✓ Translated by DotMD AI Clinical Council Source: Human vaccines & immunotherapeutics • Phase III Randomized Trial
Verify Primary Source: NIH PubMed PMID #39445787 ↗

Phase III Randomized Trial: A prospective, randomized, parallel, active controlled, phase III Indian study of immunogenicity and safety of two inactivated influenza vaccines - Vaxiflu-4 and Fluarix tetra in children aged 6 months to 35 months (N = 346)

Original Paper Title: “A prospective, randomized, parallel, active controlled, phase III Indian study of immunogenicity and safety of two inactivated influenza vaccines - Vaxiflu-4 and Fluarix tetra in children aged 6 months to 35 months”

Elena Rostova (AI Quant) Rigor Score
87 / 100
Sample Size (Participants)
N = 346
Evidence Classification
Phase III Randomized Trial
Sarah Jenkins, RN (AI Plain-English Editor) • Key Takeaways
  • Adverse events (AEs) were similar for both vaccines, including pain at the injection site, erythema, swelling, and pyrexia. The test vaccine, Vaxiflu-4, showed non-inferiority in terms of immunogenicity and safety when compared with reference vaccine, Fluarix Tetra (Clinical trial registry number: CTRI/2022/05/042514).
  • Study Design & Sample: Phase III Randomized Trial published in Human vaccines & immunotherapeutics (N = 346 human participants).
  • Biostatistical Rigor Score: 87/100 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 346 human participants investigated: Influenza is highly prevalent in children under five years, particularly those under two, accounting for 5-10% of acute respiratory infections (ARIs) in India. Key clinical takeaway: Adverse events (AEs) were similar for both vaccines, including pain at the injection site, erythema, swelling, and pyrexia. The test vaccine, Vaxiflu-4, showed non-inferiority in terms of immunogenicity and safety when compared with reference vaccine, Fluarix Tetra (Clinical trial registry number: CTRI/2022/05/042514).

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

Primary Endpoint & Quantitative Summary (Human vaccines & immunotherapeutics, 2024-12-31; N = 346; Rigor 87/100): Adverse events (AEs) were similar for both vaccines, including pain at the injection site, erythema, swelling, and pyrexia. The test vaccine, Vaxiflu-4, showed non-inferiority in terms of immunogenicity and safety when compared with reference vaccine, Fluarix Tetra (Clinical trial registry number: CTRI/2022/05/042514).

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

Condition: vaccines → Condition: vaginosis-bacterial → Condition: cytomegalovirus-infections →
Transparent AI Research Council • Grounded on NIH / FDA / PubMed Data

Ask our AI Specialists anything about PMID 39445787: Phase III Randomized Trial: A prospective, randomized, parallel, active controlled, phase III Indian study of immunogenicity and safety of two inactivated influenza vaccines - Vaxiflu-4 and Fluarix tetra in children aged 6 months to 35 months (N = 346)

3 of 3 Free Questions Remaining