Clinical trial NCT01509105: Prevenar13 Post Market Surveillance
Official title: Post Marketing Surveillance To Observe Safety Of Prevenar 13
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2012-01-12
Enrollment: 649
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All infants and children meeting the usual prescribing criteria for Prevenar 13 as per the local product information for usage

Brief summary: It is an observational multi-center study to assess the safety profile of Prevenar13 used among Korean children in the routine clinical setting following a licensure and introduction of the vaccine. This study is designed to fulfill regulatory requirement for any new drug authorized by KFDA.

Detailed description: non-randomization, non-probability sampling

Eligibility criteria: Inclusion Criteria:

* Infants and children aged 6 weeks to 5 years, whose legally authorized representatives of patients agree to provide written informed consent form (data privacy statement).

Exclusion Criteria:

* Infants and children who are not indicated and/or contraindicated for the Prevenar13 usage will not be included.

Primary outcomes:
measure: Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs): Within 7 Days After Vaccination 1
timeFrame: Within 7 days after Vaccination 1
measure: Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs): Within 7 Days After Vaccination 2
timeFrame: Within 7 days after Vaccination 2
measure: Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs): Within 7 Days After Vaccination 3
timeFrame: Within 7 days after Vaccination 3
measure: Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs): Within 28 Days After Vaccination 4
timeFrame: Within 28 days after Vaccination 4
measure: Number of Participants With Treatment-Related Adverse Events (AEs) or Serious Adverse Events (SAEs): Within 7 Days After Vaccination 1
timeFrame: Within 7 days after Vaccination 1
measure: Number of Participants With Treatment-Related Adverse Events (AEs) or Serious Adverse Events (SAEs): Within 7 Days After Vaccination 2
timeFrame: Within 7 days after Vaccination 2
measure: Number of Participants With Treatment-Related Adverse Events (AEs) or Serious Adverse Events (SAEs): Within 7 Days After Vaccination 3
timeFrame: Within 7 days after Vaccination 3
measure: Number of Participants With Treatment-Related Adverse Events (AEs) or Serious Adverse Events (SAEs): Within 28 Days After Vaccination 4
timeFrame: Within 28 days after Vaccination 4
Secondary outcomes:
measure: Duration of Adverse Events (AEs)
timeFrame: Baseline up to 28 days after last dose of study vaccination (13 Months)
measure: Number of Participants With Adverse Events (AEs) by Severity
timeFrame: Within 7 days after Vaccination 1, 2, 3 and within 28 days after Vaccination 4
measure: Number of Participants With Outcome in Response to Adverse Events (AEs)
timeFrame: Baseline up to 28 days after last dose of study vaccination (13 Months)
measure: Number of Participants Discontinued Due to Adverse Events
timeFrame: Baseline up to 28 days after last dose of study vaccination (13 Months)
Other outcomes:
Locations:
city: Wonju-si
country: Korea, Republic of
facility: Choi's Pediatric Clinic
state: Gangwon-do
city: Osan
country: Korea, Republic of
facility: Seoul Children's Hospital
state: Gyeonggi-do
city: Seongnam-si
country: Korea, Republic of
facility: Bundang Pediatric Clinic
state: Gyeonggi-do
city: Suwon-si
country: Korea, Republic of
facility: Teun Teun Pediatric clinic
state: Gyeonggi-do
city: Yangju
country: Korea, Republic of
facility: Namujungwon Women's Hospital
state: Gyeonggi-do
city: Yongin-si
country: Korea, Republic of
facility: Yonsei Pediatric Clinic
state: Gyeonggi-do
city: Busan
country: Korea, Republic of
facility: Busan National University Hospital
city: Daegu
country: Korea, Republic of
facility: Jaeil Alliance Pediatrics Clinic
city: Daegu
country: Korea, Republic of
facility: Teun Teun Pediatric Clinic
city: Daejeon
country: Korea, Republic of
facility: Eulji University Hospital
city: Gyeonggi-do
country: Korea, Republic of
facility: Korea University Ansan Hospital
city: Gyeonggi-do
country: Korea, Republic of
facility: Cha Bundang Medical Center, Cha University
city: Incheon
country: Korea, Republic of
facility: Inha University Hospital
city: Incheon
country: Korea, Republic of
facility: Lee Ha Young Pediatrics
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Eulji Medical Center
city: Suyeong-gu
country: Korea, Republic of
facility: JaMo Women's Hospital
city: Ulsan
country: Korea, Republic of
facility: Ulsan University Hospital
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: