Phase 4
N=2,590
Assess the Safety & Reactogenicity of DTPa-IPV/Hib Vaccine Administered at 3, 4, 5 & 18 Mths of Age, in Healthy Infants
Diphtheria · Tetanus · Poliomyelitis · Acellular Pertussis · Haemophilus Influenzae Type b
Bottom Line
View on ClinicalTrials.gov: NCT00325156 ↗Enrolled (actual)
2,590
Serious AEs
14.7%
Results posted
Feb 2017
Primary outcome: Primary: Number of Subjects Reporting Any Solicited Local and General Symptoms — 855; 907; 706; 929 Subjects
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- GSK Biologicals' combined DTPa-IPV/Hib vaccine (Biological)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- Aug 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects Reporting Any Solicited Local and General Symptoms |
855; 907; 706; 929; 1482; 1217 | — |
| SECONDARY Number of Subjects Reporting Any Unsolicited Adverse Events (AEs) |
914 | — |
| SECONDARY Number of Subjects Reporting Large Injection Site Swelling |
10; 1 | — |
| SECONDARY Number of Subjects Reporting Any Serious Adverse Events (SAEs) |
380 | — |
Summary
To assess the safety and reactogenicity of the DTPa-IPV/Hib vaccine as primary and booster vaccination. The DTPa-IPV/Hib vaccine given at 3 and 4 months of age is co-administered with GSK Biologicals' rotavirus vaccine or Placebo.
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Eligibility Criteria
Inclusion criteria
- Subjects must have been enrolled in the Rota-028 study.
- A male or female between, and including, 11 and 17 weeks of age at the time of the first vaccination.
- Written informed consent obtained from the parent or guardian of the subject.
- Free of obvious health problems as established by medical history and clinical examination before entering into the study.
- Subjects for whom the investigator believes that their parents/guardians can and will comply with the requirements of the protocol
Exclusion criteria
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs during the study period.
- Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before each dose of the vaccine and ending 30 days after.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
- A family history of congenital or hereditary immunodeficiency.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
- Major congenital defects or serious chronic illness.
- History of any neurologic disorders or seizures.
- Acute disease at the time of enrolment.
- Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
Data sourced from ClinicalTrials.gov (NCT00325156). 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.