Last updated: 07/17/2024 15:37:49
Immunogenicity and safety of GlaxoSmithKline Biologicals’ Infanrix™-IPV+Hib vaccine
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: Immunogenicity and safety of GlaxoSmithKline Biologicals’ DTPa-IPV/Hib (Infanrix™-IPV+Hib) vaccine in healthy Korean infants
Trial description: This study is designed to evaluate the safety and immunogenicity of Infanrix™-IPV+Hib vaccine when administered as a primary vaccination course to healthy Korean infants at 2, 4 and 6 months of age.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
Number of seroprotected subjects for anti-diphtheria (anti-D) and anti-tetanus (anti-T) antibodies.
Timeframe: At Month 5
Number of seroprotected subjects for anti-poliovirus (anti-polio) types 1, 2 and 3.
Timeframe: At Month 5
Number of seroprotected subjects for anti-polyribosyl-ribitol-phosphate (anti-PRP) antibodies.
Timeframe: At Month 5
Anti-pertussis toxoid (PT), anti-filamentous haemagglutinin (FHA) and anti-pertactin (PRN) antibody concentrations.
Timeframe: At Month 5
Secondary outcomes:
Number of seropositive subjects for anti-pertussis toxoid (PT), anti-filamentous haemagglutinin (FHA) and anti-pertactin (PRN).
Timeframe: At Month 0 and Month 5
Anti-pertussis toxoid (PT), anti-filamentous haemagglutinin (FHA) and anti-pertactin (PRN) antibody concentrations
Timeframe: At Month 0
Number of seroprotected subjects for anti-diphtheria (anti-D) and anti-tetanus (anti-T) antibodies.
Timeframe: At Month 0
Concentrations for anti-D and anti-T antibodies.
Timeframe: At Month 0 and Month 5
Number of seroprotected subjects anti-poliovirus (anti-polio) types 1, 2 and 3.
Timeframe: At Month 0
Titres for anti-polio types 1, 2 and 3.
Timeframe: At Month 0 and Month 5
Number of seroprotected subjects for anti-polyribosyl-ribitol-phosphate (anti-PRP) antibodies.
Timeframe: At Month 0
Concentrations of anti-PRP antibodies.
Timeframe: At Month 0 and Month 5
Number of subjects with a vaccine response to anti-PT, anti-FHA and anti-PRN.
Timeframe: At Month 5
Number of subjects with any solicited local symptoms.
Timeframe: During the 4-day (Days 0-3) follow-up period after any vaccination with Infanrix™-IPV+Hib or Infanrix™ IPV + Hiberix™
Number of subjects with any solicited general symptoms.
Timeframe: During the 4-day (Days 0-3) follow-up period after any vaccination with Infanrix™-IPV+Hib or Infanrix™ IPV + Hiberix™
Number of subjects with any unsolicited adverse events (AEs).
Timeframe: During the 31-day (Days 0-30) follow-up period after any vaccination with Infanrix™-IPV+Hib or Infanrix™ IPV + Hiberix™
Number of subjects with any serious adverse events (SAEs).
Timeframe: During the entire study period (from Month 0 to Month 7)
Interventions:
Biological/vaccine: Infanrix™-IPV+Hib
Biological/vaccine: Infanrix™ IPV
Biological/vaccine: Hiberix™
Biological/vaccine: Synflorix™
Biological/vaccine: Rotarix™
Enrollment:
454
Observational study model:
Not applicable
Primary completion date:
2012-24-02
Time perspective:
Not applicable
Clinical publications:
Kim KH et al. (2018) Immunogenicity and safety of a combined DTPa-IPV/Hib vaccine administered as a three-dose primary vaccination course in healthy Korean infants: phase III, randomized study. Hum Vaccin Immunother. doi: 10.1080/21645515.2018.1536588. [Epub ahead of print].
Medical condition
Poliomyelitis, Tetanus, acellular pertussis, Diphtheria, Haemophilus influenzae type b
Product
SB208108, SB213503
Collaborators
Not applicable
Study date(s)
March 2011 to February 2012
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
42 - 69 days
Accepts healthy volunteers
Yes
- A male or female between, and including, 42 and 69 days of age at the time of the first vaccination.
- Born after a gestation period of 37 to 42 weeks inclusive.
- Child in care.
- Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the first dose, or planned use during the study period.
Inclusion and exclusion criteria
Inclusion criteria:
- Born after a gestation period of 37 to 42 weeks inclusive.
- Subjects who the investigator believes that parent(s)/Legally Acceptable Representative(s) can and will comply with the requirements of the protocol.
- Written informed consent obtained from the parent(s)/ Legally Acceptable Representative(s) of the subject.
- Healthy subjects as established by medical history and clinical examination before entering into the study.
A male or female between, and including, 42 and 69 days of age at the time of the first vaccination.
Exclusion criteria:
- Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the first dose, or planned use during the study period.
- Chronic administration of immunosuppressants or other immune-modifying drugs since birth.
- Administration of a vaccine not foreseen by the study protocol, within 30 days prior to the first study visit, with the exception of hepatitis B and Bacillus Calmette-Guérin vaccination; or planned administration during the study period, with the exception of hepatitis B and influenza vaccines, which will be allowed at least 7 days before or 30 days after the administration of the DTPa vaccine.
- Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product.
- Evidence of previous or intercurrent diphtheria, tetanus, pertussis, poliomyelitis and Hib vaccination or disease.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- Family history of congenital or hereditary immunodeficiency.
- History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine(s).
- Major congenital defects or serious chronic illness.
- History of any neurological disorders or seizures.
- Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
- Acute disease and/or fever at the time of enrolment.
Child in care.
Trial location(s)
Location
GSK Investigational Site
GyeongSangNam-do, South Korea, 641-560
Status
Study Complete
Location
GSK Investigational Site
Suwon City, Gyeonggi-do, South Korea, 442-723
Status
Study Complete
Location
GSK Investigational Site
Uijeongbu, Gyeonggi-do, South Korea, 480-717
Status
Study Complete
Location
GSK Investigational Site
Wonju-si Kangwon-do, South Korea, 220-701
Status
Study Complete
Study documents
Scientific result summary
Available language(s): English
Clinical study report
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2012-24-02
Actual study completion date
2012-24-02
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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