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 Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- GlaxoSmithKline
- Enrollment
- 52
- Locations
- 18
- Primary Endpoint
- Vaccine Pneumococcal Serotype Antibody Concentrations
Study Overview
Brief Summary
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 46 Months to 50 Months (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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 NCT
- •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.
Outcomes
Primary Outcomes
Vaccine Pneumococcal Serotype Antibody Concentrations
Time Frame: Before (PRE) and one month after (POST) the additional dose
The anti-pneumococcal antibody concentration cut-off value assessed was greater than or equal to ≥ 0.05 microgram per milliliter (μg/mL). The vaccine pneumococcal serotypes assessed include 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, and 23F.
Secondary Outcomes
- Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes(Before (PRE) and one month after (POST) the additional dose)
- Cross-reactive Pneumococcal Serotype Antibody Concentrations(Before (PRE) and one month after (POST) the additional dose)
- Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms(During the 8-day (Days 0-7) post-additional dose)
- Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms(During the 8-day (Days 0-7) post-additional dose)
- Number of Subjects With Unsolicited Adverse Events (AEs)(Within 31 days (Day 0-30) post-additional vaccination)
- Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes(Before (PRE) and one month after (POST) the additional dose)
- Anti-protein D Antibody Concentrations(Before (PRE) and one month after (POST) the additional dose)
- Number of Subjects With Serious Adverse Events (SAEs)(Throughout the entire study period (approximately 1 month per subject))