Active, not recruiting
Phase 2
Safety and Immunogenicity Study of Recombinant Trivalent Rotavirus Subunit Vaccine in Healthy Infants and Toddlers
Condition(s) studied
Rotavirus InfectionsRotavirus Gastroenteritis
Investigational drug(s) / intervention(s)
Mid dose Recombinant Trivalent Subunit Rotavirus VaccineHigh dose Recombinant Trivalent Subunit Rotavirus VaccinePlacebo
Mid dose Recombinant Trivalent Subunit Rotavirus Vaccine: 0.5 mL of vaccine containing a total of 60 µg of protein (20 µg of each P type) adjuvanted with 0.5 mg aluminum hydroxide.
High dose Recombinant Trivalent Subunit Rotavirus Vaccine: 0.5 mL of vaccine containing a total of 90 µg of protein (30 µg of each P type) adjuvanted with 0.5 mg aluminum hydroxide.
Placebo: 0.5 mL per dose, containing 0.5 mg aluminium hydroxide adjuvant.
Study 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.
Eligibility
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.
Primary outcome measure(s)
- The incidence of adverse events — 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.
- The incidence of adverse events — 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.
- The incidence of adverse events — 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.
- The incidence of adverse events — 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.
- Geometric Mean Titers (GMT) of anti-P[4], anti-P[6], anti-P[8] rotavirus Immunoglobulin A (IgA) — Day 30 after the last vaccination
Measured by ELISA at baseline and 30 days after the last vaccination.
- Geometric Mean Titers (GMT) of anti-P[4], anti-P[6], anti-P[8] rotavirus Immunoglobulin G (IgG) — Day 30 after the last vaccination
Measured by ELISA at baseline and 30 days after the last vaccination.
- Geometric Mean Titers (GMT) of anti-P[4], anti-P[6], anti-P[8] rotavirus neutralizing antibody — 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.
- Seroconversion rates of anti-P[4], anti-P[6], anti-P[8] rotavirus IgA — Day 30 after the last vaccination
Seroconversion is defined as a ≥ 4-fold rise in IgA titer compared with Baseline.
- Seroconversion rates of anti-P[4], anti-P[6], anti-P[8] rotavirus IgG — Day 30 after the last vaccination
Seroconversion is defined as a ≥ 4-fold rise in IgG titer compared with Baseline.
- Seroconversion rates of anti-P[4], anti-P[6], anti-P[8] rotavirus neutralizing antibody — Day 30 after the last vaccination
Seroconversion is defined as a ≥ 2.7-fold rise in neutralizing antibody titer compared with Baseline.
Trial sites (2)
| Facility | City | Region | Status |
|---|
| Shangqiu Liangyuan District Center for Disease Control and Prevention |
Shangqiu |
Henan |
|
| Ningling County Center for Disease Control and Prevention |
Shangqiu |
Henan |
|
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