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

A Randomized, Controlled, Multicenter Phase 4 Clinic Trial to Evaluate the Safety and Immunogenicity of Simultaneously Administration of EV71 Vaccine and Influenza Vaccine (Split Virion),Inactivated

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04091880

Enrollment

1134

Registered

2019-09-17

Start date

2019-09-26

Completion date

2021-08-10

Last updated

2022-10-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Enterovirus Infections, Influenza

Keywords

EV71 vaccine, influenza vaccine, simultaneously administration

Brief summary

Subjects will be recruited and divided into 3 groups: 1. Experimental Group (378 subjects): combined immunization of EV71 vaccine and influenza vaccine; 2. Control Group A (378 subjects): EV71 vaccine only; 3. Control Group B (378 subjects): influenza vaccine only; All blood samples will be collected before and one month after vaccinatioin. The immunogenicity and safety of both experimental and control groups will be compared and the data be analyzed.

Detailed description

To further evaluate the feasibility of simultaneously administration of EV71 vaccine and flu vaccine, we design this clinical trial to test its immunogenicity and safety. 1134 subjects aged from 6 to 11 months old are divided into one experimental group and two control groups (control group A and B). 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. Blood samples are collected before the first vaccination, and one month following the second vaccination. 378 subjects from the control group A will be only administrated with two doses of EV71 vaccine (0.5 ml) (1 month apart). Blood samples are collected before the first vaccination, and one month following the second vaccination. 378 subjects from the control group B will be only administrated with two doses of influenza vaccine (0.25 ml) (1 month apart). Blood samples are collected before the first vaccination, and one month following the second vaccination. To evaluate the immunogenicity, we will detect and compare the neutralization antibody levels, the seroprotection rates, and antibody geometric mean concentrations. The safety of all groups will be monitored as well.

Interventions

BIOLOGICALEV71 vaccine and influenza vaccine

simultaneously administrated with EV71 vaccine and influenza vaccine

BIOLOGICALEV71 vaccine

administrated with EV71 vaccine only

BIOLOGICALinfluenza vaccine

administrated with influenza vaccine only

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

6 Months to 11 Months

Healthy volunteers

Yes

Inclusion criteria

* 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℃

Exclusion criteria

* 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.

Design outcomes

Primary

Measure	Time frame	Description
Seroconversion rate I	Baseline (before vaccination) and 1 month after the last dose	the rate of positive seroconversion against EV71
Seroconversion rate II	Baseline (before vaccination ) and 1 month after the last dose	the rate of positive seroconversion against Influenza A (H3N2, H1N1) and B Type viruses
Geometric mean titer (GMT) I	Baseline (before vaccination) and 1 month after the last dose	Measure neutralizing antibody titers against EV71
Geometric mean titer (GMT) II	Baseline (before vaccination) and 1 month after the last dose	Measure neutralizing antibody titers against Influenza A (H3N2, H1N1) and B Type viruses

Secondary

Measure	Time frame	Description
adverse events following vaccination	6 months	analyse the numbers and rates of participants who experience adverse events following immunization

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026