One Arm or Two? Concurrent Administration of Meningococcal C Conjugate and Hepatitis B Vaccines in Pre-Teens
Pielak, Karen L., McIntyre, Cheryl C., Remple, Valencia P., Buxton, Jane A., Skowronski, Danuta M., Canadian Journal of Public Health
Background: The purpose of this study was to: a) compare rates of local reactions from meningococcal C conjugate (Neis Vac-C®) and hepatitis B vaccines (Recombivax HB®), and b) compare local reactions when both injections were given in one arm versus one in each arm.
Methods: Schools were randomized to have grade six students receive both vaccines in one arm (One Arm Group), or one vaccine in each arm (Two Arm Group; MCC always given in left arm). Structured telephone interviews of parents were conducted, and respondents were asked about local and systemic reactions, interference with school or other activities, need for medical attention, and lost parental work time.
Findings: The Two Arm Group reported significantly more local redness >46 mm (6.5% vs. 0.5%, p<0.001), moderate to severe tenderness (28% vs. 18%, p<0.05), and drowsiness (14% vs. 7%, p<0.05). When adjusted for sex, ethnicity, and town of residence, report of any tenderness was associated with town of residence only; moderate or severe tenderness was independently associated with the Two Arm Group (OR 1.4, 95% CI 1.1-1.85). There were no statistically significant differences between groups for interference with school attendance or other activities, need for medical attention, or lost parental work time. Among participants of the Two Arm Group (188 students), there was more redness (6% vs. 2%, p<0.05) and tenderness (54% vs. 32%, p<0.001) experienced with Neis Vac-C® than with Recombivax HB®, respectively.
Conclusions: Injecting two vaccines in one arm did not cause more local reaction than one injection in each arm and remains an option for those who prefer it for logistical reasons. If vaccinating in two arms, Neis Vac-C® should preferentially be given in the non-dominant arm.
Key words: Meningococcal vaccine; hepatitis B vaccine; vaccines administration
At the time of the study, British Columbia (BC) was the first Canadian jurisdiction to implement a school-based, universal immunization program providing concurrent administration of meningococcal C conjugate (MCC) vaccine (Neis Vac-C®) and hepatitis B virus (HBV) vaccine (Recombivax HB®). Numerous studies with infants have examined the reactogenicity of these vaccines when administered separately or with other routine infant vaccines.1-7 No published studies have systematically assessed the rate of local reactions to concurrent administration of MCC and HBV vaccines when one versus two arms are used for administration in the grade six age group of 11-12 years. The purpose of this randomized, observational study was to: a) compare differences in local and systemic reactions between children having both injections in one arm to those having one injection in separate arms and b) compare local reactions from MCC and HBV vaccination. This study was conducted in response to a call from public health nurse (PHN) immunizers for practical guidance related to these questions.
This study received ethical approval from the University of British Columbia Clinical Research Ethics Board.
Sample size considerations
Assuming a binomial distribution, in order to detect a difference in reported reactions of 15% between groups with a beta of 0.8 and alpha of 0.05, 183 participants per group were required. Fifteen percent was deemed an important difference by the study investigators, who are experts in paediatric immunization.
Eligible participants were children in grade six scheduled to receive MCC and HBV vaccines through the school immunization program. Health units in Quesnel (rural, interior BC) and Cloverdale/Surrey (urban, lower mainland BC) participated. PHNs distributed consent forms to teachers who gave them to students to take home for parental signatures. Within each community, schools were randomized to receive either both vaccines in one arm (One Arm Group), or one vaccine in each arm (Two Arm Group). …