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Phase II of Live Attenuated Mumps (F-genotype) Vaccine (Human Diploid Cell, KMB-17) in Chinese Infants

NCT03133923 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 1080

Last updated 2023-10-10

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 preliminary test results showed that the vaccine possessed good immunogenicity and good antigenic cross-reactivity. The application of this vaccine will provide more effective means to prevent and control of mumps epidemic.

Conditions

  • Epidemic Parotitis,Mumps

Interventions

BIOLOGICAL

≥3.0 lgCCID50/mlbut <3.5lgCCID50/ml Live Attenuated Mumps Vaccine (Human Diploid Cell) in infants(8-24 months old)

≥3.0 lgCCID50/ml but \<3.5lgCCID50/ml;Live Attenuated Mumps (F-genotype) Vaccine (Human Diploid Cell, KMB-17) in 360 infants(aged 8-24 months ) on 0 day

BIOLOGICAL

≥4.5 lgCCID50/ml Live Attenuated Mumps Vaccine (Human Diploid Cell) in infants(8-24 months old)

≥4.5CCID50/ml;Live Attenuated Mumps (F-genotype) Vaccine (Human Diploid Cell, KMB-17) in 360 infants(aged 8-24 months ) on 0 day

BIOLOGICAL

Measles and Mumps Combined Vaccine，Live(SIBP)( positive control)

Measles and Mumps Combined Vaccine，Live(SIBP) in 360 infants(aged 8-24 months ) 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

  • Beifang Yang, PhD · Hubei Provincial Center for Disease Control and Prevention

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
8 Months
Max Age
24 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-05-20
Primary Completion
2017-11-10
Completion
2024-07-01

Countries

  • China

Study Locations

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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 NCT03133923 on ClinicalTrials.gov