Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Placebo-controlled Study to Evaluate the Immunogenicity, Reactogenicity and Safety of Two Doses of GSK Biologicals' Oral Live Attenuated Human Rotavirus (HRV) Liquid Vaccine, When Given to Healthy Infants, in Vietnam
Brief Summary: To provide specific data on immunogenicity of GSK Biologicals' HRV liquid vaccine, when co-administered with the routine Expanded Program of Immunization (EPI) in Vietnam. The study will also assess reactogenicity and safety of the HRV liquid vaccine relative to the placebo


Options:
A: Inclusion criteria: Healthy infants between 5 and 10 weeks of age at first study vaccination with (after the 2002 RV season) confirmed negative HIV status of the subject's mother during pregnancy or thereafter. Exclusion criteria: History of allergic disease, any confirmed or suspected immunosuppressive or immunodeficient condition, clinically significant history of chronic gastrointestinal disease or other serious medical condition as determined by the investigator or had not received treatment prohibited by the protocol.
B: Inclusion Criteria:

* Aged ≥ 42 days and ≤ 89 days on the day of inclusion
* Born at full term of pregnancy (≥ 36 weeks)
* Informed consent form signed by the parent(s) or other legally authorized representative(s) before the 1st study related procedure
* Vaccination with a hepatitis B vaccine at least 30 days before inclusion
* Able to attend all scheduled visits and to comply with all trial procedures(i.e., access to a phone)
* Provide blood sample prior to Dose 1
* Parent or legal representative willing to take rectal temperatures after each vaccination.

Exclusion Criteria:

* Participation in another clinical trial in the 4 weeks preceding the (first)trial vaccination
* Planned participation in another clinical trial during the present trial period
* Personal or immediate family history of congenital or acquired immunodeficiency, immunosuppressive therapy such as long-term systemic corticosteroids therapy
* Known or suspected systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to a vaccine containing the same substances as the trial vaccine(s)
* Chronic illness that could interfere with trial conduct or completion
* Received blood or blood-derived products since birth
* Any vaccination in the 2 weeks preceding the first trial vaccination or planned in the 4 weeks after any trial vaccination. Flu vaccine could be administered only 2 weeks after any trial vaccination
* Previous vaccination with any acellular pertussis- (DTaP) or whole cell pertussis- (DTwP) based combination vaccines, Haemophilus influenzae type b (Hib)-conjugate, poliovirus, or pneumococcal conjugate vaccines
* Coagulation disorder contraindicating intramuscular (IM) vaccination
* Clinically significant findings on review of systems (determined by investigator or sub-investigator to be sufficient for exclusion)
* Developmental delay or neurological disorder
* Any condition which, in the opinion of the investigator, would interfere with the evaluation of the vaccine or pose a health risk to the subject.
C: Inclusion Criteria:

* Healthy male or female infant between, and including, 6 and 10 weeks of age with a birth weight of \> 2000 grams.
* Written informed consent obtained from the parent or guardian of the subject.

Exclusion Criteria:

* Use of any investigational or non-registered product (drug or vaccine) other than the HRV liquid vaccine or placebo within 30 days preceding the first dose of HRV liquid vaccine or placebo, 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 except for DTPw, HBV and OPV vaccines within 14 days before each dose of HRV liquid vaccine or placebo and ending 14 days after.
* 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).
* History of allergic disease or reactions likely to be exacerbated by any component of the HRV liquid vaccine or placebo.
D: Inclusion Criteria:

* healthy infants/toddlers as established by medical history and clinical examination before entering study
* age:

  * toddler cohort: \> or = 2 and \<3 years old at the time of enrollment
  * infant cohort: \> or = 6 and \<8 weeks at the time of enrollment
* parental ability and willingness to provide informed consent
* parental intention to remain in the area with the child during the study period.

Exclusion Criteria:

* Presence of fever on the day of enrollment
* Acute disease at the time of enrollment
* Concurrent participation in another clinical trial throughout the entire timeframe for this study
* Presence of malnutrition or any systemic disorder (cardiovascular, pulmonary, hepatic, renal, gastrointestinal, hematological, endocrine, immunological, dermatological, neurological, cancer or autoimmune disease) as determined by medical history and/or physical examination that would compromise the participant's health or is likely to result in nonconformance to the protocol
* For infant cohort, history of premature birth (\<37 weeks gestation)
* History of congenital abdominal disorders, intussusception, or abdominal surgery
* Known or suspected impairment of immunological function based on medical history and physical examination
* For infant cohort only, prior receipt of rotavirus vaccine
* A known sensitivity or allergy to any components of the study vaccine
* History of anaphylactic reaction
* Major congenital or genetic defect
* Participant's parents not able, available or willing to accept active weekly follow-up by the study staff
* Has received any immunoglobulin therapy and/or blood products since birth or planned administration during the study period
* History of chronic administration (defined as more than 14 days) of immunosuppressant medications, including corticosteroids. Infants on inhaled or topical steroids may be permitted to participate in the study
* Any medical condition in the parents/infant that, in the judgment of the investigator, would interfere with or serves as a contraindication to protocol adherence or a participant's parents' ability to give informed consent
* HIV infection

  * For toddlers, to be assessed by HIV ELISA
  * For infants, to be assessed by PCR, if mother is not known to be negative (negative test result between 24 weeks gestation and screening)

Answer: C