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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.

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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Meningococcal Vaccine rLP2086 Repevax N Meningitidis Serogroup B Meningitis Biological: rLP2086 Biological: Repevax Biological: Saline Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 753 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: 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
Study Start Date : March 2011
Actual Primary Completion Date : October 2012
Actual Study Completion Date : February 2013

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Arms and Interventions
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Arm Intervention/treatment
Experimental: rLP2086
rLP2086 and Repevax
 Biological: rLP2086
0.5 mL dose, given at 0, 2 and 6 months.

Biological: Repevax
0.5 mL dose, given at 0 months.
Placebo Comparator: Saline and Repevax
Saline and Repevax
 Biological: Saline
0.5 mL dose, given at 0, 2 and 6 months.

Biological: Repevax
0.5 mL dose, given at 0 months.


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Participants Achieving Prespecified Criteria for the Concomitant Antigen [ Time Frame: 1 month after Vaccination 1 ]
  2. Percentage of Participants With at Least One Adverse Event (AE) [ Time Frame: Vaccination 1 up to 1 month after Vaccination 3 ]

Secondary Outcome Measures :
  1. Geometric Mean Concentration (GMC) for Diphtheria and Tetanus Antigens [ Time Frame: 1 month after Vaccination 1 ]
  2. GMC for Acellular Pertussis Antigens [ Time Frame: 1 month after Vaccination 1 ]
    Enzyme-linked immunosorbent assay (ELISA) units per milliliter (EU/mL)

  3. Geometric Mean Titer (GMT) for Poliomyelitis Antigens [ Time Frame: 1 month after Vaccination 1 ]
  4. 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 ]

Other Outcome Measures:
  1. Immunoglobulin G (IgG) Measured by Geometric Mean Titer (GMT) [ Time Frame: Before vaccination 1, 1 month after Vaccination 2, 3 ]
  2. Geometric Mean Fold-Rise (GMFR) for IgG [ Time Frame: Before Vaccination 1, 1 month after Vaccination 2, 3 ]

Eligibility Criteria
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Ages Eligible for Study:   11 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01323270


Locations
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Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01323270    
Other Study ID Numbers: B1971010
6108A1-2008 ( Other Identifier: Alias Study Number )
2010-022449-38 ( EudraCT Number )
First Posted: March 25, 2011    Key Record Dates
Results First Posted: November 26, 2014
Last Update Posted: May 15, 2015
Last Verified: April 2015
Keywords provided by Pfizer:
Healthy adolescents
Additional relevant MeSH terms:
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Meningitis
Central Nervous System Diseases
Nervous System Diseases