Safety and Immunogenicity Study of Live Attenuated Mumps Vaccines in Healthy Infants

Mumps Clinical Trial

Official title:

A Blind, Randomized and Controlled Clinical Trial With Live Attenuated Mumps Vaccines in Healthy Infants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02692599
• Other study ID #: PRO-MUMPS-3001
• Status: Completed
• Phase: Phase 3
• First received: February 23, 2016
• Last updated: October 24, 2017
• Start date: January 2016
• Est. completion date: July 15, 2016

Study information

• Verified date: April 2016
• Source: Sinovac (Dalian) Vaccine Technology Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

This study is a randomized, blind, single-center, controlled phase III clinical trial. The purpose of this study is to evaluate the immunogenicity and safety of a live attenuated mumps vaccine manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd. The control vaccine is a commercialized live attenuated mumps vaccine manufactured by Zhejiang VACN bio-pharmaceutical Co. Ltd. All participants are healthy infants between 8 - 18 months old, and will be randomly assigned into experimental group or control group in the ratio 1:1.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1150
• Est. completion date: July 15, 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Months to 18 Months

Eligibility

Inclusion Criteria:

• 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;

Exclusion Criteria:

• 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:

1. Any subunit vaccine or inactivated vaccine within 14 days prior to study entry;

2. Any live attenuated vaccine within 28 days prior to study entry;

3. Any other investigational medicine(s) within 30 days prior to study entry;

4. Blood product (e.g., immunoglobulin) within 3 months prior to study entry;

5. 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;

• Diagnosed coagulation function abnormal (e.g., coagulation factor deficiency, coagulation disorder, or platelet abnormalities);

• Any other factor that suggesting the volunteer is unsuitable for this study based on the opinions of investigators;

• Participants with the following conditions between day 0 - 28 of this study would be included in the full analysis set (FAS), but would be excluded from the per protocol set (PPS):

1. Receipt of any other investigational or unregistered product (drug or vaccine);

2. Receipt of immunosuppressant (corticosteroid dosage that equivalent to or above 0.5 mg prednisone/kg weight/day) for > 14 days consecutively, except for inhalant or locally administrated corticosteroid;

3. Receipt of immunoglobulin and/or blood product;

4. Newly diagnosed autoimmune disease or immunodeficiency (e.g., HIV infection);

Related Conditions & MeSH terms

• Mumps

Intervention

Biological:
• investigational live attenuated mumps vaccine
The investigational vaccine was manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd.
• control live attenuated mumps vaccine
The control vaccine was manufactured by Zhejiang VACN bio-pharmaceutical Co. Ltd.

Locations

Country	Name	City	State
China	Dingxing County Center for Disease Control and Prevention	Baoding	Hebei

Sponsors (1)

Lead Sponsor	Collaborator
Sinovac (Dalian) Vaccine Technology Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The incidences of adverse events (AEs) of each group	AEs occurred within 28 days after injection will be collected.	28 days
Secondary	The incidences of serious adverse events (SAEs) of each group	SAEs occurred within 28 days after injection will be collected.	28 days
Secondary	The post-immune geometric mean titers (GMTs) of susceptible subjects in each group	Subjects whose pre-immune HI antibody level < 1:2 are considered susceptible.	28 days
Secondary	The overall SCRs of each group	Subjects whose pre-immune HI antibody level < 1:2 and post-immune antibody level = 1:2, or those whose pre-immune antibody level = 1:2 and the increase of post-immune HI antibody level = 4 folds are considered seroconverted.	28 days
Secondary	The overall post-immune GMTs of each group	The GMTs of all the subjects in each group.	28 days