A Double-blind, Randomized, Controlled, Multicenter Study to Evaluate the Safety, Tolerability, and Immunogenicity of a New Formulation of RotaTeq™
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Merck Sharp & Dohme LLC
- Enrollment
- 1,020
- Primary Endpoint
- Geometric Mean Titer of Serum Neutralizing Antibody Response to Human Rotavirus Serotypes G1, G2, G3, G4, and P1A[8]
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Triple (Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 6 Weeks to 12 Weeks (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
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)
Intervention: RotaTeq™ experimental formulation (Biological)
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).
Intervention: RotaTeq™ existing formulation (Biological)
Outcomes
Primary Outcomes
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)
Secondary Outcomes
- 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))
- Number of Participants With Tier-1 Adverse Events: 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))