Status:
COMPLETED
Safety and Immunogenicity of Concomitant Administration of EV71 Vaccine With EPI Vaccines
Lead Sponsor:
Sinovac Biotech Co., Ltd
Collaborating Sponsors:
Guangdong Center for Disease Prevention and Control
Conditions:
Hand, Foot and Mouth Disease
Eligibility:
All Genders
6-6 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to evaluate the safety and immunogenicity of concomitant administration of EV71 vaccine with recombinant hepatitis B vaccine/Group A meningococcal polysaccharide vaccine.
Detailed Description
This study is an open-label, single-center, randomized, comparative phase IV clinical trial. The purpose of this study is to evaluate the safety and immunogenicity of concomitant administration of EV7...
Eligibility Criteria
Inclusion
- 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
- 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 ℃
Key Trial Info
Start Date :
April 22 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2017
Estimated Enrollment :
780 Patients enrolled
Trial Details
Trial ID
NCT03274102
Start Date
April 22 2017
End Date
November 1 2017
Last Update
July 29 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Dongguan Municipal Center for Disease Control and Prevention
Dongguan, Guangdong, China, 523129