Immunogenicity and safety of a combined DTPa-IPV/Hib vaccine administered as a three-dose primary vaccination course in healthy Korean infants: phase III, randomized study

被引：4

作者：

Kim, Ki Hwan ^{[1
]}

Kim, Chun Soo ^{[2
]}

Kim, Hwang Min ^{[3
]}

Kim, Jong-Duck ^{[4
]}

Ma, Sang Hyuk ^{[5
]}

Kim, Dong Ho ^{[6
]}

Hwang, Pyoung-Han ^{[7
]}

Han, Ji-Whan ^{[8
]}

Lee, Taek-Jin ^{[9
]}

Kim, Joon Hyung ^{[10
]}

Karkada, Naveen ^{[11
]}

Mesaros, Narcisa ^{[11
]}

Sohn, Woo-Yun ^{[10
]}

Kim, Jong-Hyun ^{[12
]}

机构：

[1] Catholic Univ Korea Incheon, Coll Med, Incheon St Marys Hosp, Incheon, South Korea

[2] Keimyung Univ, Sch Med, Daegu, South Korea

[3] Yonsei Univ, Wonju Coll Med, Wonju, South Korea

[4] Wonkwang Univ Hosp, Iksan, South Korea

[5] Changwon Fatima Hosp, Chang Won, South Korea

[6] Korea Canc Ctr Hosp, Seoul, South Korea

[7] Chonbuk Natl Univ, Med Sch, Chonbuk Natl Univ Hosp, Jeonju, South Korea

[8] Catholic Univ Korea, Uijeongbu St Marys Hosp, Uijongbu, South Korea

[9] Bundang CHA Hosp, Seongnam, South Korea

[10] GSK, Seoul, South Korea

[11] GSK, Wavre, Belgium

[12] Catholic Univ Korea, St Vincents Hosp, Coll Med, Suwon, South Korea

来源：

HUMAN VACCINES & IMMUNOTHERAPEUTICS | 2019年 / 15卷 / 02期

关键词：

diphtheria; tetanus; acellular pertussis; poliovirus; Haemophilus influenzae type b; DTPa-IPV/Hib; immunogenicity; reactogenicity; safety; infants; INFLUENZAE TYPE-B; INACTIVATED POLIOVIRUS VACCINE; DIPHTHERIA-TETANUS-PERTUSSIS; TOXOID CONJUGATE VACCINE; ACELLULAR PERTUSSIS; COMBINATION VACCINE; HEPATITIS-B; PRIMARY IMMUNIZATION; IMMUNE-RESPONSES; MEASLES ANTIBODY;

D O I：

10.1080/21645515.2018.1536588

中图分类号：

Q81 [生物工程学（生物技术）]; Q93 [微生物学];

学科分类号：

071005 ; 0836 ; 090102 ; 100705 ;

摘要：

We assessed the immunogenicity and safety of a three-dose primary vaccination schedule with the combined diphtheria-tetanus-acellular pertussis-inactivated poliovirus/Haemophilus influenzae type b vaccine (DTPa-IPV/Hib) in Korean infants. In this phase III open-label, multicenter study (NCT01309646), healthy infants aged 42-69 days (randomized 1:1) received three doses of either pentavalent DTPa-IPV/Hib (DTPa-IPV/Hib group) or DTPa-IPV and Hib vaccines administered separately (DTPa-IPV+Hib group) at 2, 4, 6 months of age. The primary objective was to demonstrate non-inferiority of DTPa-IPV/Hib compared to DTPa-IPV+Hib vaccines in terms of immune responses to all vaccine antigens, 1 month post-dose 3. Solicited symptoms (local and general) were recorded during 4 days, and unsolicited adverse events (AEs) during 31 days, after each vaccination. Serious AEs (SAEs) were recorded throughout the study duration. The immunogenicity of the pentavalent DTPa-IPV/Hib vaccine was non-inferior compared to concomitant administration of DTPa-IPV+Hib vaccines. One month post-dose 3, nearly all infants had antibody levels above the seroprotective thresholds for anti-diphtheria toxoid, anti-tetanus toxoid, anti-polyribosyl-ribitol phosphate, and anti-poliovirus type 1, 2 and 3, and had antibody levels above the seropositive thresholds for anti-pertussis toxoid (PT), anti-filamentous hemagglutinin (FHA) and anti-pertactin (PRN) antibodies. A vaccine response for PT, FHA and PRN was observed in at least 96.7% of study participants. Anti-PRP geometric mean concentrations appeared lower for the DTPa-IPV/Hib group (8.456 mu g/mL) than for the DTPa-IPV+Hib group (18.700 mu g/mL). In both groups, the most common solicited symptoms were injection site redness and irritability. Fifty-seven SAEs were reported throughout the study; none were considered to be vaccination related.

引用

页码：317 / 326

页数：10

共 38 条

[1] Immunogenicity of routine vaccination against diphtheria, tetanus, and Haemophilus influenzae type b in Asian infants born in the United Kingdom [J].