Adverse reactions to simultaneous influenza and pneumococcal conjugate vaccinations in children: randomized double-blind controlled trial.

In a randomized double-blind controlled trial, the safety was assessed of simultaneous administration of influenza and pneumococcal conjugate vaccines in children with previous physician-diagnosed respiratory tract infections. In total, 579 children aged 18-72 months were assigned to receive simultaneous intramuscular influenza and pneumococcal heptavalent conjugate vaccinations (IV + PV), influenza and placebo vaccinations (IV + plac) or control hepatitis B and placebo vaccinations (HepB + plac) in separate extremities. Local and systemic adverse events were recorded in parental diaries for 7 days after vaccination. No immediate adverse reactions were recorded. In most children local adverse reactions disappeared 2 days after vaccination. Local and systemic reactions were more prevalent (30% and 10% more) in the IV + PV group compared with the IV + plac and HepB + plac group. These results are important for designing future vaccination schedules.