US-licensed Combined Vaccine Against Tetanus & Diphtheria, Given With US-licensed Vaccine Against Meningococcal Disease
Safety & Immunogenicity of a Booster Dose of dTPa Vaccine (Boostrix®) Co-admnd. With Aventis Pasteur's Meningococcal (Serogroups A, C, Y and W-135) Polysaccharide Vaccine (Menactra™) vs Admn. of Either Vaccine Alone in Healthy Adolescents
1 other identifier
interventional
1,344
1 country
24
Brief Summary
New immunization recommendations in the US include vaccination of adolescents against pertussis and meningococcal disease. The Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention recommends that Tdap (Tetanus Toxoid, Reduced Diphtheria Toxoid And Acellular Pertussis Vaccine Adsorbed) and MCV4 (Meningococcal conjugate vaccine against serotypes A, C, Y and W-135) vaccines be administered to adolescents at the same office visit if vaccination with both vaccines is indicated. Therefore, this study is designed to evaluate the safety and immunogenicity of a booster vaccination with Boostrix co-administered with Menactra as compared to the administration of either vaccine alone in healthy adolescents 11 - 18 years of age.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Jan 2006
Shorter than P25 for phase_4
24 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 25, 2006
CompletedStudy Start
First participant enrolled
January 25, 2006
CompletedFirst Posted
Study publicly available on registry
January 26, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 8, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
August 8, 2006
CompletedResults Posted
Study results publicly available
March 16, 2017
CompletedAugust 17, 2018
June 1, 2018
7 months
January 25, 2006
January 23, 2017
June 20, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Number of Subjects With Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies
Cut-off values assessed were greater than or equal to 1.0 international units per milliliter (IU/mL).
At Month 1 (post Boostrix vaccination)
Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations
Concentrations were presented as geometric mean concentrations (GMCs), expressed in enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).
At Month 1 (post Boostrix vaccination)
Number of Subjects With Booster Responses for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibodies
Booster responses for anti-PT, anti-FHA and anti-PRN antibodies were defined as: for initially seronegative subjects (pre-vaccination concentration below the cut-off concentration of 5 EL.U/mL): antibody concentrations at least four times the cut-off (postvaccination concentration ≥ 20 EL.U/mL) one month after vaccination with the Boostrix vaccine; for initially seropositive subjects with pre-vaccination concentration ≥5 EL.U/mL and \< 20 EL.U/mL: an increase in antibody concentrations of at least four times the pre-vaccination concentration, one month after vaccination with the Boostrix vaccine; and for initially seropositive subjects with pre-vaccination concentration ≥ 20 EL.U/mL: an increase in antibody concentrations of at least two times the pre-vaccination concentration one month after vaccination with the Boostrix vaccine.
At Month 1 (post Boostrix vaccination)
Number of Subjects With Vaccine Responses for Serum Bactericidal Assay Against Neisseria Meningitidis Serogroups A (rSBA-MenA), C (rSBA-MenC), Y (rSBA-MenY) and W-135 (rSBA-MenW-135)
Vaccine responses for rSBA-MenA, rSBA-MenC, rSBA-MenY and rSBA-MenW-135 antibodies were defined as: for initially seronegative subjects (pre-vaccination concentration below the cut-off titer of 8): antibody titers at least four times the cut-off (post-vaccination concentration ≥ 32) one month after vaccination with Menactra vaccination; and for initially seropositive subjects (pre-vaccination titer ≥ 8): antibody titers at least four times the pre-vaccination antibody titers, one month after vaccination with Menactra vaccine.
One month post Boostrix vaccination ((Month 1 for Boostrix + Menactra Group and Month 2 for Menactra-Boostrix Group)
Secondary Outcomes (15)
Number of Subjects With Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) Antibodies
At Day 0 (PRE) before Boostrix vaccination
Number of Subjects With Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies
At Month 2 (one month post Boostrix vaccination)
Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Antigens
PRE (Day 0) and POST Boostrix vaccination (Month 1 for Boostrix + Menactra Group and Boostrix-Menactra Group/ Month 2 for Menactra-Boostrix Group)
Number of Subjects With Booster Responses for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies
At one month POST Boostrix vaccination (Month 1 for Boostrix + Menactra Group and Boostrix-Menactra Group/ Month 2 for Menactra-Boostrix Group)
Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) Antibody Concentrations
PRE (Day 0) and one month POST Boostrix vaccination (Month 1 for Boostrix + Menactra Group and Boostrix-Menactra Group/ Month 2 for Menactra-Boostrix Group)
- +10 more secondary outcomes
Study Arms (3)
Boostrix + Menactra Group
EXPERIMENTALSubjects, 11 through 18 years of age, received a booster dose of Boostrix® co-administered with Menactra™ at Day 0. The Boostrix® vaccine was administered intramuscularly into the left deltoid region and Menactra™ vaccine was administered intramuscularly into the right deltoid region.
Boostrix-Menactra Group
EXPERIMENTALSubjects, 11 through 18 years of age, received one dose of Boostrix® vaccine at Day 0, followed by one dose of Menactra™ vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region.
Menactra-Boostrix Group
EXPERIMENTALSubjects, 11 through 18 years of age, received one dose of Menactra™ vaccine at Day 0 followed by one dose of Boostrix® vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region.
Interventions
GlaxoSmithKline (GSK) Biologicals' registered tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed, containing 0.3 mg aluminum.
Aventis Pasteur's me ningococcal polysaccharide diphtheria toxoid conjugate vaccine containing Neisseria meningitidis serogroups, A, C, Y and W-135.
Eligibility Criteria
You may qualify if:
- Healthy subjects as established by medical history and history-directed physical examination before entering into the study.
- Previously completed routine childhood vaccinations against diphtheria, tetanus and pertussis diseases according to the recommended vaccination schedule at the time.
- Females of childbearing potential at the time of study entry are required to have a negative pregnancy test prior to administration of the dose of vaccine and are required to be abstinent or use adequate contraceptive precautions for one month prior to vaccination. Subjects also are required to agree to continue such precautions for two months after vaccination.
You may not qualify if:
- Administration of a pre-school booster of DTP vaccine within the previous 5 years
- Administration of a diphteria-tetanus (Td) booster within the previous 5 years
- Previous vaccination against N. meningitidis
- Hypersensitivity to latex
- History of serious allergic reaction (e.g. anaphylaxis) following any other tetanus toxoid, diphteria toxoid or pertussis-containing vaccine or any component of the study vaccines
- History of encephalopathy (e.g. coma, decreased level of consciousness, prolonged seizures) within seven days of administration of a previous dose of pertussis vaccine taht is not attributable to another identifiable cause
- Progressive neurologic disorder, uncontrolled epilepsy or progressive encephalopathy: pertussis vaccine should not be administered to individuals with these conditions until a treatment regimen has been established and the condition has stabilized
- Previous history of Guillain-Barré syndrome
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (24)
GSK Investigational Site
Chandler, Arizona, 85224, United States
GSK Investigational Site
Little Rock, Arkansas, 72205, United States
GSK Investigational Site
Fountain Valley, California, 92708, United States
GSK Investigational Site
Golden, Colorado, 80401, United States
GSK Investigational Site
Marietta, Georgia, 30062, United States
GSK Investigational Site
Louisville, Kentucky, 40202, United States
GSK Investigational Site
Annapolis, Maryland, 21401, United States
GSK Investigational Site
Frederick, Maryland, 21702, United States
GSK Investigational Site
Omaha, Nebraska, 68178, United States
GSK Investigational Site
Whitehouse Station, New Jersey, 08889, United States
GSK Investigational Site
Pittsford, New York, 14534, United States
GSK Investigational Site
Rochester, New York, 14620, United States
GSK Investigational Site
Akron, Ohio, 44308-1062, United States
GSK Investigational Site
University Heights, Ohio, 44118, United States
GSK Investigational Site
Erie, Pennsylvania, 16505, United States
GSK Investigational Site
Erie, Pennsylvania, 16508, United States
GSK Investigational Site
Greenville, Pennsylvania, 16125, United States
GSK Investigational Site
Philadelphia, Pennsylvania, 19140, United States
GSK Investigational Site
Pittsburgh, Pennsylvania, 15227, United States
GSK Investigational Site
Pittsburgh, Pennsylvania, 15241, United States
GSK Investigational Site
Temple, Texas, 76508, United States
GSK Investigational Site
Salt Lake City, Utah, 84109, United States
GSK Investigational Site
Salt Lake City, Utah, 84121, United States
GSK Investigational Site
West Jordan, Utah, 84084, United States
Related Publications (3)
Friedland et al. Immunogenicity of coadministered Tdap and MCV4 vaccines compared to separately administered vaccines. Accepted for poster presentation at ICAAC 2007
RESULTWeston et al. Reactogenicity of concomitant and separately administered Tdap and MCV4 vaccines. Accepted for poster presentation at ICAAC 2007
RESULTWeston WM, Friedland LR, Wu X, Howe B. Immunogenicity and reactogenicity of co-administered tetanus-diphtheria-acellular pertussis (Tdap) and tetravalent meningococcal conjugate (MCV4) vaccines compared to their separate administration. Vaccine. 2011 Jan 29;29(5):1017-22. doi: 10.1016/j.vaccine.2010.11.057. Epub 2010 Dec 4.
PMID: 21134450DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
None reported.
Results Point of Contact
- Title
- GSK Response Center
- Organization
- GlaxoSmithKline
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 25, 2006
First Posted
January 26, 2006
Study Start
January 25, 2006
Primary Completion
August 8, 2006
Study Completion
August 8, 2006
Last Updated
August 17, 2018
Results First Posted
March 16, 2017
Record last verified: 2018-06
Data Sharing
- IPD Sharing
- Will share
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.