Efficacy, Immunogenicity and Safety of S. Flexneriza-S. Sonnei Bivalent Conjugate Vaccine in Volunteers Aged From 6 Months to 5 Years

  • STATUS
    Recruiting
  • End date
    Jan 11, 2024
  • participants needed
    21000
  • sponsor
    Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd
Updated on 24 March 2022
vaccination
glycan
Accepts healthy volunteers

Summary

The purpose of this study is to evaluate the efficacy, immunogenicity and safety of S. Flexneriza-S. Sonnei Bivalent Conjugate Vaccine in infants and children aged from 6 months to 5 years.

Details
Condition Dysentery, Shigellosis
Treatment Placebo, S. Flexneriza-S. Sonnei Bivalent Conjugate Vaccine
Clinical Study IdentifierNCT05156528
SponsorBeijing Zhifei Lvzhu Biopharmaceutical Co., Ltd
Last Modified on24 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Infants and children aged from 3 months to 5 years old
The legal representative voluntarily agrees to participate in the study and signed the informed consent form
The legal representative voluntarily agrees to comply with the requirements of the clinical study protocol, and they can participate in all planned follow-up
Subjects who didn't immuned with attenuated live vaccine within 14 days and inactivated vaccine within 7 days before vaccination
Axillary temperature ≤37.0℃
According to the medical history, physical examination and the judgment of the researcher, it is determined that the subject is in good physical condition

Exclusion Criteria

Previous proven history of bacillary dysentery
Subjects who are allergic to tetanus toxoid, and have any history of other vaccination or drug allergy, or a fever above 39.5 ℃ after previous vaccination
Within 3 days before vaccination, suffering from acute diseases or in the acute episode of chronic disease or using antipyretic, analgesic and antiallergic drugs (such as acetaminophen, ibuprofen, etc.)
Had severe bowel disease, and had symptoms such as diarrhea, abdominal pain, pus and blood stool and other symptoms in the past 3 days
With pathological jaundice confirmed by existing diagnosis
History of thrombocytopenia or other coagulation disorders with definite diagnosis
Known or suspected immunological deficiency (such as perianal abscess, which indicates that infants may have immune deficiency), and received long-term (≥14 days) immunosuppressive therapy (radiotherapy, chemotherapy, systemic glucocorticosteroids≥2 mg/kg/day, antimetabolic drugs and cytotoxic drugs) within half a year before vaccination, or confirmed that the parents were HIV infected
Received immunoglobulin / blood products treatment within 3 months before vaccination
Severe congenital malformations (functional impairment of important organs), severe malnutrition, developmental disorders and serious genetic diseases (such as severe thalassemia)
Subjects with the following diseases
Serious liver and kidney diseases, cardiovascular diseases, malignant tumors and other chronic diseases
Diagnosis with infectious diseases such as tuberculosis, viral hepatitis and so on
Severe asthma
Systemic rash, dermatophyte, skin suppuration or blister
History or family history of convulsion, epilepsy, encephalopathy, mental illness
Planning to participate or currently participating in clinical trials of other
vaccines or drugs
Any situation that the investigator believed may affect the study evaluation
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How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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