✓ Translated by DotMD AI Clinical Council Source: Japanese journal of infectious diseases • Phase III Randomized Trial
Verify Primary Source: NIH PubMed PMID #33518626 ↗

Phase III Randomized Trial: The Immunogenicity and Safety Profile for KM-248, a Combined Measles, Mumps, and Rubella Vaccine, and Its Noninferiority to the Measles Vaccine in Healthy Japanese Children (N = 178)

Original Paper Title: “The Immunogenicity and Safety Profile for KM-248, a Combined Measles, Mumps, and Rubella Vaccine, and Its Noninferiority to the Measles Vaccine in Healthy Japanese Children: a Phase 3 Randomized Multicenter Single-Blind Clinical Trial”

Elena Rostova (AI Quant) Rigor Score
82 / 100
Sample Size (Participants)
N = 178
Evidence Classification
Phase III Randomized Trial
Sarah Jenkins, RN (AI Plain-English Editor) • Key Takeaways
  • Fever is one of the most common adverse reactions associated with vaccination and was observed in approximately half of the participants. KM-248 administered to healthy Japanese children aged between 12 and 90 months demonstrated a comparable safety and efficacy profile to the control vaccine.
  • Study Design & Sample: Phase III Randomized Trial published in Japanese journal of infectious diseases (N = 178 human participants).
  • Biostatistical Rigor Score: 82/100 audited by Elena Rostova (AI Biostatistician & openFDA Quant).

What the Study Found (In Plain English)

Published in Japanese journal of infectious diseases (2021), this phase iii randomized trial evaluating 178 human participants investigated: The domestic combined measles-mumps-rubella (MMR) vaccine was withdrawn in Japan in 1993 following an outbreak of aseptic meningitis attributed to the mumps component of the cocktail. Key clinical takeaway: Fever is one of the most common adverse reactions associated with vaccination and was observed in approximately half of the participants. KM-248 administered to healthy Japanese children aged between 12 and 90 months demonstrated a comparable safety and efficacy profile to the control vaccine.

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

Primary Endpoint & Quantitative Summary (Japanese journal of infectious diseases, 2021-09-22; N = 178; Rigor 82/100): Fever is one of the most common adverse reactions associated with vaccination and was observed in approximately half of the participants. KM-248 administered to healthy Japanese children aged between 12 and 90 months demonstrated a comparable safety and efficacy profile to the control vaccine.

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.

Related DotMD Clinical Hubs & Price Ledgers

Rx: healthy-back-institute-rub-on-relief-analgesic → Condition: measles → Condition: rubella → Condition: vaccines →
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