MeningitisPhase 4NCT00777257

Study of Menactra® in US Adolescents When Administered Concomitantly With Tdap Vaccine

A Phase 4 study testing T dap + Meningococcal Polysaccharide Diphtheria Toxoid Conj., Tdap + Meningococcal Polysaccharide Diphtheria Toxoid Conj. and Meningococcal Polysaccharide Diphtheria Toxoid Conj. + T dap in people with Meningitis and Meningococcemia, run by Sanofi Pasteur, a Sanofi Company at 20 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

The purpose of this study was to evaluate the immunogenicity and safety of the concomitant administration of Menactra® vaccine and Tdap vaccine in adolescents aged 11 to 17 years. Read more about this study

Who is it for?: Ages 11 to 17 yearsHealthy volunteers can take part
Conditions the study is for: Meningitis, Meningococcemia, Pertussis
What is being tested?: T dap + Meningococcal Polysaccharide Diphtheria Toxoid Conj., Tdap + Meningococcal Polysaccharide Diphtheria Toxoid Conj. and Meningococcal Polysaccharide Diphtheria Toxoid Conj. + T dap
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,345 participants
Where: 20 sitesUnited States
Study dates: Apr 2005to Sep 2007
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 17 years
All sexes
Healthy volunteers accepted
Child

Who may be able to join

Healthy as determined by medical history and physical examination.
Aged ≥ 11 to 17 years at the time of study vaccination on Day 0.
Informed consent form that has been approved by the Institutional Review Board (IRB) signed by the parent or legal guardian.
Informed assent form that has been approved by the IRB signed by the subject.
Subject (female) agrees to use measures to prevent pregnancy during the study.

Who cannot join

Serious chronic disease (i.e. cardiac, renal, neurologic, metabolic, rheumatologic, psychiatric, etc.).
Known or suspected impairment of immunologic function.
Acute medical illness with or without fever within the last 72 hours or an oral temperature ≥ 100.4°F (≥ 38.0°C) at the time of enrolment.
History of documented invasive meningococcal disease or previous meningococcal vaccination.
History of documented infection with Bordetella pertussis, Clostridium tetani, or Corynebacterium diphtheriae or vaccination with any tetanus, diphtheria or pertussis vaccine within the previous 5 years.
Received either immune globulin or other blood products within the last 3 months; or received injected or oral corticosteroids, or other immunomodulator therapy, within 6 weeks of the study vaccines. Individuals on a tapering dose schedule of oral steroids lasting <7 days and individuals (e.g., asthmatics) on a short schedule of oral steroids lasting 3 to 4 days may be included in the trial as long as they have not received more than one course within the last 2 weeks prior to enrolment.

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Received antibiotic therapy within the 72 hours prior to vaccination on Day 0.
Received any vaccine 28 days prior to the 1st study vaccination or scheduled to receive any vaccination during the course of the study.
Suspected or known hypersensitivity to either of the two study vaccines or their components.
Unavailable for the entire study period, or unable to attend the scheduled visits or to comply with the study procedures.
Enrolled in another clinical trial.
Diagnosed with any condition, which, in the opinion of the investigator, would pose a health risk to the subject or interfere with the evaluation of the vaccine.
For all females, a positive or equivocal urine pregnancy test at time of study vaccination.
Nursing mothers.

Trial locations and contacts

20 sites in 1 country.

City, postcode or hospital

20 sites in 1 country

United States20 sites

Study site
Akron, Ohio, 44308
Study site
Albuquerque, New Mexico, 87108
Study site
Baltimore, Maryland, 21201
Study site
Bardstown, Kentucky, 40004
Study site
Boulder, Colorado, 80303
Study site
Cleveland, Ohio, 44118
Study site
Columbus, Ohio, 43205
Study site
Dayton, Ohio, 45404
Study site
Jonesboro, Arkansas, 72401
Study site
Kingsport, Tennessee, 37660
Study site
Little Rock, Arkansas, 72205
Study site
Marietta, Georgia, 30062
Study site
Pittsburgh, Pennsylvania, 15241
Study site
Raleigh, North Carolina, 27609
Study site
Sellersville, Pennsylvania, 18960
Study site
Spokane, Washington, 99202
Study site
Sylva, North Carolina, 28779
Study site
Syracuse, New York, 13210
Study site
Woburn, Massachusetts, 01801
Study site
Woodstock, Georgia, 30189

Other trials in United States

About this study

Official title: Immunogenicity and Safety of Meningococcal (Groups A, C, Y, and W-135) Diphtheria Toxoid Conjugate Vaccine (Menactra®) in Adolescents in the US When Administered Concomitantly With Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap Vaccine)

The purpose of this study was to evaluate the immunogenicity and safety of the concomitant administration of Menactra® vaccine and Tdap vaccine in adolescents aged 11 to 17 years.

Primary Objective:

To determine whether concomitant administration of two vaccines, Tdap and Menactra®, induces antibody responses that are similar to those observed when each vaccine is given separately.

Secondary Objective:

To compare the rates of injection site reactions at the Tdap injection site after Tdap and Menactra® vaccines are administered concomitantly to the corresponding rates of reactions when Tdap vaccine is administered alone.

Conditions: Meningitis, Meningococcemia, Pertussis, Tetanus, Diphtheria
Being tested: T dap + Meningococcal Polysaccharide Diphtheria Toxoid Conj., Tdap + Meningococcal Polysaccharide Diphtheria Toxoid Conj., Meningococcal Polysaccharide Diphtheria Toxoid Conj. + T dap
Keywords: Meningitis, Meningococcemia, Pertussis, Neisseria meningitidis, Tetanus, Diphtheria
Medical subject headings: Meningitis, Meningococcal Infections, Whooping Cough, Tetanus, Diphtheria

What participants receive

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

T dap + Meningococcal Polysaccharide Diphtheria Toxoid Conj.Biological
Also called ADACEL®, Menactra®, Sterile Buffered 0.9% Sodium Chloride
Day 0: 0.5 mL (T dap)+ Placebo, Intramuscular; Day 28: 0.5 mL (Menactra®) Intramuscular
Tdap + Meningococcal Polysaccharide Diphtheria Toxoid Conj.Biological
Also called Menactra®, Adacel®, Sterile Buffered 0.9% Sodium Chloride
Day 0: 0.5 mL (T dap) + 0.5 mL (Menactra®) Intramuscular; Day 28: Placebo 0.5 mL Intramuscular
Meningococcal Polysaccharide Diphtheria Toxoid Conj. + T dapBiological
Also called Menactra®, Adacel®, Sterile Buffered 0.9% Sodium Chloride
Day 0: 0.5 mL (Menactra®)+0.5 mL Placebo, Intramuscular; Day 28: 0.5 mL (T dap) Intramuscular

Study groups in NCT00777257
Study group	Role	What they receive
Study Group A	Experimental	Tdap vaccine + placebo concomitantly on Day 0; Menactra® vaccine 28 days later Receives: Biological: T dap + Meningococcal Polysaccharide Diphtheria Toxoid Conj.
Study Group B	Experimental	Tdap vaccine + Menactra® vaccine concomitantly on Day 0; placebo 28 days later Receives: Biological: Tdap + Meningococcal Polysaccharide Diphtheria Toxoid Conj.
Study Group C	Experimental	Menactra® vaccine + placebo concomitantly on Day 0; Tdap vaccine 28 days later Receives: Biological: Meningococcal Polysaccharide Diphtheria Toxoid Conj. + T dap

What is being measured

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

Percentage of Participants With at Least a 4-fold Rise in Meningococcal Antibody Titer From Baseline (Day 0) to Day 28 Post-vaccination With Menactra® Vaccine.
Measured: Day 0 to Day 28 post-vaccination
Geometric Mean Concentrations (GMCs) of Diphtheria and Tetanus Antibodies at Baseline and on Day 28 Post-vaccination With Tdap Vaccine.
Measured: Day 0 and Day 28 post-vaccination
Geometric Mean Concentrations (GMCs) of Pertussis Antibodies at Baseline and on Day 28 Post-vaccination With Tdap Vaccine.
Measured: Day 0 and Day 28 Post-vaccination

Secondary outcomes (1)

Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively.
Solicited injection sites reactions: Erythema, swelling, and pain. Solicited systemic reactions: Fever (temperature), headache, malaise, and myalgia.
Measured: 0 to 7 days post-vaccination

Timeline

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

Apr 2005Sep 2007

First posted22 Oct 2008 (estimated)
Study startApr 2005
Primary completionMar 2007
Study completionSep 2007

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.
Other trials for MeningitisStudies of the same condition, open and under way.
More trials run by Sanofi Pasteur, a Sanofi CompanyThe 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: Crossover
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 1,345 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00777257
Sponsor's protocol ID: MTA21
Status last verified: Jan 2014
First submitted: 21 Oct 2008
Last updated: 14 Feb 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

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?

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Study at a glance

From the registry record, last updated by the sponsor on 14 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Immunogenicity and Safety of Meningococcal (Groups A, C, Y, and W-135) Diphtheria Toxoid Conjugate Vaccine (Menactra®) in Adolescents in the US When Administered Concomitantly With Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap Vaccine)
ClinicalTrials.gov ID: NCT00777257
Acronym / sponsor ID: MTA21
Conditions: Meningitis, Meningococcemia, Pertussis, Tetanus, Diphtheria
Keywords: Meningitis, Meningococcemia, Pertussis, Neisseria meningitidis, Tetanus, Diphtheria
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,345 participants (actual)
Lead sponsor: Sanofi Pasteur, a Sanofi CompanyIndustry (pharma, biotech, devices)
Study start: Apr 2005
Primary completion: Mar 2007 (actual)
Study completion: Sep 2007 (actual)
First posted: 22 Oct 2008 (estimated)
Results: Posted 31 Dec 2009

Clinical summary

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

The purpose of this study was to evaluate the immunogenicity and safety of the concomitant administration of Menactra® vaccine and Tdap vaccine in adolescents aged 11 to 17 years.

Primary Objective:

To determine whether concomitant administration of two vaccines, Tdap and Menactra®, induces antibody responses that are similar to those observed when each vaccine is given separately.

Secondary Objective:

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Study Group A	Experimental	Biological: T dap + Meningococcal Polysaccharide Diphtheria Toxoid Conj.Tdap vaccine + placebo concomitantly on Day 0; Menactra® vaccine 28 days later
Study Group B	Experimental	Biological: Tdap + Meningococcal Polysaccharide Diphtheria Toxoid Conj.Tdap vaccine + Menactra® vaccine concomitantly on Day 0; placebo 28 days later
Study Group C	Experimental	Biological: Meningococcal Polysaccharide Diphtheria Toxoid Conj. + T dapMenactra® vaccine + placebo concomitantly on Day 0; Tdap vaccine 28 days later

Who may qualify

Ages: 11 to 17 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (5 listed)

Healthy as determined by medical history and physical examination.
Aged ≥ 11 to 17 years at the time of study vaccination on Day 0.
Informed consent form that has been approved by the Institutional Review Board (IRB) signed by the parent or legal guardian.
Informed assent form that has been approved by the IRB signed by the subject.
Subject (female) agrees to use measures to prevent pregnancy during the study.

Key exclusion criteria (14 listed)

Serious chronic disease (i.e. cardiac, renal, neurologic, metabolic, rheumatologic, psychiatric, etc.).
Known or suspected impairment of immunologic function.
Acute medical illness with or without fever within the last 72 hours or an oral temperature ≥ 100.4°F (≥ 38.0°C) at the time of enrolment.
History of documented invasive meningococcal disease or previous meningococcal vaccination.
History of documented infection with Bordetella pertussis, Clostridium tetani, or Corynebacterium diphtheriae or vaccination with any tetanus, diphtheria or pertussis vaccine within the previous 5 years.

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
T dap + Meningococcal Polysaccharide Diphtheria Toxoid Conj.Also: ADACEL®, Menactra®, Sterile Buffered 0.9% Sodium ChlorideDay 0: 0.5 mL (T dap)+ Placebo, Intramuscular; Day 28: 0.5 mL (Menactra®) Intramuscular	Biological	Study Group A
Tdap + Meningococcal Polysaccharide Diphtheria Toxoid Conj.Also: Menactra®, Adacel®, Sterile Buffered 0.9% Sodium ChlorideDay 0: 0.5 mL (T dap) + 0.5 mL (Menactra®) Intramuscular; Day 28: Placebo 0.5 mL Intramuscular	Biological	Study Group B
Meningococcal Polysaccharide Diphtheria Toxoid Conj. + T dapAlso: Menactra®, Adacel®, Sterile Buffered 0.9% Sodium ChlorideDay 0: 0.5 mL (Menactra®)+0.5 mL Placebo, Intramuscular; Day 28: 0.5 mL (T dap) Intramuscular	Biological	Study Group C

Primary outcome

Percentage of Participants With at Least a 4-fold Rise in Meningococcal Antibody Titer From Baseline (Day 0) to Day 28 Post-vaccination With Menactra® Vaccine.
Time frame: Day 0 to Day 28 post-vaccination
Geometric Mean Concentrations (GMCs) of Diphtheria and Tetanus Antibodies at Baseline and on Day 28 Post-vaccination With Tdap Vaccine.
Time frame: Day 0 and Day 28 post-vaccination
Geometric Mean Concentrations (GMCs) of Pertussis Antibodies at Baseline and on Day 28 Post-vaccination With Tdap Vaccine.
Time frame: Day 0 and Day 28 Post-vaccination

1 secondary outcome

Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively.
Time frame: 0 to 7 days post-vaccination

Results and safety

Results posted to the registry on 31 Dec 2009, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Tdap + Placebo Vaccines Day 0	444	433
Tdap + Menactra® Vaccines Day 0	450	438
Menactra® + Placebo Vaccines Day 0	451	442

Primary outcome: Percentage of Participants With at Least a 4-fold Rise in Meningococcal Antibody Titer From Baseline (Day 0) to Day 28 Post-vaccination With Menactra® Vaccine.

Time frame: Day 0 to Day 28 post-vaccination. Number. Unit: Percentage of participants

Measure	Tdap + Placebo Vaccines Day 0 n = 376	Tdap + Menactra® Vaccines Day 0 n = 382	Menactra® + Placebo Vaccines Day 0 n = 382
Meningococcal Serogroup A	92	94	93
Meningococcal Serogroup C	80	84	87
Meningococcal Serogroup Y	79	87	87
Meningococcal Serogroup W-135	94	96	96

Population analysed: Serum bactericidal activity using baby rabbit complement (SBA-BR) titers for each meningococcal serogroup was evaluated in the per-protocol population

Primary outcome: Geometric Mean Concentrations (GMCs) of Diphtheria and Tetanus Antibodies at Baseline and on Day 28 Post-vaccination With Tdap Vaccine.

Time frame: Day 0 and Day 28 post-vaccination. Geometric mean (95% Confidence Interval). Unit: IU/mL

Measure	Tdap + Placebo Vaccines Day 0 n = 377	Tdap + Menactra® Vaccines Day 0 n = 384	Menactra® + Placebo Vaccines Day 0 n = 383
Diphtheria toxoid - Day 0	0.2 (0.2 to 0.3)	0.3 (0.3 to 0.3)	56.2 (48.9 to 64.6)
Diphtheria toxoid - Day 28	7.9 (7.0 to 8.8)	49.8 (43.8 to 56.7)	38.2 (33.3 to 43.9)
Tetanus toxoid - Day 0	0.9 (0.8 to 0.9)	0.8 (0.8 to 0.9)	1.0 (0.9 to 1.1)
Tetanus toxoid - Day 28	22.8 (21.0 to 24.7)	16.4 (15.2 to 17.5)	21.1 (19.6 to 22.7)

Population analysed: Geometric mean concentration for each vaccine antigen was evaluated in the per-protocol population.

Primary outcome: Geometric Mean Concentrations (GMCs) of Pertussis Antibodies at Baseline and on Day 28 Post-vaccination With Tdap Vaccine.

Time frame: Day 0 and Day 28 Post-vaccination. Geometric mean (95% Confidence Interval). Unit: EU/mL

Measure	Tdap + Placebo Vaccines Day 0 n = 377	Tdap + Menactra® Vaccines Day 0 n = 384	Menactra® + Placebo Vaccines Day 0 n = 383
Pertussis Toxoid - Day 0	15.3 (13.3 to 17.5)	14.0 (12.2 to 16.0)	20.7 (18.0 to 23.9)
Pertussis Toxoid - Day 28	88.0 (79.8 to 97.1)	73.4 (67.0 to 80.3)	107.4 (97.6 to 118.2)
Filamentous Haemagglutinin - Day 0	21.4 (18.9 to 24.3)	20.0 (17.9 to 22.3)	28.5 (25.4 to 31.9)
Filamentous Haemagglutinin - Day 28	179.5 (163.2 to 197.6)	140.2 (128.0 to 153.6)	245.1 (226.4 to 265.2)
Pertactin - Day 0	9.0 (7.9 to 10.3)	8.4 (7.4 to 9.5)	11.9 (10.4 to 13.6)
Pertactin - Day 28	176.5 (156.6 to 199.0)	130.3 (116.5 to 145.9)	213.6 (192.8 to 236.6)
Fimbriae Types 2 and 3 - Day 0	13.8 (12.0 to 15.9)	12.7 (11.1 to 14.6)	14.2 (12.2 to 16.6)
Fimbriae Types 2 and 3 - Day 28	1133.4 (979.3 to 1311.7)	699.1 (602.9 to 810.7)	832.3 (712.0 to 972.8)

Population analysed: Geometric mean concentration for each vaccine antigen was evaluated in the per-protocol population.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse event data were collected over 2 months post-dose 1 vaccination. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Tdap + Placebo Vaccines Day 0	2 of 444 (0.5%)	0 of 444 (0%)	Not reported
Tdap + Menactra® Vaccines Day 0	1 of 450 (0.2%)	0 of 450 (0%)	Not reported
Menactra® + Placebo Vaccines Day 0	1 of 451 (0.2%)	0 of 451 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink provided by the sponsor.

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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.

Medical Monitor study director

Sanofi Pasteur Inc.

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

Questions about this trial

What is this clinical trial studying?

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 5 inclusion and 14 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 14 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 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 31 Dec 2009). 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?

Percentage of Participants With at Least a 4-fold Rise in Meningococcal Antibody Titer From Baseline (Day 0) to Day 28 Post-vaccination With Menactra® Vaccine. (time frame: Day 0 to Day 28 post-vaccination). The study lists 3 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 NCT00777257.

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 14 Feb 2014.