Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Phase 4, Randomized, Open-Label Study to Assess Humoral and Intestinal Polio Immunity Following a Three-Dose Trivalent Inactivated Polio Vaccine Schedule Relative to Two Sequential Schedules of IPV/Bivalent Oral Polio Vaccines
Brief Summary: The rationale for this study (IPV 002ABMG) is to evaluate and compare three doses of IPV, two doses of IPV plus one bOPV, and one dose of IPV plus two doses of bOPV in order to provide evidence for better immunization policy making in regions of the world that must switch to use of IPV/bOPV schedules in the 2014-2015 time frame. The goal is to identify the best option optimizing humoral immune responses, intestinal immunity and thereby prevent community transmission as well as preventing VAPP. Specifically, the study seeks to show that both of the sequential regimens are equivalent (not-inferior) to the 3-dose IPV regimen in the seroconversion rates to both type 1 and type 3 poliovirus such that not more than 10% of subjects fall below the 95% confidence interval observed for the 3-dose IPV alone regimen and the geometric mean titers (GMTs) are no more than 2/3 logs less than those for the 3-dose IPV regimen. In addition, the study will evaluate by a novel method (poliovirus shedding index), the adequacy of IPV vaccines in inducing intestinal immunity, specifically by reducing the shedding of poliovirus type 2 after an OPV challenge. The hypotheses of the study are:

* A 3-dose IPV/bOPV sequential schedule including 1 or 2 doses of bOPV is non-inferior in terms of types 1 and 3 seroconversion rates and GMTs to a 3-dose IPV schedule.
* Two and possibly 1 IPV dose(s) provides significant seroconversion rates and GMTs to type 2 poliovirus and sufficient priming to induce a rapid immune response in the context of an oral challenge at 7 months of age.
* Three, 2, and possibly 1 dose of IPV will induce intestinal immunity to poliovirus type 2 as measured by a combination of quantity of virus in stools and duration of shedding (shedding index).

In addition to these 3 hypotheses, the study will explore the following hypothesis:

• Co-administration of bOPV and rotavirus at 16 weeks of age (the second rotavirus dose) provides similar antirotavirus IgA seroconversion rates and GMCs compared to subjects receiving rotavirus vaccine together with IPV.


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:

* Aged 15 to 18 months on the day of inclusion
* Informed consent form signed by the parent(s) or other legally acceptable representative
* Subjects and parent/guardian able to attend all scheduled visits and comply with all trial procedures
* Child having completed all visits of the IPV25 study (NCT00604058), including the three-dose primary vaccination series with the study vaccine (IMOVAX Polio), using the route of administration as designated by randomization.

Exclusion Criteria:

* Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the trial vaccination
* Planned participation in another clinical trial during the present trial period
* Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroids therapy
* Known systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccine or to a vaccine containing any of the same substances
* Chronic illness at a stage that could interfere with trial conduct or completion, in the opinion of the investigator
* Receipt of blood or blood-derived products since birth that might interfere with the assessment of immune response
* Receipt of any vaccine in the 4 weeks preceding the trial vaccination
* Planned receipt of any vaccine during the present trial period
* Known personal or maternal Human Immunodeficiency Virus (HIV), Hepatitis B antigen or Hepatitis C seropositivity
* History of seizures
* History of poliomyelitis infection (confirmed either clinically, serologically or microbiologically)
* Previous fourth dose vaccination against the poliomyelitis disease with either the trial vaccine or another vaccine
* Thrombocytopenia, bleeding disorder or anticoagulants in the 3 weeks preceding inclusion contraindicating IM injection
* Febrile illness (temperature ≥38.0 °C) or moderate or severe acute illness/infection on the day of vaccination, according to investigator judgment.
C: 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.
D: 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

Answer: A