Safety and Reactogenicity of the 10-Valent Pneumococcal Non-typeable Haemophilus influenzae Protein D Conjugate Vaccine (PHiD-CV) When Coadministered With Routine Childhood Vaccines

Abstract

The safety and reactogenicity profiles of PHiD-CV and 7vCRM were within the same range when administered for primary and booster vaccination in coadministration with other routinely used pediatric vaccines.

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

“…This was in line with previous experience with PHiD-CV primary and booster vaccination studies, 12,14,15,17 in which SAEs considered causally related to PHiD-CV vaccination occurred rarely and resolved without sequelae.…”

“…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.…”

“…Reactogenicity and safety were evaluated in all subjects using diary cards that were completed by the subjects' parents/guardians, as described previously. 15 An extended safety follow-up period followed the booster/ catch-up stage, ending with a telephone contact at 26-29 months of age. Specific AEs commonly associated with injectable childhood vaccines were actively solicited for 4 days following each vaccine dose, large swelling reactions were recorded following vaccine administrations in the second year of life, and other non-serious and unsolicited AEs were recorded within a 31-day follow-up period after each vaccine dose.…”

“…[8][9][10] Previous primary and booster studies showed that PHiD-CV is immunogenic and safe when co-administered with other routine pediatric vaccines. [11][12][13][14][15][16][17][18] The present study, conducted in Chile, assessed the safety (primary objective) and immunogenicity (secondary objective) of 2 PHiD-CV immunization regimens: a 3-dose PHiD-CV primary immunization course administered at 2, 4 and 6 months of age followed by a booster dose at 20 to 23 months of age and a 2-dose PHiD-CV catch-up immunization schedule at 18 to 21 and 20 to 23 months of age.…”

Effectiveness of the ten-valent pneumococcal Haemophilus influenzae protein D conjugate vaccine (PHiD-CV10) against invasive pneumococcal disease: a cluster randomised trial

“…[4][5][6][7] Another pneumococcal vaccine containing ten serotype-specific polysaccharides conjugated to Haemophilus influenzae protein D, tetanus toxoid and diphtheria toxoid as the carrier proteins was developed (PHiD-CV10). [8][9][10] It was licensed in EU in March 2009 (Synflorix™, GlaxoSmithKline Vaccines) based on PHiD-CV10 immunological data according to criteria recommended by WHO 11 for licensure for protection against IPD, PHiD-CV10 safety data, and efficacy results of the 11-valent precursor formulation against acute otitis media. 12 The Finnish Invasive Pneumococcal disease (FinIP) vaccine trial was designed to demonstrate the clinical vaccine effectiveness (VE) of PHiD-CV10 against IPD.…”