Rotarix Adverse Reactions

Clinical trial data: The following convention has been used for the classification of frequency: Very common ≥1/10; Common ≥1/100 and <1/10; Uncommon ≥1/1,000 and <1/100; Rare ≥1/10,000 and <1/1,000; Very rare <1/10,000.
The safety profile presented as follows is based on data from clinical trials conducted with either the lyophilised or the liquid formulation of Rotarix.
In a total of four clinical trials, approximately 3,800 doses of Rotarix liquid formulation were administered to approximately 1,900 infants. Those trials have shown that the safety profile of the liquid formulation is comparable to the lyophilised formulation.
In a total of twenty-three clinical trials, approximately 106,000 doses of Rotarix (lyophilised or liquid formulation) were administered to approximately 51,000 infants.
In three placebo-controlled clinical trials, in which Rotarix was administered alone (administration of routine paediatric vaccines was staggered), the incidence and severity of the solicited events (collected 8 days post-vaccination), diarrhoea, vomiting, loss of appetite, fever, irritability and cough/runny nose, were not significantly different in the group receiving Rotarix when compared to the group receiving placebo. No increase in the incidence or severity of these events was seen with the second dose.
In a pooled analysis from seventeen placebo-controlled clinical trials including trials in which Rotarix was co-administered with routine paediatric vaccines (see Interactions), 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.
The risk of intussusception has been evaluated in a large safety trial conducted in Latin America and Finland where 63,225 subjects were enrolled. This trial gave evidence of no increased risk of intussusception in the Rotarix group when compared with the placebo group as shown in the table as follows. (See Table 6.)


Click on icon to see table/diagram/image


Safety in preterm infants: In a clinical study, 1,009 preterm infants were administered with Rotarix lyophilised formulation or placebo (198 were 27-30 weeks gestational age and 801 were 31-36 weeks gestational age). The first dose was administered from 6 weeks after birth. Serious adverse events were observed in 5.1% of recipients of Rotarix as compared to 6.8% of placebo recipients. Similar rates of other adverse events were observed in Rotarix and placebo recipients. No cases of intussusception were reported.
Post-marketing data: Gastrointestinal disorders: Rare: haematochezia, gastroenteritis with vaccine viral shedding in infants with Severe Combined Immunodeficiency (SCID) disorder.
Very rare: intussusceptions (see Precautions).