Clinical trial NCT00920439: Safety and Reactogenicity of GlaxoSmithKline (GSK) Biologicals' IPV Vaccine (PoliorixTM) in Toddlers
Official title: An Open-label Study to Assess the Safety and Reactogenicity of GlaxoSmithKline Biologicals' Inactivated Poliomyelitis Vaccine Poliorix Administered as a Booster Dose at 18-24 Months of Age in Healthy Toddlers in China.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Poliomyelitis
Keywords: Poliomyelitis Vaccines
IPV
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2009-06-15
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The study will evaluate the safety and reactogenicity of PoliorixTM given as a single booster dose to Chinese children at 18-24 months of age.


Eligibility criteria: Inclusion Criteria:

* A male or female toddler between, and including, 18 and 24 months of age at the time of the booster vaccination.
* Subjects who received three doses of OPV as primary vaccination in the first year of life as per Chinese recommendations.
* 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 within 30 days preceding the booster dose of study vaccine, or planned use during the study period.
* Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the booster vaccination
* 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 and/or Hib vaccine(s).
* Administration of immunoglobulins and/or any blood products within the three months preceding the booster vaccination, 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
* Previous booster vaccination against poliomyelitis since the end of the primary vaccination series.
* History of poliomyelitis disease.
* 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 vaccines.
* 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.

Primary outcomes:
measure: Number of Subjects With Any and Grade 3 Solicited Local Symptoms
timeFrame: During the 4-day (Days 0-3) post-vaccination period
measure: Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
timeFrame: During the 4-day (Days 0-3) post-vaccination period
measure: Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
timeFrame: During the 31-day (Days 0-30) post-vaccination period
measure: Number of Subjects With Serious Adverse Events (SAEs)
timeFrame: During the entire study period (from Day 0 to Month 1)
Secondary outcomes:
Other outcomes:
Locations:
city: Wuzhou
country: China
facility: GSK Investigational Site
state: Guangxi
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Li R, Li CG, Li Y, Liu Y, Zhao H, Chen X, Kuriyakose S, Van Der Meeren O, Hardt K, Hezareh M, Roy-Ghanta S. Primary and booster vaccination with an inactivated poliovirus vaccine (IPV) is immunogenic and well-tolerated in infants and toddlers in China. Vaccine. 2016 Mar 14;34(12):1436-43. doi: 10.1016/j.vaccine.2016.02.010. Epub 2016 Feb 9.