Safety and Immunogenicity Study of a Booster Dose of GSK Biologicals' 10-valent Pneumococcal Conjugate Vaccine.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00370396
First received: August 30, 2006
Last updated: June 12, 2014
Last verified: June 2012
  Purpose

This study will evaluate the safety, reactogenicity and immunogenicity of a booster dose of GSK Biologicals' pneumococcal conjugate vaccine compared to Prevenar™ given at 12-18 mo of age to children primed with either pneumococcal vaccine or Prevenar™ in study 105553. Antibody persistence will be evaluated at 8-14 mo after completion of the 3-dose immunization course in study 105553. The immune response to a booster dose of GSK Biologicals' pneumococcal conjugate vaccine will also be evaluated when given at 12-18 mo to subjects not primed with GSK Biologicals' vaccine but with Prevenar™.

The study has 3 groups. 1 group of children primed with GSK Biologicals' pneumococcal conjugate vaccine will receive a booster dose of the same vaccine. 2nd group of children primed with Prevenar™ will receive a booster dose of Prevenar™ (control group). 3rd group of children primed with Prevenar™ will receive a booster dose of GSK Biologicals' pneumococcal conjugate vaccine. All children will receive concomitantly a booster dose of DTPa-HBV-IPV/Hib vaccine.


Condition Intervention Phase
Infections, Streptococcal
Biological: 10 valent pneumococcal conjugate (vaccine)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Prevention
Official Title: To Assess the Safety, Reactogenicity & Immunogenicity of a 4th Dose of GSK Biologicals' Pneumococcal Vaccine or Prevenar™ in Children (12-18 mo) Previously Vaccinated in the Primary Study 105553 With Either Pneumococcal Vaccine or Prevenar™

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Post vacc: rectal fever >39°C

Secondary Outcome Measures:
  • Solicited/unsolicited AEs (4/31 days post vacc), SAEs (up to 6 mo post vacc); 1 mo post vacc: Ab conc to all vaccines antigens.

Estimated Enrollment: 1200
Study Start Date: September 2006
Intervention Details:
    Biological: 10 valent pneumococcal conjugate (vaccine)
    Other Name: 10 valent pneumococcal conjugate (vaccine)
  Eligibility

Ages Eligible for Study:   12 Months to 18 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • a healthy male or female, 12 to 18 months of age at the time of vaccination, who received at least one dose of either pneumococcal conjugate vaccine or Prevenar™ during study 105553 and with written informed consent obtained from the parent/guardian of the subject.

Exclusion Criteria:

  • use of any investigational or non-registered drug or vaccine other than the study vaccine within 30 days preceding the vaccination, or planned use during the entire study period (active phase and safety follow-up).
  • Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting one month before vaccination up to Visit 2.
  • Administration of any additional pneumococcal vaccine or DTPa-combined vaccine since end of study 105553. Children with a history of seizures or neurological disease, allergic disease, immunosuppressive or immunodeficient condition.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00370396

Locations
Finland
GSK Investigational Site
Espoo, Finland, 02100
GSK Investigational Site
Helsinki, Finland, 00930
GSK Investigational Site
Helsinki, Finland, 00100
GSK Investigational Site
Jarvenpaa, Finland, 04400
GSK Investigational Site
Jyväskylä, Finland, 40100
GSK Investigational Site
Kokkola, Finland, 67100
GSK Investigational Site
Kotka, Finland, 48600
GSK Investigational Site
Kuopio, Finland, 70100
GSK Investigational Site
Lahti, Finland, 15140
GSK Investigational Site
Oulu, Finland, 90100
GSK Investigational Site
Pori, Finland, 28120
GSK Investigational Site
Seinajoki, Finland, 60100
GSK Investigational Site
Tampere, Finland, 33200
GSK Investigational Site
Turku, Finland, 20520
GSK Investigational Site
Vantaa, Finland, 01300
GSK Investigational Site
Vantaa, Finland, 01600
France
GSK Investigational Site
Bernay, France, 27300
GSK Investigational Site
Colombes, France, 92701
GSK Investigational Site
Courbevoie, France, 92400
GSK Investigational Site
Créteil, France, 94000
GSK Investigational Site
Dax, France, 40100
GSK Investigational Site
Draguignan, France, 83300
GSK Investigational Site
Essey les Nancy, France, 54270
GSK Investigational Site
Le Havre, France, 76600
GSK Investigational Site
Maromme, France, 76150
GSK Investigational Site
Nice, France, 06300
GSK Investigational Site
Nogent-sur-Marne, France, 94130
GSK Investigational Site
Paris, France, 75019
GSK Investigational Site
Rouen, France, 76000
GSK Investigational Site
Saint Quentin, France, 02100
Poland
GSK Investigational Site
Bydgoszcz, Poland, 85-021
GSK Investigational Site
Debica, Poland, 39-200
GSK Investigational Site
Krakow, Poland, 31-202
GSK Investigational Site
Olesnica, Poland, 56-400
GSK Investigational Site
Poznan, Poland, 61-709
GSK Investigational Site
Siemianowice Slaskie, Poland, 41-103
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Publications:
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00370396     History of Changes
Other Study ID Numbers: 107046
Study First Received: August 30, 2006
Last Updated: June 12, 2014
Health Authority: Finland: Finnish Medicines Agency

Keywords provided by GlaxoSmithKline:
Streptococcus pneumonia, pneumococcal conjugate vaccine

Additional relevant MeSH terms:
Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on September 18, 2014