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| ID | Type | Description | Link |
|---|---|---|---|
| EUDRA 2006-003525-82 |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MENC-CRM/MENC-CRM | Experimental | Children primed with 3 doses of MenC-CRM vaccine, Intervention: boosted with one dose of MenC-CRM vaccine |
|
| MENC-CRM/MENC-TT | Experimental | Children Primed with three doses of MenC-CRM vaccine. Intervention: boosted with one dose of MenC-TT |
|
| MENC-TT/MENC-CRM | Experimental | Children primovacccinated with two MenC-TT vaccine doses. Intervention: boosted with one dose MenC-CRM vaccine |
|
| MENC-TT/MENC-TT | Experimental | Children primovacccinated with two MenC-TT vaccine doses. Intervention boosted with one dose MenC-TT vaccine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| conjugated polysaccharide menC vaccine | Biological | Booster vaccine dose at 14 to 18 months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Serum Bactericidal Activity Against MenC | One month after booster dose | |
| Serum Antibody Titers Against Haemophilus Influenzae Type b. | One year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Javier Diez-Domingo, PhD | Centro Superior Investigacion Salud Publica (CSISP) | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universidad Rey Juan Carlos I | Madrid | 28922 | Spain | |||
| Centro Superior Investigación en Salud Publica |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20375851 | Result | 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. | |
| 19927040 |
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Recruitment was done in primary care pediatric clinics, between january and may 2007.
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| ID | Title | Description |
|---|---|---|
| FG000 | MENC-TT/MENC-TT | Children primovacccinated with two MenC-TT vaccine doses and primed with MenC-TT vaccine |
| FG001 | MENC-TT/MENC-CRM | Children primovacccinated with two MenC-TT vaccine doses and primed with MenC-CRM vaccine |
| FG002 | MENC-CRM/MENC-TT | Children Primed with three doses of MenC-CRM vaccine and boosted with MenC-TT |
| FG003 | MENC-CRM/MENC-CRM | Children primed with 3 doses of MenC-CRM vaccine, and boosted with MenC-CRM vaccine |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | MENC-CRM/MENC-CRM | Children primed with 3 doses of MenC-CRM vaccine, and boosted with MenC-CRM vaccine |
| BG001 | MENC-CRM/MENC-TT | Children Primed with three doses of MenC-CRM vaccine and boosted with MenC-TT |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Serum Bactericidal Activity Against MenC | Posted | Geometric Mean | 95% Confidence Interval | GMTs | One month after booster dose |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | MENC-TT/MENC-TT | Children primovacccinated with two MenC-TT vaccine doses and primed with MenC-TT vaccine |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile seizures | Nervous system disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| local reactions: pain, induration | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Javier Diez-Domingo | Centro Superior de Investigacion en Salud Publica | +34961925937 | diez_jav@gva.es |
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| ID | Term |
|---|---|
| D008589 | Meningococcal Infections |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D016870 | Neisseriaceae Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
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| Valencia |
| 46020 |
| Spain |
| Diez-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. |
| Unable to withdraw blood |
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| BG002 | MENC-TT/MENC-CRM | Children primovacccinated with two MenC-TT vaccine doses and primed with MenC-CRM vaccine |
| BG003 | MENC-TT/MENC-TT | Children primovacccinated with two MenC-TT vaccine doses and primed with MenC-TT vaccine |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| OG003 | MENC-CRM/MENC-CRM | Children primed with 3 doses of MenC-CRM vaccine, and boosted with MenC-CRM vaccine |
|
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| Primary | Serum Antibody Titers Against Haemophilus Influenzae Type b. | Posted | Geometric Mean | 95% Confidence Interval | GMCs | One year |
|
|
|
| 3 |
| 87 |
| 0 |
| 87 |
| EG001 | MENC-TT/MENC-CRM | Children primovacccinated with two MenC-TT vaccine doses and primed with MenC-CRM vaccine | 5 | 89 | 1 | 89 |
| EG002 | MENC-CRM/MENC-TT | Children Primed with three doses of MenC-CRM vaccine and boosted with MenC-TT | 2 | 109 | 6 | 109 |
| EG003 | MENC-CRM/MENC-CRM | Children primed with 3 doses of MenC-CRM vaccine, and boosted with MenC-CRM vaccine | 2 | 104 | 5 | 104 |
| cutaneous abscess | General disorders | Non-systematic Assessment |
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| ataxia | Nervous system disorders | Non-systematic Assessment |
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| pneumonia | Infections and infestations | Non-systematic Assessment |
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| Leishmaniasis | Infections and infestations | Non-systematic Assessment |
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| asthma | General disorders | Non-systematic Assessment |
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| gastroenteritis | Gastrointestinal disorders | Non-systematic Assessment |
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| hypoglycemia | Metabolism and nutrition disorders | Non-systematic Assessment |
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| fever | General disorders | Non-systematic Assessment |
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| fever | General disorders | Non-systematic Assessment |
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| urticaria | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| acropustulosis | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| D007239 | Infections |
| D009385 | Neoplastic Processes |
| D009369 | Neoplasms |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |