MeningitisPhase 1NCT00631995
Safety and Immunogenicity of a Quadrivalent Meningococcal Tetanus Protein Conjugate Vaccine in Toddlers
A Phase 1 study testing Meningococcal Polysaccharide Tetanus Protein Conjugate and Meningococcal polysaccharide group C conjugated in people with Meningitis and Meningococcal Infection, run by Sanofi Pasteur, a Sanofi Company at 5 sites in Australia.
Trial summary
This study is aimed at studying quadrivalent meningococcal (A, C, Y, and W-135) Tetanus Protein Conjugate Vaccine (TetraMen-T) formulations in Toddlers. Primary Objectives: Safety and Immunogenicity: To describe the safety and immunogenicity profiles of: A single dose of each formulation of TetraMen-T vaccine A single… Read more about this study
- Who is it for?
- Ages 12 to 12 monthsHealthy volunteers can take part
- Conditions the study is for
- Meningitis, Meningococcal Infection
- What is being tested?
- Meningococcal Polysaccharide Tetanus Protein Conjugate and Meningococcal polysaccharide group C conjugated
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 5 sitesAustralia
- Study dates
- Apr 2008to Apr 2009
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 12 to 12 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Subject is healthy, as determined by medical history and physical assessment.
- Aged 12 months (± 21 days) on the day of inclusion.
- Institutional Review Board (IRB)-approved informed consent form signed by the subject's parent/legal guardian.
- Able to attend all scheduled visits and to comply with all trial procedures.
Who cannot join
- Serious acute or chronic disease (e.g., cardiac, renal, metabolic, rheumatologic, psychiatric, hematologic, or autoimmune disorders, diabetes, atopic conditions, congenital defects, convulsions, encephalopathy, blood dyscrasias, leukemia, lymphomas of any type, or other malignant neoplasms affecting the bone marrow or lymphatic system, acute untreated tuberculosis) that could interfere with trial conduct or completion.
- Known or suspected impairment of immunologic function.
- Acute medical illness within the last 72 hours, or temperature ≥ 37.5ºC (axillary) at the time of enrollment (temporary contraindication).
- History of documented invasive meningococcal disease or previous meningococcal vaccination.
- Known human immunodeficiency virus (HIV), hepatitis B, or hepatitis C seropositivity as reported by the parent or legal guardian.
- 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 two weeks prior to enrollment. Topical steroids are not included in this exclusion criterion.
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- Anticipated to receive oral or injected antibiotic therapy within the 72 hours prior to the study blood draw. Topical antibiotics or antibiotic drops are not included in this exclusion criterion.
- Suspected or known hypersensitivity to any of the vaccine components.
- Thrombocytopenia or a bleeding disorder contraindicating intramuscular (IM) vaccination.
- Parent or legal guardian unable or unwilling to comply with the stu dy procedures.
- Participation in another interventional clinical trial in the 30 days preceding enrollment, or participation in another clinical trial involving the investigation of a drug, vaccine, medical procedure, or medical device during the subject's trial period.
- 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.
- Received any vaccine in the 30-day period prior to receipt of study vaccine, or scheduled to receive any vaccination other than influenza vaccination and hyposensitization therapy in the 30-day period after receipt of any study vaccine. Hyposensitization therapy and influenza vaccination may be received up to 14 days before or 14 days after receiving the study vaccines.
- History of seizures, including febrile seizures, or any other neurologic disorder.
- Personal or family history of Guillain-Barré Syndrome (GBS).
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Australia5 sites
Study site
Herston
Study site
Melbourne
Study site
North Adelaide
Study site
Perth
Study site
Westmead
About this study
Official title: Safety and Immunogenicity of a Quadrivalent Meningococcal (A, C, Y, and W-135) Tetanus Protein Conjugate Vaccine (TetraMen-T) in Toddlers
This study is aimed at studying quadrivalent meningococcal (A, C, Y, and W-135) Tetanus Protein Conjugate Vaccine (TetraMen-T) formulations in Toddlers.
Primary Objectives: Safety and Immunogenicity:
To describe the safety and immunogenicity profiles of:
- A single dose of each formulation of TetraMen-T vaccine
- A single dose of NeisVac-C® vaccine.
Read the detailed description
The study is designed to evaluate the safety profile and the immunogenicity response after a single dose of TetraMen-T in toddlers.
- Conditions
- Meningitis, Meningococcal Infection
- Being tested
- Meningococcal Polysaccharide Tetanus Protein Conjugate, Meningococcal polysaccharide group C conjugated
- Keywords
- Neisseria meningitidis
- Medical subject headings
- Meningitis, Meningococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meningococcal Polysaccharide Tetanus Protein ConjugateBiological
0.5 mL, Intramuscular
Meningococcal Polysaccharide Tetanus Protein ConjugateBiological
0.5 mL, Intramuscular
Meningococcal Polysaccharide Tetanus Protein ConjugateBiological
0.5 mL, Intramuscular
Meningococcal Polysaccharide Tetanus Protein ConjugateBiological
0.5 mL, Intramuscular
Meningococcal Polysaccharide Tetanus Protein ConjugateBiological
0.5 mL, Intramuscular
Meningococcal polysaccharide group C conjugatedDietary supplement
Also called NeisVac-C® vaccine (Baxter Healthcare)
0.5 mL, Intramuscular
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Not described Receives: Biological: Meningococcal Polysaccharide Tetanus Protein Conjugate |
| Group 2 | Experimental | Not described Receives: Biological: Meningococcal Polysaccharide Tetanus Protein Conjugate |
| Group 3 | Experimental | Not described Receives: Biological: Meningococcal Polysaccharide Tetanus Protein Conjugate |
| Group 4 | Experimental | Not described Receives: Biological: Meningococcal Polysaccharide Tetanus Protein Conjugate |
| Group 5 | Experimental | Not described Receives: Biological: Meningococcal Polysaccharide Tetanus Protein Conjugate |
| Group 6 | Active comparator | Not described Receives: Dietary Supplement: Meningococcal polysaccharide group C conjugated |
What is being measured
The primary outcome is the main question the study is designed to answer.
To provide information concerning the safety and immunogenicity after administration of TetraMenT
Measured: 30 days after each injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2008 (estimated)
- Study startApr 2008
- Primary completionFeb 2009
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 360 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi Pasteur, a Sanofi Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Sanofi Pasteur Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00631995
- Sponsor's protocol ID
- MET32
- Status last verified
- Feb 2018
- First submitted
- 29 Feb 2008
- Last updated
- 6 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
McVernon J, Nolan T, Richmond P, Reynolds G, Nissen M, Lambert SB, Marshall H, Papa T, Rehm C. A randomized trial to assess safety and immunogenicity of alternative formulations of a quadrivalent meningococcal (A, C, Y, and W-135) tetanus protein conjugate vaccine in toddlers. Pediatr Infect Dis J. 2012 Jan;31(1):e15-23. doi: 10.1097/INF.0b013e31823e1e34.
PubMed 22094636
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Immunogenicity of a Quadrivalent Meningococcal (A, C, Y, and W-135) Tetanus Protein Conjugate Vaccine (TetraMen-T) in Toddlers
- ClinicalTrials.gov ID
- NCT00631995
- Acronym / sponsor ID
- MET32
- Conditions
- Meningitis, Meningococcal Infection
- Keywords
- Neisseria meningitidis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 360 participants (actual)
- Lead sponsor
- Sanofi Pasteur, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- Apr 2008
- Primary completion
- Feb 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 10 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is aimed at studying quadrivalent meningococcal (A, C, Y, and W-135) Tetanus Protein Conjugate Vaccine (TetraMen-T) formulations in Toddlers.
Primary Objectives: Safety and Immunogenicity:
To describe the safety and immunogenicity profiles of:
- A single dose of each formulation of TetraMen-T vaccine
- A single dose of NeisVac-C® vaccine.
Detailed description
The study is designed to evaluate the safety profile and the immunogenicity response after a single dose of TetraMen-T in toddlers.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Biological: Meningococcal Polysaccharide Tetanus Protein Conjugate |
| Group 2 | Experimental | Biological: Meningococcal Polysaccharide Tetanus Protein Conjugate |
| Group 3 | Experimental | Biological: Meningococcal Polysaccharide Tetanus Protein Conjugate |
| Group 4 | Experimental | Biological: Meningococcal Polysaccharide Tetanus Protein Conjugate |
| Group 5 | Experimental | Biological: Meningococcal Polysaccharide Tetanus Protein Conjugate |
| Group 6 | Active comparator | Dietary Supplement: Meningococcal polysaccharide group C conjugated |
Who may qualify
- Ages
- 12 to 12 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Subject is healthy, as determined by medical history and physical assessment.
- Aged 12 months (± 21 days) on the day of inclusion.
- Institutional Review Board (IRB)-approved informed consent form signed by the subject's parent/legal guardian.
- Able to attend all scheduled visits and to comply with all trial procedures.
Key exclusion criteria (15 listed)
- Serious acute or chronic disease (e.g., cardiac, renal, metabolic, rheumatologic, psychiatric, hematologic, or autoimmune disorders, diabetes, atopic conditions, congenital defects, convulsions, encephalopathy, blood dyscrasias, leukemia, lymphomas of any type, or other malignant neoplasms affecting the bone marrow or lymphatic system, acute untreated tuberculosis) that could interfere with trial conduct or completion.
- Known or suspected impairment of immunologic function.
- Acute medical illness within the last 72 hours, or temperature ≥ 37.5ºC (axillary) at the time of enrollment (temporary contraindication).
- History of documented invasive meningococcal disease or previous meningococcal vaccination.
- Known human immunodeficiency virus (HIV), hepatitis B, or hepatitis C seropositivity as reported by the parent or legal guardian.
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 |
|---|---|---|
| Meningococcal Polysaccharide Tetanus Protein Conjugate0.5 mL, Intramuscular | Biological | Group 1 |
| Meningococcal Polysaccharide Tetanus Protein Conjugate0.5 mL, Intramuscular | Biological | Group 2 |
| Meningococcal Polysaccharide Tetanus Protein Conjugate0.5 mL, Intramuscular | Biological | Group 3 |
| Meningococcal Polysaccharide Tetanus Protein Conjugate0.5 mL, Intramuscular | Biological | Group 4 |
| Meningococcal Polysaccharide Tetanus Protein Conjugate0.5 mL, Intramuscular | Biological | Group 5 |
| Meningococcal polysaccharide group C conjugatedAlso: NeisVac-C® vaccine (Baxter Healthcare)0.5 mL, Intramuscular | Dietary supplement | Group 6 |
Primary outcome
To provide information concerning the safety and immunogenicity after administration of TetraMenT
Time frame: 30 days after each injection
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2018.
- Results publication: PubMed 22094636McVernon J, Nolan T, Richmond P, Reynolds G, Nissen M, Lambert SB, Marshall H, Papa T, Rehm C. A randomized trial to assess safety and immunogenicity of alternative formulations of a quadrivalent meningococcal (A, C, Y, and W-135) tetanus protein conjugate vaccine in toddlers. Pediatr Infect Dis J. 2012 Jan;31(1):e15-23. doi: 10.1097/INF.0b013e31823e1e34.
- 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 Director study director
Sanofi Pasteur Inc.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Meningococcal Polysaccharide Tetanus Protein Conjugate and Meningococcal polysaccharide group C conjugated in people with Meningitis and Meningococcal Infection, run by Sanofi Pasteur, a Sanofi Company at 5 sites in Australia.
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 4 inclusion and 15 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 6 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Australia. 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To provide information concerning the safety and immunogenicity after administration of TetraMenT (time frame: 30 days after each injection). 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 NCT00631995, which also lists 1 linked publication.
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 6 Feb 2018.