Please select the eligibility criteria that correspond to the clinical trial below.
Title: Impact of Systematic Infants Vaccination Against Rotavirus on Gastroenteritis Hospitalization: a Prospective Study in Brest District, France.
Brief Summary: Universal rotavirus vaccination program for infants born in Brest after February 2007, applied by the Centers for Maternal and Infant Health Protection, pediatricians and general practitioners.

Prospective surveillance of hospitalizations for gastroenteritis within the Pediatric Units of Brest University Hospital with systematic testing for Rotavirus.

Evaluation of the impact of the vaccination program on rotaviral gastroenteritis hospitalizations from 2007-2008 and 2008-2009, by comparison with epidemiological data from 2002-2007 in the absence of vaccination.

The principal judgement criterion is the number of pediatric hospitalizations for rotaviral GEA during the 2008-2009 epidemic in children A) under the age of 2 and B) residing in the suburbs of Brest.


Options:
A: 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.
B: Inclusion criteria:

* Healthy infants 6 -12 weeks old at Dose 1 with written informed consent.

Exclusion criteria:

* Allergic reaction to vaccine components;
* clinically significant history of chronic GI disease (uncorrected GI congenital malformation) or other serious medical condition per investigator, received vaccines or treatment prohibited by the protocol;
* immunocompromised.
C: Inclusion Criteria:

At dose 1

* Healthy male or female, 18 to 40 years of age,
* Free of disease,
* Written informed consent obtained from subjects. At dose 2
* Received dose 1.
* Oral informed consent obtained from subject for continuing participate the study.

Exclusion Criteria:

At dose 1

1. Pregnant woman or planning to be pregnant during the study period.
2. Has a chronic disease (cardiovascular, liver, kidney disease).
3. Acute disease at the time of enrolment.
4. Administering corticosteroids (\> 1mg/kg/day).
5. Received any immunosuppressive therapy within 4 week before vaccination (Administration of immunoglobulins and/or any blood product or corticosteroids for \>2 weeks).
6. Immunosuppressive or immunodeficient condition.
7. Allergic or reaction with any component of vaccine, includes anaphylactic and shock with any antibiotic.
8. Fever (axillary temperature \>38oC) within 3 days before or on the day of vaccination.
9. Has any type of blood disorder, leukemia, or malignant tumor which can affect the bone marrow or lymph system.
10. Use of any investigational or non-registered product (unlicensed drug or vaccine) other than the study vaccine during the study period.

At dose 2

1. Pregnant woman or planning to be pregnant in next 1 month.
2. Acute disease at the time of 2nd dose.
3. Administering corticosteroids (\> 1mg/kg/day).
4. Received any immunosuppressive therapy within 4 week before vaccination (administration of immunoglobulins and/or any blood product or corticosteroids for \>2 weeks).
5. Immunosuppressive or immunodeficient condition.
6. History of allergic disease or reactions likely to be exacerbated by any component of the study vaccine.
7. Fever (axillary temperature \>38oC) within 3 days before or on the day of vaccination.
8. Has any type of blood disorder, leukemia, or malignant tumor which can affect the bone marrow or lymph system.
9. Use of any investigational or non-registered product (unlicensed drug or vaccine) other than the study vaccine during the study period.
D: 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

Answer: D