Prevention of Meningococcal InfectionPhase 3NCT00311415
Immunogenicity, Safety, Tolerability and Ability to Prime for Memory of Meningococcal C Conjugate Vaccine in Healthy Children
A Phase 3 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
Immunogenicity, Safety, Tolerability and Ability to Prime for Memory of Meningococcal C Conjugate Vaccine in healthy children Read more about this study
- Who is it for?
- Ages 7 to 16 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
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 257 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Oct 2005to Apr 2008
- Phase
- Phase 3
- 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 to 16 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- healthy infants
Who cannot join
- known hypersensitivity to any vaccine component
- significant acute or chronic infections
- 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
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: A Phase III, Multi-Center, Open-Label, Controlled, Randomized Study to Evaluate the Immunogenicity, Safety, Tolerability and the Ability to Prime for Memory of Chiron Meningococcal C Conjugate Vaccine When Administered to Healthy Infants as One Dose Given at 2 or 6 Months of Age With a Booster at 12-16 Months of Age, in Comparison to Two Doses in the First Year of Life, Given Two Months Apart, With a Booster at 12-16 Months of Age; and in Comparison to One Dose Given at 12-16 Months of Age
Immunogenicity, Safety, Tolerability and Ability to Prime for Memory of Meningococcal C Conjugate Vaccine in healthy children
Read the detailed description
The aim of this study is to investigate the immunogenicity offered by MenCC vaccine when administered in different schedules at different years of life: 2 doses in the first year of life given 2 months apart (at 2 and 4 months of age), with a booster in the second year of life, or 1 dose in the first year of life (at 2 or 6 months of age), with a booster in the second year of life, or only 1 dose in the second year of life.
- Conditions
- Prevention of Meningococcal Infection
- Being tested
- Meningococcal C conjugate vaccine
- Keywords
- Prevention of Meningococcal Meningitis, meningococcal 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
Meningococcal conjugate vaccine, active comparator.
Groups 1 to 3 were given a booster dose in the second year of life at 12-16 months of age
| Study group | Role | What they receive |
|---|---|---|
| Group 1: 2+4 Months (2-doses) | Experimental | Not described Receives: Biological: Meningococcal C conjugate vaccine |
| Group 2: 2 Months (1-dose) | Experimental | Not described Receives: Biological: Meningococcal C conjugate vaccine |
| Group 3: 6 Months (1-dose) | Experimental | Not described Receives: Biological: Meningococcal C conjugate vaccine |
| Group 4: 12-16 Months (1 dose in the second year of life) | Active comparator | 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.
Demonstration of non-inferiority of memory antibody response after 1 dose of MenC Vaccine administered to healthy infants at 2 to 6 months of age and as first, second or third dose in the second year of life,as measured by rBCA.
Measured: Overall study period
Secondary outcomes (1)
Evaluation and comparison of antibody response and its persistence in terms of GMT and percent responders, as measured by rBCA.
Measured: Overall study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2006 (estimated)
- Study startOct 2005
- Primary completionApr 2008
- Study completionApr 2008
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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 257 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
- NCT00311415
- Sponsor's protocol ID
- M14P6
- Other IDs
- Impact N° 919
- Status last verified
- Feb 2012
- First submitted
- 3 Apr 2006
- Last updated
- 8 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Multi-Center, Open-Label, Controlled, Randomized Study to Evaluate the Immunogenicity, Safety, Tolerability and the Ability to Prime for Memory of Chiron Meningococcal C Conjugate Vaccine When Administered to Healthy Infants as One Dose Given at 2 or 6 Months of Age With a Booster at 12-16 Months of Age, in Comparison to Two Doses in the First Year of Life, Given Two Months Apart, With a Booster at 12-16 Months of Age; and in Comparison to One Dose Given at 12-16 Months of Age
- ClinicalTrials.gov ID
- NCT00311415
- Acronym / sponsor ID
- M14P6
- Conditions
- Prevention of Meningococcal Infection
- Keywords
- Prevention of Meningococcal Meningitis, meningococcal vaccines, conjugate, immunology, infant, antibody persistence
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 257 participants (actual)
- Lead sponsor
- Novartis VaccinesIndustry (pharma, biotech, devices)
- Study start
- Oct 2005
- Primary completion
- Apr 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 6 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.
Immunogenicity, Safety, Tolerability and Ability to Prime for Memory of Meningococcal C Conjugate Vaccine in healthy children
Detailed description
The aim of this study is to investigate the immunogenicity offered by MenCC vaccine when administered in different schedules at different years of life: 2 doses in the first year of life given 2 months apart (at 2 and 4 months of age), with a booster in the second year of life, or 1 dose in the first year of life (at 2 or 6 months of age), with a booster in the second year of life, or only 1 dose in the second year of life.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1: 2+4 Months (2-doses) | Experimental | Biological: Meningococcal C conjugate vaccine |
| Group 2: 2 Months (1-dose) | Experimental | Biological: Meningococcal C conjugate vaccine |
| Group 3: 6 Months (1-dose) | Experimental | Biological: Meningococcal C conjugate vaccine |
| Group 4: 12-16 Months (1 dose in the second year of life) | Active comparator | Biological: Meningococcal C conjugate vaccine |
Who may qualify
- Ages
- 7 to 16 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- healthy infants
Key exclusion criteria (4 listed)
- known hypersensitivity to any vaccine component
- significant acute or chronic infections
- 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 vaccineMeningococcal conjugate vaccine, active comparator. Groups 1 to 3 were given a booster dose in the second year of life at 12-16 months of age | Biological | Group 1: 2+4 Months (2-doses), Group 2: 2 Months (1-dose), Group 3: 6 Months (1-dose), Group 4: 12-16 Months (1 dose in the second year of life) |
Primary outcome
Demonstration of non-inferiority of memory antibody response after 1 dose of MenC Vaccine administered to healthy infants at 2 to 6 months of age and as first, second or third dose in the second year of life,as measured by rBCA.
Time frame: Overall study period
1 secondary outcome
Evaluation and comparison of antibody response and its persistence in terms of GMT and percent responders, as measured by rBCA.
Time frame: Overall study period
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 8 Feb 2012.
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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
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 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 4 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 Feb 2012. 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 Germany, Poland. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Demonstration of non-inferiority of memory antibody response after 1 dose of MenC Vaccine administered to healthy infants at 2 to 6 months of age and as first, second or third dose in the second year of life,as measured by rBCA. (time frame: Overall study period). 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 Feb 2012.