US-licensed Combined Vaccine Against Tetanus & Diphtheria, Given With US-licensed Vaccine Against Meningococcal Disease

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

1344 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-25

Study Completion Date

2006-08-08

Brief Summary

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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.

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Detailed Description

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A phase IV, randomized, partially blinded multicenter study to evaluate the safety and immunogenicity of a booster vaccination with GlaxoSmithKline's tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine, adsorbed \[Tdap Boostrix®\] co-administered intramuscularly with Aventis-Pasteur's meningococcal (serogroups A, C, Y and W-135) polysaccharide diphtheria toxoid conjugate vaccine (Menactra™) as compared to the administration of either vaccine alone in healthy adolescents 11-18 years of age. "Experimental design: Prospective, randomized, controlled multicenter study with three groups:

Group 1: Boostrix + Menactra on Day 0, blood samples at Month 0 and Month 1 Group 2: Boostrix on Day 0, Menactra at Month 1, blood samples at Month 0, Month 1, and Month 2 Group 3: Menactra on Day 0, Boostrix at Month 1, blood samples at Month 0, Month 1 and Month 2 Treatment allocation: randomized 1:1:1 Type of study: self-contained Duration of the study: Approximately one month for each subject in Group 1 and approximately two months for each subject in the Group 2 and Group 3."

Conditions

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Acellular Pertussis Tetanus Diphtheria

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Boostrix + Menactra Group

Subjects, 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.

Group Type EXPERIMENTAL

Boostrix®

Intervention Type BIOLOGICAL

GlaxoSmithKline (GSK) Biologicals' registered tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed, containing 0.3 mg aluminum.

Menactra™

Intervention Type BIOLOGICAL

Aventis Pasteur's me ningococcal polysaccharide diphtheria toxoid conjugate vaccine containing Neisseria meningitidis serogroups, A, C, Y and W-135.

Boostrix-Menactra Group

Subjects, 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.

Group Type EXPERIMENTAL

Boostrix®

Intervention Type BIOLOGICAL

GlaxoSmithKline (GSK) Biologicals' registered tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed, containing 0.3 mg aluminum.

Menactra™

Intervention Type BIOLOGICAL

Aventis Pasteur's me ningococcal polysaccharide diphtheria toxoid conjugate vaccine containing Neisseria meningitidis serogroups, A, C, Y and W-135.

Menactra-Boostrix Group

Subjects, 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.

Group Type EXPERIMENTAL

Boostrix®

Intervention Type BIOLOGICAL

GlaxoSmithKline (GSK) Biologicals' registered tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed, containing 0.3 mg aluminum.

Menactra™

Intervention Type BIOLOGICAL

Aventis Pasteur's me ningococcal polysaccharide diphtheria toxoid conjugate vaccine containing Neisseria meningitidis serogroups, A, C, Y and W-135.

Interventions

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Boostrix®

GlaxoSmithKline (GSK) Biologicals' registered tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed, containing 0.3 mg aluminum.

Intervention Type BIOLOGICAL

Menactra™

Aventis Pasteur's me ningococcal polysaccharide diphtheria toxoid conjugate vaccine containing Neisseria meningitidis serogroups, A, C, Y and W-135.

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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

Minimum Eligible Age

11 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Chandler, Arizona, United States

Site Status

GSK Investigational Site

Little Rock, Arkansas, United States

Site Status

GSK Investigational Site

Fountain Valley, California, United States

Site Status

GSK Investigational Site

Golden, Colorado, United States

Site Status

GSK Investigational Site

Marietta, Georgia, United States

Site Status

GSK Investigational Site

Louisville, Kentucky, United States

Site Status

GSK Investigational Site

Annapolis, Maryland, United States

Site Status

GSK Investigational Site

Frederick, Maryland, United States

Site Status

GSK Investigational Site

Omaha, Nebraska, United States

Site Status

GSK Investigational Site

Whitehouse Station, New Jersey, United States

Site Status

GSK Investigational Site

Pittsford, New York, United States

Site Status

GSK Investigational Site

Rochester, New York, United States

Site Status

GSK Investigational Site

Akron, Ohio, United States

Site Status

GSK Investigational Site

University Heights, Ohio, United States

Site Status

GSK Investigational Site

Erie, Pennsylvania, United States

Site Status

GSK Investigational Site

Erie, Pennsylvania, United States

Site Status

GSK Investigational Site

Greenville, Pennsylvania, United States

Site Status

GSK Investigational Site

Philadelphia, Pennsylvania, United States

Site Status

GSK Investigational Site

Pittsburgh, Pennsylvania, United States

Site Status

GSK Investigational Site

Pittsburgh, Pennsylvania, United States

Site Status

GSK Investigational Site

Temple, Texas, United States

Site Status

GSK Investigational Site

Salt Lake City, Utah, United States

Site Status

GSK Investigational Site

Salt Lake City, Utah, United States

Site Status

GSK Investigational Site

West Jordan, Utah, United States

Site Status

Countries

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United States

References

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Friedland et al. Immunogenicity of coadministered Tdap and MCV4 vaccines compared to separately administered vaccines. Accepted for poster presentation at ICAAC 2007

Reference Type RESULT

Weston et al. Reactogenicity of concomitant and separately administered Tdap and MCV4 vaccines. Accepted for poster presentation at ICAAC 2007

Reference Type RESULT

Weston 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.

Reference Type DERIVED

PMID: 21134450 (View on PubMed)

Study Documents

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