Vaccination With GSK 1024850A in Children Primed With GSK 1024850A & Boosted With Pneumovax 23™

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00907777
First received: May 21, 2009
Last updated: January 19, 2012
Last verified: March 2011
  Purpose

The aim of this study is to assess the immune response, safety and reactogenicity following administration of an additional dose of a pneumococcal conjugate vaccine at approximately 4 years of age in children previously vaccinated with 3 primary doses of GSK 1024850A or Prevenar™ vaccine within the first 6 months of life and a booster dose of plain polysaccharide pneumococcal (Pneumovax 23™) vaccine at 11-14 months of age.

Antibody persistence will also be assessed at approximately 4 years of age in children previously vaccinated with 3 doses of either GSK 1024850A or Prevenar™ vaccine followed by a booster dose of Pneumovax 23™.

This protocol posting deals with objectives & outcome measures of the extension phase at year 4. The objectives & outcome measures of the primary phase are presented in a separate protocol posting (NCT 00307541). The objectives & outcome measures of the booster phase are presented in a separate protocol posting (NCT 00333450).


Condition Intervention Phase
Streptococcus Pneumoniae
Pneumococcal Disease
Haemophilus Influenzae Infections
Biological: Pneumococcal conjugate vaccine GSK 1024850A
Biological: Pneumococcal conjugate vaccine Prevenar™ (Wyeth Lederle's)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Vaccination With the Pneumococcal Vaccine GSK 1024850A or Prevenar™ at Approximately 4 Years of Age in Children Primed With 3 Doses of GSK 1024850A Vaccine or Prevenar™ and Boosted With 23-valent Pneumococcal Plain Polysaccharide Vaccine

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Immune response to components of the investigational pneumococcal conjugate vaccine [ Time Frame: One month after vaccination ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Immune response to components of the investigational pneumococcal conjugate vaccine for additional parameters [ Time Frame: One month after vaccination ] [ Designated as safety issue: No ]
  • Immune response to components of the investigational pneumococcal conjugate vaccine [ Time Frame: Prior to vaccination ] [ Designated as safety issue: No ]
  • Occurrence of solicited local and general adverse events. [ Time Frame: Within 8 days after each vaccination. ] [ Designated as safety issue: No ]
  • Occurrence of unsolicited adverse events. [ Time Frame: Within 31 days after each vaccination. ] [ Designated as safety issue: No ]
  • Occurrence of serious adverse events [ Time Frame: After vaccination up to study end ] [ Designated as safety issue: No ]

Enrollment: 52
Study Start Date: June 2009
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pn Group
Subjects receiving GSK 1024850A vaccine.
Biological: Pneumococcal conjugate vaccine GSK 1024850A
One dose of vaccine will be injected intramuscularly into the deltoid.
Active Comparator: Prev Group
Subjects receiving Prevenar™ vaccine.
Biological: Pneumococcal conjugate vaccine Prevenar™ (Wyeth Lederle's)
One dose of vaccine will be injected intramuscularly into the deltoid.

  Eligibility

Ages Eligible for Study:   46 Months to 50 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male or female between, and including, 46-50 months of age at the time of vaccination.
  • Subjects for whom the investigator believes that their parents/guardians can and will comply with the requirements of the protocol.
  • Subjects who previously participated in study NCT00333450 in centres with more than 2 subjects and received a booster dose of Pneumovax 23™.
  • Written informed consent obtained from both parents/guardians of the subject.
  • Healthy subjects as established by medical history and clinical examination before entering into the study.

Exclusion Criteria:

  • Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the vaccination, or planned use during the study period.
  • Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the vaccination.
  • Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting one month before study vaccination and during the entire study period.
  • Administration of any pneumococcal vaccine since the end of study NCT00333450.
  • Administration of immunoglobulins and/or any blood products less than 3 months prior to the vaccination or planned use during the study period.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical
  • History of any neurologic disorders or seizures
  • Anaphylactic reaction following previous administration of the vaccine or history of reactions or allergic disease likely to be exacerbated by any component of the vaccine.
  • History of hypotonic-hyporesponsive episode after any previous vaccination.
  • Major congenital defects or serious chronic illness.
  • History of invasive pneumococcal diseases.
  • Acute disease at the time of vaccination
  • Rectal temperature >= 38.0°C or oral/axillary/tympanic temperature >= 37.5°C. A temperature greater than or equal to these cut-offs warrants deferral of the vaccination pending recovery of the subject.
  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: NCT00907777

Locations
Germany
GSK Investigational Site
Mannheim, Baden-Wuerttemberg, Germany, 68163
GSK Investigational Site
Noerdlingen, Bayern, Germany, 86720
GSK Investigational Site
Bad Oeynhausen, Nordrhein-Westfalen, Germany, 32549
GSK Investigational Site
Goch, Nordrhein-Westfalen, Germany, 47574
GSK Investigational Site
Heiligenhaus, Nordrhein-Westfalen, Germany, 42579
GSK Investigational Site
Moenchengladbach, Nordrhein-Westfalen, Germany, 41061
GSK Investigational Site
Moenchengladbach, Nordrhein-Westfalen, Germany, 41236
GSK Investigational Site
Willich, Nordrhein-Westfalen, Germany, 47877
GSK Investigational Site
Frankenthal, Rheinland-Pfalz, Germany, 67227
GSK Investigational Site
Mainz, Rheinland-Pfalz, Germany, 55131
GSK Investigational Site
Leipzig, Sachsen, Germany, 04178
GSK Investigational Site
Lobenstein, Thueringen, Germany, 07356
GSK Investigational Site
Neuhaus am Rennweg, Thueringen, Germany, 98724
GSK Investigational Site
Weimar, Thueringen, Germany, 99425
GSK Investigational Site
Berlin, Germany, 13055
GSK Investigational Site
Berlin, Germany, 10315
GSK Investigational Site
Berlin, Germany, 14197
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Publications:
Knuf M et al. (2011) 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. [Epub ahead of print].

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT00907777     History of Changes
Other Study ID Numbers: 112807
Study First Received: May 21, 2009
Last Updated: January 19, 2012
Health Authority: Germany: Paul-Ehrlich-Institut

Keywords provided by GlaxoSmithKline:
Haemophilus influenzae
Streptococcus pneumoniae
safety
Pneumococcal conjugate vaccine
immunogenicity

Additional relevant MeSH terms:
Haemophilus Infections
Pneumonia
Bacterial Infections
Gram-Negative Bacterial Infections
Lung Diseases
Pasteurellaceae Infections
Respiratory Tract Diseases
Respiratory Tract Infections

ClinicalTrials.gov processed this record on October 20, 2014