An Alternate Dosing Schedule for Pentavalent Rotavirus Vaccine (RotaTeq)
Condition: Diarrhea; Gastroenteritis
MeSH terms: Gastroenteritis; Diarrhea
Intervention: RV5 (Pentavalent Rotavirus Vaccine)
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Masking description: Open Label
Enrollment: 66.0
Sex: All
Minimum age: 14 Days
Maximum age: 83 Days
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Gastroenteritis; Diarrhea; Rotavirus; Vaccine; Dehydration

Summary:

      This is a pilot study to assess the safety and immunogenicity of pentavalent rotavirus
      vaccine (RV5) when administered according to an alternate dosing schedule (2-5 weeks, 2
      months and 4 months). In this interventional, open-label study, infants 2 through 5 weeks of
      age (14 to 41 days) will be enrolled and vaccinated with RV5 according to a 2-5 week, 2 and 4
      month schedule and infants 2 months of age (56 to 83 days) will be vaccinated according to
      the standard recommended schedule (2, 4, and 6 months of age). Sera will be obtained from
      subjects one month following the final dose of vaccine and will be assayed for anti-rotavirus
      IgA and rotavirus neutralizing antibody responses against the G1, G2, G3, G4 and P[8]
      serotypes. Post dose 3 G1 serum-neutralizing antibody (SNA) geometric mean titers (GMTs) will
      be compared between children receiving pentavalent rotavirus vaccine (RV5) according to the
      alternate dosing schedule versus the standard recommended schedule. Likewise, post dose 3 G2,
      G3, G4 and P[8] SNA and serum rotavirus IgA GMTs will be compared between children receiving
      RV5 according to the alternate dosing schedule and the standard recommended schedule. The
      safety and tolerability of RV5 in children receiving vaccine according to the alternate
      dosing schedule will be described.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female infants who are 14 through 41 or 56 through 83 days of age at Visit 1
             (Day of initial vaccination)

          2. Parent / legal guardian has read and signed the informed consent document

          3. Child and parent / legal guardian is available for the entire study period and can be
             reached by telephone

          4. Healthy infant as determined by medical history and by a baseline physical examination

          5. Infant weight at time of enrollment must exceed birth weight

        Exclusion Criteria:

          1. History of hypersensitivity to the vaccine or any component of the vaccine

          2. History of Severe Combined Immunodeficiency Disease (SCID)

          3. History of immunocompromise ( infant is known to be HIV positive, to have
             hypogammaglobulinemia or to have an underlying malignancy)

          4. History of intussusception

          5. Any clinically significant history of gastrointestinal disease including active acute
             gastrointestinal illness, chronic diarrhea, failure to thrive, congenital abdominal
             disorders, abdominal surgery or liver disease

          6. Prior receipt of a rotavirus vaccine

          7. Less than 37 weeks gestation

          8. The subject has participated in a study with an experimental agent within one month of
             enrollment in the study or anticipated receipt of an experimental agent during
             participation in the study

          9. Receipt of blood products within 4 weeks of study vaccination

         10. Receipt of a live virus vaccine within 4 weeks of study vaccination or an inactivated
             vaccine within 2 weeks. Concomitant administration of routinely recommended vaccines
             is allowed. A dose of hepatitis B vaccine administered in the birthing hospital is
             permitted. Planned routine use of inactivated influenza vaccine for children over 6
             months of age is permitted.

         11. Acute illness within 48 hours of vaccination (axillary temperature of 100.4°F or
             higher, 3 or more grossly watery stools, vomiting). (Infants with stable unchanged
             gastroesophageal reflux may be enrolled).

         12. Insufficient weight gain requiring future weight checks in addition to routine
             scheduled well child visits

         13. The subject has any condition that the investigator believes would put the subject at
             an increased risk of injury or would render the subject unable to complete the trial
             or fulfill the requirements of the study protocol.

         14. Household contact who is immunodeficient (any malignancies or otherwise
             immunocompromised, primary immunodeficiency, receiving immunosuppressive therapy)