A Phase 1 interventional study of S.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine and S.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine in Dysentery and Dysentery, Bacillary, sponsored by Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd. Completed at 1 site in China. Open to participants aged 3 Months and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-10-17.
Sponsored by Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd (part of Chongqing Zhifei Biological Products Co., Ltd.) · Phase 1, Interventional, and Prevention
The purpose of this study is to evaluate safety of S.flexneriza-S.sonnei Bivalent Conjugate Vaccine in healthy volunteers aged above 3 Months.
61 studies on the registry are indexed under Dysentery, Bacillary; 6 are open to participants now.
This study's enrollment of 180 is above the median of 76 across 54 interventional studies indexed under Dysentery, Bacillary.
Browse Dysentery, Bacillary studies →Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd is the lead sponsor of 22 studies on the registry; 5 are open to participants now.
Compared within Dysentery, Bacillary, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Dysentery. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
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.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
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.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
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.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Received Vaccine: S.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine,10μg/dose
Biological: S.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine
Received Vaccine: S.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine,5μg/dose
Biological: S.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine
Group 1:3/2/1 dose(s) according to age of subjects. Single intramuscular dose contains 10 µg S.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine.
Group 2:3/2/1 dose(s) according to age of subjects. Single intramuscular dose contains 5 µg S.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine.
Occurrence of adverse events during a 30 day follow-up period after each vaccination
Time frame: 30 day after each vaccination
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Oct 2018. 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.
Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd →