Comparative investigation of the safety of hexavalent vaccines for primary scheduled infant immunizations in Germany over a time period of 2 years.
BACKGROUND
Confidence in hexavalent vaccines has recently been shattered in Germany, after 5 infant deaths occurred shortly after such a vaccination. The aim of this study was to evaluate the safety of hexavalent vaccines over a time period of 2 years.


METHODS
With the written informed consent of the parents, we enrolled in the study all healthy infants who attended our office for a primary scheduled infant immunization during the study period from July 1, 2001, to June 30, 2003. This period was divided into two parts: (1) In a pilot study (July 1 to December 31, 2001), the two hexavalent vaccines licensed in Germany, Hexavac and Infanrix hexa, were compared to each other to evaluate if one of these vac-cines would be better tolerated. (2) During the follow-up study period (January 1, 2002, to June 30, 2003), that hexavalent vaccine was to be used, if any, which had been shown to have lower side effects during the pilot period. The trivalent measles-mumps-rubella vaccine Priorix was applied to all infants during both study periods. The parents were advised to immediately consult our office in any case of suspected or proven side effect from the vaccination.


RESULTS
3,658 polyvalent (hexavalent and trivalent) vaccinations were applied to 1997 infants. Local reactions were observed after application of Priorix in 0.0%, of Infanrix hexa in 0.46%, and of Hexavac in 3.1%, respectively.


CONCLUSIONS
The safety of Priorix and Infanrix hexa in particular could be established. Hexavalent vaccines can be recommended for introduction in all European countries for primary scheduled infant immunizations.
Lackmann
Gerd M
GM
Outpatient Paediatric Office, Hamburg, Germany. GMLackmann.Praxis@t-online.de
D005858:Germany; D006801:Humans; D007223:Infant; D010865:Pilot Projects; D017778:Vaccines, Combined / Q000009:adverse effects* / Q000737:chemistry / Q000276:immunology / Q000627:therapeutic use
D017778:Vaccines, Combined