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Immunogenicity of the Booster Dose of Two MenC Vaccines (CSISP-MENC1)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Centro Superior de Investigación en Salud Publica
ClinicalTrials.gov Identifier:
NCT00392808
First received: October 25, 2006
Last updated: August 6, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention Phase
Meningococcal Infection
Biological: conjugated polysaccharide menC vaccine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
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.

Resource links provided by NLM:


Further study details as provided by Centro Superior de Investigación en Salud Publica:

Primary Outcome Measures:
  • Serum Bactericidal Activity Against MenC [ Time Frame: One month after booster dose ] [ Designated as safety issue: No ]
  • Serum Antibody Titers Against Haemophilus Influenzae Type b. [ Time Frame: One year ] [ Designated as safety issue: No ]

Enrollment: 389
Study Start Date: January 2007
Study Completion Date: May 2009
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MENC-CRM/MENC-CRM
Children primed with 3 doses of MenC-CRM vaccine, Intervention: boosted with one dose of MenC-CRM vaccine
Biological: conjugated polysaccharide menC vaccine
Booster vaccine dose at 14 to 18 months.
Experimental: MENC-CRM/MENC-TT
Children Primed with three doses of MenC-CRM vaccine. Intervention: boosted with one dose of MenC-TT
Biological: conjugated polysaccharide menC vaccine
Booster vaccine dose at 14 to 18 months.
Experimental: MENC-TT/MENC-CRM
Children primovacccinated with two MenC-TT vaccine doses. Intervention: boosted with one dose MenC-CRM vaccine
Biological: conjugated polysaccharide menC vaccine
Booster vaccine dose at 14 to 18 months.
Experimental: MENC-TT/MENC-TT
Children primovacccinated with two MenC-TT vaccine doses. Intervention boosted with one dose MenC-TT vaccine
Biological: conjugated polysaccharide menC vaccine
Booster vaccine dose at 14 to 18 months.

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

Ages Eligible for Study:   14 Months to 19 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00392808

Locations
Spain
Universidad Rey Juan Carlos I
Madrid, Spain, 28922
Centro Superior Investigación en Salud Publica
Valencia, Spain, 46020
Sponsors and Collaborators
Centro Superior de Investigación en Salud Publica
Investigators
Study Chair: Javier Diez-Domingo, PhD Centro Superior Investigacion Salud Publica (CSISP)
  More Information

Publications:
Responsible Party: Centro Superior de Investigación en Salud Publica
ClinicalTrials.gov Identifier: NCT00392808     History of Changes
Other Study ID Numbers: CSISP-VAC-MENC1, EUDRA 2006-003525-82
Study First Received: October 25, 2006
Results First Received: August 6, 2013
Last Updated: August 6, 2013
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by Centro Superior de Investigación en Salud Publica:
Meningococcal vaccine
Immunization, secondary
vaccines conjugated
Meningococcal disease

Additional relevant MeSH terms:
Meningococcal Infections
Bacterial Infections
Gram-Negative Bacterial Infections
Neisseriaceae Infections

ClinicalTrials.gov processed this record on November 25, 2014