Large scale safety study of a liquid hexavalent vaccine (D-T-acP-IPV-PRP similar to T-HBs) administered at 2, 4, 6 and 12-14 months of age

A study was conducted to assess the safety of a new, liquid hexavalent vacc ine (Hexavac (R). Aventis Pasteur MSD, Lyon. France) in a large population of 1783 children in Germany vaccinated at 2, 4, 6 and 12-14 months of age. Immediate reactions, local and systemic reactions, and serious adverse even ts (SAEs) were monitored. The frequencies of redness greater than or equal to2 cm and swelling greater than or equal to2 cm were 6.7 and 7.1% after al l doses of the primary series combined and 13.4 and 12.0% following the boo ster dose, respectively. Transient swelling of the entire thigh was reporte d in seven infants after all doses of the primary series (0.1%) and in four children after the booster dose (0.2%). The most frequent systemic adverse events within 3 days after vaccination were irritability (19.3% after prim ary series and 13.2% after booster) and fever greater than or equal to 38.0 C (15.4% after primary series and 28.5% after booster). Fever above 40.0 d egreesC was reported in 0.1% of the infants post-primary series and in 0.9% of the children after the booster immunization. Only 3 of 144 SAE were con sidered to be vaccine related and were seen to resolve spontaneously and wi thout sequelae. The liquid hexavalent vaccine was generally well tolerated when given to children as a primary immunization series at 2, 4 and 6 month s and as a booster dose at 12-14 months. (C) 2001 Elsevier Science Ltd. All rights reserved.