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Rotarix

Rotarix

SIDE EFFECTS

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a vaccine cannot be directly compared to rates in the clinical trials of another vaccine, and may not reflect the rates observed in practice. As with any vaccine, there is the possibility that broad use of ROTARIX (rotavirus vaccine, live, oral suspension) could reveal adverse reactions not observed in clinical trials.

Solicited and unsolicited adverse events, serious adverse events and cases of intussusception were collected in 7 clinical studies. Cases of intussusception and serious adverse events were collected in an additional large safety study. These 8 clinical studies evaluated a total of 71,209 infants who received ROTARIX (rotavirus vaccine, live, oral suspension) (N = 36,755) or placebo (N = 34,454). The racial distribution for these studies was as follows: Hispanic 73.4%, White 16.2%, Black 1.0%, and other 9.4%; 51% were male.

Solicited Adverse Events

In 7 clinical studies, detailed safety information was collected by parents/guardians for 8 consecutive days following vaccination with ROTARIX (rotavirus vaccine, live, oral suspension) (i.e., day of vaccination and the next 7 days). A diary card was completed to record fussiness/irritability, cough/runny nose, the infant's temperature, loss of appetite, vomiting, or diarrhea on a daily basis during the first week following each dose of ROTARIX (rotavirus vaccine, live, oral suspension) or placebo. Adverse events among recipients of ROTARIX (rotavirus vaccine, live, oral suspension) and placebo occurred at similar rates (Table 1).

Table 1 : Solicited Adverse Events Within 8 Days Following Doses 1 and 2 of ROTARIX (rotavirus vaccine, live, oral suspension) or Placebo (Total Vaccinated Cohort)

  Dose 1 Dose 2
ROTARIX (rotavirus vaccine, live, oral suspension)
N = 3,284
%
Placebo
N = 2,013
%
ROTARIX (rotavirus vaccine, live, oral suspension)
N = 3,201
%
Placebo
N = 1,973
%
Fussiness/irritability* 52 52 42 42
Cough/runny nose† 28 30 31 33
Fever‡ 25 33 28 34
Loss of appetite§ 25 25 21 21
Vomiting 13 11 8 8
Diarrhea 4 3 3 3
Total vaccinated cohort = all vaccinated infants for whom safety data were available.
N = number of infants for whom at least one symptom sheet was completed.
* Defined as crying more than usual.
† Data not collected in 1 of 7 studies; Dose 1: ROTARIX (rotavirus vaccine, live, oral suspension) N = 2,583; placebo N = 1,897; Dose 2: ROTARIX (rotavirus vaccine, live, oral suspension) N = 2,522; placebo N = 1,863.
‡ Defined as temperature ≥ 100.4°F ( ≥ 38.0°C) rectally or ≥ 99.5°F ( ≥ 37.5°C) orally.
§ Defined as eating less than usual.

Unsolicited Adverse Events

Infants were monitored for unsolicited serious and non-serious adverse events that occurred in the 31-day period following vaccination in 7 clinical studies. The following adverse events occurred at a statistically higher incidence (95% CI of Relative Risk excluding 1) among recipients of ROTARIX (rotavirus vaccine, live, oral suspension) (N = 5,082) as compared with placebo recipients (N = 2,902): irritability (ROTARIX (rotavirus vaccine, live, oral suspension) 11.4%, placebo 8.7%) and flatulence (ROTARIX (rotavirus vaccine, live, oral suspension) 2.2%, placebo 1.3%).

Serious Adverse Events (SAEs)

Infants were monitored for serious adverse events that occurred in the 31-day period following vaccination in 8 clinical studies. Serious adverse events occurred in 1.7% of recipients of ROTARIX (rotavirus vaccine, live, oral suspension) (N = 36,755) as compared with 1.9% of placebo recipients (N = 34,454). Among placebo recipients, diarrhea (placebo 0.07%, ROTARIX (rotavirus vaccine, live, oral suspension) 0.02%), dehydration (placebo 0.06%, ROTARIX (rotavirus vaccine, live, oral suspension) 0.02%), and gastroenteritis (placebo 0.3%, ROTARIX (rotavirus vaccine, live, oral suspension) 0.2%) occurred at a statistically higher incidence (95% CI of Relative Risk excluding 1) as compared with recipients of ROTARIX (rotavirus vaccine, live, oral suspension) .

Deaths

During the entire course of 8 clinical studies, there were 68 (0.19%) deaths following administration of ROTARIX (rotavirus vaccine, live, oral suspension) (N = 36,755) and 50 (0.15%) deaths following placebo administration (N = 34,454). The most commonly reported cause of death following vaccination was pneumonia, which was observed in 19 (0.05%) recipients of ROTARIX (rotavirus vaccine, live, oral suspension) and 10 (0.03%) placebo recipients (Relative Risk: 1.74, 95% CI: 0.76, 4.23).

Intussusception

In a controlled safety study conducted in Latin America and Finland, the risk of intussusception was evaluated in 63,225 infants (31,673 received ROTARIX (rotavirus vaccine, live, oral suspension) and 31,552 received placebo). Infants were monitored by active surveillance including independent, complementary methods (prospective hospital surveillance and parent reporting at scheduled study visits) to identify potential cases of intussusception within 31 days after vaccination and, in a subset of 20,169 infants (10,159 received ROTARIX (rotavirus vaccine, live, oral suspension) and 10,010 received placebo), up to one year after the first dose.

No increased risk of intussusception following administration of ROTARIX (rotavirus vaccine, live, oral suspension) was observed within a 31-day period following any dose, and rates were comparable to the placebo group after a median of 100 days (Table 2). In a subset of 20,169 infants (10,159 received ROTARIX (rotavirus vaccine, live, oral suspension) and 10,010 received placebo) followed up to one year after dose 1, there were 4 cases of intussusception with ROTARIX (rotavirus vaccine, live, oral suspension) compared with 14 cases of intussusception with placebo [Relative Risk: 0.28 (95% CI: 0.10, 0.81)]. All of the infants who developed intussusception recovered without sequelae.

Table 2 : Intussusception and Relative Risk With ROTARIX (rotavirus vaccine, live, oral suspension) Compared With Placebo

Confirmed Cases of Intussusception ROTARIX
N = 31,673
Placebo
N = 31,552
Within 31 days of diagnosis after any dose 6 7
Relative Risk (95% CI) 0.85 (0.30,2.42)
Within 100 days of dose 1* 9 16
Relative Risk (95% CI) 0.56 (0.25,1.24)
CI = Confidence Interval.
* Median duration after dose 1 (follow-up visit at 30 to 90 days after dose 2).

Among vaccine recipients, there were no confirmed cases of intussusception within the 0- to 14-day period after the first dose (Table 3), which was the period of highest risk for the previously licensed oral live rhesus rotavirus-based vaccine.1

Table 3 : Intussusception Cases by Day Range in Relation to Dose

Day Range Dose1 Dose2 AnyDose
ROTARIX
N = 31,673
Placebo
N = 31,552
ROTARIX
N = 29,616
Placebo
N = 29,465
ROTARIX
N = 31,673
Placebo
N = 31,552
0-7 0 0 2 0 2 0
8-14 0 0 0 2 0 2
15-21 1 1 2 1 3 2
22-30 0 1 1 2 1 3
Total (0-30) 1 2 5 5 6 7

Kawasaki Disease

Kawasaki disease has been reported in 18 (0.035%) recipients of ROTARIX (rotavirus vaccine, live, oral suspension) and 9 (0.021%) placebo recipients from 16 completed or ongoing clinical trials. Of the 27 cases, 5 occurred following ROTARIX (rotavirus vaccine, live, oral suspension) in clinical trials that were either not placebo-controlled or 1:1 randomized. In placebo-controlled trials, Kawasaki disease was reported in 17 recipients of ROTARIX (rotavirus vaccine, live, oral suspension) and 9 placebo recipients [Relative Risk: 1.71 (95% CI: 0.71, 4.38)]. Three of the 27 cases were reported within 30 days post-vaccination: two cases (ROTARIX (rotavirus vaccine, live, oral suspension) = 1, placebo = 1) were from placebo-controlled trials [Relative Risk: 1.00 (95% CI: 0.01, 78.35)] and one case following ROTARIX (rotavirus vaccine, live, oral suspension) was from a non-placebo-controlled trial. Among recipients of ROTARIX (rotavirus vaccine, live, oral suspension) , the time of onset after study dose ranged 3 days to 19 months.

Postmarketing Experience

The following adverse events have been reported since market introduction of ROTARIX (rotavirus vaccine, live, oral suspension) outside the U.S. Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to vaccination with ROTARIX (rotavirus vaccine, live, oral suspension) .

Blood and Lymphatic System Disorders: Idiopathic thrombocytopenic purpura.

Gastrointestinal Disorders: Hematochezia, intussusception.

General Disorders and Administration Site Conditions: Maladministration.

REFERENCES

1. Murphy TV, Gargiullo PM, Massoudi MS, et al. Intussusception among infants given an oral rotavirus vaccine. N Engl J Med 2001;344:564–572.

Read the Rotarix (rotavirus vaccine, live, oral suspension) Side Effects Center for a complete guide to possible side effects

DRUG INTERACTIONS

Concomitant Vaccine Administration

In clinical trials, ROTARIX (rotavirus vaccine, live, oral suspension) was administered concomitantly with US-licensed and non-US-licensed vaccines. In a US coadministration study in 484 infants, there was no evidence of interference in the immune responses to any of the antigens when PEDIARIX® [Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined], a US-licensed 7-valent pneumococcal conjugate vaccine (Wyeth Pharmaceuticals Inc.), and a US-licensed Hib conjugate vaccine (Sanofi Pasteur SA) were coadministered with ROTARIX (rotavirus vaccine, live, oral suspension) as compared with separate administration of ROTARIX (rotavirus vaccine, live, oral suspension) .

Immunosuppressive Therapies

Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs, and corticosteroids (used in greater than physiologic doses), may reduce the immune response to ROTARIX. [See WARNINGS AND PRECAUTIONS.]

Read the Rotarix Drug Interactions Center for a complete guide to possible interactions

Last reviewed on RxList: 10/30/2009
This monograph has been modified to include the generic and brand name in many instances.

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