A Study of the Immunogenicity, Tolerability, and Safety of a New Formulation of RotaTeq™ in Infants (V260-035 AM2) - Full Text View

Purpose

A study to compare safety 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.

Condition	Intervention	Phase
Rotavirus Gastroenteritis	Biological: RotaTeq™ experimental formulation Biological: RotaTeq™ existing formulation	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention
Official Title:	A Double-blind, Randomized, Controlled, Multicenter Study to Evaluate the Safety, Tolerability, and Immunogenicity of a New Formulation of RotaTeq™

Resource links provided by NLM:

MedlinePlus related topics: Gastroenteritis

Drug Information available for: Rotarix

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Number of participants with Tier-1 Adverse Events [ Time Frame: Through 42 days after vaccination 3 ] [ Designated as safety issue: Yes ]
Prespecified tier-1 adverse events are diarrhea, vomiting, elevated temperature, irritability, and intussusception
Geometric Mean Titer of Serum Anti-Rotavirus Immunoglobulin A [ Time Frame: 42 days after vaccination 3 ] [ Designated as safety issue: No ]
Number of participants with ≥ 3-Fold Rise in Titers of Serum Neutralizing Antibody Titer Against Human Rotavirus Serotypes G1, G2, G3, G4, P1A[8], and Serum Anti-Rotavirus Immunoglobulin A [ Time Frame: From Day 1 before vaccination 1 to 42 days after vaccination 3 ] [ Designated as safety issue: No ]

Estimated Enrollment:	924
Study Start Date:	April 2013
Estimated Study Completion Date:	May 2014
Estimated Primary Completion Date:	May 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: RotaTeq™ Experimental Formulation	Biological: 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) Other Name: V260
Active Comparator: RotaTeq™ Existing 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) Other Name: V260

Eligibility

Ages Eligible for Study:	6 Weeks to 12 Weeks
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01600092

Contacts

Contact: Toll Free Number

1-888-577-8839

Locations

United States, Arkansas
Call for Information (Investigational Site 0007)	Recruiting
Little Rock, Arkansas, United States, 72205
United States, Nebraska
Call for Information (Investigational Site 0003)	Recruiting
Omaha, Nebraska, United States, 68131
United States, South Carolina
Call for Information (Investigational Site 0002)	Recruiting
Charleston, South Carolina, United States, 29406-9170
United States, Virginia
Call for Information (Investigational Site 0001)	Recruiting
Richmond, Virginia, United States, 23294
Canada, Quebec
Merck Frosst Canada	Recruiting
Kirkland, Quebec, Canada, H9H 3L1
Contact: Mauricio Ede 1-514-428-3044

Sponsors and Collaborators

Merck

More Information

No publications provided

Responsible Party:	Merck
ClinicalTrials.gov Identifier:	NCT01600092 History of Changes
Other Study ID Numbers:	V260-035
Study First Received:	May 14, 2012
Last Updated:	May 8, 2013
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on May 19, 2013