Please select the eligibility criteria that correspond to the clinical trial below.
Title: Safety and Efficacy of Pentavalent (G1, G2, G3, G4 , and P1) Human-Bovine Reassortant Rotavirus Vaccine in Healthy Infants
Brief Summary: This study was designed to evaluate the safety of the investigational rotavirus vaccine and the efficacy to prevent rotavirus gastroenteritis.


Options:
A: Inclusion Criteria:

* Healthy male or female infant between, and including, 6 and 12 weeks of age born after a gestation period of 36 to 42 weeks or a birth weight of \>2000g.
* Written informed consent obtained from the parent or guardian of the subject.

Exclusion Criteria:

* Planned administration of oral polio vaccine during the period starting from 2 weeks before each dose of study vaccine(s) and ending 2 weeks after.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection
* History of diphtheria, tetanus, pertussis, Hib disease and/ or hepatitis B.
* Previous vaccination against diphtheria, tetanus, pertussis, and/or Haemophilus influenzae type b.
* History of allergic disease
* Any clinically significant history of chronic gastrointestinal disease including any uncorrected congenital malformation of the GI tract or other serious medical condition as determined by the investigator.
* Gastroenteritis within 7 days preceding the study vaccine administration (warrants deferral of the vaccination)
* Previous confirmed occurrence of RV GE.
* Household contact with an immunosuppressed individual or pregnant women.
* Administration of immunoglobulins and/or blood products since birth or planned administration during the study period
B: Inclusion Criteria:

1. Access to telephone at home or in the immediate neighborhood.
2. Healthy male and female non-malnourished (weight for length not ≤ -3 SD of WHO child growth standards) infants aged 6 weeks (till 6 weeks + 2 days).
3. Parent's permission to participate in the study is available.
4. No plans to travel over the next 4 months

Exclusion Criteria:

1. Gestational age \<37 weeks.
2. Any major physical congenital malformation.
3. Living in a household or has contact with an individual who is immunosuppressed.
4. Hospitalized once or more for the following illnesses since birth: heart disease, pneumonia, sepsis, meningitis, unconsciousness.
5. Is required to take daily medications other than vitamins or herbal "tonics".
6. Evidence of cardiovascular disease as indicated by any of the following:

   * Central cyanosis
   * Cyanotic or apnoeic spells
   * Features of congestive heart failure
   * Significant heart murmur detected on physical examination
7. Evidence of gastrointestinal disease indicated by following:

   * Diarrhea in the previous 7 days
   * Blood in the stools any time since birth
8. Evidence of neurological disease, as indicated by:

   * History of seizures any time since birth
   * History of unconsciousness
   * Focal deficit on physical examination
9. Evidence of liver or other reticuloendothelial disease, as indicated by any of the following:

   * Positive serology for hepatitis B surface antigen
   * Positive serology for hepatitis C antibody
   * SGOT or SGPT more than 1.25 times upper limit of normal (Upper limit normal SGOT 80 IU/L, SGPT 40 IU/L)
   * Alkaline phosphatase more than 1.25 times upper limit of normal (Upper limit of normal -470 IU/L)
   * Hepatomegaly (liver palpable 3 cm below costal margin), splenomegaly (palpable spleen), jaundice, or lymphadenopathy on physical examination
   * Serum bilirubin 1.25 times the upper limit of normal for age (Upper limit of normal 1.0 mg/dL).
10. Evidence of hematologic, rheumatologic, or immunologic disease, as indicated by any of the following:

    * Total leukocyte count \<3500 or \>15,000/mm3
    * Hemoglobin \<9 g/dL or \>17g/dL
    * Platelet count \<100,000/mm3
    * Any episode of sepsis, pneumonia or meningitis requiring hospitalization since birth.
11. Evidence of renal disease as indicated by any of the following:

    * Creatinine \>0.5 mg/dL
    * Hematuria (≥5 RBC/hpf)
    * Proteinuria (≥1+ per day)
C: Inclusion Criteria:

1. aged 6-8 weeks at the time of inclusion
2. able to swallow and no history of vomiting within 24 hours
3. resident in Madarounfa Health District and within the catchment area of the central health facility
4. intending to remain in the study area for 2 years
5. parent/guardian providing written informed consent

Exclusion Criteria:

Any of the following will exclude an infant from randomization in the study:

1. known history of congenital abdominal disorders, intussusception, or abdominal surgery
2. receipt of intramuscular, oral, or intravenous corticosteroid treatment within 2 wks
3. receipt or planned administration of a blood transfusion or blood products, including immunoglobulins
4. any known immunodeficiency condition
5. any serious medical condition
6. any other condition in which, in the judgment of the investigator, would interfere with or serves as a contraindication to protocol adherence or the parent/guardian's ability to give informed consent
D: Inclusion Criteria:

* Healthy infants

Exclusion Criteria:

* None Specified

Answer: D