A Double-Blind, Randomized, Controlled, Multicenter Study to Evaluate the Safety, Tolerability, and Immunogenicity of a New Formulation of RotaTeq?

• Conditions: Prevention of rotavirus gastroenteritis in infants and children caused by serotypes G1, G2, G3, G4, and G serotypes that contain P1A[8] (e.g., G9); MedDRA version: 14.1Level: LLTClassification code 10039232Term: Rotavirus gastroenteritisSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2012-001611-23-ES
• Lead Sponsor: Merck Sharp & Dohme Corp., una filial de Merck & Co., Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-07-19
• Last Update Posted: 5 November 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 800

Inclusion Criteria

a. Healthy infant age 6 weeks to 12 weeks (42 to 84 days) at receipt of the first study vaccination (Date of Birth is age Day 1).
b. Parent/legal guardian who agrees to have infant participate by giving written informed consent and is willing and able to comply with study requirements. The subject?s parent/legal guardian may also provide written informed consent for Future Biomedical Research. However, the subject may participate in the main trial without participating in Future Biomedical Research.
Are the trial subjects under 18? yes
Number of subjects for this age range: 800
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

a. History of congenital abdominal disorders, prior rotavirus gastroenteritis, chronic diarrhea, failure to thrive, or abdominal surgery.
b. History of intussusception.
c. Known or suspected impairment of immunological function, including Severe Combined Immunodeficiency (SCID).
d. Known hypersensitivity to any component of the rotavirus vaccine.
e. Prior administration of any rotavirus vaccine.
f. Receipt of an oral polio vaccine (OPV) less than 14 days prior to the administration of study vaccine. Note: Concomitant administration (same-day dosing) of study vaccine and routine vaccines, including OPV, is acceptable per standard vaccination schedule. If non-concomitant administration of OPV is necessary, it is strongly recommended that OPV be given at least 14 days (preferably 28 days) after the study vaccine.
g. Fever, with a rectal temperature ?38.1°C (?100.5°F), or equivalent, at the time of vaccination. Note: Re-schedule the study vaccination visit after complete resolution of febrile illness.
h. Clinical evidence of active gastrointestinal illness. Note: Infants with gastroesophageal reflux disease (GERD) may participate in the study as long as the GERD is well controlled with or without medication.
i. Receipt of 1) systemic corticosteroids (?2mg/kg total daily dose of prednisone or equivalent) since birth, 2) any dose of systemic corticosteroids within 7 days prior to entering study, or 3) expected to require systemic corticosteroids during the course of the study. Subject using non-systemic corticosteroids (e.g., topical, ophthalmic, or inhaled) will be eligible for vaccination.
j. Subject residing in a household with an immunocompromised person, including individuals with congenital immunodeficiency, human immunodeficiency virus (HIV) infection, leukemia, lymphoma, Hodgkin?s disease, multiple myeloma, generalized malignancy, chronic renal failure, organ or bone marrow transplantation, or with those receiving anti-cancer drugs or immunosuppressive chemotherapy, including long-term systemic corticosteroids.
k. Prior receipt of a blood transfusion or blood products, including immunoglobulins.
l. Participation in another interventional study within 14 days prior to the first study vaccination or expected anytime during the study.
m. 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.
n. Any condition that, in the opinion of the investigator, may interfere with the evaluation of the study objectives.
o. Inability to obtain blood specimen at randomization visit. Note: Re-schedule visit so that baseline specimen may be obtained prior to the first vaccination.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified