A Phase 2 interventional study of EV71 vaccine ([0.5 μg total protein + adjuvant 150 μg AI(OH)3] per dose) and EV71 vaccine ([1 μg total protein + adjuvant 150 μg AI(OH)3] per dose) in Enterovirus Infections, sponsored by Enimmune Corporation. Completed at 4 sites in Taiwan. Open to participants aged 2 Months to 6 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-10-26.
Sponsored by Enimmune Corporation · Phase 2, Interventional, and Prevention
The objectives of this study are to evaluate the immune response and safety profiles of two injections of EV71 vaccine administrated with or without adjuvant Al(OH)3 at 0.5-μg and 1-μg dose in children aged 3 to 6 years old and 2 to 35 months old infants/toddlers.
48 studies on the registry are indexed under Enterovirus Infections; 3 are open to participants now.
This study's enrollment of 140 is close to the median of 132 across 31 interventional studies indexed under Enterovirus Infections.
Browse Enterovirus Infections studies →Enimmune Corporation is the lead sponsor of 5 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
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:
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.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
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.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
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.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
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.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
3 to 6 years
Biological: EV71 vaccine ([0.5 μg total protein + adjuvant 150 μg AI(OH)3] per dose)
3 to 6 years
Biological: EV71 vaccine ([1 μg total protein + adjuvant 150 μg AI(OH)3] per dose)
3 to 6 years
Biological: EV71 vaccine ([1 μg total protein ] per dose)
2 to 35 months
Biological: EV71 vaccine ([0.5 μg total protein + adjuvant 150 μg AI(OH)3] per dose)
2 to 35 months
Biological: EV71 vaccine ([1 μg total protein + adjuvant 150 μg AI(OH)3] per dose)
2 to 35 months
Biological: EV71 vaccine ([1 μg total protein ] per dose)
Serum neutralizing antibody titers (NT) induced by the EV71 vaccine
Evaluate the immunogenicity change of serum neutralizing antibody titers induced by the EV71 vaccine from baseline on Day 56
Time frame: Day 56
Seroconversion rate (SCR) based on neutralizing antibody titers
Evaluate the immunogenicity change of SCR from baseline on Day 56
Time frame: Day 56
Serum neutralizing antibody titers (NT) induced by the EV71 vaccine
Evaluate the immunogenicity change of serum neutralizing antibody titers induced by the EV71 vaccine from baseline on Day 28
Time frame: Day 28
Serum neutralizing antibody titers (NT) induced by the EV71 vaccine
Evaluate the immunogenicity change of serum neutralizing antibody titers induced by the EV71 vaccine from baseline on Day 196
Time frame: Day 196
Seroconversion rate (SCR) based on neutralizing antibody titers
Evaluate the immunogenicity change of SCR from baseline on Day 28
Time frame: Day 28
Seroconversion rate (SCR) based on neutralizing antibody titers
Evaluate the immunogenicity change of SCR from baseline on Day 196
Time frame: Day 196
Solicited adverse events
Time frame: 7 days after each vaccination
Unsolicited adverse events
Time frame: 28 days after each vaccination
The occurrence of overall adverse events (AEs) and serious adverse event (SAEs)
Time frame: Day 0 to Day 196
The occurrence of EV 71 breakthrough infection after Visit 3
Time frame: Day 57 to Day 364
Serum neutralizing antibody titers (NT) induced by the EV71 vaccine
Evaluate the immunogenicity of serum neutralization antibody titer induced by the EV 71 vaccine on Day 364
Time frame: Day 364
Plan to share: No
Ran from Jul 2016 to primary completion in Aug 2017, 13 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: EV71
Enimmune Corporation