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
Overview
- Phase
- Phase 2
- Intervention
- Mid dose Recombinant Trivalent Subunit Rotavirus Vaccine
- Conditions
- Rotavirus Infections
- Sponsor
- MAXVAX Biotechnology Limited Liability Company
- Enrollment
- 1512
- Locations
- 2
- Primary Endpoint
- Geometric Mean Titers (GMT) of anti-P[4], anti-P[6], anti-P[8] rotavirus Immunoglobulin A (IgA)
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
Brief 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.
Detailed Description
This clinical trial is aimed to evaluate the immunogenicity, safety and immune persistence of recombinant trivalent rotavirus subunit vaccine in Chinese healthy infants aged 6-12 weeks and healthy toddlers aged 7-71 months.The subjects will be divided into 12 subgroups. Two different immune regimens and two dose levels will be evaluated in each age group. Toddlers aged 7-71 months will receive two intramuscular injections on Day 0 and 28 or three intramuscular injections on Day 0, 28 and 56. Infants aged 6-12 weeks will receive three intramuscular injections on Day 0, 28 and 56 or Day 0, 56 and 112. Two dose (mid dose and high dose) will be included in each age group. To maintain blindness in the trial, in each age group with fixed immune regimen, subjects will be randomized in a 1:1:1 ratio to receive mid dose vaccine, high dose vaccine, or placebo.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Healthy infants aged 6-12 weeks and healthy toddlers aged 7-71 months;
- •Legally acceptable representative (guardian) properly informed about the study and having signed the informed consent form (ICF).
Exclusion Criteria
- •First dose 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;
- •Acute diseases (such as fever\>39.0℃) or acute exacerbation of chronic disease within 3 days before vaccination;
Arms & Interventions
Mid dose in toddlers (7-71 months old, 3 doses)
Mid dose recombinant trivalent rotavirus subunit vaccine in toddlers aged 7-71 months on Day 0, 28 and 56, intramuscularly injected.
Intervention: Mid dose Recombinant Trivalent Subunit Rotavirus Vaccine
Mid dose in toddlers (7-71 months old, 2 doses)
Mid dose recombinant trivalent rotavirus subunit vaccine in toddlers aged 7-71 months on Day 0 and 28, intramuscularly injected.
Intervention: Mid dose Recombinant Trivalent Subunit Rotavirus Vaccine
High dose in toddlers (7-71 months old, 3 doses)
High dose recombinant trivalent rotavirus subunit vaccine in toddlers aged 7-71 months on Day 0, 28 and 56, intramuscularly injected.
Intervention: High dose Recombinant Trivalent Subunit Rotavirus Vaccine
High dose in toddlers (7-71 months old, 2 doses)
High dose recombinant trivalent rotavirus subunit vaccine in toddlers aged 7-71 months on Day 0 and 28, intramuscularly injected.
Intervention: High dose Recombinant Trivalent Subunit Rotavirus Vaccine
Placebo in toddlers (7-71 months old, 3 doses)
Placebo in toddlers aged 7-71 months on Day 0, 28 and 56, intramuscularly injected.
Intervention: Placebo
Placebo in toddlers (7-71 months old, 2 doses)
Placebo in toddlers aged 7-71 months on Day 0 and 28, intramuscularly injected.
Intervention: Placebo
Mid dose in infants (6-12 weeks of age, 3 doses at 4-week intervals)
Mid dose recombinant trivalent rotavirus subunit vaccine in infants aged 6-12 weeks on Day 0, 28 and 56, intramuscularly injected.
Intervention: Mid dose Recombinant Trivalent Subunit Rotavirus Vaccine
Mid dose in infants (6-12 weeks of age, 3 doses at 8-week intervals)
Mid dose recombinant trivalent rotavirus subunit vaccine in infants aged 6-12 weeks on Day 0, 56 and 112, intramuscularly injected.
Intervention: Mid dose Recombinant Trivalent Subunit Rotavirus Vaccine
High dose in infants (6-12 weeks of age, 3 doses at 4-week intervals)
High dose recombinant trivalent rotavirus subunit vaccine in infants aged 6-12 weeks on Day 0, 28 and 56, intramuscularly injected.
Intervention: High dose Recombinant Trivalent Subunit Rotavirus Vaccine
High dose in infants (6-12 weeks of age, 3 doses at 8-week intervals)
High dose recombinant trivalent rotavirus subunit vaccine in infants aged 6-12 weeks on Day 0, 56 and 112, intramuscularly injected.
Intervention: High dose Recombinant Trivalent Subunit Rotavirus Vaccine
Placebo in infants (6-12 weeks of age, 3 doses at 4-week intervals)
Placebo in infants aged 6-12 weeks on Day 0, 28 and 56, intramuscularly injected.
Intervention: Placebo
Placebo in infants (6-12 weeks of age, 3 doses at 8-week intervals)
Placebo in infants aged 6-12 weeks on Day 0, 56 and 112, intramuscularly injected.
Intervention: Placebo
Outcomes
Primary Outcomes
Geometric Mean Titers (GMT) of anti-P[4], anti-P[6], anti-P[8] rotavirus Immunoglobulin A (IgA)
Time Frame: Day 30 after the last vaccination
Measured by ELISA at baseline and 30 days after the last vaccination.
The incidence of adverse events
Time Frame: 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 G (IgG)
Time Frame: Day 30 after the last vaccination
Measured by ELISA at baseline and 30 days after the last vaccination.
Seroconversion rates of anti-P[4], anti-P[6], anti-P[8] rotavirus IgA
Time Frame: 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
Time Frame: 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
Time Frame: Day 30 after the last vaccination
Seroconversion is defined as a ≥ 2.7-fold rise in neutralizing antibody titer compared with Baseline.
Geometric Mean Titers (GMT) of anti-P[4], anti-P[6], anti-P[8] rotavirus neutralizing antibody
Time Frame: 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.
Secondary Outcomes
- Geometric Mean Titers (GMT) of anti-P[4], anti-P[6], anti-P[8] rotavirus IgG(Day 360 after the last vaccination)
- Seroconversion rates of anti-P[4], anti-P[6], anti-P[8] rotavirus IgA(Day 360 after the last vaccination)
- Geometric Mean Titers (GMT) of anti-P[4], anti-P[6], anti-P[8] rotavirus neutralizing antibody(Day 360 after the last vaccination)
- Incidence of serious adverse events (SAE)(From the first vaccination to 12 months after the last vaccination.)
- Geometric Mean Titers (GMT) of anti-P[4], anti-P[6], anti-P[8] rotavirus IgA(Day 360 after the last vaccination)
- Seroconversion rates of anti-P[4], anti-P[6], anti-P[8] rotavirus IgG(Day 360 after the last vaccination)
- Seroconversion rates of anti-P[4], anti-P[6], anti-P[8] rotavirus neutralizing antibody(Day 360 after the last vaccination)