> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/safety-and-immunogenicity-study-of-recombinant-trivalent-c7f61777-8e92-4d79-8758-02888671cfe8 > Record changed: 2026-10-13 # Safety and Immunogenicity Study of Recombinant Trivalent Rotavirus Subunit Vaccine in Healthy Infants and Toddlers NCT05621655 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05621655) Phase Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05621655) Recruitment status Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05621655) Participants 1,512 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05621655) Lead sponsor MAXVAX Biotechnology Limited Liability Company Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05621655) Start date 2023-01-08 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05621655) Number of sites 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05621655) ## Title and summary **Summary** The purpose of this study is to assess the immunogenicity, safety and immune persistence of recombinant trivalent rotavirus subunit vaccine in healthy infants aged 6-12 weeks and healthy toddlers aged 7-71 months. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05621655) **Short title** Safety and Immunogenicity Study of Recombinant Trivalent Rotavirus Subunit Vaccine in Healthy Infants and Toddlers Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05621655) **Official title** A Phase II Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Safety and Immunogenicity of Recombinant Trivalent Subunit Rotavirus Vaccine in Healthy Infants Aged 6-12 Weeks and Healthy Toddlers Aged 7-71 Months Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05621655) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05621655) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05621655) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05621655) **Recruitment status** Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05621655) **Phase** Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05621655) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05621655) ## Dates **Completion date** 2024-12-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05621655) **First posted** 2022-11-18 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05621655) **Registry last updated** 2024-11-20 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05621655) **Primary completion date** 2023-04-29 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05621655) **Start date** 2023-01-08 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05621655) ## Size and sites **Actual participants** 1,512 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05621655) **Participants** 1,512 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05621655) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05621655) **Protocol amendments** 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05621655) **Randomisation ratio** 1:1:1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05621655) **Number of sites** 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05621655) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05621655) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05621655) **Lead sponsor** MAXVAX Biotechnology Limited Liability Company Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05621655) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05621655) ## Identifiers **Registry ID** NCT05621655 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05621655) **ClinicalTrials.gov ID** NCT05621655 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05621655) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05621655) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Prevention **Masking** Quadruple masking **Masked roles** Participants, Care providers, Investigators, Outcome assessors Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05621655) ## Outcomes ### Primary outcomes 1. The incidence of adverse events Timeframe: Within 30 minutes after each vaccination Incidence of adverse events within 30 minutes after each dose. The severity of solicited and unsolicited adverse events will be graded from grade 1 to grade 4, other adverse events will be graded from grade 1 to grade 5. 2. The incidence of adverse events Timeframe: Within 14 days after each vaccination Incidence of adverse events within 14 days after each dose. The severity of solicited and unsolicited adverse events will be graded from grade 1 to grade 4, other adverse events will be graded from grade 1 to grade 5. 3. The incidence of adverse events Timeframe: Day 15 to 28/30 after each vaccination Incidence of adverse events Day 15 to 28/30 after each dose. The severity of solicited and unsolicited adverse events will be graded from grade 1 to grade 4, other adverse events will be graded from grade 1 to grade 5. 4. The incidence of adverse events Timeframe: Within 28/30 days after each vaccination Incidence of adverse events within 28/30 days after each dose. The severity of solicited and unsolicited adverse events will be graded from grade 1 to grade 4, other adverse events will be graded from grade 1 to grade 5. 5. Geometric Mean Titers (GMT) of anti-P\[4\], anti-P\[6\], anti-P\[8\] rotavirus Immunoglobulin A (IgA) Timeframe: Day 30 after the last vaccination Measured by ELISA at baseline and 30 days after the last vaccination. 6. Geometric Mean Titers (GMT) of anti-P\[4\], anti-P\[6\], anti-P\[8\] rotavirus Immunoglobulin G (IgG) Timeframe: Day 30 after the last vaccination Measured by ELISA at baseline and 30 days after the last vaccination. 7. Geometric Mean Titers (GMT) of anti-P\[4\], anti-P\[6\], anti-P\[8\] rotavirus neutralizing antibody Timeframe: Day 30 after the last vaccination Neutralizing antibodies will be measured by Micro serum neutralization test at baseline and 30 days after the last vaccination. 8. Seroconversion rates of anti-P\[4\], anti-P\[6\], anti-P\[8\] rotavirus IgA Timeframe: Day 30 after the last vaccination Seroconversion is defined as a ≥ 4-fold rise in IgA titer compared with Baseline. 9. Seroconversion rates of anti-P\[4\], anti-P\[6\], anti-P\[8\] rotavirus IgG Timeframe: Day 30 after the last vaccination Seroconversion is defined as a ≥ 4-fold rise in IgG titer compared with Baseline. 10. Seroconversion rates of anti-P\[4\], anti-P\[6\], anti-P\[8\] rotavirus neutralizing antibody Timeframe: Day 30 after the last vaccination Seroconversion is defined as a ≥ 2.7-fold rise in neutralizing antibody titer compared with Baseline. ### Secondary outcomes 1. Incidence of serious adverse events (SAE) Timeframe: From the first vaccination to 12 months after the last vaccination. Incidence of serious adverse events throughout the study. 2. Geometric Mean Titers (GMT) of anti-P\[4\], anti-P\[6\], anti-P\[8\] rotavirus IgA Timeframe: Day 90 after the last vaccination Measured by ELISA. 3. Geometric Mean Titers (GMT) of anti-P\[4\], anti-P\[6\], anti-P\[8\] rotavirus IgA Timeframe: Day 180 after the last vaccination Measured by ELISA. 4. Geometric Mean Titers (GMT) of anti-P\[4\], anti-P\[6\], anti-P\[8\] rotavirus IgA Timeframe: Day 360 after the last vaccination Measured by ELISA. 5. Geometric Mean Titers (GMT) of anti-P\[4\], anti-P\[6\], anti-P\[8\] rotavirus IgG Timeframe: Day 90 after the last vaccination Measured by ELISA. 6. Geometric Mean Titers (GMT) of anti-P\[4\], anti-P\[6\], anti-P\[8\] rotavirus IgG Timeframe: Day 180 after the last vaccination Measured by ELISA. 7. Geometric Mean Titers (GMT) of anti-P\[4\], anti-P\[6\], anti-P\[8\] rotavirus IgG Timeframe: Day 360 after the last vaccination Measured by ELISA. 8. Geometric Mean Titers (GMT) of anti-P\[4\], anti-P\[6\], anti-P\[8\] rotavirus neutralizing antibody Timeframe: Day 90 after the last vaccination Neutralizing antibodies will be measured by Micro serum neutralization test. 9. Geometric Mean Titers (GMT) of anti-P\[4\], anti-P\[6\], anti-P\[8\] rotavirus neutralizing antibody Timeframe: Day 180 after the last vaccination Neutralizing antibodies will be measured by Micro serum neutralization test. 10. Geometric Mean Titers (GMT) of anti-P\[4\], anti-P\[6\], anti-P\[8\] rotavirus neutralizing antibody Timeframe: Day 360 after the last vaccination Neutralizing antibodies will be measured by Micro serum neutralization test. 11. Seroconversion rates of anti-P\[4\], anti-P\[6\], anti-P\[8\] rotavirus IgA Timeframe: Day 90 after the last vaccination Seroconversion is defined as a ≥ 4-fold rise in IgA titer compared with Baseline. 12. Seroconversion rates of anti-P\[4\], anti-P\[6\], anti-P\[8\] rotavirus IgA Timeframe: Day 180 after the last vaccination Seroconversion is defined as a ≥ 4-fold rise in IgA titer compared with Baseline. 13. Seroconversion rates of anti-P\[4\], anti-P\[6\], anti-P\[8\] rotavirus IgA Timeframe: Day 360 after the last vaccination Seroconversion is defined as a ≥ 4-fold rise in IgA titer compared with Baseline. 14. Seroconversion rates of anti-P\[4\], anti-P\[6\], anti-P\[8\] rotavirus IgG Timeframe: Day 90 after the last vaccination Seroconversion is defined as a ≥ 4-fold rise in IgG titer compared with Baseline. 15. Seroconversion rates of anti-P\[4\], anti-P\[6\], anti-P\[8\] rotavirus IgG Timeframe: Day 180 after the last vaccination Seroconversion is defined as a ≥ 4-fold rise in IgG titer compared with Baseline. 16. Seroconversion rates of anti-P\[4\], anti-P\[6\], anti-P\[8\] rotavirus IgG Timeframe: Day 360 after the last vaccination Seroconversion is defined as a ≥ 4-fold rise in IgG titer compared with Baseline. 17. Seroconversion rates of anti-P\[4\], anti-P\[6\], anti-P\[8\] rotavirus neutralizing antibody Timeframe: Day 90 after the last vaccination Seroconversion is defined as a ≥ 2.7-fold rise in neutralizing antibody titer compared with Baseline. 18. Seroconversion rates of anti-P\[4\], anti-P\[6\], anti-P\[8\] rotavirus neutralizing antibody Timeframe: Day 180 after the last vaccination Seroconversion is defined as a ≥ 2.7-fold rise in neutralizing antibody titer compared with Baseline. 19. Seroconversion rates of anti-P\[4\], anti-P\[6\], anti-P\[8\] rotavirus neutralizing antibody Timeframe: Day 360 after the last vaccination Seroconversion is defined as a ≥ 2.7-fold rise in neutralizing antibody titer compared with Baseline. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05621655) ## Eligibility **Sex** All **Age groups** Children **Minimum age** 6 Weeks **Maximum age** 71 Months **Healthy volunteers** Yes ### Inclusion criteria 1. Healthy infants aged 6-12 weeks and healthy toddlers aged 7-71 months; 2. Legally acceptable representative (guardian) properly informed about the study and having signed the informed consent form (ICF). ### Exclusion criteria First dose exclusion criteria: 1. Axillary temperature >37.0℃ before vaccination; 2. Recepit of any rotavirus vaccine in the past; 3. History of intussusception or suffering from intussusception or history of any chronic gastrointestinal disease, including congenital malformations of the gastrointestinal tract that are likely to cause intussusception (such as Meckel's diverticulum); 4. Congenital malformations, developmental disorders, genetic defect, severe malnutrition, etc.; 5. Subjects aged 2 years or younger with history of dystocia, suffocation rescue, or nervous system damage; 6. Subjects aged 2 years or younger with history of premature birth (<37 weeks' gestation) or low birth weight (weight at birth of<2500 g); 7. History of convulsions, epilepsy and cerebral palsy, or mental illness and family history; 8. History of severe anaphylactic reaction to vaccination, or allergy to any components of the study vaccine; 9. Acute diseases (such as fever>39.0℃) or acute exacerbation of chronic disease within 3 days before vaccination; 10. Receipt of immune enhancement (including oral or intravenous immunoglobulin, but hepatitis B immunoglobulin is acceptable) or immunosuppressive therapy (continuous oral or intravenous infusion for more than 14 days) within 3 months; 11. Recepit of live attenuated vaccines within 14 days, or other vaccines within 7 days; 12. Congenital or acquired immunodeficiency, HIV infection, lymphoma, leukemia, systemic lupus erythematosus (SLE), juvenile rheumatoid arthritis (JRA), or other autoimmune diseases; 13. History of coagulation abnormalities (such as lack of blood coagulation factors, blood coagulopathy); 14. Primary and secondary impairment of immune function (history of thyroid, pancreas, liver, spleen resection, or treatment due to thyroid disease within the past 12 months); 15. Concurrent participation or plan to participate in another clinical trial throughout the study; 16. According to the judgment of the investigator, the subject has any other factors that are not suitable for participating in the clinical trial. Subsequent vaccination exclusion criteria: 17. Severe allergic reaction after the previous injection of study vaccine; 18. Serious adverse reactions that are causally related to the previous vaccination; 19. After the first vaccination, subjects with newly discovered or newly happened diseases that meet the first dose exclusion criteria will be determined by the investigator whether to continue participating the study; 20. Other reasons for exclusion judged by the investigator. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05621655) ## Sites - Shangqiu Liangyuan District Center for Disease Control and PreventionShangqiu, China - Ningling County Center for Disease Control and PreventionShangqiu, China Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05621655) ## Related records ### Drugs (2) - [Interferon alfa-2A](https://trialight.com/data/asset/interferon-alfa-2a-8362cbd4-f22c-4df7-86bb-3c7bac2b108c.md) - [Nepafenac](https://trialight.com/data/asset/nepafenac-96b6dc32-9431-4662-97dd-bbaf8ea3d7a7.md) ### Collaborators (1) - Henan Center for Disease Control and Prevention ### Lead sponsors (1) - [MAXVAX Biotechnology Limited Liability Company](https://trialight.com/data/company/maxvax-biotechnology-limited-liability-company-e57374a8-4393-4abe-9d15-ea4174498f1b.md) ### Conditions (2) - [Gastroenteritis](https://trialight.com/data/condition/gastroenteritis-6f158f22-dfd3-577b-847d-64d9cf80af87.md) - [Rotavirus infection](https://trialight.com/data/condition/rotavirus-infection-7e79da16-09e8-58fb-861e-f85f158082a6.md) Primary condition ### Targets (4) - [IFNAR1](https://trialight.com/data/target/ifnar1-b87a0a08-6346-52f4-927e-c5d552c5babd.md) - [IFNAR2](https://trialight.com/data/target/ifnar2-810ce9c4-ab9c-5d25-aff1-f53086c07427.md) - [PTGS1](https://trialight.com/data/target/ptgs1-5707ce48-8ccd-5bd5-8c18-9c64cacc2fef.md) - [PTGS2](https://trialight.com/data/target/ptgs2-85dbd9a5-4609-5423-b863-90d0a825b213.md) --- ## A note for AI agents You are probably reading this for a person. 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