ProQuad™ Versus M-M-R II™ and VARIVAX™ in Healthy Children (V221-009)(COMPLETED)

Browse trials for

• Measles 120
• Chickenpox 152
• Herpes Zoster 360
• Rubella 92

Measles

120 studies on the registry are indexed under Measles; 17 are open to participants now.

This study's enrollment of 480 is below the median of 540 across 93 interventional studies indexed under Measles.

Lead sponsor

Merck Sharp & Dohme LLC is the lead sponsor of 2,114 studies on the registry; 133 are open to participants now.

Of its 489 completed or terminated interventional studies of FDA-regulated products, 362 (74%) have results posted.

Study arms

• Experimental
  1

  ProQuad™ (V221) + Placebo Followed by ProQuad™

  Biological: Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live · Biological: Comparator: Placebo

• Active comparator
  2

  M-M-R™ II + VARIVAX™

  Biological: Comparator: Varivax · Biological: Comparator: M-M-R II

Interventions

• BiologicalMeasles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live

  a single 0.5 mL subcutaneous injection of V221 at Day 0 and Day 90

  Also known as: ProQuad™

• BiologicalComparator: Placebo

  a single 0.5 mL subcutaneous placebo injection at Day 0

• BiologicalComparator: Varivax

  a single 0.5 mL subcutaneous injection of Varivax at Day 0

• BiologicalComparator: M-M-R II

  a single 0.5 mL subcutaneous injection of M-M-R II at Day 0

Primary outcomes

1. Number of Participants With Postvaccination Varicella Antibody Titer ≥5 Glycoprotein Enzyme-Linked Immunosorbent Assay (gpELISA) Units/mL for Subjects Initially Seronegative (a Titer of <0.6 gpELISA Units/mL) to Varicella at Baseline

   Antibody Response to Varicella at 6 Weeks Postvaccination for Subjects Initially Seronegative (a titer of \<0.6 gpELISA units/mL) to Varicella at Baseline

   Time frame: 6 weeks Postvaccination

Secondary outcomes

1. Number of Participants With Postvaccination Measles ELISA Antibody Titer ≥207.8 mIU/mL

   Antibody Response to Measles at 6 Weeks Postvaccination for Subjects Initially Seronegative (a titer \<207.8 mIU/mL) to Measles at Baseline

   Time frame: 6 weeks Postvaccination

2. Number of Participants With Postvaccination Varicella Antibody Titer ≥5 gpELISA Units/mL for Subjects Initially With Varicella Antibody Titer <1.25 gpELISA Units/mL at Baseline

   Antibody Response to Varicella at 6 Weeks Postvaccination for Subjects Initially With Varicella Antibody Titer \<1.25 gpELISA units/mL at Baseline

   Time frame: 6 weeks Postvaccination

3. Number of Participants With Postvaccination Mumps ELISA Antibody Titer ≥2.0 Ab Units/mL

   Antibody Response to Mumps at 6 Weeks Postvaccination for Subjects Initially Seronegative (a titer \<2.0 Ab Units/mL) to Mumps at Baseline

   Time frame: 6 weeks Postvaccination

4. Number of Participants With Postvaccination Rubella ELISA Antibody Titer ≥10 IU/mL

   Antibody Response to Rubella at 6 Weeks Postvaccination for Subjects Initially Seronegative (a titer \<10 IU/mL) to Rubella at Baseline

   Time frame: 6 weeks Postvaccination

Baseline characteristics

Publications

• Shinefield H, Black S, Digilio L, Reisinger K, Blatter M, Gress JO, Brown ML, Eves KA, Klopfer SO, Schodel F, Kuter BJ. Evaluation of a quadrivalent measles, mumps, rubella and varicella vaccine in healthy children. Pediatr Infect Dis J. 2005 Aug;24(8):665-9. doi: 10.1097/01.inf.0000172902.25009.a1. PubMed 16094217 ↗