NCT04364399

Brief Summary

The purpose of this study is to evaluate the safety and immunogenicity of mumps vaccine in healthy infants aged 8-12months, compared with measles, mumps and rubella combined vaccine, live (MMRV).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
920

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Nov 2020

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 7, 2020

Completed
21 days until next milestone

First Posted

Study publicly available on registry

April 28, 2020

Completed
7 months until next milestone

Study Start

First participant enrolled

November 18, 2020

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 18, 2020

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 7, 2021

Completed
Last Updated

August 18, 2021

Status Verified

August 1, 2021

Enrollment Period

Same day

First QC Date

April 7, 2020

Last Update Submit

August 16, 2021

Conditions

Mumps

Keywords

MumpsMumps vaccinemeasles, mumps and rubella combined vaccine, liveinfants

Outcome Measures

Primary Outcomes (1)

  • The seroconversion rate of hemagglutination inhibition (HI) antibody

    Immunogenicity index, One of the standard to evaluate the immunogenicity of experimental vaccine

    the 30th day after vaccination

Secondary Outcomes (4)

  • The GMT of HI antibody

    the 30th day after vaccination

  • The incidence of the solicited local and systemic adverse reactions

    from day 0 to day 14 after vaccination

  • The incidence of the unsolicited adverse events

    from day 0 to day 30 after immunization

  • The incidence of the serious adverse events

    from day 0 to day 30 after immunization

Study Arms (2)

Experimental group

EXPERIMENTAL

Mumps vaccine, one dose

Biological: Mumps vaccine

Control group

ACTIVE COMPARATOR

measles, mumps and rubella combined vaccine, live, one dose

Biological: measles, mumps and rubella combined vaccine, live

Interventions

Mumps vaccineBIOLOGICAL

One dose of mumps vaccine: 0.5 ml per dose, mumps live virus not less than 3.7 lg CCID50

Experimental group
measles, mumps and rubella combined vaccine, liveBIOLOGICAL

One dose of measles, mumps and rubella combined vaccine, live: 0.5 ml per dose, mumps live virus not less than 4.3 lg CCID50

Control group

Eligibility Criteria

Age8 Months - 12 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Healthy volunteers between 8 - 12 months old;
  • Proven legal identity;
  • Written consent of the guardian(s) of the volunteer

You may not qualify if:

  • Received mumps vaccine or vaccine containing mumps virus;
  • History of mumps;
  • Axillary temperature \> 37.4 °C;
  • History of allergy to any vaccine or vaccine ingredient;
  • History of serious adverse reaction(s) to vaccination, such as urticaria, difficulty in breathing, angioneurotic edema, abdominal pain, etc;
  • Autoimmune disease or immunodeficiency or immunosuppression;
  • Congenital malformation, genetic defects, severe malnutrition;
  • Diagnosed coagulation function abnormal (e.g., coagulation factor deficiency, coagulation disorder, or platelet abnormalities) , or obvious bruising or coagulation disorders;
  • Severe chronic diseases (e.g., severe cardiovascular disease, liver and kidney disease beyond the control of drugs, or cancer)
  • Severe neurological disorders (epilepsy, seizures or convulsions) or psychosis;
  • History of thyroidectomy, absence of spleen, functional absence of spleen, and any condition resulting from absence of spleen or splenectomy;
  • Receipt of any of the following products:
  • Any subunit vaccine or inactivated vaccine within 7 days prior to study entry;
  • Any live attenuated vaccine within 28 days prior to study entry;
  • Any other investigational medicine(s) or vaccine within 30 days prior to study entry;
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hezhou Center for Disease Prevention and Control

Hezhou, Guangxi, 542699, China

Location

MeSH Terms

Conditions

MumpsMeasles

Interventions

Mumps Vaccine

Condition Hierarchy (Ancestors)

Rubulavirus InfectionsParamyxoviridae InfectionsMononegavirales InfectionsRNA Virus InfectionsVirus DiseasesInfectionsParotitisParotid DiseasesSalivary Gland DiseasesMouth DiseasesStomatognathic DiseasesMorbillivirus Infections

Intervention Hierarchy (Ancestors)

Viral VaccinesVaccinesBiological ProductsComplex Mixtures

Study Officials

  • Lirong Huang, Bachelor

    Guangxi Zhuang Autonomous Region Center for Disease Prevention and Control

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 7, 2020

First Posted

April 28, 2020

Study Start

November 18, 2020

Primary Completion

November 18, 2020

Study Completion

April 7, 2021

Last Updated

August 18, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)