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NCT00850603 · ClinicalTrials.gov registry record · Phase 4
Safety and Immunogenicity of Intradermal Versus Subcutaneous Doses of Menomune®
A Phase 4 study, sponsored by Sanofi Pasteur, a Sanofi Company.
- Completed
- Registry status
- Phase 4
- Development phase
- 170
- Enrollment target
NCT00850603: Completed Phase 4 study, sponsored by Sanofi Pasteur, a Sanofi Company.
NCT00850603 is a Phase 4 study that has completed, run by Sanofi Pasteur, a Sanofi Company. The registered enrollment target is 170 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (67% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00850603, a Phase 4 study, has completed, sponsored by Sanofi Pasteur, a Sanofi Company.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 170 participants
- Enrollment target
Study Summary
The objective of this trial is to study the administration of the Menomune vaccine given intradermally and low-dose subcutaneously versus standard subcutaneously. This study will describe the immunogenicity of Menomune® - A/C/Y/W-135 administered subcutaneously (standard dose) versus intradermally over a dose range (1/10th, 2/10th, and 3/10th of standard dose) and a low dose (2/10th of standard dose) subcutaneously. The secondary objective is to describe the safety of the subcutaneous (SC) and intradermal (ID) routes at different dosages
Primary Outcome
Percentage of participants with a 4-fold rise in Serum bactericidal assay using baby rabbit complement (SBA-BR) antibody titers to each meningococcal serogroup from baseline to Day 28 post-vaccination.
Interventions
- BIOLOGICAL Meningococcal Polysaccharide Groups A\C\Y\W-135 Combined
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 170 participants |
| Start Date | 2002-10 |
| Est. Completion | 2004-11 |
| Phase | Phase 4 |
What the finished NCT00850603 record still lists
NCT00850603 is an interventional study that assigns participants to a tested intervention. The registered 170 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (67% lower).
The record links to 0 conditions, and to 1 intervention - of which Meningococcal Polysaccharide Groups A\C\Y\W-135 Combined is the first listed.
NCT00850603 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00850603 about?
NCT00850603 is a clinical study titled "Safety and Immunogenicity of Intradermal Versus Subcutaneous Doses of Menomune®". The objective of this trial is to study the administration of the Menomune vaccine given intradermally and low-dose subcutaneously versus standard subcutaneously. This study will describe the immunogenicity of Menomune® - A/C/Y/W-135 administered subcutaneously (standard dose) versus intradermally o...
What is the current status of trial NCT00850603?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 170 participants. The study started on 2002-10. Estimated completion is 2004-11.
What interventions are being tested in trial NCT00850603?
The interventions under investigation include: Meningococcal Polysaccharide Groups A\C\Y\W-135 Combined (BIOLOGICAL).
Who is sponsoring clinical trial NCT00850603?
This trial is sponsored by Sanofi Pasteur, a Sanofi Company, which has 153 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00850603's enrollment target sits among peer trials
170 484th of 2000 higher than 1,514 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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