목적: 인플루엔자 유행 예방에 대한 가장 효과적인 방법은 인플루엔자 백신이나 한국의 소아청소년을 대상으로 한 면역원성 및 안전성에 대한 자료가 많지 않다. 이에 본 연구는 국내에서 많이 사용되는 불활성화 3가 백신의 면역원성과 안전성을 확인하고자 하였다. 방법: 2008년 10월부터 12월까지 고려대학교 의료원 안산병원 소아청소년과에 인플루엔자 예방접종을 위해 내원한 건강한 소아청소년 중 임상시험 지원자 65명을 대상으로 하여 접종 전과 접종 후 30일째 혈구응집억제(hemagglutinin inhibition) 항체검사를 시행하고 접종 직후부터 접종 후 7일까지 국소반응과 전신반응을 포함한 이상반응을 관찰하여 기록하도록 하였다. 결과: 분할 인플루엔자 백신의 세 항원(H1N1, H3N2, B) 각각에 대한 접종 후 혈청보호율은 87.7%, 89.2%, 89.2% (${\geq}70%$)였으며 혈청전환율은 44.6%, 73.8%, 63.1% (${\geq}40%$), 혈청전환인자는 3.35, 7.18, 5.13 (>2.5)으로 Committee for Proprietary Medicinal Products (CPMP) 기준을 만족하였다. 전체 피험자 65명 중 48명(73.8%)이 백신 접종 후 이상반응을 보고하였으나 아나필락시스나 경련과 같은 심각한 이상반응은 없었다. 발적(29.2%), 동통(43.1%), 종창(41.5%)과 같은 국소반응을 보고한 피험자는 42명(64.6%)이었고, 권태(23.1%), 근육통(20.0%), 두통(10.8%), 관절통(10.8%), 오한(9.2%), 발열(7.7%) 등과 같은 전신반응을 보고한 피험자는 26명(40.0%)이었다. 결론: 6개월에서 18세까지의 소아청소년을 대상으로 한 불활성화 3가 백신의 면역원성과 안전성에 대한 연구 결과 H1N1, H3N2, B 항원 모두 CPMP 기준에 부합하여 적합한 면역원성이 있는 것으로 나타났으며, 국소반응 및 경미한 전신반응 이외에 심각한 이상반응은 보이지 않아 비교적 안전하다고 판단된다.
목적: 인플루엔자 유행 예방에 대한 가장 효과적인 방법은 인플루엔자 백신이나 한국의 소아청소년을 대상으로 한 면역원성 및 안전성에 대한 자료가 많지 않다. 이에 본 연구는 국내에서 많이 사용되는 불활성화 3가 백신의 면역원성과 안전성을 확인하고자 하였다. 방법: 2008년 10월부터 12월까지 고려대학교 의료원 안산병원 소아청소년과에 인플루엔자 예방접종을 위해 내원한 건강한 소아청소년 중 임상시험 지원자 65명을 대상으로 하여 접종 전과 접종 후 30일째 혈구응집억제(hemagglutinin inhibition) 항체검사를 시행하고 접종 직후부터 접종 후 7일까지 국소반응과 전신반응을 포함한 이상반응을 관찰하여 기록하도록 하였다. 결과: 분할 인플루엔자 백신의 세 항원(H1N1, H3N2, B) 각각에 대한 접종 후 혈청보호율은 87.7%, 89.2%, 89.2% (${\geq}70%$)였으며 혈청전환율은 44.6%, 73.8%, 63.1% (${\geq}40%$), 혈청전환인자는 3.35, 7.18, 5.13 (>2.5)으로 Committee for Proprietary Medicinal Products (CPMP) 기준을 만족하였다. 전체 피험자 65명 중 48명(73.8%)이 백신 접종 후 이상반응을 보고하였으나 아나필락시스나 경련과 같은 심각한 이상반응은 없었다. 발적(29.2%), 동통(43.1%), 종창(41.5%)과 같은 국소반응을 보고한 피험자는 42명(64.6%)이었고, 권태(23.1%), 근육통(20.0%), 두통(10.8%), 관절통(10.8%), 오한(9.2%), 발열(7.7%) 등과 같은 전신반응을 보고한 피험자는 26명(40.0%)이었다. 결론: 6개월에서 18세까지의 소아청소년을 대상으로 한 불활성화 3가 백신의 면역원성과 안전성에 대한 연구 결과 H1N1, H3N2, B 항원 모두 CPMP 기준에 부합하여 적합한 면역원성이 있는 것으로 나타났으며, 국소반응 및 경미한 전신반응 이외에 심각한 이상반응은 보이지 않아 비교적 안전하다고 판단된다.
Purpose: This study aimed to evaluate the immunogenicity and safety of a trivalent inactivated influenza vaccine (TIV) among healthy Korean children and adolescents. Methods: From October to December 2008, 65 healthy patients aged 6 months to 18 years who visited Korea University Ansan Hospital for ...
Purpose: This study aimed to evaluate the immunogenicity and safety of a trivalent inactivated influenza vaccine (TIV) among healthy Korean children and adolescents. Methods: From October to December 2008, 65 healthy patients aged 6 months to 18 years who visited Korea University Ansan Hospital for influenza vaccination were enrolled in this study. We measured the hemagglutinin inhibition antibody titers at baseline and 30 days after vaccinating enrollees with split influenza vaccine and calculated the seroprotection rates, geometric mean titers, and seroconversion rates. Local and systemic adverse events were assessed after vaccination. Results: The seroprotection rates against all three viral strains (A/H1N1, A/H3N2, B) were 87.7%, 89.2%, and 89.2% (${\geq}70%$), respectively; seroconversion rates were 44.6%, 73.8%, and 63.1% (${\geq}40%$), respectively; and seroconversion factors were 4.5, 8.4, and 10.5 (>2.5), respectively. The TIV immunogenicity was acceptable according to the CPMP (Committee for Proprietary Medicinal Products) criteria. Although 48 patients (73.8%) reported one or more adverse events, no severe adverse events such as anaphylaxis and convulsion were observed. Forty-two patients (64.6%) reported a local skin reaction, including redness (29.2%), pain (43.1%), or swelling (41.5%) of the injected site, and 26 (40.0%) reported a systemic reaction: fatigue (23.1%), myalgia (20.0%), headache (10.8%), arthralgia (10.8%), chills (9.2%), or fever (7.7%). Conclusions: This study shows that the immunogenicity of the TIV vaccine is acceptable. As there were no serious adverse events aside from local reactions and mild systemic reactions, this vaccine can be safely used among healthy Korean children and adolescents.
Purpose: This study aimed to evaluate the immunogenicity and safety of a trivalent inactivated influenza vaccine (TIV) among healthy Korean children and adolescents. Methods: From October to December 2008, 65 healthy patients aged 6 months to 18 years who visited Korea University Ansan Hospital for influenza vaccination were enrolled in this study. We measured the hemagglutinin inhibition antibody titers at baseline and 30 days after vaccinating enrollees with split influenza vaccine and calculated the seroprotection rates, geometric mean titers, and seroconversion rates. Local and systemic adverse events were assessed after vaccination. Results: The seroprotection rates against all three viral strains (A/H1N1, A/H3N2, B) were 87.7%, 89.2%, and 89.2% (${\geq}70%$), respectively; seroconversion rates were 44.6%, 73.8%, and 63.1% (${\geq}40%$), respectively; and seroconversion factors were 4.5, 8.4, and 10.5 (>2.5), respectively. The TIV immunogenicity was acceptable according to the CPMP (Committee for Proprietary Medicinal Products) criteria. Although 48 patients (73.8%) reported one or more adverse events, no severe adverse events such as anaphylaxis and convulsion were observed. Forty-two patients (64.6%) reported a local skin reaction, including redness (29.2%), pain (43.1%), or swelling (41.5%) of the injected site, and 26 (40.0%) reported a systemic reaction: fatigue (23.1%), myalgia (20.0%), headache (10.8%), arthralgia (10.8%), chills (9.2%), or fever (7.7%). Conclusions: This study shows that the immunogenicity of the TIV vaccine is acceptable. As there were no serious adverse events aside from local reactions and mild systemic reactions, this vaccine can be safely used among healthy Korean children and adolescents.
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문제 정의
However, there are limited immunogenicity and safety data on Korean children and adolescents. This study was aimed at evaluating the immunogenicity and safety of an inactivated split influenza vaccine, which is widely used in Korea, among healthy Korean children and ado lescents8-11).
This study was conducted to investigate the immu nogenicity and safety of an inactivated split influenza vaccine that is widely used in Korea, among healthy children and adolescents.
제안 방법
Immediately after the vaccination, the examiner moni tored possible emergence of immediate and serious ad verse events such as anaphylaxis, allergic asthma, and angioedema for 30 minutes at the hospital. A diary was kept by each guardian until the 7th day, and adverse events were subdivided into systemic reactions and local reactions.
3%) were first-time vac cine recipients, all under 5 years of age. In this study, two vaccinations were administered to unprimed sub jects with a 1-month interval (Table 4).
The seroprotection rate, seroconversion rate, geo metric mean titer (GMT), and seroconversion factor were calculated from the antibody titers for the three viruses (A/H1N1, A/H3N2, and B) whose antigens were contained in the vaccine. Afterwards, immunogenicity was assessed based on the CPMP (Committee for Pro prietary Medicinal Products) standards12-13).
In Korea, nationwide free inactivated split influenza vaccination of 6- to 59-month-old children was started in September 2017. Therefore, in this study, we tried to compare immunogenicity by subdividing the subjects into two age groups: the 6- to 59-month-old group and 5- to 18-year-old group (Table 3). There are not many studies on the efficacy and effectiveness of the inactivated influenza vaccine in children, and some studies have shown that immunogenicity of the vaccine is lower in infants than in adolescents and adults14-17).
Thus, our study can be meaningful in that we have added basic data on immunogenicity and safety in the target age group of the policy. This study also included data comparing the unprimed and primed group.
대상 데이터
From October to December 2008, healthy children and adolescents, aged 6 months to 18 years, who vi sited the Department of Pediatrics, Korea University Ansan Hospital, for influenza vaccination were included in the study. Of the 68 patients who agreed to partici pate in the study with informed consents, three with drew and 65 completed the study.
데이터처리
The statistical me thods for age-specific comparisons of immunogenicity, seroconversion rates, and serum protection rates were as follows: the chi-square test, one-way analysis of variance for discontinuous variables, and the t-test for continuous variables.
성능/효과
According to the comprehensive analysis of the results by age, this study shows statistically significantly higher seroprotection rates in the 5- to 18-year-old group than in the 6- to 59-month-old group for all three viral strains, and the seroconversion rate tended to be higher in the younger age group albeit statistically not significantly. These age differences may be closely re lated to differences in the immunity already obtained before vaccination.
Among all the subjects, seroprotection rates toward viruses H1N1, H3N2, and B were >70%; seroconversion rates for the three inactivated viruses in the vaccine were >40%; and the serum conversion factor for the three viral strains were >2.5.
5. Based on these results, it was confirmed that the immunogenicity was acceptable according to the CPMP standards (Table 2).
In conclusion, this study shows that the seroprotection rate, seroconversion rate, and GMT-of the vaccine under study toward influenza viruses H1N1, H3N2, and B-meet the CPMP criteria. There were no serious adverse events aside from local reactions and mild sys temic reactions such as fatigue and myalgia.
In the analysis of pre- and post-vaccination GMT of each viral strain by age of the participants, the H1N1 virus’ pre-vaccination GMTs were 20.0 and 72.0 (P=0.015), and post-vaccination GMTs were 134.5 and 219.3 (P=0.329), respectively.
In this study, the seroprotection rates toward viruses H1N1, H3N2, and B in the two age groups were in compliance with the CPMP standards (≥70%).
398). The serocon version rate for the H3N2 virus was 80.6% and 67.6%, respectively (P=0.620). The seroconversion rates for the influenza B virus were 74.
The seroconversion rate for the H1N1 virus was 42.1% in the primed group and 62.5% in the unprimed group (P=0.284). The seroconversion rates for the H3N2 virus were 71.
284). The seroconversion rates for the H3N2 virus were 71.9% and 100% (P=0.084), whereas the seroconversion rates for influenza B were 59.6% and 87.5%, respectively (P=0.126).
021). The seropro tection rates for the H3N2 virus were 87.7% and 100% (P=0.294), whereas the seroprotection rates for influ enza B were 89.5% and 87.2%, respectively (P=0.866).
021). The seroprotection rates toward the H3N2 virus were 83.9% and 94.1%, respectively (P=0.042). The seroprotection rates for influenza B virus were 83.
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