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Mixed Schedule Study of Live Oral Rotavirus Vaccines and Trivalent P2-VP8 Subunit Rotavirus Vaccine

NCT04344054 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 850

Last updated 2022-11-29

No results posted yet for this study

Summary

The study will evaluate safety and immunogenicity of LORV (Rotarix and RV3-BB) when TV P2-VP8, a parentally administered rotavirus vaccine is administered either concomitantly or as a prime/boost model. Participants would be newborn babies or infants approximately at 6 weeks of age ta the time of enrollment. The vaccines will be administered at birth (only for one cohort) and at 6, 10 and 14 weeks. Immune response will be assessed prior to first vaccination, 14 weeks and at 18 weeks of age. The study will also evaluate the shedding of Rotarix virus after a challenge dose administered 28 days after last investigational product administration. Safety assessments will be conducted throughout the study duration.

Conditions

  • Rotavirus Vaccine

Interventions

BIOLOGICAL

RV3-BB

1.0 mL of the thawed rotavirus vaccine to be administered orally at birth, 6 weeks and 10 weeks of age

BIOLOGICAL

Trivalent P2-VP8

0.5 mL of vaccine containing 90 μg of the TV P2-VP8 antigen; IM; at approximately 6, 10 and 14 weeks of age

BIOLOGICAL

Rotarix

1.5 mL of the liquid vaccine containing the RIX4414 strain of human rotavirus vaccine to be administered orally at 6 weeks and 10 weeks of age.

BIOLOGICAL

RV3-BB birth dose

1.0 mL of the thawed rotavirus vaccine to be administered orally at birth.

BIOLOGICAL

Trivalent P2-VP8 Booster dose

0.5 mL of vaccine containing 90 μg of the TV P2-VP8 antigen; IM; at 14 weeks of age

Sponsors & Collaborators

  • SK Bioscience Co., Ltd.

    collaborator INDUSTRY

  • Murdoch Childrens Research Institute

    collaborator OTHER

  • Children's Hospital Medical Center, Cincinnati

    collaborator OTHER

  • Bill and Melinda Gates Foundation

    collaborator OTHER

  • PATH

    lead OTHER

Principal Investigators

  • Stanley Cryz, PhD · PATH

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Max Age
56 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-02-22
Primary Completion
2022-09-06
Completion
2022-09-09

Countries

  • South Africa

Study Locations

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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 NCT04344054 on ClinicalTrials.gov