A Phase 4 interventional study of EV71 +SIV and EV71 in Seasonal Influenza and Hand, Foot and Mouth Disease, sponsored by Zhejiang Provincial Center for Disease Control and Prevention. Completed at 1 site in China. Open to participants aged 6 Months to 11 Months. Per ClinicalTrials.gov, last updated 2022-07-13.
Sponsored by Zhejiang Provincial Center for Disease Control and Prevention · Phase 4, Interventional, and Prevention
The purpose of this study is to evaluate the Immunogenicity and safety of the simultaneously vaccination of Inactivated Enterovirus 71 Vaccine (EV71) and seasonal influenza vaccine(SIV)
Main subjects:
The seroconversion rate for each antigen when EV71 is administrated with SIV
Secondary subjects:
The positive rate of antibody for each antigen when EV71 is administrated with SIV The safety for each antigen when EV71 is administrated with SIV
59 studies on the registry are indexed under Hand, Foot and Mouth Disease; 10 are open to participants now.
This study's enrollment of 1,134 is above the median of 467 across 50 interventional studies indexed under Hand, Foot and Mouth Disease.
Browse Hand, Foot and Mouth Disease studies →Zhejiang Provincial Center for Disease Control and Prevention is the lead sponsor of 13 studies on the registry; 5 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Known allergy to any constituent of the vaccine.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Give 2 doses of Inactivated Enterovirus 71 Vaccine (EV71) and seasonal influenza vaccine(SIV) simultaneously with 28 days apart
Biological: EV71 +SIV
Give 2 doses of Inactivated Enterovirus 71 Vaccine (EV71) with 28 days apart
Biological: EV71
Give 2 doses of seasonal influenza vaccine(SIV) simultaneously with 28 days apart
Biological: SIV
Give 2 doses of EV71 +SIV, get 2 blood samples before the first dose and 28-43 days after the last dose.
Give 2 doses of EV71 , get 2 blood samples before the first dose and 28-43 days after the last
Give 2 doses of SIV , get 2 blood samples before the first dose and 28-43 days after the last
immunogenicity evaluation
The positive rate of antibody
Time frame: change from baseline antibody concentration at 28 days after the last dose
safety evaluation: The occurrence of adverse events
The occurrence of adverse events
Time frame: up to 30 days after every injection
Plan to share: No
No publications or documents are linked to this record.
Ran from Sep 2019 to primary completion in Jun 2021, 21 months.
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This study is completed, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.
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Hand, Foot and Mouth Disease →
Zhejiang Provincial Center for Disease Control and Prevention