Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Phase III, Randomized, Double Blind, Placebo Controlled Trial to Evaluate the Protective Efficacy of Three Doses of Oral Rotavirus Vaccine (ORV) 116E, Against Severe Rotavirus Gastroenteritis in Infants
Brief Summary: The trial is a phase III randomized, double-blind, placebo-controlled trial with the primary objective of evaluating the efficacy of three doses of ORV 116E, 10\^5.0 FFU, against severe rotavirus gastroenteritis, in comparison with a placebo in India.


Options:
A: 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)
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:

* Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study.
* A male or female between, and including 6 and 10 weeks of age at the time of the first vaccination.
* Written informed consent obtained from the parents or guardians of the subject
* Documented HIV status of the subject as confirmed by PCR.
* HIV asymptomatic and HIV mildly symptomatic; Stages I and II disease according to WHO's most recent classification for HIV stages in infants and children.
* Born after a gestation period of 36 to 42 weeks.

Exclusion Criteria:

* Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
* Previous routine vaccination except OPV, BCG and HBV vaccination at birth
* 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.
* History of allergic disease or reaction likely to be exacerbated by any component of the vaccine.
* Acute disease at time of enrolment.
* Gastroenteritis within 7 days preceding the study vaccine administration.
* Previous confirmed occurrence of RV gastroenteritis.
* Other conditions which in the opinion of the investigator may potentially interfere with interpretation of study outcomes.
* HIV moderately and severely symptomatic: stages III and IV according to WHO's recent classification.
* Administration of immunoglobulins and/or blood products since birth or planned administration during the study period.
D: Inclusion Criteria:

* Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study.
* Healthy male or female infant between, and including, 6 and 14 weeks (42 - 104 days) of age at the time of first study vaccination in Portugal, France and Poland. A male or female infant between, and including, 6 and 12 weeks of age at the time of first study vaccination in Spain.
* Medically stable pre-term infants, born within a gestational period of 27 -36 weeks.
* Written informed consent obtained from the parent or guardian of the subject.
* Planned to be discharged from hospital's neonatal stay on or before the day of the first HRV vaccine/Placebo administration.

Exclusion Criteria:

* Use of any investigational or non-registered product (drug or vaccine) other than the HRV vaccine within 30 days preceding the first dose of HRV vaccine, or planned use during the study period.
* Chronic administration of immunosuppressants or other immune-modifying drugs since birth.
* Planned administration/ administration of a vaccines not foreseen by the study protocol from birth till study end.
* Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
* Any clinically significant history of chronic gastrointestinal disease.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
* History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
* Major congenital defects or serious chronic illness (subjects with severe broncho-pulmonary dysplasia requiring persistent oxygen-therapy will be excluded).
* History of any neurologic disorders or seizures. Grade I and II intra-ventricular bleeding are allowed.
* Acute disease at the time of enrolment.
* Administration of immunoglobulins, and/or any blood products within one month (30 days) preceding the first dose of study vaccines or planned administration during the study period. Monoclonal anti-RSV therapy/prophylaxis and recombinant erythropoietin are allowed.

Answer: A