ReviewIndian journal of community medicine : official publication of Indian Association of Preventive & Social Medicine
TAK-003 Dengue Vaccine Safety: Evidence from a Systematic Review and Meta-analysis of Clinical Trials.
Review in Indian journal of community medicine : official publication of Indian Association of Preventive & Social Medicine. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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
0 citing papers in PubMed.
No citing paper in PubMed yet.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Dengue remains a growing global health threat with no specific antiviral treatment available. TAK-003, a tetravalent live-attenuated vaccine, offers a promising preventive option, particularly for seronegative individuals, necessitating a comprehensive safety evaluation to inform public health strategies.Following Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines, we conducted a systematic review and meta-analysis by searching various indexes and registries up to May 31, 2025. Phase 1-3 RCTs comparing TAK-003 with placebo or control vaccines were included. Pooled risk ratios (RRs or odds ratios (ORs with 95% confidence intervals (CIs were calculated; heterogeneity and subgroup analyses were performed. Eighteen clinical trials were included in the systematic review, and 11 clinical trials were included in the meta-analysis. No significant difference emerged in serious adverse events (SAEs (RR: 0.91, 95% CI: 0.55-1.50 or mortality (RR: 0.38, 95% CI: 0.04-3.92 between TAK-003 and placebo. Local solicited adverse events-especially injection-site pain and redness-were significantly higher with TAK-003 after the first dose (OR: 5.24, 95% CI: 1.02- 27.02. Systemic adverse events like headache and myalgia were also slightly higher in the TAK-003 group after the first dose (OR: 1.48, 95% CI: 1.10-1.99 but not after the second. Unsolicited adverse events and pregnancy outcomes were comparable, revealing no new safety concerns. TAK-003 shows an acceptable safety profile, with no rise in SAEs or mortality. Although local and mild systemic reactions were more common, they were brief and tolerable, supporting an acceptable safety profile within the available randomized clinical trial evidence.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
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.