Please select the eligibility criteria that correspond to the clinical trial below.
Title: Efficacy of GSK Biologicals' Candidate Malaria Vaccine (257049) Against Malaria Disease Caused by P. Falciparum Infection in Infants and Children in Africa
Brief Summary: The purpose of this observer-blind study is to gather key efficacy, safety, and immunogenicity information on GSK's candidate malaria vaccine in infants and children.


Options:
A: Inclusion Criteria:

* Family with child between ages 3-8 years

Exclusion Criteria:

* None
B: Inclusion Criteria:

* Men and women over 40 years of age, who meet at least one of the following criteria:

  1. have established cardiovascular disease: Coronary Artery Disease, Cerebrovascular disease (documented stroke and/or TIA), and Peripheral Vascular Disease;
  2. have Diabetes Mellitus;
  3. have Chronic Kidney Disease ;
  4. are at high risk for CVD based on a presence of at least three of the following established cardiovascular risk factors: age (males ≥ 45, females ≥ 55), smoker status, hypertension, and dyslipidemia.
* No restrictions will be imposed on the recruitment process; all practices in the region will be eligible to participate.

Exclusion Criteria:

* see above
C: Inclusion Criteria:

* Parent Inclusion

  * Either mother or father born in Latin American country
  * Speaks Spanish
  * Parent willing to give consent for self \& youth
* Youth Inclusion

  * Age 10-14 years
  * Speak English or Spanish
  * Youth willing to give assent

Exclusion Criteria:

* Parent Exclusion

  * Not meeting inclusion criteria
  * Past participant Padres Informados parenting program
D: Inclusion Criteria:

All subjects must satisfy the following criteria at study entry:

* A male or female child of:5-17 months (inclusive) of age at time of first vaccination,or between 6-12 weeks of age at time of first vaccination and NOT have already received a dose of vaccine against diphtheria, tetanus or pertussis or Hemophilus influenzae type B and must be \> 28 days of age at screening.
* Signed informed consent or thumb-printed and witnessed informed consent obtained from the parent(s)/guardian(s) of the child.
* Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol.

All subjects must satisfy the following criteria at the start of the extension phase:

* Subjects who were enrolled and who received at least one vaccine dose in the primary trial phase.
* Subjects who were present for Visit 35 on or before 30 September 2013.
* Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol (e.g. return for follow-up visits) should be enrolled in the study.

Exclusion Criteria:

The following criteria should be checked at the time of study entry. If any apply, the subject must not be included in the study:

* Acute disease at the time of enrollment.
* Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality.
* Anemia associated with clinical signs or symptoms of decompensation or hemoglobin ≥ 5.0 g/dL.
* Major congenital defects.
* History of allergic reactions, significant IgE-mediated events or anaphylaxis to previous immunizations.
* Children with a past history of a neurological disorder or atypical febrile seizure.
* Children with malnutrition requiring hospital admission.
* Children currently meeting the criteria for HIV disease of Stage III or Stage IV severity as defined by the World Health Organization.
* History of allergic disease or reactions likely to be exacerbated by any component of the 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 a drug or vaccine that is not licensed for that indication with the exception of studies with the objective of improving the drug treatment or clinical management of severe malaria disease.
* Use of a drug or vaccine that is not approved for that indication other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period.
* Previous participation in any other malaria vaccine trial.
* Receipt of a vaccine within the preceding 7 days.
* Any other findings that the investigator feels would increase the risk of having an adverse outcome from participation in the trial.
* Any other findings that the investigator feels would result in data collected being incomplete or of poor quality

Answer: D