Tokyo, July 9 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058407) titled 'The Effect of Dosing Intervals on the Diphtheria Immunogenicity Response in DTwP-HB-Hib Vaccination' on July 9.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Open -no one is blinded Control - Dose comparison

Primary Sponsor: Institute - Universitas Sriwijaya

Condition: Condition - Healthy infants who had not received DTwP-HB-Hib vaccinations Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To compare the anti-diphtheria toxoid immunoglobulin G (IgG) antibody levels before and after DTP vaccination at four-weeks and eight-weeks intervals. Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - Intervention: DTwP-HB-Hib vaccination at eight-weeks interval Interventions/Control_2 - Control: DTwP-HB-Hib vaccination at four-weeks interval

Eligibility: Age-lower limit - Not applicable Age-upper limit - 2 months-old >= Gender - Male and Female Key inclusion criteria - Healthy infants aged two months who had not previously received DTP vaccination, and whose parents consented to participate in the study by singing informed consent form. Key exclusion criteria - infants who have already received diphtheria and those with contraindications following the administration of diphtheria, tetanus, pertussis, hepatitis B, and Haemophilus influenzae type b (DTwP-HepB-Hib) vaccines. The dropout criteria were infants who failed to attend scheduled appointments, declined to complete the study, relocated from Palembang during the study, switched to the DtaP vaccine, experienced a severe adverse reaction to the vaccine, died during the study, or had insufficient or inadequate blood samples. Target Size - 60

Recruitment Status: Recruitment status - Completed Date of protocol fixation - 2020 Year 12 Month 07 Day Date of IRB - 2021 Year 02 Month 20 Day Anticipated trial start date - 2021 Year 03 Month 01 Day Last follow-up date - 2021 Year 09 Month 17 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066773

Disclaimer: Curated by HT Syndication.