Prevention of Meningococcal InfectionPhase 4NCT00310700
Kinetics of B Cell Response in Infants Menjugate Vaccination
A Phase 4 study testing Meningococcal C conjugate vaccine in people with Prevention of Meningococcal Infection, run by Novartis at 1 site in United Kingdom.
Trial summary
Kinetics of B cell response in infants Menjugate vaccination Read more about this study
- Who is it for?
- Ages 8 to 11 weeksHealthy 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
- 75 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- May 2005to Nov 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 8 to 11 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- healthy infants
Who cannot join
- previously ascertained or suspected disease caused by N. meningitidis
- previous household contact with an individual with a positive culture of N. meningitidis serogroup C
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Centre for Clinical Vaccinology and Tropical Medicine, Churchill Hospital
Oxford, Oxon, OX3 7LJ
About this study
Official title: A Phase IV, Single Centre, Open-label Study to Investigate the Kinetics of the B Cell Response to the First and the Third Immunization With Chiron Meningococcal C Conjugate Vaccine Administered to Healthy Infants at 2, 3 and 4 Months of Age
Kinetics of B cell response in infants Menjugate vaccination
- Conditions
- Prevention of Meningococcal Infection
- Being tested
- Meningococcal C conjugate vaccine
- Keywords
- Prevention of Meningococcal Meningitis, vaccines, conjugate, immunology, infant, 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.
To establish at which day meningococcal C specific B cells are detectable in the blood of healthy infants following first and third immunisation with MenC Conjugate Vaccine as determined by Men C specific B-cell ELISPot assay.
Secondary outcomes (3)
To establish how long the B cells persist in the blood
To note the difference between plasma cell response following the first and third MenC vaccination.
To determine the immune response to Neisseria meningitidis serogroup C 26-34 days after the third immunisation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2006 (estimated)
- Study startMay 2005
- Primary completionNov 2005
- Study completionNov 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Single group
- Masking
- None (open label)
- Enrolment
- 75 participants
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Novartis Vaccines
- Investigators
- Novartis Vaccines - Information Services, Principal investigator, Novartis Vaccines & Diagnostics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00310700
- Sponsor's protocol ID
- M14P5
- Other IDs
- Impact N° 1457, 2004-004962-33, 2004
- Status last verified
- Sep 2014
- First submitted
- 3 Apr 2006
- Last updated
- 19 Sep 2014
- Results posted
- No
Publications
Kelly DF, Snape MD, Perrett KP, Clutterbuck EA, Lewis S, Blanchard Rohner G, Jones M, Yu LM, Pollard AJ. Plasma and memory B-cell kinetics in infants following a primary schedule of CRM 197-conjugated serogroup C meningococcal polysaccharide vaccine. Immunology. 2009 May;127(1):134-43. doi: 10.1111/j.1365-2567.2008.02934.x.
PubMed 19175802
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IV, Single Centre, Open-label Study to Investigate the Kinetics of the B Cell Response to the First and the Third Immunization With Chiron Meningococcal C Conjugate Vaccine Administered to Healthy Infants at 2, 3 and 4 Months of Age
- ClinicalTrials.gov ID
- NCT00310700
- Acronym / sponsor ID
- M14P5
- Conditions
- Prevention of Meningococcal Infection
- Keywords
- Prevention of Meningococcal Meningitis, vaccines, conjugate, immunology, infant, antibody persistence
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Collaborators
- Novartis Vaccines
- Study start
- May 2005
- Primary completion
- Nov 2005 (actual)
- Study completion
- Nov 2005 (actual)
- First posted
- 4 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.
Kinetics of B cell response in infants Menjugate vaccination
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 8 to 11 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- healthy infants
Key exclusion criteria (2 listed)
- previously ascertained or suspected disease caused by N. meningitidis
- previous household contact with an individual with a positive culture of N. meningitidis serogroup C
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
To establish at which day meningococcal C specific B cells are detectable in the blood of healthy infants following first and third immunisation with MenC Conjugate Vaccine as determined by Men C specific B-cell ELISPot assay.
3 secondary outcomes
To establish how long the B cells persist in the blood
To note the difference between plasma cell response following the first and third MenC vaccination.
To determine the immune response to Neisseria meningitidis serogroup C 26-34 days after the third immunisation
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 19 Sep 2014.
- Background: PubMed 19175802Kelly DF, Snape MD, Perrett KP, Clutterbuck EA, Lewis S, Blanchard Rohner G, Jones M, Yu LM, Pollard AJ. Plasma and memory B-cell kinetics in infants following a primary schedule of CRM 197-conjugated serogroup C meningococcal polysaccharide vaccine. Immunology. 2009 May;127(1):134-43. doi: 10.1111/j.1365-2567.2008.02934.x.
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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 - Information Services principal investigator
Novartis Vaccines & Diagnostics
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 C conjugate vaccine in people with Prevention of Meningococcal Infection, run by Novartis at 1 site in United Kingdom.
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 2 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 19 Sep 2014. 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 United Kingdom. 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?
To establish at which day meningococcal C specific B cells are detectable in the blood of healthy infants following first and third immunisation with MenC Conjugate Vaccine as determined by Men C specific B-cell ELISPot assay.. 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 NCT00310700, 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 19 Sep 2014.