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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.

Last updated on December 15, 2017

FOR MORE INFORMATION
Study Location
Espoo Vaccine Research Clinic
Espoo, , 02100 Finland
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Meningococcal Vaccine, rLP2086, Repevax, N Meningitidis Serogroup B, Meningitis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
11-18 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT01323270
Pfizer
Completed
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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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.
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
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
  • Meningococcal Vaccine
  • rLP2086
  • Repevax
  • N Meningitidis Serogroup B
  • Meningitis
  • 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.
  • Experimental: rLP2086
    rLP2086 and Repevax
    Interventions:
    • Biological: rLP2086
    • Biological: Repevax
  • Placebo Comparator: Saline and Repevax
    Saline and Repevax
    Interventions:
    • Biological: Saline
    • Biological: Repevax
Vesikari T, Wysocki J, Beeslaar J, Eiden J, Jiang Q, Jansen KU, Jones TR, Harris SL, O'Neill RE, York LJ, Perez JL. Immunogenicity, Safety, and Tolerability of Bivalent rLP2086 Meningococcal Group B Vaccine Administered Concomitantly With Diphtheria, Tetanus, and Acellular Pertussis and Inactivated Poliomyelitis Vaccines to Healthy Adolescents. J Pediatric Infect Dis Soc. 2016 Jun;5(2):180-7. doi: 10.1093/jpids/piv064. Epub 2016 Jan 23.


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
753
February 2013
October 2012   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
11 Years to 18 Years   (Child, Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Finland,   Germany,   Poland
 
 
NCT01323270
B1971010
6108A1-2008 ( Other Identifier: Alias Study Number )
2010-022449-38 ( EudraCT Number )
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
April 2015

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



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