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ProQuad™ Concomitant Use Study with Prevnar™ and IPOL™ - Article


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German Measles Vaccine

 




Clinical Trial: ProQuad™ Concomitant Use Study with Prevnar™ and IPOL™

This study is not yet open for patient recruitment.

Sponsored by: Merck
Information provided by: Merck

Purpose

The study is being conducted to demonstrate that ProQuad™ may be administered concomitantly with a fourth dose of Prevnar™ and a third dose of IPOL™ without impairing the safety or immunogenicity of vaccines for measles, mumps, rubella, varicella, 7 serotypes of S. pneumoniae or 3 serotypes of poliovirus.

Condition Treatment or Intervention Phase
Measles
Mumps
Rubella
Varicella
 Vaccine: Investigational Measles, Mumps, Rubella, Varicella Vaccine
Phase II
Phase III

MedlinePlus related topics:  Chickenpox;   Measles;   Mumps;   Rubella

Study Type: Interventional
Study Design: Prevention, Randomized, Open Label, Safety/Efficacy Study

Eligibility

Ages Eligible for Study:  12 Months   -   15 Months,  Genders Eligible for Study:  Both

Accepts Healthy Volunteers

Criteria

Inclusion Criteria:

  • In good health
  • 12 to 15 months of age
  • Negative clinical history to measles, mumps, rubella, varicella and/or zoster
  • Received only the 2-dose primary series of IPOL™ with the second dose at least 2 months prior to the receipt of any study vaccines and received the 3-dose primary series of Prevnar™ with at least 2 months prior to the receipt of any of the study vaccines
  • Signed consent

Exclusion Criteria:

  • Previous administration of any measles, mumps, rubella, or varicella vaccine either alone or in any combination
  • Received OPV or Pediarix™
  • Any condition resulting in depressed immunity
  • Any allergy to any vaccine component as stated in the package circulars
  • Exposure to measles, mumps, rubella, varicella, or zoster within 4 weeks prior to the study vaccination
  • History of seizure disorder
  • Receipt of an inactivated vaccine within 14 days prior to enrollment or live vaccine within 30 days
  • Recent febrile illness

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00109343

Toll Free Number      1-888-577-8839 

More Information

Study ID Numbers:  2005_027
Record last reviewed:  April 2005
Last Updated:  April 26, 2005
Record first received:  April 26, 2005
ClinicalTrials.gov Identifier:  NCT00109343
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-05-03


Source: ClinicalTrials.gov
Cache Date: May 4, 2005


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December 2, 2009



Page Updated: January 17, 2009
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