A Study of the Immunogenicity, Tolerability, and Safety of a New Formulation of RotaTeq™ in Infants (V260-035)

Phase 3

Completed

Interventions: Biological: RotaTeq™ experimental formulation
Biological: RotaTeq™ existing formulation

Brief Summary: 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.

Recruitment & Eligibility

Inclusion Criteria

Parent or legal guardian agrees to have infant participate by giving written informed consent

Exclusion Criteria

History of congenital abdominal disorders, prior rotavirus gastroenteritis, chronic diarrhea, failure to thrive, or abdominal surgery
History of intussusception
Known or suspected impairment of immunological function, including Severe

Combined Immunodeficiency (SCID)

Prior administration of any rotavirus vaccine
Clinical evidence of active gastrointestinal illness, with the exception of well-controlled gastroesophageal reflux disease (GERD)
Receipt of 1) systemic corticosteroids (≥ 2mg/kg total daily dose of prednisone or equivalent) for 14 consecutive days or more since birth, or 2) systemic corticosteroids ≥ 2mg/kg/dose within 7 days prior to the administration of the first dose of study vaccine. Participant using non-systemic corticosteroids will be eligible for vaccination.
Residing in a household with an immunocompromised person
Prior receipt of a blood transfusion or blood products, including immunoglobulins
Participation in another interventional study within 14 days prior to the first study vaccination or expected anytime during the study
Receipt of investigational inactivated vaccines within 14 days or investigational live vaccines within 28 days prior to the first study vaccination or expected anytime during the study

Arm && Interventions

Group	Intervention	Description
RotaTeq™ Experimental Formulation	RotaTeq™ experimental formulation	Three 2.0 mL oral doses of RotaTeq™ experimental formulation. Vaccination 1 will be administered between 6 and 12 weeks of age and the third vaccination will be administered before 32 weeks of age. Each vaccination will be separated from the next by ≥ 4 weeks (28 days)
RotaTeq™ Existing Formulation	RotaTeq™ existing formulation	Three 2.0 mL oral doses of RotaTeq™ existing formulation. Vaccination 1 will be administered between 6 and 12 weeks of age and the third vaccination will be administered before 32 weeks of age. Each vaccination will be separated from the next by ≥ 4 weeks (28 days).

Primary Outcome Measures

Name	Time	Method
Geometric Mean Titer of Serum Neutralizing Antibody Response to Human Rotavirus Serotypes G1, G2, G3, G4, and P1A[8]	42 days after vaccination 3 (up to 185 days)

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Tier-1 Adverse Events: Diarrhea, Vomiting, Elevated Temperature, and Irritability	Up to 7 days after any vaccination (up to 147 days)	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.
Number of Participants With Tier-1 Adverse Events: Intussusception	Up to Day 185	The protocol-defined Tier-1 adverse event to be collected for the duration of the study (up to Day 185) was intussusception
Geometric Mean Titer of Serum Anti-Rotavirus Immunoglobulin A	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]	Baseline and 42 days after vaccination 3 (up to 185 days)