UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062217 |
|---|---|
| Receipt number | R000071194 |
| Scientific Title | Comparing the Immunogenicity of 4-Week and 8-Week Pentavalent Vaccination Schedules on Pertussis IgG Levels: A Randomized Controlled Trial |
| Date of disclosure of the study information | 2026/07/12 |
| Last modified on | 2026/07/12 16:18:04 |
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Basic information
Public title
Comparing the Immunogenicity of 4-Week and 8-Week Pentavalent Vaccination Schedules on Pertussis IgG Levels: A Randomized Controlled Trial
Acronym
Pentavalent Vaccine Intervals and Pertussis Immunogenicity
Scientific Title
Comparing the Immunogenicity of 4-Week and 8-Week Pentavalent Vaccination Schedules on Pertussis IgG Levels: A Randomized Controlled Trial
Scientific Title:Acronym
Pentavalent Vaccine Intervals and Pertussis Immunogenicity
Region
| Asia(except Japan) |
Condition
Condition
Healthy infants who had not received DTwP-HB-Hib vaccinations
Classification by specialty
| Infectious disease | Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
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
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Anti-pertussis Immunoglobulin G (IgG) levels measured one month after the third doses of DTwP-HB-Hib vaccinations
Key secondary outcomes
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
DTwP-HB-Hib vaccination at 8-week interval
Interventions/Control_2
DTwP-HB-Hib vaccination at 4-week 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
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 sample size
62
Research contact person
Name of lead principal investigator
| 1st name | Ariesti |
| Middle name | |
| Last name | Karmila |
Organization
Faculty of Medicine, Universitas Sriwijaya-Dr. Mohammad Hoesin General Hospital
Division name
Department of Child Health
Zip code
30126
Address
Jalan Jenderal 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-Dr. Mohammad Hoesin General Hospital
Division name
Department of Child Health
Zip code
30126
Address
Jalan Jenderal Sudirman
TEL
+62-711-376445
Homepage URL
a.karmila@unsri.ac.id
Sponsor or person
Institute
Faculty of Medicine, Universitas Sriwijaya-Dr. Mohammad Hoesin General Hospital
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
| 2026 | Year | 07 | Month | 12 | 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
Baseline IgG levels were uniformly below the assay's detection limit (5.00 IU/mL) for all subjects, indicating absolute vulnerability. Post-vaccination, 100% of infants achieved complete seroprotection. Crucially, the 8-week interval cohort elicited a higher median IgG titer compared to the 4-week cohort. Vaccine reactogenicity, including localized pain, swelling, and fever, was predominantly mild and did not differ significantly between the two schedules across all doses.
Results date posted
| 2026 | Year | 07 | Month | 12 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The cohort comprised 30 males (47%) and 34 females (53%), with an overall mean birth weight of 3,100 g. The majority of the infants (58%) had a well-nourished status, and were exclusively breastfed. There were no statistically significant baseline differences between the two intervention groups concerning gender, birth weight, nutritional status, or exclusive breastfeeding status (all P > 0.05), indicating successful randomization.
Participant flow
Of the 92 infants who met the inclusion criteria, 12 were excluded as their parents declined participation, resulting in an initial enrollment of 80 subjects. During the follow-up period, a total of 16 subjects dropped out due to refusal of post-vaccination blood sampling or lysed blood samples, leaving 64 infants who successfully completed the study. These 64 subjects were equally divided into the 8-week interval group (n = 32) and the 4-week interval group (n = 32).
Adverse events
No severe adverse reaction is observed.
Outcome measures
Baseline IgG levels were uniformly below the assay's detection limit (5.00 IU/mL) for all subjects, indicating absolute vulnerability. Post-vaccination, 100% of infants achieved complete seroprotection. Crucially, the 8-week interval cohort elicited a higher median IgG titer compared to the 4-week cohort. Vaccine reactogenicity, including localized pain, swelling, and fever, was predominantly mild and did not differ significantly between the two schedules across all doses.
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 | 01 | 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
| 2026 | Year | 07 | Month | 12 | Day |
Last modified on
| 2026 | Year | 07 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071194
