Meningococcal DiseasePhase 4NCT01430611
Study of Sanofi Pasteur and Lanzhou Institute's Meningococcal (Group A and C) Polysaccharide Vaccine in Children
A Phase 4 study testing Meningococcal (Groups A and C) Polysaccharide Vaccine in people with Meningococcal Disease and Meningitis, run by Sanofi Pasteur, a Sanofi Company at 2 sites in China.
Trial summary
This study is part of the post-licensure commitment to evaluate the safety and immunogenicity of Meningo A+C vaccine in healthy Chinese children 2 to 6 years of age. Primary Objective: To demonstrate the non-inferiority in terms of seroconversion rate for serogroups A and C, 30 days after a single dose of Sanofi… Read more about this study
- Who is it for?
- Ages 2 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Meningococcal Disease, Meningitis
- What is being tested?
- Meningococcal (Groups A and C) Polysaccharide Vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 666 participants
- Where
- 2 sitesChina
- Study dates
- Aug 2011to Nov 2012
- 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 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Aged 2 to 6 years on the day of inclusion
- Informed consent form has been signed and dated by the parent or another legally acceptable representative
- Subject and parent/ legally acceptable representative are able to attend all scheduled visits and to comply with all trial procedures
- Written documentation of immunization history against meningococcal disease according to the national Expanded Program on Immunization (EPI) schedule (including 2 doses with Meningococcal Group A Polysaccharide Vaccine between 6 and 18 months of age).
Who cannot join
- Participation in the 4 weeks preceding the trial vaccination or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure
- Receipt of any vaccine in the 4 weeks preceding the trial vaccination or planned receipt of any vaccine in the 4 weeks following the trial vaccination (except for influenza vaccination, which may be received at least 2 weeks before study vaccines)
- Previous vaccination against meningococcal disease within the past 12 months with either the trial vaccine or another vaccine
- Previous vaccination with any meningococcal conjugate vaccine.
- Receipt of immune globulins, blood or blood-derived products in the past 3 months
- Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
Show all 20Show fewer
- History of meningococcal infection, confirmed either clinically, serologically, or microbiologically
- At high risk for meningococcal disease during the trial, including:
- persons with increased susceptibility such as persistent complement component deficiencies,
- persons with anatomic or functional asplenia,
- persons who have exposure (e.g., microbiologists routinely working with N. meningitidis, or travelers to or residents of areas where meningococcal disease is hyperendemic or epidemic)
- Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccines used in the trial or to a vaccine containing any of the same substances
- Known thrombocytopenia, as reported by the parent/ legally acceptable representative, contraindicating intramuscular vaccination
- Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination
- Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily
- Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion
- Moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination or febrile illness (axillary temperature ≥ 37.1°C). A prospective subject should not be included in the study until the condition has resolved or the febrile event has subsided
- Receipt of oral or injected antibiotic therapy within 72 hours before the first blood draw
- Identified as a natural or adopted child of the Investigator or employee with direct involvement in the proposed study
- Any contraindication as listed in the study vaccines leaflets.
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Safety and Immunogenicity of Sanofi Pasteur Meningococcal (Groups A and C) Polysaccharide Vaccine Versus Lanzhou Institute for Biological Products Meningococcal (Groups A and C) Polysaccharide Vaccine in Children 2-6 Years of Age in China
This study is part of the post-licensure commitment to evaluate the safety and immunogenicity of Meningo A+C vaccine in healthy Chinese children 2 to 6 years of age.
Primary Objective:
Read more
To demonstrate the non-inferiority in terms of seroconversion rate for serogroups A and C, 30 days after a single dose of Sanofi Pasteur Meningococcal (Groups A and C) Polysaccharide Vaccine versus Lanzhou Institute for Biological Products Meningococcal (Groups A and C) Polysaccharide Vaccine.
Secondary Objective:
- To describe the immunogenicity for serogroups A and C, 30 days after administration of the study vaccines given as a single dose.
- To describe the full reactogenicity profile after administration of the study vaccines given as a single dose.
Read the detailed description
Eligible participants will receive one injection of either Sanofi Pasteur Meningococcal (Groups A and C) Polysaccharide Vaccine or Lanzhou Institute for Biological Products Meningococcal (Groups A and C) Polysaccharide Vaccine and will be monitored for safety and immunogenicity for up to 30 days post-vaccination.
- Conditions
- Meningococcal Disease, Meningitis
- Being tested
- Meningococcal (Groups A and C) Polysaccharide Vaccine
- Keywords
- Meningitis, Neisseria meningitidis, Meningo A+C®, Meng Ling Kang®
- 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 (Groups A and C) Polysaccharide VaccineBiological
Also called Meningo A+C®
0.5 mL, Subcutaneous
Meningococcal (Groups A and C) Polysaccharide VaccineBiological
Also called Meng Ling Kang®
0.5 mL, Subcutaneous
| Study group | Role | What they receive |
|---|---|---|
| Sanofi Pasteur Meningococcal A+C Polysaccharide Vaccine | Experimental | Not described Receives: Biological: Meningococcal (Groups A and C) Polysaccharide Vaccine |
| Lanzhou Institute Meningococcal A+C Polysaccharide Vaccine | Active comparator | Not described Receives: Biological: Meningococcal (Groups A and C) Polysaccharide Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Seroconversion Following Vaccination With Either Sanofi Pasteur Meningococcal A+C Polysaccharide Vaccine or Lanzhou Institute of Biological Products Meningococcal A+C Polysaccharide Vaccine
Seroconversion status was defined as antibody titers against meningococcal serogroups A and C, 30 days after vaccine administration ≥ 4-fold increase from pre-vaccination level measured by 2,3,5 triphenyltetrazolium chloride (TTC) serum bactericidal assay using baby rabbit complement (SBA-BR).
Measured: Day 30 post-vaccination
Secondary outcomes (6)
Percentage of Participants With Post-vaccination Titer ≥1:8 for Serogroup A Before and Following Vaccination of Sanofi Pasteur Meningococcal A+C Polysaccharide Vaccine or Lanzhou Institute of Biological Products Meningococcal A+C Polysaccharide Vaccine
Meningococcal Group A antibodies were measured by 2,3,5 triphenyltetrazolium chloride (TTC) serum bactericidal assay using baby rabbit complement (SBA-BR)..
Measured: Day 0 (pre-vaccination) and Day 30 post-vaccination
Percentage of Participants With Post-vaccination Titer ≥1:8 for Serogroup C Before and Following Vaccination of Sanofi Pasteur Meningococcal A+C Polysaccharide Vaccine or Lanzhou Institute of Biological Products Meningococcal A+C Polysaccharide Vaccine
Meningococcal Group C antibodies were measured by 2,3,5 triphenyltetrazolium chloride (TTC) serum bactericidal assay using baby rabbit complement (SBA-BR)..
Measured: Day 0 (pre-vaccination) and Day 30 post-vaccination
Geometric Mean Titers of Serogroup A and C Antibodies Following Vaccination With Either Sanofi Pasteur Meningococcal A+C Polysaccharide Vaccine or Lanzhou Institute of Biological Products Meningococcal A+C Polysaccharide Vaccine
Meningococcal Group A and C antibodies were measured by 2,3,5 triphenyltetrazolium chloride (TTC) serum bactericidal assay using baby rabbit complement (SBA-BR).
Measured: Day 0 (pre-vaccination) and Day 30 post-vaccination
Geometric Mean Titers of Serogroup A Antibodies Following Vaccination With Either Sanofi Pasteur Meningococcal A+C Polysaccharide Vaccine or Lanzhou Institute of Biological Products Meningococcal A+C Polysaccharide Vaccine
Meningococcal Group A antibodies were measured by 2,3,5 triphenyltetrazolium chloride (TTC) serum bactericidal assay using baby rabbit complement (SBA-BR).
Measured: Day 0 (pre-vaccination) and Day 30 post-vaccination
Geometric Mean Titers of Serogroup C Antibodies Following Vaccination With Either Sanofi Pasteur Meningococcal A+C Polysaccharide Vaccine or Lanzhou Institute of Biological Products Meningococcal A+C Polysaccharide Vaccine
Meningococcal Group C antibodies were measured by 2,3,5 triphenyltetrazolium chloride (TTC) serum bactericidal assay using baby rabbit complement (SBA-BR).
Measured: Day 0 (pre-vaccination) and Day 30 post-vaccination
Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Following Vaccination of Sanofi Pasteur Meningococcal A+C Polysaccharide Vaccine or Lanzhou Institute of Biological Products Meningococcal A+C Polysaccharide Vaccine
Solicited injection site: Pain, Erythema, and Swelling; Solicited systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia. Grade 3 injection site: Pain, Incapacitating, unable to perform usual activities; Erythema and Swelling, ≥30 mm. Grade 3 systemic reactions: Fever, temperature >39˚C; Headache, Malaise, and Myalgia, Significant, preventing daily activity.
Measured: Day 0 up 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 Sep 2011 (estimated)
- Study startAug 2011
- Primary completionAug 2012
- Study completionNov 2012
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 DiseaseStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 666 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 SA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01430611
- Sponsor's protocol ID
- MPS01
- Other IDs
- U1111-1120-1190
- Status last verified
- Apr 2014
- First submitted
- 6 Sep 2011
- Last updated
- 8 May 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 8 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Immunogenicity of Sanofi Pasteur Meningococcal (Groups A and C) Polysaccharide Vaccine Versus Lanzhou Institute for Biological Products Meningococcal (Groups A and C) Polysaccharide Vaccine in Children 2-6 Years of Age in China
- ClinicalTrials.gov ID
- NCT01430611
- Acronym / sponsor ID
- MPS01
- Conditions
- Meningococcal Disease, Meningitis
- Keywords
- Meningitis, Neisseria meningitidis, Meningo A+C®, Meng Ling Kang®
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 666 participants (actual)
- Lead sponsor
- Sanofi Pasteur, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- Aug 2011
- Primary completion
- Aug 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 8 Sep 2011 (estimated)
- Results
- Posted 8 May 2014
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 part of the post-licensure commitment to evaluate the safety and immunogenicity of Meningo A+C vaccine in healthy Chinese children 2 to 6 years of age.
Primary Objective:
To demonstrate the non-inferiority in terms of seroconversion rate for serogroups A and C, 30 days after a single dose of Sanofi Pasteur Meningococcal (Groups A and C) Polysaccharide Vaccine versus Lanzhou Institute for Biological Products Meningococcal (Groups A and C) Polysaccharide Vaccine.
Secondary Objective:
- To describe the immunogenicity for serogroups A and C, 30 days after administration of the study vaccines given as a single dose.
- To describe the full reactogenicity profile after administration of the study vaccines given as a single dose.
Detailed description
Eligible participants will receive one injection of either Sanofi Pasteur Meningococcal (Groups A and C) Polysaccharide Vaccine or Lanzhou Institute for Biological Products Meningococcal (Groups A and C) Polysaccharide Vaccine and will be monitored for safety and immunogenicity for up to 30 days post-vaccination.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sanofi Pasteur Meningococcal A+C Polysaccharide Vaccine | Experimental | Biological: Meningococcal (Groups A and C) Polysaccharide Vaccine |
| Lanzhou Institute Meningococcal A+C Polysaccharide Vaccine | Active comparator | Biological: Meningococcal (Groups A and C) Polysaccharide Vaccine |
Who may qualify
- Ages
- 2 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Aged 2 to 6 years on the day of inclusion
- Informed consent form has been signed and dated by the parent or another legally acceptable representative
- Subject and parent/ legally acceptable representative are able to attend all scheduled visits and to comply with all trial procedures
- Written documentation of immunization history against meningococcal disease according to the national Expanded Program on Immunization (EPI) schedule (including 2 doses with Meningococcal Group A Polysaccharide Vaccine between 6 and 18 months of age).
Key exclusion criteria (20 listed)
- Participation in the 4 weeks preceding the trial vaccination or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure
- Receipt of any vaccine in the 4 weeks preceding the trial vaccination or planned receipt of any vaccine in the 4 weeks following the trial vaccination (except for influenza vaccination, which may be received at least 2 weeks before study vaccines)
- Previous vaccination against meningococcal disease within the past 12 months with either the trial vaccine or another vaccine
- Previous vaccination with any meningococcal conjugate vaccine.
- Receipt of immune globulins, blood or blood-derived products in the past 3 months
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 and C) Polysaccharide VaccineAlso: Meningo A+C®0.5 mL, Subcutaneous | Biological | Sanofi Pasteur Meningococcal A+C Polysaccharide Vaccine |
| Meningococcal (Groups A and C) Polysaccharide VaccineAlso: Meng Ling Kang®0.5 mL, Subcutaneous | Biological | Lanzhou Institute Meningococcal A+C Polysaccharide Vaccine |
Primary outcome
Number of Participants With Seroconversion Following Vaccination With Either Sanofi Pasteur Meningococcal A+C Polysaccharide Vaccine or Lanzhou Institute of Biological Products Meningococcal A+C Polysaccharide Vaccine
Time frame: Day 30 post-vaccination
Seroconversion status was defined as antibody titers against meningococcal serogroups A and C, 30 days after vaccine administration ≥ 4-fold increase from pre-vaccination level measured by 2,3,5 triphenyltetrazolium chloride (TTC) serum bactericidal assay using baby rabbit complement (SBA-BR).
6 secondary outcomes
Percentage of Participants With Post-vaccination Titer ≥1:8 for Serogroup A Before and Following Vaccination of Sanofi Pasteur Meningococcal A+C Polysaccharide Vaccine or Lanzhou Institute of Biological Products Meningococcal A+C Polysaccharide Vaccine
Time frame: Day 0 (pre-vaccination) and Day 30 post-vaccination
Percentage of Participants With Post-vaccination Titer ≥1:8 for Serogroup C Before and Following Vaccination of Sanofi Pasteur Meningococcal A+C Polysaccharide Vaccine or Lanzhou Institute of Biological Products Meningococcal A+C Polysaccharide Vaccine
Time frame: Day 0 (pre-vaccination) and Day 30 post-vaccination
Geometric Mean Titers of Serogroup A and C Antibodies Following Vaccination With Either Sanofi Pasteur Meningococcal A+C Polysaccharide Vaccine or Lanzhou Institute of Biological Products Meningococcal A+C Polysaccharide Vaccine
Time frame: Day 0 (pre-vaccination) and Day 30 post-vaccination
Geometric Mean Titers of Serogroup A Antibodies Following Vaccination With Either Sanofi Pasteur Meningococcal A+C Polysaccharide Vaccine or Lanzhou Institute of Biological Products Meningococcal A+C Polysaccharide Vaccine
Time frame: Day 0 (pre-vaccination) and Day 30 post-vaccination
Geometric Mean Titers of Serogroup C Antibodies Following Vaccination With Either Sanofi Pasteur Meningococcal A+C Polysaccharide Vaccine or Lanzhou Institute of Biological Products Meningococcal A+C Polysaccharide Vaccine
Time frame: Day 0 (pre-vaccination) and Day 30 post-vaccination
Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Following Vaccination of Sanofi Pasteur Meningococcal A+C Polysaccharide Vaccine or Lanzhou Institute of Biological Products Meningococcal A+C Polysaccharide Vaccine
Time frame: Day 0 up 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 8 May 2014.
- 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 SA
2 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 Meningococcal (Groups A and C) Polysaccharide Vaccine in people with Meningococcal Disease and Meningitis, run by Sanofi Pasteur, a Sanofi Company at 2 sites in China.
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 20 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 8 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. 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 8 May 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?
Number of Participants With Seroconversion Following Vaccination With Either Sanofi Pasteur Meningococcal A+C Polysaccharide Vaccine or Lanzhou Institute of Biological Products Meningococcal A+C Polysaccharide Vaccine (time frame: 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 8 May 2014.