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Rotarix (Rotavirus Vaccine Live Oral) - Summary

 
 



ROTARIX SUMMARY

ROTARIX (Rotavirus Vaccine, Live, Oral), for oral administration,  is a live, attenuated rotavirus vaccine derived from the human 89-12 strain which belongs to G1P[8] type. The rotavirus strain is propagated on Vero cells. After reconstitution, the final formulation (1 mL) contains at least 106.0 median Cell Culture Infective Dose (CCID50) of live, attenuated rotavirus. The lyophilized vaccine contains amino acids, dextran, Dulbecco's Modified Eagle Medium (DMEM), sorbitol, and sucrose. DMEM contains the following ingredients: sodium chloride, potassium chloride, magnesium sulfate, ferric (III) nitrate, sodium phosphate, sodium pyruvate, D-glucose, concentrated vitamin solution, L-cystine, L-tyrosine, amino acids solution, L-glutamine, calcium chloride, sodium hydrogenocarbonate, and phenol red. The liquid diluent contains calcium carbonate, sterile water, and xanthan. The diluent includes an antacid component (calcium carbonate) to protect the vaccine during passage through the stomach and prevent its inactivation due to the acidic environment of the stomach. ROTARIX contains no preservatives. The tip cap and the rubber plunger of the oral applicator contain dry natural latex rubber. The vial stopper and transfer adapter are latex-free.

ROTARIX® is indicated for the prevention of rotavirus gastroenteritis caused by G1 and non-G1 types (G3, G4, and G9) when administered as a 2-dose series [see Clinical Studies]. ROTARIX is approved for use in infants 6 weeks to 24 weeks of age.


See all Rotarix indications & dosage >>

NEWS HIGHLIGHTS

Published Studies Related to Rotarix (Rotavirus Vaccine)

Human and bovine rotavirus strain antigens for evaluation of immunogenicity in a randomized, double-blind, placebo-controlled trial of a single dose live attenuated tetravalent, bovine-human-reassortant, oral rotavirus vaccine in Indian adults. [2014]
A single dose of live attenuated tetravalent (G1-G4) bovine human reassortant rotavirus vaccine (BRV-TV) was administered to healthy Indian adult volunteers, who were assessed for safety and immunogenicity of the vaccine with 3:1 randomization to vaccine or placebo...

Evaluation of safety and immunogenicity of a live attenuated tetravalent (G1-G4) Bovine-Human Reassortant Rotavirus vaccine (BRV-TV) in healthy Indian adults and infants. [2014]
equally safe and immunogenic as compared to available licensed vaccines... CONCLUSIONS: Overall, the results showed that all three doses of BRV-TV vaccine

Active surveillance for intussusception in a phase III efficacy trial of an oral monovalent rotavirus vaccine in India. [2014]
monovalent rotavirus vaccine developed from the neonatal 116E strain... CONCLUSION: In this licensure study, 23 cases of intussusception were identified

Reactogenicity and safety of a liquid human rotavirus vaccine (RIX4414) in healthy adults, children and infants in China: randomized, double-blind, placebo-controlled Phase I studies. [2013]
We report the findings of three randomized, double-blind, placebo-controlled Phase I studies undertaken to support licensure of the liquid formulation of the human G1P[8] rotavirus (RV) vaccine (RIX4414; GlaxoSmithKline Biologicals SA) in China... Vaccine take in infants who received the liquid human RV vaccine was 86.7% (95% CI: 59.5-98.3).

Efficacy, safety and immunogenicity of a human rotavirus vaccine (RIX4414) in Hong Kong children up to three years of age: a randomized, controlled trial. [2013]
children up to three years of age... CONCLUSION: RIX4414 was efficacious, immunogenic and safe in the prevention of

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Clinical Trials Related to Rotarix (Rotavirus Vaccine)

Immunogenicity of Rotavirus Vaccine [Completed]
Rotavirus is one of the most common causes of severe diarrhea, responsible for 40% of all diarrhea related deaths in children worldwide. Two vaccines against Rotavirus, Rotarix® and Rotateq® were licensed in many high and middle income countries in 2006, but lack of efficacy data in low income countries had prevented WHO from making a universal recommendation of their use until recently. This study will be conducted in Pakistan and will look at two objectives: 1. To compare the immunogenicity of Rotarix® vaccine when administered at 6 and 10 weeks of life and at 6, 10 and 14 weeks of life. 2. To compare the immunogenicity of Rotarix® vaccine in infants breast fed at the time of vaccine administration with infants whose breast feeding is withheld for one hour before and after vaccine administration.

Pilot Study of the Rotavirus Vaccine in Infants With Intestinal Failure [Completed]
The purpose of this study is to assess the safety and immune response of the rotavirus vaccine in infants who have undergone abdominal surgery.

Improving Rotavirus Vaccine Immune Response [Completed]
Rotavirus is the leading cause of severe gastroenteritis in infants and young children worldwide and is estimated to account for 600,000 deaths in children <5 years of age. However, live oral enteric vaccines (e. g. OPV, cholera vaccines, typhoid vaccine) have been less immunogenic in poor communities with high levels of malnutrition and poor sanitation. Rotavirus vaccines also appear to be less immunogenic in the setting where they are most needed. High maternal antibody (IgG) to rotavirus and breast feeding near the time of vaccination may inhibit rotavirus vaccine effectiveness. We propose a quick study to look at practical ways to improve the immunogenicity of rotavirus vaccine in our own setting in Bangladesh. The objectives are to assess if delaying Rotarix vaccination will improve the immune response to the vaccine and to assess if avoiding breastfeeding in the 45 minutes before and after vaccine administration will improve the immune response to administration of Rotarix vaccine. The study will be conducted in the urban Dhaka Mirpur Community, a setting where previous rotavirus vaccine immunogenicity studies have been successfully conducted. A total of 300 infant will be randomly assigned to one of the following groups: 1) Administration of Rotarix at 6 and 10 weeks co-administered with oral polio virus vaccine with no intervention in normal breastfeeding practices before and after receiving vaccine. 2) Administration of Rotarix at 6 and 10 weeks co-administered with oral polio virus. Breastfeeding will not be permitted 45 minutes prior to vaccine administration and 45 minutes after each vaccine administration. 3) Administration of Rotarix at 14 and 18 weeks co-administered with oral polio virus, with no intervention in normal breastfeeding practices before and after receiving vaccine. 4) Administration of Rotarix at 14 and 18 weeks co-administered with oral polio virus. Breastfeeding will not be permitted 45 minutes prior to vaccine administration and 45 minutes after each vaccine administration. Blood and stool samples will be collected from infants and breast milk from mothers. The primary outcome is to determine the sero-conversion rate of anti-rotavirus IgA in different groups of infants.

Rotavirus Vaccine Produced by Butantan Institute [Completed]

Rotavirus Efficacy and Safety Trial (REST)(V260-006) [Completed]
This study was designed to evaluate the safety of the investigational rotavirus vaccine and the efficacy to prevent rotavirus gastroenteritis.

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Page last updated: 2015-08-10

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