Safety and Immunogenicity of Sequential Rotavirus Vaccine Schedules
Condition: Rotavirus Infection
MeSH terms: Rotavirus Infections
Intervention: Rotarix®; RotaTeq®
Intervention description: Each 1-mL dose of Rotarix® contains a suspension of at least 10^6 median Cell Culture Infective Dose (CCID50) of live, attenuated human G1P rotavirus after reconstitution. The lyophilized vaccine contains amino acids, dextran, Dulbecco's Modified Eagle Medium (DMEM), sorbitol, and sucrose. The liquid diluent contains calcium carbonate, sterile water, and xanthan. The diluent includes an antacid component (calcium carbonate) to protect the vaccine during passage through the acid environment of the stomach. Rotarix® contains no preservatives. Once reconstituted, the vaccine will appear white and turbid.; 2-mL ready-to-use oral solution of live reassortant rotaviruses, containing G1, G2, G3, G4, and P1A, which contains a minimum of 2.0 to 2.8 x 10^6 infectious units (IU) per individual reassortant dose, depending on the serotype, and not greater than 116 x 10^6 IU per aggregate dose. The buffered stabilizer solution contains sucrose, sodium citrate, sodium phosphate monobasic monohydrate, sodium hydroxide, polysorbate 80, cell culture media, and trace amounts of fetal bovine serum. RotaTeq® contains no preservatives. RotaTeq® is a pale yellow clear liquid that may have a pink tint.
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1384.0
Sex: All
Minimum age: 6 Weeks
Maximum age: 14 Weeks
Healthy volunteers: Accepts Healthy Volunteers
Keywords: vaccine, rotavirus, gastroenteritis, infants

Summary:

      Rotavirus, sometimes called the "stomach flu," is the most common cause of severe diarrhea in
      children. Vaccines can prevent many types of infections and work by causing the body to make
      proteins called antibodies that fight infection. For some vaccines, more than one vaccination
      is needed so that the body will make enough antibodies to fight infection. The vaccines
      (RotaTeq® or Rotarix® oral vaccines) given in this study are recommended for infants by the
      Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices
      (ACIP). These vaccines require either 2 or 3 vaccinations to be effective. Healthy infants
      between 6 weeks and 14 weeks, 6 days of age at Visit 1 will participate for about 10-12
      months. Study procedures include reaction assessment and blood sample.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female infants who are at least 6 weeks of age and no more than 14 weeks, 6
             days of age at Visit 1.

          -  Parent(s)/legal guardian(s) have signed informed consent documents.

          -  Children who will be available for the entire study period and whose parents/legal
             guardians can be reached by telephone.

          -  Healthy infants as determined by medical history and by a baseline physical
             examination with no clinically significant abnormal findings within 14 days before the
             first dose.

          -  Parents/legal guardians able to complete all relevant study procedures during study
             participation.

        Exclusion Criteria:

          -  Any clinically significant history of gastrointestinal disease including abdominal
             surgery or liver disease or other serious medical conditions as determined by the site
             investigator.

          -  Any history of immunodeficiency in the infant (e.g., the infant is known to be human
             immunodeficiency virus (HIV) positive, to have hypogammaglobulinemia, or to have an
             underlying malignancy), or any infant with any unvaccinated household contact who is
             immunocompromised such as:

               -  Any malignancies or are otherwise immunocompromised;

               -  Primary immunodeficiency; or

               -  Receiving immunosuppressive therapy.

          -  Known sensitivity to any vaccine components, such as latex in the Rotarix® applicator.

          -  Previous receipt of a rotavirus vaccine.

          -  Acute illness at the time of vaccine administration, such as any of the following
             within the past 48 hours:

               1. Axillary temperature of 100.4 degrees Fahrenheit or higher, or

               2. More than 3 grossly watery stools, or

               3. Any episodes of vomiting (forceful expulsion of partially digested milk/food).
                  Infants with previous diagnoses of gastroesophageal reflux whose regurgitation
                  episodes have not changed in the 48-hour period prior to the first vaccination
                  may be enrolled.

        If these symptoms clear within 48 hours and the subject meets the other inclusion/exclusion
        criteria, then the subject may be enrolled.

          -  The subject is currently participating in a study that involves an experimental agent
             (vaccine, drug, biologic, device, blood product, or medication) or has received an
             experimental agent within 1 month prior to enrollment in this study, or expects to
             receive another experimental agent during participation in this study.

          -  Less than 37 weeks gestation at birth.

          -  Receipt of blood and/or blood products (including immunoglobulin) within 4 weeks
             before vaccine administration.

          -  Receipt of live vaccine within the past 30 days or a nonreplicating, inactivated, or
             subunit vaccine within the last 14 days, although planned licensed trivalent
             inactivated influenza vaccine that may be administered to children over 6 months of
             age during a routine clinic visit is permitted and would not be exclusionary.

          -  The subject has any condition that would, in the opinion of the site investigator,
             place the subject at an unacceptable risk of injury or render the subject unable to
             meet the requirements of the protocol.