Phase 4
N=224
Immunogenicity and Safety of GSK Biologicals' Infanrix Hexa in Infants
Hepatitis B · Tetanus · Poliomyelitis · Diphtheria · Haemophilus Influenzae Type b
Bottom Line
View on ClinicalTrials.gov: NCT00753649 ↗Enrolled (actual)
224
Serious AEs
2.7%
Results posted
Nov 2016
Primary outcome: Primary: Number of Seroprotected Subjects Against Polyribosyl-ribitol Phosphate (Anti-PRP) — 92; 106 Subjects
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Infanrix™ hexa (Biological)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- Mar 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Seroprotected Subjects Against Polyribosyl-ribitol Phosphate (Anti-PRP) |
92; 106 | — |
| SECONDARY Number of Subjects With Anti-PRP Antibody Concentrations ≥1µg/mL |
83; 91 | — |
| SECONDARY Anti-PRP Antibody Concentrations |
6.123; 3.51 | — |
| SECONDARY Number of Seroprotected Subjects Against Hepatitis B (Anti-HBs) |
91; 103 | — |
| SECONDARY Number of Subjects With Anti-HBs Antibody Concentrations ≥100 mIU/mL |
89; 100 | — |
| SECONDARY Anti-HBs Antibody Concentrations |
1797.9; 1544.4 | — |
| SECONDARY Number of Subjects With Unsolicited Adverse Events (AEs) |
26; 19 | — |
| SECONDARY Number of Subjects With Serious Adverse Events (SAEs) |
6; 0 | — |
Summary
This study will evaluate GSK Biologicals' DTPa-HBV-IPV/Hib vaccine given as a three-dose primary vaccination course at 2, 4 and 6 months of age, in terms of safety and immunogenicity in different population of infants residing in Canada.
Eligibility Criteria
Inclusion Criteria
- Subjects who the investigator believes that their parent/guardian can and will comply with the requirements of the protocol should be enrolled in the study.
- A male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination.
- Born after a gestation period of 36 to 42 weeks inclusive.
- Healthy subjects as established by medical history before entering into the study.
- Written informed consent obtained from the parent or guardian of the subject.
Exclusion Criteria
- Use of any investigational or non-registered product within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- Chronic administration of immunosuppressants or other immune-modifying drugs from birth until first primary vaccination dose..
- Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
- 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.
- Major congenital defects or serious chronic illness.
- Evidence of previous or intercurrent diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B and/or Hib vaccination or disease.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
- 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 of ≥ 37.5 ºC or other moderate to severe illness within 24 hours of study vaccine administration.
Data sourced from ClinicalTrials.gov (NCT00753649). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.