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).

Invasive meningococcal disease in Malaysia, Philippines, Thailand, and Vietnam: An Asia-Pacific expert group perspective on current epidemiology and vaccination policies

“…MenACWY polysaccharide vaccine and a bivalent B Outer Membrane Vesicles and C meningococcal polysaccharide vaccines are the only meningococcal vaccines available in Vietnam. 45 , 46 These are mainly provided through the private health sector.…”