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:

* Healthy infants of 6 weeks of age (±2 days).
* Study families reside within the Health and Demographic Surveillance System (HDSS) area, service area of the ICDDR,B.
* Family able to understand and comply with planned study procedures

Exclusion Criteria:

* Family residence outside the ICDDR,B HDSS service area, or families expecting to move away during the study period, will be excluded.
* A diagnosis or suspicion of immunodeficiency disorder (either in the infant or in a member of the immediate family).
* A diagnosis or suspicion of bleeding disorder that would contraindicate venipuncture.
* Acute diarrhea, infection or illness at the time of the first visit (6 weeks of age) that would require infant's admission to a hospital or would contraindicate provision of OPV per country guidelines.
* Acute vomiting and intolerance to liquids within 24 hours before the first visit (6 weeks of age).
* Receipt of OPV or IPV at any time before enrollment based upon mother's recall or immunization card if available.
* Because of contact transmission of vaccine poliovirus strains, newborns from multiple births will be excluded from the study to prevent transmission of vaccine strains received during routine immunization from the twin to the study participant.
B: 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.
C: Inclusion Criteria:

1. Mother willing to sign informed consent form.
2. Healthy infant aged 0 to 7 days old.
3. No obvious congenital abnormalities or birth defects.
4. No abnormal (frequency and consistency) stools since birth.
5. Stable household with no plans to leave the area for the next one year.

Exclusion Criteria:

1. Parents are not willing to have child vaccinated at the field clinic.
2. Parents are not willing to have child's blood drawn.
3. Parents are planning to enroll child into another clinical study during the time period of this trial.
4. Mother not willing to have blood drawn and breast milk extracted.
5. Parents not willing to have field research assistant in home two times per week.
6. History of seizures or other apparent neurologic disorders.
7. Infant received any vaccines before start of study, except Bacillus Calmette-Guerin (BCG).
8. Infant has any sibling currently or previously enrolled in this study, including a twin.
D: 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.

Answer: D