A Study to Evaluate the Efficacy, Immunogenicity and Safety of an EV71 Vaccine in Healthy Infants and Children

NCT ID: NCT05099029

Last Updated: 2024-08-28

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 3982 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-27
• Study Completion Date: 2024-12-31

Brief Summary

The objectives of this study are to evaluate the EV71vaccine efficacy, immune response and safety profiles after two injections of the cell culture-based inactivated EV71 vaccine with adjuvant Al(OH)3 administrated in pediatric population aged 2 months to 6 years old.

Detailed Description

The clinical trial designed in this Study is a placebo-controlled, double-blinded Phase III and is aimed to evaluate the vaccine efficacy, safety, immunogenicity and immune persistence of cell culture-based inactivated EV71 vaccine in children age of 2 months to <6 years old. Two doses of Alum-adjuvanted 1.0 μg per dose of EV71 vaccine candidate will be administrated to subjects. The efficacy will be evaluated within a two year period after receiving 2-regimen vaccination by comparing the EV71-associated disease rates between the vaccine and placebo groups. Whereas, the immunogenicity will be assessed on Day 56 and Day 196, and the immune persistence will be evaluated on Day 392. Safety will be followed up to Day 392.

Conditions

Enterovirus Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

EV71 Vaccine

Group Type: EXPERIMENTAL

EV71 vaccine

Intervention Type: BIOLOGICAL

EV71 vaccine (\[1 μg total protein + adjuvant 150 μg AI(OH)3\] per dose) Two vaccinations at 28 days apart

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: BIOLOGICAL

Placebo (\[ adjuvant 150 μg AI(OH)3\] per dose) Two vaccinations at 28 days apart

Interventions

EV71 vaccine

EV71 vaccine (\[1 μg total protein + adjuvant 150 μg AI(OH)3\] per dose) Two vaccinations at 28 days apart

Intervention Type: BIOLOGICAL

Placebo

Placebo (\[ adjuvant 150 μg AI(OH)3\] per dose) Two vaccinations at 28 days apart

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

1. Healthy children aged from 2 months to 6 years old (i.e. >= 2 months old and < 7 years old) at the time of first vaccination.

2. Subject's guardians are able and willing to comply with study procedures and provide the signed informed consent.

3. Subject is able and can comply with the requirements of the protocol.

4. Subject with body temperature <= 38℃.

Exclusion Criteria

1. Subject with previous known Enterovirus 71 (EV71) infection or investigational EV71 vaccination.

2. Subject with a history of herpangina, hand-foot-mouth disease, and acute hemorrhagic conjunctivitis associated with enterovirus infection in the past 30 days.

3. Subject with a history of hypersensitivity to vaccines, or a history of allergic disease or reactions likely to be exacerbated by any component of the vaccine.

4. Subject under 2 years old with gestation <34weeks or a birth weight <2200g.

5. History of epilepsy, seizures or non-febrile convulsions that may affect subject participation in the study in the opinion of the investigator.

6. Severe malnutrition or dysgenopathy at the screening visit.

7. Major congenital defects or serious chronic illness, including perinatal brain damage at the screening visit.

8. Subject diagnosed of having autoimmune disease (e.g., celiac disease, type I diabetes, lupus (SLE), juvenile dermatomyositis, scleroderma, juvenile idiopathic arthritis (JIA), immune (or idiopathic) thrombocytopenia purpura) that may affect subject participation in the study in the opinion of the investigator.

9. Bleeding disorder diagnosed by a doctor or significant bruising or hemostatic difficulties with IM injections or blood draws.

10. Any acute febrile illness 3 days prior to administrating the first vaccination.

11. Use of any investigational product (including drug, vaccine) within 30 days prior to vaccination or planned use during Visit 1 to Visit 4 (Day 0 to Day 196).

12. Administration of any vaccine within 14 days prior to each study vaccination.

13. Use of immunoglobulins or any blood products within 3 months prior to vaccination.

14. Chronic administration (defined as > 14 day of continuous use) of systemic immunosuppressants, other systemic immunomodulators, or systemic corticosteroids within 6 months prior to vaccination.

15. Any condition that in the opinion of the investigator may interfere with the evaluation of study objectives.

16. Subject with any confirmed or suspected immunodeficiency.

• Minimum Eligible Age: 2 Months
• Maximum Eligible Age: 71 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Enimmune Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chin-Fen Yang

Role: STUDY_DIRECTOR

Enimmune Corporation

Locations

Changhua Christian Hospital

Changhua, , Taiwan

National Taiwan University Hospital HsinChu Branch

Hsinchu, , Taiwan

China Medical University Hospital

Taichung, , Taiwan

Taichung Veterans General Hospital

Taichung, , Taiwan

National Taiwan University Hospital

Taipei, , Taiwan

Taipei Veterans General Hospital

Taipei, , Taiwan

Linkou Chang Gung Memorial Hospital

Taoyuan District, , Taiwan

Pasteur Institute of HCMC

Ho Chi Minh City, , Vietnam

Countries

Taiwan; Vietnam

Other Identifiers

EV-BR1701

Identifier Type: -

Identifier Source: org_study_id