Trial reportHuman vaccines & immunotherapeutics2024
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.
Trial report in Human vaccines & immunotherapeutics, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 6 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
6 citing papers in PubMed.
- Comparison of safety and immunogenicity between high-dose and low-dose quadrivalent influenza vaccines in children aged 6-35 months in China: A randomized, double-blind clinical study.Human vaccines & immunotherapeutics · 2026Trial
- Reactogenicity, safety, and immunogenicity of a quadrivalent seasonal influenza vaccine in adults aged 65 years and older: Phase 4 study results from India during December 2023-February 2024.Human vaccines & immunotherapeutics · 2025Trial
- Safety profile of India's influenza vaccine in a large-scale corporate vaccination drive.Human vaccines & immunotherapeutics · 2026Observational
- Incorporating meteorological factors into a SARIMA model for predicting pediatric influenza epidemics.Frontiers in public health · 2026Article
- Influenza vaccination post-COVID-19 expands vaccine-specific effector CD4 T-cells and Tregs under positive influence of host trained innate immunity.NPJ vaccines · 2025Article
- Mapping Pediatric Seasonal Influenza Vaccine Safety and Immunogenicity Evidence: A Systematic Review of Clinical Trials.Vaccines · 2025Review
Corrections and comments
- Erratum issuedCorrection.2024
Authors and funding
11 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Influenza is highly prevalent in children under five years, particularly those under two, accounting for 5-10% of acute respiratory infections (ARIs) in India. This study was conducted to compare the immunogenicity and safety of two tetravalent inactivated influenza vaccines in healthy children aged 6-35 months. The dose recommendation for this group increased from 0.25 mL to 0.5 mL to ensure adequate immune response, as per the Advisory Committee on Immunization Practices. This Phase III, randomized, single-blind, active-controlled, multicentre study was conducted from May to October 2022 across five centers in India. A total of 346 subjects were randomized to receive two doses of either the test vaccine (Vaxiflu-4, Zydus Lifesciences Limited;
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.