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

Primary Purpose

Acellular Pertussis, Tetanus, Diphtheria

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Boostrix®

Menactra™

About this trial

This is an interventional prevention trial for Acellular Pertussis focused on measuring tetanus, pertussis, Prophylaxis, meningococcus, diptheria

Eligibility Criteria

11 Years - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Boostrix + Menactra Group

Boostrix-Menactra Group

Menactra-Boostrix Group

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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).

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).

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.

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.

Secondary Outcome Measures

Number of Subjects With Anti-diphteria (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).

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).

Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Antigens

Cut-off values assessed were greater than or equal to 0.1 international units per milliliter (IU/m L).

Number of Subjects With Booster Responses for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies

Booster responses for anti-D and anti-T antibodies were defined as: for initially seronegative subjects (pre-vaccination concentration below the cut-off concentration of 0.1 IU/mL): antibody concentrations at least four times the cut-off (postvaccination concentration ≥ 0.4 IU/mL), one month after vaccination with the Boostrix vaccine; and for initially seropositive subjects (pre-vaccination concentration ≥ 0.1 IU/mL): an increase in antibody concentrations of at least four times the pre-vaccination concentration one month after vaccination with the Boostrix vaccine.

Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) Antibody Concentrations

Concentrations are presented as geometric mean concentrations (GMCs), expressed in international units per milliliter (IU/mL).

Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) Antibody Concentrations

Concentrations are presented as geometric mean concentrations (GMCs), expressed in international units per milliliter (IU/mL).

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.

Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations

Concentrations are presented as geometric mean concentrations (GMCs), expressed in ELISA units per milliliter (EL.U/mL).

Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations

Concentrations are presented as geometric mean concentrations (GMCs), expressed in ELISA units per milliliter (EL.U/mL).

Titers for rSBA-MenA, rSBA-MenC, rSBA-MenY and rSBA-MenW-135 Antibodies

Antibody titers are presented as geometric mean titers (GMTs).

Number of Subjects With Vaccine Responses for rSBA-MenA, rSBA-MenC, rSBA-MenY and rSBA-MenW-135 Antibodies

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 the vaccine, 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 the Menactra vaccine.

Number of Subjects With Any and Grade 3 Solicited Local Symptoms

Assessed solicited local symptoms were pain, redness and swelling. Any = any solicited local symptom irrespective of intensity grade. Grade 3 pain = pain that prevented normal activities. Grade 3 redness/swelling = redness/swelling with diameter ≥ 50 millimeters (mm).

Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms

Assessed solicited general symptoms were fatigue, fever [defined as oral temperature equal to or above 37.5 degrees Celsius (°C)], headache and gastrointestinal symptoms [gastro sympt]. Any = any solicited general symptom irrespective of intensity grade or relationship to vaccination. Grade 3 = symptoms that prevented normal activities. Grade 3 Fever = temperature higher than (>) 39° C. Related = symptoms considered by the investigator to have a causal relationship to vaccination. Gastrointestinal symptoms included nausea, vomiting, diarrhea and/or abdominal pain.

Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)

An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE =An AE which prevented normal, everyday activities. Such an AE, for example, prevented attendance at work/school and necessitated the administration of corrective therapy. Related = AE assessed by the investigator as related to the vaccination.

Number of Subjects With Serious Adverse Events (SAEs)

Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

Full Information

NCT ID

NCT00282295

First Posted

January 25, 2006

Last Updated

June 20, 2018

Sponsor

GlaxoSmithKline

1. Study Identification

Unique Protocol Identification Number

NCT00282295

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2018

Overall Recruitment Status

Completed

Study Start Date

January 25, 2006 (Actual)

Primary Completion Date

August 8, 2006 (Actual)

Study Completion Date

August 8, 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

GlaxoSmithKline

4. Oversight

5. Study Description

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.

Detailed Description

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."

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acellular Pertussis, Tetanus, Diphtheria

Keywords

tetanus, pertussis, Prophylaxis, meningococcus, diptheria

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

1344 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Boostrix + Menactra Group

Arm Type

Experimental

Arm Description

Arm Title

Boostrix-Menactra Group

Arm Type

Experimental

Arm Description

Arm Title

Menactra-Boostrix Group

Arm Type

Experimental

Arm Description

Intervention Type

Biological

Intervention Name(s)

Boostrix®

Intervention Description

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

Intervention Type

Biological

Intervention Name(s)

Menactra™

Intervention Description

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

Primary Outcome Measure Information:

Title

Number of Subjects With Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies

Description

Cut-off values assessed were greater than or equal to 1.0 international units per milliliter (IU/mL).

Time Frame

At Month 1 (post Boostrix vaccination)

Title

Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations

Description

Concentrations were presented as geometric mean concentrations (GMCs), expressed in enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).

Time Frame

At Month 1 (post Boostrix vaccination)

Title

Number of Subjects With Booster Responses for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibodies

Description

Time Frame

At Month 1 (post Boostrix vaccination)

Title

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)

Description

Time Frame

One month post Boostrix vaccination ((Month 1 for Boostrix + Menactra Group and Month 2 for Menactra-Boostrix Group)

Secondary Outcome Measure Information:

Title

Number of Subjects With Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) Antibodies

Description

Cut-off values assessed were greater than or equal to 1.0 international units per milliliter (IU/mL).

Time Frame

At Day 0 (PRE) before Boostrix vaccination

Title

Number of Subjects With Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies

Description

Cut-off values assessed were greater than or equal to 1.0 international units per milliliter (IU/mL).

Time Frame

At Month 2 (one month post Boostrix vaccination)

Title

Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Antigens

Description

Cut-off values assessed were greater than or equal to 0.1 international units per milliliter (IU/m L).

Time Frame

PRE (Day 0) and POST Boostrix vaccination (Month 1 for Boostrix + Menactra Group and Boostrix-Menactra Group/ Month 2 for Menactra-Boostrix Group)

Title

Number of Subjects With Booster Responses for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies

Description

Time Frame

At one month POST Boostrix vaccination (Month 1 for Boostrix + Menactra Group and Boostrix-Menactra Group/ Month 2 for Menactra-Boostrix Group)

Title

Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) Antibody Concentrations

Description

Concentrations are presented as geometric mean concentrations (GMCs), expressed in international units per milliliter (IU/mL).

Time Frame

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)

Title

Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) Antibody Concentrations

Description

Concentrations are presented as geometric mean concentrations (GMCs), expressed in international units per milliliter (IU/mL).

Time Frame

At one month POST Menactra vaccination (Month 2 for Boostrix-Menactra Group and Month 1 for Menactra-Boostrix Group)

Title

Number of Subjects With Booster Responses for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibodies

Description

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.

Time Frame

At Month 2 (one month post Boostrix vaccination)

Title

Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations

Description

Concentrations are presented as geometric mean concentrations (GMCs), expressed in ELISA units per milliliter (EL.U/mL).

Time Frame

At Day 0 before (PRE) Boostrix vaccination

Title

Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations

Description

Concentrations are presented as geometric mean concentrations (GMCs), expressed in ELISA units per milliliter (EL.U/mL).

Time Frame

At Month 2 (one month post Boostrix vaccination)

Title

Titers for rSBA-MenA, rSBA-MenC, rSBA-MenY and rSBA-MenW-135 Antibodies

Description

Antibody titers are presented as geometric mean titers (GMTs).

Time Frame

PRE (Day 0) and one month POST Menactra vaccination (Month 2 for Boostrix + Menactra Group and Boostrix-Menactra Group / Month 1 for Menactra-Boostrix Group)

Title

Number of Subjects With Vaccine Responses for rSBA-MenA, rSBA-MenC, rSBA-MenY and rSBA-MenW-135 Antibodies

Description

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 the vaccine, 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 the Menactra vaccine.

Time Frame

At Month 2 (one month after vaccination with Menactra vaccine)

Title

Number of Subjects With Any and Grade 3 Solicited Local Symptoms

Description

Time Frame

Within 4-days (Day 0-3) after each dose and across doses

Title

Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms

Description

Time Frame

Within 4-days (Days 0-3) after each dose and across doses

Title

Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)

Description

Time Frame

Within the 31-day (Days 0-30) period after each vaccination

Title

Number of Subjects With Serious Adverse Events (SAEs)

Description

Time Frame

Throughout the entire study period (Day 0 - Month 2)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

11 Years

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

GSK Clinical Trials

Organizational Affiliation

GlaxoSmithKline

Official's Role

Study Director

Facility Information:

Facility Name

GSK Investigational Site

City

Chandler

State/Province

Arizona

ZIP/Postal Code

85224

Country

United States

Facility Name

GSK Investigational Site

City

Little Rock

State/Province

Arkansas

ZIP/Postal Code

72205

Country

United States

Facility Name

GSK Investigational Site

City

Fountain Valley

State/Province

California

ZIP/Postal Code

92708

Country

United States

Facility Name

GSK Investigational Site

City

Golden

State/Province

Colorado

ZIP/Postal Code

80401

Country

United States

Facility Name

GSK Investigational Site

City

Marietta

State/Province

Georgia

ZIP/Postal Code

30062

Country

United States

Facility Name

GSK Investigational Site

City

Louisville

State/Province

Kentucky

ZIP/Postal Code

40202

Country

United States

Facility Name

GSK Investigational Site

City

Annapolis

State/Province

Maryland

ZIP/Postal Code

21401

Country

United States

Facility Name

GSK Investigational Site

City

Frederick

State/Province

Maryland

ZIP/Postal Code

21702

Country

United States

Facility Name

GSK Investigational Site

City

Omaha

State/Province

Nebraska

ZIP/Postal Code

68178

Country

United States

Facility Name

GSK Investigational Site

City

Whitehouse Station

State/Province

New Jersey

ZIP/Postal Code

08889

Country

United States

Facility Name

GSK Investigational Site

City

Pittsford

State/Province

New York

ZIP/Postal Code

14534

Country

United States

Facility Name

GSK Investigational Site

City

Rochester

State/Province

New York

ZIP/Postal Code

14620

Country

United States

Facility Name

GSK Investigational Site

City

Akron

State/Province

Ohio

ZIP/Postal Code

44308-1062

Country

United States

Facility Name

GSK Investigational Site

City

University Heights

State/Province

Ohio

ZIP/Postal Code

44118

Country

United States

Facility Name

GSK Investigational Site

City

Erie

State/Province

Pennsylvania

ZIP/Postal Code

16505

Country

United States

Facility Name

GSK Investigational Site

City

Erie

State/Province

Pennsylvania

ZIP/Postal Code

16508

Country

United States

Facility Name

GSK Investigational Site

City

Greenville

State/Province

Pennsylvania

ZIP/Postal Code

16125

Country

United States

Facility Name

GSK Investigational Site

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19140

Country

United States

Facility Name

GSK Investigational Site

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15227

Country

United States

Facility Name

GSK Investigational Site

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15241

Country

United States

Facility Name

GSK Investigational Site

City

Temple

State/Province

Texas

ZIP/Postal Code

76508

Country

United States

Facility Name

GSK Investigational Site

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84109

Country

United States

Facility Name

GSK Investigational Site

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84121

Country

United States

Facility Name

GSK Investigational Site

City

West Jordan

State/Province

Utah

ZIP/Postal Code

84084

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Citations:

Citation

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

Results Reference

result

Citation

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

Results Reference

result

PubMed Identifier

21134450

Citation

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.

Results Reference

derived

Links:

URL

https://www.clinicalstudydatarequest.com

Description

Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Available IPD and Supporting Information:

Available IPD/Information Type

Individual Participant Data Set

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

105753

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Statistical Analysis Plan

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

105753

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Clinical Study Report

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

105753

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Dataset Specification

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

105753

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Informed Consent Form

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

105753

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Study Protocol

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

105753

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Learn more about this trial

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

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

Acellular Pertussis, Tetanus, Diphtheria

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial