Immunogenicity of the Booster Dose of Two MenC Vaccines

Meningococcal Infection Clinical Trial

— CSISP-MENC1  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00392808
• Other study ID #: CSISP-VAC-MENC1
• Secondary ID: EUDRA 2006-00352
• Status: Completed
• Phase: Phase 4
• First received: October 25, 2006
• Last updated: August 6, 2013
• Start date: January 2007
• Est. completion date: May 2009

Study information

• Verified date: August 2013
• Source: Centro Superior de Investigación en Salud Publica
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 389
• Est. completion date: May 2009
• Est. primary completion date: May 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 14 Months to 19 Months

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Meningococcal Infection
• Meningococcal Infections

Intervention

Biological:
• conjugated polysaccharide menC vaccine
Booster vaccine dose at 14 to 18 months.

Locations

Country	Name	City	State
Spain	Universidad Rey Juan Carlos I	Madrid
Spain	Centro Superior Investigación en Salud Publica	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
Centro Superior de Investigación en Salud Publica

Country where clinical trial is conducted

Spain, 

References & Publications (2)

Díez-Domingo J, Cantarino MV, Torrentí JM, Sansano MI, Rosich AJ, Merino AH, de Miguel AG, González JB, Marcos MD; MenC Study Group. A randomized, multicenter, open-label clinical trial to assess the immunogenicity of a meningococcal C vaccine booster dos — View 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum Bactericidal Activity Against MenC		One month after booster dose	No
Primary	Serum Antibody Titers Against Haemophilus Influenzae Type b.		One year	No