AI Article Synopsis
- A Phase 1 study evaluated the safety and tolerability of the DTaP-IPV + Hib vaccine in 24 healthy adults aged 18-45, who received a single 0.5 mL dose.
- All participants completed the study, with only mild, temporary adverse events reported in three individuals; no serious complications occurred.
- The study concluded that the vaccine was well tolerated and safe, with plans for further studies in young children, the intended target population.
Article Abstract
Background: To assess safety and tolerability of a diphtheria and tetanus toxoid, acellular pertussis, inactivated poliovirus and conjugate adsorbed vaccine (DTaP-IPV + Hib), manufactured by Serum Institute of India Pvt. Ltd. (SIIPL)'s, the current first-in-human Phase 1 study was conducted in healthy adults.
Methods: Vaccine was administered as a single 0.5 mL dose intramuscularly into deltoid muscle of 24 healthy adults aged 18-45 years, who were then followed prospectively for one month for safety outcomes.
Results: All 24 participants completed the study in compliance with protocol. Four solicited adverse events were reported in three participants during the study; all adverse events were mild and recovered completely. No deaths, unsolicited adverse events, or serious adverse events were reported.
Conclusion: SIIPL DTaP-IPV + Hib vaccine was well tolerated and safe in study subjects. Further clinical development will be conducted to assess safety and immunogenicity in young children, the target population. CTRI/2017/07/009034.
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Source |
|---|---|
| http://www.ncbi.nlm.nih.gov/pmc/articles/PMC10148180 | PMC |
| http://dx.doi.org/10.1016/j.jvacx.2023.100300 | DOI Listing |
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