Phase 3
Completed N=702
Safety of DTPa-IPV/Hib & DTPa-HBV-IPV/Hib, Followed by DTPa-IPV/Hib Vaccine in Infants Who Received Hepatitis B Vaccine
Source: ClinicalTrials.gov NCT00325143 ↗Enrolled (actual)
702
Serious AEs
15.4%
Results posted
Feb 2017
Primary outcomePrimary: Number of Subjects Reporting Any Solicited Local Symptoms — 130; 120; 89; 134 Participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
To assess the safety and reactogenicity of the DTPa-HBV-IPV/Hib vaccine and DTPa-IPV/Hib vaccine. This 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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects Reporting Any Solicited Local Symptoms |
130; 120; 89; 134; 137; 100 | — |
| PRIMARY Number of Subjects Reporting Any Solicited General Symptoms |
165; 139; 229; 173; 140; 124 | — |
| SECONDARY Number of Subjects Reporting Any Unsolicited Adverse Events (AEs) |
321 | — |
| SECONDARY Number of Subjects Reporting Any Large Swelling Reactions |
— | — |
| SECONDARY Number of Subjects Reporting Any Serious Adverse Events (SAEs) |
108 | — |
Eligibility Criteria
Inclusion criteria
- Subjects must have been enrolled in the Rota-028 study.
- Subjects for whom the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the 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 should have received two doses of hepatitis B vaccine: at birth and at approximately one month of age.
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 (NCT00325143). 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. Informational only — not medical advice.