Immunogenicity and safety study of GSK Biologicals’ Infanrix-IPV+Hib™ vaccine
Trial overview
Number of seroprotected subjects against diphtheria (D) and tetanus (T) antigens
Timeframe: One month after the third vaccine dose (Month 3 or Month 4)
Number of seroprotected subjects against polyribosyl-ribitol-phosphate (PRP) antigen
Timeframe: One month after the third vaccine dose (Month 3 or Month 4)
Number of seroprotected subjects against poliovirus types 1, 2 and 3 antigens
Timeframe: One month after the third vaccine dose (Month 3 or Month 4)
Number of subjects with a vaccine response to pertussis toxoid (PT), filamentous haemagglutinin (FHA) and pertactin (PRN) antigens
Timeframe: One month after the third vaccine dose (Month 3 or Month 4)
Anti-D and anti-T antibody concentrations
Timeframe: Before the first dose (Month 0) and one month after the third dose of vaccination (Month 3 or Month 4)
Anti-PRP antibody concentrations
Timeframe: Before the first dose (Month 0) and one month after the third dose of study vaccine (Month 3 or Month 4)
Anti-polio types 1, 2 and 3 antibody titers
Timeframe: Before the first dose (Month 0) and one month after the third dose of study vaccine (Month 3 or Month 4)
Anti-PT, anti-FHA and anti-PRN antibody concentrations
Timeframe: Before (Month 0) and one month after the third dose of study vaccine (Month 3 or Month 4)
Number of subjects with any solicited local symptoms
Timeframe: During the 4-day (Days 0-3) post-vaccination period after each vaccine dose and across doses
Number of subjects with any solicited general symptoms
Timeframe: During the 4-day (Days 0-3) post-vaccination period after each vaccine dose and across doses
Number of subjects with unsolicited adverse events (AEs)
Timeframe: During the 31-day (Days 0-30) post-vaccination period after any dose
Number of subjects with serious adverse events (SAEs)
Timeframe: During the entire study period (from Month 0 to Month 4/5)
Participation criteria
- A male or female infant between, and including, 60 and 90 days of age at the time of the first study visit.
- Born after a gestation period of 36 to 42 weeks, inclusive.
- Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- Child in care.
- Born after a gestation period of 36 to 42 weeks, inclusive.
- Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) (LAR) can and will comply with the requirements of the protocol.
- Written informed consent obtained from the parent(s) or LAR(s) of the subject.
- Healthy subjects as established by medical history and clinical examination before entering into the study.
A male or female infant between, and including, 60 and 90 days of age at the time of the first study visit.
- Child in care.
- Chronic administration of immunosuppressants or other immune-modifying drugs since birth.
- Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
- Administration of a vaccine not foreseen by the study protocol within 30 days prior to vaccination, or planned administration during the study period, with the exception of hepatitis B 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/or Haemophilus influenzae type b (Hib) disease or vaccination.
- History of seizures or progressive neurological disease.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine(s).
- Major congenital defects or serious chronic illness. The following condition is temporary or self-limiting and a subject may be vaccinated once the condition has resolved and no other exclusion criteria are met:
- Current febrile illness or axillary temperature > 37.0°C or other moderate to severe illness within 24 hours of study vaccine administration.
Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
Trial location(s)
Study documents
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
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.