UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058407 |
|---|---|
| Receipt number | R000066773 |
| Scientific Title | The Effect of Dosing Intervals on the Diphtheria Immunogenicity Response in DTwP-HB-Hib Vaccination |
| Date of disclosure of the study information | 2025/07/09 |
| Last modified on | 2025/07/09 00:37:13 |
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Basic information
Public title
The Effect of Dosing Intervals on the Diphtheria Immunogenicity Response in DTwP-HB-Hib Vaccination
Acronym
Dosing Intervals and the Diphtheria Immunogenicity Response in DTwP-HB-Hib Vaccination
Scientific Title
The Effect of Dosing Intervals on the Diphtheria Immunogenicity Response in DTwP-HB-Hib Vaccination
Scientific Title:Acronym
Dosing Intervals and the Diphtheria Immunogenicity Response in DTwP-HB-Hib Vaccination
Region
| Asia(except Japan) |
Condition
Condition
Healthy infants who had not received DTwP-HB-Hib vaccinations
Classification by specialty
| Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
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
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Anti-diphtheria toxoid immunoglobulin G (IgG) antibody levels measured after three doses of DTwP-HB-Hib vaccinations
Key secondary outcomes
Adverse effects following the administration of the vaccine (local pain, local edema, fever, seizure)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Vaccine |
Interventions/Control_1
Intervention: DTwP-HB-Hib vaccination at eight-weeks interval
Interventions/Control_2
Control: DTwP-HB-Hib vaccination at four-weeks interval
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
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 sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Ariesti |
| Middle name | |
| Last name | Karmila |
Organization
Faculty of Medicine, Universitas Sriwijaya
Division name
Department of Child Health
Zip code
30126
Address
Jl. Jend. Sudirman
TEL
+62-711-376445
a.karmila@unsri.ac.id
Public contact
Name of contact person
| 1st name | Ariesti |
| Middle name | |
| Last name | Karmila |
Organization
Faculty of Medicine, Universitas Sriwijaya
Division name
Department of Child Health
Zip code
30126
Address
Jl. Jend. Sudirman
TEL
+62-711-376445
Homepage URL
a.karmila@unsri.ac.id
Sponsor or person
Institute
Universitas Sriwijaya
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Universitas Sriwijaya
Address
Jalan Dokter Muhammad Ali
Tel
+62-711-373438
kedokteran@unsri.ac.id
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 07 | Month | 09 | Day |
Related information
URL releasing protocol
None
Publication of results
Unpublished
Result
URL related to results and publications
None
Number of participants that the trial has enrolled
64
Results
All study participants exhibited no protection against diphtheria antibody prior to the intervention. No statistically significant difference in the antibody levels was observed following three doses of the vaccination. The incidence of local pain following the first dose of the DTP vaccine was significantly higher in the 4-week interval group compared to the 8-week interval group.
Results date posted
| 2025 | Year | 07 | Month | 08 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The majority are female (n=34; 53%) and exclusively breastfed (n=43; 67%). The mean birth weight was 3,100 grams.
Participant flow
Eighty subjects were enrolled at the beginning of the study, where 36 and 44 subjects were randomized to receive DTwP-HB-Hib vaccinations at eight-weeks or four-weeks interval, respectively. Twelve subjects declined to participate in the second sampling, three respondents' blood samples got lysis, and one subject's sample was insufficient, making 64 subjects fulfilled the study requirements.
Adverse events
No severe adverse reaction is observed.
Outcome measures
All study participants exhibited no protection against diphtheria antibody (0.01-0.99 IU/mL) at the beginning of the study. Following three doses of the vaccination, no statistically significant difference in the antibody levels was observed.
Plan to share IPD
IPD sharing Plan description
Progress
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 |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 07 | Month | 09 | Day |
Last modified on
| 2025 | Year | 07 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066773
