Meningococcal Sero-type C InfectionPhase 4NCT00936962
Evaluation of Meningococcal C Vaccine Programmes in Canadian Children
A Phase 4 study testing NeisVac C vaccine (12mth) in people with Meningococcal Sero-type C Infection, run by University of British Columbia at 3 sites in Canada.
Trial summary
The purpose of the study is to see which of the three current provincial Meningococcal C Conjugate vaccine schedules in Canada provide the longest lasting protection against Meningococcal C disease and to see if a booster vaccination is needed. Read more about this study
- Who is it for?
- Ages 12 to 13 monthsHealthy volunteers can take part
- Conditions the study is for
- Meningococcal Sero-type C Infection
- What is being tested?
- NeisVac C vaccine (12mth)
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 452 participants
- Where
- 3 sitesCanada
- Study dates
- Jul 2009to Jun 2015
- 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
- 12-13 mths of age
- over 34 weeks gestation
- healthy children
- having had all vaccinations of Meningococcal C vaccine per the recommended schedule for their respective province within a month of the recommended age - documented.
- Communication in English
Who cannot join
- No contraindication to receiving 12 mth dose of MenC vaccine
- No other MenC vaccine or MenC disease
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
Alberta Health Services (Alberta Children's Hospital)
Calgary, Alberta
Canadian Centre for Vaccinology (Dalhousie/IWK,)
Halifax, Nova Scotia
Vaccine Evaluation Center (University of BC at Children's Hospital)
Vancouver, British Columbia
About this study
Official title: Evaluation of Meningococcal C Vaccine Programmes in Canadian (BC, NS, Alta.) Children During Peak Years of Risk (0-<5 Years of Age)
The purpose of the study is to see which of the three current provincial Meningococcal C Conjugate vaccine schedules in Canada provide the longest lasting protection against Meningococcal C disease and to see if a booster vaccination is needed.
Read the detailed description
In 2002-2005, Canada introduced universal MenC programmes consisting of 1,2 or 3 infant doses. Most are one (12 mth) dose. High rates of serogroupC disease in 2000 and 2001 prompted some provinces to launch universal MenC vaccination programmes in 2002. The goal was to provide protection in infancy and early childhood (the time of most risk) with the hope that the protection would extend throughout adolescence (the second highest risk). It is unclear if early multi-dosing or 1 dose programmes would offer better protection (lack of data). Each province in Canada has chosen different Meningococcal C Conjugate vaccine provision schedules for the primary vaccinations.
This study will look at short term protection after the differing provincial series of vaccinations has been given and compare those who do not get primary vaccination under 1 year of age (NS) with two schedules of primary immunization (BC at 2 and 4 mths and Alberta at 2 months). A blood sample will be collected at 12-13 mths for this comparison. A booster vaccination of the current provincial Men C vaccine will be provided at 12 months. Another blood sample will be collected 1 mth later to look at the difference in responses between the groups (different provincial primary vaccination schedule). 2 years and 4 years later (at age 3 and age 5), another blood sample will be collected to look at the difference in long term protection of the groups where the primary schedule was different.
- Conditions
- Meningococcal Sero-type C Infection
- Being tested
- NeisVac C vaccine (12mth)
- Keywords
- Meningococcal C vaccine, Meningitis study, Canadian vaccine schedule, Prevention of Meningococcal C disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeisVac C vaccine (12mth)Biological
Also called NeisVac C vaccine (Baxter), Meningococcal C congugate vaccine
NeisVac C Meningococcal C Conjugate vaccine given IM 0.5mL in the deltoid muscle at 12 mths of age
| Study group | Role | What they receive |
|---|---|---|
| Group 1 NeisVac C vaccine - 0 doses | Experimental | NeisVac C (Meningococcal C) vaccine - 0 doses Receives: Biological: NeisVac C vaccine (12mth) |
| Group 2 NeiscVac C - 2 doses | Experimental | 2 priming doses of NeisVac C vaccine at 2 and 4 mths of age Receives: Biological: NeisVac C vaccine (12mth) |
| Group 3 NeiscVac C - 1 dose | Experimental | 1 priming dose of NeisVac C vaccine at 2 mths of age Receives: Biological: NeisVac C vaccine (12mth) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the longest lasting protection against Meningococcal C disease and to see if a booster vaccination is needed.
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2009 (estimated)
- Study startJul 2009
- Primary completionJun 2015
- Study completionJun 2015
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 Meningococcal Sero-type C InfectionStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe 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
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 452 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Sponsor
- Investigators
- Julie Bettinger, Ph.D, Principal investigator, University of British ColumbiaDavid Scheifele, Ph.D, Study director, University of British ColumbiaScott Halperin, Ph.D, Study director, Dalhousie University, HalifaxJames Kellner, Ph.D, Study director, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00936962
- Sponsor's protocol ID
- H07-02175
- Status last verified
- Jul 2015
- First submitted
- 8 Jul 2009
- Last updated
- 15 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Bettinger JA, Scheifele DW, Halperin SA, Kellner JD, Vanderkooi OG, Schryvers A, De Serres G, Alcantara J. Evaluation of meningococcal serogroup C conjugate vaccine programs in Canadian children: interim analysis. Vaccine. 2012 Jun 8;30(27):4023-7. doi: 10.1016/j.vaccine.2012.04.034. Epub 2012 Apr 23.
PubMed 22537988
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Meningococcal C Vaccine Programmes in Canadian (BC, NS, Alta.) Children During Peak Years of Risk (0-<5 Years of Age)
- ClinicalTrials.gov ID
- NCT00936962
- Acronym / sponsor ID
- H07-02175
- Conditions
- Meningococcal Sero-type C Infection
- Keywords
- Meningococcal C vaccine, Meningitis study, Canadian vaccine schedule, Prevention of Meningococcal C disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 452 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- Jul 2009
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 10 Jul 2009 (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.
The purpose of the study is to see which of the three current provincial Meningococcal C Conjugate vaccine schedules in Canada provide the longest lasting protection against Meningococcal C disease and to see if a booster vaccination is needed.
Detailed description
In 2002-2005, Canada introduced universal MenC programmes consisting of 1,2 or 3 infant doses. Most are one (12 mth) dose. High rates of serogroupC disease in 2000 and 2001 prompted some provinces to launch universal MenC vaccination programmes in 2002. The goal was to provide protection in infancy and early childhood (the time of most risk) with the hope that the protection would extend throughout adolescence (the second highest risk). It is unclear if early multi-dosing or 1 dose programmes would offer better protection (lack of data). Each province in Canada has chosen different Meningococcal C Conjugate vaccine provision schedules for the primary vaccinations.
This study will look at short term protection after the differing provincial series of vaccinations has been given and compare those who do not get primary vaccination under 1 year of age (NS) with two schedules of primary immunization (BC at 2 and 4 mths and Alberta at 2 months). A blood sample will be collected at 12-13 mths for this comparison. A booster vaccination of the current provincial Men C vaccine will be provided at 12 months. Another blood sample will be collected 1 mth later to look at the difference in responses between the groups (different provincial primary vaccination schedule). 2 years and 4 years later (at age 3 and age 5), another blood sample will be collected to look at the difference in long term protection of the groups where the primary schedule was different.
Study design
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 NeisVac C vaccine - 0 doses | Experimental | Biological: NeisVac C vaccine (12mth)NeisVac C (Meningococcal C) vaccine - 0 doses |
| Group 2 NeiscVac C - 2 doses | Experimental | Biological: NeisVac C vaccine (12mth)2 priming doses of NeisVac C vaccine at 2 and 4 mths of age |
| Group 3 NeiscVac C - 1 dose | Experimental | Biological: NeisVac C vaccine (12mth)1 priming dose of NeisVac C vaccine at 2 mths of age |
Who may qualify
- Ages
- 12 to 13 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 12-13 mths of age
- over 34 weeks gestation
- healthy children
- having had all vaccinations of Meningococcal C vaccine per the recommended schedule for their respective province within a month of the recommended age - documented.
- Communication in English
Key exclusion criteria (2 listed)
- No contraindication to receiving 12 mth dose of MenC vaccine
- No other MenC vaccine or MenC 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 |
|---|---|---|
| NeisVac C vaccine (12mth)Also: NeisVac C vaccine (Baxter), Meningococcal C congugate vaccineNeisVac C Meningococcal C Conjugate vaccine given IM 0.5mL in the deltoid muscle at 12 mths of age | Biological | Group 1 NeisVac C vaccine - 0 doses, Group 2 NeiscVac C - 2 doses, Group 3 NeiscVac C - 1 dose |
Primary outcome
To evaluate the longest lasting protection against Meningococcal C disease and to see if a booster vaccination is needed.
Time frame: 4 years
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 15 Jul 2015.
- Derived from this study: PubMed 22537988Bettinger JA, Scheifele DW, Halperin SA, Kellner JD, Vanderkooi OG, Schryvers A, De Serres G, Alcantara J. Evaluation of meningococcal serogroup C conjugate vaccine programs in Canadian children: interim analysis. Vaccine. 2012 Jun 8;30(27):4023-7. doi: 10.1016/j.vaccine.2012.04.034. Epub 2012 Apr 23.
- click here for information on the trialLink provided by the sponsor.
- Click here for interim analysis publicationLink provided by the sponsor.
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.
Julie Bettinger, Ph.D principal investigator
University of British Columbia
David Scheifele, Ph.D study director
University of British Columbia
Scott Halperin, Ph.D study director
Dalhousie University, Halifax
3 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 NeisVac C vaccine (12mth) in people with Meningococcal Sero-type C Infection, run by University of British Columbia at 3 sites in Canada.
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 5 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 15 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. 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 evaluate the longest lasting protection against Meningococcal C disease and to see if a booster vaccination is needed. (time frame: 4 years). 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 NCT00936962, 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 15 Jul 2015.