Evaluation of the Safety and Immunogenicity of Simultaneously Administration of EV71 Vaccine and Influenza Vaccine

NCT04091880 | Completed Phase 4 DMC

• 1 other identifier: EV71-Flu-Combine-01
• Study Type: interventional
• Target: 1,134
• Locations: 1 country
• Sites: 1

Brief Summary

Subjects will be recruited and divided into 3 groups:

1. 1.Experimental Group (378 subjects): combined immunization of EV71 vaccine and influenza vaccine;
2. 2.Control Group A (378 subjects): EV71 vaccine only;
3. 3.Control Group B (378 subjects): influenza vaccine only;

Conditions

Enterovirus Infections; Influenza

Keywords

EV71 vaccine; influenza vaccine; simultaneously administration

Outcome Measures

Primary Outcomes (4)

• Seroconversion rate I

  the rate of positive seroconversion against EV71

  Baseline (before vaccination) and 1 month after the last dose

• Seroconversion rate II

  the rate of positive seroconversion against Influenza A (H3N2, H1N1) and B Type viruses

  Baseline (before vaccination ) and 1 month after the last dose

• Geometric mean titer (GMT) I

  Measure neutralizing antibody titers against EV71

  Baseline (before vaccination) and 1 month after the last dose

• Geometric mean titer (GMT) II

  Measure neutralizing antibody titers against Influenza A (H3N2, H1N1) and B Type viruses

  Baseline (before vaccination) and 1 month after the last dose

Secondary Outcomes (1)

• adverse events following vaccination

  6 months

Study Arms (3)

experimental group

EXPERIMENTAL

378 subjects from the experimental group will be simultaneously administrated with one dose of EV71 vaccine (0.5 ml) and one dose of influenza vaccine (0.25 ml). One month later, they are going to receive a second dose of EV71 vaccine and influenza vaccine, simultaneously.

Biological: EV71 vaccine and influenza vaccine

control group A

ACTIVE COMPARATOR

378 subjects from the control group A will be only administrated with two doses of EV71 vaccine (0.5 ml) (1 month apart).

Biological: EV71 vaccine

control group B

ACTIVE COMPARATOR

378 subjects from the control group B will be only administrated with two doses of influenza vaccine (0.25 ml) (1 month apart).

Biological: influenza vaccine

Interventions

EV71 vaccine and influenza vaccine BIOLOGICAL

simultaneously administrated with EV71 vaccine and influenza vaccine

experimental group

EV71 vaccine BIOLOGICAL

administrated with EV71 vaccine only

control group A

influenza vaccine BIOLOGICAL

administrated with influenza vaccine only

control group B

Eligibility Criteria

• Age: 6 Months - 11 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• subjects aged from 6-11 months old at the date of recruitment;
• with informed consent signed by parent(s) or guardians;
• parent(s) or guardians are able to attend all planned clinical appointments and comply with all study instructions;
• subjects not receive any vaccination within 14 days at the date of recruitment;
• subjects have not been vaccinated with EV71 vaccine, seasonal flu vaccine;
• subjects with no medical history of EV71 infection;
• axillary temperature ≤37.0℃

You may not qualify if:

• subject who has a medical history with Hypersensitiveness, eclampsia, epilepsy, cerebropathia and neurological illness;
• allergic to any ingredient of vaccine or with allergy history to any vaccine;
• subjects with immunodeficency or suspected impairment of immunologic function (e.g. caused by HIV), or subjects are in the process of immunosuppressor therapy(Taking orally injecting of steroid hormone);
• administration of immunoglobulins within 30 days prior to this study;
• acute febrile disease(temperature ≥ 37.0°C) or infectious disease;
• have a clearly diagnosed history of thrombocytopenia or other coagulopathy,
• may cause contraindications for subcutaneous injection;
• any serious chronic illness, acute infectious diseases, or respiratory diseases;
• severe cardiovascular disease, liver and kidney diseases or diabetes mellitus with complications;
• any kind of infectious, purulent, or allergic skin diseases;
• any other factor that makes the investigator determines the subject is unsuitable for this study.

Sponsors & Collaborators

• China National Biotec Group Company Limited: lead
• Zhejiang Provincial Center for Disease Control and Prevention: collaborator
• Henan Center for Disease Control and Prevention: collaborator
• Guizhou Center for Disease Control and Prevention: collaborator
• Wuhan Institute of Biological Products Co., Ltd: collaborator
• Changchun Institute of Biological Products Co., Ltd.: collaborator
• Peking University: collaborator
• National Institutes for Food and Drug Control, China: collaborator

Study Sites (1)

Zhejiang provincial center for disease control and prevention

Hangzhou, Zhejiang, 310051, China

Location

Related Publications (1)

• Chen Y, Xiao Y, Ye Y, Jiang F, He H, Luo L, Chen H, Shi L, Mu Q, Chen W, Guo X, Zhang M, Li J, Guan Q, Chen Z, Yang X. Immunogenicity and safety of an inactivated enterovirus 71 vaccine coadministered with trivalent split-virion inactivated influenza vaccine: A phase 4, multicenter, randomized, controlled trial in China. Front Immunol. 2022 Dec 8;13:1080408. doi: 10.3389/fimmu.2022.1080408. eCollection 2022.

  PMID: 36569946 DERIVED

MeSH Terms

Conditions

Enterovirus Infections; Influenza, Human

Interventions

Influenza Vaccines

Condition Hierarchy (Ancestors)

Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Orthomyxoviridae Infections; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Hanqing He

  Zhejiang Provincial Center for Disease Control and Prevention

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2019
• First Posted: September 17, 2019
• Study Start: September 26, 2019
• Primary Completion: January 6, 2020
• Study Completion: August 10, 2021
• Last Updated: October 12, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)