Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Phase III, Double-blind, Randomized, Placebo-controlled, Multi-country and Multi-center Study to Assess the Efficacy and Safety of Two Doses of GSK Biologicals' Oral Live Attenuated Human Rotavirus (HRV) Vaccine in Healthy Infants
Brief Summary: The main objectives of this study are to determine vaccine efficacy against severe rotavirus (RV) gastroenteritis (GE) during the period starting from 2 weeks after Dose 2 until two years of age and to determine the safety of GSK Biologicals' HRV vaccine with respect to definite intussusception (IS) within 31 days (Day 0-Day 30) after each HRV vaccine dose.


Options:
A: Inclusion Criteria:

* 6 weeks 0 days to 6 weeks 6 days age at the time of enrollment.
* Healthy infant free of chronic or serious medical condition as determined by history and physical exam at time of enrollment into in the study.
* Written informed consent obtained from the parents or guardians.

Exclusion Criteria:

* Hypersensitivity to any of the vaccine components.
* Use of any investigational drug or vaccine other than the study vaccine within 30 days of first dose of study vaccine or during the study.
* Use of any immunosuppressive drugs.
* Previous intussusception or abdominal surgery.
* Enrolment in any other trial (Simplified Antibiotic Therapy for Neonatal Sepsis Trial, Management of Omphalitis Trial).
* Birth weight less than 1500 grams; or if birth weight is unknown, weight less than 2000 grams on or before 28 days.
* Immunoglobulin and/or blood products use since birth or during the study period.
B: 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.
C: 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.
D: Inclusion Criteria:

* Healthy infants birth weigh \>2000 g, 11 -17 weeks old at Dose 1 with written informed consent.

Exclusion Criteria:

* Allergic reaction to vaccine components; clinically significant history of chronic GI disease (uncorrected GI congenital malformation) or other serious medical condition per investigator, received vaccines or treatment prohibited by the protocol; immunocompromised.

Answer: B