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

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

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.

Study Overview

• Status: Completed
• Conditions: Poliomyelitis
• Intervention / Treatment: Biological: Poliorix TM; Biological: Infanrix TM

• Study Type: Interventional
• Enrollment (Actual): 400
• Phase: Phase 4

Contacts and Locations

Study Locations

• Russian Federation
  • Barnaul, Russian Federation, 656056
    • GSK Investigational Site
  • Ekaterinburg, Russian Federation, 620085
    • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 months to 6 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms	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)	During the 4-day (Days 0 - 3) post vaccination period
Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms	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.	During the 4-day (Days 0 - 3) post vaccination period
Number of Subjects Reporting 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 was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.	During the 31-day (Days 0 - 30) post vaccination period
Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs).	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.	During the entire study period (Day 0 - Month 4)

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 3, 2010
• Primary Completion (Actual): October 27, 2012
• Study Completion (Actual): October 27, 2012

Study Registration Dates

• First Submitted: March 4, 2010
• First Submitted That Met QC Criteria: March 25, 2010
• First Posted (Estimate): March 26, 2010

Study Record Updates

• Last Update Posted (Actual): March 11, 2019
• Last Update Submitted That Met QC Criteria: February 12, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: Children; poliomyelitis; diphtheria; Primary immunization; pertussis; tetanus
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; RNA Virus Infections; Virus Diseases; Infections; Neuromuscular Diseases; Central Nervous System Infections; Enterovirus Infections; Picornaviridae Infections; Spinal Cord Diseases; Myelitis; Poliomyelitis
• Other Study ID Numbers: 113586; 2013-002804-15 (EudraCT Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No