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

NCT ID: NCT01600092

Last Updated: 2018-11-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 1020 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-04-29
• Study Completion Date: 2014-03-25

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.

Conditions

Rotavirus Gastroenteritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

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)

Group Type: EXPERIMENTAL

RotaTeq™ experimental formulation

Intervention Type: 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).

Group Type: ACTIVE_COMPARATOR

RotaTeq™ existing formulation

Intervention Type: BIOLOGICAL

Interventions

RotaTeq™ experimental formulation

Intervention Type: BIOLOGICAL

RotaTeq™ existing formulation

Intervention Type: BIOLOGICAL

Other Intervention Names

V260; V260

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

• Minimum Eligible Age: 6 Weeks
• Maximum Eligible Age: 12 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

Martinon-Torres F, Greenberg D, Varman M, Killar JA, Hille D, Strable EL, Stek JE, Kaplan SS. Safety, Tolerability and Immunogenicity of Pentavalent Rotavirus Vaccine Manufactured by a Modified Process. Pediatr Infect Dis J. 2017 Apr;36(4):417-422. doi: 10.1097/INF.0000000000001511.

Reference Type: RESULT

PMID: 28141698 (View on PubMed)

Study Documents

Document Type: CSR Synopsis

View Document

Other Identifiers

V260-035

Identifier Type: -

Identifier Source: org_study_id