A Trial to Assess the Safety, Tolerability and Immunogenicity of Repevax and rLP2086 Vaccine When Given Together in Healthy Subjects Aged >=11 to <19 Years.
NCT01323270
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
- Evidence of a personally signed and dated informed consent document indicating that the parent/legally acceptable representative and/or subject has been informed of all pertinent aspects of the study.
- Parent/legally acceptable representative and/or subjects who are willing and able to comply with scheduled visits, laboratory tests, and other study procedures.
- Male or female subject aged ≥11 and <19 years at the time of enrollment.
- Available for the entire study period and can be reached by telephone.
- Healthy subject as determined by medical history, physical examination, and judgment of the investigator.
- Has received full series of diphtheria, tetanus, and pertussis (DTP)/DTaP vaccines and oral poliomyelitis virus (OPV)/IPV vaccines per country-specific recommendations applicable at the time of receipt.
- All male and female subjects must agree to practice a form of effective contraception, such as barrier contraception (ie, condom plus spermicide, a female condom, diaphragm, cervical cap or intrauterine device), implants, injectables, combined oral contraceptives or sexual abstinence prior to entering into the study, for the duration of the vaccination period and for 28 days after the last study vaccination. For Germany: The phrase sexual abstinence is not applicable, with the understanding that all male and all female subjects of childbearing potential must practice an effective form of contraception during the study.
- Negative urine pregnancy test for female subjects.
- Previous vaccination with any meningococcal serogroup B vaccine.
- Vaccination with any diphtheria, tetanus, pertussis, or poliomyelitis virus vaccine
within 5 years of the first study vaccination.
- A previous anaphylactic reaction to any vaccine or vaccine-related component.
- Contraindication to vaccination with diphtheria, tetanus, pertussis, or poliomyelitis
virus vaccine.
- Bleeding diathesis or condition associated with prolonged bleeding time that would
contraindicate intramuscular injection.
- A known or suspected disease of the immune system or those receiving immunosuppressive
therapy.
- History of culture-proven disease caused by Neisseria meningitidis or Neisseria
gonorrhoeae.
- Significant neurological disorder or history of seizure (excluding simple febrile
seizure).
- Receipt of any blood products, including immunoglobulin within 6 months before the
first study vaccination.
- Current chronic use of systemic antibiotics.
- Participation in other studies during study participation. Participation in purely
observational studies is acceptable.
- Received any investigational drugs, vaccines or devices within 28 days before
administration of the first study vaccination.
- Any neuroinflammatory or autoimmune condition, including, but not limited to,
transverse myelitis, uveitis, optic neuritis, and multiple sclerosis.
- Other severe acute or chronic medical or psychiatric condition or laboratory
abnormality that may increase the risk associated with study participation or
investigational product administration or may interfere with the interpretation of
study results and, in the judgment of the investigator, would make the subject
inappropriate for entry into this study.
- Subjects who are investigational site staff members or subjects who are Pfizer
employees directly involved in the conduct of the trial.
- Subject is a direct descendant (eg, child, grandchild or other family member) of study
site or Pfizer personnel.
- Subject is pregnant or breastfeeding.
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Descriptive Information | ||||
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Brief Title ICMJE | A Trial to Assess the Safety, Tolerability and Immunogenicity of Repevax and rLP2086 Vaccine When Given Together in Healthy Subjects Aged >=11 to <19 Years. | |||
Official Title ICMJE | A Phase 2, Randomized, Placebo-controlled, Single-blind Trial To Assess The Safety, Tolerability, And Immunogenicity Of Repevax(Registered) And Bivalent Rlp2086 Vaccine When Administered Concomitantly In Healthy Subjects Aged >/= 11 To <19 Years | |||
Brief Summary | This study is to look at a new vaccine that might prevent meningococcal disease, and to look at the safety of the new vaccine as well as how it is tolerated when given together with Repevax. The study will be done in healthy adolescents. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 2 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single (Participant) Primary Purpose: Prevention | |||
Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * |
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* 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 | 753 | |||
Original Estimated Enrollment ICMJE | 750 | |||
Actual Study Completion Date ICMJE | February 2013 | |||
Actual Primary Completion Date | October 2012 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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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 | Finland, Germany, Poland | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01323270 | |||
Other Study ID Numbers ICMJE | B1971010 6108A1-2008 ( Other Identifier: Alias Study Number ) 2010-022449-38 ( EudraCT Number ) | |||
Has Data Monitoring Committee | Yes | |||
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 |
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PRS Account | Pfizer | |||
Verification Date | April 2015 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |