Status:

COMPLETED

Frozen ProQuad Administered Concomitantly Versus Nonconcomitantly With Other Pediatric Vaccines

Lead Sponsor:

Merck Sharp & Dohme LLC

Conditions:

Measles

Mumps

Eligibility:

All Genders

12-15 years

Phase:

PHASE3

Brief Summary

This study will assess the safety and immunogenicity of ProQuad when administered concomitantly and nonconcomitantly with Tripedia and Comvax.

Eligibility Criteria

Inclusion

  • In good health
  • Negative clinical history of varicella, zoster, measles, mumps, rubella, diptheria, tetanus, pertussis, invasive Hib disease and hepatitis B
  • Had completed either a 2-dose primary series of PedvaxHIB or COMVAX or any 3-dose primary series of a licensed Hib vaccine
  • Had received 2 or 3 doses of any hepatitis B vaccine or COMVAX prior to entry into trial

Exclusion

  • Previous receipt of measles, mumps, rubella or varicella vaccine either alone or in combination
  • Any immune impairment or deficiency
  • Recent household, daycare or school exposure to invasive Hib disease or hepatitis B
  • Exposure to measles, mumps, rubella, varicella, or zoster in the 4 weeks prior to vaccination
  • Vaccination with an inactive vaccine with in the past 14 days
  • Vaccination with a live vaccine within the past 30 days
  • Receipt of immune globulin, blood transfusion or blood-derived product in the past 3 months
  • Recent history of fever or underlying medical problems

Key Trial Info

Start Date :

June 1 2000

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

December 1 2001

Estimated Enrollment :

1913 Patients enrolled

Trial Details

Trial ID

NCT00984295

Start Date

June 1 2000

End Date

December 1 2001

Last Update

August 7 2015

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