Publications by authors named "Lourdes Pena Mendez"
Article Synopsis
- A study was conducted in the Dominican Republic to evaluate the safety and immune response of the trivalent oral polio vaccine (tOPV) in healthy children and infants in the context of developing new oral polio vaccines.
- No serious adverse reactions were reported, and significant improvements in seroconversion (SC) and seroprotection (SP) rates were observed in both groups after vaccination.
- These findings provide a reference point to compare the safety and effectiveness of new monovalent or trivalent oral polio vaccine formulations currently in development.
Background: The novel oral poliovirus vaccine type 2 (nOPV2) is now authorised by a WHO emergency use listing and widely distributed to interrupt outbreaks of circulating vaccine-derived poliovirus type 2. As protection of vulnerable populations, particularly young infants, could be facilitated by shorter intervals between the two recommended doses, we aimed to assess safety and non-inferiority of immunogenicity of nOPV2 in 1-week, 2-week, and 4-week schedules.
Methods: In this phase 3, open-label, randomised trial, healthy, full-term, infants aged 6-8 weeks from a hospital or a clinic in the Dominican Republic were randomly allocated (1:1:1 ratio) using a pre-prepared, computer-generated randomisation schedule to three groups to receive two doses of nOPV2 immunisations with a 1-week interval (group A), 2-week interval (group B), or 4-week interval (group C).
Immunogenicity and Reactogenicity of an Inactivated Quadrivalent Influenza Vaccine Administered Intramuscularly to Children 6 to 35 Months of Age in 2012-2013: A Randomized, Double-Blind, Controlled, Multicenter, Multicountry, Clinical Trial.
J Pediatric Infect Dis Soc
September 2015
Background: Influenza attack rates are high in 6- to 35-month-old children; vaccines containing both lineages of influenza B (Yamagata and Victoria), in addition to the H3N2 and H1N1 antigens, may improve protection rates.
Methods: In a randomized double-blind controlled trial, the immunogenicity and reactogenicity of an inactivated quadrivalent influenza vaccine (QIV) and a trivalent control vaccine (TIV) were assessed.
Results: Six hundred one children (QIV, n = 299; TIV, n = 302) were enrolled at 8 sites in 3 countries.