Meningococcal InfectionPhase 4CSISP-MENC1NCT00392808
Immunogenicity of the Booster Dose of Two MenC Vaccines
A Phase 4 study testing conjugated polysaccharide menC vaccine in people with Meningococcal Infection, run by Centro Superior de Investigación en Salud Publica at 2 sites in Spain.
Trial summary
The purpose of the study is to evaluate the immune response of toddlers, to a booster dose in the second year of life of two meningococcal C conjugated polysaccharide vaccine, and to assess the interchangeability of the two different vaccines. Read more about this study
- Who is it for?
- Ages 14 to 19 monthsHealthy volunteers can take part
- Conditions the study is for
- Meningococcal Infection
- What is being tested?
- conjugated polysaccharide menC vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 389 participants
- Where
- 2 sitesSpain
- Study dates
- Jan 2007to May 2009
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 14 to 19 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy toddlers of both sexes
- Toddlers of 14 to 19 months of age (including the day that the toddler is 14 and the day before he is 19 months of age)
- Children previously vaccinated with two doses of polysaccharide meningococcal C vaccine conjugated to tetanus toxoid or three doses of polysaccharide meningococcal C conjugated to CRM197 before 7 month of age.
- Informed consent signed by one or both parents who are adequately informed about the study.
Who cannot join
- Toddlers with severe diseases or axilar temperature ≥ 38,0ºC at inclusion time
- Toddlers with severe chronic diseases
- Toddlers who have received any other vaccine within the last month or with a programmed vaccination within the 28 subsequent days after the administration of the vaccine of study.
- Toddlers with clinical or bacteriological diagnosis of previous meningococcal disease.
- Toddlers with hypersensitivity to any of the components of the vaccines to study or antibiotics used during the manufacturing process that could be present as non- detectable traces (streptomycin, neomycin, polymyxin B).
- Toddlers with personal history of convulsions.
Show all 12Show fewer
- Toddlers with known bleeding disorder no controlled
- Toddlers with known congenital or acquired immunodeficiency
- Toddlers who are receiving or have been received any treatment that could change the immune response (administration of intravenous immunoglobulin, systemic corticosteroids or haemoderivates) within the 3 previous months.
- A toddler that under investigator opinion is probable to be lost during the follow-up
- A toddler that is currently included or is planned to be included in any other clinical trial.
- A toddler that under investigator opinion must not be included in the study due to other medical or social reasons.
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Universidad Rey Juan Carlos I
Madrid, 28922
Centro Superior Investigación en Salud Publica
Valencia, 46020
About this study
Official title: Randomized, Open Label, Active Control, Parallel Assignment Clinical Trial to Evaluate the Immunogenicity of Polysaccharide Meningococcal C Vaccines Conjugated With Tetanus Toxoid or CRM197 Given as a Booster Dose at 14-18 Months of Life.
The purpose of the study is to evaluate the immune response of toddlers, to a booster dose in the second year of life of two meningococcal C conjugated polysaccharide vaccine, and to assess the interchangeability of the two different vaccines.
Read the detailed description
Children 14 to 18 months of life, previously vaccinated with 2 doses of tetanus toxoid conjugated polysaccharide men C vaccine or three doses of the CRM197 conjugated polysaccharide men C vaccine before 7 months of age, are randomized to receive any of the two vaccines. Serum antibody activity against meningococcus C will be measured inmediately before and 4 weeks after the booster dose. Children will also be vaccinated with a combined vaccine containing DTaP+IPV+Hib.
- Conditions
- Meningococcal Infection
- Being tested
- conjugated polysaccharide menC vaccine
- Keywords
- Meningococcal vaccine, Immunization, secondary, vaccines conjugated, Meningococcal disease
- Medical subject headings
- Meningococcal Infections, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conjugated polysaccharide menC vaccineBiological
Booster vaccine dose at 14 to 18 months.
| Study group | Role | What they receive |
|---|---|---|
| MENC-CRM/MENC-CRM | Experimental | Children primed with 3 doses of MenC-CRM vaccine, Intervention: boosted with one dose of MenC-CRM vaccine Receives: Biological: conjugated polysaccharide menC vaccine |
| MENC-CRM/MENC-TT | Experimental | Children Primed with three doses of MenC-CRM vaccine. Intervention: boosted with one dose of MenC-TT Receives: Biological: conjugated polysaccharide menC vaccine |
| MENC-TT/MENC-CRM | Experimental | Children primovacccinated with two MenC-TT vaccine doses. Intervention: boosted with one dose MenC-CRM vaccine Receives: Biological: conjugated polysaccharide menC vaccine |
| MENC-TT/MENC-TT | Experimental | Children primovacccinated with two MenC-TT vaccine doses. Intervention boosted with one dose MenC-TT vaccine Receives: Biological: conjugated polysaccharide menC vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum Bactericidal Activity Against MenC
Measured: One month after booster dose
Serum Antibody Titers Against Haemophilus Influenzae Type b.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2006 (estimated)
- Study startJan 2007
- Primary completionMay 2008
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 389 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centro Superior de Investigación en Salud Publica
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Javier Diez-Domingo, PhD, Study chair, Centro Superior Investigacion Salud Publica (CSISP)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00392808
- Sponsor's protocol ID
- CSISP-VAC-MENC1
- Other IDs
- EUDRA 2006-003525-82
- Acronym
- CSISP-MENC1
- Status last verified
- Aug 2013
- First submitted
- 25 Oct 2006
- Last updated
- 11 Oct 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Diez-Domingo J, Planelles-Cantarino MV, Baldo-Torrenti JM, Ubeda-Sansano I, Jubert-Rosich A, Puig-Barbera J, Gutierrez-Gimeno MV. Antibody persistence 12 months after a booster dose of meningococcal-C conjugated vaccine in the second year of life. Pediatr Infect Dis J. 2010 Aug;29(8):768-70. doi: 10.1097/INF.0b013e3181d9e653.
PubMed 20375851Diez-Domingo J, Cantarino MV, Torrenti JM, Sansano MI, Rosich AJ, Merino AH, de Miguel AG, Gonzalez JB, Marcos MD; MenC Study Group. A randomized, multicenter, open-label clinical trial to assess the immunogenicity of a meningococcal C vaccine booster dose administered to children aged 14 to 18 months. Pediatr Infect Dis J. 2010 Feb;29(2):148-52. doi: 10.1097/INF.0b013e3181b9a831.
PubMed 19927040
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Open Label, Active Control, Parallel Assignment Clinical Trial to Evaluate the Immunogenicity of Polysaccharide Meningococcal C Vaccines Conjugated With Tetanus Toxoid or CRM197 Given as a Booster Dose at 14-18 Months of Life.
- ClinicalTrials.gov ID
- NCT00392808
- Acronym / sponsor ID
- CSISP-MENC1 / CSISP-VAC-MENC1
- Conditions
- Meningococcal Infection
- Keywords
- Meningococcal vaccine, Immunization, secondary, vaccines conjugated, Meningococcal disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 389 participants (actual)
- Lead sponsor
- Centro Superior de Investigación en Salud PublicaOther government
- Study start
- Jan 2007
- Primary completion
- May 2008 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 26 Oct 2006 (estimated)
- Results
- Posted 11 Oct 2013
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 evaluate the immune response of toddlers, to a booster dose in the second year of life of two meningococcal C conjugated polysaccharide vaccine, and to assess the interchangeability of the two different vaccines.
Detailed description
Children 14 to 18 months of life, previously vaccinated with 2 doses of tetanus toxoid conjugated polysaccharide men C vaccine or three doses of the CRM197 conjugated polysaccharide men C vaccine before 7 months of age, are randomized to receive any of the two vaccines. Serum antibody activity against meningococcus C will be measured inmediately before and 4 weeks after the booster dose. Children will also be vaccinated with a combined vaccine containing DTaP+IPV+Hib.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| MENC-CRM/MENC-CRM | Experimental | Biological: conjugated polysaccharide menC vaccineChildren primed with 3 doses of MenC-CRM vaccine, Intervention: boosted with one dose of MenC-CRM vaccine |
| MENC-CRM/MENC-TT | Experimental | Biological: conjugated polysaccharide menC vaccineChildren Primed with three doses of MenC-CRM vaccine. Intervention: boosted with one dose of MenC-TT |
| MENC-TT/MENC-CRM | Experimental | Biological: conjugated polysaccharide menC vaccineChildren primovacccinated with two MenC-TT vaccine doses. Intervention: boosted with one dose MenC-CRM vaccine |
| MENC-TT/MENC-TT | Experimental | Biological: conjugated polysaccharide menC vaccineChildren primovacccinated with two MenC-TT vaccine doses. Intervention boosted with one dose MenC-TT vaccine |
Who may qualify
- Ages
- 14 to 19 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Healthy toddlers of both sexes
- Toddlers of 14 to 19 months of age (including the day that the toddler is 14 and the day before he is 19 months of age)
- Children previously vaccinated with two doses of polysaccharide meningococcal C vaccine conjugated to tetanus toxoid or three doses of polysaccharide meningococcal C conjugated to CRM197 before 7 month of age.
- Informed consent signed by one or both parents who are adequately informed about the study.
Key exclusion criteria (12 listed)
- Toddlers with severe diseases or axilar temperature ≥ 38,0ºC at inclusion time
- Toddlers with severe chronic diseases
- Toddlers who have received any other vaccine within the last month or with a programmed vaccination within the 28 subsequent days after the administration of the vaccine of study.
- Toddlers with clinical or bacteriological diagnosis of previous meningococcal disease.
- Toddlers with hypersensitivity to any of the components of the vaccines to study or antibiotics used during the manufacturing process that could be present as non- detectable traces (streptomycin, neomycin, polymyxin B).
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 |
|---|---|---|
| conjugated polysaccharide menC vaccineBooster vaccine dose at 14 to 18 months. | Biological | MENC-CRM/MENC-CRM, MENC-CRM/MENC-TT, MENC-TT/MENC-CRM, MENC-TT/MENC-TT |
Primary outcome
Serum Bactericidal Activity Against MenC
Time frame: One month after booster dose
Serum Antibody Titers Against Haemophilus Influenzae Type b.
Time frame: One year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 20375851Diez-Domingo J, Planelles-Cantarino MV, Baldo-Torrenti JM, Ubeda-Sansano I, Jubert-Rosich A, Puig-Barbera J, Gutierrez-Gimeno MV. Antibody persistence 12 months after a booster dose of meningococcal-C conjugated vaccine in the second year of life. Pediatr Infect Dis J. 2010 Aug;29(8):768-70. doi: 10.1097/INF.0b013e3181d9e653.
- Results publication: PubMed 19927040Diez-Domingo J, Cantarino MV, Torrenti JM, Sansano MI, Rosich AJ, Merino AH, de Miguel AG, Gonzalez JB, Marcos MD; MenC Study Group. A randomized, multicenter, open-label clinical trial to assess the immunogenicity of a meningococcal C vaccine booster dose administered to children aged 14 to 18 months. Pediatr Infect Dis J. 2010 Feb;29(2):148-52. doi: 10.1097/INF.0b013e3181b9a831.
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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.
Javier Diez-Domingo, PhD study chair
Centro Superior Investigacion Salud Publica (CSISP)
2 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 conjugated polysaccharide menC vaccine in people with Meningococcal Infection, run by Centro Superior de Investigación en Salud Publica at 2 sites in Spain.
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 4 inclusion and 12 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 11 Oct 2013. 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 Spain. 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?
Yes. Results are posted in the registry (first posted 11 Oct 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Serum Bactericidal Activity Against MenC (time frame: One month after booster dose). 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?
On the ClinicalTrials.gov record for NCT00392808, which also lists 2 linked publications.
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 11 Oct 2013.