Immunogenicity of the Booster Dose of Two MenC Vaccines - Full Text View

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:

MedlinePlus related topics: Meningococcal Infections

U.S. FDA Resources

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

Primary Outcome Measures:

Serum bactericidal activity against MenC [ Time Frame: One year ] [ 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, and boosted with 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 and boosted with 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 and primed with 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 and primed with 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

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

No publications provided

Responsible Party:	Centro Superior de Investigación en Salud Pública, CSISP
ClinicalTrials.gov Identifier:	NCT00392808 History of Changes
Other Study ID Numbers:	CSISP-VAC-MENC1, EUDRA 2006-003525-82
Study First Received:	October 25, 2006
Last Updated:	February 8, 2010
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
Neisseriaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on May 22, 2013

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