V260 Study: Concomitant Use of V260 and INFANRIX™ Hexa in Healthy Infants (V260-010)
Condition: Rotavirus Disease
MeSH terms: Rotavirus Infections
Intervention: Rotavirus Vaccine, Live, Oral, Pentavalent; Comparator: placebo; Comparator: Infanrix(tm) Hexa
Intervention description: 3 doses of rotavirus vaccine live, oral, pentavalent on Day 1, 28 to 42 days post dose 1 and 28 to 42 days post dose 2; 3 doses of placebo to rotavirus vaccine live, oral, pentavalent on Day 1, 28 to 42 days post dose 1 and 28 to 42 days post dose 2; 3 doses of oral Infanrix(tm) Hexa on Day 1, 28 to 42 days post dose 1 and 28 to 42 days post dose 2
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 403.0
Sex: All
Minimum age: 6 Weeks
Maximum age: 12 Weeks
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      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.
    

Eligibility criteria:

        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