Phase III Clinical Trial to Evaluate the Human Norovirus Bivalent (Gā .1/Gā ”.4)Vaccineļ¼Recombinant ⦠(NCT05916326) | Clinical Trial Compass
CompletedPhase 3
Phase III Clinical Trial to Evaluate the Human Norovirus Bivalent (Gā .1/Gā ”.4)Vaccineļ¼Recombinant (Hansenula Polymorpha)
China8,000 participantsStarted 2023-06-30
Plain-language summary
The purpose of this study is to evaluate the Efficacy, Safety and Immunogenicity of the Human Norovirus Bivalent (Gā .1/Gā ”.4)Vaccineļ¼Recombinant (Hansenula polymorpha) in Healthy People Aged 6 Months to 13 Years After Vaccination
Who can participate
Age range6 Months ā 13 Years
SexALL
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Inclusion Criteria:
* Aged from 6 months to 13 years old, and can provide legal identity certificate;
* Volunteers and/or their guardians have the ability to understand the study requirements and process, agree to participate in the clinical trial and sign the informed consent, and can participate in all planned follow-up visits ( by an authorized entrusted person on the premise of written authorization by the guardian the informed consent can be signed);
* Those \<12 months old: born in full-term pregnancy (gestational week 37-42 weeks) and birth weight ā„ 2.5kg.
Exclusion Criteria:
First dose exclusion criteriaļ¼
* Axillary body temperature \> 37.0°C ;
* Have a history of chronic gastrointestinal diseases;
* Had gastroenteritis requiring treatment or current diarrhea, vomiting or other digestive system diseases within 7 days;
* Have a history of allergy to any excipients of the experimental vaccine (L-histidine, sodium chloride, aluminum hydroxide and water for injection, etc.);
* Have a history of severe allergy to any vaccine or drug, such as anaphylactic shock, allergic laryngeal edema, allergic purpura, Arthus reaction;
* Have been diagnosed with congenital or acquired immunodeficiency, or received immunosuppressant treatment, such as the application of systemic glucocorticoid therapy for more than 2 consecutive weeks 2 months before vaccination, such as prednisone or similar drugs \> 5mg/day (note: use of topical and inhaled/nebulized steroids can participate);
* Infā¦
What they're measuring
1
To evaluate efficacy of moderate/severe acute gastroenteritis caused by laboratory-confirmed (RT-PCR) infection with GI.1 or GII.4 norovirus after full vaccination with Human Norovirus Bivalent (Gā .1/Gā ”.4)Vaccineļ¼Recombinant (Hansenula polymorpha)
Timeframe: 14 days after the full course of vaccination to end of studyļ¼about two yearsļ¼
Trial details
NCT IDNCT05916326
SponsorNational Vaccine and Serum Institute, China