13 Valent Pneumococcal Conjugate Vaccine - Follow-on Study
13 Valent Pneumococcal Conjugate Vaccine - Follow-on Study
This is a follow-on, multi-centre, open-label, clinical trial. The purpose of this trial is
 to investigate the concentrations of serotype-specific antibodies to IgG included in PCV13 in
 children who have received either the PCV7 or PCV13 primary immunisation at 2, 4 and 12
 months of age. We intend to recruit all interested participants who completed the
 Wyeth-sponsored PCV13 infant trial study (6096A1-007) at selected study sites (i.e. those
 that recruited the majority of the children in the original study). The study will start in
 March 2010, at which time the eldest participants in the 6096A1-007 study will be
 approximately 42 months of age. There will be two visits per participant, 1 month apart from
 each other. At visit one, all participants will have a blood test and receive a dose of
 PCV13. At visit 2, all participants will have a blood test and will be offered the remaining
 pre-school booster vaccinations unless they have already received them.
Inclusion Criteria:

 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.

 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:

 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.