Study

Overview

Official Title: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Efficacy, Safety, and Immunogenicity of V260 in Healthy Chinese Infants

This study will assess the efficacy, safety, and immunogenicity of a 3-dose regimen of RotaTeq™ (V260) in healthy Chinese infants. Approximately 4040 participants at least 6 weeks and up to 12 weeks of age at the time of the first vaccination with V260 or placebo will be enrolled and randomized (1:1) to receive either V260 or placebo. Participants will also receive the routine China Expanded Program on Immunization (EPI) vaccines (oral poliovirus vaccine [OPV] and diphtheria, tetanus, and acellular pertussis vaccine [DTaP]) either staggered or concomitantly with V260 or placebo. All participants will be followed for efficacy and safety. Immune responses to OPV and DTaP will be evaluated in a subset of participants. The primary hypothesis of the study states that V260 will be efficacious in preventing any severity of rotavirus gastroenteritis as compared with placebo.

Study Type:

Interventional

Study Phase:

Phase 3

Enrollment:

4040

Study Start Date:

May 2014

Study Completion Date:

June 2015

Primary Completion Date:

June 2015

Eligibility

Ages Eligible for Study:

6 weeks to 12 weeks

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

Yes

CRITERIA

Inclusion Criteria:

Healthy infants at least 6 weeks (42 days) and up to 12 weeks (84 days) of age at the time of the first study vaccination
Parent/legal guardian agrees to participate by giving written informed consent and is willing and able to comply with study requirements

Exclusion Criteria:

History of congenital abdominal disorders, prior rotavirus gastroenteritis, chronic diarrhea, failure to thrive, or abdominal surgery
History of intussusception
Impairment of immunological function, including Severe Combined Immunodeficiency (SCID)
Acute disease, severe chronic disease, or chronic disease during the acute period
Uncontrolled epilepsy, encephalopathy, seizure, or other progressive neurological disease
Hypersensitivity to any component of the rotavirus vaccine, OPV, or DTaP
Prior receipt of any rotavirus vaccine
Fever, with an axillary temperature >=37.5 °C (or equivalent) within 24 hours before study vaccination (study vaccination can be deferred until complete resolution of febrile illness)
Clinical evidence of active gastrointestinal illness
Received intramuscular, oral, or intravenous corticosteroid treatment since birth (topical, ophthalmic, and inhaled steroids are permitted)
Resides in a household with an immunocompromised person
Receipt of a blood transfusion or blood products, including immunoglobulins
Participation in another interventional study within 14 days before the first study vaccination or during the study
Receipt of an investigational or non-registered product other than the study vaccine within 30 days before the first study vaccination or during the study
For participants in immunogenicity arms: inability to obtain a blood specimen at randomization visit (note: the visit may be rescheduled so that a baseline specimen may be obtained); history of polio, diphtheria, tetanus, or pertussis disease; previous vaccination against diphtheria, tetanus, pertussis, or poliomyelitis
Any condition which, in the opinion of the investigator, may interfere with the evaluation of the study objectives

Locations

No Contacts or Locations in US/Canada Provided

Results

No Study Results Posted

Clinical Study Reports

Synopsis V260-024

Study Detail

Efficacy, Safety, and Immunogenicity of V260 in Healthy Chinese Infants (V260-024)

Overview

Eligibility

CRITERIA

Locations

Results