Active immunisation for the prevention of invasive disease, pneumonia and acute otitis media caused by Streptococcus pneumoniae in infants and children from 6 weeks to 5 years of age. MedDRA version: 12.1 Level: LLT Classification code 10042193 Term: Streptococcus pneumoniae acute exacerbation of chronic bronchitis MedDRA version: 12.1 Level: LLT Classification code 10042194 Term: Streptococcus pneumoniae meningitis MedDRA version: 12.1 Level: LLT Classification code 10042195 Term: Streptococ
Conditions
Sponsors
University of Oxford
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Participant completed the Wyeth-sponsored PCV13 infant trial study (6096A1-007) 2. Aged 39-44 months (inclusive) at time of enrolment. 3. Available for entire study period and whose parent/legal guardian can be reached by telephone. 4. Healthy children as determined by medical history, physical examination, done by a study nurse (and/or study doctor if required, depending on the medical history of the participant and physical assessment), and judgment of the investigator. 5. Parent/legal guardian must be able to complete all relevant study procedures during study participation. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Has received further doses of pneumococcal vaccination with licensed or investigational pneumococcal vaccine other than those given as part of the Wyeth-sponsored PCV13 infant trial study (6096A1-007). 2. A previous anaphylactic reaction to any vaccine or vaccine-related component. 3. Contraindication to vaccination with pneumococcal conjugate vaccine. 4. Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection. 5. Known or suspected immune deficiency or suppression. 6. History of culture-proven invasive disease caused by S pneumoniae. 7. Major known congenital malformation or serious chronic disorder. 8. Significant neurologic disorder or history of seizures including febrile seizure, or significant stable or evolving disorders such as cerebral palsy, encephalopathy, hydrocephalus, or other significant disorder. 9. Receipt of blood products or gamma-globulin (including hepatitis B immunoglobulin and monoclonal antibodies; eg, synagisB). 10. Participation in another investigational study other than the Wyeth-sponsored PCV13 infant trial study (6096A1-007). Participation in purely observational studies is acceptable. 11. Child who is a direct descendant (child, grandchild) of the study site personnel. 6.3.4 Temporary exclusion criteria 1. In the event of systemic illness or fever > 38 degrees centigrade at the time of the visit, immunisation will be deferred and rearranged as appropriate when the participant is recovered. 2. Any live immunisation within 28 days prior to enrolment, or any other (non-live) vaccine within the 7 days prior to enrolment.Any immunisation within 28 days of enrolment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the proportion of participants, immunised with the 13-valent pneumococcal conjugate vaccine (PCV13) at 2, 4 and 12 months of age, who have IgG concentrations = 0.35mcg/ml for PCV13 serotypes at the time when preschool booster vaccinations are due (approximately at 40 months of age).;Secondary Objective: To assess the proportion of participants, immunised with the PCV7 vaccine at 2, 4 and 12 months of age, who have IgG concentrations = 0.35mcg/ml for PCV13 serotypes at the time when preschool booster vaccinations are due (at ~40 months of age) and comparing these to the proportion of participants achieving this threshold after infant immunisation with PCV 13. To assess and compare PCV13 serotype-specific IgG geometric mean concentrations (GMCs), opsonophagocytic activity (OPA) geometric mean titres (GMTs) and the proportion of participants with PCV13 serotype-specific OPA titres = 1:8 at ~40 months of age in children immunised in infancy with either PCV7 or PCV13. To assess and compare PCV serotype-specific IgG GMCs, OPA GMTs and the proportion of participants with IgG concentrations = 0.35mcg/ml and OPA titres = 1:8 one month following a booster dose of PCV13 at ~40 months of age in children previously immunised with PCV7 and PCV13 at 2, 4 and 12 months of age. ;Primary end point(s): The proportion of participants with PCV13 serotype-specific IgG concentrations = 0.35mcg/ml at approximately 40 months of age following immunisation with PCV13 at 2, 4 and 12 months of age. | — |
Countries
United Kingdom
Outcome results
None listed