Potential Mechanisms for Intussusception After Rotavirus Vaccine-Pilot Study
Condition: Intussusception; Rotavirus Infections
MeSH terms: Rotavirus Infections; Intussusception
Intervention: Rotarix®,; Rotarix®, with other routine vaccines; RotaTeq®,; RotaTeq®, with other routine vaccines
Intervention description: Single oral dose of licensed rotavirus vaccine given alone; Single oral dose of licensed rotavirus vaccine given with other routine vaccines; Single oral dose of licensed rotavirus vaccine given alone; Single oral dose of licensed rotavirus vaccine given with other routine vaccines
Intervention MeSH terms: Vaccines
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Enrollment: 144.0
Sex: All
Minimum age: 42 Days
Maximum age: 90 Days
Healthy volunteers: Accepts Healthy Volunteers
Keywords: mechanisms for intussusception; rotavirus vaccine

Summary:

      This is a prospective randomized clinical trial that aims to evaluate the potential effects
      of the first dose of rotavirus vaccines on gastrointestinal motility and anatomy and blood
      and stool cytokine responses. It will also assess the association between these outcomes and
      the pattern of the shedding of vaccine strain rotavirus in the stool. Infants will be
      randomized to one of four arms: monovalent rotavirus vaccine (Rotarix®, RV1) alone, RV1 with
      other recommended vaccines, pentavalent rotavirus vaccine (RotaTeq®, RV5) alone, or RV5 with
      other recommended vaccines. Data derived from the pilot study will be used to assess the
      feasibility of conducting a larger scale study.
    

Eligibility criteria:

        Inclusion Criteria:

          1. healthy infant 6 to 13 weeks (12 weeks and 6 days) of age at day of rotavirus vaccine
             administration

          2. free of obvious health problems as established by medical history and confirmed with
             infant's primary physician prior to Visit 1

          3. parent/legal guardian willing to have infant feed from a bottle for contrast

          4. parent/legal guardian willing and capable of signing informed consent

          5. parent/legal guardian and infant expected to be available for entire study

          6. parent/legal guardian can be reached by telephone

          7. parent/legal guardian expresses willingness to complete study procedures and receive 2
             month immunizations, according to recommended schedule

        Exclusion Criteria:

          1. gestational age of <37 weeks

          2. infant unable to fast for 4 hours prior to MRI procedure

          3. receipt of any vaccine except initial HBV (must have at least 28 days between HBV and
             Visit 1 to be included)

          4. history of severe allergic reaction to HBV vaccine

          5. contraindications for any of the routine vaccines

               1. Severe Combined Immune Deficiency

               2. history of intussusception

          6. precautions for either RV1 or RV5 (may interfere with study outcomes)

             a. altered immunocompetence i. infants with primary and acquired immunodeficiency
             states, cellular immunodeficiency, hypogammaglobulinemic and dysgammaglobulinemic
             states ii. infants with blood dyscrasias, leukemia, lymphomas, or other malignant
             neoplasms affecting the bone marrow or lymphatic system iii. infants on
             immunosuppressive therapy (including high-dose systemic corticosteroids) iv. infants
             who are HIV-exposed or infected b. acute gastroenteritis c. moderate or severe acute
             illness with or without fever d. pre-existing chronic gastrointestinal diseases (e.g.,
             congenital malabsorption syndromes, Hirschsprung's disease, or short-gut syndrome) e.
             infants with spina bifida or bladder exstrophy (latex rubber is contained in the RV1
             oral applicator)

          7. sensitivity to latex (latex rubber is contained in the RV1 oral applicator)

          8. febrile illness within previous 14 days (axillary temperature of 100.4◦ F or higher)

          9. history of vomiting (forceful expulsion of partially digested milk/food) and/or
             diarrhea (3 watery stools) within 14 days of Visit 1

         10. receipt of any steroids, immunoglobulins, other blood products/transfusion

         11. receipt of non-steroidal anti-inflammatory drugs in previous 72 hours (may affect
             cytokine response)

         12. receipt of an antipyretic medication (acetaminophen or ibuprofen) within 72 hours
             prior to the first dose of rotavirus vaccine or is already planning to administer a
             prophylactic antipyretic medication on the day of and the day following vaccination
             (this exclusion does not apply if the caretaker indicates he/she might administer
             antipyretics after vaccination to reduce a fever)

         13. is enrolled or plans to enroll in another clinical trial with an investigational
             product while participating in this study (observational studies are allowed)

         14. any condition which, in the opinion of the investigators, may post a health risk to
             the subject or interfere with the MRI or vaccine evaluation

         15. currently receiving medication for gastroesophageal reflux (GERD) or any other
             gastrointestinal condition including colic

         16. infant who is a relative of any research study personnel

         17. allergy to barium

         18. failed newborn hearing screening

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