Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Phase 1 Study to Evaluate Safety and Reactogenicity of a Vietnamese Rotavirus Vaccine (Rotavin-M1 at 10e6.3FFU/Dose) Among Healthy Adults in Vietnam
Brief Summary: The purpose of this study is to evaluate the safety of Rotavin-M1 produced by the Center for Research and Production of Vaccines and Biologicals (POLYVAC) in adult volunteers in Vietnam.


Options:
A: 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.
B: Inclusion Criteria:

At dose 1

* Healthy male or female, 18 to 40 years of age,
* Free of disease,
* Written informed consent obtained from subjects. At dose 2
* Received dose 1.
* Oral informed consent obtained from subject for continuing participate the study.

Exclusion Criteria:

At dose 1

1. Pregnant woman or planning to be pregnant during the study period.
2. Has a chronic disease (cardiovascular, liver, kidney disease).
3. Acute disease at the time of enrolment.
4. Administering corticosteroids (\> 1mg/kg/day).
5. Received any immunosuppressive therapy within 4 week before vaccination (Administration of immunoglobulins and/or any blood product or corticosteroids for \>2 weeks).
6. Immunosuppressive or immunodeficient condition.
7. Allergic or reaction with any component of vaccine, includes anaphylactic and shock with any antibiotic.
8. Fever (axillary temperature \>38oC) within 3 days before or on the day of vaccination.
9. Has any type of blood disorder, leukemia, or malignant tumor which can affect the bone marrow or lymph system.
10. Use of any investigational or non-registered product (unlicensed drug or vaccine) other than the study vaccine during the study period.

At dose 2

1. Pregnant woman or planning to be pregnant in next 1 month.
2. Acute disease at the time of 2nd dose.
3. Administering corticosteroids (\> 1mg/kg/day).
4. Received any immunosuppressive therapy within 4 week before vaccination (administration of immunoglobulins and/or any blood product or corticosteroids for \>2 weeks).
5. Immunosuppressive or immunodeficient condition.
6. History of allergic disease or reactions likely to be exacerbated by any component of the study vaccine.
7. Fever (axillary temperature \>38oC) within 3 days before or on the day of vaccination.
8. Has any type of blood disorder, leukemia, or malignant tumor which can affect the bone marrow or lymph system.
9. Use of any investigational or non-registered product (unlicensed drug or vaccine) other than the study vaccine during the study period.
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:

* Healthy infants at least 6 weeks (42 days) and up to 12 weeks (84 days) of age at the time of the first study vaccination
* Parent/legal guardian agrees to participate by giving written informed consent and is willing and able to comply with study requirements

Exclusion Criteria:

* History of congenital abdominal disorders, prior rotavirus gastroenteritis, chronic diarrhea, failure to thrive, or abdominal surgery
* History of intussusception
* Impairment of immunological function, including Severe Combined Immunodeficiency (SCID)
* Acute disease, severe chronic disease, or chronic disease during the acute period
* Uncontrolled epilepsy, encephalopathy, seizure, or other progressive neurological disease
* Hypersensitivity to any component of the rotavirus vaccine, OPV, or DTaP
* Prior receipt of any rotavirus vaccine
* Fever, with an axillary temperature \>=37.5 °C (or equivalent) within 24 hours before study vaccination (study vaccination can be deferred until complete resolution of febrile illness)
* Clinical evidence of active gastrointestinal illness
* Received intramuscular, oral, or intravenous corticosteroid treatment since birth (topical, ophthalmic, and inhaled steroids are permitted)
* Resides in a household with an immunocompromised person
* Receipt of a blood transfusion or blood products, including immunoglobulins
* Participation in another interventional study within 14 days before the first study vaccination or during the study
* Receipt of an investigational or non-registered product other than the study vaccine within 30 days before the first study vaccination or during the study
* For participants in immunogenicity arms: inability to obtain a blood specimen at randomization visit (note: the visit may be rescheduled so that a baseline specimen may be obtained); history of polio, diphtheria, tetanus, or pertussis disease; previous vaccination against diphtheria, tetanus, pertussis, or poliomyelitis
* Any condition which, in the opinion of the investigator, may interfere with the evaluation of the study objectives

Answer: B