Immunogenicity of the Booster Dose of Two MenC Vaccines

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.

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Key information

Conditions

Meningococcal Infection Bacterial Infections Bacterial Infections and Mycoses Gram-Negative Bacterial Infections Infections Meningococcal Infections Neisseriaceae Infections Neoplasm Metastasis Neoplasms Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

14 month–19 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Universidad Rey Juan Carlos I, Madrid, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

conjugated polysaccharide menC vaccine

Biological

Booster vaccine dose at 14 to 18 months.

Primary outcomes

Serum Bactericidal Activity Against MenC

Time frame: One month after booster dose
Serum Antibody Titers Against Haemophilus Influenzae Type b.

Time frame: One year

Sponsors and collaborators

Lead sponsor

Centro Superior de Investigación en Salud Publica

Other Gov

Registry information

Official study 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.

Acronym: CSISP-MENC1

Important dates

Study start: 2007
Primary completion: 2008
Study completion: 2009
First posted: Oct 26, 2006
Registry last updated: Oct 11, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed