ROTATEQ Rx

• 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.