Clinical trial NCT00392808: Immunogenicity of the Booster Dose of Two MenC Vaccines
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Meningococcal Infection
Keywords: Meningococcal vaccine
Immunization, secondary
vaccines conjugated
Meningococcal disease
Lead sponsor: Centro Superior de Investigación en Salud Publica
Sponsor class: OTHER_GOV
First posted: 2006-10-26
Enrollment: 389
Sex: ALL
Minimum age (years): 14
Maximum age (years): 19
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Serum Bactericidal Activity Against MenC
timeFrame: One month after booster dose
measure: Serum Antibody Titers Against Haemophilus Influenzae Type b.
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Universidad Rey Juan Carlos I
city: Valencia
country: Spain
facility: Centro Superior Investigación en Salud Publica
Study officials:
affiliation: Centro Superior Investigacion Salud Publica (CSISP)
name: Javier Diez-Domingo, PhD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.