BACKGROUND: Previous research suggests vaccine injection technique can influence local reactogenicity. OBJECTIVE: To identify characteristics of vaccination technique and individual vaccinees associated with frequency and severity of pain on injection and local reactogenicity following immunisation with quadrivalent human papillomavirus vaccine. DESIGN: Randomised cross-over trial of three injection techniques. Data were collected on health history, perceived stress and social support using a 10 item perceived stress scale and a single item social support question. Pain on injection was measured using a visual analogue scale and reactogenicity data was collected using participant-held diaries. SETTING:Clinic rooms at the University of Auckland. PARTICIPANTS: Females aged 14-45 years and males aged 14-26 years recruited to the study. MAIN OUTCOME MEASURES: Primary outcome measures were perceived pain on injection and the local injection site reactions pain, erythema, swelling and induration. RESULTS: The three injection techniques did not affect injection site reactogenicity. Females tended to experience more reactogenicity. Perceived stress, social support and atopy were not associated with reactogenicity outcomes and exercise showed little effect. No variables, including injection technique, were associated with wide variation in perceived pain in injection. Case by case observational data suggest some variations in anatomical site may be important. CONCLUSIONS: Most injection site reactions in this study were mild. The three injection techniques used in this study were equivalent in their reactogenicity and pain profiles and could be recommended for use in this population.
RCT Entities:
BACKGROUND: Previous research suggests vaccine injection technique can influence local reactogenicity. OBJECTIVE: To identify characteristics of vaccination technique and individual vaccinees associated with frequency and severity of pain on injection and local reactogenicity following immunisation with quadrivalent human papillomavirus vaccine. DESIGN: Randomised cross-over trial of three injection techniques. Data were collected on health history, perceived stress and social support using a 10 item perceived stress scale and a single item social support question. Pain on injection was measured using a visual analogue scale and reactogenicity data was collected using participant-held diaries. SETTING: Clinic rooms at the University of Auckland. PARTICIPANTS: Females aged 14-45 years and males aged 14-26 years recruited to the study. MAIN OUTCOME MEASURES: Primary outcome measures were perceived pain on injection and the local injection site reactions pain, erythema, swelling and induration. RESULTS: The three injection techniques did not affect injection site reactogenicity. Females tended to experience more reactogenicity. Perceived stress, social support and atopy were not associated with reactogenicity outcomes and exercise showed little effect. No variables, including injection technique, were associated with wide variation in perceived pain in injection. Case by case observational data suggest some variations in anatomical site may be important. CONCLUSIONS: Most injection site reactions in this study were mild. The three injection techniques used in this study were equivalent in their reactogenicity and pain profiles and could be recommended for use in this population.