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

NCT05621655 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 1512

Last updated 2024-11-20

No results posted yet for this 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.

Conditions

  • Rotavirus Infections
  • Rotavirus Gastroenteritis

Interventions

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.

Sponsors & Collaborators

  • Henan Center for Disease Control and Prevention

    collaborator OTHER_GOV

  • MAXVAX Biotechnology Limited Liability Company

    lead INDUSTRY

Principal Investigators

  • Yanxia Wang · Henan Center for Disease Control and Prevention

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Weeks
Max Age
71 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-01-08
Primary Completion
2023-04-29
Completion
2024-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05621655 on ClinicalTrials.gov