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NCT00905385 · ClinicalTrials.gov registry record · Phase 1

Nontypeable H. Influenzae in Healthy Adults

A Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

Completed
Registry status
Phase 1
Development phase
15
Enrollment target

NCT00905385: Completed Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

NCT00905385 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 15 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (75% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00905385, a Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

COMPLETED
Registry status
Phase 1
Development phase
15 participants
Enrollment target

Study Summary

The purpose of this study is to learn more about the safety of Haemophilus (H.) influenzae, its ability to produce adverse reactions and to live in the nose and throat. The nose and throat of healthy adults will be populated with a specific type of H. influenzae Nontypeable Haemophilus influenzae (NTHi) 2019 Streptomycin Resistant (StrR) number 1. Researchers will study whether the germ settles in the nose and throat, whether it causes symptoms after it has been placed in the nose, how long the germs last in the nose and throat, and whether the body tries to produce a permanent defense to the germ. Volunteers will receive a lower dose (3,200 germs) or a higher dose (32,000 germs). Active participation will last about 28 days, including a 3 night hospital stay, additional follow-up visits, followed by a 6 month follow-up phone call. Study procedures will include blood samples, saliva samples, several nose washes and throat swabs.

Interventions

  • BIOLOGICAL NTHi Strain 2019

Trial Details

FieldValue
Enrollment Target 15 participants
Start Date 2009-08
Est. Completion 2011-03
Phase Phase 1

What the finished NCT00905385 record still lists

NCT00905385 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (75% lower).

The record links to 0 conditions, and to 1 intervention - of which NTHi Strain 2019 is the first listed.

NCT00905385 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00905385 about?

NCT00905385 is a clinical study titled "Nontypeable H. Influenzae in Healthy Adults". The purpose of this study is to learn more about the safety of Haemophilus (H.) influenzae, its ability to produce adverse reactions and to live in the nose and throat. The nose and throat of healthy adults will be populated with a specific type of H. influenzae Nontypeable Haemophilus influenzae (N...

What is the current status of trial NCT00905385?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 15 participants. The study started on 2009-08. Estimated completion is 2011-03.

What interventions are being tested in trial NCT00905385?

The interventions under investigation include: NTHi Strain 2019 (BIOLOGICAL).

Who is sponsoring clinical trial NCT00905385?

This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00905385's enrollment target sits among peer trials

15 1798th of 2000 higher than 157 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 NCT00905385, the US trial registry maintained by the National Library of Medicine. NCT00905385 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.