NCT04591405View on ClinicalTrials.gov

Phase II/III of Live Attenuated Mumps (F-genotype) Vaccine (Human Diploid Cell, KMB-17) in Healthy Children Aged 5-11

PHASE2/PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

11,999

Participants

Timeline

Start Date

October 12, 2020

Primary Completion Date

July 1, 2024

Study Completion Date

July 1, 2024

Conditions
Epidemic Parotitis, Mumps
Interventions
BIOLOGICAL

Attenuated Mumps vaccine (KMB-17) in phase II and III

≥4.3logCCID50/ml Attenuated Mumps vaccine (KMB-17)\[≥4.3 logCCID50/ml\] in 360 children (5-11 years old) on 0 day

BIOLOGICAL

Placebo in phase II

Freeze-dried stabilizer and diluent without mumps virus antigen in 360 children (5-11 years old) on 0 day

BIOLOGICAL

Attenuated Mumps vaccine (KMB-17) in phase III

≥4.3logCCID50/ml Attenuated Mumps vaccine (KMB-17)\[≥4.3 logCCID50/ml\] in 5640 children (5-11 years old) on 0 day

BIOLOGICAL

Placebo in phase III

Freeze-dried stabilizer and diluent without mumps virus antigen in 5640 children (5-11 years old) on 0 day

Trial Locations (1)

430079

Hubei Provincial Center for Disease Control and Prevention, Wuhan

All Listed Sponsors
collaborator

Hubei Provincial Center for Disease Control and Prevention

OTHER

lead

Institute of Medical Biology, Chinese Academy of Medical Sciences

OTHER