MeningitisPhase 4NCT01270503
Post-Marketing Safety Study of Menactra® in Healthy Children, Adolescents, and Adults in the Philippines
A Phase 4 study testing Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate in people with Meningitis and Meningococcal Disease, run by Sanofi Pasteur, a Sanofi Company at 127 sites in Philippines.
Trial summary
This aim of the study is to assess post-marketing safety of a single dose of Menactra® vaccine with the intent to support conversion from monitored release to initial registration of Menactra® vaccine in the Philippines. Read more about this study
- Who is it for?
- Ages 2 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Meningitis, Meningococcal Disease
- What is being tested?
- Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 538 participants
- Where
- 127 sitesPhilippines
- Study dates
- Dec 2010to Jul 2014
- 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 2 to 55 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Aged 2 to 11 years of age on the day of inclusion (Group 1)
- Aged 12 to 17 years of age on the day of inclusion (Group 2)
- Aged 18 to 55 years of age on the day of inclusion (Group 3)
- Provision of informed consent form signed by the parent(s) or legal representative (Group 1)
- Provision of assent form signed by the subject and informed consent form signed by the parent (s) or legal representative (Group 2)
- Provision of informed consent form signed by the subject (Group 3)
Show all 9Show fewer
- If the subject (Group 3) or the subject's parents or legally accepted representative (Group 1 and 2) are illiterate, an independent witness is required to sign the consent form
- Subject and parent/legally acceptable representative (if applicable) able to attend all scheduled visits and comply with all trial procedures
- For a woman of child-bearing potential, sexually active, use of a medically acceptable and effective method of contraception for at least 4 weeks prior to vaccination, until at least 4 weeks after vaccination (not applicable for females not of child-bearing potential or not sexually active).
Who cannot join
- For a woman of child-bearing potential sexually active, known or suspected pregnancy or positive serum/urine pregnancy test (not applicable for females not of child-bearing potential or not sexually active)
- Breast-feeding woman
- Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the trial vaccination
- Planned participation in another clinical trial during the present trial period
- Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months or long-term systemic corticosteroid therapy
- Known systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccine or to a vaccine containing any of the same substances
Show all 13Show fewer
- Chronic illness at a stage that could interfere with trial conduct or completion, in the opinion of the Investigator
- Receipt of any vaccine in the 4 weeks preceding the trial vaccination
- Planned receipt of any vaccine during the present trial period
- Known personal or maternal Human Immunodeficiency virus (HIV), Hepatitis B antigen or Hepatitis C seropositivity as reported by the subject/parent/guardian and/or based on medical history
- History of seizures
- Thrombocytopenia, bleeding disorder or anticoagulants in the 3 weeks preceding inclusion contraindicating intramuscular injection
- Personal of family history of Guillain-Barré Syndrome.
Trial locations and contacts
127 sites in 1 country.
127 sites in 1 country
Philippines127 sites
Study site
Alaminos, LA Union
Study site
Angeles City, Benguet
Study site
Angeles City, Isabela
Study site
Angeles City, Pangasinan
Study site
Angeles City, Tarlac
Study site
Bacolod City, Benguet
Study site
Bacolod City, Ilocos Norte
Study site
Bacolod City, La Union
Study site
Bacolod City, Tarlac
Study site
Bacoor, Pangasinan
Study site
Baguio City, Benguet
Study site
Baguio City, Ilocos Norte
Study site
Baguio City, Isabela
Study site
Baguio City, Nueva Ecija
Study site
Baguio City, Pangasinan
Study site
Baguio City, Tarlac
Study site
Balanga, Pangasinan
Study site
Baliwag, Benguet
Study site
Batangas, NCR
Study site
Batangas, Pampanga
Study site
Batangas, Zambales
Study site
Biñan, Pampanga
Study site
Bocaue, NCR
Study site
Cabanatuan City, NCR
Study site
Cagayan de Oro, Bulacan
Study site
Cagayan de Oro, Pampanga
Study site
Calamba, Bataan
Study site
Calamba, NCR
Study site
Calamba, Zambales
Study site
Caloocan, NCR
Study site
Caloocan, Pampanga
Study site
Cardona, Bulacan
Study site
Cauayan, Zambales
Study site
Cavite City, Bulacan
Study site
Cebu, Bulacan
Study site
Cebu, Capiz
Study site
Cebu, NCR
Study site
Cebu, Pampanga
Study site
City of Muntinlupa, Cavite
Study site
City of Muntinlupa, Laguna
Study site
City of Taguig, Davao Del Sur
Study site
City of Taguig, Misamis Oriental
Study site
Concepcion, NCR
Study site
Concepcion, Rizal
Study site
Dagupan, NCR
Study site
Dasmariñas, Iloilo
Study site
Dasmariñas, NCR
Study site
Davao City, NCR
Study site
Davao City, Rizal
Study site
Fairview, NCR
Study site
General Santos, Antique
Study site
General Santos, Iloilo
Study site
General Santos, Rizal
Study site
Guagua, NCR
Study site
Iligan City, NCR
Study site
Iloilo City, Iloilo
Study site
Iloilo City, NCR
Study site
Imus, NCR
Study site
Imus, Pasig City
Study site
Imus, Rizal
Study site
Kidapawan, NCR
Study site
La Trinidad, NCR
Study site
Laoag, NCR
Study site
Las Piñas, NCR
Study site
Lipa, NCR
Study site
Lipa City, NCR
Study site
Los Baños, NCR
Study site
Maasin, NCR
Study site
Makati, NCR
Study site
Makati City, NCR
Study site
Malabon, NCR
Study site
Malolos, NCR
Study site
Mandaluyong, NCR
Study site
Manila, NRC
Study site
Marikina City, Batangas
Study site
Marikina City, NRC
Study site
Montalban, Batangas
Study site
Naguila, Cavite
Study site
Navotas, Batangas
Study site
Noveleta, Batangas
Study site
Olongapo City, Batangas
Study site
Olongapo City, Cavite
Study site
Ormoc City, Cavite
Study site
Ormoc City, Laguna
Study site
Ortigas, Cavite
Study site
Paranaque City, Batangas
Study site
Paranaque City, Cavite
Study site
Pasay, Batangas
Study site
Pasay, Cavite
Study site
Pasig, Batangas
Study site
Pasig, Cavite
Study site
Plaridel, Batangas
Study site
Pulilan, Cavite
Study site
Quezon City, Batangas
Study site
Quezon City, Cavite
Study site
Quezon City, Cebu
Study site
Quezon City, Laguna
Study site
Quezon City, Leyte
Study site
Quezon City, Negros Occidental
Study site
Roxas, Cebu
Study site
Roxas City, Negros Occidental
Study site
San Fernando City, Cebu
Study site
San Fernando City, Leyte
Study site
San Fernando City, Negros Occidental
Study site
San Jose, Cebu
Study site
San Jose del Monte, Negros Occidental
Study site
San Miguel, Leyte
Study site
San Pedro, Southern Leyte
Study site
Santa Rosa, Cebu
Study site
Santa Rosa, Davao Del Sur
Study site
Santa Rosa, Misamis Oriental
Study site
Tacloban City, Davao Del Sur
Study site
Tacloban City, Lanao Del Norte
Study site
Tacloban City, South Cotabato
Study site
Tagug, Davao Del Norte
Study site
Tagum, South Cotabato
Study site
Talisay City, Davao Del Sur
Study site
Tanauan, Lanao Del Norte
Study site
Tanauan, South Cotabato
Study site
Tarlac City, Davao Del Sur
Study site
Tarlac City, Misamis Oriental
Study site
Tarlac City, South Cotabato
Study site
Taytay, Davao Del Sur
Study site
Taytay, South Cotabato
Study site
Theresa, Davao Del Sur
Study site
Urdaneta, North Cotobato
Study site
Valenzuela, Davao Del Sur
About this study
Official title: Meningococcal (Groups A, C, Y, W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (Menactra®) Post-Marketing Safety Study in Healthy Children (2-11 Years), Adolescents (12-17 Years) and Adults (18-55 Years) in the Philippines
This aim of the study is to assess post-marketing safety of a single dose of Menactra® vaccine with the intent to support conversion from monitored release to initial registration of Menactra® vaccine in the Philippines.
Primary Objective:
To describe the serious adverse events occurring within 30 days among participants who have received one dose of Menactra® vaccine.
Read the detailed description
Each study participant will receive one dose of Menactra® vaccine and will be monitored for safety for 30 days post-vaccination.
- Conditions
- Meningitis, Meningococcal Disease
- Being tested
- Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate
- Keywords
- Meningitis, Meningococcal disease, Menactra®
- 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.
Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid ConjugateBiological
Also called Menactra®
0.5 mL, Intramuscular
Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid ConjugateBiological
Also called Menactra®
0.5 mL, Intramuscular
Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid ConjugateBiological
Also called Menactra®
0.5 mL, Intramuscular
| Study group | Role | What they receive |
|---|---|---|
| Menactra® Group 1 | Experimental | Participants aged 2 to 11 on enrollment Receives: Biological: Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate |
| Menactra® Group 2 | Experimental | Participants aged 12 to 17 on enrollment Receives: Biological: Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate |
| Menactra® Group 3 | Experimental | Participants aged 18 to 55 on enrollment Receives: Biological: Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety Overview Within 30 Days in Participants Vaccinated With Menactra®
Measured: Day 0 up to Day 30 post-vaccination
Secondary outcomes (1)
Number of Subjects Reporting Non-serious Related Adverse Events Not Listed in Prescribing Information (PI) Following Vaccination With Menactra®
Measured: Day 0 up to Day 30 post-vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2011 (estimated)
- Study startDec 2010
- Primary completionDec 2013
- Study completionJul 2014
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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 538 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 Philippines, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01270503
- Sponsor's protocol ID
- MTA71
- Other IDs
- U1111-1116-4853
- Status last verified
- Oct 2014
- First submitted
- 4 Jan 2011
- Last updated
- 14 Nov 2014
- 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 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Meningococcal (Groups A, C, Y, W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (Menactra®) Post-Marketing Safety Study in Healthy Children (2-11 Years), Adolescents (12-17 Years) and Adults (18-55 Years) in the Philippines
- ClinicalTrials.gov ID
- NCT01270503
- Acronym / sponsor ID
- MTA71
- Conditions
- Meningitis, Meningococcal Disease
- Keywords
- Meningitis, Meningococcal disease, Menactra®
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 538 participants (actual)
- Lead sponsor
- Sanofi Pasteur, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- Dec 2010
- Primary completion
- Dec 2013 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 5 Jan 2011 (estimated)
- Results
- Posted 14 Nov 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This aim of the study is to assess post-marketing safety of a single dose of Menactra® vaccine with the intent to support conversion from monitored release to initial registration of Menactra® vaccine in the Philippines.
Primary Objective:
To describe the serious adverse events occurring within 30 days among participants who have received one dose of Menactra® vaccine.
Detailed description
Each study participant will receive one dose of Menactra® vaccine and will be monitored for safety for 30 days post-vaccination.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Menactra® Group 1 | Experimental | Biological: Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid ConjugateParticipants aged 2 to 11 on enrollment |
| Menactra® Group 2 | Experimental | Biological: Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid ConjugateParticipants aged 12 to 17 on enrollment |
| Menactra® Group 3 | Experimental | Biological: Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid ConjugateParticipants aged 18 to 55 on enrollment |
Who may qualify
- Ages
- 2 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- Aged 2 to 11 years of age on the day of inclusion (Group 1)
- Aged 12 to 17 years of age on the day of inclusion (Group 2)
- Aged 18 to 55 years of age on the day of inclusion (Group 3)
- Provision of informed consent form signed by the parent(s) or legal representative (Group 1)
- Provision of assent form signed by the subject and informed consent form signed by the parent (s) or legal representative (Group 2)
Key exclusion criteria (13 listed)
- For a woman of child-bearing potential sexually active, known or suspected pregnancy or positive serum/urine pregnancy test (not applicable for females not of child-bearing potential or not sexually active)
- Breast-feeding woman
- Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the trial vaccination
- Planned participation in another clinical trial during the present trial period
- Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months or long-term systemic corticosteroid therapy
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 Polysaccharide Diphtheria Toxoid ConjugateAlso: Menactra®0.5 mL, Intramuscular | Biological | Menactra® Group 1 |
| Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid ConjugateAlso: Menactra®0.5 mL, Intramuscular | Biological | Menactra® Group 2 |
| Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid ConjugateAlso: Menactra®0.5 mL, Intramuscular | Biological | Menactra® Group 3 |
Primary outcome
Safety Overview Within 30 Days in Participants Vaccinated With Menactra®
Time frame: Day 0 up to Day 30 post-vaccination
1 secondary outcome
Number of Subjects Reporting Non-serious Related Adverse Events Not Listed in Prescribing Information (PI) Following Vaccination With Menactra®
Time frame: Day 0 up to Day 30 post-vaccination
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Related InfoLink provided by the sponsor.
Related trials for Meningitis
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
RecruitingObservational study
Pain Phenotyping of Rheumatic Diseases - An Observational Study
Rheumatic Diseases, Lupus Erythematosus, Systemic
RecruitingObservational study
Fungal Infection Susceptibility
Cryptococcal Infection, Cryptococcal Pneumonia
RecruitingObservational study
Acute Treatment and Long-term Assessment of Adult Infectious Meningitis
Viral Meningitis, Bacterial Meningitis
RecruitingObservational study
Etiology, Pathogenesis, and Natural History of Idiopathic CD4+ Lymphocytopenia
Idiopathic CD4+ Lymphocytopenia, Cryptococcal Meningitis
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 Philippines, Inc.
127 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate in people with Meningitis and Meningococcal Disease, run by Sanofi Pasteur, a Sanofi Company at 127 sites in Philippines.
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 9 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 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 127 sites in Philippines. 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 14 Nov 2014). 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?
Safety Overview Within 30 Days in Participants Vaccinated With Menactra® (time frame: Day 0 up to Day 30 post-vaccination). 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 Nov 2014.