Rotavirus (RV) is the cause of severe acute gastroenteritis in infants and young children, which affects over 95% of children by the time they reach the age of 5 years, regardless of their socio-economic status and the state of the environment. It is estimated that every year in the world, 138 million children ill rotavirus gastroenteritis (RVG). In hot climates (tropical and subtropical), rotavirus gastroenteritis is a seasonal disease epidemics attributable to the winter months. In the world of rotavirus causes about 28 to 71% of hospitalizations for diarrhea, regardless of the geographical region and season.
Protection from natural rotavirus infection (RVI) is largely serotype-specific. The RotaTeq vaccine includes the most common human rotavirus serotypes G1, G2, G3, G4 and P1, which accounted for more than 88% of all cases of RVI from 1973 to 2003 around the world. The exact immunological mechanism by which Rotatek® protects against rotavirus gastroenteritis, unknown. Studies suggest a combination of factors that are important for immunity against rotavirus, including neutralizing antibodies to the outer capsid proteins of the G, serum and secretory IgA, and other local mucosal responses. Rotatek® induces antibodies that neutralized serotypes G1, G2, G3, G4 and P1. In phase III studies from 92.9% to 100% in treated Rotateq trehdozovom mode reached a significant increase in the serum anti-rotavirus IgA.
RotaTeq protects against the G-serotypes included and not included in the vaccine. In clinical studies, the effectiveness against REST gastroenteritis of any severity caused by natural rotavirus from among G-serotypes included in the vaccine was 73.8%, and efficacy against severe rotavirus gastroenteritis – 98.2% for the first rotavirus season after completion of vaccination. Efficacy against gastroenteritis of any severity caused to non-vaccine serotype G9, was 74.1%. Efficacy Rotateq, for two rotavirus season after completion of vaccination against rotavirus gastroenteritis of any severity was 71.3%. Rotatek® reduced hospitalizations, emergency department visits, and job loss dneypo childcare.
Efficacy and safety in premature infants:
In a placebo-controlled study of 1007 preterm infants (gestational age 25 to 36 weeks) who received Rotatek® according to their chronological age, the safety profile and efficacy (70.3%) Rotateka® were generally the same as the safety and effectiveness in the general population.
Rotavirus vaccine live, pentavalent
Merck Sharp & Dohme BV, USA
1 dose (2 ml) reassortants contain living human and bovine rotaviruses: G1 reassortant at least 2.2 × 106 IU *; G2 reassortant at least 2.8 × 106 IU *; G3 reassortant at least 2.2 × 106 IU *; G4ne reassortant at least 2 × 106 IU *; reassortant P1A  is not less than 2.3 × 106 IU *.
* IE – infectious units
sucrose – 1080 mg,
Sodium hydroxide – 2.75 mg
Sodium Citrate dihydrate – 127 mg
sodium dihydrogen phosphate dihydrate – 29.8 mg,
polysorbate 80 – from 0.17 to 0.86 mg,
culture media – 15% (by volume).
Active immunization of children aged from 6 to 32 weeks to prevent gastroenteritis caused by rotavirus serotypes G1, G2, G3, G4 and serotype G, containing P1a  (e.g., G9).
- intussusception history;
- congenital malformation of the gastrointestinal tract that predispose to intussusception;
- immunodeficiency, immunodeficiency or suspected HIV status;
- acute inflammatory processes accompanied by high temperature (in these cases, vaccination is performed after recovery or remission). Infectious disease mild should not be a reason for non-vaccination;
- an acute form of diarrhea or vomiting (in these cases, the vaccination is carried out at a stage of remission);
- fructose intolerance, malabsorption of glucose-galactose complex failure enzymes sucrase and (or) isomaltase;
- hypersensitivity to any component RotaTeq vaccines, as well as administering RotaTeq vaccine history.
- during active gastrointestinal disease, including chronic diarrhea (no clinical findings);
- with developmental delay (no clinical findings);
- at immunocompromised state (e.g., as a result of malignancy, or immunosuppressive therapy);
- when blood transfusion or blood products, including immunoglobulins, less than 42 days prior to the planned vaccination.
Infectious and parasitic diseases: often – upper respiratory tract infection; rarely – nasopharyngitis, otitis media.
From the digestive system: very often – diarrhea, vomiting; rarely – pain in the upper abdomen, gematoheziya *; rarely – intussusception *.
Skin and subcutaneous tissue disorders: rarely – rash; rarely – urticaria *.
The respiratory system: rarely – bronchospasm.
General disorders: very often – hyperthermia.
Kawasaki disease was observed in 5 out of 36,150 children in the vaccine group (
The risk of intussusception has been evaluated in a placebo-controlled study. When observing for 42 days after administration of each dose was observed in 6 cases of intussusception in the group receiving the vaccine RotaTeq (34,837 patients) and 5 cases in placebo group (34 788 patients). Regardless of intussusception was observed over time after administration of any dose.
These post-marketing studies do not confirm an increased risk of intussusception after RotaTeq vaccination drug.
Special patient groups
Children with SCID have been noted cases of gastroenteritis caused by rotavirus strains included in the vaccine. There is a risk of apnea in preterm infants (born at gestational age 28 weeks, inclusive).
How to accept, acceptance rate and dosage
RotaTeq vaccine is taken orally. Not suitable for injection.
The vaccination schedule
vaccination course consists of three doses of drug RotaTeq intervals between doses from 4 to 10 weeks.
The first dose of RotaTeq administered the drug to children aged 6 to 12 weeks.
All three doses recommended to enter until the child is 32 weeks.
When administered incomplete dose (e.g., a child or regurgitated srygnul of the dose) is not recommended to introduce additional dose, since this dosing regimen has not been studied in clinical trials. The remaining dose should be administered according to the scheme of vaccination.
RotaTeq vaccine can be used in premature infants born at gestational age of at least 25 weeks. The vaccine should be administered to these children at the earliest chemcherez 6 weeks after birth.
Terms of administration of the vaccine
Vaccine RotaTeq is a ready-to-use liquid.
The vaccine can be used regardless of the meal or any liquids, including breast milk.
The vaccine should not be mixed with other solutions, and vaccines in a single container. The vaccine can not be dissolved or diluted. Do not use if found damage to the exterior of the tube and / or the contents of the tube looks unusual.
Recommendations on preparation and holding of vaccination
Remove one package from the freezer, break it and get the plastic tube. If the tube with the vaccine is not placed in a foil packet, it is necessary to start from the second stage.
Holding the tube vertically, the cap up, tap the cap to remove liquid from the dispensing tip.
Puncture the dispensing tip by turning the screw-cap all the way clockwise.
Rotate the cap counterclockwise and remove it.
Enter dose gently squeezing out the liquid into the child’s mouth toward the inner side of the cheeks, while tube is empty (at the tip of the tube can remain liquid droplet).
In the dark place at a temperature of 2-8 ° C (not frozen)
Rotavirus vaccine live, pentavalent
Vaccine RotaTeq can be given to children at the same time with all the following antigens that are part of both monovalent and combination vaccines: diphtheria toxoid, tetanus toxoid, acellular pertussis vaccine, a conjugated vaccine against Haemophilus influenzae type b, inactivated poliomyelitis vaccine, a vaccine against hepatitis B virus, hexavalent vaccine (containing the above-mentioned components), conjugated pneumococcal vaccine, meningococcal serogroup C vaccine showed no decrease in you abotki protective antibodies with simultaneous introduction of several vaccines and RotaTeq vaccine.
Simultaneous administration of oral poliovirus vaccine (OPV) and RotaTeq vaccine did not affect the immune response elicited by OPV, but somewhat reduced immune response to RotaTeq, but no data confirming the decrease in the degree of protection against severe rotavirus gastroenteritis. The immune response to the vaccine when administered RotaTekne modifications OPV two weeks after administration RotaTeq vaccine.
According to clinical studies vaccine virus was detected in feces from 8.9% vaccinated only within 1 week after the first vaccine dose and only 0.3% of the children (1 case) after administration of the third dose. According to postmarketing data can be transmitted vaccine virus to unvaccinated individuals. RotaTeq vaccine must be administered with caution to children in close contact with people with immunodeficiency (including those with cancer, or immunocompromised persons receiving immunosuppressive therapy). specific hygiene rules must be observed when in contact with the feces of vaccinated children.
Data on the efficacy and safety of RotaTeq vaccine in children with compromised immune systems, children with asymptomatic HIV infection or children who received blood transfusions or made immunoglobulins administered no more than 42 days before the introduction, there is no vaccine. It is unlikely that an asymptomatic HIV infection (HIV carrier) will affect the safety and efficacy of RotaTeq vaccine. However, due to the lack of clinical data is not recommended the appointment of RotaTeq vaccine for asymptomatic HIV infection.
Children with SCID have been noted cases of gastroenteritis caused by rotavirus strains included in the vaccine.
In a clinical study, RotaTeq vaccine used in approximately 1,000 children born at the gestational age of 25 to 36 weeks, the first dose was administered 6 weeks after birth. The effectiveness of RotaTeq vaccine in this subgroup did not differ from the subgroup of children born at term. However, among these 1,000 children, 19 were born in the period from 25 to 28 weeks of gestation, 55 – from 29 to 31 weeks, and the rest – from 32 to 36 weeks.
According to clinical studies, the risk of intussusception in the group of patients who received RotaTeq vaccine was comparable to the risk in the placebo group. However, within 31 days after the first dose of vaccine and RotaTeq, especially during the first 7 days, a small increase in the risk of intussusception can not be excluded. In this regard, should be closely monitored for the appearance of symptoms characteristic of the disease: acute abdominal pain, uncontrollable vomiting, blood in the stool, abdominal distention, fever – and immediately seek medical attention if they occur.
Said level of protection after vaccination preparation RotaTeq provided with completed course of immunization consisting of three doses. As with any other vaccine, RotaTeq may not provide complete protection of all vaccinated. RotaTeq vaccine is only effective against rotavirus infection and does not protect against gastroenteritis caused by other pathogens.
Clinical study of the effectiveness of protection against rotavirus gastroenteritis were performed in Europe, USA, Latin America and Asia. During the data from clinical studies the most common rotavirus genotype was G1P , while the other genotypes G2P , G3P , G4P  and G9P  were observed less frequently. level of protection, which provides the RotaTeq vaccine against rotavirus other types and in other populations is unknown.
Data from clinical studies on the use of vaccines for prevention RotaTeq after exposure rotavirus gastroenteritis absent.
When the decision on vaccination of a child with severe prematurity (gestation ≤28 weeks, but not less than 25 weeks), especially those with a history of the immaturity of the respiratory system, it is necessary to take into account the fact that the benefits of immunization against rotavirus infection in this group of patients is high, and should not be or abandon vaccination nor tolerate its terms. However, given the potential risk of apnea, holding the first vaccination of a premature baby is preferably done in a hospital environment with the possibility of medical observation of the state of the patient for 48-72 hours.
Because in producing reassortants comprising the vaccine RotaTeq used biological material of animal origin, in the vaccine found small DNA fragments of porcine circovirus types 1 and 2 (PCV-1 and PCV-2), with itself viral particles PCV-1 and / or CMC -2 absent in the vaccine. The ability of CMC-1 and / or PCV2 cause disease in humans is not known.
RotaTeq should be administered as soon as possible after removal from the refrigerator.
The drug may be used after removal from the refrigerator for 48 hours under the condition that it was kept at a temperature not higher than 25 ° C. If the packaging of the vaccine is not used within the specified time, it must be disposed of.
Use in Pediatrics
RotaTeq vaccine is generally well tolerated and highly effective for the prevention of rotavirus gastroenteritis in applying in children aged from 6 to 32 weeks.
Efficacy and safety have not been established in children under the age of 6 weeks.
Effects on ability to drive vehicles and management mechanisms
Pregnancy and lactation
RotaTeq vaccine is only intended for children, these pregnancy and / or lactation is not.
There are several cases of vaccine RotaTeq overdose. Differences in the profile of adverse events compared to the use of the drug at the recommended doses, no.