Skip to main content
OpenTrials
Completed

NCT Number: NCT00333450

Immune Memory Evaluation in Children Following a Primary Vaccination With Pneumococcal Conjugate Vaccines.

To evaluate the immunological memory against pneumococcal vaccine serotypes in children primed with conjugate vaccines by administering a booster dose of plain polysaccharide vaccine.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Infections, Streptococcal Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections Streptococcal Infections

Age range

11 month–14 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

GSK Investigational Site, Mannheim, Baden-Wurttemberg, Germany

Loading trial locations.

About this study

2 groups (60 per group), booster of Pneumovax 23 after priming with Prevnar or GSK Biologicals' pneumococcal vaccine.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion:

  • healthy children between 11-14 months old who received primary vaccination with Prevnar or GSK Biologicals' pneumococcal conjugate vaccine.

Exclusion:

  • children having received or planning to receive any investigational products, vaccines not foreseen in the protocol and immune modifying drugs;
  • children having received any additional pneumococcal vaccine than in the primary study;
  • children with any disease that affect the immune system and history of seizures and/or allergic disease.

Treatment and study plan

Pneumococcal vaccine

Biological

Primary outcomes

  1. Antibody concentrations against pneumococcal serotypes 1 month post-booster

Secondary outcomes

  1. Immunogenicity pre and post-booster and safety (follow up of SAEs)

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

Multicentre Immune Memory Study in Healthy Children Following a 3 Dose Primary Vaccination With Prevenar or GSK Biologicals' Pneumococcal Conjugate Vaccine Via the Administration of a Single Booster Dose of Pneumovax 23

Important dates

Study start
2006
Study completion
2006
First posted
Jun 5, 2006
Registry last updated
Oct 7, 2016

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.

Related clinical trials

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