Last updated: 02/13/2019 08:11:01
Study to evaluate the safety of co-administration of GSK Biologicals’ Poliorix and Infanrix in healthy children in Russia
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
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
Trial description: 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.
Primary purpose:
Prevention
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Not applicable
Primary outcomes:
Number of subjects reporting any and grade 3 solicited local symptoms
Timeframe: During the 4-day (Days 0 - 3) post vaccination period
Number of subjects reporting any and grade 3 solicited general symptoms
Timeframe: During the 4-day (Days 0 - 3) post vaccination period
Number of subjects reporting any unsolicited adverse events (AEs)
Timeframe: During the 31-day (Days 0 - 30) post vaccination period
Number of subjects reporting any and related serious adverse events (SAEs).
Timeframe: During the entire study period (Day 0 – Month 4)
Secondary outcomes:
Not applicable
Interventions:
Biological/vaccine: Poliorix TM
Biological/vaccine: Infanrix TM
Enrollment:
400
Observational study model:
Not applicable
Primary completion date:
2012-27-10
Time perspective:
Not applicable
Clinical 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.
Medical condition
Poliomyelitis
Product
SB208132, SB208355
Collaborators
Not applicable
Study date(s)
December 2010 to October 2012
Type
Interventional
Phase
4
Participation criteria
Sex
Female & Male
Age
3 - 6 months
Accepts healthy volunteers
Yes
- 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.
- 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.
Inclusion and exclusion criteria
Inclusion criteria:
- 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
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.
Exclusion criteria:
- 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.
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.
Trial location(s)
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2012-27-10
Actual study completion date
2012-27-10
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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