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Hexaxim exhibited comparable safety, immunogenicity to Infanrix Hexa in infants
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An investigational fully-liquid hexavalent vaccine for protection against diphtheria, tetanus, pertussis, poliovirus, Haemophilus influenzae type b and hepatitis B was found to be noninferior to the current hexavalent regimen, according to recently published data.
“The immunization schedules for infants and toddlers across the EU countries are diverse, but several countries like the U.K. and Germany follow the ‘accelerated schedule’ at 2, 3, 4 and 12 months, to induce early protection against pertussis and Haemophilus influenze,” Timo Vesikari, MD, professor of virology and pediatrics and director of the Vaccine Research Centre at the University of Tampere in Finland, and colleagues wrote. “Most EU countries prefer to use hexavalent combination vaccines to reduce the number of shots and to improve coverage and timeliness.”
While a hexavalent vaccine with a 3-antigen pertussis component (Infanrix Hexa, GlaxoSmithKline) has been licensed in Europe for more than a decade, a fully liquid hexavalent vaccine (Hexaxim, Sanofi-Pasteur) with a 5-antigen pertussis component has been recently introduced to improve compliance through reduced number of vaccinations.
Vesikari and colleagues conducted a phase 3, double blind, comparator-controlled study (NCT01341639) comprising 1,250 infants in Belgium, Finland and Germany over a 2-year period to compare the efficacy and immunogenicity results of the Hexaxim vaccine (DTaP5-HB-IPV-Hib) with the current Infanrix Hexa vaccine (DTPa3-HBV-IPV-Hib). The researchers randomly assigned infants 1:1 to receive either DTaP5-HB-IPV-Hib (n = 628) or DTPa3-HBV-IPV/Hib (n = 622) via intramuscular injection to the upper anterolateral thigh at ages 2, 3, 4 and 12 months.
In addition, all study infants received Prevnar 13 (PCV13; Pfizer) and Rotateq (RV5; Merck) vaccines at ages 2, 3 and 4 months and ProqQad (MMRV; Merck) at age 12 months. Further, infants were administered ProqQad at 13 months of age. To evaluate immunogenicity, blood specimens were collected from all infants through venipuncture 5 days prior to first dose administration.
Among all infants, 1,187 received all three infant series doses and the toddler dose. Per-protocol analysis indicated that immune responses to investigational vaccine antigens 1 month following the third dose and toddler dose met the response rate criteria and were not inferior to DTPa3-HBV-IPV-Hib. Both were associated with a low risk for adverse events; researchers determined that 0 participants in the DTaP5-HB-IPV-Hib group and only 4 participants in the DTPa3-HBV-IPV-Hib group discontinued use due to vaccine-related adverse events.
“In this study, all primary acceptability and non-inferiority immunogenicity comparisons to control [DTPa3-HBV-IPV-Hib] were met, providing evidence to support the use of DTaP5-HB-IPV-Hib at 2, 3, 4 and 12 months of age,” the researchers wrote. “The postdose 3 anti-PRP responses at the threshold of 0.15 µg/mL or greater were numerically higher than control with an estimated difference that excluded 0, suggesting a statistically significant difference.
“Additionally, the pre-booster difference might be of clinical significance for protection against Hib diseases between ages 4 and 12 months, a time of peak incidence and highest burden of Hib, when DTaP5-HB-IPV-Hib results in more rapid development of protective levels of anti-PRP antibody.” – by Kate Sherrer
Disclosure: Vesikari reports receiving research grants from Merck. Please see the full study for a list of all other researchers’ relevant financial disclosures.
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