Study Evaluating Safety & Immunogenicity of rLP2086 Vaccine in Healthy Toddlers
This study has been completed.
Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00387569
First received: October 11, 2006
Last updated: May 6, 2008
Last verified: May 2008
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Purpose
A study to assess the safety of an investigational meningitis vaccine in toddlers and their immune response to it.
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy |
Biological: MnB vaccine rLP8026 |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | A Randomized, Observer-Blinded, Parallel-Group, Active-Control, Phase 1/2 Trial of the Safety, Immunogenicity, and Tolerability of 20 µg, 60 µg, and 200 µg of Meningococcal Group B rLP2086 Vaccine in Healthy Adolescents Aged 10 to 12 Years |
Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:
Primary Outcome Measures:
- Local and systemic reactions through 14 days post-injection; Vaccinations at 0,1,6 months [ Time Frame: Vaccinations at 0,1,6 months ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 99 |
| Study Start Date: | October 2006 |
| Study Completion Date: | March 2008 |
| Primary Completion Date: | March 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Cohort 1
Experimental (20ug); Active Comparator/Placebo
|
Biological: MnB vaccine rLP8026
MnB vaccine at 20ug dose (0,1,6 months) or control (Hepatitis A vaccine, placebo, Hepatitis A vaccine at 0,1,6 months, respectively)
|
|
Experimental: Cohort 2
Experimental (60ug); Active Comparator/Placebo
|
Biological: MnB vaccine rLP8026
MnB vaccine at 60ug dose (0,1,6 months) or control (Hepatitis A vaccine, placebo, Hepatitis A vaccine at 0,1,6 months, respectively)
|
|
Experimental: Cohort 3
Experimental (200ug); Active Comparator/Placebo
|
Biological: MnB vaccine rLP8026
MnB vaccine at 200ug dose (0,1,6 months) or control (Hepatitis A vaccine, placebo, Hepatitis A vaccine at 0,1,6 months, respectively)
|
Eligibility| Ages Eligible for Study: | 18 Months to 36 Months |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria
- Aged 18- to 36-months
- Healthy male or female subjects
Exclusion Criteria
- Prior vaccination with a serogroup B meningococcal vaccine
- Prior history of any invasive meningococcal disease
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00387569
Locations
| Australia, Western Australia | |
| Perth, Western Australia, Australia, 6840 | |
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
| Study Director: | Medical Monitor | Wyeth is now a wholly owned subsidiary of Pfizer |
| Principal Investigator: | Trial Manager | For Australia, medinfo@wyeth.com |
More Information
No publications provided
| Responsible Party: | Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth |
| ClinicalTrials.gov Identifier: | NCT00387569 History of Changes |
| Other Study ID Numbers: | 6108A1-502 |
| Study First Received: | October 11, 2006 |
| Last Updated: | May 6, 2008 |
| Health Authority: | Australia: Human Research Ethics Committee |
Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
|
Toddlers Vaccine Safety |
ClinicalTrials.gov processed this record on June 13, 2013