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

Phase 2

Completed

Conditions: Vaccines
Meningococcal Vaccines

Interventions: Biological: rLP2086 + MCV4 + Tdap
Biological: MCV4 + Tdap + saline
Biological: rLP2086 + saline

Registration Number: NCT01461980

Lead Sponsor: Pfizer

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 available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 2648

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
MCV4 + Tdap+ rLP2086	rLP2086 + MCV4 + Tdap	Group 1 - MCV4 + Tdap + rLP2086
MCV4 + Tdap + saline	MCV4 + Tdap + saline	Group 2, MCV4 + Tdap+ saline
Saline + saline + rLP2086	rLP2086 + saline	Group 3- rLP2086 + saline

Primary Outcome Measures

Name	Time	Method
Geometric Mean Concentrations (GMC) for Diphtheria and Tetanus Antigens	1 Month after Vaccination 1	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.
Serum Bactericidal Assay Using Human Complement (hSBA) GMTs of PMB80 [A22] and PMB2948 [B24] 1 Month After Vaccination 3	1 Month after Vaccination 3	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.
Geometric Mean Concentrations (GMC) for Acellular Pertussis Antigens	1 Month after Vaccination 1	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	1 Month after Vaccination 1	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.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level	Before Vaccination 1, 1 Month after Vaccination (Vac) 2, 3	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.
Percentage of Participants With Seroresponse for Tetanus, Diphtheria and Acellular Pertussis (Tdap) and Meningococcal Conjugate Vaccine (MCV4) Antigens	1 Month after Vaccination 1	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.
Serum Bactericidal Assay Using Human Complement (hSBA) GMTs of PMB80 [A22] and PMB2948 [B24] Before Vaccination 1 and 1 Month After Vaccination 2	Before Vaccination 1, 1 Month after Vaccination (Vac) 2	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)	Before Vaccination 1, 1 Month after Vaccination (Vac) 2, 3	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 Achieving Predefined Antibody Level for Diphtheria and Tetanus Antigens	1 Month after Vaccination 1	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.

Trial Locations

Locations (98): The Children's Clinic of Jonesboro, PA
🇺🇸
Jonesboro, Arkansas, United States
Center for Clinical Trials, LLC
🇺🇸
Paramount, California, United States
Pediatrics and Adolescent Medicine, PA
🇺🇸
Marietta, Georgia, United States
Kaiser Permanente Fresno
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Fresno, California, United States
Bayview Research Group, LLC
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Valley Village, California, United States
Pediatric Care Medical Group
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Huntington Beach, California, United States
Kaiser Permanente Hayward
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Hayward, California, United States
Kaiser Permanente Sacramento
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Sacramento, California, United States
Loma Linda University Medical Center
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Loma Linda, California, United States
California Research Foundation
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San Diego, California, United States
Duke University Medical Center - Duke Health Center
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Durham, North Carolina, United States
Durham Pediatrics
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Durham, North Carolina, United States
Cincinnati Center for Clinical Research, Satellite Site - Clinic
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Cincinnati, Ohio, United States
Heartland Research Associates, LLC
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Wichita, Kansas, United States
Colorado Springs Family Practice
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Colorado Springs, Colorado, United States
J. Lewis Research Inc. - Foothill Family Clinic South
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Salt Lake City, Utah, United States
Clinical Research Associates, Inc.
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Nashville, Tennessee, United States
J. Lewis Resarch Incorporated, Foothill Family Clinic
🇺🇸
Salt Lake City, Utah, United States
Radiant Research, Inc.
🇺🇸
Murray, Utah, United States
Clinical Research Advantage, Inc./Mesa Family Medical Center, PC
🇺🇸
Mesa, Arizona, United States
Loma Linda University Health Care Pediatric Clinic
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Loma Linda, California, United States
Loma Linda University
🇺🇸
Loma Linda, California, United States
Loma Linda University Health Care - Moreno Valley Pediatrics
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Moreno Valley, California, United States
Lynn Institute of the Rockies
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Colorado Springs, Colorado, United States
Emory University School of Medicine Department of Pediatrics
🇺🇸
Atlanta, Georgia, United States
Emory University School of Medicine
🇺🇸
Atlanta, Georgia, United States
Radiant Research, Inc
🇺🇸
Akron, Ohio, United States
North Georgia Clinical Research Center dba Whites Pediatrics
🇺🇸
Dalton, Georgia, United States
Pediatrics and Adolescent Medicine
🇺🇸
Woodstock, Georgia, United States
Advanced Clinical Research
🇺🇸
West Jordan, Utah, United States
Northern Illinois Research Associates
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DeKalb, Illinois, United States
Clinical Research Advantage, Inc./ Ridge Family Practice, PC
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Council Bluffs, Iowa, United States
Via Christi Clinic, P.A.
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Wichita, Kansas, United States
Kentucky Pediatric/Adult Research
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Bardstown, Kentucky, United States
University of Louisville Pediatrics: Children and Youth Project
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Louisville, Kentucky, United States
Brownsboro Park Pediatrics
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Louisville, Kentucky, United States
Allina Health Bandana Square Clinic
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Saint Paul, Minnesota, United States
Aspen Medical Group/ Odyssey Research
🇺🇸
Saint Paul, Minnesota, United States
Aspen Medical Group
🇺🇸
Saint Paul, Minnesota, United States
Saint Louis University
🇺🇸
Saint Louis, Missouri, United States
Mercy Health Research
🇺🇸
Saint Louis, Missouri, United States
Sundance Clinical Research, LLC
🇺🇸
Saint Louis, Missouri, United States
Clinical Research Advantage, Inc. / Prairie Fields Family Medicine, PC
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Fremont, Nebraska, United States
Quality Clinical Research, Inc.
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Omaha, Nebraska, United States
Creighton Pediatric Infectious Diseases Creighton University Medical Center
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Omaha, Nebraska, United States
Clinical Research Center of Nevada
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Las Vegas, Nevada, United States
Child Health Care Associates
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East Syracuse, New York, United States
Duke Health Center
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Durham, North Carolina, United States
PMG Research of Raleigh, LLC -
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Raleigh, North Carolina, United States
PMG Research of Raleigh, LLC
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Raleigh, North Carolina, United States
Innovis Health
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Fargo, North Dakota, United States
Odyssey Research
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Fargo, North Dakota, United States
Cincinnati Childrens Hospital Medical Center Gamble Program for Clinical Studies
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Cincinnati, Ohio, United States
Dr. Shelly David Senders, MD Inc. dba Senders Pediatrics
🇺🇸
Cleveland, Ohio, United States
Senders Pediatrics
🇺🇸
Cleveland, Ohio, United States
Rapid Medical Research, Inc.
🇺🇸
Cleveland, Ohio, United States
Ohio Pediatric Research Association
🇺🇸
Dayton, Ohio, United States
Ohio Pediatric Research
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Kettering, Ohio, United States
Lynn Institute of Norman (LION)
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Norman, Oklahoma, United States
Ohio Pediatrics, Inc.
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Huber Heights, Ohio, United States
Christopher Brad Redden, ARNP Healthcare One Urgent Care and Family Practice
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El Reno, Oklahoma, United States
Oklahoma State University - Center for Health Sciences - Pediatric Research
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Tulsa, Oklahoma, United States
Office of Richard Ohnmacht
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Cranston, Rhode Island, United States
Omega Medical Research
🇺🇸
Warwick, Rhode Island, United States
Charleston Pediatrics
🇺🇸
Charleston, South Carolina, United States
Tekton Research, Inc.
🇺🇸
Austin, Texas, United States
Advances in Health Research, Inc
🇺🇸
Houston, Texas, United States
West Houston Clinical Research Service
🇺🇸
Houston, Texas, United States
Pediatric Healthcare of Northwest Houston
🇺🇸
Tomball, Texas, United States
Texas Center for Drug Development, Inc.
🇺🇸
Houston, Texas, United States
Child Care Associates
🇺🇸
San Antonio, Texas, United States
Clinical Trials of Texas, Inc.
🇺🇸
San Antonio, Texas, United States
First Steps Pediatrics
🇺🇸
San Antonio, Texas, United States
Pediatric Healthcare of Northwest Houston, PA
🇺🇸
Tomball, Texas, United States
Jean Brown Research
🇺🇸
Salt Lake City, Utah, United States
J. Lewis Research, Inc. - Jordan River Family Medicine
🇺🇸
South Jordan, Utah, United States
Pediatric Associates of Charlottesville, PLC
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Charlottesville, Virginia, United States
PI-Coor Clinical Research, LLC
🇺🇸
Burke, Virginia, United States
Pediatric Associates of Charlottesville, PLC - West Satellite
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Charlottesville, Virginia, United States
Pediatric Associates of Charlottesville, PLC - North Satellite
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Charlottesville, Virginia, United States
The Vancouver Clinic
🇺🇸
Vancouver, Washington, United States
Southwestern Medical Clinic Lakeland Healthcare Affiliate
🇺🇸
Stevensville, Michigan, United States
Arkansas Pediatric Clinic
🇺🇸
Little Rock, Arkansas, United States
Norwich Pediatric Group, P.C.
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Norwich, Connecticut, United States
Clinical Research Advantage, Inc./Desert
🇺🇸
Mesa, Arizona, United States
Clinical Research Advantage Inc/ East Valley Family Physicians, PLC
🇺🇸
Chandler, Arizona, United States
PMG Research of Charleson
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Mount Pleasant, South Carolina, United States
PMG Research of Bristol
🇺🇸
Bristol, Tennessee, United States
Midwest Children's Health Research Institute
🇺🇸
Lincoln, Nebraska, United States
Internal Medicine & Pediatric Associates of Bristol, PC
🇺🇸
Bristol, Tennessee, United States
Monroe Clinic
🇺🇸
Monroe, Wisconsin, United States
Gundersen Clinic, LTD
🇺🇸
La Crosse, Wisconsin, United States
Costal Clinical Research, Inc.
🇺🇸
Daphne, Alabama, United States
Lynn Health Science Institute
🇺🇸
Oklahoma City, Oklahoma, United States
University of South Florida
🇺🇸
Tampa, Florida, United States
Bluegrass Clinical Research, Inc.
🇺🇸
Louisville, Kentucky, United States
The Center for Pharmaceutical Research, PC
🇺🇸
Kansas City, Missouri, United States
Radiant Research
🇺🇸
Columbus, Ohio, United States