Efficacy Against RGE*

ROTARIX demonstrated efficacy vs placebo in the prevention of rotavirus gastroenteritis (RGE)1

 

ROTARIX demonstrated significant efficacy in the prevention of RGE of any grade of severity1,2

In a clinical trial studying the prevention of RGE, ROTARIX demonstrated:

87% pie chart icon

87% efficacy in the prevention of RGE of any grade of severity1,2

Primary efficacy endpoint from 2 weeks after the second dose through 1 rotavirus season (95% CI: 80, 92) (P<0.001 vs placebo; according to protocol [ATP])1

90% pie chart icon

90% first-dose efficacy in the prevention of RGE of any grade of severity1,†

Secondary efficacy endpoint immediately following dose 1 and prior to dose 2 (95% CI: 9, 100) (total vaccinated cohort)1

  • †

    ROTARIX is not approved for use as a single dose.

100% pie chart icon

100% efficacy in reducing hospitalizations for RGE1

Secondary efficacy endpoint through 1 rotavirus season (95% CI: 82, 100) (P<0.001; ATP)1

Study design

 

A randomized, double-blind, placebo-controlled study was conducted in 6 European countries comparing ROTARIX (n=2646) vs placebo (n=1348) (total vaccinated cohort). The first dose was given at 6-14 weeks of age, and the second dose was given at least 4 weeks after the first dose. The 2-dose series was completed by 24 weeks of age. Analysis of the ATP cohort included all infants in the efficacy cohort who received 2 doses of vaccine according to randomization (ROTARIX, n=2572; placebo n=1302).1,2

 

  • *

    There are two formulations of ROTARIX: a reconstituted lyophilized formulation (supplied in a vial and oral dosing applicator presentation) and a liquid formulation (supplied in an oral dosing applicator-only presentation). Efficacy was evaluated using the reconstituted lyophilized formulation. These data are relevant to the liquid formulation because both formulations contain the same live, attenuated rotavirus strain and are manufactured using a similar process.1

CI=confidence interval.

 

INDICATIONS & IMPORTANT SAFETY INFO

INDICATIONS

IMPORTANT SAFETY INFORMATION FOR ROTARIX

INDICATIONS

ROTARIX is a vaccine 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. ROTARIX is approved for use in infants 6 weeks and up to 24 weeks of age.

IMPORTANT SAFETY INFORMATION FOR ROTARIX

  • Contraindications for ROTARIX include a history of any of the following: hypersensitivity to the vaccine or any component of the vaccine; uncorrected congenital malformation of the gastrointestinal tract (such as Meckel’s diverticulum) that would predispose the infant to intussusception; intussusception (in postmarketing experience, intussusception resulting in death following a second dose has been reported following a history of intussusception after the first dose); or Severe Combined Immunodeficiency Disease (SCID)
  • The tip caps of the prefilled oral dosing applicators contain natural rubber latex, which may cause allergic reactions
  • Administration in infants suffering from acute diarrhea or vomiting should be delayed. Safety and effectiveness in infants with chronic gastrointestinal disorders have not been evaluated
  • Safety and effectiveness in infants with known primary or secondary immunodeficiencies, including infants with human immunodeficiency virus (HIV), infants on immunosuppressive therapy, or infants with malignant neoplasms affecting the bone marrow or lymphatic system have not been established
  • Rotavirus shedding in stool occurs after vaccination with peak excretion occurring around Day 7 after Dose 1. One clinical trial demonstrated that vaccinees transmit vaccine virus to healthy seronegative contacts. Caution is advised when considering whether to administer ROTARIX to individuals with immunodeficient close contacts
  • A study conducted after approval of ROTARIX showed an increased risk of intussusception in the 31 days after the first dose of ROTARIX, especially in the first 7 days. In other reports, an increased risk of intussusception has been observed within 7 days after dose 2
  • Safety and effectiveness of ROTARIX when administered after exposure to rotavirus have not been evaluated
  • In clinical studies, common (≥5%) solicited adverse reactions among recipients of ROTARIX included fussiness/irritability, cough/runny nose, fever, loss of appetite, and vomiting
  • Safety and effectiveness of ROTARIX in infants younger than 6 weeks or older than 24 weeks of age have not been evaluated
  • The effectiveness of ROTARIX in pre-term infants has not been established
  • Vaccination with ROTARIX may not result in protection in all vaccine recipients

 

Please see full Prescribing Information for ROTARIX.

References

  1. Prescribing Information for ROTARIX.
  2. Vesikari T, Karvonen A, Prymula R, et al. Efficacy of human rotavirus vaccine against rotavirus gastroenteritis during the first 2 years of life in European infants: randomised, double-blind controlled study. Lancet. 2007;370:1757-1763.