What is Rotarix?
Rotarix is an oral vaccine (vaccine given by mouth) available in the following forms:
- powder and solvent to mix to form an oral suspension in an oral applicator,
- oral suspension in a pre-filled oral applicator or tube.
Rotarix contains a live attenuated (weakened) form of human rotavirus (strain RIX4414).
What is Rotarix used for?
Rotarix is used in infants from the sixth week of life as a vaccine to prevent gastroenteritis (diarrhea and vomiting) due to rotavirus infection. Rotarix is administered based on official recommendations.
The vaccine can only be obtained with a prescription.
How is Rotarix used?
Rotarix is given in two doses at least four weeks apart. The first dose should be given after the sixth week of the infant's life. It is preferable that both doses are administered within the 16th week of life, in any case never after the 24th week of life. The same vaccination protocol can be applied in preterm infants born up to 13 weeks before term (starting at 27 weeks of management age).
If the powder and solvent are used, they must be mixed together shortly before administration of the vaccine and the resulting suspension should be introduced directly into the child's mouth using the oral applicator provided. If the ready-made oral suspension is used, the contents of the "Oral applicator or pre-filled tube should be introduced directly into the baby's mouth. Rotarix can be given at the same time as other vaccines.
How does Rotarix work?
Rotarix contains tiny amounts of rotavirus, a virus that causes gastroenteritis. The virus is alive, but it has been weakened so that it does not cause disease, making it suitable for use in a vaccine. When the vaccine is given to a newborn, the immune system (the disease-fighting system) recognizes the virus weakens as a foreign body and produces antibodies.An antibody is one
special protein that can neutralize or destroy an antigen, such as a virus. Following vaccination, the immune system will be able to produce antibodies more quickly if the virus is re-exposed. This facilitates protection against gastroenteritis caused by rotavirus.
After vaccination with Rotarix, the percentage of newborns producing rotavirus antibodies ranges from 78 to 95%.
How has Rotarix been studied?
In total, clinical trials of Rotarix in humans involved more than 72,000 infants and took place in various locations around the world. The main study compared the efficacy and safety of the vaccine with placebo (a dummy vaccine) and involved more than 63,000 infants born at full term (after at least 36 weeks' gestation). The study was very large. as intended to verify whether the vaccine was capable of causing an extremely rare serious complication, known as intussusception, a disease in which part of the intestine slips into another intestinal tract, causing an obstruction (blockage) . Effectiveness was measured by looking at how many infants developed severe rotavirus gastroenteritis in the months following vaccination and before the age of one.
Another study compared the safety of Rotarix versus placebo and their ability to stimulate the production of antibodies in 1 009 newborns, born premature of no more than 13 weeks. These results were compared with findings from a study of full-term infants vaccinated with Rotarix.
Four additional studies involving over 3,000 infants were then carried out to show that the two forms of the vaccine had equivalent safety and efficacy in stimulating the production of antibodies against rotavirus.
What benefit has Rotarix shown during the studies?
Rotarix was more effective than placebo in preventing severe gastroenteritis due to rotavirus. In the main study, the number of cases of severe rotavirus gastroenteritis decreased after vaccination with Rotarix: 0.1% of infants vaccinated with Rotarix, in which its efficacy was evaluated, developed severe forms of rotavirus gastroenteritis. (12 out of over 9,000) compared to 0.9% of infants who were given a placebo (77 out of nearly 9,000).
The study in premature babies found that Rotarix was well tolerated and produced levels of antibodies comparable to those of full-term babies.
What is the risk associated with Rotarix?
In the main study, in which approximately 31 500 infants received Rotarix and over 31 500 a placebo, nine infants developed intussusception after vaccination with Rotarix, compared with 16 who developed the disease after receiving a placebo vaccine. This shows that Rotarix does not carry an increased risk of developing intussusception. The most common side effects (seen in more than one in 10 patients) are irritability and loss of appetite. For the full list of side effects reported with Rotarix, see the package leaflet.
Rotarix must not be used in infants who may be hypersensitive (allergic) to any of the components of the vaccine. Rotarix should not be given to infants who have shown signs of allergy after receiving a previous dose of rotavirus vaccine, who have developed intussusception in the past or who have intestinal problems that could predispose them to this complication. Vaccination with Rotarix it should be postponed in infants presenting with sudden high fever, diarrhea or vomiting. For the full list of restrictions on use, see the package leaflet.
Rotarix must never be given into a vein.
Like other vaccines, the use of Rotarix in very premature infants may carry a risk of respiratory apnea (short pauses to stop breathing). The breathing of these infants should be monitored for three days following vaccination, particularly after vaccination. first vaccination.
Why has Rotarix been approved?
The Committee for Medicinal Products for Human Use (CHMP) decided that Rotarix's benefits are greater than its risks for vaccinating infants past the sixth week of life for the prevention of gastroenteritis due to rotavirus infection. The committee therefore recommended the granting of a marketing authorization for Rotarix.
Other information about Rotarix:
On 21 February 2006, the European Commission released GlaxoSmithKline Biologicals s.a. a "marketing authorization" for Rotarix, valid throughout the European Union.
For the full version of the Rotarix EPAR, click here
Last update of this summary: 09-2009
The information on Rotarix - vaccine published on this page may be out of date or incomplete. For a correct use of this information, see the Disclaimer and useful information page.
