Safety and Immunogenicity Study of Recombinant Trivalent Rotavirus Subunit Vaccine in Healthy Inf… (NCT05621655) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Safety and Immunogenicity Study of Recombinant Trivalent Rotavirus Subunit Vaccine in Healthy Infants and Toddlers
China1,512 participantsStarted 2023-01-08
Plain-language 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.
Who can participate
Age range6 Weeks – 71 Months
SexALL
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✓. Legally acceptable representative (guardian) properly informed about the study and having signed the informed consent form (ICF).
Exclusion criteria
✕. Axillary temperature \>37.0℃ before vaccination;
✕. Recepit of any rotavirus vaccine in the past;
✕. 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);
✕. Congenital malformations, developmental disorders, genetic defect, severe malnutrition, etc.;
✕. Subjects aged 2 years or younger with history of dystocia, suffocation rescue, or nervous system damage;
✕. Subjects aged 2 years or younger with history of premature birth (\<37 weeks' gestation) or low birth weight (weight at birth of\<2500 g);
✕. History of convulsions, epilepsy and cerebral palsy, or mental illness and family history;
✕. History of severe anaphylactic reaction to vaccination, or allergy to any components of the study vaccine;
What they're measuring
1
The incidence of adverse events
Timeframe: Within 30 minutes after each vaccination
2
The incidence of adverse events
Timeframe: Within 14 days after each vaccination
3
The incidence of adverse events
Timeframe: Day 15 to 28/30 after each vaccination
4
The incidence of adverse events
Timeframe: Within 28/30 days after each vaccination
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
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
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
8
Seroconversion rates of anti-P[4], anti-P[6], anti-P[8] rotavirus IgA
Trial details
NCT IDNCT05621655
SponsorMAXVAX Biotechnology Limited Liability Company