Please select the eligibility criteria that correspond to the clinical trial below.
Title: Safety and Immunogenicity of Sequential Rotavirus Vaccine Schedules With RotaTeq® and Rotarix®
Brief 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.


Options:
A: 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.
B: Inclusion Criteria:

* Parent or legal guardian agrees to have infant participate by giving written informed consent

Exclusion Criteria:

* History of congenital abdominal disorders, prior rotavirus gastroenteritis, chronic diarrhea, failure to thrive, or abdominal surgery
* History of intussusception
* Known or suspected impairment of immunological function, including Severe

Combined Immunodeficiency (SCID)

* Prior administration of any rotavirus vaccine
* Clinical evidence of active gastrointestinal illness, with the exception of well-controlled gastroesophageal reflux disease (GERD)
* Receipt of 1) systemic corticosteroids (≥ 2mg/kg total daily dose of prednisone or equivalent) for 14 consecutive days or more since birth, or 2) systemic corticosteroids ≥ 2mg/kg/dose within 7 days prior to the administration of the first dose of study vaccine. Participant using non-systemic corticosteroids will be eligible for vaccination.
* Residing in a household with an immunocompromised person
* Prior receipt of a blood transfusion or blood products, including immunoglobulins
* Participation in another interventional study within 14 days prior to the first study vaccination or expected anytime during the study
* Receipt of investigational inactivated vaccines within 14 days or investigational live vaccines within 28 days prior to the first study vaccination or expected anytime during the study
C: Inclusion Criteria:

* Between 42 and 55 days of age at the time of enrollment.
* Healthy infant free of chronic or serious medical condition as determined by history and physical examination at the time of study enrollment.
* Parents/guardians of each subject are able to understand and follow study procedures and agree to participate in the study by providing parental/guardian permission.

Exclusion Criteria:

* If child has previously had intussusception or abdominal surgery.
* Use of any immunosuppressive drugs or immunoglobulin and/or blood product use since birth or anticipated during study period.
* Current enrollment in any other intervention trial or use of any investigational drug or vaccine throughout the study period.
* Birthweight less than 2000 grams or gestation \< 36 weeks, if this information is available.
* Any subject who reports plan to leave the study area before the completion of the study (i.e., relocation, migration, etc.).
* Another child living in the same compound is already enrolled in the trial (i.e., only one participant can be enrolled per compound).
* After the rotavirus vaccine is introduced into the routine EPI system in Navrongo: Another child in the compound is less than 16 weeks of age.
* The child has received rotavirus vaccine outside of this study.
D: Inclusion Criteria:

* At least one parent(s) or legally acceptable representative's consent for participation and are able to understand study procedures
* Subjects aged 6 to 7 weeks at recruitment
* No plans to move in the next 24 months

Exclusion Criteria:

* Administration of rotavirus vaccine in the past
* Presence of any illness requiring hospital referral (temporary exclusion)
* Known case of immunodeficiency disease, known HIV positive
* Known case of chronic gastroenteritis disease
* Any other conditions which in the judgment of the investigator warrant exclusion (e.g. no exclusion criteria but seems "ill", investigators suspects neglect)
* Diarrhea on the day of enrollment (temporary exclusion)

Answer: A