Meningococcal InfectionsPhase 1/2NCT00874549

Exploratory Trial to Evaluate the Safety and Immunogenicity of Menactra® and Menomune® Vaccines in Subjects ≥ 56 Years

A Phase 1/2 study testing Menomune®: A, C, Y, W-135 Meningococcal Polysaccharide and Menactra®: Polysaccharide Diphtheria Toxoid Conjugate in people with Meningococcal Infections and Meningococcal Meningitis, run by Sanofi Pasteur, a Sanofi Company at 6 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

Safety: To describe the rates of immediate reactions, solicited injection-site and systemic reactions, all unsolicited adverse events, and serious adverse events following vaccination with either Menactra® vaccine or Menomune® vaccine. Read more about this study

Who is it for?: Ages 56 years and olderHealthy volunteers can take part
Conditions the study is for: Meningococcal Infections, Meningococcal Meningitis
What is being tested?: Menomune®: A, C, Y, W-135 Meningococcal Polysaccharide and Menactra®: Polysaccharide Diphtheria Toxoid Conjugate
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 216 participants
Where: 6 sitesUnited States
Study dates: Oct 2007to Oct 2008
Phase: Phase 1/2
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 56 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Ambulatory and healthy, as determined by medical history.
56 years of age or older at the time of vaccination.
Signed Institutional Review Board (IRB)-approved informed consent form.
Able to attend all scheduled visits and to comply with all trial procedures.
For a woman, inability to become pregnant or a negative urine pregnancy test at the time of enrollment.

Who cannot join

Any condition which, in the opinion of the Investigator, would pose a health risk to the participant or interfere with the evaluation of the vaccine.
Serious chronic disease (i.e., cardiac, renal, neurologic, metabolic, rheumatologic, psychiatric, etc) that is unstable or that might 1) interfere with the ability to participate fully in the study or 2) interfere with evaluation of the vaccines.
Known or suspected impairment of immunologic function.
Febrile illness within the last 72 hours or an oral temperature ≥ 100.4ºF at the time of inclusion.
History of documented invasive meningococcal disease or previous meningococcal vaccination.
Known or suspected receipt of a diphtheria-containing vaccine within the preceding 2 years.

Show all 18Show fewer

Administration of immune globulin or other blood products within the last three months, or injected or oral corticosteroids or other immunomodulator therapy within six weeks of the study vaccine. Individuals on a tapering dose schedule of oral steroids lasting < 7 days may be included in the trial as long as they have not received more than one course within the last two weeks prior to enrollment.
Systemic antibiotic therapy within the 72 hours prior to collection of any blood samples.
Received any vaccine in the 28-day period prior to enrollment or scheduled to receive any vaccination through Visit 2 for Groups 1 and 2 and through Visit 3 for Groups 3 and 4. Influenza vaccines may be received 2 weeks before or after a study vaccination.
Suspected or known hypersensitivity to latex or to any of the components of either Menactra® vaccine or Menomune® vaccine.
Previous personal history of Guillain-Barré syndrome.
Not available for the entire study period or unable to attend the scheduled visits or to comply with the study procedures.
In females of childbearing potential, a positive or equivocal urine pregnancy test at enrollment.
A nursing mother.
Participation in another interventional clinical trial in the 4 weeks preceding enrollment or planning to participate in another interventional clinical trial during the planned period of this study.
Current use of alcohol or recreational drugs that may interfere with the subject's ability to comply with trial visits or procedures.
Thrombocytopenia or bleeding disorder contraindicating intramuscular vaccination.
Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent.

Trial locations and contacts

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

United States6 sites

Study site
Albuquerque, New Mexico, 87108
Study site
Bardstown, Kentucky, 40004
Study site
Scottsdale, Arizona, 85251
Study site
Seattle, Washington, 98101
Study site
Spokane, Washington, 99202
Study site
West Jordon, Utah, 84088

Other trials in United States

About this study

Official title: A Safety and Immunogenicity Evaluation of a Meningococcal (Groups A, C, Y, and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (Menactra®) and a Meningococcal Polysaccharide Vaccine Groups A, C, Y, and W-135 Combined (Menomune® - A/C/Y/W-135) in Subjects 56 Years of Age or Older

Safety:

To describe the rates of immediate reactions, solicited injection-site and systemic reactions, all unsolicited adverse events, and serious adverse events following vaccination with either Menactra® vaccine or Menomune® vaccine.

Immunogenicity:

To evaluate the immune response to serogroups A, C, Y, and W-135 in each of the four study groups.

Conditions: Meningococcal Infections, Meningococcal Meningitis
Being tested: Menomune®: A, C, Y, W-135 Meningococcal Polysaccharide, Menactra®: Polysaccharide Diphtheria Toxoid Conjugate
Keywords: Meningococcal Vaccine, Menactra®, Menomune®
Medical subject headings: Meningococcal Infections, Meningitis, Meningococcal

What participants receive

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

Menomune®: A, C, Y, W-135 Meningococcal PolysaccharideBiological
Also called Menomune®
0.5 mL, Subcutaneous
Menactra®: Polysaccharide Diphtheria Toxoid ConjugateBiological
Also called Menactra®
0.5 mL, Intramuscular
Menactra®: Polysaccharide Diphtheria Toxoid ConjugateBiological
Also called Menactra®
0.5 mL. Intramuscular
Menactra®: Polysaccharide Diphtheria Toxoid ConjugateBiological
Also called Menactra®
0.5 mL, Intramuscular

Study groups in NCT00874549
Study group	Role	What they receive
Group 1: Menomune Day 0	Active comparator	Participants received a single dose of Menomune® vaccine on Day 0. Receives: Biological: Menomune®: A, C, Y, W-135 Meningococcal Polysaccharide
Group 2: Menactra® Day 0 x 2	Experimental	Participants received two single-dose injections of Menactra® vaccine on Day 0 Receives: Biological: Menactra®: Polysaccharide Diphtheria Toxoid Conjugate
Group 3: Menactra® Day 0 and 14	Experimental	Participants received a single dose of Menactra® vaccine on Day 0 and on Day 14 Receives: Biological: Menactra®: Polysaccharide Diphtheria Toxoid Conjugate
Group 4: Menactra® Day 0 and 28	Experimental	Participants received a single dose of Menactra® vaccine on Day 0 and on Day 28. Receives: Biological: Menactra®: Polysaccharide Diphtheria Toxoid Conjugate

What is being measured

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

Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-Vaccination 1.
Solicited injection site reactions: pain, erythema, and swelling. Solicited systemic reactions: Fever (temperature), Headache, Malaise, Myalgia, chills, Arthralgia, Urticaria, Anorexia, Diarrhea, and Vomiting.
Measured: 0-7 days post-vaccination 1
Number of Participants With At Least One Solicited Injection Site Reaction Post-Vaccination 2
Solicited injection site reactions: Pain, Erythema, and Swelling.
Measured: 0-7 Days Post-vaccination 2
Number of Participants With At Least One Solicited Systemic Reaction Post-Vaccination 2
Solicited systemic reactions: Fever (temperature), Headache, Malaise, Myalgia, chills, Arthralgia, Urticaria, Anorexia, Diarrhea, and Vomiting.
Measured: Day 0 to 7 Post-vaccination 2

Timeline

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

Oct 2007Oct 2008

First posted2 Apr 2009 (estimated)
Study startOct 2007
Primary completionJan 2008
Study completionOct 2008

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 Meningococcal InfectionsStudies 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 1/2
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 216 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00874549
Sponsor's protocol ID: MTA29
Status last verified: Sep 2013
First submitted: 31 Mar 2009
Last updated: 20 Sep 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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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Immunogenicity and Safety Study of an Investigational Quadrivalent Meningococcal Conjugate Vaccine Administered in Healthy Infants and Toddlers in China
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Safety, Tolerability, and Immunogenicity of MenABCWY Administered on Different Dosing Schedules in Healthy Adolescents
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A Study to Learn About the Safety of PENBRAYA During Pregnancy
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All Meningococcal Infections trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Safety and Immunogenicity Evaluation of a Meningococcal (Groups A, C, Y, and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (Menactra®) and a Meningococcal Polysaccharide Vaccine Groups A, C, Y, and W-135 Combined (Menomune® - A/C/Y/W-135) in Subjects 56 Years of Age or Older
ClinicalTrials.gov ID: NCT00874549
Acronym / sponsor ID: MTA29
Conditions: Meningococcal Infections, Meningococcal Meningitis
Keywords: Meningococcal Vaccine, Menactra®, Menomune®
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 216 participants (actual)
Lead sponsor: Sanofi Pasteur, a Sanofi CompanyIndustry (pharma, biotech, devices)
Study start: Oct 2007
Primary completion: Jan 2008 (actual)
Study completion: Oct 2008 (actual)
First posted: 2 Apr 2009 (estimated)
Results: Posted 25 Mar 2010

Clinical summary

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

Safety:

Immunogenicity:

To evaluate the immune response to serogroups A, C, Y, and W-135 in each of the four study groups.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Group 1: Menomune Day 0	Active comparator	Biological: Menomune®: A, C, Y, W-135 Meningococcal PolysaccharideParticipants received a single dose of Menomune® vaccine on Day 0.
Group 2: Menactra® Day 0 x 2	Experimental	Biological: Menactra®: Polysaccharide Diphtheria Toxoid ConjugateParticipants received two single-dose injections of Menactra® vaccine on Day 0
Group 3: Menactra® Day 0 and 14	Experimental	Biological: Menactra®: Polysaccharide Diphtheria Toxoid ConjugateParticipants received a single dose of Menactra® vaccine on Day 0 and on Day 14
Group 4: Menactra® Day 0 and 28	Experimental	Biological: Menactra®: Polysaccharide Diphtheria Toxoid ConjugateParticipants received a single dose of Menactra® vaccine on Day 0 and on Day 28.

Who may qualify

Ages: 56 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Ambulatory and healthy, as determined by medical history.
56 years of age or older at the time of vaccination.
Signed Institutional Review Board (IRB)-approved informed consent form.
Able to attend all scheduled visits and to comply with all trial procedures.
For a woman, inability to become pregnant or a negative urine pregnancy test at the time of enrollment.

Key exclusion criteria (18 listed)

Any condition which, in the opinion of the Investigator, would pose a health risk to the participant or interfere with the evaluation of the vaccine.
Serious chronic disease (i.e., cardiac, renal, neurologic, metabolic, rheumatologic, psychiatric, etc) that is unstable or that might 1) interfere with the ability to participate fully in the study or 2) interfere with evaluation of the vaccines.
Known or suspected impairment of immunologic function.
Febrile illness within the last 72 hours or an oral temperature ≥ 100.4ºF at the time of inclusion.
History of documented invasive meningococcal disease or previous meningococcal vaccination.

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
Menomune®: A, C, Y, W-135 Meningococcal PolysaccharideAlso: Menomune®0.5 mL, Subcutaneous	Biological	Group 1: Menomune Day 0
Menactra®: Polysaccharide Diphtheria Toxoid ConjugateAlso: Menactra®0.5 mL, Intramuscular	Biological	Group 2: Menactra® Day 0 x 2
Menactra®: Polysaccharide Diphtheria Toxoid ConjugateAlso: Menactra®0.5 mL. Intramuscular	Biological	Group 3: Menactra® Day 0 and 14
Menactra®: Polysaccharide Diphtheria Toxoid ConjugateAlso: Menactra®0.5 mL, Intramuscular	Biological	Group 4: Menactra® Day 0 and 28

Primary outcome

Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-Vaccination 1.
Time frame: 0-7 days post-vaccination 1
Solicited injection site reactions: pain, erythema, and swelling. Solicited systemic reactions: Fever (temperature), Headache, Malaise, Myalgia, chills, Arthralgia, Urticaria, Anorexia, Diarrhea, and Vomiting.
Number of Participants With At Least One Solicited Injection Site Reaction Post-Vaccination 2
Time frame: 0-7 Days Post-vaccination 2
Solicited injection site reactions: Pain, Erythema, and Swelling.
Number of Participants With At Least One Solicited Systemic Reaction Post-Vaccination 2
Time frame: Day 0 to 7 Post-vaccination 2
Solicited systemic reactions: Fever (temperature), Headache, Malaise, Myalgia, chills, Arthralgia, Urticaria, Anorexia, Diarrhea, and Vomiting.

Results and safety

Results posted to the registry on 25 Mar 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Group 1: Menomune® Day 0	51	50
Group 2: Menactra® Day 0 x 2	56	55
Group 3: Menactra® Day 0 and 14	51	47
Group 4: Menactra® Day 0 and 28	58	56

Primary outcome: Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-Vaccination 1.

Time frame: 0-7 days post-vaccination 1. Number. Unit: Participants

Measure	Group 1: Menomune® Day 0 n = 51	Group 2: Menactra® Day 0 x 2 n = 56	Group 3: Menactra® Day 0 and 14 n = 51	Group 4: Menactra® Day 0 and 28 n = 58
Any Solicited Injection Site Reaction	26	20	28	23
Grade 3 Solicited Injection Site Reaction	4	0	1	3
Any Pain	12	16	24	18
Grade 3 Pain (Incapacitating)	1	0	0	1
Any Erythema	22	5	9	8
Grade 3 Erythema (≥ 5 cm)	3	0	1	0
Any Swelling	10	6	5	3
Grade 3 Swelling (≥ 5 cm)	0	0	1	2

Population analysed: Safety analysis post-vaccination 1 was on all enrolled and vaccinated participants, intent-to-treat population.

Primary outcome: Number of Participants With At Least One Solicited Injection Site Reaction Post-Vaccination 2

Time frame: 0-7 Days Post-vaccination 2. Number. Unit: Participants

Measure	Group 1: Menomune® Day 0 n = 0	Group 2: Menactra® Day 0 x 2 n = 56	Group 3: Menactra® Day 0 and 14 n = 51	Group 4: Menactra® Day 0 and 28 n = 58
Any Solicited Injection site reaction	–	17	25	24
Grade 3 Solicited Injection site reaction	–	0	0	1
Any Pain	–	14	24	22
Grade 3 Pain (Incapacitating)	–	0	0	0
Any Erythema	–	7	5	6
Grade 3 Erythema (≥ 5 cm)	–	0	0	1
Any Swelling	–	5	5	3
Grade 3 Swelling (≥ 5 cm)	–	0	0	1

Population analysed: Safety analysis post-vaccination 2 was on all enrolled and vaccinated participants, intent-to-treat population. No data were collected for participants in Group 1.

Primary outcome: Number of Participants With At Least One Solicited Systemic Reaction Post-Vaccination 2

Time frame: Day 0 to 7 Post-vaccination 2. Number. Unit: Participants

Measure	Group 1: Menomune® Day 0 n = 0	Group 2: Menactra® Day 0 x 2 n = 0	Group 3: Menactra® Day 0 and 14 n = 51	Group 4: Menactra® Day 0 and 28 n = 58
Any Solicited Systemic Reaction	–	–	19	13
Grade 3 Solicited Systemic Reaction	–	–	3	1
Any Anorexia	–	–	1	2
Grade 3 Anorexia (Prevents daily activities)	–	–	0	0
Any Arthralgia	–	–	5	2
Grade 3 Arthralgia (Prevents daily activities)	–	–	1	2
Any Chills	–	–	4	1
Grade 3 Chills (Prevents daily activities)	–	–	0	1

Population analysed: Safety analysis post-vaccination 2 was on all enrolled and vaccinated participants, intent-to-treat population. No data were collected for participants in Group 1 and Group 2.

Adverse events

Time frame: Adverse events data were collected from day of enrollment to 6 Months after the last vaccination.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Menomune® Day 0	4 of 51 (7.8%)	3 of 51 (5.9%)	Not reported
Menactra® Day 0 x 2	3 of 56 (5.4%)	5 of 56 (8.9%)	Not reported
Menactra® Day 0 and Day 14	1 of 51 (2%)	8 of 51 (15.7%)	Not reported
Menactra® Day 0 and Day 28	0 of 58 (0%)	12 of 58 (20.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink provided by the sponsor.

Related trials for Meningococcal Infections

Not yet recruitingPhase 4
Single-center, Open-label Study: Immunogenicity and Safety Observation After Vaccination With ACYW135 Meningococcal Polysaccharide Vaccine in Junior High School Students Aged 13-15 Years
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RecruitingPhase 3
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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.

6 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 18 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 20 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 25 Mar 2010). 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 Participants With At Least One Solicited Injection Site or Systemic Reaction Post-Vaccination 1. (time frame: 0-7 days post-vaccination 1). 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 NCT00874549.

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 20 Sep 2013.