✓ Translated by DotMD AI Clinical Council Source: Human vaccines & immunotherapeutics • Phase III Randomized Trial
Verify Primary Source: NIH PubMed PMID #38509699 ↗

Phase III Randomized Trial: A phase 3 randomized, open-label study evaluating the immunogenicity and safety of concomitant and staggered administration of a live, pentavalent rotavirus vaccine and an inactivated poliomyelitis vaccine in healthy infants in China

Original Paper Title: “A phase 3 randomized, open-label study evaluating the immunogenicity and safety of concomitant and staggered administration of a live, pentavalent rotavirus vaccine and an inactivated poliomyelitis vaccine in healthy infants in China”

Elena Rostova (AI Quant) Rigor Score
82 / 100
Sample Size (Participants)
Systematic Review
Evidence Classification
Phase III Randomized Trial
Sarah Jenkins, RN (AI Plain-English Editor) • Key Takeaways
  • No safety concerns were identified. These data support the concomitant use of RV5 and IPV in healthy Chinese infants.
  • Study Design & Sample: Phase III Randomized Trial published in Human vaccines & immunotherapeutics (Multi-cohort synthesis).
  • Biostatistical Rigor Score: 82/100 audited by Elena Rostova (AI Biostatistician & openFDA Quant).

What the Study Found (In Plain English)

Published in Human vaccines & immunotherapeutics (2024), this phase iii randomized trial evaluating human clinical outcomes investigated: This open-label, randomized, phase 3 study in China (V260-074; NCT04481191) evaluated the immunogenicity and safety of concomitant and staggered administration of three doses of an oral, live, pentavalent rotavirus vaccine (RV5) and three doses of an intramuscular, inactivated poliomyelitis vaccine (IPV) in 400 healthy infants. Key clinical takeaway: No safety concerns were identified. These data support the concomitant use of RV5 and IPV in healthy Chinese infants.

Dr. Lin (AI Evidence Lead): Statistical Endpoints & Numbers

Primary Endpoint & Quantitative Summary (Human vaccines & immunotherapeutics, 2024-12-31; Phase III Randomized Trial; Rigor 82/100): No safety concerns were identified. These data support the concomitant use of RV5 and IPV in healthy Chinese infants.

Study Limitations & Caveats Before You Act

Clinical trials evaluate specific inclusion/exclusion cohorts under protocol-controlled conditions (Phase III Randomized Trial). Individual response, hepatic/renal clearance, CYP450 drug interactions, and baseline comorbidities vary; verify applicability with a board-certified physician before modifying any prescription or supplement regimen.

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