Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Phase III, Multicenter, Open Label, Randomized Study of Bovine Rotavirus Pentavalent Vaccine (BRV-PV) to Evaluate Lot-To-Lot Consistency and to Investigate Potential Interference With Routine UIP Vaccinations in Healthy Infants in India.
Brief Summary: This is a Phase 3, open-label, randomized study to evaluate lot-to-lot consistency in the manufacture of Bovine Rotavirus Pentavalent Vaccine (BRV-PV).


Options:
A: Inclusion Criteria:

1. Healthy infants as established by medical history and clinical examination before entering the study.
2. Age: 6-8 weeks at the time of enrollment.
3. Parental ability and willingness to provide written informed consent.
4. Parent who intends to remain in the area with the child during the study period.
5. Receipt of birth dose of Hepatitis B vaccine and OPV.

Exclusion Criteria:

1. Presence of diarrhea or vomiting in the previous 72 hours or on the day of enrollment (temporary exclusion).
2. Presence of fever on the day of enrollment (temporary exclusion).
3. Acute disease at the time of enrollment (temporary exclusion).
4. Concurrent participation in another clinical trial at any point throughout the entire timeframe for this study.
5. Presence of significant malnutrition or any systemic disorder 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.
6. History of congenital abdominal disorders, intussusception, or abdominal surgery.
7. Known or suspected impairment of immunological function based on medical history and physical examination.
8. Household contact with an immunosuppressed individual or pregnant woman.
9. Prior receipt or intent to receive rotavirus and / or diphtheria, tetanus, pertussis, Haemophilus Influenzae type b, Hepatitis B vaccine (other than birth dose) or inactivated polio vaccine (IPV) during the study period and outside of the study. OPV dose received during national / subnational immunization days will be allowed.
10. A known sensitivity or allergy to any components of the study vaccine.
11. Clinically detectable congenital or genetic defect.
12. History of persistent diarrhea (defined as diarrhea that lasts 14 days or longer).
13. Receipt of any immunoglobulin therapy and / or blood products since birth or planned administration during the study period.
14. 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.
15. History of any neurologic disorders or seizures.
16. 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 written informed consent.
B: Inclusion Criteria:

1. At least one parent(s) or legally acceptable representative's consent for participation and are able to understand study procedures
2. Subjects aged 6 to 7 weeks at recruitment
3. No plans to move in the next 4 months
4. Weight for age not ≤ -3 SD of WHO child growth standards

Exclusion Criteria:

1. Infant not breastfed
2. Administration of rotavirus vaccine in the past
3. Known immunodeficiency disease, including HIV infection in the subject or the mother
4. Known chronic enteric disease
5. Diarrhea on the day of enrollment (temporary exclusion)
6. Any illness requiring hospitalization (temporary exclusion)
7. Any other conditions which in the judgment of the investigator warrant exclusion (e.g. no exclusion criteria but seems 'ill', investigators suspects neglect)
C: Inclusion Criteria:

* Between 42 and 55 days of age at the time of enrollment.
* Healthy infant free of chronic or serious medical condition as determined by history and physical examination at the time of study enrollment.
* Parents/guardians of each subject are able to understand and follow study procedures and agree to participate in the study by providing parental/guardian permission.

Exclusion Criteria:

* If child has previously had intussusception or abdominal surgery.
* Use of any immunosuppressive drugs or immunoglobulin and/or blood product use since birth or anticipated during study period.
* Current enrollment in any other intervention trial or use of any investigational drug or vaccine throughout the study period.
* Birthweight less than 2000 grams or gestation \< 36 weeks, if this information is available.
* Any subject who reports plan to leave the study area before the completion of the study (i.e., relocation, migration, etc.).
* Another child living in the same compound is already enrolled in the trial (i.e., only one participant can be enrolled per compound).
* After the rotavirus vaccine is introduced into the routine EPI system in Navrongo: Another child in the compound is less than 16 weeks of age.
* The child has received rotavirus vaccine outside of this study.
D: Inclusion Criteria:

* Healthy infants, aged from 6 weeks through full 7 weeks,
* Consent form signed by at least one parent or by the legal representative properly informed about the study,
* Parent(s) / legal representative able to understand the protocol requirements and to fill in the Diary Card.

Exclusion Criteria:

* History of congenital abdominal disorders, congenital malformation of the gastrointestinal tract that could predispose to intussusception, or abdominal surgery,
* Congenital fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency,
* Known or suspected impairment of immunological function,
* Known hypersensitivity to any component of RotaTeq® (e.g. sucrose) or of NeisVac-C® (including tetanus toxoid),
* Prior administration of any rotavirus vaccine,
* Prior administration of any vaccine within the 28 days prior to randomisation,
* Fever (rectal temperature ≥38.1°C) and/or acute diarrhoea and/or vomiting at randomisation,
* History of known prior rotavirus gastroenteritis, chronic diarrhoea, or failure to thrive,
* Any severe thrombocytopenia or any other coagulation disorder that would contraindicate intramuscular injection,
* Clinical evidence of active gastrointestinal illness,
* Receipt of intramuscular, oral, or intravenous corticosteroid treatment within the 14 days prior to randomisation. Note: Infants on inhaled and/or topical steroids may participate in the study,
* Infants residing in a household with an immunocompromised person,
* Prior receipt of a blood transfusion or blood products, including immunoglobulins.

Answer: A