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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 3

Conditions: Rotavirus Gastroenteritis

Treatments: Biological: RotaTeq™ experimental formulation; Biological: RotaTeq™ existing formulation

Study type: Interventional

Funder types: Industry

Identifiers

NCT01600092

V260-035

Details and patient eligibility

About

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.

Enrollment: 1,020 patients

Sex: All

Ages: 6 to 12 weeks old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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1,020 participants in 2 patient groups

RotaTeq™ Experimental Formulation

Experimental group

Description:

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)

Treatment:

Biological: RotaTeq™ experimental formulation

RotaTeq™ Existing Formulation

Active Comparator group

Description:

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).

Treatment:

Biological: RotaTeq™ existing formulation