dm+d

116077000

Refrigerated Storage

RotarixGSK

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

In the event of an inadvertent temperature excursion the following data may be used:

The vaccine components are stable at temperatures up to 25°C for a cumulative time of 72 hours or temperatures up to 37°C for a cumulative time of 24 hours.

Temperature excursions down to -18°C do not impact the quality of the product.

The product can be returned to the fridge and no change in expiry dates is required if exposed to the above conditions.

Contact GSK in cases where additional stability data is required. Refer to the electronic medicines compendium (eMC) at https://www.medicines.org.uk for company contact details.

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

20 December 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)
Pre-registration (Filed)
January 2021
Feb 22Has been filed in the US [8].
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