Prevention of Meningococcal InfectionPhase 4NCT00316654
Persistence of Antibody Response to N. Meningitidis Group C in Children
A Phase 4 study testing Meningococcal C conjugate vaccine in people with Prevention of Meningococcal Infection, run by Novartis Vaccines at 2 sites in 2 countries.
Trial summary
Persistence of Antibody Response to N. meningitidis Group C in Children Read more about this study
- Who is it for?
- Ages 7 months and olderHealthy volunteers can take part
- Conditions the study is for
- Prevention of Meningococcal Infection
- What is being tested?
- Meningococcal C conjugate vaccine
- Type of treatment
- Vaccines
- How many people
- 489 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Feb 2005to Oct 2005
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 7 months and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- healthy children
Who cannot join
- previous ascertained or suspected disease caused by N. meningitidis
- previous significant acute or chronic infections
- any other serious disease
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: A Phase IV,Multi-Center,Open-Label,Unrandomized Study to Evaluate the Persistence of Antibody Response to N.Meningitidis Group C,Before & After 2 Doses of the Conjugate Pneumococcal Vaccine,in Children Seven Months & Older Who Previously Received Immunization With Chiron Meningococcal C Conjugate Vaccine & a Hexavalent Infant Vaccine According to the Applicable Infant Immunization Schedule
Persistence of Antibody Response to N. meningitidis Group C in Children
- Conditions
- Prevention of Meningococcal Infection
- Being tested
- Meningococcal C conjugate vaccine
- Keywords
- Prevention of Meningococcal Meningitis, vaccines, conjugate, immunology, child, antibody persistence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meningococcal C conjugate vaccineBiological
What is being measured
The primary outcome is the main question the study is designed to answer.
Immunogenicity: serum antibody responses, as measured by bactericidal activity,using hBCA
Secondary outcomes (2)
Evaluate and compare persistence of antibody response to N. meningitidis serogroup C as measured by serum bactericidal activity
safety and tolerability
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2006 (estimated)
- Study startFeb 2005
- Primary completionOct 2005
- Study completionOct 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prevention of Meningococcal InfectionStudies of the same condition, open and under way.
- 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
- 489 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Vaccines
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- GlaxoSmithKline
- Responsible party
- Sponsor
- Investigators
- Novartis Vaccines Drug Information Services, Principal investigator, Novartis Vaccines & Diagnostics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00316654
- Sponsor's protocol ID
- V14P38E1
- Other IDs
- 2004-001522-24, 2004
- Status last verified
- Jul 2017
- First submitted
- 19 Apr 2006
- Last updated
- 25 Jul 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IV,Multi-Center,Open-Label,Unrandomized Study to Evaluate the Persistence of Antibody Response to N.Meningitidis Group C,Before & After 2 Doses of the Conjugate Pneumococcal Vaccine,in Children Seven Months & Older Who Previously Received Immunization With Chiron Meningococcal C Conjugate Vaccine & a Hexavalent Infant Vaccine According to the Applicable Infant Immunization Schedule
- ClinicalTrials.gov ID
- NCT00316654
- Acronym / sponsor ID
- V14P38E1
- Conditions
- Prevention of Meningococcal Infection
- Keywords
- Prevention of Meningococcal Meningitis, vaccines, conjugate, immunology, child, antibody persistence
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 489 participants (actual)
- Lead sponsor
- Novartis VaccinesIndustry (pharma, biotech, devices)
- Collaborators
- GlaxoSmithKline
- Study start
- Feb 2005
- Primary completion
- Oct 2005 (actual)
- Study completion
- Oct 2005 (actual)
- First posted
- 21 Apr 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Persistence of Antibody Response to N. meningitidis Group C in Children
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 7 months and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- healthy children
Key exclusion criteria (3 listed)
- previous ascertained or suspected disease caused by N. meningitidis
- previous significant acute or chronic infections
- any other serious disease
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 C conjugate vaccine | Biological | – |
Primary outcome
Immunogenicity: serum antibody responses, as measured by bactericidal activity,using hBCA
2 secondary outcomes
Evaluate and compare persistence of antibody response to N. meningitidis serogroup C as measured by serum bactericidal activity
safety and tolerability
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2017.
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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.
Novartis Vaccines Drug Information Services principal investigator
Novartis Vaccines & Diagnostics
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Meningococcal C conjugate vaccine in people with Prevention of Meningococcal Infection, run by Novartis Vaccines at 2 sites in 2 countries.
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 1 inclusion and 3 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 25 Jul 2017. 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 Poland, Spain. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Immunogenicity: serum antibody responses, as measured by bactericidal activity,using hBCA. 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 25 Jul 2017.