Safety and immunogenicity of two Haemophilus influenzae type b conjugate vaccines

Objectives. Haemophilus influenzae type b (Hib) infection remains a major public health problem inthe developing world. We evaluated the safety and immunogenicity of a new PRP-CRM197 conjugate Hib vaccine (Vaxem Hib, Chiron Vacdnes), compared with theHibTITER vaccine (WyethLederle Vaccines), following the World Health Organisation (WHO)'s accelerated schedule which allows 4-week intervals between doses.Study design. A phase II, observer-blind, multicentre, randomised, controlled, non-inferiority study.Methods. In total, 331 babies were immunised with either Vaxem Hib (N = 167) or HibTITER (N = 164) vaccine at 6, 10 and 14 weeks of age, in parallel with oral polio, diphtheriatetanus- pertussis and hepatitis B vaccines. Postimmunisation reactions were recorded after each immunisation and arfollow-up visits. Anti-polyribosylribitol phosphate (PRP) antibodies were measured using enzyme-linked immunosorbent assays (ELISAs) before and 1 month after the third immunisation. Results. Overall, there was no significant difference in the anti-PRP levels between the two groups .. One month after the third immunisation, 76% of vacdnees in the Vaxem Hib group and 70% in the HibTITER group hadanti-PRP antibody mres i:: 1.0 vg/ tnl, while 96% of the Vaxem l-Iib group and.90% of the HibTITER gn;mp d.e!l}onstrated a),lt1- PRP antibody titres;:: 0.15 vg/ml. The geometric me<t:ntitre at day 90 was 3.77 pg/ml for the VaxemHib and 3.0 Jlg/Inl for the HibTITER groups. Although the Vaxem Hib vaccine produced more redness (6% versus 1 %; p = 0.006) and swelling (5% versus 1%, p = 0.037), overall it was well tolerated compared with the B:ibTITER vaccine. There wa~ no significant difference in vaccine-relateq elevated temperature (;:: 38°(:) between the two groups (p = 0. 11), Conclusion. Both vaccines showed comparable safety llJ:\d immunogenicity profiles when administered to SouthAfrican babies at 6, 10 and 14weeks of age

Safety of MF59-adjuvanted versus non-adjuvanted influenza vaccines in children and adolescents : an integrated analysis.

We reviewed the safety of MF59-adjuvanted versus non-adjuvanted influenza vaccines in children and adolescents (aged 6 months-18 years) in an integrated analysis of all pediatric trials evaluating MF59-containing influenza vaccines completed to date (5 trials). In the MF59-adjuvanted group (n=1181) versus the non-adjuvanted group (n=545) there was no increase in the incidence of unsolicited adverse events and serious adverse events. As expected, solicited local or systemic reactions occurred more frequently in MF59-adjuvanted subjects; however, a majority of reactions were mild and transient. These data support the safety of MF59-adjuvanted influenza vaccines in the pediatric population

Immunogenicity and Safety of an MF59\uae-Adjuvanted and a Non- Adjuvanted Inactivated Subunit Influenza Vaccine in Adults Affected by Chronic Diseases

Background: Influenza is a leading cause of morbidity and mortality in subjects with chronic diseases, who may also exhibit reduced immunogenicity to conventional influenza vaccines. MF59-adjuvanted influenza vaccine may enhance their immune response. Methods: We compared immunogenicity and safety of MF59-Adjuvanted Trivalent Influenza Vaccine (ATIV; Fluad\uae, Novartis Vaccines) and non-adjuvanted subunit (TIV; Agrippal\uae, Novartis Vaccines) in adults with at least one moderate to severe chronic condition. In this phase III, randomised, controlled, observer-blind study all subjects (18- 60 years of age) received one dose of ATIV (N=180) or TIV (N=179) vaccine during 2006/07 NH influenza season. Immunogenicity was tested using Hemagglutination Inhibition (HI) assay against vaccine and mismatched strains. Subjects were followed for safety for six months. Results: ATIV elicited significantly higher HI geometric mean titres (GMTs; P < .01) and mean-fold increases in titres (GMRs; P < .01) against all vaccine strains, compared with TIV. Seroprotection rates (HI 65 40) were 67\u201393% and 49\u201378% for ATIV and TIV groups, respectively (P < .01). ATIV also induced significantly higher GMTs against three mismatched strains (P < .05), and significantly greater GMRs against mismatched A strains (P < .05). Both influenza vaccines were well tolerated and safe, although ATIV elicited more solicited local and systemic (both 49%) reactions than TIV (both 28%). Most reactions (> 97%) were mild to moderate and all resolved spontaneously. Conclusion: ATIV is well tolerated, safe and confers higher and broader immunogenicity, when compared with a TIV, in adults with underlying chronic diseases