NCT02692599

Brief Summary

The purpose of this study is to evaluate the immunogenicity and safety of a live attenuated mumps vaccine in healthy infants between 8 - 18 months old with a commercialized live attenuated mumps vaccine as the control vaccine.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,150

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jan 2016

Shorter than P25 for phase_3

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 23, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 26, 2016

Completed
4 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2016

Completed
Last Updated

October 26, 2017

Status Verified

April 1, 2016

Enrollment Period

2 months

First QC Date

February 23, 2016

Last Update Submit

October 24, 2017

Conditions

Mumps

Keywords

live attenuated mumps vaccinesafetyimmunogenicityinfant

Outcome Measures

Primary Outcomes (1)

  • The seroconversion rates (SCRs) of susceptible subjects in each group

    Subjects whose pre-immune HI antibody level \< 1:2 are considered susceptible; among these subjects, those with post-immune HI antibody level ≥ 1:2 are considered seroconverted.

    28 days

Secondary Outcomes (5)

  • The incidences of adverse events (AEs) of each group

    28 days

  • The incidences of serious adverse events (SAEs) of each group

    28 days

  • The post-immune geometric mean titers (GMTs) of susceptible subjects in each group

    28 days

  • The overall SCRs of each group

    28 days

  • The overall post-immune GMTs of each group

    28 days

Study Arms (2)

Experimental Group

EXPERIMENTAL

* Single intramuscular injection of the investigational vaccine (0.5 ml) on Day 0; * Intervention: investigational live attenuated mumps vaccine;

Biological: investigational live attenuated mumps vaccine

Control Group

ACTIVE COMPARATOR

* Single intramuscular injection of the control vaccine (0.5 ml) on Day 0; * Intervention: control live attenuated mumps vaccine;

Biological: control live attenuated mumps vaccine

Interventions

investigational live attenuated mumps vaccineBIOLOGICAL

The investigational vaccine was manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd.

Experimental Group
control live attenuated mumps vaccineBIOLOGICAL

The control vaccine was manufactured by Zhejiang VACN bio-pharmaceutical Co. Ltd.

Control Group

Eligibility Criteria

Age8 Months - 18 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Healthy volunteer between 8 - 18 months old;
  • Proven legal identity;
  • Guardian(s) of the volunteer should be capable of understanding the written consent form, and such form should be signed before the infant being included into this study;
  • Complying with the requirement of the study protocol;

You may not qualify if:

  • Axillaty temperature \> 37.0 °C;
  • Any significant abnormity of heart, lung, liver, spleen, lymph nodes, or pharynx;
  • Acute disease or acute stage of chronic disease within 7 days prior to study entry;
  • Prior vaccination with mumps vaccine or with history of mumps infection;
  • History of allergy to any vaccine or vaccine ingredient, or serious adverse reaction(s) about vaccination, such as urticaria, difficulty in breathing, angioneurotic edema, abdominal pain, etc;
  • Receipt of any of the following products:
  • Any subunit vaccine or inactivated vaccine within 14 days prior to study entry;
  • Any live attenuated vaccine within 28 days prior to study entry;
  • Any other investigational medicine(s) within 30 days prior to study entry;
  • Blood product (e.g., immunoglobulin) within 3 months prior to study entry;
  • Any immunosuppressant, cytotoxic medicine, or inhaled corticosteroids (except corticosteroid spray for treatment of allergic rhinitis or corticosteroid treatment on surface for acute non-complicated dermatitis) within 6 month prior to study entry;
  • Epilepsy (except febrile seizures), history of seizures or convulsions, or a family history of mental illness;
  • Autoimmune disease or immunodeficiency;
  • Congenital malformation, developmental disorders, or serious chronic diseases (such as Down's syndrome, diabetes, sickle cell anemia or neurological disorders;
  • Severe malnutrition;
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dingxing County Center for Disease Control and Prevention

Baoding, Hebei, 072650, China

Location

MeSH Terms

Conditions

Mumps

Condition Hierarchy (Ancestors)

Rubulavirus InfectionsParamyxoviridae InfectionsMononegavirales InfectionsRNA Virus InfectionsVirus DiseasesInfectionsParotitisParotid DiseasesSalivary Gland DiseasesMouth DiseasesStomatognathic Diseases

Study Officials

  • Jingchen Ma

    Hubei Provincial Center for Disease Control and Prevention

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 23, 2016

First Posted

February 26, 2016

Study Start

January 1, 2016

Primary Completion

March 1, 2016

Study Completion

July 15, 2016

Last Updated

October 26, 2017

Record last verified: 2016-04

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)