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Trial record 1 of 1 for:    NCT01323270
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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.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01323270
Recruitment Status : Completed
First Posted : March 25, 2011
Results First Posted : November 26, 2014
Last Update Posted : May 15, 2015
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE February 17, 2011
First Posted Date  ICMJE March 25, 2011
Results First Submitted Date  ICMJE November 21, 2014
Results First Posted Date  ICMJE November 26, 2014
Last Update Posted Date May 15, 2015
Study Start Date  ICMJE March 2011
Actual Primary Completion Date October 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 21, 2014)
  • Percentage of Participants Achieving Prespecified Criteria for the Concomitant Antigen [ Time Frame: 1 month after Vaccination 1 ]
  • Percentage of Participants With at Least One Adverse Event (AE) [ Time Frame: Vaccination 1 up to 1 month after Vaccination 3 ]
Original Primary Outcome Measures  ICMJE
 (submitted: March 24, 2011)
The proportions of subjects achieving prespecified criteria for the concomitant antigens 1 month after vaccination 1 (visit 2). [ Time Frame: 1 month after Vaccination 1 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 21, 2014)
  • Geometric Mean Concentration (GMC) for Diphtheria and Tetanus Antigens [ Time Frame: 1 month after Vaccination 1 ]
  • GMC for Acellular Pertussis Antigens [ Time Frame: 1 month after Vaccination 1 ]
    Enzyme-linked immunosorbent assay (ELISA) units per milliliter (EU/mL)
  • Geometric Mean Titer (GMT) for Poliomyelitis Antigens [ Time Frame: 1 month after Vaccination 1 ]
  • Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal to (>=) Prespecified Titer Level [ Time Frame: 1 month after Vaccination 3 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: March 24, 2011)
  • The concomitant antigens measured as GMT or GMCs at 1-month after vaccination 1 (visit 2). [ Time Frame: 1 month after Vaccination 1 ]
  • The immunoglobulin G (IgG) as measured by GMT for subfamily A and B proteins, at 1-month after vaccination 3 (visit 6). [ Time Frame: 1 month after vaccination 3 ]
  • The IgG as measured by GMT for subfamily A and B proteins, at 1-month after vaccination 2 (visit 4). [ Time Frame: 1 month after vaccination 2 ]
  • The IgG as measured by GMT for subfamily A and B proteins, at baseline (visit 1). [ Time Frame: At baseline ]
  • The Geometric Mean Fold Rises (GMFRs) for subfamily A and B proteins, from baseline (visit 1) to 1-month after vaccination 3 (visit 6). [ Time Frame: 1 month after vaccination 3 ]
  • The GMFRs for subfamily A and B proteins, from baseline (visit 1) to 1-month after vaccination 2 (visit 4). [ Time Frame: 1 month after vaccination 2 ]
Current Other Pre-specified Outcome Measures
 (submitted: April 27, 2015)
  • Immunoglobulin G (IgG) Measured by Geometric Mean Titer (GMT) [ Time Frame: Before vaccination 1, 1 month after Vaccination 2, 3 ]
  • Geometric Mean Fold-Rise (GMFR) for IgG [ Time Frame: Before Vaccination 1, 1 month after Vaccination 2, 3 ]
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
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
  • Meningococcal Vaccine
  • rLP2086
  • Repevax
  • N Meningitidis Serogroup B
  • Meningitis
Intervention  ICMJE
  • Biological: rLP2086
    0.5 mL dose, given at 0, 2 and 6 months.
  • Biological: Repevax
    0.5 mL dose, given at 0 months.
  • Biological: Saline
    0.5 mL dose, given at 0, 2 and 6 months.
Study Arms  ICMJE
  • Experimental: rLP2086
    rLP2086 and Repevax
    Interventions:
    • Biological: rLP2086
    • Biological: Repevax
  • Placebo Comparator: Saline and Repevax
    Saline and Repevax
    Interventions:
    • Biological: Saline
    • Biological: Repevax
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
 (submitted: March 12, 2013)
753
Original Estimated Enrollment  ICMJE
 (submitted: March 24, 2011)
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:

  • 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.

Exclusion Criteria:

  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
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
Study Director: Pfizer CT.gov Call Center Pfizer
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