✓ Translated by DotMD AI Clinical Council Source: Vaccine • Phase III Randomized Trial

Verify Primary Source: NIH PubMed PMID #38575433 ↗

Phase III Randomized Trial: Immunogenicity and safety of SARS-CoV-2 recombinant protein subunit vaccine (IndoVac) adjuvanted with alum and CpG 1018 in Indonesian adults (N = 4,050)

Original Paper Title: “Immunogenicity and safety of SARS-CoV-2 recombinant protein subunit vaccine (IndoVac) adjuvanted with alum and CpG 1018 in Indonesian adults: A phase 3, randomized, active-controlled, multicenter trial”

Elena Rostova (AI Quant) Rigor Score

90 / 100

Sample Size (Participants)

N = 4,050

Evidence Classification

Phase III Randomized Trial

Sarah Jenkins, RN (AI Plain-English Editor) • Key Takeaways

IndoVac in adults showed favourable safety profile and elicited non-inferior immune response to Covovax.
Study Design & Sample: Phase III Randomized Trial published in Vaccine (N = 4050 human participants).
Biostatistical Rigor Score: 90/100 audited by Elena Rostova (AI Biostatistician & openFDA Quant).

What the Study Found (In Plain English)

Published in Vaccine (2024), this phase iii randomized trial evaluating 4,050 human participants investigated: Bio Farma has developed a recombinant protein subunit vaccine (IndoVac) that is indicated for active immunization in population of all ages. Key clinical takeaway: IndoVac in adults showed favourable safety profile and elicited non-inferior immune response to Covovax.

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

Primary Endpoint & Quantitative Summary (Vaccine, 2024-04-30; N = 4050; Rigor 90/100): IndoVac in adults showed favourable safety profile and elicited non-inferior immune response to Covovax.

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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Transparent AI Research Council • Grounded on NIH / FDA / PubMed Data

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