Clinical Trials Logo
  1. Home
  2. Infections, Streptococcal
  3. NCT00333450
  4. Details
NCT00333450 Clinical Trial

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

Infections, Streptococcal Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00333450
Other study ID # 106623
Secondary ID
Status Completed
Phase Phase 3
First received June 2, 2006
Last updated October 6, 2016
Start date August 2006
Est. completion date December 2006

Study information
Verified date October 2016
Source GlaxoSmithKline
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical Devices
Study type Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility
Status Completed
Enrollment 120
Est. completion date December 2006
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 11 Months to 14 Months
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Biological:
• Pneumococcal vaccine

Locations
Country Name City State
Germany GSK Investigational Site Bad Oeynhausen Nordrhein-Westfalen
Germany GSK Investigational Site Berlin
Germany GSK Investigational Site Berlin
Germany GSK Investigational Site Berlin
Germany GSK Investigational Site Berlin
Germany GSK Investigational Site Berlin
Germany GSK Investigational Site Erkrath Nordrhein-Westfalen
Germany GSK Investigational Site Frankenthal Rheinland-Pfalz
Germany GSK Investigational Site Goch Nordrhein-Westfalen
Germany GSK Investigational Site Heiligenhaus Nordrhein-Westfalen
Germany GSK Investigational Site Leipzig Sachsen
Germany GSK Investigational Site Lobenstein Thueringen
Germany GSK Investigational Site Mainz Rheinland-Pfalz
Germany GSK Investigational Site Mannheim Baden-Wuerttemberg
Germany GSK Investigational Site Marbach Baden-Wuerttemberg
Germany GSK Investigational Site Minden Nordrhein-Westfalen
Germany GSK Investigational Site Moenchengladbach Nordrhein-Westfalen
Germany GSK Investigational Site Moenchengladbach Nordrhein-Westfalen
Germany GSK Investigational Site Muenster Nordrhein-Westfalen
Germany GSK Investigational Site Neuhaus am Rennweg Thueringen
Germany GSK Investigational Site Noerdlingen Bayern
Germany GSK Investigational Site Oberhausen Nordrhein-Westfalen
Germany GSK Investigational Site Rostock Mecklenburg-Vorpommern
Germany GSK Investigational Site Stollberg Sachsen
Germany GSK Investigational Site Trier Rheinland-Pfalz
Germany GSK Investigational Site Tutzing Bayern
Germany GSK Investigational Site Waren Mecklenburg-Vorpommern
Germany GSK Investigational Site Weimar Thueringen
Germany GSK Investigational Site Wiesbaden Hessen
Germany GSK Investigational Site Willich Nordrhein-Westfalen

Sponsors (1)
Lead Sponsor Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Knuf M, Pankow-Culot H, Grunert D, Rapp M, Panzer F, Köllges R, Fanic A, Habib A, Borys D, Dieussaert I, Schuerman L. Induction of immunologic memory following primary vaccination with the 10-valent pneumococcal nontypeable Haemophilus influenzae protein D conjugate vaccine in infants. Pediatr Infect Dis J. 2012 Jan;31(1):e31-6. doi: 10.1097/INF.0b013e3182323ac2. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Antibody concentrations against pneumococcal serotypes 1 month post-booster
Secondary Immunogenicity pre and post-booster and safety (follow up of SAEs)
See also
  Status Clinical Trial Phase
Completed NCT01641133 - Primary Vaccination With Either Synflorix™ or Prevenar 13™ or Both Vaccines and Booster Vaccination With Synflorix™ Phase 3
Completed NCT01204658 - Safety & Immunogenicity of Pneumococcal Vaccine 2189242A Co-administered With DTPa-HBV-IPV/Hib in Healthy Infants Phase 2
Completed NCT00370396 - Safety and Immunogenicity Study of a Booster Dose of GSK Biologicals' 10-valent Pneumococcal Conjugate Vaccine. Phase 3
Completed NCT02838407 - Identification and Characterization of Bacteria in the Lungs of Children From 6 Months up to 6 Years Old, With Suspected Infection of the Lungs, in Spain. N/A
Completed NCT00523770 - Exploratory Study in Healthy Elderly Subjects to Collect Urine for Development of Assays to Detect S. Pneumoniae N/A
Completed NCT00756067 - Evaluation of Pneumococcal Vaccine Formulations in Elderly Phase 1
Completed NCT00345358 - Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' 10-valent Pneumococcal Conjugate Vaccine Phase 3
Completed NCT01153893 - Immunization of Children Previously Primed With GSK Pneumococcal Vaccine GSK1024850A and of Unprimed Children in Nigeria Phase 3
Completed NCT00307541 - Assess the Immunogenicity of GSK Biologicals' 10-valent Pneumococcal Conjugate Vaccine Phase 3
Completed NCT00547248 - Pneumococcal Vaccine Booster Study in Healthy Children 12-18 Mths Old Previously Primed With the Same Vaccines Phase 3
Withdrawn NCT01160055 - Study to Characterize and Identify Bacteria Causing Acute Otitis Media in Young Egyptian Children N/A
Completed NCT00370227 - Safety and Immunogenicity Study of a Booster Dose of GSK Biologicals' 10-valent Pneumococcal Conjugate Vaccine Phase 3
Completed NCT00390910 - Study to Evaluate the Safety and Immunogenicity of a 10-valent Pneumococcal Conjugate Vaccine in Preterm Infants Phase 3
Completed NCT00985751 - Safety & Immunogenicity of Pneumococcal Vaccine 2189242A in Children Aged 12-23 Months at the Time of First Vaccination Phase 2
Withdrawn NCT01031329 - Study to Identify and Characterize Bacteria Causing Acute Otitis Media in Young Children in Turkey N/A
Completed NCT00307554 - A Lot-to-lot Consistency (3 Lots of GSK Biologicals' 10-valent Pneumococcal Conjugate Vaccine) & Non-inferiority Study Phase 3
Completed NCT02270944 - Safety and Immunogenicity of the Liquid Formulation of Group B Streptococcus Trivalent Vaccine and of the Lyophilized Formulation of Group B Streptococcus Trivalent Vaccine Phase 2
Completed NCT01235949 - Primary and Booster Vaccination Study With Pneumococcal Vaccine GSK1024850A and Prophylactic Antipyretic Treatment Phase 4
Completed NCT00985465 - Immunization of Children Previously Primed With GSK Pneumococcal Vaccine GSK1024850A and of Unprimed Children in Mali Phase 3
Completed NCT00861380 - Evaluation of Effectiveness of GSK Biologicals' Pneumococcal Conjugate Vaccine 1024850A Against Invasive Disease Phase 3

External Links