Trial record 1 of 1 for:    B1971015
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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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01461980
First received: September 28, 2011
Last updated: June 23, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Vaccines
Meningococcal Vaccines
Biological: rLP2086 + MCV4 + Tdap
Biological: MCV4 + Tdap + saline
Biological: rLP2086 + saline
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: 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 > = to 10 Years to Less Than 13 Years

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • The geometric mean titers (GMTs) or geometric mean concentrations (GMCs) for each of the antibodies reactive with each of the 10 antigenic components in the marketed vaccines at visit 2, among subjects in Groups 1 and 2. [ Time Frame: Month 1 ] [ Designated as safety issue: No ]
  • The hSBA geometric mean titers (GMTs) for each of the 2 primary strains (PMB80 [A22] and PMB2948 [B24]) at visit 6, among subjects in Groups 1 and 3. [ Time Frame: Month 7 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The seroresponse rate at visit 2 for each of the 10 marketed vaccine antigens in Group 1 and Group 2. [ Time Frame: Month 1 ] [ Designated as safety issue: No ]
  • Proportion of subjects (Groups 1 and 2) who achieve an antibody level >=1.0 IU/mL to tetanus and proportion of subjects (Groups 1 and 2) who achieve an antibody level >1.0 IU/mL to diphtheria toxoid. [ Time Frame: Month 1 ] [ Designated as safety issue: No ]
  • hSBA titers as measured by GMTs for each of the 2 primary MnB test strains (PMB80 [A22] and PMB2948 [B24]) at each applicable blood sampling time point. [ Time Frame: Month 0, 1, 3, 7 ] [ Designated as safety issue: No ]
  • Proportion of subjects with hSBA titers ≥LLOQ, ≥1:4, ≥1:8, ≥1:16 , ≥1:32, ≥1:64, ≥1:128 at each blood draw visit, for each of the 2 primary strains (PMB80 [A22] and PMB2948 [B24]). [ Time Frame: Month 0, 1, 3, 7 ] [ Designated as safety issue: No ]
  • Exploratory immunogenicity endpoints will be applied to MCV4 antigenic components in subjects from Group 1 and Group 2. The exploratory endpoints are IgG response (measured as GMCs) in serogroups A, C, Y and W-135. [ Time Frame: Month 1 ] [ Designated as safety issue: No ]
  • Proportion of subjects achieving at least a 4-fold increase in hSBA titer from baseline to 1-month after the second and the third vaccination with the bivalent rLP2086 vaccine for each of the 2 primary strains (PMB80 [A22], PMB2948 [B24]). [ Time Frame: Month 3, 7 ] [ Designated as safety issue: No ]
  • Safety measured by subjects reporting adverse events and use of antipyretic medication. [ Time Frame: Throughout the study. ] [ Designated as safety issue: Yes ]

Enrollment: 2657
Study Start Date: September 2011
Study Completion Date: May 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: MCV4 + Tdap+ rLP2086
Group 1 - MCV4 + Tdap + rLP2086
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.
Active Comparator: MCV4 + Tdap + saline
Group 2, MCV4 + Tdap+ saline
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.
Placebo Comparator: Saline + saline + rLP2086
Group 3- rLP2086 + saline
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).

  Eligibility

Ages Eligible for Study:   10 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01461980

  Hide Study Locations
Locations
United States, Alabama
Pfizer Investigational Site
Birmingham, Alabama, United States, 35209
Pfizer Investigational Site
Daphne, Alabama, United States, 36526
United States, Arizona
Pfizer Investigational Site
Chandler, Arizona, United States, 85224
Pfizer Investigational Site
Mesa, Arizona, United States, 85213
Pfizer Investigational Site
Tucson, Arizona, United States, 85712
United States, Arkansas
Pfizer Investigational Site
Jonesboro, Arkansas, United States, 72401
Pfizer Investigational Site
Little Rock, Arkansas, United States, 72205
United States, California
Pfizer Investigational Site
Fresno, California, United States, 93726
Pfizer Investigational Site
Hayward, California, United States, 94545
Pfizer Investigational Site
Huntington Beach, California, United States, 92647-7180
Pfizer Investigational Site
Loma Linda, California, United States, 92354
Pfizer Investigational Site
Loma Linda, California, United States, 92350
Pfizer Investigational Site
Moreno Valley, California, United States, 92557
Pfizer Investigational Site
Paramount, California, United States, 90723
Pfizer Investigational Site
Sacramento, California, United States, 95815
Pfizer Investigational Site
San Diego, California, United States, 92103
Pfizer Investigational Site
Valley Village, California, United States, 91607
United States, Colorado
Pfizer Investigational Site
Colorado Springs, Colorado, United States, 80907
Pfizer Investigational Site
Colorado Springs, Colorado, United States, 80909
Pfizer Investigational Site
Denver, Colorado, United States, 80239
United States, Connecticut
Pfizer Investigational Site
Norwich, Connecticut, United States, 06360
United States, Florida
Pfizer Investigational Site
Tampa, Florida, United States, 33606
United States, Georgia
Pfizer Investigational Site
Atlanta, Georgia, United States, 30322
Pfizer Investigational Site
Atlanta, Georgia, United States, 30342
Pfizer Investigational Site
Dalton, Georgia, United States, 30721
Pfizer Investigational Site
Marietta, Georgia, United States, 30062
Pfizer Investigational Site
Woodstock, Georgia, United States, 30189
United States, Idaho
Pfizer Investigational Site
Meridian, Idaho, United States, 83642
United States, Illinois
Pfizer Investigational Site
DeKalb, Illinois, United States, 60115
United States, Iowa
Pfizer Investigational Site
Council Bluffs, Iowa, United States, 51503
United States, Kansas
Pfizer Investigational Site
Augusta, Kansas, United States, 67010
Pfizer Investigational Site
Wichita, Kansas, United States, 67207
Pfizer Investigational Site
Wichita, Kansas, United States, 67208
United States, Kentucky
Pfizer Investigational Site
Bardstown, Kentucky, United States, 40004
Pfizer Investigational Site
Louisville, Kentucky, United States, 40291
Pfizer Investigational Site
Louisville, Kentucky, United States, 40202
United States, Michigan
Pfizer Investigational Site
Stevensville, Michigan, United States, 49127
United States, Minnesota
Pfizer Investigational Site
Saint Pail, Minnesota, United States, 55108
Pfizer Investigational Site
Saint Paul, Minnesota, United States, 55108
Pfizer Investigational Site
St. Paul, Minnesota, United States, 55108
United States, Missouri
Pfizer Investigational Site
Kansas City, Missouri, United States, 64114
Pfizer Investigational Site
Saint Louis, Missouri, United States, 63104
Pfizer Investigational Site
St. Louis, Missouri, United States, 63141
United States, Nebraska
Pfizer Investigational Site
Fremont, Nebraska, United States, 68025
Pfizer Investigational Site
Lincoln, Nebraska, United States, 68504
Pfizer Investigational Site
Omaha, Nebraska, United States, 68114
Pfizer Investigational Site
Omaha, Nebraska, United States, 68131
United States, Nevada
Pfizer Investigational Site
Henderson, Nevada, United States, 89014
Pfizer Investigational Site
Las Vegas, Nevada, United States, 89104
United States, New York
Pfizer Investigational Site
East Syracuse, New York, United States, 13057
Pfizer Investigational Site
Syracuse, New York, United States, 13210
United States, North Carolina
Pfizer Investigational Site
Durham, North Carolina, United States, 27705
Pfizer Investigational Site
Durham, North Carolina, United States, 27704
Pfizer Investigational Site
Raleigh, North Carolina, United States, 27609
Pfizer Investigational Site
Raleigh, North Carolina, United States, 27612
United States, North Dakota
Pfizer Investigational Site
Fargo, North Dakota, United States, 58103
United States, Ohio
Pfizer Investigational Site
Akron, Ohio, United States, 44311
Pfizer Investigational Site
Cincinnati, Ohio, United States, 45206
Pfizer Investigational Site
Cincinnati, Ohio, United States, 45229-3039
Pfizer Investigational Site
Cleveland, Ohio, United States, 44122
Pfizer Investigational Site
Columbus, Ohio, United States, 43212
Pfizer Investigational Site
Dayton, Ohio, United States, 45414
Pfizer Investigational Site
Huber Heights, Ohio, United States, 45424
Pfizer Investigational Site
Kettering, Ohio, United States, 45420
Pfizer Investigational Site
South Euclid, Ohio, United States, 44121
United States, Oklahoma
Pfizer Investigational Site
El Reno, Oklahoma, United States, 73036
Pfizer Investigational Site
Norman, Oklahoma, United States, 73069
Pfizer Investigational Site
Oklahoma City, Oklahoma, United States, 73112
Pfizer Investigational Site
Tulsa, Oklahoma, United States, 74127
United States, Rhode Island
Pfizer Investigational Site
Cranston, Rhode Island, United States, 02920
Pfizer Investigational Site
Warwick, Rhode Island, United States, 02886
United States, South Carolina
Pfizer Investigational Site
Anderson, South Carolina, United States, 29621
Pfizer Investigational Site
Charleston, South Carolina, United States, 29401
Pfizer Investigational Site
Mount Pleasant, South Carolina, United States, 29464
United States, Tennessee
Pfizer Investigational Site
Bristol, Tennessee, United States, 37620
Pfizer Investigational Site
Nashville, Tennessee, United States, 37203
United States, Texas
Pfizer Investigational Site
Austin, Texas, United States, 78745
Pfizer Investigational Site
Dallas, Texas, United States, 75231
Pfizer Investigational Site
Houston, Texas, United States, 77030
Pfizer Investigational Site
Houston, Texas, United States, 77070
Pfizer Investigational Site
Houston, Texas, United States, 77081
Pfizer Investigational Site
Houston, Texas, United States, 77055
Pfizer Investigational Site
San Antonio, Texas, United States, 78212
Pfizer Investigational Site
San Antonio, Texas, United States, 78229
Pfizer Investigational Site
Tomball, Texas, United States, 77375
United States, Utah
Pfizer Investigational Site
Murray, Utah, United States, 84123
Pfizer Investigational Site
Salt Lake City, Utah, United States, 84109
Pfizer Investigational Site
Salt Lake City, Utah, United States, 84124
Pfizer Investigational Site
Salt Lake City, Utah, United States, 84121
Pfizer Investigational Site
South Jordan, Utah, United States, 84095
Pfizer Investigational Site
West Jordan, Utah, United States, 84088
United States, Virginia
Pfizer Investigational Site
Burke, Virginia, United States, 22015
Pfizer Investigational Site
Charlottesville, Virginia, United States, 22911
Pfizer Investigational Site
Charlottesville, Virginia, United States, 22903
Pfizer Investigational Site
Charlottesville, Virginia, United States, 22902
United States, Washington
Pfizer Investigational Site
Vancouver, Washington, United States, 98664
Pfizer Investigational Site
Vancouver, Washington, United States, 98686
United States, Wisconsin
Pfizer Investigational Site
La Crosse, Wisconsin, United States, 54601
Pfizer Investigational Site
Monroe, Wisconsin, United States, 53566
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01461980     History of Changes
Other Study ID Numbers: B1971015, 6108A1-2005
Study First Received: September 28, 2011
Last Updated: June 23, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
vaccine
rLP2086
MCV4
Tdap
meningitis B
N. meningitidis serogroup B
adolescents
observer-blind

ClinicalTrials.gov processed this record on October 20, 2014