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

February 7, 2007
April 3, 2009
January 2005
July 2006   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT00432523 on ClinicalTrials.gov Archive Site
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Not Provided
Not Provided
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Immunogenicity and Safety of Concomitant Administration of MMR™ rHA and VARIVAX® by Intramuscular Versus Subcutaneous Route
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

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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
  • Measles
  • Mumps
  • Varicella
Biological: M-M-R™II manufactured with recombinant Human Albumin (rHA) and VARIVAX®
Not Provided
Gillet Y, Habermehl P, Thomas S, Eymin C, Fiquet A. Immunogenicity and safety of concomitant administration of a measles, mumps and rubella vaccine (M-M-RvaxPro) and a varicella vaccine (VARIVAX) by intramuscular or subcutaneous routes at separate injection sites: a randomised clinical trial. BMC Med. 2009 Apr 14;7:16.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
752
July 2006
July 2006   (final data collection date for primary outcome measure)

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
Both
12 Months to 18 Months
Yes
Contact information is only displayed when the study is recruiting subjects
France,   Germany
 
NCT00432523
X04-MMRr-301
Not Provided
Anne FIQUET MD, Sanofi Pasteur MSD
Sanofi Pasteur MSD
Not Provided
Study Director: Anne FIQUET, MD SPMSD
Sanofi Pasteur MSD
April 2009

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