Status:
COMPLETED
Safety & Immunogenicity of Enterovirus Type 71 Vaccine in Healthy Adults and Children 6-71months
Lead Sponsor:
International Centre for Diarrhoeal Disease Research, Bangladesh
Conditions:
Hand Foot & Mouth Disease
Eligibility:
All Genders
6-45 years
Phase:
PHASE1
PHASE2
Brief Summary
1. Burden: Hand-foot-and-mouth disease (HFMD) characterized by skin rash in extremities, mouth ulcer and fever among \<5 years children.Primarily caused by Enterovirus- predominantly human Enterovirus...
Detailed Description
General objective: 1. To evaluate the safety of EV71 vaccine in adults and in children age 6-71 months 2. To evaluate the immunogenicity of the vaccine in children by assessing the neutralization ant...
Eligibility Criteria
Inclusion
- Bangladeshi healthy adults 18-45yrs and children aged 6-71 months on the day of screening;
- Either sex;
- The participant /parents or guardian of the participant properly informed about the study and having signed the informed consent form (ICF);
- Participant/Parents' or guardian's availability for the entire period of the study and reachability by study staff for post-vaccination follow-up
Exclusion
- Exclusion Criteria for Inoculation of the First Dose:
- Whether the participant should be enrolled should be judged according to the following criteria. The participant cannot participate in the study if any of the following circumstances exists:
- Previous history of hand, foot and mouth disease;
- Allergy history to vaccine or components of the vaccine, previous history of asthma, serious adverse effects of the vaccine such as urticaria, dyspnea, angioneurotic edema or stomachache, etc;
- Congenital malformation or developmental disorder, genetic defect, serious malnutrition, etc;
- Autoimmune disease or immunodeficiency or immunosuppression;
- Severe neurological disorders (epilepsy, convulsion or tic) or family history of mental disease;
- History of thyroidectomy, or asplenia or functional asplenia;
- Severely malnourished children
- Abnormal coagulation functions (such as coagulation factor deficiency, blood coagulation disease and blood platelet disorders) or obvious bruise or blood coagulation disorders diagnosed by the doctors;
- Received immunosuppressant therapy, cytotoxic drug therapy and inhaled corticosteroid therapy (excluding the corticosteroid aerosol therapy for allergic rhinitis and surface corticosteroid therapy for acute non-complicated dermatitis) in the past 6 months;
- Received blood products within 3 months before receiving the investigational vaccine;
- Received other study drugs or vaccines within 30 days before receiving the investigational vaccine;
- Received live attenuated vaccines within 14 days before receiving the investigational vaccine;
- Received subunit or inactivated vaccines within 7 days before receiving the investigational vaccine;
- Various acute diseases or acute exacerbation of chronic diseases within 7 days;
- Fever before vaccine inoculation, axillary temperature \>37.5°C;
- Any other factors which are unsuitable for participation in the clinical trial as judged by the investigator.
- Exclusion Criteria for Inoculation of the Second Dose of Vaccine:
- Any serious adverse event related to the inoculation of the investigational product;
- Hypersensitivity after vaccine inoculation (including urticaria/rash appeared within 30 minutes after inoculation);
- Any confirmed or suspected autoimmune disease or immunodeficiency disease, including human immunodeficiency virus (HIV) infection;
- If acute or newly onset chronic disease occurs during vaccine inoculation;
- The investigator judged that other significant reactions occur (including serious pain, serious swelling, serious activity limitation, continuous hyperthermia, serious headache or other systemic or local reactions);
- The patient develops acute disease when vaccine is inoculated (acute diseases means the moderate or severe disease with or without fever);
- Axillary temperature \>37.5°C when vaccine is inoculated;
- The patient has received subunit inactivated vaccine within 7 days or live attenuated vaccines within 14 days.
Key Trial Info
Start Date :
December 24 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 31 2020
Estimated Enrollment :
430 Patients enrolled
Trial Details
Trial ID
NCT04467541
Start Date
December 24 2019
End Date
January 31 2020
Last Update
February 2 2021
Active Locations (1)
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1
Icddr,B
Dhaka, Bangladesh, 1000