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OpenTrials
Completed

NCT Number: NCT00316654

Persistence of Antibody Response to N. Meningitidis Group C in Children

Persistence of Antibody Response to N. meningitidis Group C in Children

Completed

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Key information

Conditions

Prevention of Meningococcal Infection

Age range

7 month and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Olsztyn, Lubartów, Kielce, Kraków, Bydgoszcz, Poland

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • healthy children

Exclusion criteria

  • previous ascertained or suspected disease caused by N. meningitidis
  • previous significant acute or chronic infections
  • any other serious disease

Treatment and study plan

Meningococcal C conjugate vaccine

Biological

Primary outcomes

  1. Immunogenicity: serum antibody responses, as measured by bactericidal activity,using hBCA

Secondary outcomes

  1. Evaluate and compare persistence of antibody response to N. meningitidis serogroup C as measured by serum bactericidal activity

  2. safety and tolerability

Sponsors and collaborators

Lead sponsor

Novartis Vaccines

Industry

Collaborators

  • GlaxoSmithKline

Registry information

Official study title

A Phase IV,Multi-Center,Open-Label,Unrandomized Study to Evaluate the Persistence of Antibody Response to N.Meningitidis Group C,Before & After 2 Doses of the Conjugate Pneumococcal Vaccine,in Children Seven Months & Older Who Previously Received Immunization With Chiron Meningococcal C Conjugate Vaccine & a Hexavalent Infant Vaccine According to the Applicable Infant Immunization Schedule

Important dates

Study start
2005
Primary completion
2005
Study completion
2005
First posted
Apr 21, 2006
Registry last updated
Jul 25, 2017

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.

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