Last updated: 07/17/2024 15:14:30

Pneumococcal Vaccine Booster Study in Healthy Children 11-18 Months Old Previously Primed With the Same Vaccines

GSK study ID
109507
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: Booster Vaccination With Pneumococcal Vaccine GSK1024850A, a DTPa-Combined and MenC or Hib-MenC Vaccines
Trial description: The purpose of this study is to assess the safety in terms of fever (rectal temperature) higher than 39 degree Celcius (°C) and the immunogenicity in terms of antibody response following a booster vaccination with pneumococcal vaccine GSK1024850A at 11 to 18 months of age in children previously primed with the same vaccines including a pneumococcal conjugate vaccine co-administered with a diphtheria, tetanus, acellular pertussis (DTPa)-combined and meningococcal serogroup C (MenC) or combined meningococcal serogroup C and Haemophilus influenzae type b (Hib-MenC) vaccine.
This protocol posting deals with objectives & outcome measures of the booster phase. The objectives & outcome measures of the primary phase are presented in a separate protocol posting (NCT number = NCT00334334).
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:

Number of subjects reporting fever above 39.0 degree Celsius (°C)

Timeframe: During the 4-day (Day 0-3) period after the booster vaccination

Secondary outcomes:

Number of subjects reporting solicited local symptoms

Timeframe: During the 4-day (Day 0-3) period after the booster vaccination

Number of subjects reporting solicited general symptoms

Timeframe: During the 4-day (Day 0-3) period after the booster vaccination

Number of subjects reporting unsolicited adverse events (AE)

Timeframe: During the 31-day (Day 0-30) period after the booster vaccination

Number of subjects reporting serious adverse events (SAE)

Timeframe: During the 31-day (Day 0-30) period after the booster vaccination

Number of subjects reporting serious adverse events (SAE)

Timeframe: From the beginning of the study up to the end of the extended 6-month safety follow-up period

Number of subjects with vaccine pneumococcal serotype antibody concentrations above the cut-off value

Timeframe: Before (pre) and one month after (post) the booster administration

Number of subjects with opsonophagocytic activity against vaccine pneumococcal serotypes above the cut-off value

Timeframe: Before (pre) and one month after (post) the booster administration

Number of subjects with cross-reactive pneumococcal serotype antibody concentrations above the cut-off value

Timeframe: Before (pre) and one month after (post) the booster administration

Number of subjects with opsonophagocytic activity against cross-reactive pneumococcal serotypes above the cut-off value

Timeframe: Before (pre) and one month after (post) the booster administration

Number of subjects with anti-protein D antibody concentrations above the cut-off value

Timeframe: Before (pre) and one month after (post) the booster administration

Number of subjects with meningococcal serogroup C serum bactericidal assay titer above the cut-off value

Timeframe: Before (pre) and one month after (post) the booster administration

Number of subjects with anti-meningococcal polysaccharide C antibody concentrations above the cut-off value

Timeframe: Before (pre) and one month after (post) the booster administration

Number of subjects with anti-polyribosyl-ribitol phosphate antibody concentrations above the cut-off value

Timeframe: Before (pre) and one month after (post) the booster administration

Interventions:
Biological/vaccine: Pneumococcal conjugate vaccine GSK1024850A
Biological/vaccine: Prevenar
Biological/vaccine: Infanrix hexa
Biological/vaccine: Infanrix IPV Hib
Biological/vaccine: Infanrix penta
Biological/vaccine: Infanrix IPV
Biological/vaccine: Meningitec
Biological/vaccine: NeisVac-C
Biological/vaccine: Menitorix
Enrollment:
1437
Observational study model:
Not applicable
Primary completion date:
2008-21-01
Time perspective:
Not applicable
Clinical publications:
Chevallier B et al. (2009) Safety and reactogenicity of the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) when coadministered with routine childhood vaccines. Pediatr Infect Dis J. 28(4 Suppl):S109-S118.
Knuf M et al. (2009) Immunogenicity of routinely used childhood vaccines when coadministered with the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV). Pediatr Infect Dis J. 28(4 Suppl):S97-S108.
Wysocki J et al. (2009) Immunogenicity of the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) when coadministered with different neisseria meningitidis serogroup C conjugate vaccines. Pediatr Infect Dis J. 28(4 Suppl):S77-88.
Silfverdal SA et al. (2016) Safety profile of the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV). Expert Rev Vaccines. [Epub ahead of print]
Medical condition
Hepatitis B, acellular pertussis, Tetanus, Poliomyelitis, Diphtheria, Streptococcus pneumoniae Vaccines
Product
GSK1024850A
Collaborators
Not applicable
Study date(s)
April 2007 to June 2008
Type
Interventional
Phase
3

Participation criteria

Sex
Female & Male
Age
11 - 18 months
Accepts healthy volunteers
Yes
  • Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol.
  • A male or female between, and including, 11-18 months of age at the time of the booster vaccination.
  • Concurrently participating in another clinical study, at any time during the study period (active phase and extended safety follow-up), in which the subject has been or will be exposed to an investigational or a non-investigational product.
  • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within one month preceding the booster dose of study vaccines, or planned use during the entire study period

Trial location(s)

Location
Status
Contact us
Contact us
Location
GSK Investigational Site
Valladolid, Spain, 47010
Status
Study Complete
Location
GSK Investigational Site
Tona/Barcelona, Spain, 08551
Status
Study Complete
Location
GSK Investigational Site
Worms, Rheinland-Pfalz, Germany, 67547
Status
Study Complete
Location
GSK Investigational Site
Loehne, Nordrhein-Westfalen, Germany, 32584
Status
Study Complete
Location
GSK Investigational Site
Vélez-Málaga / Málaga, Spain, 29700
Status
Study Complete
Location
GSK Investigational Site
Bretten, Baden-Wuerttemberg, Germany, 75015
Status
Study Complete
Location
GSK Investigational Site
Olching, Bayern, Germany, 82140
Status
Study Complete
Location
GSK Investigational Site
Mannheim, Baden-Wuerttemberg, Germany, 68167
Status
Study Complete
Location
GSK Investigational Site
Ettenheim, Baden-Wuerttemberg, Germany, 77955
Status
Study Complete
Location
GSK Investigational Site
Karlsruhe, Baden-Wuerttemberg, Germany, 76189
Status
Study Complete
Location
GSK Investigational Site
Blanes (Girona), Spain, 17300
Status
Study Complete
Location
GSK Investigational Site
Bad Saulgau, Baden-Wuerttemberg, Germany, 88348
Status
Study Complete
Location
GSK Investigational Site
Gerolstein, Rheinland-Pfalz, Germany, 54568
Status
Study Complete
Location
GSK Investigational Site
Berlin, Berlin, Germany, 10967
Status
Study Complete
Location
GSK Investigational Site
Debica, Poland, 39-200
Status
Study Complete
Location
GSK Investigational Site
Berlin, Berlin, Germany, 12679
Status
Study Complete
Location
GSK Investigational Site
Lobenstein, Thueringen, Germany, 07356
Status
Study Complete
Location
GSK Investigational Site
Niedernhausen, Hessen, Germany, 65527
Status
Study Complete
Location
GSK Investigational Site
Berlin, Berlin, Germany, 12627
Status
Study Complete
Location
GSK Investigational Site
Montgat/Barcelona, Spain, 08390
Status
Study Complete
Location
GSK Investigational Site
Siemianowice Slaskie, Poland, 41-103
Status
Study Complete
Location
GSK Investigational Site
Marid, Spain, 28040
Status
Study Complete
Location
GSK Investigational Site
Berlin, Berlin, Germany, 14197
Status
Study Complete
Location
GSK Investigational Site
Muenchen, Bayern, Germany, 81735
Status
Study Complete
Location
GSK Investigational Site
Madrid, Spain, 28035
Status
Study Complete
Location
GSK Investigational Site
Tarnow, Poland, 33-100
Status
Study Complete
Location
GSK Investigational Site
Cham, Bayern, Germany, 93413
Status
Study Complete
Location
GSK Investigational Site
Trier, Rheinland-Pfalz, Germany, 54290
Status
Study Complete
Location
GSK Investigational Site
Madrid, Spain, 28047
Status
Study Complete
Location
GSK Investigational Site
Trier, Rheinland-Pfalz, Germany, 54294
Status
Study Complete
Location
GSK Investigational Site
Frankenthal, Rheinland-Pfalz, Germany, 67227
Status
Study Complete
Location
GSK Investigational Site
Mainz, Rheinland-Pfalz, Germany, 55131
Status
Study Complete
Location
GSK Investigational Site
Tettnang, Baden-Wuerttemberg, Germany, 88069
Status
Study Complete
Location
GSK Investigational Site
Kehl, Baden-Wuerttemberg, Germany, 77694
Status
Study Complete
Location
GSK Investigational Site
Bodenheim, Rheinland-Pfalz, Germany, 55294
Status
Study Complete
Location
GSK Investigational Site
Schwaebisch-Hall, Baden-Wuerttemberg, Germany, 74523
Status
Study Complete
Location
GSK Investigational Site
Stuttgart, Baden-Wuerttemberg, Germany, 70469
Status
Study Complete
Location
GSK Investigational Site
Burgos, Spain, 09005
Status
Study Complete
Location
GSK Investigational Site
Muenster, Nordrhein-Westfalen, Germany, 48163
Status
Study Complete
Location
GSK Investigational Site
Bad Kreuznach, Rheinland-Pfalz, Germany, 55543
Status
Study Complete
Location
GSK Investigational Site
Berlin, Berlin, Germany, 10315
Status
Study Complete
Location
GSK Investigational Site
Boennigheim, Baden-Wuerttemberg, Germany, 74357
Status
Study Complete
Location
GSK Investigational Site
Weimar, Thueringen, Germany, 99425
Status
Study Complete
Location
GSK Investigational Site
Sant Vicenç dels Horts /Barcelona, Spain, 08620
Status
Study Complete
Location
GSK Investigational Site
Poznan, Poland, 61-709
Status
Study Complete
Location
GSK Investigational Site
Noerdlingen, Bayern, Germany, 86720
Status
Study Complete
Location
GSK Investigational Site
Hille, Nordrhein-Westfalen, Germany, 32479
Status
Study Complete
Location
GSK Investigational Site
Eschwege, Hessen, Germany, 37269
Status
Study Complete
Location
GSK Investigational Site
Bydgoszcz, Poland, 85-021
Status
Study Complete
Location
GSK Investigational Site
Porta Westfalica, Nordrhein-Westfalen, Germany, 32457
Status
Study Complete
Location
GSK Investigational Site
Krakow, Poland
Status
Study Complete
Location
GSK Investigational Site
Roding, Bayern, Germany, 93426
Status
Study Complete
Location
GSK Investigational Site
Málaga, Spain, 29011
Status
Study Complete
Location
GSK Investigational Site
Móstoles/Madrid, Spain, 28935
Status
Study Complete
Location
GSK Investigational Site
Singwitz, Sachsen, Germany, 02692
Status
Study Complete
Location
GSK Investigational Site
Oberstenfeld, Baden-Wuerttemberg, Germany, 71720
Status
Study Complete
Location
GSK Investigational Site
Wolfenbuettel, Niedersachsen, Germany, 38302
Status
Study Complete
Location
GSK Investigational Site
Wola, Poland, 43-225
Status
Study Complete
Location
GSK Investigational Site
Doebeln, Sachsen, Germany, 04720
Status
Study Complete
Location
GSK Investigational Site
Muenchen, Bayern, Germany, 81675
Status
Study Complete
Location
GSK Investigational Site
Bilbao, Spain, 48013
Status
Study Complete
Location
GSK Investigational Site
Berlin, Berlin, Germany, 13355
Status
Study Complete
Location
GSK Investigational Site
Madrid, Spain, 28034
Status
Study Complete
Location
GSK Investigational Site
Herford, Nordrhein-Westfalen, Germany, 32049
Status
Terminated/Withdrawn

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
2008-21-01
Actual study completion date
2008-14-06

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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