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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00432523
First Posted: February 8, 2007
Last Update Posted: March 10, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
  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
Intervention Model: Parallel Assignment
Masking: None (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 Merck Sharp & Dohme Corp.:

Estimated Enrollment: 752
Study Start Date: January 2005
Study Completion Date: July 2016
Primary Completion Date: July 2006 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   12 Months to 18 Months   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00432523


Locations
France
France, France
Germany
Germany, Germany
Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Anne FIQUET, MD SPMSD
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00432523     History of Changes
Other Study ID Numbers: V205-011
X04-MMRr-301 ( Other Identifier: MCMVaccBV (SPMSD) Secondary ID )
First Submitted: February 7, 2007
First Posted: February 8, 2007
Last Update Posted: March 10, 2017
Last Verified: March 2017

Keywords provided by Merck Sharp & Dohme Corp.:
Prevention of : Measles, Mumps, Rubella and Varicella diseases

Additional relevant MeSH terms:
Measles
Chickenpox
Herpes Zoster
Morbillivirus Infections
Paramyxoviridae Infections
Mononegavirales Infections
RNA Virus Infections
Virus Diseases
Herpesviridae Infections
DNA Virus Infections