Prevention of Meningococcal InfectionPhase 4NCT00310713
Persistence of Antibodies and Kinetics of B Cell Response in Healthy Children After Vaccination With MCC Vaccine
A Phase 4 study testing Meningococcal C conjugate vaccine in people with Prevention of Meningococcal Infection, run by Novartis Vaccines at 1 site in United Kingdom.
Trial summary
Persistence of antibodies and kinetics of B cell response in healthy children after vaccination with MCC vaccine Read more about this study
- Who is it for?
- Ages 12 to 13 monthsHealthy 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
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Apr 2006to Aug 2006
- 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 12 to 13 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy children
Who cannot join
- Known hypersensitivity to any vaccine products
- Any immunodeficiency, genetic anomaly or severe acute or chronic illness
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Oxford Vaccine Group, Centre for Clinical Vaccinology and Tropical Medicine, Churchill Hospital, Old Road
Headington, Oxford, 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 C Saccharide Component of Chiron's Meningococcal C Conjugate Vaccine Administered to Healthy Children at Least 12 Months of Age After Priming With a Commercially Available Men ACWY Conjugate Vaccine at 2, 3 and 4 Months of Age
Persistence of antibodies and kinetics of B cell response in healthy children after vaccination with MCC vaccine
- Conditions
- Prevention of Meningococcal Infection
- Being tested
- Meningococcal C conjugate vaccine
- Keywords
- Prevention of Meningococcal Meningitis, vaccines, conjugate, immunology, children, 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
Group 1: Meningococcal C conjugate vaccine dose boost on Visit 6 (day 0), blood sample on Visit 7 (day 3 post immunization) Group 2: Meningococcal C conjugate vaccine dose boost on Visit 6 (day 0), blood sample on Visit 7 (day 5 post immunization) Group 3: Meningococcal C conjugate vaccine dose boost on Visit 6 (day 0), blood sample on Visit 7 (day 7 post immunization) Group 4: Meningococcal C conjugate vaccine dose boost on Visit 6 (day 0), blood sample on Visit 7 (day 9 post immunization) Group 5: Meningococcal C conjugate vaccine dose boost on Visit 6 (day 0), blood sample on Visit 7 (day 10 post immunization)
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Not described Receives: Biological: Meningococcal C conjugate vaccine |
| Group 2 | Experimental | Not described Receives: Biological: Meningococcal C conjugate vaccine |
| Group 3 | Experimental | Not described Receives: Biological: Meningococcal C conjugate vaccine |
| Group 4 | Experimental | Not described Receives: Biological: Meningococcal C conjugate vaccine |
| Group 5 | Experimental | Not described Receives: Biological: Meningococcal C conjugate vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Persistence of memory B cells in the blood at least one year after primary immunisation with MenC Vaccine at 2, 3 and 4 months of age, as determined by meningococcal C specific B-cell ELISPot assay or limiting dilution
Secondary outcomes (2)
Immune Response measured 4 weeks after the booster immunisation.
establish at which day CRM -197 specific B cells are detectable in the blood after booster immunisation, as determined by meningococcal C specific B-cell ELISpot assay or limiting dilution.
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 startApr 2006
- Primary completionAug 2006
- Study completionAug 2006
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
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Vaccines
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Vaccines - Information Services, Principal investigator, Novartis Vaccines & Diagnostics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00310713
- Sponsor's protocol ID
- M14P5E1
- Other IDs
- Impact N° 1637
- Status last verified
- Sep 2014
- First submitted
- 3 Apr 2006
- Last updated
- 19 Sep 2014
- Results posted
- No
Publications
Blanchard Rohner G, Snape MD, Kelly DF, John T, Morant A, Yu LM, Borkowski A, Ceddia F, Borrow R, Siegrist CA, Pollard AJ. The magnitude of the antibody and memory B cell responses during priming with a protein-polysaccharide conjugate vaccine in human infants is associated with the persistence of antibody and the intensity of booster response. J Immunol. 2008 Feb 15;180(4):2165-73. doi: 10.4049/jimmunol.180.4.2165.
PubMed 18250423
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 C Saccharide Component of Chiron's Meningococcal C Conjugate Vaccine Administered to Healthy Children at Least 12 Months of Age After Priming With a Commercially Available Men ACWY Conjugate Vaccine at 2, 3 and 4 Months of Age
- ClinicalTrials.gov ID
- NCT00310713
- Acronym / sponsor ID
- M14P5E1
- Conditions
- Prevention of Meningococcal Infection
- Keywords
- Prevention of Meningococcal Meningitis, vaccines, conjugate, immunology, children, antibody persistence
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Novartis VaccinesIndustry (pharma, biotech, devices)
- Study start
- Apr 2006
- Primary completion
- Aug 2006 (actual)
- Study completion
- Aug 2006 (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.
Persistence of antibodies and kinetics of B cell response in healthy children after vaccination with MCC vaccine
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Biological: Meningococcal C conjugate vaccine |
| Group 2 | Experimental | Biological: Meningococcal C conjugate vaccine |
| Group 3 | Experimental | Biological: Meningococcal C conjugate vaccine |
| Group 4 | Experimental | Biological: Meningococcal C conjugate vaccine |
| Group 5 | Experimental | Biological: Meningococcal C conjugate vaccine |
Who may qualify
- Ages
- 12 to 13 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Healthy children
Key exclusion criteria (2 listed)
- Known hypersensitivity to any vaccine products
- Any immunodeficiency, genetic anomaly or severe acute or chronic illness
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 vaccineGroup 1: Meningococcal C conjugate vaccine dose boost on Visit 6 (day 0), blood sample on Visit 7 (day 3 post immunization) Group 2: Meningococcal C conjugate vaccine dose boost on Visit 6 (day 0), blood sample on Visit 7 (day 5 post immunization) Group 3: Meningococcal C conjugate vaccine dose boost on Visit 6 (day 0), blood sample on Visit 7 (day 7 post immunization) Group 4: Meningococcal C conjugate vaccine dose boost on Visit 6 (day 0), blood sample on Visit 7 (day 9 post immunization) Group 5: Meningococcal C conjugate vaccine dose boost on Visit 6 (day 0), blood sample on Visit 7 (day 10 post immunization) | Biological | Group 1, Group 2, Group 3, Group 4, Group 5 |
Primary outcome
Persistence of memory B cells in the blood at least one year after primary immunisation with MenC Vaccine at 2, 3 and 4 months of age, as determined by meningococcal C specific B-cell ELISPot assay or limiting dilution
2 secondary outcomes
Immune Response measured 4 weeks after the booster immunisation.
establish at which day CRM -197 specific B cells are detectable in the blood after booster immunisation, as determined by meningococcal C specific B-cell ELISpot assay or limiting dilution.
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 18250423Blanchard Rohner G, Snape MD, Kelly DF, John T, Morant A, Yu LM, Borkowski A, Ceddia F, Borrow R, Siegrist CA, Pollard AJ. The magnitude of the antibody and memory B cell responses during priming with a protein-polysaccharide conjugate vaccine in human infants is associated with the persistence of antibody and the intensity of booster response. J Immunol. 2008 Feb 15;180(4):2165-73. doi: 10.4049/jimmunol.180.4.2165.
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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 Vaccines 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?
Persistence of memory B cells in the blood at least one year after primary immunisation with MenC Vaccine at 2, 3 and 4 months of age, as determined by meningococcal C specific B-cell ELISPot assay or limiting dilution. 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 NCT00310713, 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.