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

NCT ID: NCT01094171

Last Updated: 2019-03-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-12-03
• Study Completion Date: 2012-10-27

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.

Conditions

Poliomyelitis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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).

Group Type: EXPERIMENTAL

Poliorix TM

Intervention Type: BIOLOGICAL

Intramuscular administration, 3 doses

Infanrix TM

Intervention Type: BIOLOGICAL

Intramuscular administration, 3 doses

Interventions

Poliorix TM

Intramuscular administration, 3 doses

Intervention Type: BIOLOGICAL

Infanrix TM

Intramuscular administration, 3 doses

Intervention Type: BIOLOGICAL

Eligibility 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.

• Minimum Eligible Age: 3 Months
• Maximum Eligible Age: 6 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Barnaul, , Russia

GSK Investigational Site

Yekaterinburg, , Russia

Countries

Russia

References

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.

Reference Type: BACKGROUND

Other Identifiers

2013-002804-15

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

113586

Identifier Type: -

Identifier Source: org_study_id