Phase 3
N=1,100
Immunogenicity and Safety Study of GlaxoSmithKline Biologicals' Poliorix™ Vaccine
Poliomyelitis · Poliomyelitis Vaccines
Bottom Line
View on ClinicalTrials.gov: NCT01021293 ↗Enrolled (actual)
1,100
Serious AEs
0.8%
Results posted
Apr 2017
Primary outcome: Primary: Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3 — 306; 296; 306; 296 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Poliorix™ (Biological); Oral Poliovirus vaccine (Biological)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- Jul 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3 |
131; 113; 93; 99; 48; 52 | — |
| SECONDARY Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3 |
131; 113; 93; 99; 48; 52 | — |
| SECONDARY Anti-poliovirus Types 1, 2 and 3 Antibody Titers |
8.7; 7.8; 485.1; 2817; 6.5; 7.2 | — |
| SECONDARY Number of Subjects With Any and Grade 3 Solicited Local Symptoms |
80; 1; 20; 0; 9; 0 | — |
| SECONDARY Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms |
99; 75; 0; 1; 71; 51 | — |
| SECONDARY Number of Subjects With Any Unsolicited Adverse Events (AEs) |
155; 162 | — |
| SECONDARY Number of Subjects With Serious Adverse Events (SAEs) |
3; 6 | — |
Summary
The purpose of the study is to evaluate the immunogenicity and safety of Poliorix™ when administered to healthy Chinese infants at 2, 3 and 4 months of age.
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 parent(s)/Legally Acceptable Representative (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.
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 any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine(s).
- Major congenital defects or serious chronic illness.
- Child in care.
The following condition is temporary or self-limiting, and a subject may be vaccinated once the condition has resolved and if 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 (NCT01021293). 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.