Safety and immunogenicity of two formulations of rotavirus vaccine in Vietnamese infants

Thiểm, Vũ Đình; Anh, Đặng Đức; Ha, Vu Hai; Hien, Nguyen Dang; Huong, Ngo Thu; Nga, Nguyen Tuyet; Thang, Tran Cong; McNeal, Monica; Meyer, Nicole; Pham, H.L.; Huong, Nguyen Manh; Gompana, G; Cassels, Frederick J.; Tang, Yuxiao; Flores, Jorge; Rathi, Niraj

doi:10.1016/j.vaccine.2021.06.056

Cited by 6 publications

(1 citation statement)

References 12 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…The prevalence of AEFIs after the first dose of vaccine (9.5%) was higher than after the second dose (7.3%) in all study sites. This trend was similar to that observed in previous clinical studies of Rotavin where the expected AEs after the first dose and the second dose, respectively, were 27.8% and 17.0% [ 36 ]. The risk of AEFIs increased more than 4–6 times when Rotavin-M1 and pentavalent/tetravalent vaccine were co-administered simultaneously.…”

Section: Discussionsupporting

confidence: 90%

Intussusception and Other Adverse Event Surveillance after Pilot Introduction of Rotavirus Vaccine in Nam Dinh and Thua Thien Hue Provinces—Vietnam, 2017–2021

Le,

Pham,

Mai

et al. 2024

Vaccines

View full text Add to dashboard Cite

Rotavin-M1 (POLYVAC) was licensed in Vietnam in 2012. The association of Rotavin-M1 with intussusception, a rare adverse event associated with rotavirus vaccines, and with adverse events following immunization (AEFI) have not been evaluated and monitored under conditions of routine use. From February 2017 to May 2021, we conducted a pilot introduction of Rotavin-M1 into the routine vaccination program in two provinces. Surveillance for intussusception was conducted at six sentinel hospitals. AEFI reports at 30 min and 7 days after vaccination were recorded. Among 443 children <12 months of age admitted for intussusception, most (92.3%) were children ≥ 6 months. Of the 388 children who were age-eligible to receive Rotavin-M1, 116 (29.9%) had received ≥1 dose. No intussusception cases occurred in the 1–21 days after dose 1 and one case occurred on day 21 after dose 2. Among the 45,367 children who received ≥1 dose of Rotavin-M1, 9.5% of children reported at least one AEFI after dose 1 and 7.3% after dose 2. Significantly higher AEFI rates occurred among children given Rotavin-M1 with pentavalent vaccines (Quinvaxem®, ComBE Five®) compared to Rotavin-M1 without pentavalent vaccines. There was no association between intussusception and Rotavin-M1. The vaccine was generally safe when administered alone and when co-administered with other vaccines.

show abstract

Section: Discussionsupporting

confidence: 90%