Please select the eligibility criteria that correspond to the clinical trial below.
Title: Immunogenicity Study of a DTaP-IPV-Hep B-PRP~T Combined Vaccine in Comparison to CombAct-HIB® Concomitantly Administered With Engerix B® Paediatric and OPV at 6, 10, and 14 Weeks of Age in South African Infants
Brief Summary: The purpose of this study is to document the immunological response to the investigational hexavalent vaccine at the 6, 10, and 14 weeks schedule

The primary objective is to demonstrate that the hexavalent DTaP-IPV-HB-PRP\~T combined vaccine does not induce lower immune responses than CombAct-HIB® with Engerix B® Paediatric and OPV in terms of seroprotection rates to Diphtheria (D), Tetanus (T), polio, Hepatitis B (HB), and Polyribosyl ribitol phosphate (PRP), one month after a 3-dose primary series (6, 10, and 14 weeks) with no HB vaccination at birth.

The secondary Objectives are:

To describe the safety in terms of any adverse events in the first 28 days after each injection and any serious adverse events during the entire trial.

To describe Immunogenicity after the primary series and prior to and after a booster vaccination.


Options:
A: Eligibility Criteria

1. All cases and controls must be registered on ACIR as having had a first dose of any pertussis containing vaccine before age 16 weeks and during the period of time in which the transition between aP and wP vaccine occurred; birth dates within 1st Janurary 1997 and 31st December 1999 depending on the jurisdiction.

Case Inclusion Criteria- Cases will be considered to have IgE-mediated food allergy on the basis of

1. a documented history of consistent clinical symptoms following ingestion of an implicated food, and
2. evidence of sensitisation to that food via either positive skin-prick test or elevated specific IgE to the implicated food, with onset after the first pertussis-containing vaccine but before age 15 years.

IgE-mediated food allergy is defined as BOTH:

1. The clinical notes or clinical letter arising from the allergy consult must explicitly document the presence of one or more of the following features. Onset of at least one these features must be within 1 hour of ingestion of suspected food where this can reasonably inferred from statements such as "immediate", "within x mins" where x is \<60:

   * urticaria
   * angioedema
   * emesis
   * vocal hoarseness
   * persistent cough
   * wheeze
   * stridor
   * collapse
   * hypotension

   AND
2. Documented evidence of allergic sensitisation to the implicated food through EITHER:

   * specific IgE positive (serum specific IgE \>0.35KU/l) to suspected food ), OR
   * positive skin prick test (wheal diameter \>3mm) against suspected food (SPT) Evidence of sensitisation must be at the time of consultation or the 6 months after the clinical encounter for the case to meet definition.

Exclusion Criteria- none
B: Inclusion Criteria:

* 0 to 3 day old infants
* Mother seronegative for Human Immunodeficiency Virus (HIV)
* Born at full term of pregnancy (≥ 37 weeks) with a birth weight ≥ 2.5 kg
* Apgar score \>7 at 5 or 10 minutes of life
* Informed consent form signed by a parent or other legal guardian and by an independent witness if the parent or other legal guardian is illiterate
* Able to attend all scheduled visits and to comply with all trial procedures.

Exclusion Criteria:

* Current or planned participation in another clinical trial during the entire duration of the present trial
* Suspected congenital or acquired immunodeficiency
* Suspected maternal acute seroconversion syndrome to HIV after 24 weeks gestation based on clinical history
* Chronic illness at a stage that could interfere with trial conduct or completion
* Blood or blood-derived products received since birth
* Any planned vaccination (except Bacille Calmette Guérin and trial vaccinations) from birth to 18 weeks of age
* Oral Poliovirus Vaccine (OPV) administration at birth
* Known maternal history of HIV, Hepatitis B (HB) (HbsAg carrier) or Hepatitis C seropositivity
* Thrombocytopenia or bleeding disorder contraindicating intramuscular (IM) vaccination
* History of seizures
* Febrile or acute illness on the day of inclusion.
C: Inclusion Criteria:

* 2 months old infants on the day of inclusion
* Born at full term of pregnancy (≥ 37 weeks) with a birth weight ≥ 2.5 kg
* Informed consent form signed by one or both parents or by the legally acceptable representative and 1 or 2 independent witnesses
* Able to attend all scheduled visits and to comply with all trial procedures
* Has complied with the national immunization calendar (BCG for both countries) for the first 2 months of life.

Exclusion Criteria:

* Participation in another clinical trial in the 4 weeks preceding the first trial vaccination
* Planned participation in another clinical trial during the present trial period
* Congenital or acquired immunodeficiency, immunosuppressive therapy such as long-term systemic corticosteroids therapy
* Subjects with congenital or acquired immunodeficiency in the child's surrounding
* Systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccine or a vaccine containing the same substances
* Chronic illness at a stage that could interfere with trial conduct or completion
* Blood or blood-derived products received since birth
* Any vaccination in the 4 weeks preceding the first trial vaccination
* Vaccination planned in the 4 weeks following the trial vaccination
* Documented history of pertussis, tetanus, diphtheria, poliomyelitis, Haemophilus influenzae type b or hepatitis B infection(s) (confirmed either clinically, serologically or microbiologically)
* Mother known as seropositive for HIV or Hepatitis C, or known carrier of Hepatitis B surface antigen
* Previous vaccination against pertussis, tetanus, diphtheria, poliomyelitis, or Haemophilus influenzae type b infection(s)
* Coagulopathy, thrombocytopenia or a bleeding disorder contraindicating IM vaccination
* History of seizures
* Febrile or acute illness on the day of inclusion.
D: Inclusion Criteria:

* Healthy adults aged 18 to 45 years inclusive on the day of screening
* Fully conversant in the English language
* Able to communicate easily by both mobile telephone and text messaging
* Able and willing (in the investigator's opinion) to comply with all study requirements
* Written informed consent to participate in the trial
* Willingness to take a curative antibiotic regimen after inoculation with B. pertussis according to the study protocol
* Agreement to be admitted to the National Institute for Health Research (NIHR)-Clinical research facility (CRF) Southampton for 17 days for phase A (from inoculation until two days after the eradication therapy is given) and for the duration necessary for phase B, depending on phase A results
* Able to answer all questions on the informed consent quiz correctly

Exclusion Criteria:

* Individuals who have inviolable commitments within 3 months of discharge from the inpatient phase of the study to make contact with:

  1. unimmunised or partially immunised children and infants aged \< 1 year
  2. pregnant women \>32 weeks who have not received pertussis vaccination at least a week prior to contact
* Individuals who have household contacts working with

  1. unimmunised or partially immunised children and infants aged \< 1 year
  2. pregnant women \>32 weeks who have not received pertussis vaccination at least a week prior to contact
* Phase A only: Volunteers will be excluded from this study if they have evidence of recent exposure to B. pertussis, as determined by anti-PT IgG ELISA (\>20 IU/mL)
* B. pertussis detected on nasopharyngeal swab taken before the challenge
* Individuals who have a signs of a current infection at the time of inoculation with B. pertussis
* Individuals who have participated in other interventional clinical trials in the last 12 weeks
* Individuals who have a history of receiving B. pertussis vaccination in the last 5 years
* Individuals who have a history of never being vaccinated against B. pertussis
* Current smokers defined as having had a cigarette/cigar in the last week.
* Use of systemic antibiotics within 30 days of or during the challenge
* Any confirmed or suspected immunosuppressive or immune-deficient state, including HIV infection; asplenia; recurrent, severe infections and chronic (more than 14 days) immunosuppressant medication within the past 6 months (topical steroids are allowed)
* Use of immunoglobulins or blood products within 3 months prior to enrolment
* History of allergic disease or reactions likely to be exacerbated by any component of the inoculum
* Contraindications to the use of azithromycin or macrolides
* Pregnancy, lactation or intention to become pregnant during the study
* Any clinically significant abnormal finding on biochemistry, haematology, toxicology or serological blood tests, urinalysis or clinical examination - in the event of abnormal test results, confirmatory repeat tests will be requested
* Any other significant disease, disorder, or finding which may significantly increase the risk to the volunteer because of participation in the study, affect the ability of the volunteer to participate in the study or impair interpretation of the study data, for example recent surgery to the nasopharynx

Answer: B