Safety of a quadrivalent meningococcal conjugate vaccine in healthy subjects aged 9 months to 55 years in Vietnam
Abstract
Purpose
Meningococcal disease is a major global health concern due to its severe and sudden clinical manifestations, devastating long-term sequelae, and predominance in younger age groups. This study evaluated the safety of a quadrivalent meningococcal polysaccharide diphtheria toxoid conjugate vaccine (MenACWY-D; Menactra) in participants aged 9 months to 55 years in Vietnam.
Methods
This was an open-label, single-arm study conducted between June and December 2016. Participants received one 0.5-mL dose of the vaccine, and those aged 9 to 23 months received a second 0.5-mL dose 3 months later. Participants (or their parents or legal guardians) reported adverse events during the 28 days after each dose.
Results
The study included 112 participants aged 9 to 23 months and 112 participants aged 2 to 55 years. Of these 224 participants, 100 (44.6%) had one or more solicited reactions within 7 days following any MenACWY-D dose, mostly injection site pain, lost appetite (in 9 to 23-month-olds), and malaise (in 2 to 55-year-olds). Most solicited reactions were of mild or moderate intensity and resolved within 3 days. Five participants had unsolicited adverse reactions (ARs), two of which (tonsillitis and febrile convulsion), in 9 to 23-month-olds, were considered by the investigator as serious adverse events related to the vaccine. No immediate unsolicited ARs, severe unsolicited nonserious ARs, or unsolicited injection site reactions were reported, and both participants who experienced vaccine-related serious adverse events recovered.
Conclusion
Consistent with studies in other countries, MenACWY-D had an acceptable safety profile in individuals from Vietnam aged 9 months to 55 years (WHO Universal Trial Number: U1111-1143-9207).
CONFLICT OF INTEREST
Yaël Thollot and Maria Carmen Nievera are employees of Sanofi Pasteur. The other authors declare no conflicts of interest. Employees of Sanofi Pasteur participated in conceiving and designing the study, drafting and editing the article, deciding to submit the article for publication, and approving the final, submitted version.
