Safety, Tolerability, and Immunogenicity of 3 Frozen ProQuad Consistency Lots in Healthy Children (V221-012)(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 3,927 is above 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 Lot 1

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

• Experimental
  2

  ProQuad Lot 2

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

• Experimental
  3

  ProQuad Lot 3

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

• Active comparator
  4

  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 at Day 0

  Also known as: ProQuad

• BiologicalComparator: Varivax

  A Single 0.5 mL subcutaneous injection at Day 0

• BiologicalComparator: M-M-R II

  A Single 0.5 mL subcutaneous injection at Day 0

Primary outcomes

1. Number of Participants With Postvaccination Varicella Antibody Titer ≥ 5 Glycoprotein Enzyme-Linked Immunosorbent Assay (gpELISA) Units/mL

   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

2. Number of Participants With Postvaccination Measles Enzyme-Linked Immunosorbent Assay (ELISA) Antibody Titer ≥ 120 mIU/mL

   Antibody Response to Measles at 6 Weeks Postvaccination for Subjects Initially Seronegative (a titer \< 120 mIU/mL) to Measles at Baseline

   Time frame: 6 weeks Postvaccination

3. Number of Participants With Postvaccination Mumps ELISA Antibody Titer ≥ 10 Ab Units/mL

   Antibody Response to Mumps at 6 Weeks Postvaccination for Subjects Initially Seronegative (a titer \< 10 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

5. Antibody Response to Varicella for Subjects Initially With Varicella Antibody Titer < 1.25 gpELISA Units/mL at Baseline - Geometric Mean Titer

   Postvaccination observed Geometric Mean Titer of antibody to Varicella

   Time frame: 6 weeks Postvaccination

6. Antibody Response to Measles for Subjects Initially Seronegative (a Titer < 120 mIU/mL) to Measles at Baseline - Geometric Mean Titer

   Postvaccination observed Geometric Mean Titer of antibody to Measles.

   Time frame: 6 weeks Postvaccination

7. Antibody Response to Mumps for Subjects Initially Seronegative (a Titer < 10 Ab Units/mL) to Mumps at Baseline - Geometric Mean Titer

   Postvaccination observed Geometric Mean Titer of antibody to Mumps.

   Time frame: 6 weeks Postvaccination

8. Antibody Response to Rubella for Subjects Initially Seronegative (a Titer < 10 IU/mL) to Rubella at Baseline - Geometric Mean Titer

   Postvaccination observed Geometric Mean Titer of antibody to Rubella

   Time frame: 6 weeks Postvaccination

9. Number of Participants With Serious Vaccine-related CAEs

   Subjects with a serious vaccine-related CAE (an AE which is assessed by an investigator/qualified physician as being related to study vaccine and results in death, persistent or significant disability/incapacity, prolongs an existing inpatient hospitalization, is life-threatening, a congenital anomaly/birth defect, a cancer, or an overdose).

   Time frame: 6 weeks Postvaccination

Baseline characteristics

Publications

• Lieberman JM, Williams WR, Miller JM, Black S, Shinefield H, Henderson F, Marchant CD, Werzberger A, Halperin S, Hartzel J, Klopfer S, Schodel F, Kuter BJ; Consistency Lot Study Group for ProQuad. The safety and immunogenicity of a quadrivalent measles, mumps, rubella and varicella vaccine in healthy children: a study of manufacturing consistency and persistence of antibody. Pediatr Infect Dis J. 2006 Jul;25(7):615-22. doi: 10.1097/01.inf.0000220209.35074.0b. PubMed 16804432 ↗