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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01309646
First received: February 24, 2011
Last updated: April 18, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention Phase
Poliomyelitis
Haemophilus Influenzae Type b Disease
Diphtheria
Pertussis
Tetanus
Biological: Infanrix™-IPV+Hib
Biological: Infanrix™ IPV
Biological: Hiberix™
Biological: Synflorix™
Biological: Rotarix™
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Immunogenicity and Safety of GlaxoSmithKline Biologicals' DTPa-IPV/Hib (Infanrix™-IPV+Hib) Vaccine in Healthy Korean Infants

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Number of Seroprotected Subjects for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies. [ Time Frame: At Month 0 and Month 5 ] [ Designated as safety issue: No ]
    A seroprotected subject was defined as a vaccinated subject who had an anti-D and anti-T antibody concentration greater to or above (≥) 0.1 international units per milliliter (IU/mL). The Month 5 results are the primary outcome variables.

  • Number of Seropositive Subjects for Anti-pertactin (Anti-PRN) Antibodies. [ Time Frame: At Month 0 and Month 5 ] [ Designated as safety issue: No ]
    A seropositive subjects was defined as a vaccinated subjects who had an anti-PRN antibody concentration ≥ 5 ELISA units per milliliter (EL.U/mL). The Month 5 results are the primary outcome variables.

  • Number of Seroprotected Subjects for Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Antibodies. [ Time Frame: At Month 0 and Month 5 ] [ Designated as safety issue: No ]
    A seroprotected subject was defined as a vaccinated subject who had an anti-PRP antibody concentration ≥ 0.15 micrograms per milliliter (µg/mL). The Month 5 results are the primary outcome variables.

  • Number of Seroprotected Subjects Anti-poliovirus (Anti-polio) Types 1, 2 and 3. [ Time Frame: At Month 0 and Month 5 ] [ Designated as safety issue: No ]
  • Concentrations of Anti-PT Antibodies. [ Time Frame: At Month 0 and Month 5 ] [ Designated as safety issue: No ]
  • Concentrations of Anti-FHA Antibodies. [ Time Frame: At Month 0 and Month 5 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of Subjects With Any Solicited Local Symptoms. [ Time Frame: During the 4-day (Days 0-3) follow-up period after any vaccination with Infanrix™-IPV+Hib or Infanrix™ IPV + Hiberix™ ] [ Designated as safety issue: No ]
    Assessed solicited local symptoms were pain, redness and swelling at the injection site. Any = incidence of a particular symptom regardless of intensity grade.

  • Number of Subjects With Any Solicited General Symptoms. [ Time Frame: During the 4-day (Days 0-3) follow-up period after any vaccination with Infanrix™-IPV+Hib or Infanrix™ IPV + Hiberix™ ] [ Designated as safety issue: No ]
    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.

  • Number of Subjects With Any Unsolicited Adverse Events (AEs). [ Time Frame: During the 31-day (Days 0-30) follow-up period after any vaccination with Infanrix™-IPV+Hib or Infanrix™ IPV + Hiberix™ ] [ Designated as safety issue: No ]
    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.

  • Number of Subjects With Any Serious Adverse Events (SAEs). [ Time Frame: During the entire study period (from Month 0 to Month 5 ½) ] [ Designated as safety issue: No ]
    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.

  • Concentrations for Anti-D and Anti-T Antibodies. [ Time Frame: At Month 0 and Month 5 ] [ Designated as safety issue: No ]
    Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection cut-off of the assay was 0.1 IU/mL.

  • Concentrations of Anti-PRN Antibodies. [ Time Frame: At Month 0 and Month 5 ] [ Designated as safety issue: No ]
    Concentrations were expressed as geometric mean concentrations (GMCs). The seropositivity cut-off of the assay was 5 EL.U/mL.

  • Concentrations of Anti-PRP Antibodies. [ Time Frame: At Month 0 and Month 5 ] [ Designated as safety issue: No ]
    Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection cut-off of the assay was 0.15 µg/mL.

  • Number of Subjects With a Vaccine Response. [ Time Frame: At Month 5 ] [ Designated as safety issue: No ]
    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.

  • Concentrations for Anti-polio Types 1, 2 and 3. [ Time Frame: At Month 0 and Month 5 ] [ Designated as safety issue: No ]
  • Number of Seropositive Subjects for Anti-PT Antibodies. [ Time Frame: At Month 0 and Month 5 ] [ Designated as safety issue: No ]
  • Number of Seropositive Subjects for Anti-FHA Antibodies. [ Time Frame: At Month 0 and Month 5 ] [ Designated as safety issue: No ]

Enrollment: 454
Study Start Date: March 2011
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Infanrix-IPV+Hib Group
Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™-IPV+Hib at 2, 4 and 6 months of age, 3 doses of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™-IPV+Hib was administered intramuscularly in the right thigh, the Synflorix™ vaccine was administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
Biological: Infanrix™-IPV+Hib
Intramuscular, 3 doses
Biological: Synflorix™
Intramuscular, 3 doses
Biological: Rotarix™
Oral, 2 doses
Active Comparator: Infanrix IPV Group
Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™ IPV and Hiberix™ co-administered at separate injection sites at 2, 4 and 6 months of age, 3 dose of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™ IPV was administered intramuscularly in the right thigh, the Synflorix™ and Hiberix™ vaccines were administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
Biological: Infanrix™ IPV
Intramuscular, 3 doses
Biological: Hiberix™
Intramuscular, 3 doses
Biological: Synflorix™
Intramuscular, 3 doses
Biological: Rotarix™
Oral, 2 doses

  Eligibility

Ages Eligible for Study:   42 Days to 69 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01309646

Locations
Korea, Republic of
GSK Investigational Site
Daegu, Korea, Republic of, 700-712
GSK Investigational Site
Goyang, Korea, Republic of
GSK Investigational Site
GyeongSangNam-do, Korea, Republic of, 641-560
GSK Investigational Site
Iksan, Korea, Republic of, 570-711
GSK Investigational Site
Jeonju Jeonbuk, Korea, Republic of, 561-712
GSK Investigational Site
Seongnam-si, Korea, Republic of, 463-712
GSK Investigational Site
Seoul, Korea, Republic of, 139-706
GSK Investigational Site
Seoul, Korea, Republic of, 120-752
GSK Investigational Site
Suwon City, Gyeonggi-do, Korea, Republic of, 442-723
GSK Investigational Site
Uijeongbu, Gyeonggi-do, Korea, Republic of, 480-717
GSK Investigational Site
Wonju-si Kangwon-do, Korea, Republic of, 220-701
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01309646     History of Changes
Other Study ID Numbers: 114260
Study First Received: February 24, 2011
Results First Received: February 21, 2013
Last Updated: April 18, 2013
Health Authority: Korea: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
Primary vaccination
combination vaccine
South Korea

Additional relevant MeSH terms:
Poliomyelitis
Central Nervous System Diseases
Central Nervous System Infections
Central Nervous System Viral Diseases
Enterovirus Infections
Myelitis
Nervous System Diseases
Neuromuscular Diseases
Picornaviridae Infections
RNA Virus Infections
Spinal Cord Diseases
Virus Diseases

ClinicalTrials.gov processed this record on October 22, 2014