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

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05621655

Enrollment

1512

Registered

2022-11-18

Start date

2023-01-08

Completion date

2024-12-31

Last updated

2024-11-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rotavirus Gastroenteritis, Rotavirus Infections

Keywords

Rotavirus, Gastroenteritis

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.

Interventions

BIOLOGICALMid 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.

BIOLOGICALHigh 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.

BIOLOGICALPlacebo

0.5 mL per dose, containing 0.5 mg aluminium hydroxide adjuvant.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

6 Weeks to 71 Months

Healthy volunteers

Yes

Inclusion criteria

1. Healthy infants aged 6-12 weeks and healthy toddlers aged 7-71 months; 2. Legally acceptable representative (guardian) properly informed about the study and having signed the informed consent form (ICF).

Exclusion criteria

First dose

Design outcomes

Primary

Measure	Time frame	Description
Seroconversion rates of anti-P[4], anti-P[6], anti-P[8] rotavirus neutralizing antibody	Day 30 after the last vaccination	Seroconversion is defined as a ≥ 2.7-fold rise in neutralizing antibody titer compared with Baseline.
The incidence of adverse events	Within 30 minutes after each vaccination	Incidence of adverse events within 30 minutes 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 A (IgA)	Day 30 after the last vaccination	Measured by ELISA at baseline and 30 days after the last vaccination.
Geometric Mean Titers (GMT) of anti-P[4], anti-P[6], anti-P[8] rotavirus Immunoglobulin G (IgG)	Day 30 after the last vaccination	Measured by ELISA at baseline and 30 days after the last vaccination.
Geometric Mean Titers (GMT) of anti-P[4], anti-P[6], anti-P[8] rotavirus neutralizing antibody	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.
Seroconversion rates of anti-P[4], anti-P[6], anti-P[8] rotavirus IgA	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	Day 30 after the last vaccination	Seroconversion is defined as a ≥ 4-fold rise in IgG titer compared with Baseline.

Secondary

Measure	Time frame	Description
Incidence of serious adverse events (SAE)	From the first vaccination to 12 months after the last vaccination.	Incidence of serious adverse events throughout the study.
Geometric Mean Titers (GMT) of anti-P[4], anti-P[6], anti-P[8] rotavirus IgA	Day 90 after the last vaccination	Measured by ELISA.
Geometric Mean Titers (GMT) of anti-P[4], anti-P[6], anti-P[8] rotavirus IgG	Day 90 after the last vaccination	Measured by ELISA.
Geometric Mean Titers (GMT) of anti-P[4], anti-P[6], anti-P[8] rotavirus neutralizing antibody	Day 90 after the last vaccination	Neutralizing antibodies will be measured by Micro serum neutralization test.
Seroconversion rates of anti-P[4], anti-P[6], anti-P[8] rotavirus IgA	Day 90 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	Day 90 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	Day 90 after the last vaccination	Seroconversion is defined as a ≥ 2.7-fold rise in neutralizing antibody titer compared with Baseline.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026