VJPM
Page: 30
Volume XXVI, Issue 12(185) 2016
Safety of a single-dose of a live attenuated measles and rubella vaccine in Vietnamese children: A clinical open-label trial
Author: Pham Ngoc Hung, Ha The Tan and Nguyen Ngoc Chau
Summary:
In this study, 316 Vietnamese volunteers aged 1-14 years were administered a single dose of the MR vaccine (a live attenuated measles-rubella vaccine) to assess the safety of the vaccine. The vaccine’s safety was evaluated by the percentage of adverse events (AE) and serious adverse events (SAE) in a time frame of 30 minutes, 7, 14 and 30 days after administration. Results showed that within 30 minutes after injection, the total AEs rate was approximately 9.2%, of which, the local and systemic AE rates were equally reported at 4.8% of vaccinees. In the first 7 days of postvaccination, the frequency of pain and redness at the injection site were 0.3% for both groups; solicited AEs including cough (13.9%), fever (12.1%), irritability (3.6%); the other systemic AEs were reported under 2.9% of vaccinees. From the day 8- day 30 none of local AEs was reported; the highest figure of systemic AEs was cough (7.1%), other AEs were accounted for very low rates, just under 3.0%. None of unexpected adverse events and serious adverse events was reported during the study process.
Keywords:
Measles and rubella vaccine, India, Vietnamese children
File:
E161230.pdf
Download:
Download with virtual money of member account.