Rota virus

Rotavirus vaccine is not intended for use in adults. There are no data on the use of rotavirus vaccine during pregnancy.

Rotavirus vaccine is not intended for use in adults. There are no data on the use of rotavirus vaccine during lactation.

Based on evidence generated in clinical trials, breast-feeding does not reduce the protection against rotavirus gastro-enteritis afforded by rotavirus vaccine. Therefore, breast-feeding may be continued during the vaccination schedule.

Not relevant.

Summary of the safety profile

The safety profile presented below is based on data from clinical trials conducted with either the lyophilised or the liquid formulation of rotavirus vaccine. In a total of four clinical trials, approximately 3,800 doses of rotavirus vaccine 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 rotavirus vaccine (lyophilised or liquid formulation) were administered to approximately 51,000 infants.

In three placebo-controlled clinical trials (Finland, India and Bangladesh), in which rotavirus vaccine 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 rotavirus vaccine 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 (Europe, North America, Latin America, Asia, Africa) including trials in which rotavirus vaccine was co-administered with routine paediatric vaccines, the following adverse reactions (collected 31 days post-vaccination) were considered as possibly related to vaccination.

Tabulated list of adverse reactions

Adverse reactions reported are listed according to the following frequency: Frequencies are reported as: Very common (≥1/10), Common (≥1/100 to <1/10), Uncommon (≥1/1,000 to <1/100), Rare (≥1/10,000 to <1/1,000), Very rare (<1/10,000).

^* Because these events were reported spontaneously, it is not possible to reliably estimate their frequency.

Description of selected adverse reactions

Intussusception

Data from observational safety studies performed in several countries indicate that rotavirus vaccines carry an increased risk of intussusception, mostly within 7 days of vaccination. Up to 6 additional cases per 100,000 infants have been observed in these countries against a background incidence of 25 to 101 per 100,000 infants (less than one year of age) per year, respectively.

There is limited evidence of a smaller increased risk following the second dose.

It remains unclear whether rotavirus vaccines affect the overall incidence of intussusception based on longer periods of follow-up.

Other special populations

Safety in preterm infants

In a clinical study, 670 pre-term infants from 27 to 36 weeks of gestational age were administered rotavirus vaccine and 339 received placebo. The first dose was administered from 6 weeks after birth. Serious adverse events were observed in 5.1% of recipients of rotavirus vaccine as compared with 6.8% of placebo recipients. Similar rates of other adverse events were observed in rotavirus vaccine and placebo recipients. No cases of intussusception were reported.

Safety in infants with human immunodeficiency (HIV) infection

In a clinical study, 100 infants with HIV infection were administered rotavirus vaccine or placebo. The safety profile was similar between rotavirus vaccine and placebo recipients.