title: A randomized, controlled, blinded study of the safety and immunogenicity of Haemophilus influenzae type b conjugate vaccine injected at different intramuscular sites in Chinese infants.
abstract: To compare the safety and immunogenicity of Haemophilus influenzae type b (Hib) conjugate vaccine administered via the vastus lateralis and deltoid muscles, 320 healthy Chinese infants<12 mo of age were enrolled in a randomized, controlled, blinded study and divided into 2 age groups: 2-5 mo and 6-12 mo. Each age group was then randomized (1:1) to either the vastus lateralis (experimental) group who received Hib vaccination into this muscle 2 or 3 times at monthly intervals, or the deltoid (control) group who received Hib vaccination into this muscle either 3 times (2-5 mo group) or twice (6-12 mo group) at monthly intervals. Local and systemic adverse reactions after each vaccine dose were recorded, and Hib-PRP antibody concentrations were determined by ELISA at 28 d after completion of the immunization schedule. There were no significant differences in the proportions of subjects with post-immunization Hib-PRP antibody concentrations ≥1.0 μg/mL or ≥0.15 μg/mL with the two injection sites for either age group, or in the post-immunization Hib-PRP antibody concentrations achieved (P>0.05). In addition, there were no significant differences in the rates of local and systemic reactions after the first and second vaccinations between the 2 injection sites for either age group (P>0.05), but the rate of systemic reactions in the 2-5 mo group after the third vaccination via the vastus lateralis muscle was significantly lower than after deltoid vaccination (0% vs 8.57%; P<0.05). Thus, administration via the vastus lateralis muscle is worth considering for Hib vaccination.
authors.affiliation: Chaoyang Diseases Control and Prevention Center; Beijing, PR China.
authors.forename: Nianmin
authors.initials: N
authors.lastname: Shi
authors.forename: Fengji
authors.initials: F
authors.lastname: Luo
authors.forename: Li
authors.initials: L
authors.lastname: Li
authors.forename: Dongyi
authors.initials: D
authors.lastname: Zheng
authors.forename: Zheng
authors.initials: Z
authors.lastname: Zhang
authors.forename: Zhaoyun
authors.initials: Z
authors.lastname: Wang
authors.forename: Liqing
authors.initials: L
authors.lastname: Yang
authors.forename: Zhaoqiu
authors.initials: Z
authors.lastname: Liu
authors.forename: Xing
authors.initials: X
authors.lastname: Ai
authors.forename: Yunhua
authors.initials: Y
authors.lastname: Bai
authors.forename: Qiang
authors.initials: Q
authors.lastname: Lu
mesh_terms: D000907:Antibodies, Bacterial / Q000097:blood; D016667:Bacterial Capsules / Q000276:immunology*; D002681:China; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology / Q000473:pathology; D004797:Enzyme-Linked Immunosorbent Assay; D005260:Female; D006192:Haemophilus Infections / Q000517:prevention & control*; D018073:Haemophilus Vaccines / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology*; D019741:Haemophilus influenzae type b / Q000276:immunology*; D006801:Humans; D007223:Infant; D007273:Injections, Intramuscular / Q000009:adverse effects; D008297:Male; D016037:Single-Blind Method; D014611:Vaccination / Q000009:adverse effects* / Q000379:methods*; D018074:Vaccines, Conjugate / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology
chemical_list: D000907:Antibodies, Bacterial; D018073:Haemophilus Vaccines; C044237:Haemophilus influenzae type b polysaccharide vaccine; D018074:Vaccines, Conjugate
keywords: Haemophilus influenzaetype b vaccine; deltoid; immunogenicity; safety; vaccination site; vastus lateralis