Immunogenicity and Safety of Concomitant and Non-Concomitant Administration of RotaTeq® (V260) and Inactivated Poliomyelitis Vaccine in Healthy Chinese Infants (V260-074)
Condition: Prevention of Rotavirus Gastroenteritis in Infants and Children Caused by Serotypes G1, G2, G3, G4, and G9
MeSH terms: Poliomyelitis; Gastroenteritis
Intervention: RotaTeq (V260); IPV
Intervention description: Live, pentavalent rotavirus vaccine administered as a 2 mL-dose oral solution; 0.5 mL dose IPV (Sabin strain based), administered via IM injection
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 400.0
Sex: All
Minimum age: 48 Days
Maximum age: 63 Days
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study will evaluate the immunogenicity and safety of concomitant administration of
      RotaTeq® (V260) and inactivated poliomyelitis vaccine (IPV) in Chinese infants. Its primary
      objective is to demonstrate that the immunogenicity of IPV in the concomitant-use group is
      non-inferior to the immunogenicity of IPV in the staggered-use group. The hypothesis to be
      tested is: The seroconversion percentage at 1 month post dose 3 for poliovirus types 1, 2,
      and 3 in the concomitant-use group is non-inferior to those of the staggered-use group.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy Chinese infant 48 days to 63 days of age.

          -  Infant's legally acceptable representative provides written informed consent for the
             study.

        Exclusion Criteria:

          -  History of rotavirus disease, congenital gastrointestinal disorders, chronic diarrhea,
             failure to thrive, or abdominal surgery.

          -  History of intussusception.

          -  History of poliomyelitis.

          -  Clinical evidence of active gastrointestinal illness. Note: Infants with
             gastroesophageal reflux disease [GERD] may participate in the study if the GERD is
             well controlled with or without medication.

          -  Known or suspected impairment of immunological function, including severe combined
             immunodeficiency disease (SCID).

          -  Has a fever, with an axillary temperature ≥37.5°C (or equivalent) at the time of
             vaccination or within 24 hours prior to vaccination. Note: The Visit 1 may be
             rescheduled after complete resolution of febrile illness.

          -  Has acute disease.

          -  Has underlying diseases such as cardiovascular, renal, liver, or blood disease.

          -  History of known hypersensitivity to any components of rotavirus vaccine and/or IPV.

          -  Uncontrolled epilepsy, encephalopathy, seizure, or other progressive neurological
             diseases.

          -  Known thrombocytopenia or any coagulation disorder that would contraindicate
             intramuscular injections.

          -  Resides in a household with an immunocompromised person, including individuals with
             congenital immunodeficiency (including SCID), human immunodeficiency virus (HIV)
             infection, leukemia, lymphoma, multiple myeloma, generalized malignance, chronic renal
             failure, organ or bone marrow transplantation, or with those receiving
             immunosuppressive chemotherapy including long-term systemic corticosteroids.

          -  Any condition, which in the opinion of the investigator, may interfere with the
             evaluation of the study objectives.

          -  Prior administration of any rotavirus vaccines or poliovirus vaccines.

          -  Has received inactivated or recombinant vaccines within 14 days prior to Visit 1 or
             live vaccines within 28 days prior to Visit 1.

          -  Has received an investigational or non-registered product other than study vaccines or
             is planning to use such product during the study.

          -  Has received immunosuppressive therapies including systemic (intramuscular, oral, or
             intravenous) corticosteroids. Note: Participants using non-systemic corticosteroids
             (e.g., topical, ophthalmic, and inhaled) are considered eligible for the study.

          -  Has received a blood transfusion or blood products, including immunoglobulins or is
             planning to receive such product during the study.

          -  Has participated in another interventional study prior to Visit 1 or expected to
             anytime during the study.

          -  The infant's legally acceptable representative is unlikely to adhere to the study
             procedures, keep appointments or is planning to permanently relocate from the area
             prior to the completion of the study or to leave for an extended period when study
             visits would need to be scheduled.

          -  Is or has an immediate family member (e.g., spouse, parent/legal guardian, sibling, or
             child) who is an investigational site or Sponsor staff member directly involved with
             this study.