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ProQuad vs M-M-R II + Varivax in Healthy Korean Children
NCT00839917Phase 3
Key facts
- Status
- Terminated
- Start
- Feb 2008
- Primary completion
- May 2008
- Sponsor
- Merck & Co.
- Modality
- Live Attenuated Vaccines
- Conditions
- measlesmumpsrubellavaricella (VZV)
01
Overview
Phase 3, randomised, open-label trial of varicella virus vaccine live in measles, mumps, rubella and 1 more (2 arms), sponsored by Merck & Co. Primary endpoints: Percentage of Participants With Measles Antibody Levels ≥255 mIU/mL at 6 weeks, Percentage of Participants With Mumps Antibody Levels ≥10 Mumps Antibody Units/mL at 6 weeks and 2 more. Started Feb 2008; status: terminated.
02
Design
2 arms- Study design
- RandomizedOpen-label
ProQuad
Single administration of ProQuad vaccine
M-M-R II + Varivax
Concomitant administration of M-M-R II and Varivax vaccines
03
Who it enrols
Healthy Korean children with no history of measles, mumps, rubella, varicella, or zoster, and no prior vaccination for these diseases.
04
Endpoints
Primary
Percentage of Participants With Measles Antibody Levels ≥255 mIU/mL
Percentage of Participants With Mumps Antibody Levels ≥10 Mumps Antibody Units/mL
Percentage of Participants With Rubella Antibody Levels ≥10 IU/mL
Percentage of Participants With Varicella-zoster Virus (VZV) Antibody Levels ≥5 Glycoprotein Enzyme-linked Immunosorbent Assay (gpELISA) Units/mL
Secondary
Geometric Mean Titer of Measles Antibodies
Geometric Mean Titer of Mumps Antibodies
Geometric Mean Titer of Rubella Antibodies
Geometric Mean Titer of VZV (gpELISA) Antibodies
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