title: Reactogenicity and safety of the human rotavirus vaccine, Rotarix™ in The Philippines, Sri Lanka, and India: a post-marketing surveillance study.
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.
authors.affiliation: a National Institutes of Health-University of The Philippines Manila; Manila, The Philippines.
authors.forename: Lulu
authors.initials: L
authors.lastname: Bravo
authors.forename: Amarjeet
authors.initials: A
authors.lastname: Chitraka
authors.forename: Aixue
authors.initials: A
authors.lastname: Liu
authors.forename: Jaydeep
authors.initials: J
authors.lastname: Choudhury
authors.forename: Kishore
authors.initials: K
authors.lastname: Kumar
authors.forename: Lennie
authors.initials: L
authors.lastname: Berezo
authors.forename: Leonard
authors.initials: L
authors.lastname: Cimafranca
authors.forename: Pallab
authors.initials: P
authors.lastname: Chatterjee
authors.forename: Pankaj
authors.initials: P
authors.lastname: Garg
authors.forename: Prasanna
authors.initials: P
authors.lastname: Siriwardene
authors.forename: Rommel
authors.initials: R
authors.lastname: Bernardo
authors.forename: Shailesh
authors.initials: S
authors.lastname: Mehta
authors.forename: Sundaram
authors.initials: S
authors.lastname: Balasubramanian
authors.forename: Naveen
authors.initials: N
authors.lastname: Karkada
authors.forename: Htay
authors.initials: H
authors.lastname: Htay Han
mesh_terms: D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology* / Q000473:pathology*; D006801:Humans; D007194:India / Q000453:epidemiology; D007223:Infant; D007231:Infant, Newborn; D008297:Male; D010679:Philippines / Q000453:epidemiology; D015995:Prevalence; D011358:Product Surveillance, Postmarketing; D012400:Rotavirus Infections / Q000517:prevention & control*; D022243:Rotavirus Vaccines / Q000008:administration & dosage / Q000009:adverse effects*; D013188:Sri Lanka / Q000453:epidemiology; D014613:Vaccines, Attenuated / Q000008:administration & dosage / Q000009:adverse effects
chemical_list: C492457:RIX4414 vaccine; D022243:Rotavirus Vaccines; D014613:Vaccines, Attenuated
keywords: India; Rotarix™; Sri Lanka; The Philippines; infectious disease; prescribing information; reactogenicity; safety; tolerance; vaccinology