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NCT03725618 · ClinicalTrials.gov registry record · Phase 4
Immunogenicity of Fractional One-fifth and One-half Doses of Yellow Fever Vaccine Compared to Full Dose in Children 9-23 Months Old
A Phase 4 study, sponsored by Centers for Disease Control and Prevention.
- Completed
- Registry status
- Phase 4
- Development phase
- 1,788
- Enrollment target
NCT03725618: Completed Phase 4 study, sponsored by Centers for Disease Control and Prevention.
NCT03725618 is a Phase 4 study that has completed, run by Centers for Disease Control and Prevention. The registered enrollment target is 1,788 participants, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (245% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03725618, a Phase 4 study, has completed, sponsored by Centers for Disease Control and Prevention.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 1,788 participants
- Enrollment target
Study Summary
A randomized clinical trial comparing fractional dose Yellow Fever vaccination to the full dose among children aged 9-23 months in Uganda. Children will have immune response assessed at baseline, 4 weeks, and 12 months after vaccination. Enrolled participants will be randomized to one of three arms: A. One-fifth fractional dose (0.1 ml) administered subcutaneously B. One-half fractional dose (0.25 ml) administered subcutaneously C. Full dose (0.5 ml) administered subcutaneously
Primary Outcome
Assess whether seroconversion following one-fifth (0.1 ml) and one-half (0.25 ml) doses of YF 17DD vaccine is non-inferior to seroconversion following a full dose (0.5 ml) at 4 weeks post-vaccination in children aged 9 - 23 months. Study endpoints at 4 weeks will be the following: Seroconversion will be defined as seronegative participants (plaque reduction neutralization test with a 50% cut-off (PRNT50) \< 10) at enrollment who become seropositive (PRNT50 ≥ 10) at 4 week follow-up. A boosted re
Interventions
- BIOLOGICAL Yellow Fever 17DD Vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,788 participants |
| Start Date | 2018-11-01 |
| Est. Completion | 2021-09-01 |
| Phase | Phase 4 |
What the finished NCT03725618 record still lists
NCT03725618 is an interventional study that assigns participants to a tested intervention. Its 1,788 participants enrollment target places it among the larger protocols in the corpus, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (245% higher).
The record links to 0 conditions, and to 1 intervention - of which Yellow Fever 17DD Vaccine is the first listed.
NCT03725618 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03725618 about?
NCT03725618 is a clinical study titled "Immunogenicity of Fractional One-fifth and One-half Doses of Yellow Fever Vaccine Compared to Full Dose in Children 9-23 Months Old". A randomized clinical trial comparing fractional dose Yellow Fever vaccination to the full dose among children aged 9-23 months in Uganda. Children will have immune response assessed at baseline, 4 weeks, and 12 months after vaccination. Enrolled participants will be randomized to one of three arms...
What is the current status of trial NCT03725618?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 1,788 participants. The study started on 2018-11-01. Estimated completion is 2021-09-01.
What interventions are being tested in trial NCT03725618?
The interventions under investigation include: Yellow Fever 17DD Vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT03725618?
This trial is sponsored by Centers for Disease Control and Prevention, which has 139 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03725618's enrollment target sits among peer trials
1,788 45th of 2000 higher than 1,956 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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