1. Reactogenicity and safety of the human rotavirus vaccine, Rotarix™ in The Philippines, Sri Lanka, and India: A post-marketing surveillance study
- Author
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Shailesh Mehta, Rommel Bernardo, Lennie Berezo, Prasanna Siriwardene, Aixue Liu, Amarjeet Chitraka, Kishore Kumar, Sundaram Balasubramanian, Pankaj Garg, Htay Htay Han, Leonard Cimafranca, Naveen Karkada, Lulu Bravo, Pallab Chatterjee, and Jaydeep Choudhury
- Subjects
safety ,Male ,Drug-Related Side Effects and Adverse Reactions ,health care facilities, manpower, and services ,infectious disease ,Philippines ,Immunology ,Postmarketing surveillance ,India ,reactogenicity ,Vaccines, Attenuated ,Rotavirus Infections ,prescribing information ,Environmental health ,parasitic diseases ,medicine ,Prescribing information ,Rotarix™ ,Prevalence ,Product Surveillance, Postmarketing ,Immunology and Allergy ,Humans ,Adverse effect ,health care economics and organizations ,Sri Lanka ,The Philippines ,Pharmacology ,Reactogenicity ,tolerance ,Traditional medicine ,business.industry ,Infant, Newborn ,Rotavirus Vaccines ,Infant ,social sciences ,Vaccination ,Diarrhea ,Vomiting ,vaccinology ,medicine.symptom ,Sri lanka ,business ,geographic locations ,Research Paper - Abstract
Regulatory bodies in The Philippines, Sri Lanka, and India require post-marketing surveillance to provide additional safety data on Rotarix™ in real-life settings. In such studies conducted in The Philippines (November 2006 to July 2012; NCT00353366), Sri Lanka (November 2008 to August 2009; NCT00779779), and India (August 2009 to April 2010; NCT00938327), 2 doses of Rotarix™ were administered according to the local prescribing information (PI). The occurrence of at least Grade "2"/"3" solicited adverse event (AE) (fever, vomiting, or diarrhea), within 15 days in The Philippines or 8 days in Sri Lanka and India; unsolicited AEs within 31 days and serious adverse events (SAEs) throughout the study were recorded. Of the 1494, 522, and 332 infants enrolled in The Philippines, Sri Lanka, and India, 14.7% 14.9% and 12.7% infants, respectively recorded at least Grade "2"/"3" solicited AEs. The most commonly reported solicited AEs were irritability in The Philippines (32.2% post-Dose-1; 23.5% post-Dose-2) and India (23.0% post-Dose-1; 13.2% post-Dose-2), and fever (18.0% post-Dose-1; 20.2% post-Dose-2) in Sri Lanka. Unsolicited AEs were recorded in 24.5% (The Philippines), 4.8% (Sri Lanka), and 6.9% (India) of infants. Forty-one SAEs were recorded in the Philippines of which 6 (decreased oral intake with increased sleeping time and constipation; pneumonia, urinary tract infection, and intussusception) were considered by the investigators as causally related to vaccination. One vaccine-unrelated SAE occurred in a Sri Lankan infant. All SAEs resolved and the infants recovered. Two doses of Rotarix™, administered to healthy infants according to local PI, were well tolerated in The Philippines, Sri Lanka, and India.
- Published
- 2014