Immunogenicity and safety of 10-valent pneumococcal non-typeable Haemophilus influenzae protein D-conjugate vaccine (PHiD-CV) co-administered with routine childhood vaccines in Taiwan

Tzou Yien Lin, Chun Yi Lu, Luan Yin Chang, Cheng Hsun Chiu, Yhu Chering Huang, Hans L. Bock, Haiwen Tang, Nancy François, Marta Moreira, Lode Schuerman, Li Min Huang

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Abstract

Background/Purpose: The immunogenicity and safety of the 10-valent pneumococcal nontypeable Haemophilus influenzae (H. Influenzae) protein D conjugate vaccine (PHiD-CV), co-administered with routine childhood vaccines, were assessed in Taiwanese infants. Methods: In this open study, 230 healthy infants were primed with three doses of PHiD-CV (Synflorix) and diphtheria, tetanus, acellular pertussis, hepatitis B (HBV), inactivated poliomyelitis and Haemophilus influenzae type b (Hib) conjugate vaccine (DTPa-HBV-IPV/Hib vaccine) at 1.5, 3 and 6 months of age and two doses of oral human rotavirus vaccine at 1.5 and 3 months. Pneumococcal immune responses were assessed 1 month post-dose three, by 22F-inhibition ELISA and opsonophagocytic activity (OPA) assay. Local and general solicited/unsolicited symptoms and serious adverse events (SAEs) were recorded. Results: At least 95.4% of participants had an antibody concentration ≥0.2 μg/mL against each vaccine serotype. At least 96.1% of participants had an OPA titer ≥8 against each vaccine serotype except 6B (87.3%). All infants, but one, were seropositive for antibodies against nontypeable H. influenzae protein D. Immune responses to the co-administered vaccines were good and in line with previous reports. PHiD-CV was well tolerated, with low (≤6.3%) incidences of grade 3 solicited local symptoms. The frequencies of general symptoms were in line with other pneumococcal conjugate vaccine studies. There were no systematic increases in incidences of solicited general or local symptoms with successive doses. There were no reports of grade 3 fever (rectal temperature > 40 °C) or SAEs considered to be causally related to vaccination. Conclusion: PHiD-CV co-administered with routine childhood vaccines within the first 6 months of life, was highly immunogenic, and well tolerated in Taiwanese infants.

Original languageEnglish
Pages (from-to)495-503
Number of pages9
JournalJournal of the Formosan Medical Association
Volume111
Issue number9
DOIs
Publication statusPublished - Sep 2012
Externally publishedYes

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Conjugate Vaccines
Taiwan
Vaccines
Safety
Haemophilus influenzae type b
Haemophilus Vaccines
Rotavirus Vaccines
Pneumococcal Vaccines
Diphtheria
Antibodies
Whooping Cough
Incidence
Tetanus
Poliomyelitis
Hepatitis B
Vaccination
Fever
Enzyme-Linked Immunosorbent Assay
Haemophilus influenzae glpQ protein
Temperature

Keywords

  • Antibody response
  • Pneumococcal conjugate vaccine
  • Safety
  • Taiwan

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Immunogenicity and safety of 10-valent pneumococcal non-typeable Haemophilus influenzae protein D-conjugate vaccine (PHiD-CV) co-administered with routine childhood vaccines in Taiwan. / Lin, Tzou Yien; Lu, Chun Yi; Chang, Luan Yin; Chiu, Cheng Hsun; Huang, Yhu Chering; Bock, Hans L.; Tang, Haiwen; François, Nancy; Moreira, Marta; Schuerman, Lode; Huang, Li Min.

In: Journal of the Formosan Medical Association, Vol. 111, No. 9, 09.2012, p. 495-503.

Research output: Contribution to journalArticle

Lin, Tzou Yien ; Lu, Chun Yi ; Chang, Luan Yin ; Chiu, Cheng Hsun ; Huang, Yhu Chering ; Bock, Hans L. ; Tang, Haiwen ; François, Nancy ; Moreira, Marta ; Schuerman, Lode ; Huang, Li Min. / Immunogenicity and safety of 10-valent pneumococcal non-typeable Haemophilus influenzae protein D-conjugate vaccine (PHiD-CV) co-administered with routine childhood vaccines in Taiwan. In: Journal of the Formosan Medical Association. 2012 ; Vol. 111, No. 9. pp. 495-503.
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abstract = "Background/Purpose: The immunogenicity and safety of the 10-valent pneumococcal nontypeable Haemophilus influenzae (H. Influenzae) protein D conjugate vaccine (PHiD-CV), co-administered with routine childhood vaccines, were assessed in Taiwanese infants. Methods: In this open study, 230 healthy infants were primed with three doses of PHiD-CV (Synflorix) and diphtheria, tetanus, acellular pertussis, hepatitis B (HBV), inactivated poliomyelitis and Haemophilus influenzae type b (Hib) conjugate vaccine (DTPa-HBV-IPV/Hib vaccine) at 1.5, 3 and 6 months of age and two doses of oral human rotavirus vaccine at 1.5 and 3 months. Pneumococcal immune responses were assessed 1 month post-dose three, by 22F-inhibition ELISA and opsonophagocytic activity (OPA) assay. Local and general solicited/unsolicited symptoms and serious adverse events (SAEs) were recorded. Results: At least 95.4{\%} of participants had an antibody concentration ≥0.2 μg/mL against each vaccine serotype. At least 96.1{\%} of participants had an OPA titer ≥8 against each vaccine serotype except 6B (87.3{\%}). All infants, but one, were seropositive for antibodies against nontypeable H. influenzae protein D. Immune responses to the co-administered vaccines were good and in line with previous reports. PHiD-CV was well tolerated, with low (≤6.3{\%}) incidences of grade 3 solicited local symptoms. The frequencies of general symptoms were in line with other pneumococcal conjugate vaccine studies. There were no systematic increases in incidences of solicited general or local symptoms with successive doses. There were no reports of grade 3 fever (rectal temperature > 40 °C) or SAEs considered to be causally related to vaccination. Conclusion: PHiD-CV co-administered with routine childhood vaccines within the first 6 months of life, was highly immunogenic, and well tolerated in Taiwanese infants.",
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AU - Lu, Chun Yi

AU - Chang, Luan Yin

AU - Chiu, Cheng Hsun

AU - Huang, Yhu Chering

AU - Bock, Hans L.

AU - Tang, Haiwen

AU - François, Nancy

AU - Moreira, Marta

AU - Schuerman, Lode

AU - Huang, Li Min

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N2 - Background/Purpose: The immunogenicity and safety of the 10-valent pneumococcal nontypeable Haemophilus influenzae (H. Influenzae) protein D conjugate vaccine (PHiD-CV), co-administered with routine childhood vaccines, were assessed in Taiwanese infants. Methods: In this open study, 230 healthy infants were primed with three doses of PHiD-CV (Synflorix) and diphtheria, tetanus, acellular pertussis, hepatitis B (HBV), inactivated poliomyelitis and Haemophilus influenzae type b (Hib) conjugate vaccine (DTPa-HBV-IPV/Hib vaccine) at 1.5, 3 and 6 months of age and two doses of oral human rotavirus vaccine at 1.5 and 3 months. Pneumococcal immune responses were assessed 1 month post-dose three, by 22F-inhibition ELISA and opsonophagocytic activity (OPA) assay. Local and general solicited/unsolicited symptoms and serious adverse events (SAEs) were recorded. Results: At least 95.4% of participants had an antibody concentration ≥0.2 μg/mL against each vaccine serotype. At least 96.1% of participants had an OPA titer ≥8 against each vaccine serotype except 6B (87.3%). All infants, but one, were seropositive for antibodies against nontypeable H. influenzae protein D. Immune responses to the co-administered vaccines were good and in line with previous reports. PHiD-CV was well tolerated, with low (≤6.3%) incidences of grade 3 solicited local symptoms. The frequencies of general symptoms were in line with other pneumococcal conjugate vaccine studies. There were no systematic increases in incidences of solicited general or local symptoms with successive doses. There were no reports of grade 3 fever (rectal temperature > 40 °C) or SAEs considered to be causally related to vaccination. Conclusion: PHiD-CV co-administered with routine childhood vaccines within the first 6 months of life, was highly immunogenic, and well tolerated in Taiwanese infants.

AB - Background/Purpose: The immunogenicity and safety of the 10-valent pneumococcal nontypeable Haemophilus influenzae (H. Influenzae) protein D conjugate vaccine (PHiD-CV), co-administered with routine childhood vaccines, were assessed in Taiwanese infants. Methods: In this open study, 230 healthy infants were primed with three doses of PHiD-CV (Synflorix) and diphtheria, tetanus, acellular pertussis, hepatitis B (HBV), inactivated poliomyelitis and Haemophilus influenzae type b (Hib) conjugate vaccine (DTPa-HBV-IPV/Hib vaccine) at 1.5, 3 and 6 months of age and two doses of oral human rotavirus vaccine at 1.5 and 3 months. Pneumococcal immune responses were assessed 1 month post-dose three, by 22F-inhibition ELISA and opsonophagocytic activity (OPA) assay. Local and general solicited/unsolicited symptoms and serious adverse events (SAEs) were recorded. Results: At least 95.4% of participants had an antibody concentration ≥0.2 μg/mL against each vaccine serotype. At least 96.1% of participants had an OPA titer ≥8 against each vaccine serotype except 6B (87.3%). All infants, but one, were seropositive for antibodies against nontypeable H. influenzae protein D. Immune responses to the co-administered vaccines were good and in line with previous reports. PHiD-CV was well tolerated, with low (≤6.3%) incidences of grade 3 solicited local symptoms. The frequencies of general symptoms were in line with other pneumococcal conjugate vaccine studies. There were no systematic increases in incidences of solicited general or local symptoms with successive doses. There were no reports of grade 3 fever (rectal temperature > 40 °C) or SAEs considered to be causally related to vaccination. Conclusion: PHiD-CV co-administered with routine childhood vaccines within the first 6 months of life, was highly immunogenic, and well tolerated in Taiwanese infants.

KW - Antibody response

KW - Pneumococcal conjugate vaccine

KW - Safety

KW - Taiwan

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