Immunogenicity and Safety of GlaxoSmithKline Biologicals' Infanrix™-IPV+Hib Vaccine

Tetanus Clinical Trial

Official title:

Immunogenicity and Safety of GlaxoSmithKline Biologicals' DTPa-IPV/Hib (Infanrix™-IPV+Hib) Vaccine in Healthy Korean Infants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01309646
• Other study ID #: 114260
• Secondary ID: 2012-004137-16
• Status: Completed
• Phase: Phase 3
• Start date: March 4, 2011
• Est. completion date: February 24, 2012

Study information

• Verified date: November 2019
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 454
• Est. completion date: February 24, 2012
• Est. primary completion date: February 24, 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 42 Days to 69 Days

Eligibility

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.

Related Conditions & MeSH terms

• Acellular Pertussis
• Diphtheria
• Haemophilus Influenzae Type b
• Poliomyelitis
• Tetanus

Intervention

Biological:
• Infanrix™-IPV+Hib
Intramuscular, 3 doses
• Infanrix™ IPV
Intramuscular, 3 doses
• Hiberix™
Intramuscular, 3 doses
• Synflorix™
Intramuscular, 3 doses
• Rotarix™
Oral, 2 doses

Locations

Country	Name	City	State
Korea, Republic of	GSK Investigational Site	Daegu
Korea, Republic of	GSK Investigational Site	Goyang
Korea, Republic of	GSK Investigational Site	GyeongSangNam-do
Korea, Republic of	GSK Investigational Site	Iksan
Korea, Republic of	GSK Investigational Site	Jeonju Jeonbuk
Korea, Republic of	GSK Investigational Site	Seongnam-si
Korea, Republic of	GSK Investigational Site	Seoul
Korea, Republic of	GSK Investigational Site	Seoul
Korea, Republic of	GSK Investigational Site	Suwon City, Gyeonggi-do
Korea, Republic of	GSK Investigational Site	Uijeongbu, Gyeonggi-do
Korea, Republic of	GSK Investigational Site	Wonju-si Kangwon-do

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Seroprotected Subjects for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies.	A seroprotected subject was defined as a vaccinated subject who had an anti-D and anti-T antibody concentration equal to or above (=) 0.1 international units per milliliter (IU/mL).	At Month 5
Primary	Number of Seroprotected Subjects for Anti-poliovirus (Anti-polio) Types 1, 2 and 3.	A seroprotected subject was defined as a vaccinated subject who had an anti-polio types 1, 2 and 3 antibody titres equal to or above (=) 8, cut off corresponding to the effective dose for 50% of the vaccinated subjects.	At Month 5
Primary	Number of Seroprotected Subjects for Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Antibodies.	A seroprotected subject was defined as a vaccinated subject who had an anti-PRP antibody concentration = 0.15 micrograms per milliliter (µg/mL).	At Month 5
Primary	Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN) Antibody Concentrations.	Concentrations were expressed as geometric mean concentrations (GMCs) for the seropositivity cut-off of 5 ELISA units per milliliter (EL.U/mL).	At Month 5
Secondary	Number of Seropositive Subjects for Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN).	A seropositive subjects was defined as a vaccinated subjects who had an anti-PRN, anti-PT and anti-FHA antibody concentration = 5 ELISA units per milliliter (EL.U/mL).	At Month 0 and Month 5
Secondary	Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN) Antibody Concentrations	Concentrations were expressed as geometric mean concentrations (GMCs) for the seropositivity cut-off of 5 EL.U/mL.	At Month 0
Secondary	Number of Seroprotected Subjects for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies.	A seroprotected subject was defined as a vaccinated subject who had an anti-D and anti-T antibody concentration equal to or above (=) 0.1 international units per milliliter (IU/mL).	At Month 0
Secondary	Concentrations for Anti-D and Anti-T Antibodies.	Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection cut-off of the assay was 0.1 IU/mL.	At Month 0 and Month 5
Secondary	Number of Seroprotected Subjects Anti-poliovirus (Anti-polio) Types 1, 2 and 3.	A seroprotected subject was defined as a vaccinated subject who had an anti-polio types 1, 2 and 3 antibody titres equal to or above (=) 8, cut off corresponding to the effective dose for 50% of the vaccinated subjects.	At Month 0
Secondary	Titres for Anti-polio Types 1, 2 and 3.	Titres were expressed as geometric mean titres (GMTs). The seroprotection cut-off of the assay was 8.	At Month 0 and Month 5
Secondary	Number of Seroprotected Subjects for Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Antibodies.	A seroprotected subject was defined as a vaccinated subject who had an anti-PRP antibody concentration = 0.15 micrograms per milliliter (µg/mL).	At Month 0
Secondary	Concentrations of Anti-PRP Antibodies.	Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection cut-off of the assay was 0.15 µg/mL.	At Month 0 and Month 5
Secondary	Number of Subjects With a Vaccine Response to Anti-PT, Anti-FHA and Anti-PRN.	Vaccine response was defined as antibody concentration = 5 EL.U/mL at post vaccination, for initially seronegative subjects, and at least maintenance of antibody concentration from pre to post-vaccination (i.e. antibody concentration at post vaccination = 1 fold the pre-vaccination antibody concentration), for initially seropositive subjects.	At Month 5
Secondary	Number of Subjects With Any Solicited Local Symptoms.	Assessed solicited local symptoms were pain, redness and swelling at the injection site. Any = incidence of a particular symptom regardless of intensity grade.	During the 4-day (Days 0-3) follow-up period after any vaccination with Infanrix™-IPV+Hib or Infanrix™ IPV + Hiberix™
Secondary	Number of Subjects With Any Solicited General Symptoms.	Assessed solicited general symptoms were drowsiness, irritability/fussiness, loss of appetite and fever [defined as tympanic temperature = 37.5 degrees Celsius (°C)]. Any = incidence of a particular symptom regardless of intensity grade.	During the 4-day (Days 0-3) follow-up period after any vaccination with Infanrix™-IPV+Hib or Infanrix™ IPV + Hiberix™
Secondary	Number of Subjects With Any Unsolicited Adverse Events (AEs).	Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = any unsolicited AE regardless of intensity or relationship to vaccination.	During the 31-day (Days 0-30) follow-up period after any vaccination with Infanrix™-IPV+Hib or Infanrix™ IPV + Hiberix™
Secondary	Number of Subjects With Any Serious Adverse Events (SAEs).	Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.	During the entire study period (from Month 0 to Month 7)