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Rotarix is designed to protect infants against rotavirus disease with only two oral doses1-3

Rotarix is the only globally available 2-dose oral human rotavirus vaccine allowing full vaccination by 10 weeks of age, which is four weeks earlier than 3-dose schedule vaccines1,4

The same information was first published in Deen J et al. Hum Vaccin Immunother 2018; 14:495–4994
The illustration has been independently created by GSK from the original data

Early vaccination protects babies when they are most vulnerable5

There is a high burden of rotavirus disease in babies from around six months of age.6,7
Early vaccination helps to protect them before they are exposed to the virus, and avoids the overlap between vaccination and the natural peak of intussusception8,9

Rotarix induces a strong immune response10

Rotarix is associated with a high seroconversion rate starting with the first dose*10

With a bovine-virus-based vaccine, a greater aggregate titre is needed to provide immunisation, and 3 oral doses are required, with at least four weeks between doses11,12

Anti-RV IgA antibody seroconversion rates in European infants aged 6–12 weeks after vaccination with Rotarix*10

The same data were first published in Vesikari T et al. Vaccine 2004; 22:2836–284210
The illustration has been independently created by GSK from the original data

Anti-RV serum IgA antibody seroresponse in infants aged 41–59 days at Dose 113

The same data were first published in Dhingra MS et al. Vaccine 2014; 32:A117–A12313
The illustration has been independently created by GSK from the original data

Rotarix helps to protect babies starting from the first dose1,14,15

While Rotarix consists of two oral doses, effectiveness data show that babies can start to benefit from partial protection with the first dose1,14,15

Multi-national first-dose vaccine effectiveness data**

Brazil1

60% (95% CI: 37–75) n (cases/controls)=115/1481

El Salvador1

51% (95% CI: 26–67) n (cases/controls)=251/770

USA14

96% (95% CI: 67–99) n (cases/controls)=64/240†

England15

69% (95% CI: 40–84) n (cases/controls)=26/130

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Broad protection & impact

Rotarix protects against 9 rotavirus strains,†† all circulating globally1

SEE THE DATA

Compliance & coverage

International data suggest that a 2-dose schedule may enhance vaccination compliance and coverage16-18

VIEW THE STATISTICS

Parent support

A baby’s first check-up is one of the best moments to discuss rotavirus disease prevention

CLICK HERE

Footnotes

CI, confidence interval; Ig, immunoglobulin; RV, rotavirus
*Results correspond to a dose of 105.8 ffu
**Rotarix consists of two oral doses. It is recommended that babies who receive a first dose of Rotarix complete the 2-dose regimen with Rotarix
†In this stratified analysis, vaccine effectiveness for both Rotarix and RV5 was shown. Vaccine effectiveness after one dose of RV5 was 68% (95% CI: 45–82), but no significant difference in vaccine effectiveness was observed after the full schedules for each vaccine (p=0.100) or for receiving any vaccine dose (p=0.292)
††Combined efficacy and effectiveness data

Safety Information*

Contraindications:

  • Rotarix should not be administered to subjects with known hypersensitivity after previous administration of Rotarix vaccine or to any component of the vaccine.
  • Subjects with history of intussusception, uncorrected congenital malformation (such as Meckel’s diverticulum) of the gastrointestinal tract that would predispose to intussusception and Severe Combined Immunodeficiency (SCID) disorder.

Warnings and Precautions:

  • It is good clinical practice that vaccination should be preceded by a review of the medical history (especially with regard to previous vaccination and possible occurrence of undesirable events) and a clinical examination.
  • As with other vaccines, administration of Rotarix should be postponed in subjects suffering from acute severe febrile illness. However, the presence of a minor infection, such as a cold, should not result in the deferral of vaccination. The administration of Rotarix should be postponed in subjects suffering from diarrhoea or vomiting.
  • As a precaution, healthcare professionals should follow-up on any symptoms indicative of intussusception (severe abdominal pain, persistent vomiting, bloody stools, abdominal bloating and/or high fever). Parents/guardians should be advised to promptly report such symptoms.

Adverse Events:

Rotarix was co-administered with routine paediatric vaccines, the following adverse reactions (collected 31 days post-vaccination) were considered as possibly related to vaccination.

Gastrointestinal disorders: Common: diarrhoea; Uncommon: flatulence, abdominal pain

Skin and subcutaneous tissue disorders: Uncommon: dermatitis

General disorders and administration site conditions: Common: irritability.

*Rotarix Liquid Oral Applicator Prescribing Information v02 (GDS015/IPI11)

References

  1. Rotarix Liquid Oral Applicator Prescribing Information v02 (GDS015/IPI11).
  2. Lopman BA et al. PLoS One 2012; 7:e14720.
  3. Ward RL, Bernstein DI. Clin Infect Dis 2009; 48:222–228.
  4. Deen J et al. Hum Vaccin Immunother 2018; 14:495–499.
  5. Steele AD et al. Hum Vaccin Immunother 2016; 12:2406–2412.
  6. European Centre for Disease Prevention and Control (ECDC). Expert opinion on rotavirus vaccination in infancy. 2017. ECDC, Stockholm.
  7. Patel MM et al. PLoS Med 2012; 9:e1001330.
  8. Jiang J et al. PLoS One 2013; 8:e68482.
  9. Costantino C et al. Ital J Pediatr 2015; 41:52.
  10. Vesikari T et al. Vaccine 2004; 22:2836–2842.
  11. Glass R, Parashar U. N Engl J Med 2006; 354:75–77.
  12. RotaTeq SmPC, September 2020.
  13. Dhingra MS et al. Vaccine 2014; 32:A117–A123.
  14. Payne DC et al. Clin Infect Dis 2015; 61:1792–1799.
  15. Walker JL et al. Vaccine X 2019; 1:100005.
  16. Luna-Casas G et al. Hum Vaccin Immunother 2018; doi:10.1080/21645515.
  17. Krishnarajah G et al. Vaccine 2015; 33:479–486.
  18. Aquilani S et al. Ann Ig 2020; 32:433–435.

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PM-MY-ROT-WCNT-210008 03/21