Introduction: This paper reports 17 years of passive safety surveillance of routine use of the pediatric hexavalent diphtheria-tetanus-acellular pertussis-hepatitis B-inactivated poliovirus-Haemophilus influenzae type b-conjugate vaccine (DTPa-HBV-IPV/Hib, Infanrix hexa, GSK).
Methods: Global post-licensure passive surveillance data collected in GSK's central safety database since DTPa-HBV-IPV/Hib's launch (2000) are described.
Results: The most common spontaneously reported adverse events (AEs) after DTPa-HBV-IPV/Hib vaccination in children were fever (reporting rate: 7.74/100,000 doses distributed), crying (2.62/100,000), injection site erythema (1.87/100,000) and swelling (1.28/100,000). A review of extensive limb swelling did not reveal any safety concerns. An observed-to-expected analysis did not show an increased risk of sudden death after DTPa-HBV-IPV/Hib vaccination, in line with previous observations. The analyses confirmed that increases in spontaneous reporting proportions of convulsions with/without fever and hypotonic-hyporesponsive episodes after co-administration of DTPa-HBV-IPV/Hib and 13-valent pneumococcal conjugate vaccine remained small and their clinical significance unknown. The most common vaccination errors were mistakes in the vaccination schedule. Reporting of preparation errors (mostly reconstitution) was low and did not impact the vaccine's benefit-risk profile.
Conclusions: Seventeen years of post-licensure experience confirm confidence in the safety profile of DTPa-HBV-IPV/Hib in routine use, with a favorable benefit-risk profile in infants and toddlers.
Plain language summary: What is the context? The cornerstone of childhood vaccination in many countries worldwide is a vaccine that protects against several diseases: diphtheria, tetanus, whooping cough, hepatitis B, polio and Haemophilus influenzae type b infections (such as meningitis). One of these vaccines (the longest on the market) is called Infanrix hexa; it has been available for infants and toddlers since 2000. After a vaccine is included in a country's routine vaccination program, its safety is constantly checked; this is done in clinical trials and through spontaneous reporting of adverse events after vaccination. It is important to share up-to-date information on the safety of vaccines, particularly since concerns about vaccine safety in parents may lead to lower vaccination rates an disease outbreaks. Here we summarize 17 years of safety data for the Infanrix hexa vaccine. What is new? We analyzed spontaneously reported adverse events after Infanrix hexa vaccinations between 2000 and 2017 The most commonly reported adverse events were fever, crying and injection site redness and swelling An in-depth review of extensive limb swelling after Infanrix hexa vaccination revealed no safety concerns. There was no increased risk of sudden death after Infanrix hexa vaccination, consistent with what was shown in several other studies. As shown previously, seizures were more common when Infanrix hexa was given together with the pneumococcal conjugate vaccine, Prevnar 13, than when it was given alone. What is the take-home message? The large amount of safety data gathered from clinical trials and from spontaneous adverse event reporting during 17 years of routine vaccination with Infanrix hexa supports its continued use in young children.
Keywords: Adverse events; DTPa-HBV-IPV/Hib; post-marketing surveillance; safety; spontaneous reporting; vaccine.