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NCT07059182 · ClinicalTrials.gov registry record · Phase 1
Safety Study of a Single Dose of Pneumococcal Whole-Cell Vaccine in Healthy Adults
A Phase 1 study, sponsored by Serum Life Science Europe.
- Completed
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
NCT07059182: Completed Phase 1 study, sponsored by Serum Life Science Europe.
NCT07059182 is a Phase 1 study that has completed, run by Serum Life Science Europe. The registered enrollment target is 30 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07059182, a Phase 1 study, has completed, sponsored by Serum Life Science Europe.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
Study Summary
The goal of this clinical trial is to learn if whole-cell Streptococcus pneumoniae (wSp) vaccination is safe and tolerated in healthy adults. The main aim is to evaluate the safety and tolerability of wSp vaccine. Researchers will compare wSp vaccinated participants with placebo-treated participants. Participants will be administered once with 1mg wSp vaccine or placebo. After dosing, they will be followed up for 30 days. In addition to the screening and enrollment visits, each participant will come to the study site for scheduled study visits on Days 14 and 30 to undergo study evaluations and measurements and to monitor safety. Each participant also will receive scheduled phone calls on Days 3 and 7 to monitor safety.
Primary Outcome
Occurrence and severity of local reactogenicity (injection site pain, tenderness, redness, swelling, itching, local lymphadenopathy) and systemic reactogenicity (headache, muscle pain, fever, nausea, vomiting, excessive fatigue, and diarrhea) within 7 days post-vaccination. Occurrence, severity, and relatedness of solicited AEs and SAEs through Day 30. Occurrence, severity, and relatedness of unsolicited AEs and SAEs through Day 30.
Interventions
- DRUG Placebo
- BIOLOGICAL Inactivated whole-cell Streptococcus pneumoniae vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2025-06-11 |
| Est. Completion | 2025-08-29 |
| Phase | Phase 1 |
What the finished NCT07059182 record still lists
NCT07059182 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT07059182 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07059182 about?
NCT07059182 is a clinical study titled "Safety Study of a Single Dose of Pneumococcal Whole-Cell Vaccine in Healthy Adults". The goal of this clinical trial is to learn if whole-cell Streptococcus pneumoniae (wSp) vaccination is safe and tolerated in healthy adults. The main aim is to evaluate the safety and tolerability of wSp vaccine. Researchers will compare wSp vaccinated participants with placebo-treated participant...
What is the current status of trial NCT07059182?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2025-06-11. Estimated completion is 2025-08-29.
What interventions are being tested in trial NCT07059182?
The interventions under investigation include: Placebo (DRUG), Inactivated whole-cell Streptococcus pneumoniae vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT07059182?
This trial is sponsored by Serum Life Science Europe, which has 2 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07059182's enrollment target sits among peer trials
30 1332nd of 2000 higher than 561 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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