Clinical trial NCT01577732: Safety of GSK Biologicals' Infanrix-IPV+HibTM Vaccine in Healthy Vietnamese Toddlers
Official title: Safety and Reactogenicity of GlaxoSmithKline Biologicals' DTPa-IPV/Hib (Infanrix-IPV+HibTM) in Healthy Vietnamese Toddlers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acellular Pertussis
Haemophilus Influenzae Type b
Tetanus
Poliomyelitis
Diphtheria
Diphtheria-Tetanus-aPertussis-Poliomyelitis-Haemophilus Influenzae Type b Vaccines
Keywords: booster
Infanrix-IPV+HibTM
DTPa-IPV/Hib
Vietnamese toddlers
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2012-04-16
Enrollment: 321
Sex: ALL
Minimum age (years): 12
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This study aims to evaluate the safety and reactogenicity of a booster dose of Infanrix-IPV+Hib™ when administered to healthy Vietnamese toddlers at 12 to 24 months of age who were vaccinated previously against diphtheria, tetanus, and pertussis diseases within their first six months of lives.


Eligibility criteria: Inclusion Criteria:

* Subjects who the investigator believes that parent(s)/Legally Acceptable Representative(s) \[LAR(s)\] can and will comply with the requirements of the protocol.
* A male or female between, and including, 12 and 24 months of age at the time of vaccination.
* 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.
* Subjects who were primed with three doses of a DTP and polio vaccine in the first 6 months of life, and who have received the last dose of the primary vaccination at least six months before the receipt of study vaccine.

Exclusion Criteria:

* Child in care.
* Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the dose of study vaccine, or planned use during the study period.
* Administration of a vaccine not foreseen by the study protocol, within 30 days prior to the first study visit, or planned administration during the study period.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
* 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 booster vaccination against diphtheria, tetanus, pertussis, poliomyelitis and/or Hib disease or vaccination.
* History of any neurological disorders or seizures.
* History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine.
* Major congenital defects or serious chronic illness.
* Acute disease and/or fever at the time of enrolment.
* Administration of immunoglobulins and/or any blood products within the three months preceding vaccination or planned administration during the study period.

Primary outcomes:
measure: Number of Subjects Reporting Solicited Local Symptoms
timeFrame: Within the 4-day (Days 0-3) follow up period after vaccination.
measure: Number of Subjects Reporting Solicited General Symptoms
timeFrame: Within the 4-day (Days 0-3) follow up period after vaccination.
measure: Number of Subjects Reporting Any Unsolicited Adverse Events (AEs).
timeFrame: Within the 31-day (Days 0-30) follow up period after vaccination.
measure: Number of Subjects Reporting Any Serious Adverse Events (SAEs).
timeFrame: During the entire study period (Days 0-30).
Secondary outcomes:
Other outcomes:
Locations:
city: Hai Phong
country: Vietnam
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Anh DD, Van Der Meeren O, Karkada N, Assudani D, Yu TW, Han HH. Safety and reactogenicity of the combined diphtheria-tetanus-acellular pertussis-inactivated poliovirus-Haemophilus influenzae type b (DTPa-IPV/Hib) vaccine in healthy Vietnamese toddlers: An open-label, phase III study. Hum Vaccin Immunother. 2016 Mar 3;12(3):655-7. doi: 10.1080/21645515.2015.1084451.