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

Study Overview
=================
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.

Official Title
-----------------
A Double-blind, Randomized, Controlled, Multicenter Study to Evaluate the Safety, Tolerability, and Immunogenicity of a New Formulation of RotaTeq™

Conditions
-----------------
Rotavirus Gastroenteritis

Intervention / Treatment
-----------------
* Biological: RotaTeq™ experimental formulation
* Biological: RotaTeq™ existing formulation


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 6 Weeks
Maximum Age: 12 Weeks

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RotaTeq™ Experimental Formulation<br>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) | Biological: RotaTeq™ experimental formulation<br> <br> * Other names: V260;|
| Active Comparator: RotaTeq™ Existing Formulation<br>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). | Biological: RotaTeq™ existing formulation<br> <br> * Other names: V260;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 | Up to Day 185 | 
| 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) |