Prevention of Meningococcal InfectionPhase 3NCT00310674
Immunogenicity, Safety and Tolerability, of Chiron Meningococcal C Conjugate Vaccine Administered to Healthy Premature and Non Premature Children of 3 Months of Age
A Phase 3 study testing Meningococcal C Conjugate Vaccine in people with Prevention of Meningococcal Infection, run by Novartis at 1 site in Italy.
Trial summary
Immunogenicity, Safety and Tolerability, of Chiron Meningococcal C Conjugate Vaccine Administered to Healthy Premature and Non Premature Children of 3 months of age Read more about this study
- Who is it for?
- Ages 11 to 15 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
- 150 participants
- Where
- 1 siteItaly
- Study dates
- Sep 2004to not given
- 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 11 to 15 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy children of 11 to 15 weeks of age
Who cannot join
- Children who previously received any kind of Meningococcal C vaccine, DTaP-IPV-HBV-Hib vaccine or a Hepatitis B vaccine at birth
- Children who have a previous ascertained or suspected disease caused by N. meningitidis, Corynebacterium diphtheriae, Clostridium tetani, poliovirus, Hepatitis B or H. influenzae type b, culture proven Bordetella pertussis, or clinical condition of spasmodic cough for a period longer than or equal to 2 weeks associated with apnea or whooping
- Children who have had household contact with and/or intimate exposure to an individual with culture proven N. meningitidis serogroup C or Bordetella pertussis, within the previous 60 days
Trial locations and contacts
1 site in 1 country.
Italy1 site
Istituto di Pediatria, Università degli Studi di Milano
Milan, 20122
About this study
Official title: A Phase III, Single Center, Open Label, Uncontrolled Study to Evaluate the Immunogenicity, Safety and Tolerability, of the Chiron Meningococcal C Conjugate Vaccine When Administered to Healthy Premature and Non Premature Children at 3, 5, 11 Months of Age Concomitantly With a Hexavalent Infant Vaccine
Immunogenicity, Safety and Tolerability, of Chiron Meningococcal C Conjugate Vaccine Administered to Healthy Premature and Non Premature Children of 3 months of age
- Conditions
- Prevention of Meningococcal Infection
- Being tested
- Meningococcal C Conjugate Vaccine
- Keywords
- Prevention of Meningococcal Meningitis, meningococcal vaccines, conjugate, Immunology, infant
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.
antibody response, as measured by ELISA, to N. meningitidis serogroup C at one month following three doses of MenC Conjugate Vaccine administered at 3, 5, 11 months of age, together with a hexavalent vaccine.
safety and tolerability
Secondary outcomes (2)
antibody response as measured by ELISA at 1 month after second dose of MenC Vaccine and before third dose with hexavalent vaccine
antibody response as measured by BCA in subset of subjects in each group, at 1 month after second dose, immediately before the third and at 1 month following the third dose of MenC Vaccine together with a hexavalent vaccine.
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 startSep 2004
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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Novartis Vaccines
- Investigators
- Novartis - Information Services, Principal investigator, Novartis Vaccines & Diagnostics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00310674
- Sponsor's protocol ID
- M14P3
- Other IDs
- Impact N° 926
- Status last verified
- Mar 2007
- First submitted
- 3 Apr 2006
- Last updated
- 13 Mar 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Single Center, Open Label, Uncontrolled Study to Evaluate the Immunogenicity, Safety and Tolerability, of the Chiron Meningococcal C Conjugate Vaccine When Administered to Healthy Premature and Non Premature Children at 3, 5, 11 Months of Age Concomitantly With a Hexavalent Infant Vaccine
- ClinicalTrials.gov ID
- NCT00310674
- Acronym / sponsor ID
- M14P3
- Conditions
- Prevention of Meningococcal Infection
- Keywords
- Prevention of Meningococcal Meningitis, meningococcal vaccines, conjugate, Immunology, infant
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Collaborators
- Novartis Vaccines
- Study start
- Sep 2004
- 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.
Immunogenicity, Safety and Tolerability, of Chiron Meningococcal C Conjugate Vaccine Administered to Healthy Premature and Non Premature Children of 3 months of age
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 11 to 15 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Healthy children of 11 to 15 weeks of age
Key exclusion criteria (3 listed)
- Children who previously received any kind of Meningococcal C vaccine, DTaP-IPV-HBV-Hib vaccine or a Hepatitis B vaccine at birth
- Children who have a previous ascertained or suspected disease caused by N. meningitidis, Corynebacterium diphtheriae, Clostridium tetani, poliovirus, Hepatitis B or H. influenzae type b, culture proven Bordetella pertussis, or clinical condition of spasmodic cough for a period longer than or equal to 2 weeks associated with apnea or whooping
- Children who have had household contact with and/or intimate exposure to an individual with culture proven N. meningitidis serogroup C or Bordetella pertussis, within the previous 60 days
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
antibody response, as measured by ELISA, to N. meningitidis serogroup C at one month following three doses of MenC Conjugate Vaccine administered at 3, 5, 11 months of age, together with a hexavalent vaccine.
safety and tolerability
2 secondary outcomes
antibody response as measured by ELISA at 1 month after second dose of MenC Vaccine and before third dose with hexavalent vaccine
antibody response as measured by BCA in subset of subjects in each group, at 1 month after second dose, immediately before the third and at 1 month following the third dose of MenC Vaccine together with a hexavalent vaccine.
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 13 Mar 2007.
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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 - 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 3 study testing Meningococcal C Conjugate Vaccine in people with Prevention of Meningococcal Infection, run by Novartis at 1 site in Italy.
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 13 Mar 2007. 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 Italy. 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?
antibody response, as measured by ELISA, to N. meningitidis serogroup C at one month following three doses of MenC Conjugate Vaccine administered at 3, 5, 11 months of age, together with a hexavalent vaccine.. The study lists 2 primary outcomes in all. 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 13 Mar 2007.