Post Marketing Surveillance of Synflorix Vaccine Safety Among Infants in Korea

Launched by GLAXOSMITHKLINE · Nov 24, 2010

Keywords

ClinConnect Summary

Rationale for the protocol amendment: The therapeutic indication for Synflorix in Korea has been updated. The protocol is being amended to reflect this update.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Subjects who the investigator believes that their parent(s)/Legally Acceptable Representatives can and will comply with the requirements of the protocol.
• • Korean male or female subjects whose age while receiving the first vaccination with Synflorix is 6 weeks - 5 years.
• • Written, signed or thumb-printed informed consent obtained from the parent(s)/ Legally Acceptable Representative(s) of the child. Where parent(s)/Legally acceptable representatives are illiterate, the consent form will be countersigned by a witness.
• Exclusion Criteria:
• • At the time of Post Marketing Surveillance entry, the contraindications and precautions of use indicated in the local Prescribing Information should be checked and the infant must not be included in the Post Marketing Surveillance if there is any contraindication. Any changes in the locally approved Prescribing Information must be implemented immediately.
• • Subjects who receive any investigational or non-registered pneumococcal vaccine 30 days prior to the study start will not be enrolled. Subjects who had previous administration of a pneumococcal vaccine other than Synforix will not be enrolled into the study.
• • A male or female children \>= 5 years of age at study entry.