Last updated: 11/06/2020 12:10:04

Vaccination with GSK 1024850A in children primed with GSK 1024850A & boosted with Pneumovax 23™

GSK study ID
112807
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

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
Trial description: 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).
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:

Vaccine pneumococcal serotype antibody concentrations

Timeframe: Before (PRE) and one month after (POST) the additional dose

Secondary outcomes:

Opsonophagocytic activity against vaccine pneumococcal serotypes

Timeframe: Before (PRE) and one month after (POST) the additional dose

Cross-reactive pneumococcal serotype antibody concentrations

Timeframe: Before (PRE) and one month after (POST) the additional dose

Opsonophagocytic activity against cross-reactive pneumococcal serotypes

Timeframe: Before (PRE) and one month after (POST) the additional dose

Anti-protein D antibody concentrations

Timeframe: Before (PRE) and one month after (POST) the additional dose

Number of subjects reporting any and grade 3 solicited local symptoms

Timeframe: During the 8-day (Days 0-7) post-additional dose

Number of subjects with any, Grade 3 and related solicited general symptoms

Timeframe: During the 8-day (Days 0-7) post-additional dose

Number of subjects with unsolicited adverse events (AEs)

Timeframe: Within 31 days (Day 0-30) post-additional vaccination

Number of subjects with serious adverse events (SAEs)

Timeframe: Throughout the entire study period (approximately 1 month per subject)

Interventions:
Biological/vaccine: Pneumococcal conjugate vaccine GSK 1024850A
Biological/vaccine: Pneumococcal conjugate vaccine Prevenar™ (Wyeth Lederle’s)
Enrollment:
52
Observational study model:
Not applicable
Primary completion date:
2009-05-10
Time perspective:
Not applicable
Clinical 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. 31(1):31-36.
Medical condition
Infections, Streptococcal
Product
GSK1024850A
Collaborators
Not applicable
Study date(s)
June 2009 to October 2009
Type
Interventional
Phase
3

Participation criteria

Sex
Female & Male
Age
46 - 50 months
Accepts healthy volunteers
Yes
  • 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.
  • 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.

Trial location(s)

Location
Status
Contact us
Contact us
Location
GSK Investigational Site
Bad Oeynhausen, Nordrhein-Westfalen, Germany, 32549
Status
Study Complete
Location
GSK Investigational Site
Berlin, Berlin, Germany, 10315
Status
Study Complete
Location
GSK Investigational Site
Berlin, Berlin, Germany, 13055
Status
Study Complete
Location
GSK Investigational Site
Berlin, Berlin, Germany, 14197
Status
Study Complete
Location
GSK Investigational Site
Frankenthal, Rheinland-Pfalz, Germany, 67227
Status
Study Complete
Location
GSK Investigational Site
Goch, Nordrhein-Westfalen, Germany, 47574
Status
Study Complete
Location
GSK Investigational Site
Heiligenhaus, Nordrhein-Westfalen, Germany, 42579
Status
Study Complete
Location
GSK Investigational Site
Leipzig, Sachsen, Germany, 04178
Status
Study Complete
Location
GSK Investigational Site
Lobenstein, Thueringen, Germany, 07356
Status
Study Complete
Location
GSK Investigational Site
Mainz, Rheinland-Pfalz, Germany, 55131
Status
Study Complete
Location
GSK Investigational Site
Mannheim, Baden-Wuerttemberg, Germany, 68163
Status
Study Complete
Location
GSK Investigational Site
Moenchengladbach, Nordrhein-Westfalen, Germany, 41061
Status
Study Complete
Location
GSK Investigational Site
Moenchengladbach, Nordrhein-Westfalen, Germany, 41236
Status
Study Complete
Location
GSK Investigational Site
Neuhaus am Rennweg, Thueringen, Germany, 98724
Status
Study Complete
Location
GSK Investigational Site
Noerdlingen, Bayern, Germany, 86720
Status
Study Complete
Location
GSK Investigational Site
Weimar, Thueringen, Germany, 99425
Status
Study Complete
Location
GSK Investigational Site
Willich, Nordrhein-Westfalen, Germany, 47877
Status
Study Complete

Study documents

Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English

If you wish to request for full study report, please contact - [email protected]

Results overview

Results posted on ClinicalTrials.gov

Recruitment status
Completed
Actual primary completion date
2009-05-10
Actual study completion date
2009-05-10

Plain language summaries

Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

Additional information about the trial

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