Please select the eligibility criteria that correspond to the clinical trial below.
Title: Randomized Placebo-Controlled Trial of Inactivated Poliovirus Vaccine in Cuba
Brief Summary: The purpose of this study was to evaluated the effectiveness of inactivated poliovirus vaccine at a vaccine schedule that is commonly used in developing countries. The effectiveness of inactivated poliovaccine given at this schedule is important to national policy makers as they consider vaccination policies after the use of oral polio vaccine is discontinued.


Options:
A: Inclusion Criteria:

1. Age: 8 weeks (-7 to +7 days).
2. Healthy infants of all ethnicities and both genders without obvious medical conditions that preclude the subject to be in the study as established by the medical history and physical examination.
3. Written informed consent obtained from 1 parent or legal guardian who, in the opinion of the investigator, is capable of understanding and complying with the protocol requirements.

Exclusion Criteria:

1. Previous vaccination against poliovirus.
2. Low birth weight (BW \<2,500 grams).
3. Twins or multiple pregnancy infants.
4. Another family or household member who has received OPV within the past 6 months or is going to receive OPV within the following 6 months.
5. Any confirmed or suspected immunosuppressive or immunedeficient condition including human immunodeficiency virus (HIV) infection.
6. Family history of congenital or hereditary immunodeficiency.
7. Major congenital defects or serious chronic illness (neurologic, pulmonary, gastrointestinal, hepatic, renal, or endocrine).
8. Known allergy to any component of the study vaccines.
9. Uncontrolled coagulopathy or blood disorder contraindicating intramuscular injections.
10. Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
11. Subject who, in the opinion of the Investigator, is unlikely to comply with the protocol or is inappropriate to be included in the study for the safety or the benefit-risk ratio of the subject.
B: Inclusion Criteria:

* Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) can and will comply with the requirements of the protocol.
* Subjects who received the complete three-dose primary vaccination course in study NCT01021293.
* Healthy male or female toddlers 18 to 24 months of age at the time of Visit 1 (Day 0).
* Written informed consent obtained from the parent(s)/ Legally Acceptable Representative(s) of the subject.
* Healthy subjects as established by medical history and clinical examination before entering into the study.

Exclusion Criteria:

* Child in care.
* Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the booster dose of study vaccine(s), or planned use during the study period.
* Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to Visit 1 (Day 0).
* Administration of immunoglobulins and/or any blood products within the 3 months preceding Visit 1 (Day 0) or planned administration during the study period.
* Administration of a vaccine not foreseen by the study protocol within 30 days of Visit 1 (Day 0) or planned administration 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.
* Evidence of previous booster vaccination against poliomyelitis or the disease since the conclusion visit of Study NCT01021293.
* History of seizures or progressive neurological disease.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
* History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine.
* Major congenital defects or serious chronic illness.
* Acute disease and/or fever at the time of enrolment.
C: Inclusion Criteria:

* Nine to ten months of age inclusive
* Receipt of at least three doses of tOPV (excluding a dose given at birth) a minimum of four weeks prior to recruitment date
* Informed consent for trial participation obtained from a parent/guardian (see section 19.1.2 for definition of guardian and section 19.1.3 for details regarding consent procedure)
* Resident in the study area and with no plans to travel outside the study area during the period of subject participation
* Willingness and capacity to comply with the study protocol as judged by a member of the clinical trial team

Exclusion Criteria:

* Use of any Investigational Medicinal Product(IMP) within the 28 days preceding enrolment
* Planned administration of any vaccine outside those defined in the study protocol at anytime during trial participation (for procedure in the event of a national OPV campaign see section 12.5.1.1)
* Previous receipt of a measles, rubella, yellow fever or IPV vaccine
* Bacillus Calmette-Guérin(BCG) vaccination in the month prior to recruitment
* Any suspected or confirmed congenital or acquired state of immune deficiency including but not limited to primary immunodeficiencies including thymus disorders, HIV/AIDS, hematological or lymphoid malignancies (blood tests will not be routinely undertaken with this regard as part of the study)
* Any current immunosuppressive/immunomodulatory medication or treatment including, but not limited to corticosteroids, cyclosporin, azathioprine, cyclophosphamide, methotrexate, radiotherapy, bone marrow transplantation
* Receipt of any immunosuppressive or immunomodulatory medication or treatment within the six months preceding trial enrolment (for corticosteroids this is defined as a dose of prednisolone (or equivalent) of greater than 2mg/kg/day for one week or 1mg/kg/day for one month. The use of inhaled or topical corticosteroids is not an exclusion criteria
* Receipt of pooled human immunoglobulin, other blood product or any monoclonal antibody therapy at any point prior to recruitment or plans to receive such therapy at any point during the trial-
* Any significant congenital defect or significant chronic health problem (e.g. chronic hematological (including severe anemia), renal, gastrointestinal, respiratory, neurological and cardiovascular disorders).
* A history of anaphylactic or anaphylactoid reaction to egg, chicken proteins, neomycin, streptomycin polymyxin B, any previous vaccination or any individual component of one of the vaccines
* Confirmed fructose intolerance
* Severe protein-energy malnutrition (weight-for-age Z-score of less than -3)
* Any clinically suspected or confirmed congenital or acquired clotting or bleeding disorder or any mediation known to significantly interfere with clotting (e.g. hemophilia or current anti-coagulant therapy) (blood tests will not be routinely undertaken with this regard as part of the study)
* Any other condition which, in the opinion of the research clinician or ultimately the PI, is likely to interfere with the assessment of the primary and secondary objectives
* Any significant signs or symptoms of an acute illness or infection including a tympanic temperature \>38.0°C or documented fever \>38°C in the preceding 48 hours
D: Inclusion Criteria:

Infants born 18 - 20 weeks prior to the first round of the 2002 National Immunization Days in cuba (in March 2002).

Born healthy at one of the 4 designated maternity hospitals in Cuba

Exclusion Criteria:

Serious congenital defect/disease at birth

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Answer: D