Safety and Preliminary Immunogenicity Study of Inactivated Vaccine for Prevention of Rotavirus Infection

Summary

This study is a randomized, double-blinded, placebo-controlled, Phase 1, dose-escalation study to evaluate the safety, reactogenicity and immunogenicity of Inactivated Rotavirus Vaccine (IRV) performed in healthy adult (aged 18-49 years), adolescent (aged 6-17 years) and infant subjects (aged 2-71 months). Primary objectives of the clinical trial include assessing the safety and tolerability of IRV given at two and three dose levels and comparing the safety and tolerability of IRV after each vaccination, between dosage groups, and by pre-vaccination rotavirus immune status. Secondary objective of the clinical trial is immunogenicity evaluation after each vaccination, between dosage groups, and by pre-vaccination rotavirus immune status.

Conditions

• Rotavirus Infection

Interventions

BIOLOGICAL

Low dosage IRV on a 0- and 28-day schedule

Inactivated Rotavirus vaccine (Vero cell) of 80EU/0.5ml on day 0, 28

BIOLOGICAL

Medium dosage IRV on a 0- and 28-day schedule

Inactivated Rotavirus vaccine (Vero cell) of 160EU/0.5ml on day 0, 28

BIOLOGICAL

High dosage IRV on a 0- and 28-day schedule

Inactivated Rotavirus vaccine (Vero cell) of 320EU/0.5ml on day 0,28

BIOLOGICAL

Low dosage IRV on a 0- and 28-day schedule

Inactivated Rotavirus vaccine (Vero cell) of 80EU/0.5ml on day 0,28

BIOLOGICAL

Medium dosage IRV on a 0- and 28-day schedule

Inactivated Rotavirus vaccine (Vero cell) of 160EU/0.5ml on day 0,28

BIOLOGICAL

High dosage IRV on a 0- and 28-day schedule

Inactivated Rotavirus vaccine (Vero cell) of 320EU/0.5ml on day 0,28

BIOLOGICAL

Low dosage IRV on a 0- and 28-day schedule

Inactivated Rotavirus vaccine (Vero cell) of 80EU/0.5ml on day 0,28

BIOLOGICAL

Medium dosage IRV on a 0- and 28-day schedule

Inactivated Rotavirus vaccine (Vero cell) of 160EU/0.5ml on day 0,28

BIOLOGICAL

High dosage IRV on a 0- and 28-day schedule

Inactivated Rotavirus vaccine (Vero cell) of 320EU/0.5ml on day 0,28

BIOLOGICAL

Low dosage IRV on a 0- and 28-day schedule

Inactivated Rotavirus vaccine (Vero cell) of 80EU/0.5ml on day 0,28

BIOLOGICAL

Medium dosage IRV on a 0- and 28-day schedule

Inactivated Rotavirus vaccine (Vero cell) of 160EU/0.5ml on day 0,28

BIOLOGICAL

High dosage IRV on a 0- and 28-day schedule

Inactivated Rotavirus vaccine (Vero cell) of 320EU/0.5ml on day 0,28

BIOLOGICAL

Low dosage IRV on a 0- , 28- and 56-day schedule

Inactivated Rotavirus vaccine (Vero cell) of 80EU/0.5ml on day 0,28,56

BIOLOGICAL

Medium dosage IRV on a 0- , 28- and 56-day schedule

Inactivated Rotavirus vaccine (Vero cell) of 160EU/0.5ml on day 0,28,56

BIOLOGICAL

High dosage IRV on a 0- , 28- and 56-day schedule

Inactivated Rotavirus vaccine (Vero cell) of 320EU/0.5ml on day 0,28,56

BIOLOGICAL

Placebo on day 0, 28

Two doses of placebo at the vaccination schedule of day 0,28

BIOLOGICAL

Placebo on day 0, 28, 56

Three doses of placebo at the vaccination schedule of day 0, 28,56

Sponsors & Collaborators

• Henan Provincal Center for Disease Control and Prevention

  collaborator UNKNOWN

• Chinese Academy of Medical Sciences

  lead OTHER

Principal Investigators

• Hongjun Li, Ph.D · Chinese Academy of Medical Sciences

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

2 Months

Max Age

49 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2020-12-03

Primary Completion

2021-06-30

Completion

2021-08-31

Countries

• China