MeningitisPhase 4NCT02591290
Immunogenicity and Safety of Two-Dose Series of Menactra® in Japanese Healthy Adult Subjects
A Phase 4 study testing Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate in people with Meningitis and Meningococcal Meningitis, run by Sanofi Pasteur, a Sanofi Company at 1 site in Japan.
Trial summary
The aim of this study was to collect further information regarding an increase immune response of SP284 after an additional dose in Japanese participants. Primary Objective: To evaluate and describe the immune responses to meningococcal antigens (serogroups A,C, Y and W-135) at 28 days following each vaccination with… Read more about this study
- Who is it for?
- Ages 20 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Meningitis, Meningococcal Meningitis, Meningococcal Infections
- What is being tested?
- Meningococcal (Groups A, C, Y and W-135) 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
- 60 participants
- Where
- 1 siteJapan
- Study dates
- 20 Oct 2015to 16 Mar 2016
- 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 20 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Aged 20 through 55 years on the day of inclusion,
- Informed consent form had been signed and dated by the participant,
- Able to attend all scheduled visits and to comply with all trial procedures,
- For female participants who had childbearing potential, use of an effective method of contraception from at least 4 weeks prior to vaccination until at least 4 weeks after vaccination
- a) "20 through 55 years" meant from the day of the 20th birthday to the day before the 56th birthday.
- b) To be considered to be not of childbearing potential, a woman must either had undergone surgical sterilization (hysterectomy or bilateral tubal ligation) or be postmenopausal (at least one year without menses) at the time of vaccination. Effective methods of contraception include oral contraception (pill), intrauterine device, diaphragm or condoms used with sponge, contraceptive foam or cream, hormonal implants, transdermal patch, or parenteral contraception.
Who cannot join
- Chronic illness that, in the opinion of the investigator, was at a stage where it might interfere with trial conduct or completion,
- History of meningococcal diseases, confirmed either clinically, serologically, or microbiologically,
- Known systemic hypersensitivity to any of the vaccine components, or history of a life threatening reaction to a vaccine containing the same substances of the study vaccine,
- Known or suspected congenital or current/ previous acquired immunodeficiency; or receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months; or long-term systemic corticosteroids therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months),
- Participation in another clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 4 weeks preceding the trial inclusion,
- Planned participation in another clinical trial during the present trial period,
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- Receipt of immune globulins, blood or blood-derived products in the past 3 months, which might interfere with assessment of the immune response,
- Receipt of any vaccine within the four weeks preceding the trial vaccination, except for influenza vaccination, which might be received at least two weeks before the study vaccine,
- Planned receipt of any vaccine during the trial period,
- Clinical or known serological evidence of systemic illness including Hepatitis B, Hepatitis C and/or Human Immunodeficiency Virus infection,
- Participant was pregnant, or lactating, or of childbearing potential (to be considered of non-childbearing potential, a female must be pre-menarche or post-menopausal for at least 1 year, surgically sterile, or using an effective method of contraception or abstinence from at least 4 weeks prior to the first vaccination and until at least 4 weeks after the last vaccination),
- Known thrombocytopenia, contraindicating intramuscular (IM) vaccination,
- Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating IM vaccination,
- Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily,
- Current alcohol abuse or drug addiction,
- Identified as employee of the Investigator or study center, with direct involvement in the proposed study or other studies under the direction of that Investigator or study center, as well as family member (i.e., immediate, husband, wife and their children, adopted or natural) of the employees or the Investigator,
- Previous vaccination against meningococcal disease with either the trial vaccine or another vaccine,
- At high risk for meningococcal infection during the trial,
- Febrile illness (temperature ≥ 37.5°C) or moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination. A prospective participant should not be included in the study until the condition had resolved or the febrile event had subsided,
- Received oral or injected antibiotic therapy within the 72 hours prior to blood draw (Visit 1),
- History of Guillain-Barré Syndrome (GBS).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Immunogenicity and Safety of Two-Dose Series of a Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (SP284; Menactra®) in Japanese Healthy Adult Subjects
The aim of this study was to collect further information regarding an increase immune response of SP284 after an additional dose in Japanese participants.
Primary Objective:
- To evaluate and describe the immune responses to meningococcal antigens (serogroups A,C, Y and W-135) at 28 days following each vaccination with SP284 vaccine in participants 20 through 55 years of age.
Other Pre-specified objective:
- To describe the safety in terms of immediate systemic adverse events (AEs), solicited reactions, unsolicited non-serious adverse events, and serious adverse events (SAEs) following receipt of each dose of SP284 vaccine in persons 20 through 55 years of age.
Read the detailed description
All participants received a 2-dose series of the study vaccine with 8-week interval and was monitored for safety and assessed for immunogenicity at baseline (pre-vaccination) and at 28 to 35 days following each vaccination.
- Being tested
- Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate
- Keywords
- Meningitis, Meningococcal Meningitis, Meningococcal Infections, Menactra®, Meningococcal Vaccine
- Medical subject headings
- Meningitis, Meningitis, Meningococcal, Meningococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid ConjugateBiological
Also called SP284, Menactra®
0.5 mL, Intramuscular (2 doses with 8-week interval)
| Study group | Role | What they receive |
|---|---|---|
| Menactra® Vaccine | Experimental | Participants received 2-dose series of the study vaccine with 8-week interval. Receives: Biological: Meningococcal (Groups A, C, Y and W-135) 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 Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers >=1:128
Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by Serum Bactericidal Assay using Baby Rabbit complement (SBA-BR).
Measured: Day 0 (pre-vaccination), Day 28 post-vaccination 1, Day 28 post-vaccination 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2015 (estimated)
- Study start20 Oct 2015
- Primary completion16 Mar 2016
- Study completion16 Mar 2016
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 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 KK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02591290
- Sponsor's protocol ID
- EFC14375/MTA89
- Other IDs
- U1111-1174-4291
- Status last verified
- Oct 2017
- First submitted
- 27 Oct 2015
- Last updated
- 6 Nov 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunogenicity and Safety of Two-Dose Series of a Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (SP284; Menactra®) in Japanese Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT02591290
- Acronym / sponsor ID
- EFC14375/MTA89
- Keywords
- Meningitis, Meningococcal Meningitis, Meningococcal Infections, Menactra®, Meningococcal Vaccine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Sanofi Pasteur, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- 20 Oct 2015 (actual)
- Primary completion
- 16 Mar 2016 (actual)
- Study completion
- 16 Mar 2016 (actual)
- First posted
- 29 Oct 2015 (estimated)
- Results
- Posted 6 Nov 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study was to collect further information regarding an increase immune response of SP284 after an additional dose in Japanese participants.
Primary Objective:
- To evaluate and describe the immune responses to meningococcal antigens (serogroups A,C, Y and W-135) at 28 days following each vaccination with SP284 vaccine in participants 20 through 55 years of age.
Other Pre-specified objective:
- To describe the safety in terms of immediate systemic adverse events (AEs), solicited reactions, unsolicited non-serious adverse events, and serious adverse events (SAEs) following receipt of each dose of SP284 vaccine in persons 20 through 55 years of age.
Detailed description
All participants received a 2-dose series of the study vaccine with 8-week interval and was monitored for safety and assessed for immunogenicity at baseline (pre-vaccination) and at 28 to 35 days following each vaccination.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Menactra® Vaccine | Experimental | Biological: Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid ConjugateParticipants received 2-dose series of the study vaccine with 8-week interval. |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Aged 20 through 55 years on the day of inclusion,
- Informed consent form had been signed and dated by the participant,
- Able to attend all scheduled visits and to comply with all trial procedures,
- For female participants who had childbearing potential, use of an effective method of contraception from at least 4 weeks prior to vaccination until at least 4 weeks after vaccination
- a) "20 through 55 years" meant from the day of the 20th birthday to the day before the 56th birthday.
Key exclusion criteria (21 listed)
- Chronic illness that, in the opinion of the investigator, was at a stage where it might interfere with trial conduct or completion,
- History of meningococcal diseases, confirmed either clinically, serologically, or microbiologically,
- Known systemic hypersensitivity to any of the vaccine components, or history of a life threatening reaction to a vaccine containing the same substances of the study vaccine,
- Known or suspected congenital or current/ previous acquired immunodeficiency; or receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months; or long-term systemic corticosteroids therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months),
- Participation in another clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 4 weeks preceding the trial inclusion,
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 (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid ConjugateAlso: SP284, Menactra®0.5 mL, Intramuscular (2 doses with 8-week interval) | Biological | Menactra® Vaccine |
Primary outcome
Number of Participants With Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers >=1:128
Time frame: Day 0 (pre-vaccination), Day 28 post-vaccination 1, Day 28 post-vaccination 2
Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by Serum Bactericidal Assay using Baby Rabbit complement (SBA-BR).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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 KK
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 (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate in people with Meningitis and Meningococcal Meningitis, run by Sanofi Pasteur, a Sanofi Company at 1 site in Japan.
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 6 inclusion and 21 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 Nov 2017. 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 Japan. 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 6 Nov 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 Participants With Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers >=1:128 (time frame: Day 0 (pre-vaccination), Day 28 post-vaccination 1, Day 28 post-vaccination 2). 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 6 Nov 2017.