Safety Profile for ROTARIX

There are two formulations of ROTARIX: a reconstituted lyophilized formulation and a liquid formulation. Safety data accrued with each formulation is relevant to the other because each contains the same live, attenuated rotavirus strain and is manufactured using a similar process.1

Clinical Trials Experience With Liquid Formulation1

  • The safety of the ROTARIX liquid formulation was evaluated in 3 randomized clinical studies. A total of 4223 infants received ROTARIX (liquid formulation, n=2507; reconstituted lyophilized formulation, n=1716)

Solicited Adverse Reactions Within 8 Days Following Doses 1 and 2 of ROTARIX (Liquid or Reconstituted Lyophilized Formulation), Study 10 Total Vaccinated Cohort

  Dose 1 Dose 2
  ROTARIX
(Liquid Formulation)
n=632		 ROTARIX
(Reconstituted
Lyophilized Formulation)
n=640		 ROTARIX
(Liquid Formulation)
n=607		 ROTARIX
(Reconstituted
Lyophilized Formulation)
n=609
Adverse Reactions Overall % G3 % Overall % G3 % Overall % G3 % Overall % G3 %
Fussiness/irritability a 70.9 9.2 71.6 8.8 72.5 13.7 70.1 11.8
Cough/runny nose b 27.2 0.5 28.1 1.3 36.9 3.8 36.5 3.6
Fever c 5.7 0.3 5.0 0.3 10.5 0.3 12.3 0.7
Loss of appetite d 32.3 0.2 33.4 0.9 29.5 1.2 29.2 1.8
Vomiting e 17.4 2.8 16.4 3.4 13.7 4.0 12.8 3.3
Diarrhea f 6.2 0.2 5.6 0.8 5.6 0.5 4.3 0.3
  Dose 1
  ROTARIX
(Liquid Formulation)
n=632		 ROTARIX
(Reconstituted Lyophilized Formulation)
n=640
Adverse Reactions Overall
%		 G3
%		 Overall
%		 G3
%
Fussiness/irritability a 70.9 9.2 71.6 8.8
Cough/runny nose b 27.2 0.5 28.1 1.3
Fever c 5.7 0.3 5.0 0.3
Loss of appetite d 32.3 0.2 33.4 0.9
Vomiting e 17.4 2.8 16.4 3.4
Diarrhea f 6.2 0.2 5.6 0.8
  Dose 2
  ROTARIX
(Liquid Formulation)
n=607		 ROTARIX
(Reconstituted Lyophilized Formulation)
n=609
Adverse Reactions Overall
%		 G3
%		 Overall
%		 G3
%
Fussiness/irritability a 72.5 13.7 70.1 11.8
Cough/runny nose b 36.9 3.8 36.5 3.6
Fever c 10.5 0.3 12.3 0.7
Loss of appetite d 29.5 1.2 29.2 1.8
Vomiting e 13.7 4.0 12.8 3.3
Diarrhea f 5.6 0.5 4.3 0.3

G3=Grade 3.

Total vaccinated cohort=All vaccinated infants for whom safety data were available.

n=Number of infants who received the specified dose.

  1. aOverall: Defined as crying more than usual. Grade 3: Crying that could not be comforted/prevented normal activity.
  2. bGrade 3 cough/runny nose: cough/runny nose that prevented daily activity.
  3. cOverall: Defined as temperature ≥100.4°F (≥38.0°C). Grade 3: Defined as temperature >103.1°F (>39.5°C).
  4. dOverall: Defined as eating less than usual. Grade 3: Defined as not eating at all.
  5. eOverall: Defined as 1 or more episodes of forceful emptying of partially digested stomach contents ≥1 hour after feeding within a day. Grade 3: ≥3 episodes of vomiting/day.
  6. fOverall: Defined as passage of 3 or more looser than normal stools within a day. Grade 3: ≥6 looser than normal stools/day.

Unsolicited Adverse Events1

  • Infants were monitored for unsolicited serious and non-SAEs that occurred in the 31-day period following vaccination. There were no notable differences in the occurrence and frequency of unsolicited adverse events between the groups

Serious Adverse Events1

  • During the entire course of the studies, SAEs occurred in 4.7% of recipients of ROTARIX liquid formulation (n=2507) as compared with 4.4% of ROTARIX reconstituted lyophilized formulation recipients (n=1716)

Intussusception1

  • Among participants, 2 intussusception cases were reported. One subject experienced intussusception 8 days after receiving the second dose of ROTARIX (reconstituted lyophilized formulation). The event was considered possibly related to ROTARIX. One subject from Study 9 experienced intussusception 133 days after receiving the second dose of ROTARIX (liquid formulation); the event was not considered related to ROTARIX. Both subjects were hospitalized, and the outcome of intussusception was reported as resolved

SAE=serious adverse events.

INDICATIONS & IMPORTANT SAFETY INFO
INDICATIONS

ROTARIX is a vaccine indicated for the prevention of rotavirus gastroenteritis caused by G1 and non-G1 types (G3, G4, and G9) when administered as a 2-dose series. ROTARIX is approved for use in infants 6 weeks and up to 24 weeks of age.

ROTARIX is a vaccine indicated for the prevention of rotavirus gastroenteritis caused by G1 and non-G1 types (G3, G4, and G9) when administered as a 2-dose series. ROTARIX is approved for use in infants 6 weeks and up to 24 weeks of age.

IMPORTANT SAFETY INFORMATION FOR ROTARIX
  • Contraindications for ROTARIX include a history of any of the following: hypersensitivity to the vaccine or any component of the vaccine; uncorrected congenital malformation of the gastrointestinal tract (such as Meckel’s diverticulum) that would predispose the infant to intussusception; intussusception (in postmarketing experience, intussusception resulting in death following a second dose has been reported following a history of intussusception after the first dose); or Severe Combined Immunodeficiency Disease (SCID)
  • Contraindications for ROTARIX include a history of any of the following: hypersensitivity to the vaccine or any component of the vaccine; uncorrected congenital malformation of the gastrointestinal tract (such as Meckel’s diverticulum) that would predispose the infant to intussusception; intussusception (in postmarketing experience, intussusception resulting in death following a second dose has been reported following a history of intussusception after the first dose); or Severe Combined Immunodeficiency Disease (SCID)