Please select the eligibility criteria that correspond to the clinical trial below.
Title: Introduction of an Oral Live Human Rotavirus (Rotarix) Vaccine in Matlab
Brief Summary: The study will be conducted in the Matlab Health and Demographic Surveillance System (HDSS) field area of the International Centre for Diarrhoeal Disease Research, Bangladesh (ICDDR,B) to determine the population effectiveness of Rotarix in Bangladeshi children. Villages in both intervention and government comparison areas will be included in this evaluation. We propose to introduce Rotarix into half of the villages of the Matlab HDSS. In villages randomized to receive the vaccine, all eligible children will be offered Rotarix during their first two Expanded Programme on Immunization (EPI) visits, as would routinely be done if Rotarix were included in the Government EPI schedule. In villages randomized not to receive Rotarix, children will receive their EPI vaccinations exactly as they would have in the absence of this study. Administration of Rotarix will be conducted by regular EPI staff, but ICDDR,B study staff will be present to document informed consent and collect study-specific information. The Ministry of Health will be an active partner in this evaluation since they will be the agency which may follow up with any subsequent vaccine programme. Vaccination with Rotarix will be recorded on the infant's immunization card which is normally used by the EPI programme, but also on a separate study-specific data collection form.

Vaccination with Rotarix will continue from study initiation through June 30, 2011. Surveillance for rotavirus gastroenteritis will occur at Matlab Diarrhoeal Hospital and the community treatment centres of the Matlab HDSS continuously throughout the study period. Diarrheal illness information collected through surveillance will be linked to Rotarix study-specific data through the subject's HDSS identification numbers. The primary study endpoint will be the occurrence of an illness episode of acute diarrhoea, among infants and children admitted to a medical facility, determined to be caused by wild-type rotavirus found in a stool specimen. At the end of the surveillance period, rates of this primary study endpoint among age-eligible infants will be compared for villages randomized to receive Rotarix versus for villages randomized not to receive Rotarix. We expect that the rates of rotavirus diarrhoea will be significantly lower among children from the vaccinated villages.

The first participant was enrolled in the study on September 23, 2008. Till date (May 12, 2010) a total of 2,882 participants have been enrolled and received first dose. 2,684 participants received second dose of Rotarix. There were 1013 cases gastroentritis reported to diarrhoeal treatment centres among \<2 years old children from the vaccinated and unvaccinated villages. There were six death cases among the children who received Rotarix vaccine. These death cases were not related to the vaccines/study products.


Options:
A: 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
B: Inclusion Criteria:

* A male or female infant at least 6 weeks of age and not older than 20 weeks of age at the time of first dose of Rotarix.
* An infant whose parent or guardian's primary residence, at the time of first EPI vaccinations, is a village selected to receive Rotarix.
* Written informed consent obtained from the parent or guardian of the subject, prior to the subject's first study vaccination

Exclusion Criteria:

* Hypersensitivity to the active substance or any component in the vaccine
* Hypersensitivity after previous administration of rotavirus vaccines.
* Previous history of intussusception.
* Subjects with uncorrected congenital malformation of the gastrointestinal tract that would predispose for intussusception.
* Infants with known or suspected immunodeficiency.
* Administration of Rotarix should be postponed in subjects suffering from an acute severe febrile illness only if that illness also results in postponement of other EPI vaccinations.
C: Inclusion criteria:

* Healthy infants 6-12 or 11-17 weeks of age at the time of dose 1 whose parent/guardian sign a written informed consent and whose parents/guardians can and will comply with the requirements of the protocol.

Exclusion criteria:

* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine or placebo, or planned use during the study period.
* Chronic administration of immunosuppressants or other immune-modifying drugs since birth.
* Child is unlikely to remain in the study area during study.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
* History of allergic disease or reaction likely to be exacerbated by any component of the vaccine.
* Administration of immunoglobulins and/or blood products since birth or planned administration during the study period.
* Any clinically significant history of chronic gastrointestinal disease including any uncorrected congenital malformation of the gastrointestinal tract or other serious medical condition as determined by the investigator.
* First or second degree of consanguinity of parents.
D: Inclusion Criteria:

Healthy Adults:

1. Healthy adult subjects of either sex, between 18 to 45 years of age;
2. No apparent signs or symptoms of ill health;
3. Subjects properly informed about the study and having signed the informed consent form (ICF). In case of subjects' inability to read or write, having had the ICF explained to them in the presence of a study independent witness and the witness having signed the ICF;
4. Subjects' availability for the entire period of the study and reachability by study staff for post vaccination follow-up.

Healthy Infants:

1. Healthy infants of either sex, 6-8 weeks of age at the time of enrollment;
2. Born after a gestational period of 36-42 weeks with birth weight ≥ 2kg;
3. Father, mother or other legally authorized representative (guardian) properly informed about the study and having signed the informed consent form (ICF). In case of father's, mother's or other legally acceptable representative's (guardian) inability to read or write, having had the ICF explained to them in the presence of a study independent witness and the witness having signed the ICF;
4. Infant/Parents' or guardian's availability for the entire period of the study and reachability by study staff for post-vaccination follow-up.

Exclusion Criteria:

Healthy adults:

1. Known or suspected impairment of immunological function; and known immunosuppressed family members/household contacts
2. Known hypersensitivity to any component of the rotavirus vaccine;
3. Fever, with axillary temperature ≥38.1 oC (≥100.5 oF) as measured by study staff;
4. History of chronic diarrhea;
5. Clinical evidence of active gastrointestinal illness;
6. Receipt of any IM, oral, or IV corticosteroid treatment in the past 30 days;
7. Subjects' suspected to be HIV, HBV or HCV positive from the available clinical history;
8. Any subject who cannot be adequately followed for safety assessment;
9. Any conditions which, in the opinion of the investigator, might interfere with the evaluation of the study objectives;
10. Subject's inability to maintain diary card;
11. Participation in another clinical trial investigating a vaccine, drug, medical device or medicinal procedure in the 4 weeks preceding the current vaccination trial;
12. Planned participation in another clinical trial during the present trial period;
13. Subjects identified as employees of the investigator or study center, with direct involvement in the proposed study or studies under the direction of that investigator or study center as well as children, adopted or natural, of the employees or Investigator.

Healthy Infants:

1. History of congenital abdominal disorders, intussusception, or abdominal surgery;
2. Infants exhibiting signs of severe malnutrition or Known or suspected impairment of immunological function(s) in subject or his/her immediate family;
3. Developmental delay or neurological disorder;
4. Known hypersensitivity to any component of the rotavirus vaccine;
5. Prior receipt of any rotavirus vaccine;
6. Prior receipt of any dose of Diphtheria, Tetanus, Pertussis, Hepatitis B, Hib or polio virus containing vaccine(s). Birth dose of Hepatitis B and Oral Polio Vaccine is allowed to be administered to the infants as per the local immunization practices. Oral Polio Vaccines administered as a part of the National Pulse Polio Program are allowed to be administered to the infants.
7. Fever, with axillary temperature ≥38.1 oC (≥100.5 oF) as measured by study staff.
8. History of known rotavirus disease, chronic diarrhea, or failure to thrive;
9. Clinical evidence of active gastrointestinal illness including ongoing diarrheal episode (infants with GERD can participate in the study so long as this condition is well controlled with or without medication);
10. Receipt of any IM, oral, or IV corticosteroid treatment in the past 30 days (infants on inhaled steroids may be permitted to participate in the study);
11. Infants residing in a household with an immuno-compromised person (e.g., individuals with a congenital immunodeficiency, HIV infection, leukemia, lymphoma, Hodgkin's disease, multiple myeloma, generalized malignancy, chronic renal failure, nephritic syndrome, organ or bone marrow transplantation, or those receiving immunosuppressive chemotherapy including long-term systemic corticosteroids);
12. Infants already laboratory-confirmed or suspected to be HIV, HBV or HCV positive from the available clinical history or born to mothers known to be HIV, HBV or HCV positive (no specific screening for the purpose of the study would be carried out);
13. Prior receipt of a blood transfusion or blood products, including immunoglobulins, in the past 4 weeks which might interfere with the assessment of the immune response;
14. Any infants who cannot be adequately followed for safety assessment by a home visit;
15. Any conditions which, in the opinion of the investigator, might interfere with the evaluation of the study objectives;
16. Parent/s or guardian of infant unable to maintain symptom diary;
17. Participation in another clinical trial investigating a vaccine, drug, medical device or medicinal procedure in the 4 weeks preceding the current vaccination trial;
18. Planned participation in another clinical trial during the present trial period;
19. Parents/ Guardians/ Legally Authorized Representatives identified as employees of the investigator or study center, with direct involvement in the proposed study or studies under the direction of that investigator or study center as well as children, adopted or natural, of the employees or Investigator.

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Answer: B