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CDC-9 Inactivated Rotavirus Vaccine (IRV) Intramuscular (IM) Phase 1 Clinical Trial in Healthy Adults

NCT06485258 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-03-05

No results posted yet for this study

Summary

This is a study of CDC-9 inactivated rotavirus vaccine (IRV) for intramuscular administration (IM) in healthy adults aged 18 to 45 years at two dose levels in a 3-dose series. The purpose is to determine if it is safe and if the recipient's immune system responds to the vaccine.

Conditions

  • Rotavirus Infections

Interventions

BIOLOGICAL

3.75 µg Dose of CDC-9 Inactivated Rotavirus Vaccine (IRV)

CDC-9 IRV adjuvanted with alhydrogel for IM administration in 0.5 mL is comprised of single human rotavirus for protection against rotavirus infection

BIOLOGICAL

7.5 µg Dose of CDC-9 Inactivated Rotavirus Vaccine (IRV)

CDC-9 IRV adjuvanted with alhydrogel for IM administration in 0.5 mL is comprised of single human rotavirus for protection against rotavirus infection

OTHER

Placebo

0.5 mL sterile saline administered via IM injection

Sponsors & Collaborators

  • Emory-Children's Center

    collaborator OTHER

  • Bill and Melinda Gates Foundation

    collaborator OTHER

  • Children's Hospital Medical Center, Cincinnati

    collaborator OTHER

  • Centers for Disease Control and Prevention

    lead FED

Principal Investigators

  • Christina Rostad, MD · Emory Children's Center - Vaccine Research Clinic (ECC-VRC)

  • Lauren Nolan, PA-C · Emory Children's Center - Vaccine Research Clinic (ECC-VRC)

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-08-06
Primary Completion
2026-02-04
Completion
2026-02-04
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

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 NCT06485258 on ClinicalTrials.gov