Safety and immunogenicity of a diphtheria, tetanus, acellular pertussis and Haemophilus influenzae Type b combination vaccine compared with separate administration of licensed equivalent vaccines in Chinese infants and toddlers for primary and booster immunization
To evaluate the safety and immunogenicity of a diphtheria, tetanus, acellular pertussis and Haemophilus infuenzae Type b (DTaP/Hib) combination vaccine first developed by a Chinese manufacturer, a randomized, two-stage, parallel controlled, single center clinical trial was conducted in Dafeng, Jiang...
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| Published in | Vaccine Vol. 28; no. 25; pp. 4215 - 4223 |
|---|---|
| Main Authors | , , , , , , , , , , , , , , , , , , , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
Kidlington
Elsevier Ltd
07.06.2010
Elsevier Elsevier Limited |
| Subjects | |
| Online Access | Get full text |
| ISSN | 0264-410X 1873-2518 1873-2518 |
| DOI | 10.1016/j.vaccine.2010.03.061 |
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| Abstract | To evaluate the safety and immunogenicity of a diphtheria, tetanus, acellular pertussis and
Haemophilus infuenzae Type b (DTaP/Hib) combination vaccine first developed by a Chinese manufacturer, a randomized, two-stage, parallel controlled, single center clinical trial was conducted in Dafeng, Jiangsu Province of China. A total of 720 infants were enrolled and randomly assigned to two groups with a 2:1 allocation. In Stage I, 480 subjects in Group T were administered with 3 doses of the DTaP/Hib vaccine at 3, 4 and 5 months of age, respectively, while 240 subjects in Group C received separate licensed DTaP vaccine and Hib conjugate vaccine on the same schedule. In Stage II, 633 primed toddlers (431 of Group T and 202 of Group C) were given a booster dose at 18 months of age. Sera samples were collected at pre-dose 1, 4 weeks post-dose 3, pre-dose 4 and 4 weeks post-dose 4, respectively. Levels of protective antibodies were measured by Enzyme Linked Immunoadsorbent Assay (ELISA). Immunogenicity was evaluated with regard to geometric mean concentrations (GMCs), seroconversion rates and seroprotection rates of the antibodies. Solicited adverse reactions were recorded for 3 days after each dose; unsolicited adverse events and serious adverse events were monitored for 28 days after vaccination. Results showed that seroconversion rates of anti-pertussis toxoid (PT), anti-filamentous hemagglutinin (FHA), anti-diphtheria toxoid (DT), anti-tetanus toxid (TT) and anti-polyribosyl-ribitol-phosphate (PRP) in Group T (Stage I: 98.06%, 97.33%, 100%, 100%, 98.79%; Stage II: 99.18%, 83.42%, 99.18%, 63.32%, 85.05%) were comparable to that of Group C (Stage I: 95.26%, 93.16%, 100%, 100%, 98.42%; Stage II: 98.89%, 83.89%, 98.33%, 53.89%, 76.67%). Nearly 100% of the subjects in both groups achieved seroprotective levels of anti-DT (≥0.1
IU/ml), anti-TT (≥0.1
IU/ml) and anti-PRP (≥0.15
μg/ml) after primary and booster vaccination. The frequencies of local induration, swelling and redness as well as general reactions such as fever, diarrhea and anaphylaxis were low and acceptable in both groups. In conclusion, the DTaP/Hib vaccine was demonstrated to be non-inferior to the control vaccines on safety and immunogenicity. There could be a bright future for the DTaP/Hib vaccine to be widely used in the universal vaccination of Chinese children. |
|---|---|
| AbstractList | To evaluate the safety and immunogenicity of a diphtheria, tetanus, acellular pertussis and Haemophilus infuenzae Type b (DTaP/Hib) combination vaccine first developed by a Chinese manufacturer, a randomized, two-stage, parallel controlled, single center clinical trial was conducted in Dafeng, Jiangsu Province of China. A total of 720 infants were enrolled and randomly assigned to two groups with a 2:1 allocation. In Stage I, 480 subjects in Group T were administered with 3 doses of the DTaP/Hib vaccine at 3, 4 and 5 months of age, respectively, while 240 subjects in Group C received separate licensed DTaP vaccine and Hib conjugate vaccine on the same schedule. In Stage II, 633 primed toddlers (431 of Group T and 202 of Group C) were given a booster dose at 18 months of age. Sera samples were collected at pre-dose 1, 4 weeks post-dose 3, pre-dose 4 and 4 weeks post-dose 4, respectively. Levels of protective antibodies were measured by Enzyme Linked Immunoadsorbent Assay (ELISA). Immunogenicity was evaluated with regard to geometric mean concentrations (GMCs), seroconversion rates and seroprotection rates of the antibodies. Solicited adverse reactions were recorded for 3 days after each dose; unsolicited adverse events and serious adverse events were monitored for 28 days after vaccination. Results showed that seroconversion rates of anti-pertussis toxoid (PT), anti-filamentous hemagglutinin (FHA), anti-diphtheria toxoid (DT), anti-tetanus toxid (TT) and anti-polyribosyl-ribitol-phosphate (PRP) in Group T (Stage I: 98.06%, 97.33%, 100%, 100%, 98.79%; Stage II: 99.18%, 83.42%, 99.18%, 63.32%, 85.05%) were comparable to that of Group C (Stage I: 95.26%, 93.16%, 100%, 100%, 98.42%; Stage II: 98.89%, 83.89%, 98.33%, 53.89%, 76.67%). Nearly 100% of the subjects in both groups achieved seroprotective levels of anti-DT (> or = 0.1IU/ml), anti-TT (> or = 0.1IU/ml) and anti-PRP (> or = 0.15 microg/ml) after primary and booster vaccination. The frequencies of local induration, swelling and redness as well as general reactions such as fever, diarrhea and anaphylaxis were low and acceptable in both groups. In conclusion, the DTaP/Hib vaccine was demonstrated to be non-inferior to the control vaccines on safety and immunogenicity. There could be a bright future for the DTaP/Hib vaccine to be widely used in the universal vaccination of Chinese children. To evaluate the safety and immunogenicity of a diphtheria, tetanus, acellular pertussis and Haemophilus infuenzae Type b (DTaP/Hib) combination vaccine first developed by a Chinese manufacturer, a randomized, two-stage, parallel controlled, single center clinical trial was conducted in Dafeng, Jiangsu Province of China. A total of 720 infants were enrolled and randomly assigned to two groups with a 2:1 allocation. In Stage I, 480 subjects in Group T were administered with 3 doses of the DTaP/Hib vaccine at 3, 4 and 5 months of age, respectively, while 240 subjects in Group C received separate licensed DTaP vaccine and Hib conjugate vaccine on the same schedule. In Stage II, 633 primed toddlers (431 of Group T and 202 of Group C) were given a booster dose at 18 months of age. Sera samples were collected at pre-dose 1, 4 weeks post-dose 3, pre-dose 4 and 4 weeks post-dose 4, respectively. Levels of protective antibodies were measured by Enzyme Linked Immunoadsorbent Assay (ELISA). Immunogenicity was evaluated with regard to geometric mean concentrations (GMCs), seroconversion rates and seroprotection rates of the antibodies. Solicited adverse reactions were recorded for 3 days after each dose; unsolicited adverse events and serious adverse events were monitored for 28 days after vaccination. Results showed that seroconversion rates of anti-pertussis toxoid (PT), anti-filamentous hemagglutinin (FHA), anti-diphtheria toxoid (DT), anti-tetanus toxid (TT) and anti-polyribosyl-ribitol-phosphate (PRP) in Group T (Stage I: 98.06%, 97.33%, 100%, 100%, 98.79%; Stage II: 99.18%, 83.42%, 99.18%, 63.32%, 85.05%) were comparable to that of Group C (Stage I: 95.26%, 93.16%, 100%, 100%, 98.42%; Stage II: 98.89%, 83.89%, 98.33%, 53.89%, 76.67%). Nearly 100% of the subjects in both groups achieved seroprotective levels of anti-DT (≥0.1 IU/ml), anti-TT (≥0.1 IU/ml) and anti-PRP (≥0.15 μg/ml) after primary and booster vaccination. The frequencies of local induration, swelling and redness as well as general reactions such as fever, diarrhea and anaphylaxis were low and acceptable in both groups. In conclusion, the DTaP/Hib vaccine was demonstrated to be non-inferior to the control vaccines on safety and immunogenicity. There could be a bright future for the DTaP/Hib vaccine to be widely used in the universal vaccination of Chinese children. To evaluate the safety and immunogenicity of a diphtheria, tetanus, acellular pertussis andHaemophilus infuenzaeType b (DTaP/Hib) combination vaccine first developed by a Chinese manufacturer, a randomized, two-stage, parallel controlled, single center clinical trial was conducted in Dafeng, Jiangsu Province of China. A total of 720 infants were enrolled and randomly assigned to two groups with a 2:1 allocation. In Stage I, 480 subjects in Group T were administered with 3 doses of the DTaP/Hib vaccine at 3, 4 and 5 months of age, respectively, while 240 subjects in Group C received separate licensed DTaP vaccine and Hib conjugate vaccine on the same schedule. In Stage II, 633 primed toddlers (431 of Group T and 202 of Group C) were given a booster dose at 18 months of age. Sera samples were collected at pre-dose 1, 4 weeks post-dose 3, pre-dose 4 and 4 weeks post-dose 4, respectively. Levels of protective antibodies were measured by Enzyme Linked Immunoadsorbent Assay (ELISA). Immunogenicity was evaluated with regard to geometric mean concentrations (GMCs), seroconversion rates and seroprotection rates of the antibodies. Solicited adverse reactions were recorded for 3 days after each dose; unsolicited adverse events and serious adverse events were monitored for 28 days after vaccination. Results showed that seroconversion rates of anti-pertussis toxoid (PT), anti-filamentous hemagglutinin (FHA), anti-diphtheria toxoid (DT), anti-tetanus toxid (TT) and anti-polyribosyl-ribitol-phosphate (PRP) in Group T (Stage I: 98.06%, 97.33%, 100%, 100%, 98.79%; Stage II: 99.18%, 83.42%, 99.18%, 63.32%, 85.05%) were comparable to that of Group C (Stage I: 95.26%, 93.16%, 100%, 100%, 98.42%; Stage II: 98.89%, 83.89%, 98.33%, 53.89%, 76.67%). Nearly 100% of the subjects in both groups achieved seroprotective levels of anti-DT (≥0.1IU/ml), anti-TT (≥0.1IU/ml) and anti-PRP (≥0.15μg/ml) after primary and booster vaccination. The frequencies of local induration, swelling and redness as well as general reactions such as fever, diarrhea and anaphylaxis were low and acceptable in both groups. In conclusion, the DTaP/Hib vaccine was demonstrated to be non-inferior to the control vaccines on safety and immunogenicity. There could be a bright future for the DTaP/Hib vaccine to be widely used in the universal vaccination of Chinese children. To evaluate the safety and immunogenicity of a diphtheria, tetanus, acellular pertussis and Haemophilus infuenzae Type b (DTaP/Hib) combination vaccine first developed by a Chinese manufacturer, a randomized, two-stage, parallel controlled, single center clinical trial was conducted in Dafeng, Jiangsu Province of China. A total of 720 infants were enrolled and randomly assigned to two groups with a 2:1 allocation. In Stage I, 480 subjects in Group T were administered with 3 doses of the DTaP/Hib vaccine at 3, 4 and 5 months of age, respectively, while 240 subjects in Group C received separate licensed DTaP vaccine and Hib conjugate vaccine on the same schedule. In Stage II, 633 primed toddlers (431 of Group T and 202 of Group C) were given a booster dose at 18 months of age. Sera samples were collected at pre-dose 1, 4 weeks post-dose 3, pre-dose 4 and 4 weeks post-dose 4, respectively. Levels of protective antibodies were measured by Enzyme Linked Immunoadsorbent Assay (ELISA). Immunogenicity was evaluated with regard to geometric mean concentrations (GMCs), seroconversion rates and seroprotection rates of the antibodies. Solicited adverse reactions were recorded for 3 days after each dose; unsolicited adverse events and serious adverse events were monitored for 28 days after vaccination. Results showed that seroconversion rates of anti-pertussis toxoid (PT), anti-filamentous hemagglutinin (FHA), anti-diphtheria toxoid (DT), anti-tetanus toxid (TT) and anti-polyribosyl-ribitol-phosphate (PRP) in Group T (Stage I: 98.06%, 97.33%, 100%, 100%, 98.79%; Stage II: 99.18%, 83.42%, 99.18%, 63.32%, 85.05%) were comparable to that of Group C (Stage I: 95.26%, 93.16%, 100%, 100%, 98.42%; Stage II: 98.89%, 83.89%, 98.33%, 53.89%, 76.67%). Nearly 100% of the subjects in both groups achieved seroprotective levels of anti-DT (> or = 0.1IU/ml), anti-TT (> or = 0.1IU/ml) and anti-PRP (> or = 0.15 microg/ml) after primary and booster vaccination. The frequencies of local induration, swelling and redness as well as general reactions such as fever, diarrhea and anaphylaxis were low and acceptable in both groups. In conclusion, the DTaP/Hib vaccine was demonstrated to be non-inferior to the control vaccines on safety and immunogenicity. There could be a bright future for the DTaP/Hib vaccine to be widely used in the universal vaccination of Chinese children.To evaluate the safety and immunogenicity of a diphtheria, tetanus, acellular pertussis and Haemophilus infuenzae Type b (DTaP/Hib) combination vaccine first developed by a Chinese manufacturer, a randomized, two-stage, parallel controlled, single center clinical trial was conducted in Dafeng, Jiangsu Province of China. A total of 720 infants were enrolled and randomly assigned to two groups with a 2:1 allocation. In Stage I, 480 subjects in Group T were administered with 3 doses of the DTaP/Hib vaccine at 3, 4 and 5 months of age, respectively, while 240 subjects in Group C received separate licensed DTaP vaccine and Hib conjugate vaccine on the same schedule. In Stage II, 633 primed toddlers (431 of Group T and 202 of Group C) were given a booster dose at 18 months of age. Sera samples were collected at pre-dose 1, 4 weeks post-dose 3, pre-dose 4 and 4 weeks post-dose 4, respectively. Levels of protective antibodies were measured by Enzyme Linked Immunoadsorbent Assay (ELISA). Immunogenicity was evaluated with regard to geometric mean concentrations (GMCs), seroconversion rates and seroprotection rates of the antibodies. Solicited adverse reactions were recorded for 3 days after each dose; unsolicited adverse events and serious adverse events were monitored for 28 days after vaccination. Results showed that seroconversion rates of anti-pertussis toxoid (PT), anti-filamentous hemagglutinin (FHA), anti-diphtheria toxoid (DT), anti-tetanus toxid (TT) and anti-polyribosyl-ribitol-phosphate (PRP) in Group T (Stage I: 98.06%, 97.33%, 100%, 100%, 98.79%; Stage II: 99.18%, 83.42%, 99.18%, 63.32%, 85.05%) were comparable to that of Group C (Stage I: 95.26%, 93.16%, 100%, 100%, 98.42%; Stage II: 98.89%, 83.89%, 98.33%, 53.89%, 76.67%). Nearly 100% of the subjects in both groups achieved seroprotective levels of anti-DT (> or = 0.1IU/ml), anti-TT (> or = 0.1IU/ml) and anti-PRP (> or = 0.15 microg/ml) after primary and booster vaccination. The frequencies of local induration, swelling and redness as well as general reactions such as fever, diarrhea and anaphylaxis were low and acceptable in both groups. In conclusion, the DTaP/Hib vaccine was demonstrated to be non-inferior to the control vaccines on safety and immunogenicity. There could be a bright future for the DTaP/Hib vaccine to be widely used in the universal vaccination of Chinese children. Abstract To evaluate the safety and immunogenicity of a diphtheria, tetanus, acellular pertussis and Haemophilus infuenzae Type b (DTaP/Hib) combination vaccine first developed by a Chinese manufacturer, a randomized, two-stage, parallel controlled, single center clinical trial was conducted in Dafeng, Jiangsu Province of China. A total of 720 infants were enrolled and randomly assigned to two groups with a 2:1 allocation. In Stage I, 480 subjects in Group T were administered with 3 doses of the DTaP/Hib vaccine at 3, 4 and 5 months of age, respectively, while 240 subjects in Group C received separate licensed DTaP vaccine and Hib conjugate vaccine on the same schedule. In Stage II, 633 primed toddlers (431 of Group T and 202 of Group C) were given a booster dose at 18 months of age. Sera samples were collected at pre-dose 1, 4 weeks post-dose 3, pre-dose 4 and 4 weeks post-dose 4, respectively. Levels of protective antibodies were measured by Enzyme Linked Immunoadsorbent Assay (ELISA). Immunogenicity was evaluated with regard to geometric mean concentrations (GMCs), seroconversion rates and seroprotection rates of the antibodies. Solicited adverse reactions were recorded for 3 days after each dose; unsolicited adverse events and serious adverse events were monitored for 28 days after vaccination. Results showed that seroconversion rates of anti-pertussis toxoid (PT), anti-filamentous hemagglutinin (FHA), anti-diphtheria toxoid (DT), anti-tetanus toxid (TT) and anti-polyribosyl-ribitol-phosphate (PRP) in Group T (Stage I: 98.06%, 97.33%, 100%, 100%, 98.79%; Stage II: 99.18%, 83.42%, 99.18%, 63.32%, 85.05%) were comparable to that of Group C (Stage I: 95.26%, 93.16%, 100%, 100%, 98.42%; Stage II: 98.89%, 83.89%, 98.33%, 53.89%, 76.67%). Nearly 100% of the subjects in both groups achieved seroprotective levels of anti-DT (≥0.1 IU/ml), anti-TT (≥0.1 IU/ml) and anti-PRP (≥0.15 μg/ml) after primary and booster vaccination. The frequencies of local induration, swelling and redness as well as general reactions such as fever, diarrhea and anaphylaxis were low and acceptable in both groups. In conclusion, the DTaP/Hib vaccine was demonstrated to be non-inferior to the control vaccines on safety and immunogenicity. There could be a bright future for the DTaP/Hib vaccine to be widely used in the universal vaccination of Chinese children. To evaluate the safety and immunogenicity of a diphtheria, tetanus, acellular pertussis and Haemophilus infuenzae Type b (DTaP/Hib) combination vaccine first developed by a Chinese manufacturer, a randomized, two-stage, parallel controlled, single center clinical trial was conducted in Dafeng, Jiangsu Province of China. A total of 720 infants were enrolled and randomly assigned to two groups with a 2:1 allocation. In Stage I, 480 subjects in Group T were administered with 3 doses of the DTaP/Hib vaccine at 3, 4 and 5 months of age, respectively, while 240 subjects in Group C received separate licensed DTaP vaccine and Hib conjugate vaccine on the same schedule. In Stage, 633 primed toddlers (431 of Group T and 202 of Group C) were given a booster dose at 18 months of age. Sera samples were collected at pre-dose 1, 4 weeks post-dose 3, pre-dose 4 and 4 weeks post-dose 4, respectively. Levels of protective antibodies were measured by Enzyme Linked Immunoadsorbent Assay (ELISA). Immunogenicity was evaluated with regard to geometric mean concentrations (GMCs), seroconversion rates and seroprotection rates of the antibodies. Solicited adverse reactions were recorded for 3 days after each dose; unsolicited adverse events and serious adverse events were monitored for 28 days after vaccination. Results showed that seroconversion rates of anti-pertussis toxoid (PT), anti-filamentous hemagglutinin (FHA), anti-diphtheria toxoid (DT), anti-tetanus toxid (TT) and anti-polyribosyl-ribitol-phosphate (PRP) in Group T (Stage I: 98.06%, 97.33%, 100%, 100%, 98.79%; Stage II: 99.18%, 83.42%, 99.18%, 63.32%, 85.05%) were comparable to that of Group C (Stage I: 95.26%, 93.16%, 100%, 100%, 98.42%; Stage II: 98.89%, 83.89%, 98.33%, 53.89%, 76.67%). Nearly 100% of the subjects in both groups achieved seroprotective levels of anti-DT (>=0.1 IU/ml), anti-TT (>=0.1 IU/ml) and anti-PRP (>=0.15 [micro]g/ml) after primary and booster vaccination. The frequencies of local induration, swelling and redness as well as general reactions such as fever, diarrhea and anaphylaxis were low and acceptable in both groups. In conclusion, the DTaP/Hib vaccine was demonstrated to be non-inferior to the control vaccines on safety and immunogenicity. There could be a bright future for the DTaP/Hib vaccine to be widely used in the universal vaccination of Chinese children. |
| Author | Zhang, Huajie Meng, Fanyue Qin, Chengkui Liu, Aimin Li, Fengxiang Wei, Wenjin Li, Guifan Tan, Yajun Li, Yanan Zheng, Haifa Hou, Qiming Li, Hong Liu, Jiankai Liang, Qi Xu, Yinghua Ye, Qiang Wang, Lichan Zhou, Weizhong Zhang, Shumin Zhu, Fengcai Tao, Wenjian Wang, Hua Ruan, Chengmai Ma, Xiao |
| Author_xml | – sequence: 1 givenname: Guifan surname: Li fullname: Li, Guifan organization: Beijing Minhai Biotechnology Co. Ltd., Beijing, China – sequence: 2 givenname: Huajie surname: Zhang fullname: Zhang, Huajie organization: Serum Division, National Institute for the Control of Pharmaceutical and Biological Products, Tiantan Xili No. 2, Beijing 100050, China – sequence: 3 givenname: Weizhong surname: Zhou fullname: Zhou, Weizhong organization: Jiangsu Provincial Center for Disease Control and Prevention, 172 Jiangsu Road, Nanjing, Jiangsu Province 21009, China – sequence: 4 givenname: Qiang surname: Ye fullname: Ye, Qiang organization: Serum Division, National Institute for the Control of Pharmaceutical and Biological Products, Tiantan Xili No. 2, Beijing 100050, China – sequence: 5 givenname: Fengxiang surname: Li fullname: Li, Fengxiang organization: Serum Division, National Institute for the Control of Pharmaceutical and Biological Products, Tiantan Xili No. 2, Beijing 100050, China – sequence: 6 givenname: Hua surname: Wang fullname: Wang, Hua organization: Jiangsu Provincial Center for Disease Control and Prevention, 172 Jiangsu Road, Nanjing, Jiangsu Province 21009, China – sequence: 7 givenname: Qiming surname: Hou fullname: Hou, Qiming organization: Serum Division, National Institute for the Control of Pharmaceutical and Biological Products, Tiantan Xili No. 2, Beijing 100050, China – sequence: 8 givenname: Yinghua surname: Xu fullname: Xu, Yinghua organization: Serum Division, National Institute for the Control of Pharmaceutical and Biological Products, Tiantan Xili No. 2, Beijing 100050, China – sequence: 9 givenname: Xiao surname: Ma fullname: Ma, Xiao organization: Serum Division, National Institute for the Control of Pharmaceutical and Biological Products, Tiantan Xili No. 2, Beijing 100050, China – sequence: 10 givenname: Yajun surname: Tan fullname: Tan, Yajun organization: Serum Division, National Institute for the Control of Pharmaceutical and Biological Products, Tiantan Xili No. 2, Beijing 100050, China – sequence: 11 givenname: Lichan surname: Wang fullname: Wang, Lichan organization: Serum Division, National Institute for the Control of Pharmaceutical and Biological Products, Tiantan Xili No. 2, Beijing 100050, China – sequence: 12 givenname: Yanan surname: Li fullname: Li, Yanan organization: Serum Division, National Institute for the Control of Pharmaceutical and Biological Products, Tiantan Xili No. 2, Beijing 100050, China – sequence: 13 givenname: Hong surname: Li fullname: Li, Hong organization: Serum Division, National Institute for the Control of Pharmaceutical and Biological Products, Tiantan Xili No. 2, Beijing 100050, China – sequence: 14 givenname: Fanyue surname: Meng fullname: Meng, Fanyue organization: Jiangsu Provincial Center for Disease Control and Prevention, 172 Jiangsu Road, Nanjing, Jiangsu Province 21009, China – sequence: 15 givenname: Qi surname: Liang fullname: Liang, Qi organization: Jiangsu Provincial Center for Disease Control and Prevention, 172 Jiangsu Road, Nanjing, Jiangsu Province 21009, China – sequence: 16 givenname: Aimin surname: Liu fullname: Liu, Aimin organization: Dafeng Municipal Center for Disease Control and Prevention, Dafeng, Jiangsu Province, China – sequence: 17 givenname: Chengkui surname: Qin fullname: Qin, Chengkui organization: Dafeng Municipal Center for Disease Control and Prevention, Dafeng, Jiangsu Province, China – sequence: 18 givenname: Wenjin surname: Wei fullname: Wei, Wenjin organization: Beijing Minhai Biotechnology Co. Ltd., Beijing, China – sequence: 19 givenname: Jiankai surname: Liu fullname: Liu, Jiankai organization: Beijing Minhai Biotechnology Co. Ltd., Beijing, China – sequence: 20 givenname: Chengmai surname: Ruan fullname: Ruan, Chengmai organization: Beijing Minhai Biotechnology Co. Ltd., Beijing, China – sequence: 21 givenname: Wenjian surname: Tao fullname: Tao, Wenjian organization: Beijing Minhai Biotechnology Co. Ltd., Beijing, China – sequence: 22 givenname: Shumin surname: Zhang fullname: Zhang, Shumin email: zhangsmo@hotmail.com organization: Serum Division, National Institute for the Control of Pharmaceutical and Biological Products, Tiantan Xili No. 2, Beijing 100050, China – sequence: 23 givenname: Haifa surname: Zheng fullname: Zheng, Haifa email: zhf1964@263.net organization: Beijing Minhai Biotechnology Co. Ltd., Beijing, China – sequence: 24 givenname: Fengcai surname: Zhu fullname: Zhu, Fengcai email: jszfc@vip.sina.com organization: Jiangsu Provincial Center for Disease Control and Prevention, 172 Jiangsu Road, Nanjing, Jiangsu Province 21009, China |
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| CODEN | VACCDE |
| CitedBy_id | crossref_primary_10_1080_21645515_2021_2021711 crossref_primary_10_3390_vaccines10010047 crossref_primary_10_1136_bmjopen_2021_053316 crossref_primary_10_1080_21645515_2016_1239670 crossref_primary_10_1080_21645515_2015_1033592 |
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| ContentType | Journal Article |
| Copyright | 2010 Elsevier Ltd Elsevier Ltd 2015 INIST-CNRS Copyright 2010 Elsevier Ltd. All rights reserved. Copyright Elsevier Limited Jun 7, 2010 Copyright 2010 Elsevier Ltd. All rights reserved. |
| Copyright_xml | – notice: 2010 Elsevier Ltd – notice: Elsevier Ltd – notice: 2015 INIST-CNRS – notice: Copyright 2010 Elsevier Ltd. All rights reserved. – notice: Copyright Elsevier Limited Jun 7, 2010 – notice: Copyright 2010 Elsevier Ltd. All rights reserved. |
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| DOI | 10.1016/j.vaccine.2010.03.061 |
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| Keywords | Combination vaccine Safety Immunogenicity DTaP/Hib Human Immunization Booster vaccination Infant Vaccine Diphtheria Haemophilus influenzae Infection Pasteurellaceae Bacteriosis Bacteria Tetanus |
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| Snippet | To evaluate the safety and immunogenicity of a diphtheria, tetanus, acellular pertussis and
Haemophilus infuenzae Type b (DTaP/Hib) combination vaccine first... Abstract To evaluate the safety and immunogenicity of a diphtheria, tetanus, acellular pertussis and Haemophilus infuenzae Type b (DTaP/Hib) combination... To evaluate the safety and immunogenicity of a diphtheria, tetanus, acellular pertussis and Haemophilus infuenzae Type b (DTaP/Hib) combination vaccine first... To evaluate the safety and immunogenicity of a diphtheria, tetanus, acellular pertussis andHaemophilus infuenzaeType b (DTaP/Hib) combination vaccine first... |
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| SubjectTerms | Age Allergy and Immunology Anaphylaxis Antibodies, Bacterial - blood Antibody Formation Applied microbiology Bacterial diseases Bacteriology Biological and medical sciences China - epidemiology Clinical trials Combination vaccine Diarrhea Diphtheria Diphtheria-Tetanus-Pertussis Vaccine - adverse effects Diphtheria-Tetanus-Pertussis Vaccine - immunology Disease DTaP/Hib Ent and stomatologic bacterial diseases Female Fever Fundamental and applied biological sciences. Psychology Haemophilus Infections - epidemiology Haemophilus Infections - prevention & control Haemophilus influenzae Haemophilus Vaccines - adverse effects Haemophilus Vaccines - immunology Human bacterial diseases Humans Immunization Immunization, Secondary Immunogenicity Infant Infants Infectious diseases Licenses Male Medical sciences Microbiology Miscellaneous Premature birth Safety Tetanus Vaccines Vaccines, antisera, therapeutical immunoglobulins and monoclonal antibodies (general aspects) Vaccines, Conjugate - immunology |
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| Title | Safety and immunogenicity of a diphtheria, tetanus, acellular pertussis and Haemophilus influenzae Type b combination vaccine compared with separate administration of licensed equivalent vaccines in Chinese infants and toddlers for primary and booster immunization |
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