ONE ARM OR TWO? CONCURRENT ADMINISTRATION OF MENINGOCOCCAL C CONJUGATE AND HEPATITIS B VACCINES IN PRE-TEENS Karen Pielak RN MSN Nurse Epidemiologist BC Centre for Disease Control Vancouver, BC 6th Canadian Immunization Conference December 8, 2004

BACKGROUND First Canadian jurisdiction to introduce an immunization program offering concurrent administration of these vaccines to students in grade 6 No previous studies had examined the AE profile associated with concurrent administration of these vaccines in one arm or both arms Public Health Nursing concerns/questions

PURPOSE Compare differences in local and systemic reactions between children having both injections in one arm to those having one injection in separate arms Assess and compare rates of reactions from meningococcal C conjugate (Neis Vac-C) and hepatitis B vaccine (Recombivax HB®)

…METHODS Schools randomized to receive both vaccines in one arm (One Arm Group) or one vaccine in each arm (Both Arms Group) Students in all schools randomized to the Both Arms Group received Neis Vac-C in left arm and Recombivax HB in right arm

…METHODS Structured telephone interviews 48 - 96 hours following immunization Asked about local and systemic reactions, interference with school or other activities, need for medical attention, and parental time loss from work

RESULTS Final response rate of 50.9% of immunized students from 26 schools (15 in Cloverdale/Surrey, 11 in Quesnel) 202 students in the One Arm Group, 188 in the Both Arms Group

Local Reactions: Tenderness p<0.05 p<0.05 28% 18%

Local Reactions: Redness p<0.001 6.5% 0.5%

Local Reactions: Arm Movement Limitation

Local Reactions: Swelling

Systemic Reactions p<0.05 14% 7%

Neis Vac-C vs Recombivax HB®: Tenderness (both arms group, n=188) 54% p<0.001 32% p<0.01 24% 12%

Neis Vac-C vs Recombivax HB®: Redness (both arms group, n=188) 6.4% 1.6%

Neis Vac-C vs Recombivax HB®: Arm movement limitation (both arms group, n=188)

IMPACT of Vaccine-Associated Reactions Social impact: Reactions interfered with school attendance for 2.8% social activities, sports, music lessons for 4.9% Healthcare impact: 2 students required medical attention for tenderness and fever

IMPACT of Vaccine-Associated Reactions Parental time loss from work: One caregiver in each group took time off work No statistically significant differences in impact between study groups

DISCUSSION One arm vs both arms: Statistically significant differences between groups: Both Arms Group experiencing more: moderate to severe tenderness redness > 46mm drowsiness

…DISCUSSION Neis Vac-C vs Recombivax HB®: Statistically significant differences: Experience with Neis Vac-C: more tenderness more moderate to severe tenderness more redness

…DISCUSSION Parents can be reassured that: adverse events are minimal the events may only marginally interfere with school attendance and other activities little need is anticipated for seeking medical attention

RECOMMENDATIONS Can administer both Neis Vac-C and Recombivax HB in one arm without concern for an increase in local reactions. If administered in separate arms, administer Neis Vac-C in the non-dominant arm

Co-investigators:1 Cheryl McIntyre, Associate Nurse Epidemiologist Dr Co-investigators:1 Cheryl McIntyre, Associate Nurse Epidemiologist Dr. Jane Buxton, Physician Epidemiologist Valencia Remple, Research Coordinator Dr. Danuta Skowronski, Physician Epidemiologist 1Epidemiology Services, British Columbia Centre for Disease Control Special thanks to the Public Health Nursing staff of the Quesnel and Cloverdale/Surrey Health Units