A phase III, open-label study to assess the immunogenicity and reactogenicity of GSK Biologicals’ DTPa-IPV/Hib vaccine administered as a three-dose primary vaccination course at 3, 4.5 and 6 months of age and a booster dose at 18 months of age in healthy infants in Russia. - DTPA-IPV (INFANRIX-IPV)-061

GlaxoSmithKline Biologicals0 sites235 target enrollmentAugust 17, 2016

DrugsInfanrix® -IPV/Hib

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Not specified
Sponsor: GlaxoSmithKline Biologicals
Enrollment: 235
Status: Active, not recruiting
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

August 17, 2016

End Date

TBD

Last Updated

9 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

GlaxoSmithKline Biologicals

Eligibility Criteria

Inclusion Criteria

•Subjects’ parent(s)/adoptive parent(s) who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
•A male or female child between 3 and 4 months of age at the time of the first vaccination.
•Written informed consent obtained from the parents/adoptive parent(s) of the subject prior to performing any study specific procedure.
•Healthy subjects as established by medical history and clinical examination before entering into the study.
•Born full\-term
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 235
•F.1\.2 Adults (18\-64 years) no
•F.1\.2\.1 Number of subjects for this age range
•F.1\.3 Elderly (\>\=65 years) no

Exclusion Criteria

•Child in care
•Use of any investigational or non\-registered product other than the study vaccine during the period starting 30 days before the first dose of study vaccine, or planned use during the study period.
•Any medical condition that in the judgment of the investigator would make intramuscular injection unsafe.
•Chronic administration of immunosuppressants or other immune\-modifying drugs during the period starting since birth. For corticosteroids, this will mean prednisone \>\= 0\.5 mg/kg/day, or equivalent. Inhaled and topical steroids are allowed.
•Administration of long\-acting immune\-modifying drugs at any time during the study period
•Planned administration/administration of a vaccine not foreseen by the study protocol in the period starting 30 days before the first dose and ending 30 days after the last dose of vaccine administration, with the exception of hepatitis B and other vaccines given as part of the national immunisation schedule and as part of routine vaccination practice, that are allowed at any time during the study period. Seasonal or pandemic influenza vaccine can be given at any time during the study, and according to the Summary of Product Characteristics and national recommendations.
•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 vaccine/product
•Previous vaccination against diphtheria, tetanus, pertussis, poliomyelitis and Hib diseases.
•History of diphtheria, tetanus, pertussis, poliomyelitis and Hib diseases.
•Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.