Interchangeability between 5-combined vaccine and 4-combined vaccine + Hib vaccine

JRCT ID: jRCTs071230050

Registered date:09/08/2023

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Hib infection, pertussis, diphtheria, tetanus, or acute poliomyelitis
• Date of first enrollment: 26/09/2023
• Target sample size: 40
• Study type: Interventional

Intervention(s)

5-combined vaccine group:
0.5 mL of 5-combined vaccine is administered subcutaneously in the extensor compartment of the upper arm, or intramuscularly in the anterolateral aspect of the thigh or the center of the deltoid muscle of the upper arm

4+1 group:
0.5 mL of 4-combined vaccine and Hib vaccine each is simultaneously administered subcutaneously in the extensor compartment of different upper arms

Outcome(s)

• Primary Outcome: Seropositivity rate (>= 1 ug/mL) against polyribosyl ribitol phosphate

Secondary Outcome

-Seropositivity rate (>= 0.15 ug/mL) against polyribosyl ribitol phosphate
-The geometric mean antibody titer against polyribosyl ribitol phosphate
-Changes in antibody titer against polyribosyl ribitol phosphate

Key inclusion & exclusion criteria

• Age minimum: >= 10month old
• Age maximum: < 60month old
• Gender: Both

Include criteria

Those who meet all of the following criteria are eligible for the study:
(1)Infants who received 3 doses of 4-combined vaccine and Hib vaccine each as a primary immunization (simultaneous administration is acceptable) and who are in the interval of >= 6 months and < 18 months after the third dose of 4-combined vaccine
(2) Those whose legally acceptable representatives have provided written informed consent

Exclude criteria

Those who meet any of the following criteria are excluded from the study:
(1) Those who have a medical history of Hib infection (based on interview of their legally acceptable representatives)
(2) Those who previously exhibited anaphylaxis to components contained in the investigational product
(3) Those who are judged as ineligible for participation in this research by the principal investigator or sub-investigator

Related Information

• Primary Sponsor: Sugino Shigeto
• Secondary Sponsor: Uno Shingo,KM Biologics Co., Ltd.