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Study to Evaluate the Safety of Co-administration of GSK Biologicals' Poliorix and Infanrix in Healthy Children in Russia

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ClinicalTrials.gov Identifier: NCT01094171
Recruitment Status : Completed
First Posted : March 26, 2010
Results First Posted : December 30, 2013
Last Update Posted : March 11, 2019
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Brief Summary:
The purpose of this study is to assess reactogenicity and safety of simultaneous administration of GSK Biologicals' inactivated poliomyelitis vaccine Poliorix and GSK Biologicals' DTPa-vaccine Infanrix vaccines in healthy children in Russian Federation in their first year of life according to National Calendar of Prophylactic Immunisation of Russian Federation.

Condition or disease Intervention/treatment Phase
Poliomyelitis Biological: Poliorix TM Biological: Infanrix TM Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 400 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Phase IV (Not Interventional), Open-label, Multicentre Study to Evaluate the Reactogenicity and Safety of Co-administration of GlaxoSmithKline Biologicals' DTPa (Infanrix) and IPV (Poliorix) Vaccines Administered as Three-dose Primary Immunisation Course at 3, 4.5 and 6 Months of Age in Healthy Children in Russian Federation
Actual Study Start Date : December 3, 2010
Actual Primary Completion Date : October 27, 2012
Actual Study Completion Date : October 27, 2012


Arm Intervention/treatment
Experimental: Poliorix Group
Subjects received 3 primary doses of PoliorixTM and InfanrixTM vaccines at 3, 4.5 and 6 months of age. All vaccines were administered intramuscularly in the anterolateral side of the left thigh (Poliorix) and the right thigh (Infanrix).
Biological: Poliorix TM
Intramuscular administration, 3 doses

Biological: Infanrix TM
Intramuscular administration, 3 doses




Primary Outcome Measures :
  1. Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms [ Time Frame: During the 4-day (Days 0 - 3) post vaccination period ]
    Solicited local symptoms assessed were pain, redness and swelling. Any was defined as occurrence of any specified solicited local symptoms reported irrespective of intensity grade. Grade 3 pain was defined as considerable pain that prevented normal everyday activities. Grade 3 redness and swelling were defined as redness and swelling greater than (>) 20 millimeters (mm)

  2. Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms [ Time Frame: During the 4-day (Days 0 - 3) post vaccination period ]
    Solicited general symptoms assessed were Drowsiness, Irritability, Loss of appetite and Fever [Axillary temperature greater than or equal to (≥) 37.5 degrees Celsius (°C)]. Any = occurrence of any specified solicited general symptoms reported irrespective of intensity grade or relationship to vaccination. Any fever = oral temperature ≥ 37.5 degrees Celsius (°C). Grade 3 symptoms = symptoms that prevented normal activities. Grade 3 fever = oral temperature > 39.0°C.

  3. Number of Subjects Reporting Any Unsolicited Adverse Events (AEs) [ Time Frame: During the 31-day (Days 0 - 30) post vaccination period ]
    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 was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.

  4. Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs). [ Time Frame: During the entire study period (Day 0 - Month 4) ]
    SAEs assessed included medical occurrences that resulted in death, was life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.



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Ages Eligible for Study:   3 Months to 6 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study.
  • A male or female aged 3 months including at the time of the vaccination.
  • Written informed consent obtained from the parent of the subject.
  • Healthy subjects as established by medical history and clinical examination and thermometry before entering into the study, that don't have contraindications for vaccination against diphtheria, tetanus, pertussis and poliomyelitis

Exclusion Criteria:

  • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the booster dose of study vaccine, or planned use during the study period.
  • Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs from birth.
  • Administration of immunoglobulins and/or any blood products from birth or planned administration during the study period.
  • Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days of the vaccination, except recombinant hepatitis B vaccine, Haemophilus influenzae type B vaccine and seasonal/pandemic influenza prophylactic.
  • Participation in another clinical study at any time during the study, in which the subject has been or will be exposed to an investigational or a non-registered product (pharmaceutical product or device).
  • Previous vaccination against diphtheria, tetanus, pertussis and poliomyelitis if by any reasons it was made in timeframe not stated by National Calendar of Prophylactic Vaccines of Russian Federation.
  • Medical history of convulsions and progressive neurological disease.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on physical examination (no laboratory testing required).
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
  • Chronic diseases and serious congenital defects.
  • Acute disease at the time of enrolment.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01094171


Locations
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Russian Federation
GSK Investigational Site
Barnaul, Russian Federation, 656056
GSK Investigational Site
Ekaterinburg, Russian Federation, 620085
Sponsors and Collaborators
GlaxoSmithKline
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline

Publications:
Romanenko VV et al. (2016) Safety and reactogenicity of inactivated vaccine for polio prevention (Poliorix ™) output and DTP vaccine (Infanrix ™) in a joint application for trehdozovoy scheme in healthy children in Russia. Ural Med Jq. 9(142):138-144.

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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01094171     History of Changes
Other Study ID Numbers: 113586
2013-002804-15 ( EudraCT Number )
First Posted: March 26, 2010    Key Record Dates
Results First Posted: December 30, 2013
Last Update Posted: March 11, 2019
Last Verified: February 2019

Keywords provided by GlaxoSmithKline:
poliomyelitis
diphtheria
Primary immunization
pertussis
Children
tetanus

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