A Phase 2 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 to 5 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-01-13.
Sponsored by Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd (part of Chongqing Zhifei Biological Products Co., Ltd.) · Phase 2, Interventional, and Prevention
The purpose of this study is to evaluate immunogenicity and safety of S.flexneriza-S.sonnei Bivalent Conjugate Vaccine in healthy volunteers aged from 3 months to 5 years old.
61 studies on the registry are indexed under Dysentery, Bacillary; 6 are open to participants now.
This study's enrollment of 1,050 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 →
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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.
S.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine,10μg/dose
Biological: S.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine · Biological: Haemophilus b Conjugate Vaccine
S.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine,5μg/dose
Biological: S.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine · Biological: Haemophilus b Conjugate Vaccine
Adjuvant-free S.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine,10μg/dose
Biological: S.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine · Biological: Haemophilus b Conjugate Vaccine
Haemophilus b Conjugate Vaccine,10μg/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.
Group 1:3/2/1 dose(s) according to age of subjects. Single intramuscular dose contains 10 µg adjuvant-free 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 Haemophilus b Conjugate Vaccine.
incidence of adverse events during 30 days
Occurrence of adverse events during a 30 day follow-up period after each vaccination
Time frame: 30 day after each vaccination
Antibody positive rate
Percentage of participants with seroresponse to each vaccination
Time frame: 30 day after each vaccination
Plan to share: No
This study is completed, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Haemophilus Influenzae B Vaccine
Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd →