Clinical trial · Interventional
Immunogenicity of the Booster Dose of Two MenC Vaccines
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.
NCT00392808CI-TRIAL-00012375CSISP-MENC1completedPhase 4Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Meningococcal Infection | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| conjugated polysaccharide menC vaccine | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- MENC-CRM/MENC-CRM
- description
- Children primed with 3 doses of MenC-CRM vaccine, Intervention: boosted with one dose of MenC-CRM vaccine
- interventionNames
- Biological: conjugated polysaccharide menC vaccine
- type
- EXPERIMENTAL
- label
- MENC-CRM/MENC-TT
- description
- Children Primed with three doses of MenC-CRM vaccine. Intervention: boosted with one dose of MenC-TT
- interventionNames
- Biological: conjugated polysaccharide menC vaccine
- type
- EXPERIMENTAL
- label
- MENC-TT/MENC-CRM
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 14 Months
- Maximum age
- 19 Months
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * 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. * 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.
References
Publications (2)
- RESULTDiez-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. PMID 20375851
- RESULTDiez-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. PMID 19927040