A Study Evaluating Safety And Immunogenicity Of Meningococcal B Rlp2086 Vaccine In Adolescents
NCT00808028
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
- Healthy male or female subjects between the ages of >=11 and <=18 years at the time of enrollment.
- Negative urine pregnancy test for all female subjects.
- Parent/legal guardian or subject under supervision of the parent/legal guardian must be able to complete all relevant study procedures during study participation.
- History of any invasive meningococcal disease.
- A previous anaphylactic or severe vaccine-associated adverse reaction.
- Any clinically significant chronic disease.
- A known or suspected disease of the immune system or those receiving immunosuppressive
therapy, including systemic corticosteroids. Topical, inhaled or intra-articular
corticosteroids are allowed.
- Participation in another investigational study in the 1-month (30-day) period before
study visit 1 and during the conduct of the study.
NEED INFO?
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative
TRY A NEW SEARCH
Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.
Based on your search, you may also be interested in
- Herston, Queensland
- North Adelaide, South Australia
- Carlton, Victoria
- Subiaco, Western Australia
- Debica,
- Krakow,
- Krakow,
- Leczna,
- Lodz,
- Lodz,
- Lubartow,
- Lublin,
- Melno,
- Oborniki Slaskie,
- Poznan,
- Siemianowice Slaskie,
- Torun,
- Trzebnica,
- Wroclaw,
- Wroclaw,
- Santiago de Compostela, La Coruna
- Getafe, Madrid
- Vigo, Pontevedra
- Almeria,
- Barcelona,
- Madrid,
- Valencia,
- South Miami, Florida
- Santiado de Compostela, La Coruña
- Mostóles, Madrid
- Pamplona, Navarra
- Almeria,
- Madrid,
- Madrid,
- Vigo,
- Linz,
- Wels,
- Augsburg,
- Bad Saulgau,
- Berlin,
- Bietigheim-Bissingen,
- Ettenheim,
- Heilbronn,
- Kehl,
- Nördlingen,
- Oberndorf / Neckar,
- Offenburg,
- Roding,
- Weingarten,
Descriptive Information | ||||
---|---|---|---|---|
Brief Title ICMJE | A Study Evaluating Safety And Immunogenicity Of Meningococcal B Rlp2086 Vaccine In Adolescents | |||
Official Title ICMJE | A Randomized, Single-blind, Placebo-controlled, Phase 2 Trial Of The Safety, Immunogenicity, And Tolerability Of Meningococcal Serogroup B (Mnb) Rlp2086 Vaccine At Doses Of 60 Mug, 120 Mug, And 200 Mug In Healthy Adolescents Aged 11 To 18 Years | |||
Brief Summary | The purpose of this study is to evaluate the safety and immunogenicity of an investigational meningococcal B rLP2086 vaccine in adolescents aged 11 to 18 years old. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 2 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Primary Purpose: Prevention | |||
Condition ICMJE | Meningitis, Meningococcal | |||
Intervention ICMJE |
| |||
Study Arms ICMJE |
| |||
Publications * |
| |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE | 538 | |||
Original Estimated Enrollment ICMJE | 715 | |||
Actual Study Completion Date ICMJE | March 2014 | |||
Actual Primary Completion Date | March 2014 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
Sex/Gender ICMJE |
| |||
Ages ICMJE | 11 Years to 18 Years (Child, Adult) | |||
Accepts Healthy Volunteers ICMJE | Yes | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Australia, Poland, Spain | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00808028 | |||
Other Study ID Numbers ICMJE | 6108A1-2001 B1971005 ( Other Identifier: Alias Study Number ) 2008-007789-51 ( EudraCT Number ) | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Pfizer | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
| |||
PRS Account | Pfizer | |||
Verification Date | March 2015 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |