Please select the eligibility criteria that correspond to the clinical trial below.
Title: Phase III, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Live Attenuated Bovine-Human Rotavirus Reassortant Pentavalent Vaccine (BRV-PV) Against Severe Rotavirus Gastroenteritis in Healthy Indian Infants
Brief Summary: This is a Phase 3 multicentre, randomized, double blind, placebo-controlled study to determine the effectiveness of the rotavirus vaccine.


Options:
A: Inclusion Criteria:

* At least one parent(s) or legally acceptable representative's consent for participation and are able to understand study procedures
* Subjects aged 6 to 7 weeks at recruitment
* No plans to move in the next 24 months

Exclusion Criteria:

* Administration of rotavirus vaccine in the past
* Presence of any illness requiring hospital referral (temporary exclusion)
* Known case of immunodeficiency disease, known HIV positive
* Known case of chronic gastroenteritis disease
* Any other conditions which in the judgment of the investigator warrant exclusion (e.g. no exclusion criteria but seems "ill", investigators suspects neglect)
* Diarrhea on the day of enrollment (temporary exclusion)
B: Inclusion Criteria:

* Male or female infants who are at least 6 weeks of age and no more than 14 weeks, 6 days of age at Visit 1.
* Parent(s)/legal guardian(s) have signed informed consent documents.
* Children who will be available for the entire study period and whose parents/legal guardians can be reached by telephone.
* Healthy infants as determined by medical history and by a baseline physical examination with no clinically significant abnormal findings within 14 days before the first dose.
* Parents/legal guardians able to complete all relevant study procedures during study participation.

Exclusion Criteria:

* Any clinically significant history of gastrointestinal disease including abdominal surgery or liver disease or other serious medical conditions as determined by the site investigator.
* Any history of immunodeficiency in the infant (e.g., the infant is known to be human immunodeficiency virus (HIV) positive, to have hypogammaglobulinemia, or to have an underlying malignancy), or any infant with any unvaccinated household contact who is immunocompromised such as:

  * Any malignancies or are otherwise immunocompromised;
  * Primary immunodeficiency; or
  * Receiving immunosuppressive therapy.
* Known sensitivity to any vaccine components, such as latex in the Rotarix® applicator.
* Previous receipt of a rotavirus vaccine.
* Acute illness at the time of vaccine administration, such as any of the following within the past 48 hours:

  1. Axillary temperature of 100.4 degrees Fahrenheit or higher, or
  2. More than 3 grossly watery stools, or
  3. Any episodes of vomiting (forceful expulsion of partially digested milk/food). Infants with previous diagnoses of gastroesophageal reflux whose regurgitation episodes have not changed in the 48-hour period prior to the first vaccination may be enrolled.

If these symptoms clear within 48 hours and the subject meets the other inclusion/exclusion criteria, then the subject may be enrolled.

* The subject is currently participating in a study that involves an experimental agent (vaccine, drug, biologic, device, blood product, or medication) or has received an experimental agent within 1 month prior to enrollment in this study, or expects to receive another experimental agent during participation in this study.
* Less than 37 weeks gestation at birth.
* Receipt of blood and/or blood products (including immunoglobulin) within 4 weeks before vaccine administration.
* Receipt of live vaccine within the past 30 days or a nonreplicating, inactivated, or subunit vaccine within the last 14 days, although planned licensed trivalent inactivated influenza vaccine that may be administered to children over 6 months of age during a routine clinic visit is permitted and would not be exclusionary.
* The subject has any condition that would, in the opinion of the site investigator, place the subject at an unacceptable risk of injury or render the subject unable to meet the requirements of the protocol.
C: Inclusion Criteria:

* Healthy infants as established by medical history and clinical examination before entering the study.
* Age: 6-8 weeks at the time of enrollment.
* Parental ability and willingness to provide informed consent.
* Parent who intends to remain in the area with the child during the study period.

Exclusion Criteria:

* Presence of diarrhea or vomiting in the previous 72 hours or on the day of enrollment (temporary exclusion)
* Presence of fever on the day of enrollment (temporary exclusion).
* Acute disease at the time of enrollment (temporary exclusion)
* Concurrent participation in another clinical trial throughout the entire timeframe for this study.
* Presence of significant malnutrition (weight-for-height z-score \<-3SD median) or any systemic disorder (cardiovascular, pulmonary, hepatic, renal, gastrointestinal, hematological, endocrine, immunological, dermatological, neurological, cancer or autoimmune disease) as determined by medical history and/or physical examination which would compromise the subject's health or is likely to result in nonconformance to the protocol. History of congenital abdominal disorders, intussusception or abdominal surgery
* Known or suspected impairment of immunological function based on medical history and physical examination.
* Household contact with an immunosuppressed individual or pregnant woman.
* Prior receipt of rotavirus vaccine.
* A known sensitivity or allergy to any components of the study vaccine.
* Major congenital or genetic defect.
* History of persistent diarrhea (defined as diarrhea more than 14 days).
* Participant's parents not able, available or willing to accept active weekly follow-up by the study staff.
* Has received any immunoglobulin therapy and/or blood products since birth or planned administration during the study period.
* History of chronic administration (defined as more than 14 days) of immunosuppressants including corticosteroids. Infants on inhaled or topical steroids may be permitted to participate in the study.
* History of any neurologic disorders or seizures.
* Any medical condition in the parents/infant which, in the judgment of the investigator, would interfere with or serves as a contraindication to protocol adherence or a participant's parents' ability to give informed consent.
D: Inclusion Criteria:

* A male or female infant at least 6 weeks of age and not older than 20 weeks of age at the time of first dose of Rotarix.
* An infant whose parent or guardian's primary residence, at the time of first EPI vaccinations, is a village selected to receive Rotarix.
* Written informed consent obtained from the parent or guardian of the subject, prior to the subject's first study vaccination

Exclusion Criteria:

* Hypersensitivity to the active substance or any component in the vaccine
* Hypersensitivity after previous administration of rotavirus vaccines.
* Previous history of intussusception.
* Subjects with uncorrected congenital malformation of the gastrointestinal tract that would predispose for intussusception.
* Infants with known or suspected immunodeficiency.
* Administration of Rotarix should be postponed in subjects suffering from an acute severe febrile illness only if that illness also results in postponement of other EPI vaccinations.

Answer: C