Safety,tolerability and immunogenicity of intramuscular administration of PRP-CRM197 Hib vaccine to healthy Japanese children: An open-label trial |
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Institution: | 1. Hokkaido Anti-Tuberculosis Association, Kita 8, Nishi 3-28, Kita-ku, Sapporo 060-0808, Japan;2. Takeda Pharmaceutical Company Limited, 1-1, Doshomachi 4-chome, Chuo-ku, Osaka 540-8645, Japan |
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Abstract: | BackgroundJapan licensed the conjugate Haemophilus influenzae type b vaccine, Vaxem? Hib, based on clinical studies using subcutaneous injection. The present study was performed to ensure this vaccine is suitable for intramuscular injection in Japanese children.MethodsThirty-one healthy 2–6-month-old infants received three doses of Vaxem? Hib by intramuscular injection at 4-week intervals and a booster dose 1 year later, concomitant with routine infant (DTaP-IPV and pneumococcal) and toddler (measles–rubella) vaccines. Immunogenicity was assessed before and after the primary series and booster dose by enzyme-linked immunosorbent assay for anti-polyribosyl-ribitol-phosphate (PRP) antibodies. Safety was assessed by medical examination and diary cards completed by the subjects’ parents/legal guardians.ResultsThere were no vaccine-related serious adverse events or withdrawals; all children completed the study. Four weeks after the primary series, the geometric mean anti-PRP titer (GMT) was 19.68 μg/mL, and all children had seroprotective titers (≥0.15 μg/mL) that persisted until the booster dose. Proportions of titers indicative of long-term protection (≥1.0 μg/mL) were 100% after the primary series and 77.4% before the booster. Anamnestic responses to the booster had a GMT of 51.33 μg/mL, and 100% had titers ≥1.0 μg/mL. All but one subject reported injection site reactions as resolved within 3 days of vaccination; systemic reactions due to Hib and routine vaccines were also resolved within this period.ConclusionsVaxem? Hib was generally well tolerated and immunogenic in Japanese children when administered by intramuscular injection in a three-dose primary series and as a booster with concomitant routine vaccines.Clinical trial registry: Registered on Clinical Trials.gov: NCT02074345. |
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Keywords: | Vaccine Immunogenicity Safety Intramuscular Japan AE"} {"#name":"keyword" "$":{"id":"k0040"} "$$":[{"#name":"text" "_":"adverse event CI"} {"#name":"keyword" "$":{"id":"k0050"} "$$":[{"#name":"text" "_":"confidence interval GMT"} {"#name":"keyword" "$":{"id":"k0060"} "$$":[{"#name":"text" "_":"geometric mean anti-PRP titer Hib"} {"#name":"keyword" "$":{"id":"k0070"} "$$":[{"#name":"text" "$$":[{"#name":"italic" "_":"Haemophilus influenzae"} {"#name":"__text__" "_":" type b MedDRA"} {"#name":"keyword" "$":{"id":"k0080"} "$$":[{"#name":"text" "_":"Medical Dictionary for Regulatory Activities PRP"} {"#name":"keyword" "$":{"id":"k0090"} "$$":[{"#name":"text" "_":"polyribosyl-ribitol-phosphate PRP-D"} {"#name":"keyword" "$":{"id":"k0100"} "$$":[{"#name":"text" "_":"PRP-diphtheria toxoid PRP-T"} {"#name":"keyword" "$":{"id":"k0110"} "$$":[{"#name":"text" "_":"PRP-tetanus toxoid PRP-mutated nontoxic diphtheria toxin PRP-OMP"} {"#name":"keyword" "$":{"id":"k0130"} "$$":[{"#name":"text" "$$":[{"#name":"__text__" "_":"PRP-"} {"#name":"italic" "_":"Neisseria meningitidis"} {"#name":"__text__" "_":" outer membrane protein complex SAE"} {"#name":"keyword" "$":{"id":"k0140"} "$$":[{"#name":"text" "_":"serious AE SD"} {"#name":"keyword" "$":{"id":"k0150"} "$$":[{"#name":"text" "_":"standard deviation |
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