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

NCT04591405 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 11999

Last updated 2023-10-11

No results posted yet for this study

Summary

Mumps is an acute infectious respiratory disease caused by the mumps virus (MuV), which occurs mainly in children and adolescents. Its main clinical symptoms were parotid gland suppurative swelling and pain with fever. The pathological changes and harm caused by mumps was not only confined to the parotid gland, on the contrary, the social harm caused by serious complications cannot be ignored. As mumps is a vaccine-preventable infectious disease, vaccination is a fundamental strategy for controlling mumps. So far, there are 13 genotypes of MuV. Based on the analysis of molecular epidemiology, the main epidemic strain of MuV in China was the F genotype. The commonly used vaccine strains represented only a small number of known genotypes, e.g. Jeryl-Lynn (JL) and Rubini strains, which belong to type A, Urabe strain belongs to type B, and L-Zagreb strains belongs to type D. Virus seed of Live Attenuated Mumps Vaccine (Human diploid cell) developed by the institute was SP-A strain, which was the first separation and preparation of the attenuated mumps viruses in China. SP-A belongs to F genotype, which was the domestic epidemic genotype. In addition, the cell substrate prepared for vaccine was human diploid cell (KMB-17 strain), which is much safer to use. The results of phase I and II clinical trials showed that the vaccine possessed good immunogenicity and good antigenic cross-reactivity in infants (8-24 months old).

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

Sponsors & Collaborators

  • Hubei Provincial Center for Disease Control and Prevention

    collaborator OTHER

  • Institute of Medical Biology, Chinese Academy of Medical Sciences

    lead OTHER

Principal Investigators

  • Qihan Li · Institute of Medical Biology, Chinese Academy of Medical Sciences

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
11 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-10-12
Primary Completion
2024-07-01
Completion
2024-07-01

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04591405 on ClinicalTrials.gov