Clinical trial NCT01248988: Post Marketing Surveillance of Synflorix Vaccine Safety Among Infants in Korea
Official title: Safety of GlaxoSmithKline (GSK) Biologicals' 10-valent Pneumococcal-protein D-diphtheria Toxoid-tetanus Toxoid Conjugate (10PN-PD-DiT) Vaccine, Synflorix When Administered According to the Approved Prescribing Information in Korea
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infections, Streptococcal
Keywords: Pneumococcal vaccine
Safety
Synflorix
Pneumococcal diseases
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2010-11-25
Enrollment: 622
Sex: ALL
Minimum age (years): 6
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Infants and children who receive at least one dose of Synflorix as a part of routine practice at a private clinic or hospital.

Brief summary: The purpose of this study is to collect safety information following routine vaccination with Synflorix™ among infants in Korea.

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

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.

Primary outcomes:
measure: Occurrence of unexpected adverse events
timeFrame: During the 30-day (Day 0 - Day 29) follow-up period after each vaccine dose.
measure: Occurrence of expected adverse events
timeFrame: During the 30-day (Day 0 - Day 29) follow-up period after each vaccine dose.
measure: Occurrence of serious adverse events
timeFrame: From the first dose in the study up to 30 days (Day 0 - Day 29) after the last dose.
Secondary outcomes:
Other outcomes:
Locations:
city: Suwon, Kyonggi-do
country: Korea, Republic of
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Lee SM, Lee JH, Song ES, Kim SJ, Kim JH, Jakes RW, Devadiga R, Park MS. A 6-year safety surveillance of 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) in South Korea. Hum Vaccin Immunother. 2018;14(12):3019-3025. doi: 10.1080/21645515.2018.1502525. Epub 2018 Aug 29.