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A Trial to Assess the Safety, Immunogenicity and Efficacy of a Trivalent Rotavirus P2-VP8 Subunit Vaccine in Prevention of Severe Rotavirus Gastroenteritis in Healthy Infants in Africa and India

NCT04010448 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 8200

Last updated 2021-04-09

No results posted yet for this study

Summary

The trial will be a multinational, randomized, double-blind, double-dummy, endpoint driven, group-sequential, active comparator-controlled study, in which participating infants will be randomized 1:1 to receive either: 1) 90 µg of the TV P2-VP8 vaccine IM plus oral placebo, or 2) Rotarix® per os (PO) plus IM placebo. Participants will receive three doses of TV P2-VP8/placebo IM and two doses of Rotarix®/placebo PO at monthly intervals starting at ≥6 to \<8 weeks of age, administered concomitantly with EPI/UIP vaccines. To maintain the blind, infants allocated to the TV P2-VP8 vaccine arm will receive both TV P2-VP8 IM as well as oral placebo vaccine, and infants allocated to receive Rotarix® will receive both Rotarix® PO and placebo IM. Active surveillance for episodes of gastroenteritis (GE) will be conducted throughout the study, through weekly contact with participants' parents. Unsolicited AEs grade ≥ 2 through 28 days after the last study vaccination will be recorded in the study database, as will data for SAEs (including intussusception) throughout the study.

Conditions

  • Rotavirus Infection of Children

Interventions

BIOLOGICAL

TV P2-VP8

90 µg of the TV P2-VP8 vaccine IM plus oral placebo administered on study days 1, 29 and 57

BIOLOGICAL

Rotarix

Rotarix® PO plus IM placebo administered on study days 1, 29 and 57

Sponsors & Collaborators

  • Bill and Melinda Gates Foundation

    collaborator OTHER

  • SK Bioscience Co., Ltd.

    collaborator INDUSTRY

  • PATH

    lead OTHER

Principal Investigators

  • George Armah, PhD · Noguchi Memorial Institute for Medical Research, University of Ghana, Legon

  • Desiree Witte, MD · Malawi-Liverpool-Wellcome Trust (MLW) Clinical Research Programme

  • Roma Chilengi, MD · Centre for Infectious Disease Research in Zambia (CIDRZ), Lusaka

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Weeks
Max Age
8 Weeks
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-10-10
Primary Completion
2025-12-15
Completion
2025-12-15

Countries

  • Zambia

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 NCT04010448 on ClinicalTrials.gov