Interchangeability study of switching from DPT-IPV quadrivalent vaccine and Hib vaccine to DPT-IPV-Hib pentavalent vaccine

JRCT ID: jRCT1031230708

Registered date:15/03/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Hib infection, pertussis, diphtheria, tetanus, or acute poliomyelitis
• Date of first enrollment: 15/03/2024
• Target sample size: 40
• Study type: Observational

Outcome(s)

• Primary Outcome: Anti-polyribosylribitol phosphate (PRP) antibody prevalence rate with >=1 mcg/mL 4 to 6weeks after study drug vaccination

Secondary Outcome

Immunogenicity:
Anti-PRP antibody prevalence rate with >=0.15 mcg/mL 4 to 6 weeks after study drug vaccination
Anti-PRP antibody prevalence rate by vaccination route 4 to 6 weeks after study drug vaccination
Geometric mean titer (GMT) of anti-PRP antibody 4 to 6 weeks after study drug vaccination
GMT of anti-PRP antibody by vaccination route 4 to 6 weeks after study drug vaccination
Change in GMT of anti-PRP antibody before and 4 to 6 weeks after study drug vaccination

Key inclusion & exclusion criteria

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

Include criteria

Infant aged >=10 and <60 months who has received 3 doses each of DPT-IPV quadrivalent vaccine and Hib vaccine as a primary immunization (including concomitant vaccination) and more than 6 months but less than 18 months have elapsed since the third dose of DPT-IPV quadrivalent vaccine as the primary immunization
2. As a booster immunization (fourth dose), infant who wishes to receive either DPT-IPV-Hib pentavalent vaccine (GOBIK) or concomitant vaccination with DPT-IPV quadrivalent vaccine (TETRABIK) and Hib vaccine (ActHIB)
3. Infant who can provide written consent to participate in the study from his/her legal guardians (parents)

Exclude criteria

Infant who has a past diagnosis of an immunodeficiency or currently under immunosuppressive treatment
2. Infant who is at risk of developing severe allergies due to food or medicines, etc.
3. Infant with obvious pyrexia
4. Infant who is obviously suffering from a serious acute disease
5. Infant who has previously exhibited anaphylaxis due to components contained in the study drug
6. Infant who has received DPT-IPV quadrivalent vaccine and Hib vaccine as a booster immunization (fourth dose), or DPT-IPV-Hib pentavalent vaccine
7. Infant with underlying diseases such as cardiovascular diseases, kidney diseases, liver diseases, blood diseases, growth disorders etc., which in the opinion of the principal investigator or sub-investigator may interfere with the evaluation of this study
8. Infant who has participated in another clinical research or clinical study and received any medication within 3 months prior to study drug vaccination
9. Infant who is judged as ineligible for participation in this study by the principal investigator or sub-investigator

Related Information

• Primary Sponsor: Tanaka Toshihiro