A fully liquid diphtheria-tetanus-five component acellular pertussis-inactivated poliomyelitis-Haemophilus influenzae type b conjugate vaccine: immunogenicity and safety of primary vaccination in Taiwanese infants

Tzou Yien Lin, Ying Hsiang Wang, Luan Yin Chang, Yhu Chering Huang, Hsiu Tsun Kao, Pen Yi Lin, Hsiao Kuo Lu, Pascale Chavand, Esteban Ortiz

Research output: Contribution to journalArticle

13 Citations (Scopus)

Abstract

Objective: To assess the immunogenicity of a fully liquid diphtheria-tetanus-five component acellular pertussis-inactivated poliomyelitis-Haemophilus influenzae type b (DTaP-IPV-Hib) conjugate vaccine compared to DTaP-IPV and lyophilized Hib conjugate vaccines given simultaneously at separate sites as a three-dose primary vaccination in Taiwanese infants. Methods: Two hundred infants were randomized to receive either DTaP-IPV-Hib or DTaP-IPV plus Hib vaccine at 2, 4, and 6 months of age. Both combined vaccines contained the same five pertussis antigens: pertussis toxoid (PT), filamentous hemagglutinin (FHA), pertactin (PRN), fimbriae 2 and 3 (FIM 2&3). Antibody concentrations were measured before the first and after the third dose. Reactogenicity was evaluated from parental reports. All subjects received hepatitis B vaccine at 0, 1, and 6 months of age following the national vaccination schedule of Taiwan. Results: The immunogenicity after the third dose was high for each vaccine antigen in both groups, and the vaccines had low reactogenicity. Statistical analysis showed no differences in the immune responses to the fully liquid DTaP-IPV-Hib vaccine compared with those to the DTaP-IPV plus Hib control vaccines, notably the anti-PRP (polyribose ribitol phosphate capsular polysaccharide) response, with 97-99% of infants having concentrations ≥1.0 μg/mL. Approximately 95% of all infants developed seroprotective levels of anti-hepatitis B surface antigen (HBs) antibodies (≥10 mIU/mL). Conclusions: Both combination vaccines had similar high immunogenicity for each antigen, and both were well tolerated. Thus, inclusion of a Haemophilus influenzae type b conjugate vaccine in the combination did not result in clinically significant decrease in the PRP response or increase reactogenicity. The fully liquid pentavalent vaccine has the advantages of not requiring reconstitution and of administration as a single injection.

Original languageEnglish
Pages (from-to)129-136
Number of pages8
JournalInternational Journal of Infectious Diseases
Volume11
Issue number2
DOIs
Publication statusPublished - Mar 2007
Externally publishedYes

Fingerprint

Haemophilus influenzae type b
Vaccination
Vaccines
Safety
Combined Vaccines
Whooping Cough
Antigens
Hepatitis B Antibodies
Conjugate Vaccines
Hepatitis B Vaccines
Diphtheria
Antibodies
Tetanus
Hemagglutinins
Poliomyelitis
Hepatitis B Surface Antigens
Taiwan
Polysaccharides
Vaccine Immunogenicity
diphtheria-tetanus-five component acellular pertussis-inactivated poliomyelitis -Haemophilus influenzae type b conjugate vaccine

Keywords

  • Acellular pertussis
  • Fully liquid combination vaccine
  • Haemophilus influenzae type b
  • Pentavalent vaccine

ASJC Scopus subject areas

  • Microbiology (medical)
  • Infectious Diseases

Cite this

A fully liquid diphtheria-tetanus-five component acellular pertussis-inactivated poliomyelitis-Haemophilus influenzae type b conjugate vaccine : immunogenicity and safety of primary vaccination in Taiwanese infants. / Lin, Tzou Yien; Wang, Ying Hsiang; Chang, Luan Yin; Huang, Yhu Chering; Kao, Hsiu Tsun; Lin, Pen Yi; Lu, Hsiao Kuo; Chavand, Pascale; Ortiz, Esteban.

In: International Journal of Infectious Diseases, Vol. 11, No. 2, 03.2007, p. 129-136.

Research output: Contribution to journalArticle

Lin, Tzou Yien ; Wang, Ying Hsiang ; Chang, Luan Yin ; Huang, Yhu Chering ; Kao, Hsiu Tsun ; Lin, Pen Yi ; Lu, Hsiao Kuo ; Chavand, Pascale ; Ortiz, Esteban. / A fully liquid diphtheria-tetanus-five component acellular pertussis-inactivated poliomyelitis-Haemophilus influenzae type b conjugate vaccine : immunogenicity and safety of primary vaccination in Taiwanese infants. In: International Journal of Infectious Diseases. 2007 ; Vol. 11, No. 2. pp. 129-136.
@article{68de79400e584f3bbaafe358e5a7818f,
title = "A fully liquid diphtheria-tetanus-five component acellular pertussis-inactivated poliomyelitis-Haemophilus influenzae type b conjugate vaccine: immunogenicity and safety of primary vaccination in Taiwanese infants",
abstract = "Objective: To assess the immunogenicity of a fully liquid diphtheria-tetanus-five component acellular pertussis-inactivated poliomyelitis-Haemophilus influenzae type b (DTaP-IPV-Hib) conjugate vaccine compared to DTaP-IPV and lyophilized Hib conjugate vaccines given simultaneously at separate sites as a three-dose primary vaccination in Taiwanese infants. Methods: Two hundred infants were randomized to receive either DTaP-IPV-Hib or DTaP-IPV plus Hib vaccine at 2, 4, and 6 months of age. Both combined vaccines contained the same five pertussis antigens: pertussis toxoid (PT), filamentous hemagglutinin (FHA), pertactin (PRN), fimbriae 2 and 3 (FIM 2&3). Antibody concentrations were measured before the first and after the third dose. Reactogenicity was evaluated from parental reports. All subjects received hepatitis B vaccine at 0, 1, and 6 months of age following the national vaccination schedule of Taiwan. Results: The immunogenicity after the third dose was high for each vaccine antigen in both groups, and the vaccines had low reactogenicity. Statistical analysis showed no differences in the immune responses to the fully liquid DTaP-IPV-Hib vaccine compared with those to the DTaP-IPV plus Hib control vaccines, notably the anti-PRP (polyribose ribitol phosphate capsular polysaccharide) response, with 97-99{\%} of infants having concentrations ≥1.0 μg/mL. Approximately 95{\%} of all infants developed seroprotective levels of anti-hepatitis B surface antigen (HBs) antibodies (≥10 mIU/mL). Conclusions: Both combination vaccines had similar high immunogenicity for each antigen, and both were well tolerated. Thus, inclusion of a Haemophilus influenzae type b conjugate vaccine in the combination did not result in clinically significant decrease in the PRP response or increase reactogenicity. The fully liquid pentavalent vaccine has the advantages of not requiring reconstitution and of administration as a single injection.",
keywords = "Acellular pertussis, Fully liquid combination vaccine, Haemophilus influenzae type b, Pentavalent vaccine",
author = "Lin, {Tzou Yien} and Wang, {Ying Hsiang} and Chang, {Luan Yin} and Huang, {Yhu Chering} and Kao, {Hsiu Tsun} and Lin, {Pen Yi} and Lu, {Hsiao Kuo} and Pascale Chavand and Esteban Ortiz",
year = "2007",
month = "3",
doi = "10.1016/j.ijid.2005.10.014",
language = "English",
volume = "11",
pages = "129--136",
journal = "International Journal of Infectious Diseases",
issn = "1201-9712",
publisher = "Elsevier",
number = "2",

}

TY - JOUR

T1 - A fully liquid diphtheria-tetanus-five component acellular pertussis-inactivated poliomyelitis-Haemophilus influenzae type b conjugate vaccine

T2 - immunogenicity and safety of primary vaccination in Taiwanese infants

AU - Lin, Tzou Yien

AU - Wang, Ying Hsiang

AU - Chang, Luan Yin

AU - Huang, Yhu Chering

AU - Kao, Hsiu Tsun

AU - Lin, Pen Yi

AU - Lu, Hsiao Kuo

AU - Chavand, Pascale

AU - Ortiz, Esteban

PY - 2007/3

Y1 - 2007/3

N2 - Objective: To assess the immunogenicity of a fully liquid diphtheria-tetanus-five component acellular pertussis-inactivated poliomyelitis-Haemophilus influenzae type b (DTaP-IPV-Hib) conjugate vaccine compared to DTaP-IPV and lyophilized Hib conjugate vaccines given simultaneously at separate sites as a three-dose primary vaccination in Taiwanese infants. Methods: Two hundred infants were randomized to receive either DTaP-IPV-Hib or DTaP-IPV plus Hib vaccine at 2, 4, and 6 months of age. Both combined vaccines contained the same five pertussis antigens: pertussis toxoid (PT), filamentous hemagglutinin (FHA), pertactin (PRN), fimbriae 2 and 3 (FIM 2&3). Antibody concentrations were measured before the first and after the third dose. Reactogenicity was evaluated from parental reports. All subjects received hepatitis B vaccine at 0, 1, and 6 months of age following the national vaccination schedule of Taiwan. Results: The immunogenicity after the third dose was high for each vaccine antigen in both groups, and the vaccines had low reactogenicity. Statistical analysis showed no differences in the immune responses to the fully liquid DTaP-IPV-Hib vaccine compared with those to the DTaP-IPV plus Hib control vaccines, notably the anti-PRP (polyribose ribitol phosphate capsular polysaccharide) response, with 97-99% of infants having concentrations ≥1.0 μg/mL. Approximately 95% of all infants developed seroprotective levels of anti-hepatitis B surface antigen (HBs) antibodies (≥10 mIU/mL). Conclusions: Both combination vaccines had similar high immunogenicity for each antigen, and both were well tolerated. Thus, inclusion of a Haemophilus influenzae type b conjugate vaccine in the combination did not result in clinically significant decrease in the PRP response or increase reactogenicity. The fully liquid pentavalent vaccine has the advantages of not requiring reconstitution and of administration as a single injection.

AB - Objective: To assess the immunogenicity of a fully liquid diphtheria-tetanus-five component acellular pertussis-inactivated poliomyelitis-Haemophilus influenzae type b (DTaP-IPV-Hib) conjugate vaccine compared to DTaP-IPV and lyophilized Hib conjugate vaccines given simultaneously at separate sites as a three-dose primary vaccination in Taiwanese infants. Methods: Two hundred infants were randomized to receive either DTaP-IPV-Hib or DTaP-IPV plus Hib vaccine at 2, 4, and 6 months of age. Both combined vaccines contained the same five pertussis antigens: pertussis toxoid (PT), filamentous hemagglutinin (FHA), pertactin (PRN), fimbriae 2 and 3 (FIM 2&3). Antibody concentrations were measured before the first and after the third dose. Reactogenicity was evaluated from parental reports. All subjects received hepatitis B vaccine at 0, 1, and 6 months of age following the national vaccination schedule of Taiwan. Results: The immunogenicity after the third dose was high for each vaccine antigen in both groups, and the vaccines had low reactogenicity. Statistical analysis showed no differences in the immune responses to the fully liquid DTaP-IPV-Hib vaccine compared with those to the DTaP-IPV plus Hib control vaccines, notably the anti-PRP (polyribose ribitol phosphate capsular polysaccharide) response, with 97-99% of infants having concentrations ≥1.0 μg/mL. Approximately 95% of all infants developed seroprotective levels of anti-hepatitis B surface antigen (HBs) antibodies (≥10 mIU/mL). Conclusions: Both combination vaccines had similar high immunogenicity for each antigen, and both were well tolerated. Thus, inclusion of a Haemophilus influenzae type b conjugate vaccine in the combination did not result in clinically significant decrease in the PRP response or increase reactogenicity. The fully liquid pentavalent vaccine has the advantages of not requiring reconstitution and of administration as a single injection.

KW - Acellular pertussis

KW - Fully liquid combination vaccine

KW - Haemophilus influenzae type b

KW - Pentavalent vaccine

UR - http://www.scopus.com/inward/record.url?scp=33847201507&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=33847201507&partnerID=8YFLogxK

U2 - 10.1016/j.ijid.2005.10.014

DO - 10.1016/j.ijid.2005.10.014

M3 - Article

C2 - 16762579

AN - SCOPUS:33847201507

VL - 11

SP - 129

EP - 136

JO - International Journal of Infectious Diseases

JF - International Journal of Infectious Diseases

SN - 1201-9712

IS - 2

ER -