduled tuberculin test through visit 2,
  13. Any previous (≤150 days) receipt of immune serum globulin or any blood-derived products or scheduled to be administered through visit 2,
  14. Any recent receipt of an inactivated or a live vaccine (≤30 days) or scheduled vaccination through visit 2
  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: NCT00432523

Locations
France
France, France
Germany
Germany, Germany
Sponsors and Collaborators
Sanofi Pasteur MSD
Investigators
Study Director: Anne FIQUET, MD SPMSD
  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: NCT00432523     History of Changes
Other Study ID Numbers: X04-MMRr-301
Study First Received: February 7, 2007
Last Updated: April 3, 2009
Health Authority: Germany: Paul-Ehrlich-Institut
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Sanofi Pasteur MSD:
Prevention of : Measles, Mumps, Rubella and Varicella diseases

Additional relevant MeSH terms:
Chickenpox
Herpes Zoster
Measles
Mumps
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Morbillivirus Infections
Paramyxoviridae Infections
Mononegavirales Infections
RNA Virus Infections
Rubulavirus Infections
Parotitis
Parotid Diseases
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases
Albunex
Contrast Media
Diagnostic Uses of Chemicals
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 20, 2014