Concomitant Use and Staggered Use of Vaccine and Oral Poliovirus (OPV) in Healthy Infants (V260-014)(COMPLETED)

Merck Sharp & Dohme (MSD)

Status and phase

Completed

Phase 3

Conditions

Rotavirus Infections

Gastroenteritis

Treatments

Biological: Rotavirus Vaccine, Live, Oral, Pentavalent

Biological: Comparator: Oral Poliovirus Vaccine (OPV) (staggered)

Biological: Comparator: Oral Poliovirus Vaccine (OPV)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00130832

V260-014

2005_030

Details and patient eligibility

About

The study is being conducted to demonstrate that vaccine to prevent gastroenteritis due to rotavirus may be administered concomitantly with oral polio vaccine (OPV) without impairing the safety or immunogenicity of either vaccine.

Enrollment

735 patients

Sex

All

Ages

6 to 12 weeks old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Infants in good health

Exclusion criteria

Previous administration of any oral poliovirus vaccine (OPV) and rotavirus vaccine
Receipt of inactivated poliovirus vaccine (IPV) prior to the first dose of either study vaccine, or at any time during the course of the study
Any condition resulting in depressed immunity
Any allergy to any vaccine component as stated in the package circulars
Allergies to polymyxin B, neomycin or any other antibiotics
Receipt of intramuscular, oral, or intravenous corticosteroid treatment
History of congenital abdominal disorders, intussusception, or abdominal surgery; clinical evidence of active gastrointestinal illness
History of known prior rotavirus gastroenteritis, chronic diarrhea, or failure to thrive
Prior receipt of a blood transfusion or blood products, including immunoglobulin
Fever, with a rectal temperature of ≥38.1°C (≥ 100.5°F) at the time of immunization
Infants residing in a household with an immunocompromised person