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NCT00248833 · ClinicalTrials.gov registry record · Phase 1

Safety and Immunogenicity Study of Group B Meningococcal Vaccine to Prevent Meningitis.

A Phase 1 study, sponsored by U.S. Army Medical Research and Development Command.

Completed
Registry status
Phase 1
Development phase
34
Enrollment target

NCT00248833: Completed Phase 1 study, sponsored by U.S. Army Medical Research and Development Command.

NCT00248833 is a Phase 1 study that has completed, run by U.S. Army Medical Research and Development Command. The registered enrollment target is 34 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (43% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00248833, a Phase 1 study, has completed, sponsored by U.S. Army Medical Research and Development Command.

COMPLETED
Registry status
Phase 1
Development phase
34 participants
Enrollment target

Study Summary

The purpose of this study is to determine if the vaccine called Group B Meningococcal 44/76 MOS NOMV 5D Vaccine is safe and free from side effects and if it will protect people from meningitis. This study will vaccinate three groups of people. In the first 2 groups, the study will be double-blinded. This means that neither the volunteer or the medical team will know which formulation of the vaccine was administered. The third group of volunteers and the medical team will know that they are receiving the higher dose of the vaccine.

Primary Outcome

Solicited and unsolicited summary of severity of adverse events (AEs) during the 7 day follow-up period after each vaccination

Interventions

  • BIOLOGICAL 25ug Group B Meningococcal 44/76 MOS NOMV 5D Vaccine
  • BIOLOGICAL 50ug Group B Meningococcal 44/76 MOS NOMV 5D Vaccine

Trial Details

FieldValue
Enrollment Target 34 participants
Start Date 2005-12-05
Est. Completion 2007-12
Phase Phase 1

What the finished NCT00248833 record still lists

NCT00248833 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 34 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (43% lower).

The record links to 0 conditions, and to 2 interventions - of which 25ug Group B Meningococcal 44/76 MOS NOMV 5D Vaccine is the first listed.

NCT00248833 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00248833 about?

NCT00248833 is a clinical study titled "Safety and Immunogenicity Study of Group B Meningococcal Vaccine to Prevent Meningitis.". The purpose of this study is to determine if the vaccine called Group B Meningococcal 44/76 MOS NOMV 5D Vaccine is safe and free from side effects and if it will protect people from meningitis. This study will vaccinate three groups of people. In the first 2 groups, the study will be double-blinded...

What is the current status of trial NCT00248833?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 34 participants. The study started on 2005-12-05. Estimated completion is 2007-12.

What interventions are being tested in trial NCT00248833?

The interventions under investigation include: 25ug Group B Meningococcal 44/76 MOS NOMV 5D Vaccine (BIOLOGICAL), 50ug Group B Meningococcal 44/76 MOS NOMV 5D Vaccine (BIOLOGICAL).

Who is sponsoring clinical trial NCT00248833?

This trial is sponsored by U.S. Army Medical Research and Development Command, which has 77 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00248833's enrollment target sits among peer trials

34 1273rd of 2000 higher than 721 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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Source: ClinicalTrials.gov NCT00248833, the US trial registry maintained by the National Library of Medicine. NCT00248833 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.