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

August 6, 2013 updated by: Centro Superior de Investigación en Salud Publica

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

389

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Madrid, Spain, 28922
        • Universidad Rey Juan Carlos I
      • Valencia, Spain, 46020
        • Centro Superior Investigación en Salud Publica

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 1 year (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Serum Bactericidal Activity Against MenC
Time Frame: One month after booster dose
One month after booster dose
Serum Antibody Titers Against Haemophilus Influenzae Type b.
Time Frame: One year
One year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centro Superior de Investigación en Salud Publica

Investigators

  • Study Chair: Javier Diez-Domingo, PhD, Centro Superior Investigacion Salud Publica (CSISP)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Primary Completion (Actual)

May 1, 2008

Study Completion (Actual)

May 1, 2009

Study Registration Dates

First Submitted

October 25, 2006

First Submitted That Met QC Criteria

October 25, 2006

First Posted (Estimate)

October 26, 2006

Study Record Updates

Last Update Posted (Estimate)

October 11, 2013

Last Update Submitted That Met QC Criteria

August 6, 2013

Last Verified

August 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CSISP-VAC-MENC1
  • EUDRA 2006-003525-82

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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