Please select the eligibility criteria that correspond to the clinical trial below.
Title: Non-interference and Safety of Concomitant Administration of Measles-rubella and Rotavirus Vaccines at 9 Months of Age in Rural Bangladesh
Brief Summary: The investigators aim to establish the non-inferiority of concomitant administration of measles-rubella and rotavirus vaccines to measles-rubella vaccine given alone in terms of measles seroconversion rates. The primary study hypothesis is the measles seroconversion rate as defined by the percentage of children seroconverting to measles with a measles serum antibody concentration of \>=1:120 at 8 weeks post vaccination after the concomitant administration of measles-rubella and rotavirus vaccines is non-inferior to that obtained when measles-rubella vaccine is given alone in children 9 months of age who have received a primary rotavirus vaccine series with the first dose between 6 and 10 weeks and the second at least 4 weeks later and are seronegative for measles antibody in the pre-vaccination sample.


Options:
A: Inclusion Criteria:

1. Access to telephone at home or in the immediate neighborhood.
2. Healthy male and female non-malnourished (weight for length not ≤ -3 SD of WHO child growth standards) infants aged 6 weeks (till 6 weeks + 2 days).
3. Parent's permission to participate in the study is available.
4. No plans to travel over the next 4 months

Exclusion Criteria:

1. Gestational age \<37 weeks.
2. Any major physical congenital malformation.
3. Living in a household or has contact with an individual who is immunosuppressed.
4. Hospitalized once or more for the following illnesses since birth: heart disease, pneumonia, sepsis, meningitis, unconsciousness.
5. Is required to take daily medications other than vitamins or herbal "tonics".
6. Evidence of cardiovascular disease as indicated by any of the following:

   * Central cyanosis
   * Cyanotic or apnoeic spells
   * Features of congestive heart failure
   * Significant heart murmur detected on physical examination
7. Evidence of gastrointestinal disease indicated by following:

   * Diarrhea in the previous 7 days
   * Blood in the stools any time since birth
8. Evidence of neurological disease, as indicated by:

   * History of seizures any time since birth
   * History of unconsciousness
   * Focal deficit on physical examination
9. Evidence of liver or other reticuloendothelial disease, as indicated by any of the following:

   * Positive serology for hepatitis B surface antigen
   * Positive serology for hepatitis C antibody
   * SGOT or SGPT more than 1.25 times upper limit of normal (Upper limit normal SGOT 80 IU/L, SGPT 40 IU/L)
   * Alkaline phosphatase more than 1.25 times upper limit of normal (Upper limit of normal -470 IU/L)
   * Hepatomegaly (liver palpable 3 cm below costal margin), splenomegaly (palpable spleen), jaundice, or lymphadenopathy on physical examination
   * Serum bilirubin 1.25 times the upper limit of normal for age (Upper limit of normal 1.0 mg/dL).
10. Evidence of hematologic, rheumatologic, or immunologic disease, as indicated by any of the following:

    * Total leukocyte count \<3500 or \>15,000/mm3
    * Hemoglobin \<9 g/dL or \>17g/dL
    * Platelet count \<100,000/mm3
    * Any episode of sepsis, pneumonia or meningitis requiring hospitalization since birth.
11. Evidence of renal disease as indicated by any of the following:

    * Creatinine \>0.5 mg/dL
    * Hematuria (≥5 RBC/hpf)
    * Proteinuria (≥1+ per day)
B: Inclusion Criteria:

* infants aged 6 to 12 weeks
* born in Brest District, France
* born between Feb 01, 2007 and Nov 19, 2009

Exclusion Criteria:

* contraindication to rotavirus vaccine
C: Inclusion Criteria:

* Child 9 months of age eligible for measles-rubella vaccination
* documented evidence of a primary rotavirus vaccine series with first dose between 6 and 10 weeks of age and second dose at least 4 weeks after first dose
* healthy infants free of chronic or serious medical condition as determined by history and physical examination at time of study enrollment
* parents/guardians of each participant are able to understand and follow study procedures and agree to participate in study by providing signed informed consent

Exclusion Criteria:

* hypersensitivity to any component of measles-rubella or Rotarix vaccine which would preclude administration of the vaccine
* history of intussusception, intestinal malformations, or abdominal surgery
* known history of measles and/or rubella disease
* history of previous receipt of measles and/or rubella vaccine
* use of any immunosuppressive drugs or immunoglobulin and/or blood products since birth or anticipated during study period
* current enrolment in any other intervention trial or use of any investigational drug or vaccine throughout the study period
* any participant who reports planning to leave the study area before the completion of the study
* acute diarrhea (defined as ≥3 loose stools within a 24-hour period) or vomiting (defined as projectile vomiting or any vomiting at the discretion of the clinician) at the time of enrollment or within the last 24 hours
* acute febrile illness (defined as a temperature of ≥38°C) at the time of enrollment.
D: Inclusion Criteria:

* Subjects who the investigator believes that parent(s)/Legally Acceptable Representative(s) can and will comply with the requirements of the protocol.
* A male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination.
* 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.
* Infants who have received a previous dose of hepatitis B immunoglobulin after birth.

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 with the exception of Hepatitis B immunoglobulin since birth. Child is unlikely to remain in the study area for the duration of the study.
* Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days of the first dose of vaccine.
* 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.
* Previous vaccination against rotavirus.
* 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.
* Acute disease and/or fever at the time of enrolment.
* Administration of immunoglobulins (with the exception of HBIG) and/or any blood products since birth or planned administration during the study period.
* Gastroenteritis within 7 days preceding the study vaccine administration.
* Previous confirmed occurrence of Rotavirus gastroenteritis.

Answer: C