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A Clinical Trial to Study the Safety, Tolerance and Immunogenic Response to MCV4, Tdap and Bivalent rLP2086 Vaccine When Given at the Same Time to Children Between the Ages of 10 Through 12 Years of Age

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NCT01461980

Last updated on March 26, 2020
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FOR MORE INFORMATION
Study Location
Radiant Research, Inc.
Birmingham, Alabama, 35209 United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Vaccines, Meningococcal Vaccines
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
10-12 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 (ICD) indicating
that the subject (and a legally authorized representative) has been informed of all
pertinent aspects of the study.

- Parent /legally authorized representative and subjects who are willing and able to
comply with scheduled visits, laboratory tests, and other study procedures.

- Male or female subject aged greater than or equal to 10 and 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 (5-dose series is preferred, 4-dose catch up series is
allowed) of diphtheria, tetanus and pertussis (whole cell or acellular) vaccines per
country specific recommendations applicable at the time of receipt.

- Male and female subjects of childbearing potential must agree to use a highly
effective method of contraception throughout the study.

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 or pertussis vaccine within 5 years of the
first study vaccination.

- Previous vaccination with any MCV4 vaccine.

- A previous anaphylactic reaction to any vaccine or vaccine-related component.

- Contraindication to vaccination with MCV4 and/or Tdap vaccine.

- Subjects receiving any allergen immunotherapy with a non-licensed product or
receiving allergen immunotherapy with a licensed product and are not on stable
maintenance doses.

- Bleeding diathesis or condition associated with prolonged bleeding time that would
contraindicate intramuscular injection.

- A known or suspected defect of the immune system that would prevent an immune
response to the vaccine, such as subjects with congenital or acquired defects in B
cell function, those receiving chronic systemic (oral, intravenous or intramuscular)
corticosteroid therapy, or those receiving immunosuppressive therapy. Subjects with
terminal complement deficiency may not be included.

- History of culture-proven disease caused by Neisseria meningitidis or Neisseria
gonorrhoea.

- 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.

- Any neuroinflammatory or autoimmune condition, including, but not limited to,
transverse myelitis, uveitis, optic neuritis, and multiple sclerosis.

NCT01461980
Pfizer
Completed
A Clinical Trial to Study the Safety, Tolerance and Immunogenic Response to MCV4, Tdap and Bivalent rLP2086 Vaccine When Given at the Same Time to Children Between the Ages of 10 Through 12 Years of Age

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Descriptive Information
Brief Title  ICMJE A Clinical Trial to Study the Safety, Tolerance and Immunogenic Response to MCV4, Tdap and Bivalent rLP2086 Vaccine When Given at the Same Time to Children Between the Ages of 10 Through 12 Years of Age
Official Title  ICMJE A Phase 2, Randomized, Active-controlled, Observer-blinded Trial, To Assess The Safety, Tolerability, And Immunogenicity Of Mcv4, Tdap Vaccine And Bivalent Rlp2086 Vaccine When Administered Concomitantly In Healthy Subjects Aged > = 10 To <13 Years
Brief Summary This is a clinical study to assess the safety, tolerance and immunogenic response to MCV4(quadrivalent meningococcal polysaccharide conjugate, meningococcal serogroups A,C,Y, and W135), Tdap (diphtheria, tetanus, and acellular pertussis), and bivalent rLP2086 vaccine. Healthy male and female subjects, between the ages of 10 to 12 years old, will be randomized into 1 of 3 groups. The subjects, investigators, site staff and sponsor will be blinded to all injections given throughout the study. An unblinded administrator will be responsible to administer the vaccinations to all subjects and will be unblinded to the subject randomization in order to determine which subjects were in randomized to group 3 so they may receive their catch-up vaccinations of MCV4 and Tdap. A final telephone contact will be conducted with all subjects 6-months post their last vaccination to obtain safety information.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Vaccines
  • Meningococcal Vaccines
Intervention  ICMJE
  • Biological: rLP2086 + MCV4 + Tdap
    At visit 1, group 1 will receive MCV4 + Tdap vaccines concomitantly with an injection of rLP2086. At visits 3 and 5 (Months 2 and 6), group 1 will receive an injection of rLP2086.
  • Biological: MCV4 + Tdap + saline
    At visit 1, group 2 will receive MCV4 + Tdap vaccines concomitantly with an injection of saline. At visits 3 and 5 (months 2 and 6), this group will receive a saline injection only.
  • Biological: rLP2086 + saline
    At visit 1, group 3 will receive 2 injections of saline concomitantly with an injection of rLP2086. At visits 3 and 5 (Months 2 and 6), group 3 will receive an injection of rLP2086. Subjects randomized to this group will receive MCV4 and Tdap following their final visit blood draw (Visit 6).
Study Arms  ICMJE
  • Active Comparator: MCV4 + Tdap+ rLP2086
    Group 1 - MCV4 + Tdap + rLP2086
    Intervention: Biological: rLP2086 + MCV4 + Tdap
  • Active Comparator: MCV4 + Tdap + saline
    Group 2, MCV4 + Tdap+ saline
    Intervention: Biological: MCV4 + Tdap + saline
  • Placebo Comparator: Saline + saline + rLP2086
    Group 3- rLP2086 + saline
    Intervention: Biological: rLP2086 + saline
Publications * Not Provided


*   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: May 7, 2015) 		2648
Original Estimated Enrollment  ICMJE
 (submitted: October 26, 2011) 		2625
Actual Study Completion Date  ICMJE May 8, 2014
Actual Primary Completion Date May 8, 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Evidence of a personally signed and dated informed consent document (ICD) indicating that the subject (and a legally authorized representative) has been informed of all pertinent aspects of the study.
  • Parent /legally authorized representative and subjects who are willing and able to comply with scheduled visits, laboratory tests, and other study procedures.
  • Male or female subject aged greater than or equal to 10 and <13 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 (5-dose series is preferred, 4-dose catch up series is allowed) of diphtheria, tetanus and pertussis (whole cell or acellular) vaccines per country specific recommendations applicable at the time of receipt.
  • Male and female subjects of childbearing potential must agree to use a highly effective method of contraception throughout the study.

Exclusion Criteria:

  • Previous vaccination with any meningococcal serogroup B vaccine.
  • Vaccination with any diphtheria, tetanus or pertussis vaccine within 5 years of the first study vaccination.
  • Previous vaccination with any MCV4 vaccine.
  • A previous anaphylactic reaction to any vaccine or vaccine-related component.
  • Contraindication to vaccination with MCV4 and/or Tdap vaccine.
  • Subjects receiving any allergen immunotherapy with a non-licensed product or receiving allergen immunotherapy with a licensed product and are not on stable maintenance doses.
  • Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection.
  • A known or suspected defect of the immune system that would prevent an immune response to the vaccine, such as subjects with congenital or acquired defects in B cell function, those receiving chronic systemic (oral, intravenous or intramuscular) corticosteroid therapy, or those receiving immunosuppressive therapy. Subjects with terminal complement deficiency may not be included.
  • History of culture-proven disease caused by Neisseria meningitidis or Neisseria gonorrhoea.
  • 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.
  • Any neuroinflammatory or autoimmune condition, including, but not limited to, transverse myelitis, uveitis, optic neuritis, and multiple sclerosis.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 10 Years to 12 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01461980
Other Study ID Numbers  ICMJE B1971015
6108A1-2005 ( Other Identifier: Alias Study 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 November 2018

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 the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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