Last updated: 11/06/2020 12:10:04
Vaccination with GSK 1024850A in children primed with GSK 1024850A & boosted with Pneumovax 23™
EudraCT ID
EU CT Number
Not applicable
Trial status
Study complete
Study complete
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:
Enrollment:
52
Primary completion date:
2009-05-10
Observational study model:
Not applicable
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.
Inclusion and exclusion criteria
Inclusion criteria:
- 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.
Male or female between, and including, 46-50 months of age at the time of vaccination.
Exclusion criteria:
- 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.
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.
Trial location(s)
Location
GSK Investigational Site
Bad Oeynhausen, Nordrhein-Westfalen, Germany, 32549
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
Showing 1 - 6 of 17 Results
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
Study complete
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.
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