A Phase I study to evaluate safety and tolerability of DTaP-IPV + Hib vaccine in healthy adult volunteers in India.
Clinical trial
DTaP-IPV+Hib vaccine
Phase 1
Safety
Tolerability
Journal
Vaccine: X
ISSN: 2590-1362
Titre abrégé: Vaccine X
Pays: England
ID NLM: 101748769
Informations de publication
Date de publication:
Aug 2023
Aug 2023
Historique:
received:
19
12
2022
revised:
05
04
2023
accepted:
06
04
2023
medline:
2
5
2023
pubmed:
2
5
2023
entrez:
2
5
2023
Statut:
epublish
Résumé
To assess safety and tolerability of a diphtheria and tetanus toxoid, acellular pertussis, inactivated poliovirus and 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. 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. 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.
Sections du résumé
Background
UNASSIGNED
To assess safety and tolerability of a diphtheria and tetanus toxoid, acellular pertussis, inactivated poliovirus and
Methods
UNASSIGNED
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
UNASSIGNED
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
UNASSIGNED
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.
Identifiants
pubmed: 37128477
doi: 10.1016/j.jvacx.2023.100300
pii: S2590-1362(23)00041-4
pmc: PMC10148180
doi:
Types de publication
Journal Article
Langues
eng
Pagination
100300Informations de copyright
© 2023 The Authors.
Déclaration de conflit d'intérêts
The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: The authors HS, SP, PP, SS, SD, HR, SG and US, are employees of Serum Institute of India Pvt. Ltd.
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