Clinical trial NCT01309646: Immunogenicity and Safety of GlaxoSmithKline Biologicals' Infanrix™-IPV+Hib Vaccine
Official title: Immunogenicity and Safety of GlaxoSmithKline Biologicals' DTPa-IPV/Hib (Infanrix™-IPV+Hib) Vaccine in Healthy Korean Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Poliomyelitis
Tetanus
Acellular Pertussis
Diphtheria
Haemophilus Influenzae Type b
Keywords: Primary vaccination
combination vaccine
South Korea
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2011-03-07
Enrollment: 454
Sex: ALL
Minimum age (years): 42
Maximum age (years): 69
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study is designed to evaluate the safety and immunogenicity of Infanrix™-IPV+Hib vaccine when administered as a primary vaccination course to healthy Korean infants at 2, 4 and 6 months of age.


Eligibility criteria: Inclusion Criteria:

* A male or female between, and including, 42 and 69 days of age at the time of the first vaccination.
* Born after a gestation period of 37 to 42 weeks inclusive.
* Subjects who the investigator believes that parent(s)/Legally Acceptable Representative(s) can and will comply with the requirements of the protocol.
* Written informed consent obtained from the parent(s)/ Legally Acceptable Representative(s) of the subject.
* Healthy subjects as established by medical history and clinical examination before entering into the study.

Exclusion Criteria:

* Child in care.
* Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the first dose, or planned use during the study period.
* Chronic administration of immunosuppressants or other immune-modifying drugs since birth.
* Administration of a vaccine not foreseen by the study protocol, within 30 days prior to the first study visit, with the exception of hepatitis B and Bacillus Calmette-Guérin vaccination; or planned administration during the study period, with the exception of hepatitis B and influenza vaccines, which will be allowed at least 7 days before or 30 days after the administration of the DTPa vaccine.
* 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 diphtheria, tetanus, pertussis, poliomyelitis and Hib vaccination or disease.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
* Family history of congenital or hereditary immunodeficiency.
* History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine(s).
* Major congenital defects or serious chronic illness.
* History of any neurological disorders or seizures.
* Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
* Acute disease and/or fever at the time of enrolment.

Primary outcomes:
measure: Number of Seroprotected Subjects for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies.
timeFrame: At Month 5
measure: Number of Seroprotected Subjects for Anti-poliovirus (Anti-polio) Types 1, 2 and 3.
timeFrame: At Month 5
measure: Number of Seroprotected Subjects for Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Antibodies.
timeFrame: At Month 5
measure: Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN) Antibody Concentrations.
timeFrame: At Month 5
Secondary outcomes:
measure: Number of Seropositive Subjects for Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN).
timeFrame: At Month 0 and Month 5
measure: Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN) Antibody Concentrations
timeFrame: At Month 0
measure: Number of Seroprotected Subjects for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies.
timeFrame: At Month 0
measure: Concentrations for Anti-D and Anti-T Antibodies.
timeFrame: At Month 0 and Month 5
measure: Number of Seroprotected Subjects Anti-poliovirus (Anti-polio) Types 1, 2 and 3.
timeFrame: At Month 0
measure: Titres for Anti-polio Types 1, 2 and 3.
timeFrame: At Month 0 and Month 5
measure: Number of Seroprotected Subjects for Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Antibodies.
timeFrame: At Month 0
measure: Concentrations of Anti-PRP Antibodies.
timeFrame: At Month 0 and Month 5
measure: Number of Subjects With a Vaccine Response to Anti-PT, Anti-FHA and Anti-PRN.
timeFrame: At Month 5
measure: Number of Subjects With Any Solicited Local Symptoms.
timeFrame: During the 4-day (Days 0-3) follow-up period after any vaccination with Infanrix™-IPV+Hib or Infanrix™ IPV + Hiberix™
measure: Number of Subjects With Any Solicited General Symptoms.
timeFrame: During the 4-day (Days 0-3) follow-up period after any vaccination with Infanrix™-IPV+Hib or Infanrix™ IPV + Hiberix™
measure: Number of Subjects With Any Unsolicited Adverse Events (AEs).
timeFrame: During the 31-day (Days 0-30) follow-up period after any vaccination with Infanrix™-IPV+Hib or Infanrix™ IPV + Hiberix™
measure: Number of Subjects With Any Serious Adverse Events (SAEs).
timeFrame: During the entire study period (from Month 0 to Month 7)
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: GSK Investigational Site
city: Goyang
country: Korea, Republic of
facility: GSK Investigational Site
city: GyeongSangNam-do
country: Korea, Republic of
facility: GSK Investigational Site
city: Iksan
country: Korea, Republic of
facility: GSK Investigational Site
city: Jeonju Jeonbuk
country: Korea, Republic of
facility: GSK Investigational Site
city: Seongnam-si
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Suwon City, Gyeonggi-do
country: Korea, Republic of
facility: GSK Investigational Site
city: Uijeongbu, Gyeonggi-do
country: Korea, Republic of
facility: GSK Investigational Site
city: Wonju-si Kangwon-do
country: Korea, Republic of
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Kim KH, Kim CS, Kim HM, Kim JD, Ma SH, Kim DH, Hwang PH, Han JW, Lee TJ, Kim JH, Karkada N, Mesaros N, Sohn WY, Kim JH. Immunogenicity and safety of a combined DTPa-IPV/Hib vaccine administered as a three-dose primary vaccination course in healthy Korean infants: phase III, randomized study. Hum Vaccin Immunother. 2019;15(2):317-326. doi: 10.1080/21645515.2018.1536588. Epub 2018 Nov 15.