NCT05621655

Safety and Immunogenicity Study of Recombinant Trivalent Rotavirus Subunit Vaccine in Healthy Infants and Toddlers

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

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 1,512 (actual)
• Sponsor: MAXVAX Biotechnology Limited Liability Company · Industry
• Sex: All
• Age: 6 Weeks – 71 Months
• Healthy volunteers: Accepted

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.

Conditions

• Rotavirus Infections
• Rotavirus Gastroenteritis

Interventions

Type	Name	Description
BIOLOGICAL	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.
BIOLOGICAL	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.
BIOLOGICAL	Placebo	0.5 mL per dose, containing 0.5 mg aluminium hydroxide adjuvant.

Timeline

• Start date: 2023-01-08
• Primary completion: 2023-04-29
• Completion: 2024-12-01
• First posted: 2022-11-18
• Last updated: 2024-11-20

Locations

2 sites across 1 country: China