The purpose of the study is to assess the immune response, reactogenicity and safety of a booster dose of dTpa vaccine 1 month after vaccination in healthy Japanese participants aged 11 to \<13 years.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
90
Combined reduced antigen content diphtheria, tetanus and acellular pertussis (dTpa) vaccine administered at Day 1.
GSK Investigational Site
Fukuoka, Japan
GSK Investigational Site
Hokkaido, Japan
GSK Investigational Site
Hokkaido, Japan
GSK Investigational Site
Hokkaido, Japan
Number of seropositive participants for anti-pertussis toxin (anti-PT), anti-filamentous hemagglutinin (FHA) and anti-pertactin (PRN) antibodies
Seropositivity is defined as antibody concentrations (anti-PT, anti-FHA and anti-PRN) are greater than or equal to the assessed assay cut-offs. The considered cut-off values are: anti-PT: 2.693 International Units per milliliter (IU/mL), anti-FHA: 2.046 IU/mL, anti-PRN: 2.187 IU/mL, as measured by Enzyme-Linked Immunosorbent assay (ELISA).
Time frame: 1 month after vaccination
Number of seroprotected participants for anti-diphteria and anti-tetanus antibodies
Seroprotection is defined as anti-diphtheria and anti- tetanus antibody concentrations being \>=0.1 IU/mL as measured by ELISA.
Time frame: 1 month after vaccination
Number of participants with booster-response to pertussis (PT, FHA and PRN) antigens
Booster response to PT, FHA and PRN antigens is defined as: for participants with pre-vaccination antibody concentration below the assay cut-off, post-vaccination antibody concentration \>=4 times the assay cut-off; for participants with pre-vaccination antibody concentration between the assay cut-off and below 4 times the assay cut-off, post-vaccination antibody concentration \>= 4 times the pre-vaccination antibody concentration; for participants with pre-vaccination antibody concentration \>=4 times the assay cut-off, post-vaccination antibody concentration \>=2 times the pre-vaccination antibody concentration.
Time frame: 1 month after vaccination
Antibody concentration against pertussis (PT, FHA, PRN) antigens
Time frame: At baseline (Day 1) and 1 month after vaccination
Antibody concentration for anti-diphtheria and anti-tetanus antibodies
Time frame: At baseline (Day 1) and 1 month after vaccination
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GSK Investigational Site
Kumamoto, Japan
GSK Investigational Site
Mie, Japan
GSK Investigational Site
Osaka, Japan
GSK Investigational Site
Saitama, Japan
GSK Investigational Site
Saitama, Japan
GSK Investigational Site
Shizuoka, Japan
Number of participants with solicited local adverse events (AEs)
Solicited local AEs are pain, redness (erythema) and swelling at administration site.
Time frame: From Day 1 (day of vaccination) to Day 7 post-vaccination
Number of participants with solicited systemic AEs
Solicited systemic AEs are fever, headache, myalgia (muscle pain), arthralgia (joint pain), fatigue (tiredness) and gastrointestinal symptoms.
Time frame: From Day 1 (day of vaccination) to Day 7 post-vaccination
Number of participants with unsolicited AEs
An unsolicited AE is an AE that was either not included in the list of solicited AEs or could be included in the list of solicited AEs but with an onset outside the specified period of follow-up for solicited AEs. Unsolicited AEs include both serious and non-serious AEs.
Time frame: From Day 1 (day of vaccination) to Day 30 post-vaccination
Number of participants with serious AEs (SAEs)
An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant, abnormal pregnancy outcomes, is a suspected transmission of any infectious agent via an authorized medicinal product, or other situations as per investigator's judgment.
Time frame: From Day 1 (day of vaccination) to Day 30 post-vaccination
Number of participants with AEs leading to study withdrawal
Time frame: From Day 1 (day of vaccination) to Day 30 post-vaccination