A Phase I, Safety Study of Live Attenuated Mumps (F-genotype) Vaccine (Human Diploid Cell, KMB-17) in Chinese Children

PHASE1CompletedINTERVENTIONAL
Enrollment

300

Participants

Timeline

Start Date

October 31, 2012

Primary Completion Date

April 30, 2013

Study Completion Date

April 30, 2013

Conditions
Mumps
Interventions
BIOLOGICAL

3.50±0.25logCCID50/ml

Attenuated Mumps vaccine (KMB-17) of 3.50±0.25logCCID50/ml in adults (16-59 years old),children (5-15 years old or 2-4 years old) and infants (8-23 months old) on day 0.

BIOLOGICAL

4.25±0.25 logCCID50/ml

Attenuated Mumps vaccine (KMB-17) of 4.25±0.25 logCCID50/ml in adults (16-59 years old),children (5-15 years old or 2-4 years old) and infants (8-23 months old) on day 0.

BIOLOGICAL

5.00±0.25 logCCID50/ml

Attenuated Mumps vaccine (KMB-17) of 5.00±0.25 logCCID50/ml in adults (16-59 years old),children (5-15 years old or 2-4 years old) and infants (8-23 months old) on day 0.

BIOLOGICAL

0 logCCID50/ml

0 logCCID50/ml in adults (16-59 years old),children (5-15 years old or 2-4 years old) and infants (8-23 months old) on day 0.

BIOLOGICAL

Attenuated Mumps vaccine (Zhe Jiang Vacn Bio-pharmaceutical Co., LTD.; NO.20110528-1)

Attenuated Mumps vaccine (Zhe Jiang Vacn Bio-pharmaceutical Co., LTD.; NO.20110528-1) in children (2-4 years old) and infants (8-23 months old) on day 0.

Trial Locations (1)

050021

Hebei Provincial Center for Diseases Control and Prevention, Shijiazhuang

All Listed Sponsors
collaborator

Hebei Provincial Center for Diseases Control and Prevention

UNKNOWN

lead

Institute of Medical Biology, Chinese Academy of Medical Sciences

OTHER

NCT01712906 - A Phase I, Safety Study of Live Attenuated Mumps (F-genotype) Vaccine (Human Diploid Cell, KMB-17) in Chinese Children | Biotech Hunter | Biotech Hunter