Vaccines:

Indications for: ROTATEQ

Rotavirus gastroenteritis vaccination in infants 6–32 weeks of age.

Clinical Trials:

  • 4 placebo-controlled phase 3 studies conducted in 12 countries evaluated the efficacy of RotaTeq in preventing rotavirus gastroenteritis in 73,086 healthy infants. Patients received a 3-dose series of RotaTeq with the first dose administered between 6 and 12 weeks of age then the 2 additional doses at 4- to 10-week intervals. Oral polio vaccine administration was not permitted.

  • The primary efficacy analyses included cases of rotavirus gastroenteritis caused by types G1, G2, G3, G4 (and G types containing P1A8 (in Study 029 only)) that occurred at least 14 days after the third dose through the first rotavirus season post vaccination. 

  • Analyses were also done to evaluate the efficacy of RotaTeq against rotavirus gastroenteritis caused by any of types G1, G2, G3, and G4 (and G types containing P1A8 (in Study 029 only)) at any time following the first dose through the first rotavirus season post-vaccination among infants who received at least one vaccination (Intent-to-treat, ITT).

Rotavirus Efficacy and Safety Trial (Study 006)

  • Primary efficacy against any grade of severity of rotavirus gastroenteritis caused by naturally occurring types G1, G2, G3, or G4 through the first rotavirus season after vaccination was 74.0% (95% CI, 66.8-79.9) and the ITT efficacy was 60.0% (95% CI, 51.5-67.1).

  • Primary efficacy against severe rotavirus gastroenteritis caused by naturally occurring types G1, G2, G3, or G4 through the first rotavirus season after vaccination was 98.0% (95% CI, 88.3-100.0), and ITT efficacy was 96.4% (95% CI, 86.2-99.6).

  • The vaccine efficacy of RotaTeq was 95.8% (95% CI, 90.5-98.2) in reducing hospitalizations for rotavirus gastroenteritis caused by types G1, G2, G3, and G4 through the first two years after the third dose. The ITT efficacy was 94.7% (95% CI, 89.3-97.3).

Study 007

  • Primary efficacy against any grade of severity of rotavirus gastroenteritis caused by naturally occurring types G1, G2, G3, or G4 through the first rotavirus season after vaccination was 72.5% (95% CI, 50.6-85.6) and the ITT efficacy was 58.4% (95% CI, 33.8-74.5).

  • Primary efficacy against severe rotavirus gastroenteritis caused by naturally occurring types G1, G2, G3, or G4 through the first rotavirus season after vaccination was 100% (95% CI, 13.0-100.0) and ITT efficacy against severe rotavirus disease was 100% (95% CI, 30.2-100.0).

Multiple Rotavirus Seasons – Study 006

  • Efficacy against any grade of severity of rotavirus gastroenteritis caused by rotavirus types G1, G2, G3, and G4 through the two rotavirus seasons after vaccination was 71.3% (95% CI, 64.7-76.9). 

  • The efficacy of RotaTeq in preventing cases occurring only during the second rotavirus season post-vaccination was 62.6% (95% CI, 44.3-75.4).

Rotavirus Gastroenteritis Regardless of Type

  • In Study 006, the efficacy of RotaTeq against any grade of severity of naturally occurring rotavirus gastroenteritis regardless of type was 71.8% (95% CI, 64.5-77.8) and efficacy against severe rotavirus disease was 98.0% (95% CI, 88.3-99.9). The ITT efficacy starting at dose 1 was 50.9% (95% CI, 41.6-58.9) for any grade of severity of rotavirus disease and was 96.4% (95% CI, 86.3-99.6) for severe rotavirus disease.

  • In Study 007, the primary efficacy of RotaTeq against any grade of severity of rotavirus gastroenteritis regardless of type was 72.7% (95% CI, 51.9-85.4) and efficacy against severe rotavirus disease was 100% (95% CI, 12.7-100). The ITT efficacy starting at dose 1 was 48.0% (95% CI, 21.6-66.1) for any grade of severity of rotavirus disease and was 100% (95% CI, 30.4-100.0) for severe rotavirus disease.

Rotavirus Gastroenteritis by Type

  • In Study 029 (a Phase 3 randomized, blinded, placebo-controlled study conducted in Japan), efficacy on the pre-specified primary endpoint (rotavirus gastroenteritis caused by G1, G2, G3, G4, and G-serotypes associated with serotype P1A[8] (eg, G9)) was 74.5% (95% CI, 39.9-90.6). G9P1A[8]-associated gastroenteritis was observed in 0/356 and 5/354 subjects in the RotaTeq and placebo groups, respectively (100% [95% CI, -9.0, 100]).

  • In a post hoc analysis of health care utilization data from 68,038 infants (RotaTeq 34,035 and placebo 34,003) in Study 006, using a case definition that included culture confirmation, hospitalization and emergency departments visits for rotavirus gastroenteritis, cases due to G9P1A[8] were reduced (RotaTeq 0 cases: placebo 14 cases) by 100% (95% CI, 69.6-100.0).

Immunogenicity

  • In phase 3 studies, 92.9% to 100% of 439 recipients of RotaTeq achieved a 3-fold or more rise in serum anti-rotavirus IgA after a three-dose regimen when compared to 12.3%-20.0% of 397 placebo recipients.

Adult Dosage:

Not recommended.

Children Dosage:

<6 weeks or >32 weeks: not established. Each dose is 1 tube. Give 1st dose orally at 6–12 weeks of age; give 2nd and 3rd dose at 4–10 week intervals for a total of 3 doses. If incomplete dose is given, do not give replacement dose; continue with remaining doses in the recommended series.

ROTATEQ Contraindications:

Severe combined immunodeficiency disease. History of intussusception.

ROTATEQ Warnings/Precautions:

Immunocompromised (blood dyscrasias, leukemia, lymphomas, or other malignancies; primary and acquired immunodeficiency states, HIV/AIDS; cellular immune deficiencies; and hypogammaglobulinemic and dysgammaglobulinemic states; received blood transfusion or blood products, including immunoglobulins within 42 days). Febrile illness. Active or history of GI disorders. Chronic diarrhea. Failure to thrive. History of congenital abdominal disorders. Abdominal surgery. Risk of intussusception. Immunodeficient close contacts. Pregnancy (Cat. C), women of child-bearing potential: not recommended.

ROTATEQ Interactions:

Immunosuppressants (eg, irradiation, chemotherapy, high-dose steroids): may get suboptimal response. Concomitant vaccines: see full labeling; oral polio vaccine: not recommended.

Adverse Reactions:

Diarrhea, vomiting, irritability, otitis media, nasopharyngitis, bronchospasm; rare: intussusception, hematochezia, seizures, Kawasaki disease.

How Supplied:

Single-use tube (2mL)—10, 25