Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Stratified and Controlled Clinical Trial With Split-virion, Non-adjuvanted Influenza A/H1N1 Vaccines in Healthy Pregnant Women
Brief Summary: Since October 2009, H1N1 influenza vaccine has developed and approved of immunization in population in China. However, there was little epidemiological evidence of safety when vaccinated in healthy pregnant women. The main objective of this study is to assess the safety of split-virion inactivated H1N1 vaccine without adjuvant when administered in healthy pregnant women. It is a stratified and controlled clinical trial in healthy pregnant women. And participants were included up to 226 healthy pregnant women aged 18 -35 years old who have no history of novel influenza H1N1 infection or novel influenza H1N1 vaccination. The pregnancy week ranged from 5 weeks to 32 weeks. Subjects were divided into 2 groups: vaccinated group（122） and unvaccinated group（104）. Subjects in the vaccinated group were administered one dose of 15μg H1N1 vaccine. Subjects in the unvaccinated group received no vaccine as controls. Safety will be measured by assessment of pregnancy outcomes. And observation time for pregnancy outcomes was lasting for 28 days postpartum since vaccinated; and protective effect was observed for six months.


Options:
A: Inclusion Criteria:

* Male or non-pregnant female (as indicated by a negative urine pregnancy test immediately prior to vaccine administration) between the ages of 18 and 40 years, inclusive.
* Women of childbearing potential (not surgically sterile or postmenopausal for greater than or equal to 1 year) who are at risk of becoming pregnant must agree to practice adequate contraception (i.e., barrier method, abstinence, intrauterine devices, and licensed hormonal methods) for the entire study period.
* Is in good health, as determined by vital signs (heart rate \< 100 beats per minute, blood pressure: systolic less than or equal to 140 mm Hg and greater than or equal to 90 mm Hg, diastolic less than or equal to 90 mm Hg; oral temperature \< 100 degrees Fahrenheit), medical history to ensure stable\* medical condition and a targeted physical examination based on medical history. (\*A stable medical condition is defined as no recent change in prescription medication, dose, or frequency of medication in the last 3 months and health outcomes of the specific disease are considered to be within acceptable limits in the last 6 months. Any change that is due to change of health care provider, insurance company, etc, or is done for financial reasons, as long as in the same class of medication, will not be considered a violation of the inclusion criterion. Any change to prescription medication due to improvement of a disease outcome will not be considered a violation of the inclusion criterion.)
* Able to understand and comply with planned study procedures.
* Provide informed consent prior to initiation of any study procedures and are available for all study visits.

Exclusion Criteria:

* Have a known allergy to eggs or other components of the vaccine (including gelatin, formaldehyde, octoxinol, aluminum hydroxide, and chicken protein).
* Have a positive urine or serum pregnancy test prior to vaccination (if female of childbearing potential) or women who are breastfeeding.
* Have immunosuppression as a result of an underlying illness or treatment with immunosuppressive or cytotoxic drugs, or use of anticancer chemotherapy or radiation therapy within the preceding 36 months.
* Have an active neoplastic disease or a history of any hematologic malignancy.
* Have long-term use of oral steroids, parenteral steroids, or high-dose inhaled steroids (\>800 micrograms/day of beclomethasone dipropionate or equivalent) within the preceding 6 months (nasal and topical steroids are allowed.)
* Have a history of receiving immunoglobulin or other blood product within the 3 months prior to enrollment in this study.
* Have received any other licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to vaccination in this study.
* Have an acute or chronic medical condition that, in the opinion of the investigator, would render vaccination unsafe or would interfere with the evaluation of responses. (This includes, but is not limited to: known chronic liver disease, significant renal disease, unstable or progressive neurological disorders, diabetes mellitus, and transplant recipients).
* Have a history of severe reactions following immunization with contemporary influenza virus vaccines.
* Have an acute illness, including an oral temperature greater than 100.4 degrees Fahrenheit, within 1 week of vaccination.
* Received an experimental agent (vaccine, drug, biologic, device, blood product, or medication) within 1 month prior to vaccination in this study, or expect to receive an experimental agent during the 7-month study period.
* Plan to enroll in another clinical trial at any time during the study period.
* Have 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.
* Have a diagnosis of schizophrenia, Bi-polar disease or other major psychiatric diagnosis.
* Have been hospitalized for psychiatric illness, history of suicide attempt or confinement for danger to self or others.
* Are receiving psychiatric drugs\*. Subjects who are receiving a single antidepressant drug and stable for at least 3 months prior to enrollment, without de-compensating symptoms will be allowed to be enrolled in the study.

  \* aripiprazole, clozapine, ziprasidone, haloperidol, molindone, loxapine, thioridazine, thiothixene, pimozide, fluphenazine, risperidone, mesoridazine, quetiapine, trifluoperazine, trifluopromazine, chlorprothixene, chlorpromazine, perphenazine, olanzapine, carbamazepine, divalproex sodium, lithium carbonate or lithium citrate
* Have a known active human immunodeficiency virus, hepatitis B, or hepatitis C infection.
* Have a history of alcohol or drug abuse in the last 5 years.
* Plan to travel outside of the USA in the time between the first vaccination and 56 days following the first vaccination.
* Have a history of Guillain-Barre syndrome.
* Have any condition that the investigator believes may interfere with successful completion of the study.
B: Inclusion Criteria:

* Healthy males and females aged ≥ 18 to \< 65 years at the time of vaccination
* Non pregnant/ non lactating females

Exclusion Criteria:

* Hypersensitivity to influenza vaccine or allergy to any components of the Study Vaccines
* Vaccination against influenza in the previous 6 months
* Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality
* Known history of Guillain-Barré Syndrome;
* Clinical signs of active infection and/or an oral temperature of ≥ 37.8 oC.
* History of neurological disorders or seizures
* Confirmed or suspected immunosuppressive condition or a previously diagnosed immunodeficiency disorder
* Current or recent immunosuppressive or immunomodulative therapy, including systemic corticosteroids
* Administration of immunoglobulins and/or any blood products;
* Participation in a clinical trial or use of an investigational compound;
* Vaccination with a registered vaccine within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior;
* Participants indicated to receive an influenza vaccine on an annual basis according to the local public health recommendations.
C: Inclusion Criteria:

1. Healthy pregnant women
2. Be able to show legal identity card for the sake of recruitment
3. Be able to understand and sign the informed consent

Exclusion Criteria:

1. Cases, cured cases and close contact of influenza A (H1N1) virus
2. Subject that has a medical history of any of the following: allergic history, or allergic to any ingredient of vaccine, such as egg, egg protein, etc
3. Serious adverse reactions to vaccines such as anaphylaxis, hives, respiratory difficulty, angioedema, or abdominal pain
4. Autoimmune disease or immunodeficiency
5. Asthma that is unstable or required emergent care, hospitalization or intubation during the past two years or that required the use of oral or intravenous corticosteroids
6. Diabetes mellitus (type I or II), with the exception of gestational diabetes
7. History of thyroidectomy or thyroid disease that required medication within the past 12 months
8. Serious angioedema episodes within the previous 3 years or requiring medication in the previous two years
9. Bleeding disorder diagnosed by a doctor (e.g. factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or significant bruising or bleeding difficulties with IM injections or blood draws
10. Any history of immunosuppressive medications or cytotoxic medications or inhaled corticosteroids within the past six months (with the exception of corticosteroid nasal spray for allergic rhinitis or topical corticosteroids for an acute uncomplicated dermatitis)
11. History of any blood products or seasonal influenza vaccine administration within 3 months before the dosing
12. Administration of any other investigational research agents within 30 days before the dosing
13. Administration of any live attenuated vaccine within 30 days before the dosing
14. Administration of subunit or inactivated vaccines, e.g., pneumococcal vaccine, or allergy treatment with antigen injections, within 14 days before the dosing
15. Axillary temperature \> 37.0 centigrade at the time of dosing
16. Psychiatric condition that precludes compliance with the protocol
17. Any medical, psychiatric, social condition, occupational reason or other responsibility that, in the judgment of the investigator, is a contraindication to protocol participation or impairs a volunteer's ability to give informed consent
D: Inclusion Criteria:

* Health adults of both genders
* Age ≥ 18 ≤ 50 years
* Able to understand every required study procedure
* Female volunteers should agree to take an acceptable contraceptive method Menopause is characterized by absence of menstrual flux for two consective years
* Normal values for pre-stablished laboratory assays
* Accpetance to participate and sign the consent form

Exclusion Criteria:

* Any chronic condition
* Be on immunossupressive or stimulant therapy
* Have egg alergy
* Have past history of alergy to sazonal influenza vaccine
* Have received another inactivated vaccine within the prior 2 weeks or a live vaccine in the past four weeks to his/her participation in the study
* Acute infectious disease during seven days prior vaccination
* Female on breasthfeeding
* Confirmed prior infection by pandemic influenza A
* Participation in another clinical trial in the last 6 months
* Any other condition identified by the principal investigator which is considered not safe for enrollment of the volunteer

Answer: C