Immunogenicity and Safety of Two Different Commercial EV71 Vaccines

NCT03873740 | Completed Phase 4

• 1 other identifier: EV71-SD-2018-01
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the immunogenicity and safety of sequential vaccination of two EV71 inactived vaccines in healthy infants aged 6-35 months.

Conditions

Hand, Foot and Mouth Disease

Keywords

Inactivated Enterovirus Type 71 (EV71) Vaccine; Sequential vaccination; Immunity; Safety

Outcome Measures

Primary Outcomes (1)

• The seroconversion rates (SCR) of the EV71 neutralizing antibody calculated based on the cutoff value of 1:8.

  Subjects whose pre-immune EV71 antibody level \< 1:8 and post-immune antibody level ≥ 1:8, or those whose pre-immune antibody level ≥ 1:8 and the increase of post-immune EV71 antibody level ≥ 4 folds are considered seroconverted

  30 days after two doses

Secondary Outcomes (6)

• The incidences of adverse reactions after each does

  0-30 days after each dose

• The incidence of solicited local and general adverse events after each does

  0-7 days after each dose

• Incidence of serious adverse events (SAEs) during the period of safety monitoring

  0-30 days after each dose

• EV71 neutralizing antibody positive rate of each group after two doses.

  30 days after two doses

• The Geometric mean titer (GMT) of the EV71 neutralizing antibody

  30 days after two doses

Study Arms (4)

Single vaccine group A

EXPERIMENTAL

This group receive two doses injection of EV71 inactived vaccines(Vero cells) on Day 0 and 30, and two times of blood sampling on day of 0 and 60 respectively for EV71 neutralizing antibody detection.The vaccine was manufactured by Sinovac Vaccine Technology Co., Ltd.

Biological: EV71 inactived vaccine（Vero cells）

Single vaccine group B

EXPERIMENTAL

This group receive two doses injection of EV71 inactived vaccines(human diploid cells)on Day 0 and 30, two times of blood sampling on day of 0 and 60 respectively for EV71 neutralizing antibody detection.The vaccine was manufactured by Institute of Medical Biology Chinese Academy of Medical Sciences.

Biological: EV71 inactived vaccine（Human diploid cells）

Sequential vaccination group A

EXPERIMENTAL

One dose injection of EV71 inactived vaccines(Vero cells) on Day 0，following one dose of EV71 vaccine(EV71 inactived vaccines(human diploid cells), and two times of blood sampling on day of 0 and 60 respectively for EV71 neutralizing antibody detection.

Biological: EV71 inactived vaccine（Vero cells）; Biological: EV71 inactived vaccine（Human diploid cells）

Sequential vaccination group B

EXPERIMENTAL

One dose injection of EV71 inactived vaccines(human diploid cells)on Day 0，following one does of EV71 vaccine(Sinovac Vaccine Technology Co., Ltd), and two times of blood sampling on day of 0 and 60 respectively for EV71 neutralizing antibody detection.

Biological: EV71 inactived vaccine（Vero cells）; Biological: EV71 inactived vaccine（Human diploid cells）

Interventions

EV71 inactived vaccine（Vero cells） BIOLOGICAL

The EV71 inactived vaccine（Vero cells） was manufactured by Sinovac Biotech Co., Ltd.

Sequential vaccination group A; Sequential vaccination group B; Single vaccine group A

EV71 inactived vaccine（Human diploid cells） BIOLOGICAL

The EV71 inactived vaccine（Human diploid cells） was manufactured by Institute of Medical Biology Chinese Academy of Medical Sciences.

Sequential vaccination group A; Sequential vaccination group B; Single vaccine group B

Eligibility Criteria

• Age: 6 Months - 35 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Healthy volunteer aged 6-35 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.

You may not qualify if:

• Prior vaccination with EV71 vaccine;
• History of hand，foot and mouth disease;
• 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:
• Blood product within 3 months prior to study entry;
• Any live attenuated vaccine within 14 days prior to study entry;
• Any subunit vaccine or inactivated vaccine within 7 days prior to study entry;
• 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;

Sponsors & Collaborators

• Sinovac Biotech Co., Ltd: lead
• Shandong Province Centers for Disease Control and Prevention: collaborator

Study Sites (1)

Rushan City Center for Disease Control and Prevention

Xiacun, Shandong, 264500, China

Location

Related Publications (1)

• Xu Q, Cao Q, Yang W, Liu X, Liu H, Tian X, Li J, Fang X, Jia N, Zeng G, Xu A. Interchangeability of two Enterovirus 71 inactivated vaccines in Chinese children: A phase IV, open-label, and randomized controlled trial. Vaccine. 2020 Mar 10;38(12):2671-2677. doi: 10.1016/j.vaccine.2020.02.013. Epub 2020 Feb 14.

  PMID: 32067817 DERIVED

MeSH Terms

Conditions

Hand, Foot and Mouth Disease

Condition Hierarchy (Ancestors)

Coxsackievirus Infections; Enterovirus Infections; Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Infections

Study Officials

• AIqiang Xu

  Shandong Provincal Center for Disease Control and Preventione

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2019
• First Posted: March 13, 2019
• Study Start: November 6, 2018
• Primary Completion: January 21, 2019
• Study Completion: January 23, 2019
• Last Updated: July 29, 2021

Record last verified: 2019-03

Locations

CN (1)