At a glance

ClinicalIndex Comparison Record

Phase 1Completed· 34 enrolled

Drug / intervention

25ug Group B Meningococcal 44/76 MOS NOMV 5D Vaccine +1 morebiological

Likely dose

25µg or 50µg Group B Meningococcal 44/76 MOS NOMV 5D vaccine intramuscularly at 0, 6, and 24 weeksAI-extracted

Key inclusion· 4

✓Healthy military or civilian males or non-pregnant, non-lactating females
✓Age 18-45 years
✓Willing to comply with all protocol procedures and time commitments
✓Females must be surgically sterilized or have negative pregnancy test and agree to adequate birth control for 7 months after first vaccination

Key exclusion· 6

✕History of significant organ or system disease
✕History of allergy to any vaccine or vaccine components (including aluminum hydroxide)
✕HIV sero-positive or immunosuppressive state
✕Positive test for HBsAg or hepatitis C

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00248833

NCT00248833Phase 1Completed

Compare CT.gov

Phase 1 Dose Esc Study of Safety and Immun of 3 Injections, Given at 0, 6 and 24 Wks, of Grp B Meningococcal 44/76 MOS NOMV 5D Vaccine Admin to Healthy Subjs IM With and Without Adjuvant

U.S. Army Medical Research and Development Command·interventional·Posted Nov 4, 2005·Updated Oct 29, 2018

In Brief

A Phase 1 clinical trial evaluating 25ug Group B Meningococcal 44/76 MOS NOMV 5D Vaccine and 50ug Group B Meningococcal 44/76 MOS NOMV 5D Vaccine for Meningitis, Meningococcal, Serogroup B. Completed, enrolled 34 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsMeningitis, Meningococcal, Serogroup B

CountriesUnited States

CollaboratorsWalter Reed Army Institute of Research (WRAIR)

Timeline

Phase 1CompletedFinished

2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027

First PostedNov 2005

Enrollment StartDec 2005

Primary CompletionNov 2006

Study CompletionDec 2007

TodayJul 2026

First PostedNov 4, 2005

Enrollment StartDec 5, 2005

Primary CompletionNov 30, 2006

Study CompletionDec 1, 2007

TodayJul 2, 2026

Enrollment to primary: 12 monthsPosted 20.7 years ago

Interventions

25ug Group B Meningococcal 44/76 MOS NOMV 5D Vaccinebiological

The study was conducted as a phase 1, outpatient, dose-escalating study for the Meningococcal 44/76 MOS NOMV 5D Vaccine (lot number 1119). 25µg with and without adjuvant were administered. Vaccinations were given intramuscularly at 0, 6, and 24 weeks.

50ug Group B Meningococcal 44/76 MOS NOMV 5D Vaccinebiological

The study was conducted as a phase 1, outpatient, dose-escalating study for the Meningococcal 44/76 MOS NOMV 5D Vaccine (lot number 1119). 50µg without adjuvant was administered. Vaccinations were given intramuscularly at 0, 6, and 24 weeks.