Tokyo, July 13 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062217) titled 'Comparing the Immunogenicity of 4-Week and 8-Week Pentavalent Vaccination Schedules on Pertussis IgG Levels: A Randomized Controlled Trial' on July 12.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Open -no one is blinded
Control - Dose comparison
Primary Sponsor:
Institute - Faculty of Medicine, Universitas Sriwijaya-Dr. Mohammad Hoesin General Hospital
Condition:
Condition - Healthy infants who had not received DTwP-HB-Hib vaccinations
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To assess and compare the anti-pertussis IgG antibody response elicited by the DTwP-HB-Hib pentavalent vaccine when administered at 4-week versus 8-week interval.
Basic objectives2 - Safety,Efficacy
Intervention:
Interventions/Control_1 - DTwP-HB-Hib vaccination at 8-week interval
Interventions/Control_2 - DTwP-HB-Hib vaccination at 4-week interval
Eligibility:
Age-lower limit - Not applicable
Age-upper limit - 2
months-old
>=
Gender - Male and Female
Key inclusion criteria - Inclusion criteria required infants to have a normal gestational age, a birth weight exceeding 2,500 grams, and an absence of congenital abnormalities or severe perinatal infections.
Key exclusion criteria - Infants were excluded if they presented with vaccine contraindications, had a previously confirmed pertussis infection, relocated outside the study area, or switched to an acellular (DTaP) vaccine during the study period.
Target Size - 62
Recruitment Status:
Recruitment status - Completed
Date of protocol fixation - 2020 Year 12 Month 07 Day
Date of IRB - 2021 Year 01 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=R000071194
Disclaimer: Curated by HT Syndication.
