Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Placebo-controlled, Multi-country & Multi-center Study to Assess the Efficacy, Safety & Immunogenicity of 2 Doses of GSK Biologicals' Oral Live Attenuated Human Rotavirus (HRV) Vaccine in Healthy Infants
Brief Summary: The main objectives of this study are: 1) In a subset (N = 20 000), to determine vaccine efficacy against severe rotavirus (RV) gastroenteritis (GE) during the period starting from 2 weeks after Dose 2 until one year of age. 2) In all subjects (N = 60 000), 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:

* Healthy infants 6-13 weeks of age at the time of the first study vaccination whose parent/guardian sign a written informed consent and whose parents/guardians can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow-up visits)

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 (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs since birth. (Topical steroids are allowed.)
* Child is unlikely to remain in the study area for the duration of the 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
B: Inclusion criteria:

* Healthy infants 6 -12 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.
C: Inclusion criteria:

* Healthy infants 6 -14 weeks of age at the time of the first study vaccination with birth weight \> 2000g whose parent/guardian sign a written informed consent and whose parents/guardians can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow-up visits).

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 planned use during the study period.
* Planned administration of a vaccine not foreseen by the study protocol within 14 days before each dose of study vaccine(s) and ending 14 days after.
* Chronic administration (defined as more than 14 days) of immunosuppressants since birth. (Topical steroids are allowed.)
* History of diphtheria, tetanus, pertussis, Hib disease and/ or hepatitis B disease (in all subjects). Only for subjects in Spain: history of meningococcal group C disease. Only for subjects in France and Germany: history of disease caused by Streptococcus pneumoniae.
* History of use of experimental rotavirus vaccine.
* Previous vaccination against diphtheria, tetanus, pertussis, Haemophilus influenzae type b (in all subjects). Only for subjects in Spain: previous vaccination against meningococcal group C. Only for subjects in France and Germany: previous vaccination against Streptococcus pneumoniae.
* Any clinically significant history of chronic gastrointestinal disease including any uncorrected congenital malformation of the GI tract, IS or other medical condition determined to be serious by the investigator.
* Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination (no laboratory testing is required).
* History of allergic disease or reaction likely to be exacerbated by any component of the vaccine.
* Acute disease at the time of enrolment. (Acute disease is defined as the presence of a moderate or severe illness with or without fever. All vaccines can be administered to persons with a minor illness such as mild upper respiratory infection with or without low-grade febrile illness, i.e. Oral temperature \<37.5°C (99.5°F) / Axillary temperature \<37.5°C (99.5°F) / Rectal temperature \<38°C (100.4°F).)
* Gastroenteritis within 7 days preceding the first study vaccine administration (warrants deferral of the vaccination).
* A family history of congenital or hereditary immunodeficiency.
* Administration of immunoglobulins and/or blood products since birth or planned administration during the study period.
* History of any neurologic disorders or seizures.
* Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
D: Inclusion Criteria:

* Between 42 and 55 days of age at the time of enrollment.
* Healthy infant free of chronic or serious medical condition as determined by history and physical examination at the time of study enrollment.
* Parents/guardians of each subject are able to understand and follow study procedures and agree to participate in the study by providing parental/guardian permission.

Exclusion Criteria:

* If child has previously had intussusception or abdominal surgery.
* Use of any immunosuppressive drugs or immunoglobulin and/or blood product use since birth or anticipated during study period.
* Current enrollment in any other intervention trial or use of any investigational drug or vaccine throughout the study period.
* Birthweight less than 2000 grams or gestation \< 36 weeks, if this information is available.
* Any subject who reports plan to leave the study area before the completion of the study (i.e., relocation, migration, etc.).
* Another child living in the same compound is already enrolled in the trial (i.e., only one participant can be enrolled per compound).
* After the rotavirus vaccine is introduced into the routine EPI system in Navrongo: Another child in the compound is less than 16 weeks of age.
* The child has received rotavirus vaccine outside of this study.

Answer: A