Lot-to-Lot Consistency of a Combined Hexavalent Diptheria-Tentanus-Acellular-Pertussis, Hepatitis B, Inactivated Polio and Haemophilus b Conjugate Vaccine, Adminstered to Healthy Chilean Infants at 2, 4 and 6 Months of Age

Safety and immunogenicity of the 10-valent pneumococcal nontypeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) in Chilean children

“…Moreover, the reactogenicity profile of PHiD-CV was consistent with previous experience with coadministration of pneumococcal conjugate and DTPa-based combination vaccines 19 and with reactogenicity observations from previous PHiD-CV studies. 14,15,17 As seen previously for other vaccines, 20,21 we observed higher immune responses in Chilean infants and toddlers compared to those in previous European PHiD-CV studies, 11,13,16,18 although these differences seemed to be less pronounced for OPA and post-booster responses. 11,14,[16][17][18] Overall, anti-pneumococcal IgG responses following 2-dose PHiD-CV catch-up vaccination between 18 and 23 months of age were consistent with those measured after 3-dose PHiD-CV priming, with comparable percentages of subjects with antibody concentrations ≥0.2 μg/ml and antibody GMCs within the same range or higher following catch-up immunization, except for serotypes 5, 6B and 23F.…”

Immunogenicity and safety of 10-valent pneumococcal non-typeable Haemophilus influenzae protein D-conjugate vaccine (PHiD-CV) co-administered with routine childhood vaccines in Taiwan

“…15 While the reason for the higher rate of pain in the present study remains unclear, differences in reactogenicity when the same vaccine is used in different populations have previously been reported. 39,40 Higher rates of local and general symptoms were reported in Chilean infants in comparison with Belgian infants in a study of a Hib-tetanus toxoid conjugate and DTP combination vaccine. 39 The investigators regarded this as possibly due to differences in surveillance practice.…”

Immunogenicity, safety and reactogenicity of the 10-valent pneumococcal non-typeableHaemophilus influenzaeprotein D conjugate vaccine (PHiD-CV) when co-administered with the DTPw-HBV/Hib vaccine in Indian infants: a single-blind, randomized, controlled study

“…20,26 This difference may derive from cultural perceptions and intensity of surveillance for vaccine reactions across populations, as suggested in a previous study in which different rates of local reactions were reported in Chilean and Belgian children who received the same acellular pertussis vaccine. 42 A potential limitation of this study was the absence of investigator blinding, which is unlikely to have influenced immunogenicity assessment but may have biased the safety analyses toward increased reporting of AEs in the infants who received the PHiD-CV vaccine, since the investigator was aware that the child received a new vaccine in addition to the antigens received by the infants in the control group. However, if such a bias occurred, it did not result in large differences of reactogenicity between the two study groups.…”