Topic: Medicines for Children Research Network
Conditions
Interventions
Study vaccine: 13-Valent Pneumococcal Conjugate Vaccine. Intramuscular administration on the deltoid area of the non-dominant arm at 40 months of age using a 23 gauge 25 mm needle.
This is an open st
Sponsors
John Radcliffe Hospital (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Participants must meet the following conditions in order to be enrolled: 1. Participant completed the Wyeth-sponsored PCV13 infant trial study (6096A1-007) at one of the study sites participating in this follow-on study 2. Aged 39 - 46 months (inclusive) at time of enrolment, either sex 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
Exclusion criteria
Exclusion criteria: Participants with any of the following conditions or characteristics will be excluded from study enrolment: 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, e.g., 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the proportion of participants immunised with the 13-valent pneumococcal conjugate vaccine | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The PCV13 serotype-specific IgG GMCs, OPA GMTs and proportion of participants with OPA titres = 1:8 2. Rates of local and systemic reactions following vaccination with pre-school PCV13 booster dose at 40 3. PCV13 serotype-specific IgG gemoetric mean concentrations (GMCs), opsonophagocytic activity (OPA) 4. Proportion of participants with PCV13 serotype-specific IgG concentrations = 0.35 mcg/ml at 40 months | — |
Countries
United Kingdom
Outcome results
None listed