[Heptavalent pneumococcal conjugate vaccine immunogenicity and safety in Japanese infants: primary and booster immunization results].

Takehiro Togashi, Satoshi Iwata, Toshiro Tango, William C. Gruber

Research output: Contribution to journalArticle

Abstract

A phase II clinical trial designed as a multicenter open study with 30 participating institutions in Japan was conducted in 167 of 181 infants aged 2 to 6 months to evaluate heptavalent pneumococcal conjugate vaccine (7vPnCV) immunogenicity and safety. From September 22, 2004, to September 16, 2006, of 181 infants registered 167 meeting inclusion criteria were include in the immunogenicity analysis. Among the subjects include in the immunogenicity analysis after primary immunization (3 doses), the percentage with IgG antibody levels of at least 0.5 g/mL--a primary endpoint of this study--was 94.6% or higher. In the same cohort after the booster immunization (dose 4), the percentage was 96.0% or higher. Serious adverse event whose causal relationship to 7vPnCV vaccination could not be ruled out were fever of 38 degrees C and urticaria in 1 each subject, in whom the study was thus discontinued prematurely. Major adverse systemic postvaccination events were fever, irritability and somnolence. Major local adverse events were redness, swelling or induration, and pain. All adverse events were transient and recovered spontaneously. The vaccine's immunogenicity and safety profile are therefore favorable following primary and booster immunization and compatible with those reported in overseas studies. 7vPnCV is expected to show the safety and efficacy similar to that in other countries and to reduce pneumococcal disease in Japan.

Original languageEnglish
Pages (from-to)42-48
Number of pages7
JournalKansenshōgaku zasshi. The Journal of the Japanese Association for Infectious Diseases
Volume85
Issue number1
Publication statusPublished - 2011 Jan
Externally publishedYes

Fingerprint

Secondary Immunization
Safety
Japan
Fever
Phase II Clinical Trials
Urticaria
Multicenter Studies
Immunization
Vaccination
Immunoglobulin G
Pain
Antibodies
Heptavalent Pneumococcal Conjugate Vaccine
Vaccine Immunogenicity

ASJC Scopus subject areas

  • Medicine(all)

Cite this

[Heptavalent pneumococcal conjugate vaccine immunogenicity and safety in Japanese infants : primary and booster immunization results]. / Togashi, Takehiro; Iwata, Satoshi; Tango, Toshiro; Gruber, William C.

In: Kansenshōgaku zasshi. The Journal of the Japanese Association for Infectious Diseases, Vol. 85, No. 1, 01.2011, p. 42-48.

Research output: Contribution to journalArticle

@article{06cd1ebba3294284bb6763e3947fa1e7,
title = "[Heptavalent pneumococcal conjugate vaccine immunogenicity and safety in Japanese infants: primary and booster immunization results].",
abstract = "A phase II clinical trial designed as a multicenter open study with 30 participating institutions in Japan was conducted in 167 of 181 infants aged 2 to 6 months to evaluate heptavalent pneumococcal conjugate vaccine (7vPnCV) immunogenicity and safety. From September 22, 2004, to September 16, 2006, of 181 infants registered 167 meeting inclusion criteria were include in the immunogenicity analysis. Among the subjects include in the immunogenicity analysis after primary immunization (3 doses), the percentage with IgG antibody levels of at least 0.5 g/mL--a primary endpoint of this study--was 94.6{\%} or higher. In the same cohort after the booster immunization (dose 4), the percentage was 96.0{\%} or higher. Serious adverse event whose causal relationship to 7vPnCV vaccination could not be ruled out were fever of 38 degrees C and urticaria in 1 each subject, in whom the study was thus discontinued prematurely. Major adverse systemic postvaccination events were fever, irritability and somnolence. Major local adverse events were redness, swelling or induration, and pain. All adverse events were transient and recovered spontaneously. The vaccine's immunogenicity and safety profile are therefore favorable following primary and booster immunization and compatible with those reported in overseas studies. 7vPnCV is expected to show the safety and efficacy similar to that in other countries and to reduce pneumococcal disease in Japan.",
author = "Takehiro Togashi and Satoshi Iwata and Toshiro Tango and Gruber, {William C.}",
year = "2011",
month = "1",
language = "English",
volume = "85",
pages = "42--48",
journal = "Nippon Densenbyo Gakkai zasshi",
issn = "0387-5911",
publisher = "Nihon Kansensho Gakkai",
number = "1",

}

TY - JOUR

T1 - [Heptavalent pneumococcal conjugate vaccine immunogenicity and safety in Japanese infants

T2 - primary and booster immunization results].

AU - Togashi, Takehiro

AU - Iwata, Satoshi

AU - Tango, Toshiro

AU - Gruber, William C.

PY - 2011/1

Y1 - 2011/1

N2 - A phase II clinical trial designed as a multicenter open study with 30 participating institutions in Japan was conducted in 167 of 181 infants aged 2 to 6 months to evaluate heptavalent pneumococcal conjugate vaccine (7vPnCV) immunogenicity and safety. From September 22, 2004, to September 16, 2006, of 181 infants registered 167 meeting inclusion criteria were include in the immunogenicity analysis. Among the subjects include in the immunogenicity analysis after primary immunization (3 doses), the percentage with IgG antibody levels of at least 0.5 g/mL--a primary endpoint of this study--was 94.6% or higher. In the same cohort after the booster immunization (dose 4), the percentage was 96.0% or higher. Serious adverse event whose causal relationship to 7vPnCV vaccination could not be ruled out were fever of 38 degrees C and urticaria in 1 each subject, in whom the study was thus discontinued prematurely. Major adverse systemic postvaccination events were fever, irritability and somnolence. Major local adverse events were redness, swelling or induration, and pain. All adverse events were transient and recovered spontaneously. The vaccine's immunogenicity and safety profile are therefore favorable following primary and booster immunization and compatible with those reported in overseas studies. 7vPnCV is expected to show the safety and efficacy similar to that in other countries and to reduce pneumococcal disease in Japan.

AB - A phase II clinical trial designed as a multicenter open study with 30 participating institutions in Japan was conducted in 167 of 181 infants aged 2 to 6 months to evaluate heptavalent pneumococcal conjugate vaccine (7vPnCV) immunogenicity and safety. From September 22, 2004, to September 16, 2006, of 181 infants registered 167 meeting inclusion criteria were include in the immunogenicity analysis. Among the subjects include in the immunogenicity analysis after primary immunization (3 doses), the percentage with IgG antibody levels of at least 0.5 g/mL--a primary endpoint of this study--was 94.6% or higher. In the same cohort after the booster immunization (dose 4), the percentage was 96.0% or higher. Serious adverse event whose causal relationship to 7vPnCV vaccination could not be ruled out were fever of 38 degrees C and urticaria in 1 each subject, in whom the study was thus discontinued prematurely. Major adverse systemic postvaccination events were fever, irritability and somnolence. Major local adverse events were redness, swelling or induration, and pain. All adverse events were transient and recovered spontaneously. The vaccine's immunogenicity and safety profile are therefore favorable following primary and booster immunization and compatible with those reported in overseas studies. 7vPnCV is expected to show the safety and efficacy similar to that in other countries and to reduce pneumococcal disease in Japan.

UR - http://www.scopus.com/inward/record.url?scp=84855481623&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84855481623&partnerID=8YFLogxK

M3 - Article

C2 - 21404606

AN - SCOPUS:84855481623

VL - 85

SP - 42

EP - 48

JO - Nippon Densenbyo Gakkai zasshi

JF - Nippon Densenbyo Gakkai zasshi

SN - 0387-5911

IS - 1

ER -