Phase 3
Completed N=52
Vaccination With GSK 1024850A in Children Primed With GSK 1024850A & Boosted With Pneumovax 23™
Infections, Streptococcal · Streptococcus pneumoniae
Source: ClinicalTrials.gov NCT00907777 ↗
Enrolled (actual)
52
Serious AEs
0.0%
Results posted
Jan 2017
Primary outcomePrimary: Vaccine Pneumococcal Serotype Antibody Concentrations — 0.14; 0.38; 0.16; 1.35 μg/mL
◆ Published Evidence
Not yet cited
0citations
Induction of immunologic memory following primary vaccination with the 10-valent pneumococcal nontypeable Haemophilus influenzae protein D conjugate vaccine in infants.
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).
Linked Publications
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Induction of immunologic memory following primary vaccination with the 10-valent pneumococcal nontypeable Haemophilus influenzae protein D conjugate vaccine in infants.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Vaccine Pneumococcal Serotype Antibody Concentrations |
0.14; 0.38; 0.16; 1.35; 0.27; 0.12 | — |
| SECONDARY Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes |
4; 5.8; 5.5; 49.3; 20.7; 12.3 | — |
| SECONDARY Cross-reactive Pneumococcal Serotype Antibody Concentrations |
0.22; 0.19; 1.78; 0.47; 0.39; 0.29 | — |
| SECONDARY Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes |
106.9; 117.7; 2320.4; 966.2; 10.4; 19.6 | — |
| SECONDARY Anti-protein D Antibody Concentrations |
104.1; 173.1; 85.9; 1135.6 | — |
| SECONDARY Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms |
11; 16; 0; 2; 13; 14 | — |
| SECONDARY Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms |
4; 12; 0; 1; 0; 8 | — |
| SECONDARY Number of Subjects With Unsolicited Adverse Events (AEs) |
8; 6 | — |
| SECONDARY Number of Subjects With Serious Adverse Events (SAEs) |
0; 0 | — |
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT00907777) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.