Last updated: 02/21/2025 15:41:44
A post-marketing surveillance (PMS) study to observe the safety of Infanrix-IPV (inactivated poliovirus)+Hib (Haemophilus influenzae type b) vaccine given as routine practice in South Korea
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: A prospective, observational, multi-center, post-marketing surveillance (PMS) study to observe the safety of Infanrix-IPV+Hib administered as routine practice in South Korea
Trial description: The Infanrix-IPV+Hib vaccine is indicated for active immunization against diphtheria, tetanus, pertussis, poliomyelitis, and Haemophilus influenzae type b infection in infants from the age of 2 months. The vaccine is licensed in many countries including South Korea and most European countries. The purpose of this study is to collect safety data after vaccine administration to infants, according to the local prescribing information (PI) in South Korea, over a 4-year surveillance period.
Primary purpose:
Prevention
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Number of participants with adverse events (AEs)
Timeframe: During the 30-day (Day 1 to Day 30) follow-up period after each vaccine dose
Number of participants with adverse drug reactions (ADRs)
Timeframe: During the 30-day (Day 1 to Day 30) follow-up period after each vaccine dose
Number of participants with serious adverse events (SAEs)
Timeframe: From the administration of the 1st vaccine dose up to 30 days following the last vaccine dose
Number of participants with serious adverse drug reactions (SADRs)
Timeframe: From the administration of the 1st vaccine dose up to 30 days following the last vaccine dose
Secondary outcomes:
Not applicable
Interventions:
Not applicable
Enrollment:
661
Primary completion date:
2021-11-08
Observational study model:
Cohort
Time perspective:
Prospective
Clinical publications:
Diego Mpia Elenge, Ju Sun Heo, Sung Shin Kim, Yun-Kyung Kim, Jang Hoon Lee, Stebin Xavier, Enas Bahar, Gaël Dos Santos, Adrienne Guignard. A prospective, observational, multi-center, post-marketing safety surveillance study of the GSK combined vaccine against diphtheria, tetanus, pertussis, poliomyelitis, and Haemophilus influenzae type b invasive infections (DTaP-IPV/Hib) in South Korean infants. Human vaccines & immunotherapeutics. 2024-Dec-31;20(1): 2406060.
PMID: 39376187
DOI: 10.1080/21645515.2024.2406060
Medical condition
Whooping cough
Product
SB213503
Collaborators
Not applicable
Study date(s)
August 2020 to September 2021
Type
Observational
Phase
4
Participation criteria
Sex
Female & Male
Age
2 - 12 Months
Accepts healthy volunteers
Yes
- Inclusion criteria:
- 1) Male or female infants aged at least two months who were eligible to receive the first dose of the 3 Infanrix-IPV+Hib primary dose series. 2) Signed ICF (Informed consent form) obtained from the Infant’s parent(s)/LAR(s).
Inclusion and exclusion criteria
Inclusion criteria:
- Inclusion criteria: 1) Male or female infants aged at least two months who were eligible to receive the first dose of the 3 Infanrix-IPV+Hib primary dose series. 2) Signed ICF (Informed consent form) obtained from the Infant’s parent(s)/LAR(s). Exclusion criteria: 1) Those who were not eligible for vaccination with Infanrix-IPV+Hib according to the local PI. 2) Those who were not eligible for vaccination with Infanrix-IPV+Hib according to the medical judgement of the investigator (physician).
Trial location(s)
Location
GSK Investigational Site
Yangju-si, Gyeonggi-do, South Korea, 11440
Status
Study Complete
Showing 1 - 6 of 8 Results
Study documents
Clinical study report
Available language(s): English
Protocol
Available language(s): English
Statistical analysis plan
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Study complete
Actual primary completion date
2021-11-08
Actual study completion date
2021-27-09
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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