Please select the eligibility criteria that correspond to the clinical trial below.
Title: An Evaluation of the Immune Response to Pentavalent Rotavirus Vaccine After a Supplemental Dose Given at 9 Months of Age With Local EPI Vaccines in Mali
Brief Summary: This study is an evaluation of the immune response to pentavalent rotavirus vaccine (PRV) after an additional fourth dose is given at 9 months of age with local World Health Organization (WHO) Expanded Programme on Immunization (EPI) vaccines in Mali.


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 least 9 months of age through 11 months of age (has not yet reached 1st birthday) at the time of administration of study vaccines.
* Residence in the study area.
* At least one parent or guardian who is at least 18 years of age and is willing to provide written informed consent.
* Generally healthy and free of obvious health problems as established by medical history including physical examination and clinical judgment of the investigator.
* A child who is fully vaccinated according to the local EPI schedule (exclusive of oral polio vaccine birth dose).
* A parent or guardian is willing to attend all planned study visits or allow home visits and mobile phone contacts, as required by the protocol.

Exclusion Criteria:

* Previous receipt any measles-containing vaccine.
* Previous receipt of any yellow fever vaccine.
* Previous receipt of any meningitis vaccine.
* Receipt of rotavirus vaccine within the past 90 days.
* Administration of any other vaccine within 8 weeks prior to administration of study vaccines or planned vaccination during the 4 weeks after study vaccination.
* History of allergic disease or known hypersensitivity to any component of the study vaccines and/or following administration of vaccines included in the local program of immunization
* Use of any investigational or non-registered drug within 90 days prior to the administration of study vaccines.
* Administration of immunoglobulins and/or any blood products within 90 days prior to the administration of study vaccines or planned administration during the vaccine period.
* Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying agents since birth (including systemic corticosteroids, this means prednisone, or equivalent, ≥0.5 mg/kg/day; topical steroids including inhaled steroids are allowed).
* A family history of congenital or hereditary immunodeficiency.
* History of intussusception.
* Uncorrected congenital malformation of the gastrointestinal tract that would predispose for intussusception.
* Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic, or renal functional abnormality, as determined by medical history or physical examination, which in the opinion of the investigator, might interfere with the study objectives.
* Acute illness at the time of enrollment (acute disease is defined as the presence of a moderate or severe illness with fever \[axillary temperature ≥38°C\] or without fever \[severity determined at the discretion of the investigator\]. Acute illness is a temporary exclusion.
* Any condition or criterion that in the opinion of the investigator might compromise the well-being of the subject or the compliance with study procedures or interfere with the outcome of the study.
C: 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.
D: 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.
* A male or female child between, and including, 5 and 10 weeks of age at the time of the first study vaccination.
* Written informed consent obtained from the parent or guardian of the subject who is of legal age
* Healthy subjects as established by medical history and clinical examination before entering into the study.
* In South Africa, birth weight \> 2000 grams or if weight unknown, gestation period \> 36 weeks.

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.
* 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
* 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.
* History of use of experimental rotavirus vaccine.
* Previous routine vaccination except Bacille Calmette-Guérin (BCG), hepatitis B virus (HBV) and oral poliovirus (OPV) vaccination at birth
* Any clinically significant history of chronic gastrointestinal disease including any uncorrected congenital malformation of the gastrointestinal tract, intussusception 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
* History of allergic disease or reaction likely to be exacerbated by any component of the vaccine.
* Acute disease at the time of enrolment.
* Gastroenteritis within 7 days preceding the first study vaccine administration
* Previous confirmed occurrence of rotavirus gastroenteritis (RV GE).
* 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.

Answer: B