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OpenTrials
Completed

NCT Number: NCT00311415

Immunogenicity, Safety, Tolerability and Ability to Prime for Memory of Meningococcal C Conjugate Vaccine in Healthy Children

Immunogenicity, Safety, Tolerability and Ability to Prime for Memory of Meningococcal C Conjugate Vaccine in healthy children

Completed

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Key information

Conditions

Prevention of Meningococcal Infection

Age range

7 week–16 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Mainz, Kehl, Neumünster, Ettenheim, Germany

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About this study

The aim of this study is to investigate the immunogenicity offered by MenCC vaccine when administered in different schedules at different years of life: 2 doses in the first year of life given 2 months apart (at 2 and 4 months of age), with a booster in the second year of life, or 1 dose in the first year of life (at 2 or 6 months of age), with a booster in the second year of life, or only 1 dose in the second year of life.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • healthy infants

Exclusion criteria

  • known hypersensitivity to any vaccine component
  • significant acute or chronic infections
  • previously ascertained or suspected disease caused by N. meningitidis
  • previous household contact with an individual with a positive culture of N. meningitidis serogroup C

Treatment and study plan

Meningococcal C conjugate vaccine

Biological

Meningococcal conjugate vaccine, active comparator.

Groups 1 to 3 were given a booster dose in the second year of life at 12-16 months of age

Primary outcomes

  1. Demonstration of non-inferiority of memory antibody response after 1 dose of MenC Vaccine administered to healthy infants at 2 to 6 months of age and as first, second or third dose in the second year of life,as measured by rBCA.

    Time frame: Overall study period

Secondary outcomes

  1. Evaluation and comparison of antibody response and its persistence in terms of GMT and percent responders, as measured by rBCA.

    Time frame: Overall study period

Sponsors and collaborators

Lead sponsor

Novartis Vaccines

Industry

Registry information

Official study title

A Phase III, Multi-Center, Open-Label, Controlled, Randomized Study to Evaluate the Immunogenicity, Safety, Tolerability and the Ability to Prime for Memory of Chiron Meningococcal C Conjugate Vaccine When Administered to Healthy Infants as One Dose Given at 2 or 6 Months of Age With a Booster at 12-16 Months of Age, in Comparison to Two Doses in the First Year of Life, Given Two Months Apart, With a Booster at 12-16 Months of Age; and in Comparison to One Dose Given at 12-16 Months of Age

Important dates

Study start
2005
Primary completion
2008
Study completion
2008
First posted
Apr 6, 2006
Registry last updated
Feb 8, 2012

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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