A study to compare safety, tolerability, and immunogenicity of a new formulation of RotaTeq™ with the existing formulation in infants. The primary hypothesis of the study is that the new formulation will be noninferior to the existing formulation on the basis of immunogenicity.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
1,020
Geometric Mean Titer of Serum Neutralizing Antibody Response to Human Rotavirus Serotypes G1, G2, G3, G4, and P1A[8]
Time frame: 42 days after vaccination 3 (up to 185 days)
Number of Participants With Tier-1 Adverse Events: Diarrhea, Vomiting, Elevated Temperature, and Irritability
An adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an adverse event. Protocol-defined Tier-1 adverse events to be collected up to 7 days after any vaccination were diarrhea, vomiting, elevated temperature (rectal \>=38.1° C, \>=100.5° F), and irritability.
Time frame: Up to 7 days after any vaccination (up to 147 days)
Number of Participants With Tier-1 Adverse Events: Intussusception
The protocol-defined Tier-1 adverse event to be collected for the duration of the study (up to Day 185) was intussusception
Time frame: Up to Day 185
Geometric Mean Titer of Serum Anti-Rotavirus Immunoglobulin A
Time frame: 42 days after vaccination 3 (up to 185 days)
Percentage of Participants With >=3-fold Rise From Baseline in GMT of Serum Neutralizing Antibody to Human Rotavirus Serotypes G1, G2, G3, G4, and P1A[8]
Time frame: Baseline and 42 days after vaccination 3 (up to 185 days)
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