CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,027 enrolled
Drug / intervention
Comparator: ProQuad™ (V221) +1 morebiological
Likely dose
V221 0.5 mL subcutaneous injection and PREVNAR 0.5 mL intramuscular injection, co-administeredAI-extracted
Key inclusion· 4
  • ✓12 to 15 months of age
  • ✓In good health
  • ✓Negative clinical history to measles, mumps, rubella, varicella and/or zoster
  • ✓Completed 3-dose primary series of pneumococcal conjugate vaccine with at least 2 months prior to study vaccination
Key exclusion· 7
  • ✕Previous administration of any measles, mumps, rubella, or varicella vaccine (alone or in combination)
  • ✕Any condition resulting in depressed immunity
  • ✕Allergy to any vaccine component as stated in package circulars
  • ✕Exposure to measles, mumps, rubella, varicella, or zoster within 4 weeks prior to study vaccination

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00109343
NCT00109343Phase 3Completed
CompareCT.gov

An Open, Randomized, Multicenter Study of the Safety, Tolerability, and Immunogenicity of V221 Given Concomitantly With Pneumococcal Conjugate Vaccine in Healthy Children 12 to 15 Months of Age

Merck Sharp & Dohme LLC·interventional·Posted Apr 27, 2005·Updated Apr 12, 2017

In Brief

A Phase 3 clinical trial evaluating Comparator: ProQuad™ (V221) and Comparator: PREVNAR™ (pneumococcal 7-valent conjugate vaccine) for Measles and 3 related conditions. Completed, enrolled 1,027 participants.

Detailed Summary

The study is being conducted to demonstrate that V221 may be administered concomitantly with pneumococcal conjugate vaccine without impairing the safety or immunogenicity of measles, mumps, rubella, varicella, or the 7 serotypes of S. pneumoniae.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMeasles, Mumps, Rubella, Varicella
Countries--
Collaborators--

Timeline

Phase 3CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 27, 2005
Enrollment StartMar 1, 2006
Primary CompletionSep 1, 2007
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 21.2 years ago

Interventions

Comparator: ProQuad™ (V221)biological

0.5-mL subcutaneous injection of measles, mumps, rubella, varicella virus vaccine live (MMRV)

Comparator: PREVNAR™ (pneumococcal 7-valent conjugate vaccine)biological

0.5-mL intramuscular injection of pneumococcal 7-valent conjugate vaccine