V260 Study: Concomitant Use of V260 and INFANRIX™ Hexa in Healthy Infants (V260-010)

Merck Sharp & Dohme (MSD)

Status and phase

Completed

Phase 3

Conditions

Rotavirus Disease

Treatments

Biological: Comparator: Infanrix(tm) Hexa

Biological: Rotavirus Vaccine, Live, Oral, Pentavalent

Biological: Comparator: placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT00258154

V260-010

2005_046

Details and patient eligibility

About

The study is being conducted to demonstrate that the vaccine to prevent gastroenteritis due to rotavirus may be administered concomitantly with INFANRIX(tm)hexa without impairing the safety and immunogenicity of either vaccine.

Enrollment

403 patients

Sex

All

Ages

6 to 12 weeks old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Healthy infant per investigator, 6 through 12 weeks of age

Exclusion criteria

History of congenital abdominal disorders, intussusception, or abdominal surgery
Known or suspected impairment of immunological function
Known hypersensitivity to any component of the rotavirus vaccine
Prior administration of any rotavirus vaccine
Known hypersensitivity or contraindication to any component of INFANRIX(tm) hexa
Any infant born from a known HBsAg-positive mother
Prior administration of any oral polio vaccine
Receipt of one or more doses of inactivated poliovirus vaccine, diptheria, tetanus and acellular pertussis vaccine, diptheria, tetanus and pertussis vaccine, Haemophilus influenzae type b vaccine, or any hepatitis B vaccine prior to the first vaccination, or receipt of any vaccines with these antigens at any time during the course of the study
Fever, with a rectal temperature greater than or equal to 38.1 degree C (greater than or equal to 100.5 degree F) at the time of immunization
History of known prior rotavirus gastroenteritis, chronic diarrhea, or failure to thrive
Clinical evidence of active gastrointestinal illness
Receipt of intramuscular, oral, or intravenous corticosteroid treatment within the 2 weeks prior to vaccination
Infants residing in a household with an immunocompromised person
Prior receipt of a blood transfusion or blood products
Participation in another clinical study within 42 days before the beginning or anytime during the duration of the current clinical study
Any infant who cannot be adequately followed for safety by a contact visit
History of seizure disorders or prior history followed for safety by a contact visit
Any condition that, in the opinion of the investigator, may interfere with the evaluation of the study objectives