Safety and Immunogenicity of Concomitant Administration of EV71 Vaccine With Expanded Programme on Immunization Vaccines

Sinovac

Status and phase: Completed; Phase 4

Conditions: Hand, Foot and Mouth Disease

Treatments: Biological: EV71 Vaccine only; Biological: Concomitant administration of EV71vaccine with EPI vaccines; Biological: Single injection of EPI vaccine

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04111432

EV71-SN-2019-01

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and immunogenicity of concomitant administration of EV71 vaccine with measles mumps, and rubella combined live attenuated vaccine/ encephalitis live attenuated vaccine.

Full description

This study is an open-label, single-center, randomized, comparative phase IV clinical trial. The purpose of this study is to evaluate the safety andimmunogenicity of concomitant administration of EV71 vaccine manufactured by Sinovac (Beijing) Vaccine Technology Co., Ltd. with measles mumps, and rubella combined live attenuated vaccine/ encephalitis live attenuated vaccine. 360 healthy infants of 8 months old as participants are randomly assigned into three experimental groups in the ratio 1:1:1. The group I receive EV71 Vaccine (first dose)&measles mumps, and rubella combined live attenuated vaccine on day 0 and EV71 vaccine (second dose)&encephalitis live attenuated vaccine on day 30. The group II receive measles mumps, and rubella combined live attenuated vaccine on day 0 and encephalitis live attenuated vaccine on day 30. The group III receive the first and second dose of EV71 Vaccine on day 0 and day 30 respectively.

Enrollment: 372 patients

Sex: All

Ages: 8+ months old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy volunteer aged ≥ 8 months;
• Proven legal identity;
• Guardians of the participants should be capable of understanding the written consent form, and such form should be signed before the infant being included into this study.

Exclusion criteria

• Prior vaccination with EV71 vaccine;

• Prior vaccination with MMR vaccine or vaccine including mumps or measles or mumps or rubella vaccine components;

• Prior vaccination with Encephalitis B vaccine；

• Cannot be vaccinated with both arms at the same time；

• History of hand，foot and mouth disease;

• History of measles or mumps or rubella or encephalitis B；

• Allergy to gentamicin; history of allergy to any vaccine or vaccine ingredient, or serious adverse reaction(s) to vaccination, such as urticaria,difficulty in breathing, angioneurotic edema, pain, etc;

• Congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc;

• Autoimmune diseases or immunodeficiency/immunosuppression;

• Severe neurological disorders (epilepsy, convulsions or convulsions) or psychosis;

• History of thyroidectomy, absence of spleen, functional absence of spleen, and any circumstances leading to absence of spleen or splenectomy;

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

• 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) in the past 6 months;

• Receipt of any of the following products:

  1. Blood product within 3 months prior to study entry;
  2. Any live attenuated vaccine within 14 days prior to study entry;
  3. Any subunit vaccine or inactivated vaccine within 7 days prior to study entry;
  4. Any other study drugs within 30 days prior to study entry;

• Acute disease or acute stage of chronic disease within 7 days prior to study entry;

• Axillary temperature > 37.0#;

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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372 participants in 3 patient groups

Group I-EV71 and EPI vaccines Concomitant administration

Experimental group

Description:

EV71 Vaccine (intramuscular injection,0.5ml,first dose)/measles mumps, and rubella combined live attenuated vaccine (subcutaneous injection,0.5ml) on day 0 and EV71 Vaccine (intramuscular injection, 0.5ml,second dose)/ encephalitis live attenuated vaccine (subcutaneous injection, 0.5ml) on day 30

Treatment:

Biological: Concomitant administration of EV71vaccine with EPI vaccines

Group II-EPI vaccine only Single injection of EPI vaccine:

Active Comparator group

Description:

measles mumps, and rubella combined live attenuated vaccine (subcutaneous injection,0.5ml) on day 0 and encephalitis live attenuated vaccine (subcutaneous injection, 0.5ml) on day 30

Treatment:

Biological: Single injection of EPI vaccine

Group III-EV71 vaccine only EV71 Vaccine only

Active Comparator group

Description:

the first and second dose of EV71 Vaccine (intramuscular injection,0.5ml) on day 0 andday 30 respectively

Treatment:

Biological: EV71 Vaccine only