Specified clinical research on 5-combined vaccines

JRCT ID: jRCTs071240005

Registered date:12/04/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Hib infection, pertussis, diphtheria, tetanus, or acute poliomyelitis
• Date of first enrollment: 12/04/2024
• Target sample size: 80
• Study type: Interventional
• Intervention(s): Subjects are assigned to treatment arms 1 through 4 per vaccination pattern of 5-combined vaccines, and are vaccinated 3 times with either Quintovac Aqueous Suspension Injection or GOBIK Aqueous Suspension Syringes each time in different combinations.

Outcome(s)

• Primary Outcome: Seropositivity rate (>= 1 ug/mL) against polyribosyl ribitol phosphate after primary immunization in each treatment arm

Secondary Outcome

-Seropositivity rate (>= 0.15 ug/mL) against polyribosyl ribitol phosphate after primary immunization in each treatment arm
-Seropositivity rates (disease onset prevention level or higher) against pertussis toxin, filamentous hemagglutinin, diphtheria toxin, tetanus toxoid, and attenuated poliovirus types 1, 2, and 3 after primary immunization in each treatment arm
-Antibody titers against polyribosyl ribitol phosphate, pertussis toxin, filamentous hemagglutinin, diphtheria toxin, tetanus toxoid, and attenuated poliovirus types 1, 2, and 3 after primary immunization in each treatment arm
-Changes in antibody titers against polyribosyl ribitol phosphate, pertussis toxin, filamentous hemagglutinin, diphtheria toxin, tetanus toxoid, and attenuated poliovirus types 1, 2, and 3 before and after primary immunization per each treatment arm and each subject

Key inclusion & exclusion criteria

• Age minimum: >= 2month old
• Age maximum: < 7month old
• Gender: Both

Include criteria

(1) Those who can receive the first vaccination of the investigational product at the age of >=2 months to < 7 months and can receive the second and third vaccinations of the investigational product at the defined intervals
(2) Those whose legally acceptable representatives have provided written informed consent

Exclude criteria

(1) Those who have a medical history of Hib infection, pertussis, diphtheria, tetanus, or acute poliomyelitis (polio) (based on interview of their legally acceptable representatives)
(2) Those who have received vaccination for Hib infection, pertussis, diphtheria, tetanus, or acute poliomyelitis (polio) (checked by Mother and Child Health Handbook etc.)
(3) Those who previously exhibited anaphylaxis to components contained in the investigational product
(4) Those who are receiving a drug in another clinical trial or research, or those who plan to participate in another clinical trial or research prior to a blood collection performed after primary immunization in this research
(5) Those who are judged as ineligible for participation in this research by the principal investigator or sub-investigator

Related Information

• Primary Sponsor: Shindo Shizuo
• Secondary Sponsor: KM Biologics Co., Ltd.,The Research Foundation for Microbial Diseases of Osaka University