Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Case-control Study of the Association Between Pertussis Vaccination in Infancy and the Risk of IgE-mediated Food Allergy
Brief Summary: Aim To assess the possible food allergy-preventive benefit of using whole cell pertussis(wP) vaccination compared with acelluar pertussis vaccine(aP) for whooping cough vaccination in childhood.

Background Whooping cough, caused by the bacteria, Bordetella pertussis, represents a significant public health burden in Australia and around the world. Acellular pertussis vaccination (aP) replaced whole cell vaccination against pertussis (wP) in the late 1990s. This replacement coincides temporally in an observed rapid rise in the occurrence of severe food allergy responses. Previous research has suggested that acellular pertussis vaccination results in the development of immunity that may predispose children to allergic responses. A retrospective case-controlled trial design, targeting cases of previously diagnosed allergy, and comparing case vaccination history to that of the whole population, is a powerful means of assessing the association between immunisation and allergy.

Participant Groups 1000 allergy cases, 10,000 controls

Project Design This is a retrospective individually-matched case-control study of Australian children born during the period of transition from use of wP vaccines to aP vaccines (year of birth 1997-1999 inclusive) and who are registered on the Australian Children Immunisation Register. Cases will be drawn from allergy clinics associated with tertiary teaching hospitals around Australia.

Methods Cases: will be retrospectively identified from patient lists from allergy clinics around Australia, born during the period of pertussis vaccine changeover, and be confirmed 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 laboratory testing.

Controls: Controls will be sampled from a de-identified database of children born during the transition from wP to aP vaccination appearing on the ACIR. Cases and controls will be matched by date of birth (+/-7 days), jurisdiction and socioeconomic decile.

Expected outcomes: Following the study, investigators will be able determine if there is an association between the type of vaccination received and development of IgE mediated food allergy. If whole cell vaccination is found to have a protective association against the development of allergy, this will have profound impact on health policy in Australia and around the world.


Options:
A: Arm Label: Phase A - SI; Type: EXPERIMENTAL; Interventions: Biological: Bordetella Pertussis B1917, Drug: Azithromycin 500 mg | Arm Label: Phase B Inoculum; Type: EXPERIMENTAL; Interventions: Biological: Bordetella Pertussis B1917, Drug: Azithromycin 500 mg | Arm Label: Phase B Sham; Type: EXPERIMENTAL; Interventions: Drug: Azithromycin 500 mg, Other: Sterile Saline | Intervention Type: BIOLOGICAL; Name: Bordetella Pertussis B1917; Assigned to Arm(s): Phase A - SI, Phase B Inoculum | Intervention Type: DRUG; Name: Azithromycin 500 mg; Assigned to Arm(s): Phase A - SI, Phase B Inoculum, Phase B Sham | Intervention Type: OTHER; Name: Sterile Saline; Assigned to Arm(s): Phase B Sham
B: Arm Label: Group 1: DTaP-IPV-Hep B-PRP-T; Type: EXPERIMENTAL; Interventions: Biological: DTaP-IPV-HB-PRP~T | Arm Label: Group 2: CombAct-HIB™ + OPV; Type: EXPERIMENTAL; Interventions: Biological: CombAct-HIB® | Arm Label: Group 3: DTaP-IPV-Hep B-PRP-T (ENGERIX B™ at birth); Type: ACTIVE_COMPARATOR; Interventions: Biological: Engerix B® Pediatric | Intervention Type: BIOLOGICAL; Name: DTaP-IPV-HB-PRP~T; Assigned to Arm(s): Group 1: DTaP-IPV-Hep B-PRP-T | Intervention Type: BIOLOGICAL; Name: CombAct-HIB®; Assigned to Arm(s): Group 2: CombAct-HIB™ + OPV | Intervention Type: BIOLOGICAL; Name: Engerix B® Pediatric; Assigned to Arm(s): Group 3: DTaP-IPV-Hep B-PRP-T (ENGERIX B™ at birth)
C: Arm Label: Allergy Cases; Type: N/A; Interventions: N/A | Arm Label: Controls; Type: N/A; Interventions: N/A
D: Arm Label: Group A; Type: EXPERIMENTAL; Interventions: Biological: Boostrix, Biological: Infanrix hexa | Arm Label: Group B; Type: ACTIVE_COMPARATOR; Interventions: Biological: Boostrix, Biological: Quinvaxem, Biological: OPV | Intervention Type: BIOLOGICAL; Name: Boostrix; Assigned to Arm(s): Group A, Group B | Intervention Type: BIOLOGICAL; Name: Infanrix hexa; Assigned to Arm(s): Group A | Intervention Type: BIOLOGICAL; Name: Quinvaxem; Assigned to Arm(s): Group B | Intervention Type: BIOLOGICAL; Name: OPV; Assigned to Arm(s): Group B

Answer: C