Neisseria MeningitidisPhase 3NCT00444951
Immunogenicity and Safety of Menactra® Vaccine in Adolescents in Saudi Arabia
A Phase 3 study testing Menactra®: Meningococcal A, C, Y, and W 135 Polysaccharide Diphtheria Toxoid Conjugate vaccine and Mencevax®: Group A, C, W135 and Y polysaccharide meningococcal vaccine in people with Neisseria Meningitidis and Meningococcal Infections, run by Sanofi Pasteur, a Sanofi Company at 7 sites in Saudi Arabia.
Trial summary
This study will be conducted among adolescents in Saudi Arabia who previously received one dose of A, C, Y, W 135 and at least one dose of A, C meningococcal polysaccharide vaccine. Read more about this study
- Who is it for?
- Ages 16 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Neisseria Meningitidis, Meningococcal Infections
- What is being tested?
- Menactra®: Meningococcal A, C, Y, and W 135 Polysaccharide Diphtheria Toxoid Conjugate vaccine and Mencevax®: Group A, C, W135 and Y polysaccharide meningococcal vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- 7 sitesSaudi Arabia
- Study dates
- Feb 2007to Feb 2009
- Phase
- Phase 3
- 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 16 to 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Healthy, as determined by medical history and physical examination.
- Aged between 16 to 19 years on the day of inclusion (from 16th birthday to 1 day before 20th birthday inclusive).
- For the Menactra® and Mencevax® groups, one dose of quadrivalent (A, C, Y, W 135) and at least one dose of bivalent (A, C) meningococcal polysaccharide vaccine with no meningococcal vaccine received less than 2 years prior to enrollment.
- For the Control group, no previous history of any meningococcal vaccination.
- Informed consent form signed by the parent(s) or other legal representative for subject under 18 years and signed by subject him/herself if subject above 18 years old
- Able to provide a vaccination log or has available vaccination record in the Health Center
- Able to attend all scheduled visits and to comply with all trial procedures
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 ≥ 37.5°C at the time of inclusion.
- Administration of immune globulin or other blood products within the last three months, injected or oral corticosteroids or other immunomodulatory 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 provided that they have not received more than one course within the last two weeks prior to enrollment.
- Oral or injected antibiotic therapy within the 72 hours prior to vaccination
- Received any vaccine in the 14-day period prior to study vaccination, or scheduled to receive any vaccination during the 14-day period after study vaccination.
Show all 13Show fewer
- Previous history of documented invasive meningococcal disease.
- Systemic hypersensitivity to any of the vaccines components or history of a life-threatening reaction to the trial vaccines or a vaccine containing the same substances
- Participation in another clinical trial in the 4 weeks preceding the trial vaccination
- Planned participation in another clinical trial during the present trial period
- 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.
- Personal or family history of Guillain Barré syndrome.
- For female, known or suspected to be pregnant at the time of inclusion
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Saudi Arabia7 sites
Study site
AlKhaleej, Al-Qassim Region
Study site
AlRabwa, Al-Qassim Region
Study site
Helal Ahmar, Mecca Region
Study site
Iskan, Mecca Region
Study site
Mecca, Mecca Region
Study site
S. Buraida, Al-Qassim Region
Study site
Safra-Al Midhnab, Al-Qassim Region
About this study
Official title: Evaluation of the Response to a Single Dose of Menactra® in Adolescents Aged 16 to 19 Years Who Previously Received One Dose of Quadrivalent (A, C, Y, W 135) and at Least One Dose of Bivalent (A, C) Meningococcal Polysaccharide Vaccine in Saudi Arabia.
This study will be conducted among adolescents in Saudi Arabia who previously received one dose of A, C, Y, W 135 and at least one dose of A, C meningococcal polysaccharide vaccine. This study will evaluate the booster administration of Menactra® (Meningococcal A, C, Y, and W 135 Polysaccharide Diphtheria Toxoid Conjugate vaccine) compared with Mencevax® (Meningococcal A, C, Y, and W 135 Polysaccharide vaccine)in terms of their serum bactericidal antibody responses.
- Conditions
- Neisseria Meningitidis, Meningococcal Infections
- Being tested
- Menactra®: Meningococcal A, C, Y, and W 135 Polysaccharide Diphtheria Toxoid Conjugate vaccine, Mencevax®: Group A, C, W135 and Y polysaccharide meningococcal vaccine
- Keywords
- N meningitidis
- Medical subject headings
- Meningococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Menactra®: Meningococcal A, C, Y, and W 135 Polysaccharide Diphtheria Toxoid Conjugate vaccineBiological
Also called Menactra®
0.5 mL, Intramuscular
Mencevax®: Group A, C, W135 and Y polysaccharide meningococcal vaccineBiological
Also called Mencevax®
0.5 mL, Subcutaneous
Menactra®: Meningococcal A, C, Y, and W 135 Polysaccharide Diphtheria Toxoid Conjugate vaccineBiological
Also called Menactra®
0.5 mL, Intramuscular
| Study group | Role | What they receive |
|---|---|---|
| Menactra® group | Experimental | Have received previously a dose of an A, C, Y, W 135 and at least one dose of bivalent A, C meningococcal polysaccharide vaccine, will receive a booster dose of Menactra® (Meningococcal [serogroups A, C, Y, W-135] polysaccharide diphtheria toxoid conjugate) vaccine. Receives: Biological: Menactra®: Meningococcal A, C, Y, and W 135 Polysaccharide Diphtheria Toxoid Conjugate vaccine |
| Mencevax® group | Experimental | Have received previously a dose of an A, C, Y, W 135 and at least one dose of bivalent A, C meningococcal polysaccharide vaccine, will receive a booster dose of Mencevax ACWY (serogroups A, C, Y, W-135) polysaccharide meningococcal vaccine. Receives: Biological: Mencevax®: Group A, C, W135 and Y polysaccharide meningococcal vaccine |
| Control group | Experimental | Participants have not previously received any meningococcal vaccine, will receive a booster dose of Menactra® (Meningococcal [serogroups A, C, Y, W-135] polysaccharide diphtheria toxoid conjugate) vaccine. Receives: Biological: Menactra®: Meningococcal A, C, Y, and W 135 Polysaccharide Diphtheria Toxoid Conjugate vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Geometric Mean Titers (GMTs) of Vaccine Serogroups Determined by Serum Bactericidal Activity Using Baby Rabbit Complement (SBA-BR) Pre- and Post-Menactra® Vaccination
Measured: Baseline (Day 0) and Day 28 after vaccination
Secondary outcomes (2)
Percentage of Participants With At Least a 4-Fold Rise in Titers Determined by Serum Bactericidal Activity Using Baby Rabbit Complement (SBA-BR) Post-Menatcra® Vaccination
Measured: Baseline (Day 0) and Day 28 After Vaccination
Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Post-vaccination
Measured: Day 0 to Day 7 Post-vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2007 (estimated)
- Study startFeb 2007
- Primary completionFeb 2008
- Study completionFeb 2009
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neisseria MeningitidisStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 450 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi Pasteur, a Sanofi Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Sanofi Pasteur Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00444951
- Sponsor's protocol ID
- MTA40
- Status last verified
- Jun 2015
- First submitted
- 7 Mar 2007
- Last updated
- 14 Jul 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Khalil M, Al-Mazrou Y, Findlow H, Chadha H, Bosch Castells V, Oster P, Borrow R. Meningococcal serogroup C serum and salivary antibody responses to meningococcal quadrivalent conjugate vaccine in Saudi Arabian adolescents previously vaccinated with bivalent and quadrivalent meningococcal polysaccharide vaccine. Vaccine. 2014 Sep 29;32(43):5715-21. doi: 10.1016/j.vaccine.2014.08.026. Epub 2014 Aug 20.
PubMed 25151042
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Response to a Single Dose of Menactra® in Adolescents Aged 16 to 19 Years Who Previously Received One Dose of Quadrivalent (A, C, Y, W 135) and at Least One Dose of Bivalent (A, C) Meningococcal Polysaccharide Vaccine in Saudi Arabia.
- ClinicalTrials.gov ID
- NCT00444951
- Acronym / sponsor ID
- MTA40
- Conditions
- Neisseria Meningitidis, Meningococcal Infections
- Keywords
- N meningitidis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 450 participants (actual)
- Lead sponsor
- Sanofi Pasteur, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- Feb 2007
- Primary completion
- Feb 2008 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 8 Mar 2007 (estimated)
- Results
- Posted 4 Mar 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will be conducted among adolescents in Saudi Arabia who previously received one dose of A, C, Y, W 135 and at least one dose of A, C meningococcal polysaccharide vaccine. This study will evaluate the booster administration of Menactra® (Meningococcal A, C, Y, and W 135 Polysaccharide Diphtheria Toxoid Conjugate vaccine) compared with Mencevax® (Meningococcal A, C, Y, and W 135 Polysaccharide vaccine)in terms of their serum bactericidal antibody responses.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Menactra® group | Experimental | Biological: Menactra®: Meningococcal A, C, Y, and W 135 Polysaccharide Diphtheria Toxoid Conjugate vaccineHave received previously a dose of an A, C, Y, W 135 and at least one dose of bivalent A, C meningococcal polysaccharide vaccine, will receive a booster dose of Menactra® (Meningococcal [serogroups A, C, Y, W-135] polysaccharide diphtheria toxoid conjugate) vaccine. |
| Mencevax® group | Experimental | Biological: Mencevax®: Group A, C, W135 and Y polysaccharide meningococcal vaccineHave received previously a dose of an A, C, Y, W 135 and at least one dose of bivalent A, C meningococcal polysaccharide vaccine, will receive a booster dose of Mencevax ACWY (serogroups A, C, Y, W-135) polysaccharide meningococcal vaccine. |
| Control group | Experimental | Biological: Menactra®: Meningococcal A, C, Y, and W 135 Polysaccharide Diphtheria Toxoid Conjugate vaccineParticipants have not previously received any meningococcal vaccine, will receive a booster dose of Menactra® (Meningococcal [serogroups A, C, Y, W-135] polysaccharide diphtheria toxoid conjugate) vaccine. |
Who may qualify
- Ages
- 16 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Healthy, as determined by medical history and physical examination.
- Aged between 16 to 19 years on the day of inclusion (from 16th birthday to 1 day before 20th birthday inclusive).
- For the Menactra® and Mencevax® groups, one dose of quadrivalent (A, C, Y, W 135) and at least one dose of bivalent (A, C) meningococcal polysaccharide vaccine with no meningococcal vaccine received less than 2 years prior to enrollment.
- For the Control group, no previous history of any meningococcal vaccination.
- Informed consent form signed by the parent(s) or other legal representative for subject under 18 years and signed by subject him/herself if subject above 18 years old
Key exclusion criteria (13 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 ≥ 37.5°C at the time of inclusion.
- Administration of immune globulin or other blood products within the last three months, injected or oral corticosteroids or other immunomodulatory 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 provided that they have not received more than one course within the last two weeks prior to enrollment.
- Oral or injected antibiotic therapy within the 72 hours prior to 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 |
|---|---|---|
| Menactra®: Meningococcal A, C, Y, and W 135 Polysaccharide Diphtheria Toxoid Conjugate vaccineAlso: Menactra®0.5 mL, Intramuscular | Biological | Menactra® group |
| Mencevax®: Group A, C, W135 and Y polysaccharide meningococcal vaccineAlso: Mencevax®0.5 mL, Subcutaneous | Biological | Mencevax® group |
| Menactra®: Meningococcal A, C, Y, and W 135 Polysaccharide Diphtheria Toxoid Conjugate vaccineAlso: Menactra®0.5 mL, Intramuscular | Biological | Control group |
Primary outcome
Geometric Mean Titers (GMTs) of Vaccine Serogroups Determined by Serum Bactericidal Activity Using Baby Rabbit Complement (SBA-BR) Pre- and Post-Menactra® Vaccination
Time frame: Baseline (Day 0) and Day 28 after vaccination
2 secondary outcomes
Percentage of Participants With At Least a 4-Fold Rise in Titers Determined by Serum Bactericidal Activity Using Baby Rabbit Complement (SBA-BR) Post-Menatcra® Vaccination
Time frame: Baseline (Day 0) and Day 28 After Vaccination
Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Post-vaccination
Time frame: Day 0 to Day 7 Post-vaccination
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 25151042Khalil M, Al-Mazrou Y, Findlow H, Chadha H, Bosch Castells V, Oster P, Borrow R. Meningococcal serogroup C serum and salivary antibody responses to meningococcal quadrivalent conjugate vaccine in Saudi Arabian adolescents previously vaccinated with bivalent and quadrivalent meningococcal polysaccharide vaccine. Vaccine. 2014 Sep 29;32(43):5715-21. doi: 10.1016/j.vaccine.2014.08.026. Epub 2014 Aug 20.
- 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
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Menactra®: Meningococcal A, C, Y, and W 135 Polysaccharide Diphtheria Toxoid Conjugate vaccine and Mencevax®: Group A, C, W135 and Y polysaccharide meningococcal vaccine in people with Neisseria Meningitidis and Meningococcal Infections, run by Sanofi Pasteur, a Sanofi Company at 7 sites in Saudi Arabia.
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 7 inclusion and 13 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 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Saudi Arabia. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 4 Mar 2011). 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?
Geometric Mean Titers (GMTs) of Vaccine Serogroups Determined by Serum Bactericidal Activity Using Baby Rabbit Complement (SBA-BR) Pre- and Post-Menactra® Vaccination (time frame: Baseline (Day 0) and Day 28 after vaccination). 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 NCT00444951, 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 14 Jul 2015.