Evaluation of a Hexavalent-Pentavalent-Hexavalent Infant Primary Vaccination Series Followed by a Pentavalent Booster Vaccine in Healthy Infants and Toddlers
Por:
Martinón-Torres F, Diez-Domingo J, Feroldi E, Jordanov E, B'Chir S and Da Costa X
Publicada:
1 mar 2019
Ahead of Print:
7 nov 2018
Resumen:
Background: This study assessed a pediatric mixed hexavalent diphtheria (D)-tetanus (T)-acellular pertussis (aP)-inactivated poliovirus (IPV)-hepatitis B (HB)-Haemophilus influenzae b [polyribosylribitol phosphate (PRP-T)]-pentavalent (DTaP-IPV//PRP-T)-hexavalent primary series schedule followed by a pentavalent booster. Methods: Healthy infants (N = 265) who had received a prior HB vaccination received a fully liquid, hexavalent vaccine (DTaP-IPV-HB-PRP-T) at 2 and 6 months of age and a reconstituted pentavalent vaccine (DTaP-IPV//PRP-T) at 4 months of age. Coadministered vaccines were pneumococcal vaccine at 2 and 4 months (and optionally at 6 months of age), rotavirus vaccine at 2, 4, 6 months and meningococcal serogroup C vaccine at 2 months. At 18 months, participants received DTaP-IPV//PRP-T and pneumococcal vaccine boosters. Immunogenicity was assessed using validated assays and safety by parental reports. Results: For the hexavalent and pentavalent vaccines, the primary series and booster immune responses in terms of seroprotection and vaccine response rates were high for all antigens (generally > 99% and > 95% for the primary series and booster, respectively) and prebooster antibody persistence was good for all antigens (in particular, 92.4% of participants had prebooster anti-HB antibody >= 10 mIU/mL). The incidence of solicited reactions was lower after the booster vaccination (56.9%-73.1%) than the primary series (76.6%-97.4%); there were few vaccine-related unsolicited adverse events (1.9% and 1.5% for the primary series and booster, respectively), none led to participant discontinuation and none was serious. Conclusions: This study provides data that allow recommending authorities to consider the use of a sequential hexavalent-pentavalent-hexavalent primary vaccination series followed by a pentavalent booster in coadministration with other common childhood vaccines.
Filiaciones:
Martinón-Torres F:
Hospital Clinico Universitario de Santiago de Compostela, Spain
:
FISABIO-Public Health, Valencia, Spain
Feroldi E:
Sanofi Pasteur, France
Jordanov E:
Sanofi Pasteur, USA
B'Chir S:
Sanofi Pasteur, France
Da Costa X:
Sanofi Pasteur, USA
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