Immunogenicity and safety study in infants of GlaxoSmithKline Biologicals’ Infanrix hexa™ (DTPa-HBV-IPV/Hib) vaccine
Trial overview
Number of seroprotected subjects against diphteria (D) and tetanus (T) antigens
Timeframe: One month post Dose 3 (Month 3 or Month 5)
Number of seroprotected subjects against hepatitis B (HBs)
Timeframe: One month post Dose 3 (Month 3 or Month 5)
Number of seroprotected subjects against poliovirus (Polio) types 1,2,3 antigens
Timeframe: One month post Dose 3 (Month 3 or Month 5)
Number of seroprotected subjects against polyribosyl-ribitol phosphate (PRP) antigens
Timeframe: One month post Dose 3 (Month 3 or Month 5)
Number of subjects with vaccine response for pertussis toxoid (PT), filamentous haemagglutinin (FHA) and pertactin (PRN)
Timeframe: One month post Dose 3 (Month 3 or Month 5)
Anti-D and Anti-T antibody concentrations
Timeframe: One month post Dose 3 (Month 3 or Month 5)
Anti-HBs antibody concentrations
Timeframe: One month post Dose 3 (Month 3 or Month 5)
Anti-Polio types 1, 2, 3 antibody titers
Timeframe: One month post Dose 3 (Month 3 or Month 5)
Anti-PRP antibody concentrations
Timeframe: One month post Dose 3 (Month 3 or Month 5)
Anti-PT, anti-FHA and anti-PRN antibody concentrations
Timeframe: One month post Dose 3 (Month 3 or Month 5)
Number of seropositive subjects for anti-PT, anti-FHA and anti-PRN
Timeframe: One month post Dose 3 (Month 3 or Month 5)
Number of seroprotected subjects against Polio type 1, 2 and 3 antigens
Timeframe: At Month 0
Number of seropositive subjects for anti-PT, anti-FHA and anti-PRN
Timeframe: At Month 0
Number of seroprotected subjects against anti-HBs antigens
Timeframe: At Month 0
Anti-Polio types 1, 2 and 3 antibody titers
Timeframe: At Month 0
Anti-PT, anti-FHA and anti-PRN antibody concentrations
Timeframe: At Month 0
Anti-HBs antibody concentrations
Timeframe: At Month 0
Number of subjects with any solicited local symptoms
Timeframe: During the 4-day (Days 0-3) post-vaccination period after each dose and across doses: Up to Month 2 (Infanrix Hexa 6-10-14 Group) or Month 4 (Infanrix Hexa 2-4-6 Group)
Number of subjects with solicited general symptoms
Timeframe: During the 4-day (Days 0-3) post-vaccination period after each dose and across doses: Up to Month 2 (Infanrix Hexa 6-10-14 Group) or Month 4 (Infanrix Hexa 2-4-6 Group)
Number of subjects with unsolicited adverse events (AEs)
Timeframe: During the 31-day (Days 0-30) post-vaccination period: Up to Month 3 (Infanrix Hexa 6-10-14 Group) or Month 5 (Infanrix Hexa 2-4-6 Group)
Number of subjects with serious adverse events (SAEs)
Timeframe: During the entire study period (from Month 0 up to Month 3 (Infanrix Hexa 6-10-14 Group) or Month 5 (Infanrix Hexa 2-4-6 Group))
Participation criteria
- All subjects must satisfy ALL the following criteria at study entry:
- A male or female between, and including, 6 and 10 weeks of age at the time of the first vaccination
- The following criteria should be checked at the time of study entry. If ANYexclusion criterion applies, the subject must not be included in the study:
- Child in care
- All subjects must satisfy ALL the following criteria at study entry:
- A male or female between, and including, 6 and 10 weeks of age at the time of the first vaccination
- Documented administration of a hepatitis B vaccine dose at birth
- Subjects who the investigator believes that their parent(s)/legally acceptable representative(s) [LAR(s)] can and will comply with the requirements of the protocol
- Written informed consent obtained from the parent(s)/LAR(s) of the subject
- Healthy subjects as established by medical history and clinical examination before entering into the study
- Born after a gestation period of at least 36 weeks
- The following criteria should be checked at the time of study entry. If ANYexclusion criterion applies, the subject must not be included in the study:
- Child in care
- Use of any investigational or non-registered product other than the study vaccines within 30 days preceding the first dose, or planned use during the study period
- Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose
- Administration of a vaccine not foreseen by the study protocol, within 30 days prior to the first study visit, or planned administration during the study period, with the exception of oral human rotavirus (HRV) vaccination which is allowed at any time during the study
- 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 diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and Haemophilus influenzae type b (Hib) vaccination or disease, with the exception of a birth dose of hepatitis B vaccine and oral poliovirus vaccine (OPV) as per local standard of care
- 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
- Major congenital defects or serious chronic illness
- 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
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.