- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03274102
Safety and Immunogenicity of Concomitant Administration of EV71 Vaccine With EPI Vaccines
A Randomized, Controlled Clinical Trial to Evaluate the Safety and Immunogenicity of Concomitant Administration of EV71 Vaccine With Recombinant Hepatitis B Vaccine/Group A Meningococcal Polysaccharide Vaccine
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
Guangdong
-
Dongguan, Guangdong, China, 523129
- Dongguan Municipal Center for Disease Control and Prevention
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Healthy volunteers aged 6 months
- Finished two doses of vaccination (0,1 month) of hepatitis B vaccine prior to study entry
- Proven legal identity
- Guardian(s) of the volunteer should be capable of understanding the written consent form, and such form should be signed before the infant being included into this study
Exclusion Criteria:
- Finished all the three doses vaccination (0,1,6 month) of hepatitis B vaccine prior to study entry
- Prior vaccination of meningococcal polysaccharide vaccine
- Prior vaccination of EV71 vaccine
- Unable to receive vaccination on both arms
- History of hand foot and mouth disease
- Previously tested HBsAg positive
- Mother of the subject had been previously tested HBsAg positive
- History of asthma; history of allergy to any vaccine or vaccine ingredient, or serious adverse reaction(s) to vaccination, such as urticaria, difficulty in breathing, angioneurotic edema, abdominal pain, etc
- Congenital malformation, developmental disorders, genetic defects
- Autoimmune disease or immunodeficiency/immunosuppressive
- Severe nervous system disease or mental illness
- 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) within 6 month prior to study entry
- Receipt of blood product (e.g., immunoglobulin) within 3 months prior to study entry
- Receipt of any other investigational medicine(s) within 30 days prior to study entry
- Receipt of any live attenuated vaccine within 14 days prior to study entry
- Receipt of any subunit vaccine or inactivated vaccine within 7 days prior to study entry
- Acute disease or acute stage of chronic disease within 7 days prior to study entry
- Axillary temperature > 37.0 ℃
- Any other factor that suggesting the volunteer is unsuitable for this study based on the judgement of investigators
Exclusion Criteria of the Second Injection:
Subjects with one of the following 1 to 3 conditions are forbidden to continue vaccination, while the other study steps could be carried out based on the judgement of investigator; for subjects with one of the following 4 to 5 conditions, whether to continue vaccination are determined by the investigator; for subjects with one of the following 6 to 7 conditions, vaccination may be delayed in the time window specified in the study:
- Any serious adverse event that has a causal relationship with the investigated vaccine (except the group II)
- Severe allergic reactions or hypersensitivity after vaccination (including urticaria / rash appear within 30 minutes after vaccination, except the group II )
- Any confirmed or suspected autoimmune disease or immunodeficiency disease (e.g., HIV infection)
- New chronic diseases or acute stage of chronic diseases
- Other reactions (including severe pain, severe swelling, severe activity limitation, persistent hyperthermia, severe headache or other systemic or local reactions) determined by the investigators
- Acute diseases (moderate or severe diseases with or without fever)
- Axillary temperature> 37.0 ℃
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Group I-EV71 vaccine and EPI vaccines
Concomitant administration of EV71 vaccine with EPI vaccines: EV71 Vaccine (intramuscular injection,0.5ml,first
dose)/recombinant hepatitis B vaccine(intramuscular injection,0.5ml)on
day 0 and EV71 Vaccine (injection, 0.5ml,second dose)/ Group A meningococcal polysaccharide vaccine(subcutaneous injection, 150ug) on day 30.
|
|
ACTIVE_COMPARATOR: Group II-EPI vaccine only
Single injection of EPI vaccine: recombinant hepatitis B vaccine (intramuscular injection, 0.5ml) on day 0 and Group A meningococcal polysaccharide vaccine (subcutaneous injection,150ug) on day 30.
|
|
ACTIVE_COMPARATOR: Group III-EV71 vaccine only
EV71 Vaccine only: the first and second dose of EV71 Vaccine (intramuscular injection,0.5ml)
on day 0 and day 30 respectively.
|
The investigated EV17 vaccine was manufactured by Sinovac Biotech Co., Ltd.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The seropositive rate of EV71 neutralizing antibody, anti-HBs and serum bactericidal antibody 1 month after 2 doses of vaccination
Time Frame: 30 days after 2 doses of injection
|
Immunogenicity indicator
|
30 days after 2 doses of injection
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of solicited local or systemic adverse events within 7 days after each dose
Time Frame: 7 days after each dose of injection
|
Safety indicator
|
7 days after each dose of injection
|
Incidence of unsolicited local or systemic adverse events within 30 days after each dose
Time Frame: 30 days after each dose of injection
|
Safety indicator
|
30 days after each dose of injection
|
Incidence of serious adverse events during the period of safety monitoring
Time Frame: 60 days after the first dose injection
|
Safety indicator
|
60 days after the first dose injection
|
The seroconversion rate of EV71 neutralizing antibody, anti-HBs and serum bactericidal antibody(SBA) 1 month after 2 doses of vaccination
Time Frame: 30 days after 2 doses of injection
|
Immunogenicity indicator
|
30 days after 2 doses of injection
|
EV71 neutralizing antibody GMT, anti-HBs GMC and SBA antibody GMT 1 month after 2 doses of vaccination
Time Frame: 30 days after 2 doses of injection
|
Immunogenicity indicator
|
30 days after 2 doses of injection
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Huizhen Zheng, Guangdong Center for Disease Prevention and Control
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PRO-EV71-4003
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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