Phase 1
Completed N=25
Safety and Reactogenicity of GSK Biologicals' Inactivated Poliomyelitis Vaccine (IPV) (Poliorix) in Infants
Source: ClinicalTrials.gov NCT00937404 ↗Enrolled (actual)
25
Serious AEs
0.0%
Results posted
Dec 2018
Primary outcomePrimary: Number of Subjects Reporting Solicited Local Symptoms — 1; 0; 2; 0 Participants
Summary
The study will evaluate the safety and reactogenicity of Poliorix given as primary vaccination course to Chinese children at 2, 3 and 4 months of age.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects Reporting Solicited Local Symptoms |
1; 0; 2; 0; 1; 0 | — |
| PRIMARY Number of Subjects Reporting Solicited General Symptoms |
7; 0; 7; 10; 0; 10 | — |
| PRIMARY Number of Subjects Reporting Unsolicited Adverse Events (AEs) |
15 | — |
| PRIMARY Number of Subjects Reporting Serious Adverse Events (SAEs) |
— | — |
Eligibility Criteria
Inclusion Criteria
- A male or female infant between, and including, 60 and 90 days of age at the time of the first vaccination.
- Born after a gestation period of 36 to 42 weeks inclusive.
- Subjects who the investigator believes that their parents/ guardians can and will comply with the requirements of the protocol should be enrolled in the study.
- Written informed consent obtained from the parent or guardian of the subject.
- Healthy subjects as established by medical history and clinical examination before entering into the study.
Exclusion Criteria
- 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.
- 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 exception of DTP, Hib and/or hepatitis B vaccine(s).
- 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 poliomyelitis 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 allergic disease or reactions 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 ºC or other moderate to severe illness within 24 hours of study vaccine administration.
Data sourced from ClinicalTrials.gov (NCT00937404). 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.