dm+d

116077000

Refrigerated Storage

RotarixGlaxoSmithKline UK

GlaxoSmithKline UK
Rotarix
Oral suspension in squeezable tube or pre-filled oral applicator

Contact GlaxoSmithKline UK in all cases where a deviation from the recommended storage conditions has occurred.

Refer to the current BNF for company contact details.
Please also refer to the manufacturer’s product literature for recommended storage information at https://www.medicines.org.uk

Public Health England has guidance on responding to errors in vaccine storage, handling and administration.

22 October 2021
London MI Service

New Medicines

RotarixPrevention of rotavirus infection - porcine circovirus (PCV)-free formulation

Information

Rotarix
New formulation
GlaxoSmithKline
GlaxoSmithKline

Development and Regulatory status

Launched
Approved (Licensed)
Phase III Clinical Trials
January 2021
Jan 21GSK makes stock of PCV-free Rotarix available in the UK. Due to the 3 year shelf life of Rotarix, stock of PCV-containing Rotarix will still be available from some time [7].
Mar 20New formulation approved in EU. Immunogenicity and safety results of ROTA-090 are in line with the approved PI for Rotarix in the EU. No changes to the SmPC are needed [5,6].
Dec 19File submitted to the EMA for the PCV-free live attenuated HRV vaccine [4].

Category

An oral live attenuated human rotavirus vaccine for the prevention of gastroenteritis caused by rotavirus infections (G1, G3, G4 and G9 types). Porcine circovirus (PCV) free liquid formulation.
Rotavirus infection is the most common cause of severe gastroenteritis in children. Rotavirus causes about 140,000 cases of diarrhoea a year in the under-5s in the UK. It has been estimated that approximately 18,000 children are hospitalised annually in England and Wales as a result of rotavirus-related disease [3].
Prevention of rotavirus infection - porcine circovirus (PCV)-free formulation
Oral

Trial or other data

Feb 20PIII ROTA-096 study is no longer recruiting; due to complete collection of primary outcome data in Dec 20 [3].
Jul 19PIII trial to assess the reactogenicity and safety of the PCV-free liquid formulation of HRV vaccine as compared to the GSK lyophilised formulation of HRV vaccine, when administered as a two-dose vaccination in infants starting at age 6-12 weeks starts (ROTA-096; NCT03954743). 1,390 patients will be recruited in the US, Canada, Hong Kong, Taiwan and Turkey [3].
Nov 18PIII ROTA-081 trial that assessed the clinical consistency of three production lots of the Porcine circovirus (PCV)-free liquid formulation of oral live attenuated human rotavirus (HRV) vaccine, and evaluated the PCV-free liquid formulation of HRV vaccine as compared with the licensed lyophilised formulation of the HRV vaccine in terms of immunogenicity, reactogenicity and safety when administered as a two-dose vaccination, in healthy infants, aged 6 to 12 weeks completes (NCT02914184). The trial enrolled 1 613 patients in the US, Finland, Germany, Costa Rica, Japan, South Korea, Spain, Taiwan [1].

Evidence based evaluations