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: May 7, 2015
Last verified: May 2015
  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 > = 10 To <13 Years

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Geometric Mean Concentrations (GMC) for Diphtheria and Tetanus Antigens [ Time Frame: 1 Month after Vaccination 1 ] [ Designated as safety issue: No ]
    Antibody GMCs of 2 antigens of diphtheria and tetanus toxoid were computed in International Units per milliliter (IU/mL) along with corresponding 2-sided 95 percent (%) confidence intervals (CIs). Here, 'number of participants analyzed' signifies participants with valid and determinate assay results for given antigen.

  • Geometric Mean Concentrations (GMC) for Acellular Pertussis Antigens [ Time Frame: 1 Month after Vaccination 1 ] [ Designated as safety issue: No ]
    Antibody GMCs of 4 acellular pertussis antigens (pertussis toxoid, pertussis filamentous hemagglutinin, pertussis pertactin and pertussis fimbrial agglutinogens types 2+3) were computed in Enzyme-linked immunosorbent assay (ELISA) units per milliliter (EU/mL) along with corresponding 2-sided 95% CIs.

  • Geometric Mean Titer (GMT) for Meningococcal Conjugate Vaccine (MCV4) Antigens [ Time Frame: 1 Month after Vaccination 1 ] [ Designated as safety issue: No ]
    Antibody GMTs of 4 MCV4 antigens (serogroup A, serogroup C, serogroup Y and serogroup W-135) were computed along with corresponding 2-sided 95% CIs.

  • Serum Bactericidal Assay Using Human Complement (hSBA) GMTs of PMB80 [A22] and PMB2948 [B24] 1 Month After Vaccination 3 [ Time Frame: 1 Month after Vaccination 3 ] [ Designated as safety issue: No ]
    Antibody hSBA GMTs of primary strain PMB80 [A22] and PMB2948 [B24] were computed along with corresponding 2-sided 95% CIs. hSBA titers from the 2 primary strains were logarithmically transformed for analysis. Here, 'number of participants analyzed' signifies evaluable immunogenicity population and 'N' signifies participants with valid and determinate assay results for given strain for each group, respectively.


Secondary Outcome Measures:
  • Percentage of Participants With Seroresponse for Tetanus, Diphtheria and Acellular Pertussis (Tdap) and Meningococcal Conjugate Vaccine (MCV4) Antigens [ Time Frame: 1 Month after Vaccination 1 ] [ Designated as safety issue: No ]
    Seroconversion rate for Tdap antigens was defined as greater than or equal to (>=) 4-, 2-fold rise in antibody concentration, if prevaccination antibody concentration was less than or equal to (<=), greater than (>) cutoff value, respectively. For MCV4 antigens >=4-fold rise on serum bactericidal assay using rabbit complement (rSBA) titers if baseline value >= lower limit of quantitation (LLOQ), postdose rSBA titers >=2×LLOQ if baseline value was less than (<) LLOQ. Cutoff value =0.1 IU/mL for diphtheria and tetanus, 0.9,2.9,3.0,10.6 EU/mL for pertussis toxoid, filamentous hemagglutinin, pertactin, fimbriae agglutinogens types 2 + 3, respectively.

  • Percentage of Participants Achieving Predefined Antibody Level for Diphtheria and Tetanus Antigens [ Time Frame: 1 Month after Vaccination 1 ] [ Designated as safety issue: No ]
    Participants with antibody concentration level of greater than or equal to 1.0 IU/mL for diphtheria and tetanus antigens were computed along with corresponding 2-sided 95% CIs.

  • Serum Bactericidal Assay Using Human Complement (hSBA) GMTs of PMB80 [A22] and PMB2948 [B24] Before Vaccination 1 and 1 Month After Vaccination 2 [ Time Frame: Before Vaccination 1, 1 Month after Vaccination (Vac) 2 ] [ Designated as safety issue: No ]
    Antibody hSBA of primary strain PMB80 [A22] and PMB2948 [B24] were computed along with corresponding 2-sided 95% CIs. hSBA titers from the 2 primary strains were logarithmically transformed for analysis.

  • Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Lower Limit of Quantitation (LLOQ) [ Time Frame: Before Vaccination 1, 1 Month after Vaccination (Vac) 2, 3 ] [ Designated as safety issue: No ]
    Percentage of participants achieving hSBA titer >= LLOQ were computed along with corresponding 2-sided 95% CIs. LLOQ was 1:16 for PMB80 [A22] and 1:8 for PMB2948 [B24].

  • Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level [ Time Frame: Before Vaccination 1, 1 Month after Vaccination (Vac) 2, 3 ] [ Designated as safety issue: No ]
    Antibody hSBA of primary strain PMB80 [A22] and PMB2948 [B24] with hSBA titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and >=1:128 were computed along with corresponding 2-sided 95% CIs.


Other Outcome Measures:
  • Immunogloblulin G (IgG) Measured by GMC [ Time Frame: Before Vaccination 1, 1 Month after Vaccination 1 ] [ Designated as safety issue: No ]
    IgG GMCs of 4 MCV4 antigens (serogroup A, serogroup C, serogroup Y and serogroup W-135) of participants were computed along with corresponding 2-sided 95% CIs. CIs were back transformations of confidence levels based on Student t distribution for mean logarithm of titers.

  • Percentage of Participants Achieving at Least 4-Fold Increase in Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level [ Time Frame: 1 Month after Vaccination (Vac) 2, 3 ] [ Designated as safety issue: No ]
  • Percentage of Participants With at Least One Adverse Event (AE) [ Time Frame: Vaccination phase (baseline up to 1 month after Vaccination 3); Follow-up phase (from 1 month up to 6 months after Vaccination 3) ] [ Designated as safety issue: Yes ]
    An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship.


Enrollment: 2648
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
Radiant Research, Inc.
Birmingham, Alabama, United States, 35209
Costal Clinical Research, Inc.
Daphne, Alabama, United States, 36526
United States, Arizona
Clinical Research Advantage Inc/ East Valley Family Physicians, PLC
Chandler, Arizona, United States, 85224
Radiant Research, Inc.
Chandler, Arizona, United States, 85224
Clinical Research Advantage, Inc./Desert
Mesa, Arizona, United States, 85213
Clinical Research Advantage, Inc./Mesa Family Medical Center, PC
Mesa, Arizona, United States, 85203
Radiant Research, Inc.
Tucson, Arizona, United States, 85710
Radiant Research, Inc.
Tucson, Arizona, United States, 85712
United States, Arkansas
The Children's Clinic of Jonesboro, PA
Jonesboro, Arkansas, United States, 72401
Arkansas Pediatric Clinic
Little Rock, Arkansas, United States, 72205
United States, California
Kaiser Permanente Fresno
Fresno, California, United States, 93726
Kaiser Permanente Hayward
Hayward, California, United States, 94545
Pediatric Care Medical Group
Huntington Beach, California, United States, 92647
Loma Linda University
Loma Linda, California, United States, 92350
Loma Linda University Health Care Pediatric Clinic
Loma Linda, California, United States, 92354
Loma Linda University Medical Center
Loma Linda, California, United States, 92354
Loma Linda University Health Care - Moreno Valley Pediatrics
Moreno Valley, California, United States, 92557
Bayview Research Group, LLC
Paramount, California, United States, 90723
Center for Clinical Trials, LLC
Paramount, California, United States, 90723
Kaiser Permanente Sacramento
Sacramento, California, United States, 95815
California Research Foundation
San Diego, California, United States, 92103
Bayview Research Group, LLC
Valley Village, California, United States, 91607
United States, Colorado
Colorado Springs Family Practice
Colorado Springs, Colorado, United States, 80909
Lynn Institute of the Rockies
Colorado Springs, Colorado, United States, 80907
Radiant Research, Inc.
Denver, Colorado, United States, 80239
United States, Connecticut
Norwich Pediatric Group, P.C.
Norwich, Connecticut, United States, 06360
United States, Florida
University of South Florida
Tampa, Florida, United States, 33606
United States, Georgia
Emory University School of Medicine
Atlanta, Georgia, United States, 30322
Emory University School of Medicine Department of Pediatrics
Atlanta, Georgia, United States, 30322
Radiant Research, Inc
Atlanta, Georgia, United States, 30342
North Georgia Clinical Research Center dba Whites Pediatrics
Dalton, Georgia, United States, 30721
Pediatrics and Adolescent Medicine, PA
Marietta, Georgia, United States, 30062
Pediatrics and Adolescent Medicine
Woodstock, Georgia, United States, 30189
United States, Idaho
Advanced Clinical Research
Meridian, Idaho, United States, 83642
United States, Illinois
Northern Illinois Research Associates
DeKalb, Illinois, United States, 60115
United States, Iowa
Clinical Research Advantage, Inc./ Ridge Family Practice, PC
Council Bluffs, Iowa, United States, 51503
United States, Kansas
Heartland Research Associates, LLC
Augusta, Kansas, United States, 67010
Via Christi Clinic, P.A.
Wichita, Kansas, United States, 67208
Heartland Research Associates, LLC
Wichita, Kansas, United States, 67207
United States, Kentucky
Kentucky Pediatric/Adult Research
Bardstown, Kentucky, United States, 40004
University of Louisville Pediatrics: Children and Youth Project
Louisville, Kentucky, United States, 40202
Bluegrass Clinical Research, Inc.
Louisville, Kentucky, United States, 40291
Brownsboro Park Pediatrics
Louisville, Kentucky, United States, 40207
United States, Michigan
Southwestern Medical Clinic Lakeland Healthcare Affiliate
Stevensville, Michigan, United States, 49127
United States, Minnesota
Aspen Medical Group/ Odyssey Research
Saint Pail, Minnesota, United States, 55108
Aspen Medical Group
Saint Paul, Minnesota, United States, 55108
Allina Health Bandana Square Clinic
St. Paul, Minnesota, United States, 55108
United States, Missouri
The Center for Pharmaceutical Research, PC
Kansas City, Missouri, United States, 64114
Saint Louis University
Saint Louis, Missouri, United States, 63104
Mercy Health Research
St. Louis, Missouri, United States, 63141
Radiant Research, Inc.
St. Louis, Missouri, United States, 63141
Sundance Clinical Research, LLC
St. Louis, Missouri, United States, 63141
United States, Nebraska
Clinical Research Advantage, Inc. / Prairie Fields Family Medicine, PC
Fremont, Nebraska, United States, 68025
Midwest Children's Health Research Institute
Lincoln, Nebraska, United States, 68504
Quality Clinical Research, Inc.
Omaha, Nebraska, United States, 68114
Creighton Pediatric Infectious Diseases Creighton University Medical Center
Omaha, Nebraska, United States, 68131
United States, Nevada
Clinical Research Center of Nevada
Henderson, Nevada, United States, 89014
Clinical Research Center of Nevada
Las Vegas, Nevada, United States, 89105
United States, New York
Child Health Care Associates
East Syracuse, New York, United States, 13057
SUNY Upstate Medical University
Syracuse, New York, United States, 13210
United States, North Carolina
Durham Pediatrics
Durham, North Carolina, United States, 27704
Duke Health Center
Durham, North Carolina, United States, 27705
Duke University Medical Center - Duke Health Center
Durham, North Carolina, United States, 27704
PMG Research of Raleigh, LLC
Raleigh, North Carolina, United States, 27609
PMG Research of Raleigh, LLC
Raleigh, North Carolina, United States, 27612
PMG Research of Raleigh, LLC -
Raleigh, North Carolina, United States, 27609
United States, North Dakota
Innovis Health
Fargo, North Dakota, United States, 58103
Odyssey Research
Fargo, North Dakota, United States, 58104
United States, Ohio
Radiant Research, Inc
Akron, Ohio, United States, 44311
Cincinnati Childrens Hospital Medical Center Gamble Program for Clinical Studies
Cincinnati, Ohio, United States, 45229-3039
Cincinnati Center for Clinical Research, Satellite Site - Clinic
Cincinnati, Ohio, United States, 45206
Senders Pediatrics
Cleveland, Ohio, United States, 44121
Dr. Shelly David Senders, MD Inc. dba Senders Pediatrics
Cleveland, Ohio, United States, 44121
Rapid Medical Research, Inc.
Cleveland, Ohio, United States, 44122
Radiant Research
Columbus, Ohio, United States, 43212
Ohio Pediatric Research Association
Dayton, Ohio, United States, 45414
Ohio Pediatrics, Inc.
Dayton, Ohio, United States, 45414
Ohio Pediatrics, Inc.
Huber Heights, Ohio, United States, 45424
Ohio Pediatric Research
Kettering, Ohio, United States, 45420
United States, Oklahoma
Christopher Brad Redden, ARNP Healthcare One Urgent Care and Family Practice
El Reno, Oklahoma, United States, 73036
Lynn Institute of Norman (LION)
Norman, Oklahoma, United States, 73069
Lynn Health Science Institute
Oklahoma City, Oklahoma, United States, 73112
Oklahoma State University - Center for Health Sciences - Pediatric Research
Tulsa, Oklahoma, United States, 74127
United States, Rhode Island
Office of Richard Ohnmacht
Cranston, Rhode Island, United States, 02920
Omega Medical Research
Warwick, Rhode Island, United States, 02886
United States, South Carolina
Radiant Research, Inc.
Anderson, South Carolina, United States, 29621
Charleston Pediatrics
Charleston, South Carolina, United States, 29401
PMG Research of Charleson
Mount Pleasant, South Carolina, United States, 29464
United States, Tennessee
PMG Research of Bristol
Bristol, Tennessee, United States, 37620
Internal Medicine & Pediatric Associates of Bristol, PC
Bristol, Tennessee, United States, 37620
Clinical Research Associates, Inc.
Nashville, Tennessee, United States, 37203
United States, Texas
Tekton Research, Inc.
Austin, Texas, United States, 78745
Radiant Research, Inc.
Dallas, Texas, United States, 75231
Advances in Health Research, Inc
Houston, Texas, United States, 77030
West Houston Clinical Research Service
Houston, Texas, United States, 77055
Pediatric Healthcare of Northwest Houston
Houston, Texas, United States, 77070
Texas Center for Drug Development, Inc.
Houston, Texas, United States, 77081
Pediatric Healthcare of Northwest Houston
Houston, Texas, United States, 77065
Child Care Associates
San Antonio, Texas, United States, 78212
Clinical Trials of Texas, Inc.
San Antonio, Texas, United States, 78229
First Steps Pediatrics
San Antonio, Texas, United States, 78254
Radiant Research, Inc.
San Antonio, Texas, United States, 78229
Pediatric Healthcare of Northwest Houston
Tomball, Texas, United States, 77375
Pediatric Healthcare of Northwest Houston, PA
Tomball, Texas, United States, 77375
United States, Utah
Radiant Research, Inc.
Murray, Utah, United States, 84123
J. Lewis Research Inc. - Foothill Family Clinic South
Salt Lake City, Utah, United States, 84121
Jean Brown Research
Salt Lake City, Utah, United States, 84124
J. Lewis Resarch Incorporated, Foothill Family Clinic
Salt Lake City, Utah, United States, 84109
J. Lewis Research, Inc. - Jordan River Family Medicine
South Jordan, Utah, United States, 84095
Advanced Clinical Research
West Jordan, Utah, United States, 84088
United States, Virginia
PI-Coor Clinical Research, LLC
Burke, Virginia, United States, 22015
Pediatric Associates of Charlottesville, PLC - West Satellite
Charlottesville, Virginia, United States, 22903
Pediatric Associates of Charlottesville, PLC - North Satellite
Charlottesville, Virginia, United States, 22911
Pediatric Associates of Charlottesville, PLC
Charlottesville, Virginia, United States, 22902
United States, Washington
The Vancouver Clinic
Vancouver, Washington, United States, 98664
The Vancouver Clinic
Vancouver, Washington, United States, 98686
United States, Wisconsin
Gundersen Clinic, LTD
La Crosse, Wisconsin, United States, 54601
Monroe Clinic
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
Results First Received: May 7, 2015
Last Updated: May 7, 2015
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 July 01, 2015