Please select the eligibility criteria that correspond to the clinical trial below.
Title: Comparison of Maternal and Infant Immunization Strategies to Prevent Pneumococcal Disease
Brief Summary: This prospective randomized evaluation of pneumococcal vaccine immunization of pregnant mothers, followed by pneumococcal conjugate immunization of their children is designed to assess the effects of these strategies on the immunogenicity and safety of both vaccines. We hypothesize that maternal followed by infant immunization will be safe and will provide higher levels of antibody from birth through 12 months of age.


Options:
A: Inclusion Criteria:

* Mothers from 18 to 14 years of age in the third trimester of pregnancy,
* with normal medical and obstetric history,
* who plan to deliver their infant in Dhaka city and remain there for 12m

Exclusion Criteria:

* Maternal history of systemic disease,
* Maternal history of previous complicated pregnancies, preterm delivery, abortions, or birth with congenital anomalies.
* Maternal hypersensitivity to any vaccination, or
* Maternal receipt of pneumococcal vaccine in the last 3 years.
B: 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
C: Inclusion Criteria:

* Healthy male or female aged 18 - 49 years or \>= 65 years
* Give written informed consent
* Females have a negative urine test for pregnancy before vaccination and use birth control during 28 day study period
* Willing to receive the unlicensed (VAX128) vaccine given as an i.m. injection
* Willing to provide multiple blood specimens collected by venipuncture

Exclusion Criteria:

* Chronic illness that would interfere with the subject's participation in the study or interpretation of the study results.
* Impaired immune responsiveness
* Received drugs effecting the immunity
* Received or plan to receive a nonstudy vaccine within 30 days prior to vaccination and during the study, including licensed influenza vaccines.
* History of anaphylactic type reaction to injected vaccines.
* History of drug abuse in the year prior to screening.
* History of Guillain-Barré Syndrome.
* Receipt or donation of blood products
* Acute disease within 72 hours prior to vaccination
* History of heart or lung disease
* Has other conditions that might interfere with study objectives.
D: Inclusion Criteria:

* Subjects who the investigator believes can and will comply with the requirements of the protocol should be enrolled in the study.
* For previously primed subjects: participation in the primary study (NCT00309634).
* For unprimed subjects: male or female between and including, 19 and 61 years of age at the time of the first vaccination.
* Written informed consent obtained from the subject.
* Healthy subjects as established by medical history and clinical examination before entering into the study.
* If the subject is female, she must be of non-childbearing potential or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for 2 months after completion of the vaccination series.

Exclusion Criteria:

* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
* For unprimed subjects who did not participate in the primary study (NCT00309634): Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
* Planned administration/ administration of a licenced vaccine not foreseen by the study protocol within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) of the first dose of vaccine(s).
* 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 (pharmaceutical product or device).
* Applicable for control group only: previous vaccination with a pandemic candidate vaccine or a vaccine containing the investigational vaccine adjuvant.
* History of hypersensitivity to vaccines.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
* History of allergic disease or reactions likely to be exacerbated by any component of the vaccine(s).
* Major congenital defects or serious chronic illness.
* History of any neurological disorders or seizures.
* Acute disease at the time of enrolment.
* Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
* Serious chronic disease including any medically significant chronic pulmonary, cardiovascular, renal, neurological, psychiatric or metabolic disorder, as determined by medical history and physical examination.
* Any condition which, in the opinion of the investigator, prevents the subject from participation in the study.
* Lactating female.
* History of chronic alcohol consumption and/or drug abuse

Answer: A