Please select the eligibility criteria that correspond to the clinical trial below.
Title: Assessment of the Immunogenicity of Three Doses of Bivalent, Trivalent or Type One Monovalent Oral Poliovirus Vaccines Provided at 2 or 4 Week Intervals
Brief Summary: This randomized clinical trial will assess the immune response in infants following administration of three types of oral poliovirus vaccine trivalent OPV (tOPV), monovalent OPV type 1 (mOPV1), bivalent OPV types 1 and 3 (bOPV) using two different schedules: a short schedule with administration at two week intervals and the usual schedule at four week intervals. The results of this study will guide the Global Polio Eradication Program in the implementation of new strategies that may: 1) improve the quality of the response to outbreaks following importation of wild poliovirus type 1 by shortening the interval at which several OPV doses are provided; 2) prevent alternate outbreaks of type 1 and type 3 poliovirus by using bOPV in outbreak responses in countries with weak routine immunization systems; and 3) prevent the emergence of type 2 vaccine-derived poliovirus through the replacement of tOPV with bOPV in immunization campaigns and routine immunization programs.


Options:
A: Inclusion Criteria:

* 6 weeks 0 days to 6 weeks 6 days age at the time of enrollment.
* Healthy infant free of chronic or serious medical condition as determined by history and physical exam at time of enrollment into in the study.
* Written informed consent obtained from the parents or guardians.

Exclusion Criteria:

* Hypersensitivity to any of the vaccine components.
* Use of any investigational drug or vaccine other than the study vaccine within 30 days of first dose of study vaccine or during the study.
* Use of any immunosuppressive drugs.
* Previous intussusception or abdominal surgery.
* Enrolment in any other trial (Simplified Antibiotic Therapy for Neonatal Sepsis Trial, Management of Omphalitis Trial).
* Birth weight less than 1500 grams; or if birth weight is unknown, weight less than 2000 grams on or before 28 days.
* Immunoglobulin and/or blood products use since birth or during the study period.
B: Inclusion Criteria:

* Healthy infants of 6 weeks of age (±2 days).
* Study families reside within the Health and Demographic Surveillance System (HDSS) area, service area of the ICDDR,B.
* Family able to understand and comply with planned study procedures

Exclusion Criteria:

* Family residence outside the ICDDR,B HDSS service area, or families expecting to move away during the study period, will be excluded.
* A diagnosis or suspicion of immunodeficiency disorder (either in the infant or in a member of the immediate family).
* A diagnosis or suspicion of bleeding disorder that would contraindicate venipuncture.
* Acute diarrhea, infection or illness at the time of the first visit (6 weeks of age) that would require infant's admission to a hospital or would contraindicate provision of OPV per country guidelines.
* Acute vomiting and intolerance to liquids within 24 hours before the first visit (6 weeks of age).
* Receipt of OPV or IPV at any time before enrollment based upon mother's recall or immunization card if available.
* Because of contact transmission of vaccine poliovirus strains, newborns from multiple births will be excluded from the study to prevent transmission of vaccine strains received during routine immunization from the twin to the study participant.
C: Inclusion Criteria:

* Parent or legal guardian agrees to have infant participate by giving written informed consent

Exclusion Criteria:

* History of congenital abdominal disorders, prior rotavirus gastroenteritis, chronic diarrhea, failure to thrive, or abdominal surgery
* History of intussusception
* Known or suspected impairment of immunological function, including Severe

Combined Immunodeficiency (SCID)

* Prior administration of any rotavirus vaccine
* Clinical evidence of active gastrointestinal illness, with the exception of well-controlled gastroesophageal reflux disease (GERD)
* Receipt of 1) systemic corticosteroids (≥ 2mg/kg total daily dose of prednisone or equivalent) for 14 consecutive days or more since birth, or 2) systemic corticosteroids ≥ 2mg/kg/dose within 7 days prior to the administration of the first dose of study vaccine. Participant using non-systemic corticosteroids will be eligible for vaccination.
* Residing in a household with an immunocompromised person
* Prior receipt of a blood transfusion or blood products, including immunoglobulins
* Participation in another interventional study within 14 days prior to the first study vaccination or expected anytime during the study
* Receipt of investigational inactivated vaccines within 14 days or investigational live vaccines within 28 days prior to the first study vaccination or expected anytime during the study
D: Inclusion Criteria:

* Subjects who the investigator believes that their parents/Legally Acceptable Representatives can and will comply with the requirements of the protocol.
* A male or female infant of Chinese origin between, and including, 6 and 16 weeks of age at the time of the first vaccination.
* Written informed consent obtained from the parents/Legally Acceptable Representatives of the subject.
* Healthy subjects as established by medical history and clinical examination before entering into the study.
* Born after a gestation period of 36 to 42 weeks inclusive.

Exclusion Criteria:

* Child in care.
* Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period.
* Chronic administration of immunosuppressants or other immune-modifying drugs since birth.
* Planned administration/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 the first dose of the human rotavirus vaccine or placebo except for the routine childhood vaccinations.
* 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.
* Any clinically significant history of gastrointestinal disease including any uncorrected congenital malformation (such as Meckel's diverticulum) of the gastrointestinal tract that would predispose for intussusception .
* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
* Family history of congenital or hereditary immunodeficiency.
* History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine.
* Major congenital defects or serious chronic illness.
* History of confirmed rotavirus gastroenteritis.
* Acute disease and/or fever at the time of enrolment.
* Gastroenteritis within 7 days preceding the study vaccine or placebo administration.
* Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.

In addition to the criteria mentioned above, the following criteria will be applicable to all subjects in the immunogenicity subgroup 2:

* History of diphtheria, tetanus and pertussis disease.
* History of seizures or progressive neurological disease.
* Previous vaccination against diphtheria, tetanus, pertussis and poliomyelitis.

Answer: B