Meningococcal InfectionsPhase 4NCT00850603
Safety and Immunogenicity of Intradermal Versus Subcutaneous Doses of Menomune®
A Phase 4 study testing Meningococcal Polysaccharide Groups A\C\Y\W-135 Combined in people with Meningococcal Infections and Meningitis, run by Sanofi Pasteur, a Sanofi Company at 1 site in United States.
Trial summary
The objective of this trial is to study the administration of the Menomune vaccine given intradermally and low-dose subcutaneously versus standard subcutaneously. This study will describe the immunogenicity of Menomune® - A/C/Y/W-135 administered subcutaneously (standard dose) versus intradermally over a dose range… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Meningococcal Infections, Meningitis
- What is being tested?
- Meningococcal Polysaccharide Groups A\C\Y\W-135 Combined
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2002to Nov 2004
- 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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18 to 55 years of age.
- Willing to return for 3 follow-up visits and comply with a 30 day follow-up period.
- Signed an informed consent form.
Who cannot join
- Allergy to any component of the vaccine and latex.
- Known or suspected immunodeficiency or receipt of immunosuppressive therapy or blood products within the previous two months.
- History of serious chronic diseases (such as cardiac or renal disease).
- Acute febrile illness at the time of visit.
- Pregnancy.
- Receipt of any vaccine within the 28 days prior to enrollment.
- Receipt of meningococcal vaccine (example in Military) within the past 5 years or history of meningococcal disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety and Immunogenicity of Intradermal, and Low-dose Subcutaneous vs Subcutaneous Administration of Menomune® - A/C/Y/W-135
The objective of this trial is to study the administration of the Menomune vaccine given intradermally and low-dose subcutaneously versus standard subcutaneously. This study will describe the immunogenicity of Menomune® - A/C/Y/W-135 administered subcutaneously (standard dose) versus intradermally over a dose range (1/10th, 2/10th, and 3/10th of standard dose) and a low dose (2/10th of standard dose) subcutaneously.
The secondary objective is to describe the safety of the subcutaneous (SC) and intradermal (ID) routes at different dosages
Read the detailed description
This trial will provide a proof of concept that a dose range of Menomune given ID can induce an immune response that is comparable to standard dosing by the SC route, and is equivalent or superior to a low dose given SC.
Subjects will be randomized according to a computer-generated randomization schedule to receive the vaccine by SC injection or by ID injection at different dosages.
- Conditions
- Meningococcal Infections, Meningitis
- Being tested
- Meningococcal Polysaccharide Groups A\C\Y\W-135 Combined
- Keywords
- Menomune® - A/C/Y/W-135, Meningococcal Infections, Meningitis
- Medical subject headings
- Meningococcal Infections, Meningitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meningococcal Polysaccharide Groups A\C\Y\W-135 CombinedBiological
Also called Menomune® - A/C/Y/W-135
0.5 mL, Subcutaneous
Meningococcal Polysaccharide Groups A\C\Y\W-135 CombinedBiological
Also called Menomune® - A/C/Y/W-135
0.1 mL, Subcutaneous
Meningococcal Polysaccharide Groups A\C\Y\W-135 CombinedBiological
Also called Menomune® - A/C/Y/W-135
0.05 mL, Intradermal
Meningococcal Polysaccharide Groups A\C\Y\W-135 CombinedBiological
Also called Menomune® - A/C/Y/W-135
0.1 mL, Intradermal
Meningococcal Polysaccharide Groups A\C\Y\W-135 CombinedBiological
Also called Menomune® - A/C/Y/W-135
0.15 mL, Intradermal
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | 0.5 mL Subcutaneous arm (Menomune® ) Receives: Biological: Meningococcal Polysaccharide Groups A\C\Y\W-135 Combined |
| Group 2 | Experimental | 0.1 mL Subcutaneous arm (Menomune®) Receives: Biological: Meningococcal Polysaccharide Groups A\C\Y\W-135 Combined |
| Group 3 | Experimental | 0.05 mL Intradermal arm (Menomune®) Receives: Biological: Meningococcal Polysaccharide Groups A\C\Y\W-135 Combined |
| Group 4 | Experimental | 0.1 mL Intradermal arm (Menomune®) Receives: Biological: Meningococcal Polysaccharide Groups A\C\Y\W-135 Combined |
| Group 5 | Experimental | 0.15 mL Intradermal arm (Menomune®) Receives: Biological: Meningococcal Polysaccharide Groups A\C\Y\W-135 Combined |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With ≥ 4-Fold Rise in Antibody Titers
Percentage of participants with a 4-fold rise in Serum bactericidal assay using baby rabbit complement (SBA-BR) antibody titers to each meningococcal serogroup from baseline to Day 28 post-vaccination.
Measured: Baseline to 28 days post vaccination
Geometric Mean Titers (GMTs) for Each Meningococcal Serogroup at Baseline and 28 Days Post-vaccination.
GMTs and their 95% confidence interval to the vaccine meningococcal serogroups at Day 0 and Day 28 post-vaccination.
Measured: Baseline (Day 0) and Day 28 post-vaccination
Secondary outcomes (1)
Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination.
Participants with solicited local and systemic reactions and intensity within 7 days following vaccination with Menomune®
Measured: Day 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.
- First posted25 Feb 2009 (estimated)
- Study startOct 2002
- Primary completionMay 2003
- Study completionNov 2004
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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 170 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
- NCT00850603
- Sponsor's protocol ID
- MPT01
- Status last verified
- Apr 2016
- First submitted
- 24 Feb 2009
- Last updated
- 14 Apr 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Immunogenicity of Intradermal, and Low-dose Subcutaneous vs Subcutaneous Administration of Menomune® - A/C/Y/W-135
- ClinicalTrials.gov ID
- NCT00850603
- Acronym / sponsor ID
- MPT01
- Conditions
- Meningococcal Infections, Meningitis
- Keywords
- Menomune® - A/C/Y/W-135, Meningococcal Infections, Meningitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- Sanofi Pasteur, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- Oct 2002
- Primary completion
- May 2003 (actual)
- Study completion
- Nov 2004 (actual)
- First posted
- 25 Feb 2009 (estimated)
- Results
- Posted 30 Apr 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this trial is to study the administration of the Menomune vaccine given intradermally and low-dose subcutaneously versus standard subcutaneously. This study will describe the immunogenicity of Menomune® - A/C/Y/W-135 administered subcutaneously (standard dose) versus intradermally over a dose range (1/10th, 2/10th, and 3/10th of standard dose) and a low dose (2/10th of standard dose) subcutaneously.
The secondary objective is to describe the safety of the subcutaneous (SC) and intradermal (ID) routes at different dosages
Detailed description
This trial will provide a proof of concept that a dose range of Menomune given ID can induce an immune response that is comparable to standard dosing by the SC route, and is equivalent or superior to a low dose given SC.
Subjects will be randomized according to a computer-generated randomization schedule to receive the vaccine by SC injection or by ID injection at different dosages.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Biological: Meningococcal Polysaccharide Groups A\C\Y\W-135 Combined0.5 mL Subcutaneous arm (Menomune® ) |
| Group 2 | Experimental | Biological: Meningococcal Polysaccharide Groups A\C\Y\W-135 Combined0.1 mL Subcutaneous arm (Menomune®) |
| Group 3 | Experimental | Biological: Meningococcal Polysaccharide Groups A\C\Y\W-135 Combined0.05 mL Intradermal arm (Menomune®) |
| Group 4 | Experimental | Biological: Meningococcal Polysaccharide Groups A\C\Y\W-135 Combined0.1 mL Intradermal arm (Menomune®) |
| Group 5 | Experimental | Biological: Meningococcal Polysaccharide Groups A\C\Y\W-135 Combined0.15 mL Intradermal arm (Menomune®) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 18 to 55 years of age.
- Willing to return for 3 follow-up visits and comply with a 30 day follow-up period.
- Signed an informed consent form.
Key exclusion criteria (7 listed)
- Allergy to any component of the vaccine and latex.
- Known or suspected immunodeficiency or receipt of immunosuppressive therapy or blood products within the previous two months.
- History of serious chronic diseases (such as cardiac or renal disease).
- Acute febrile illness at the time of visit.
- Pregnancy.
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 Groups A\C\Y\W-135 CombinedAlso: Menomune® - A/C/Y/W-1350.5 mL, Subcutaneous | Biological | Group 1 |
| Meningococcal Polysaccharide Groups A\C\Y\W-135 CombinedAlso: Menomune® - A/C/Y/W-1350.1 mL, Subcutaneous | Biological | Group 2 |
| Meningococcal Polysaccharide Groups A\C\Y\W-135 CombinedAlso: Menomune® - A/C/Y/W-1350.05 mL, Intradermal | Biological | Group 3 |
| Meningococcal Polysaccharide Groups A\C\Y\W-135 CombinedAlso: Menomune® - A/C/Y/W-1350.1 mL, Intradermal | Biological | Group 4 |
| Meningococcal Polysaccharide Groups A\C\Y\W-135 CombinedAlso: Menomune® - A/C/Y/W-1350.15 mL, Intradermal | Biological | Group 5 |
Primary outcome
Percentage of Participants With ≥ 4-Fold Rise in Antibody Titers
Time frame: Baseline to 28 days post vaccination
Percentage of participants with a 4-fold rise in Serum bactericidal assay using baby rabbit complement (SBA-BR) antibody titers to each meningococcal serogroup from baseline to Day 28 post-vaccination.
Geometric Mean Titers (GMTs) for Each Meningococcal Serogroup at Baseline and 28 Days Post-vaccination.
Time frame: Baseline (Day 0) and Day 28 post-vaccination
GMTs and their 95% confidence interval to the vaccine meningococcal serogroups at Day 0 and Day 28 post-vaccination.
1 secondary outcome
Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination.
Time frame: Day 0 to 7 days post-vaccination
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2016.
- 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 Director study director
Sanofi Pasteur Inc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Meningococcal Polysaccharide Groups A\C\Y\W-135 Combined in people with Meningococcal Infections and Meningitis, run by Sanofi Pasteur, a Sanofi Company at 1 site 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 7 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 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 30 Apr 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 ≥ 4-Fold Rise in Antibody Titers (time frame: Baseline to 28 days post vaccination). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Apr 2016.