Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01309646
Other study ID # 114260
Secondary ID 2012-004137-16
Status Completed
Phase Phase 3
First received
Last updated
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
Health authority
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.

Study Design


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)
See also
  Status Clinical Trial Phase
Completed NCT00352963 - Immunogenicity & Safety Study of Combined/Separate Vaccine(s) Against Common Diseases in Infants (2,4,6 Months of Age). Phase 3
Not yet recruiting NCT04056728 - A Phase IV Study to Assess the Safety of EupentaTM Inj Phase 4
Completed NCT00753649 - Immunogenicity and Safety of GSK Biologicals' Infanrix Hexa in Infants Phase 4
Completed NCT02538211 - The Role of the Intestinal Microbiome in Enteric and Systemic Vaccine Immune Responses N/A
Completed NCT01917357 - A Comparison of the Immunogenicity and Safety of Quinvaxem in Mono-dose Vials and Uniject Phase 3
Completed NCT01689324 - Study of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine (ADACEL®) as a Booster in Adolescents Phase 1/Phase 2
Completed NCT01444781 - Study of the Booster Effect of DTaP-IPV-Hep B-PRP~T Combined Vaccine or Infanrix Hexa™ and Prevenar™ in Healthy Infants Phase 3
Completed NCT01214889 - Study of PENTAXIM™ Vaccine Versus TETRAXIM™ Vaccine Given With ACTHIB™ Vaccine in South Korean Infants. Phase 3
Completed NCT00804284 - Database Surveillance Safety Study of PENTACEL® Vaccine N/A
Completed NCT00514709 - Immunogenicity Study of Antibody Persistence and Booster Effect of DTaP-HB PRP~T Combined Vaccine in Filipino Infants Phase 3
Completed NCT00534833 - Immunogenicity Study of Antibody Persistence and Booster Effect of DTaP-HB-PRP~T Combined Vaccine or Tritanrix-HepB/Hib™ Phase 3
Completed NCT00379977 - Study to Assess the Safety & Reactogenicity of GSK Biologicals' DTPa/Hib Vaccine When Given at 3, 4 and 5 Months of Age Phase 3
Completed NCT00772369 - Retrospective Survey of Safety of Fourth Dose Pentacel® in Children Phase 4
Completed NCT00879827 - Immunogenicity and Reactogenicity of GSK Bio DTPa-HBV-IPV and Hib Vaccines When Coadministered to Healthy Infants Phase 3
Completed NCT01457495 - Immunogenicity and Safety of DTPa-HBV-IPV/Hib Compared to DTPa-IPV/Hib and HBV Administered Concomitantly Phase 2
Completed NCT01267058 - Booster Study of Combined Diphtheria-tetanus-acellular Pertussis Vaccine in Healthy Adults Phase 3
Completed NCT02853929 - Evaluation of Immunogenicity and Safety of a Booster Dose of Infanrix Hexa™ in Healthy Infants Born to Mothers Vaccinated With Boostrix™ During Pregnancy or Immediately Post-delivery Phase 4
Completed NCT02858440 - A Study to Assess the Immunogenicity and Safety of GSK Biologicals' Infanrix-IPV/Hib Vaccine Administered as a Three-dose Vaccination Course at 3, 4.5 and 6 Months of Age and a Booster Dose at 18 Months of Age in Healthy Infants in Russia Phase 3
Recruiting NCT06049940 - Safety and Immunogenicity of Tetanus Vaccine, Adsorbed in 18~44 Years Old Population Phase 3
Completed NCT00385255 - Immunogenicity, Safety of GSKs Tdap Vaccine Boostrix When Coadministered With GSKs Influenza Vaccine Fluarix in Adults Phase 3