Acellular PertussisPhase 4NCT00282295

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

A Phase 4 study testing Boostrix® and Menactra™ in people with Acellular Pertussis and Tetanus, run by GlaxoSmithKline at 24 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 11 to 18 yearsHealthy volunteers can take part
Conditions the study is for: Acellular Pertussis, Tetanus, Diphtheria
What is being tested?: Boostrix® and Menactra™
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,344 participants
Where: 24 sitesUnited States
Study dates: 25 Jan 2006to 8 Aug 2006
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 11 to 18 years
All sexes
Healthy volunteers accepted
Child, Adult

Who may be able to join

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.

Who cannot join

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

Trial locations and contacts

24 sites in 1 country.

City, postcode or hospital

24 sites in 1 country

United States24 sites

GSK Investigational Site
Akron, Ohio, 44308-1062
GSK Investigational Site
Annapolis, Maryland, 21401
GSK Investigational Site
Chandler, Arizona, 85224
GSK Investigational Site
Erie, Pennsylvania, 16505
GSK Investigational Site
Erie, Pennsylvania, 16508
GSK Investigational Site
Fountain Valley, California, 92708
GSK Investigational Site
Frederick, Maryland, 21702
GSK Investigational Site
Golden, Colorado, 80401
GSK Investigational Site
Greenville, Pennsylvania, 16125
GSK Investigational Site
Little Rock, Arkansas, 72205
GSK Investigational Site
Louisville, Kentucky, 40202
GSK Investigational Site
Marietta, Georgia, 30062
GSK Investigational Site
Omaha, Nebraska, 68178
GSK Investigational Site
Philadelphia, Pennsylvania, 19140
GSK Investigational Site
Pittsburgh, Pennsylvania, 15227
GSK Investigational Site
Pittsburgh, Pennsylvania, 15241
GSK Investigational Site
Pittsford, New York, 14534
GSK Investigational Site
Rochester, New York, 14620
GSK Investigational Site
Salt Lake City, Utah, 84109
GSK Investigational Site
Salt Lake City, Utah, 84121
GSK Investigational Site
Temple, Texas, 76508
GSK Investigational Site
University Heights, Ohio, 44118
GSK Investigational Site
West Jordan, Utah, 84084
GSK Investigational Site
Whitehouse Station, New Jersey, 08889

Other trials in United States

About this study

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

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.

Read the 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."

Conditions: Acellular Pertussis, Tetanus, Diphtheria
Being tested: Boostrix®, Menactra™
Keywords: tetanus, pertussis, Prophylaxis, meningococcus, diptheria
Medical subject headings: Tetanus, Diphtheria, Whooping Cough

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Boostrix®Biological
GlaxoSmithKline (GSK) Biologicals' registered tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed, containing 0.3 mg aluminum.
Menactra™Biological
Aventis Pasteur's me ningococcal polysaccharide diphtheria toxoid conjugate vaccine containing Neisseria meningitidis serogroups, A, C, Y and W-135.

Study groups in NCT00282295
Study group	Role	What they receive
Boostrix + Menactra Group	Experimental	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. Receives: Biological: Boostrix®; Biological: Menactra™
Boostrix-Menactra Group	Experimental	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. Receives: Biological: Boostrix®; Biological: Menactra™
Menactra-Boostrix Group	Experimental	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. Receives: Biological: Boostrix®; Biological: Menactra™

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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
Cut-off values assessed were greater than or equal to 1.0 international units per milliliter (IU/mL).
Measured: At Day 0 (PRE) before Boostrix vaccination
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).
Measured: At Month 2 (one month post Boostrix vaccination)
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).
Measured: 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
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.
Measured: 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
Concentrations are presented as geometric mean concentrations (GMCs), expressed in international units per milliliter (IU/mL).
Measured: 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)
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).
Measured: At one month POST Menactra vaccination (Month 2 for Boostrix-Menactra Group and Month 1 for Menactra-Boostrix Group)
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.
Measured: At Month 2 (one month post Boostrix vaccination)
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).
Measured: At Day 0 before (PRE) Boostrix vaccination
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).
Measured: At Month 2 (one month post Boostrix vaccination)
Titers for rSBA-MenA, rSBA-MenC, rSBA-MenY and rSBA-MenW-135 Antibodies
Antibody titers are presented as geometric mean titers (GMTs).
Measured: 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)
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.
Measured: At Month 2 (one month after vaccination with 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).
Measured: Within 4-days (Day 0-3) after each dose and across doses
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.
Measured: Within 4-days (Days 0-3) after each dose and across doses
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.
Measured: Within the 31-day (Days 0-30) period after each 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.
Measured: Throughout the entire study period (Day 0 - Month 2)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

25 Jan 20068 Aug 2006

First posted26 Jan 2006 (estimated)
Study start25 Jan 2006
Primary completion8 Aug 2006
Study completion8 Aug 2006

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Acellular PertussisStudies of the same condition, open and under way.
More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 1,344 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00282295
Sponsor's protocol ID: 105753
Status last verified: Jun 2018
First submitted: 25 Jan 2006
Last updated: 17 Aug 2018
Results posted: Yes, on ClinicalTrials.gov
Individual data sharing: Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Publications

Friedland et al. Immunogenicity of coadministered Tdap and MCV4 vaccines compared to separately administered vaccines. Accepted for poster presentation at ICAAC 2007
Weston et al. Reactogenicity of concomitant and separately administered Tdap and MCV4 vaccines. Accepted for poster presentation at ICAAC 2007
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.
PubMed 21134450

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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RecruitingPhase 1/2
A Phase I/II Clinical Trial of the Diphtheria, Tetanus, Acellular Component Pertussis and Sabin Inactivated Poliomyelitis Vaccine Adsorbed
Diphtheria, Pertussis
RecruitingPhase 4
Concurrent Versus Sequential Administration of Tdap and RSV Vaccines in Pregnancy
RSV, Tdap - Tetanus, Diphtheria and Acellular Pertussis Vaccination
Active, not recruitingPhase 3
A Study on the Immune Response and Safety of a Combined Vaccine Against Diphtheria, Tetanus and Acellular Pertussis (dTpa) in Japanese Healthy Pregnant Women
Diphtheria-Tetanus-acellular Pertussis Vaccines
Not yet recruitingObservational study
A Clinical Study on Immunogenicity Persistence of Adsorbed 5-component Acellular Pertussis, Diphtheria and Tetanus Combined Vaccine
Diphtheria, Tetanus

All Acellular Pertussis trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT00282295
Acronym / sponsor ID: 105753
Conditions: Acellular Pertussis, Tetanus, Diphtheria
Keywords: tetanus, pertussis, Prophylaxis, meningococcus, diptheria
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,344 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 25 Jan 2006 (actual)
Primary completion: 8 Aug 2006 (actual)
Study completion: 8 Aug 2006 (actual)
First posted: 26 Jan 2006 (estimated)
Results: Posted 16 Mar 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 3

Arm	Type	Receives
Boostrix + Menactra Group	Experimental	Biological: Boostrix®, Biological: Menactra™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.
Boostrix-Menactra Group	Experimental	Biological: Boostrix®, Biological: Menactra™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.
Menactra-Boostrix Group	Experimental	Biological: Boostrix®, Biological: Menactra™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.

Who may qualify

Ages: 11 to 18 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (8 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Boostrix®GlaxoSmithKline (GSK) Biologicals' registered tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed, containing 0.3 mg aluminum.	Biological	Boostrix + Menactra Group, Boostrix-Menactra Group, Menactra-Boostrix Group
Menactra™Aventis Pasteur's me ningococcal polysaccharide diphtheria toxoid conjugate vaccine containing Neisseria meningitidis serogroups, A, C, Y and W-135.	Biological	Boostrix + Menactra Group, Boostrix-Menactra Group, Menactra-Boostrix Group

Primary outcome

Number of Subjects With Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies
Time frame: At Month 1 (post Boostrix vaccination)
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
Time frame: At Month 1 (post Boostrix vaccination)
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
Time frame: At Month 1 (post Boostrix vaccination)
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)
Time frame: One month post Boostrix vaccination ((Month 1 for Boostrix + Menactra Group and Month 2 for Menactra-Boostrix Group)
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.

15 secondary outcomes

Number of Subjects With Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) Antibodies
Time frame: At Day 0 (PRE) before Boostrix vaccination
Number of Subjects With Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies
Time frame: At Month 2 (one month post Boostrix vaccination)
Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Antigens
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)
Number of Subjects With Booster Responses for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies
Time frame: 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
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)
Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) Antibody Concentrations
Time frame: At one month POST Menactra vaccination (Month 2 for Boostrix-Menactra Group and Month 1 for Menactra-Boostrix Group)
Number of Subjects With Booster Responses for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibodies
Time frame: At Month 2 (one month post Boostrix vaccination)
Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations
Time frame: At Day 0 before (PRE) Boostrix vaccination
Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations
Time frame: At Month 2 (one month post Boostrix vaccination)
Titers for rSBA-MenA, rSBA-MenC, rSBA-MenY and rSBA-MenW-135 Antibodies
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)
Number of Subjects With Vaccine Responses for rSBA-MenA, rSBA-MenC, rSBA-MenY and rSBA-MenW-135 Antibodies
Time frame: At Month 2 (one month after vaccination with Menactra vaccine)
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Time frame: Within 4-days (Day 0-3) after each dose and across doses
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Time frame: Within 4-days (Days 0-3) after each dose and across doses
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Time frame: Within the 31-day (Days 0-30) period after each vaccination
Number of Subjects With Serious Adverse Events (SAEs)
Time frame: Throughout the entire study period (Day 0 - Month 2)

Results and safety

Results posted to the registry on 16 Mar 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Boostrix + Menactra Group	446	443
Boostrix-Menactra Group	446	429
Menactra-Boostrix Group	449	441

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

Time frame: At Month 1 (post Boostrix vaccination). Count of participants. Unit: Participants

Measure	Boostrix + Menactra Group n = 428	Boostrix-Menactra Group n = 415
Anti-D	427	405
Anti-T	425	412

Boostrix + Menactra Group vs Boostrix-Menactra Group: Difference: 2.18 (95% CI 0.79 to 4.17)
Boostrix + Menactra Group vs Boostrix-Menactra Group: Difference: 0.02 (95% CI -1.4 to 1.48)

Population analysed: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects with immunogenicity data available and (\&) randomization code not broken who had received at least 1 dose of study vaccine (known administration site) \& had not received a vaccine not specified or forbidden by the protocol.

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

Time frame: At Month 1 (post Boostrix vaccination). Geometric mean (95% Confidence Interval). Unit: EL.U/mL

Measure	Boostrix + Menactra Group n = 428	Boostrix-Menactra Group n = 415
Anti-PT	63.9 (58.6 to 69.7)	74.3 (67.9 to 81.3)
Anti-FHA	444.8 (415.0 to 476.7)	575.8 (532.8 to 622.1)
Anti-PRN	253.4 (224.8 to 285.6)	366.0 (321.6 to 416.6)

Boostrix + Menactra Group vs Boostrix-Menactra Group: Adjusted GMC ratio: 0.93 (95% CI 0.84 to 1.03)
Boostrix + Menactra Group vs Boostrix-Menactra Group: Adjusted GMC ratio: 0.76 (95% CI 0.69 to 0.84)
Boostrix + Menactra Group vs Boostrix-Menactra Group: Adjusted GMC ratio: 0.63 (95% CI 0.54 to 0.72)

Population analysed: The analysis was performed on the According-To-Protocol cohort for immunogenicity,which included all evaluable subjects with immunogenicity data available \& randomization code not broken who had received at least 1 dose of study vaccine (known administration site) \& had not received a vaccine not specified or forbidden by the protocol

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

Time frame: At Month 1 (post Boostrix vaccination). Count of participants. Unit: Participants

Measure	Boostrix + Menactra Group n = 427	Boostrix-Menactra Group n = 414
Anti-PT, Total	322	333
Anti-FHA, Total	385	388
Anti-PRN, Total	398	394

Boostrix + Menactra Group vs Boostrix-Menactra Group: Difference in booster response rate: -4.38 (95% CI -9.91 to 1.15)
Boostrix + Menactra Group vs Boostrix-Menactra Group: Difference in booster response rate: -3.39 (95% CI -7.03 to 0.15)
Boostrix + Menactra Group vs Boostrix-Menactra Group: Difference in booster response rate: -1.96 (95% CI -5.25 to -1.25)

Population analysed: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects with immunogenicity data available \& randomization code not broken who had received at least 1 dose of study vaccine (known administration site) \& had not received a vaccine not specified or forbidden by the protocol.

Primary outcome: 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)

Time frame: One month post Boostrix vaccination ((Month 1 for Boostrix + Menactra Group and Month 2 for Menactra-Boostrix Group). Count of participants. Unit: Participants

Measure	Boostrix + Menactra Group n = 413	Menactra-Boostrix Group n = 418
rSBA-MenA, Total	329	328
rSBA-MenC, Total	390	383
rSBA-MenY, Total	369	358
rSBA-MenW-135, Total	404	394

Boostrix + Menactra Group vs Menactra-Boostrix Group: Difference in vaccine response rate: -0.21 (95% CI -4.85 to 4.43)
Boostrix + Menactra Group vs Menactra-Boostrix Group: Difference in vaccine response rate: 1.69 (95% CI -1.69 to 5.16)
Boostrix + Menactra Group vs Menactra-Boostrix Group: Difference in vaccine response rate: 1.82 (95% CI -2.58 to 6.25)

Population analysed: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects with immunogenicity data available \& randomization code not broken who had received at least 1 dose of study vaccine (known administration site) \& had not received a vaccine not specified or forbidden by the protocol.

15 secondary outcomes are reported in the full results.

Adverse events

Time frame: Solicited local and general symptoms during the 4-day (Day 0-3) follow-up period, unsolicited AEs during the 31-day (Day 0-30) follow-up period after each vaccination and SAEs throughout the study (Day 0 - Month 2).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Boostrix + Menactra Group	1 of 446 (0.2%)	371 of 446 (83.2%)	Not reported
Boostrix-Menactra Group	0 of 446 (0%)	385 of 446 (86.3%)	Not reported
Menactra-Boostrix Group	1 of 449 (0.2%)	358 of 449 (79.7%)	Not reported

Limitations and caveats (from the sponsor): None reported.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publicationFriedland et al. Immunogenicity of coadministered Tdap and MCV4 vaccines compared to separately administered vaccines. Accepted for poster presentation at ICAAC 2007
Results publicationWeston et al. Reactogenicity of concomitant and separately administered Tdap and MCV4 vaccines. Accepted for poster presentation at ICAAC 2007
Derived from this study: PubMed 21134450Weston 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.
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

GSK Clinical Trials study director

GlaxoSmithKline

24 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Boostrix® and Menactra™ in people with Acellular Pertussis and Tetanus, run by GlaxoSmithKline at 24 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Subjects With Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies (time frame: At Month 1 (post Boostrix vaccination)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00282295, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2018.