A Study to Assess the Immunogenicity and Safety of GSK Biologicals' Infanrix-IPV/Hib Vaccine Administered as a Three-dose 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

NCT ID: NCT02858440

Last Updated: 2019-09-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 235 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-13
• Study Completion Date: 2018-11-13

Brief Summary

The purpose of this study is to evaluate the immune response, safety and reactogenicity after receiving combined DTPa-IPV/Hib vaccine when administered as a three-dose primary vaccination course at 3, 4.5 and 6 months of age and as a booster dose at 18 months of age in Russian healthy children according to the Russian immunisation schedule

Conditions

Diphtheria; Tetanus; Pertussis; Hepatitis B; Haemophilus Influenzae Type b

Study Design

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

Study Groups

DTPa-IPV/Hib Group

All subjects receive three doses of primary vaccination of the study vaccine, Infanrix-IPV/Hib (DTPa-IPV/Hib), at 3, 4.5 and 6 months of age and a single dose of booster vaccination at 18 months of age. The vaccine is administered intramuscularly into the upper side of the thigh on the right/left side.

Group Type: EXPERIMENTAL

Infanrix-IPV/Hib

Intervention Type: BIOLOGICAL

Subjects receive Infanrix-IPV/Hib three-dose primary vaccination course at 3, 4.5 and 6 months of age and a booster dose at 18 months of age. The vaccine is administered intramuscularly into the upper side of the thigh on the right/left side.

Interventions

Infanrix-IPV/Hib

Subjects receive Infanrix-IPV/Hib three-dose primary vaccination course at 3, 4.5 and 6 months of age and a booster dose at 18 months of age. The vaccine is administered intramuscularly into the upper side of the thigh on the right/left side.

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Subjects' parent(s)/Legally Acceptable Representatives [LARs] 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/LARs 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.

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.
• Family history of congenital or hereditary immunodeficiency.
• History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine.
• Major congenital defects.
• Serious chronic illness.
• History of any neurological disorders or seizures.
• Acute disease and/or fever at the time of enrolment.

• Fever is defined as temperature ≥37.5°C for oral, axillary or tympanic route, or ≥38.0°C for rectal route.
• Subjects with a minor illness without fever may be enrolled at the discretion of the investigator.
• Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.

• Minimum Eligible Age: 3 Months
• Maximum Eligible Age: 19 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

Murmansk, , Russia

GSK Investigational Site

Saint Petersburg, , Russia

GSK Investigational Site

Tomsk, , Russia

GSK Investigational Site

Yekaterinburg, , Russia

Countries

Russia

References

Romanenko V, Osipova I, Galustyan A, Scherbakov M, Baudson N, Farhi D, Anaya L, Kuriyakose SO, Meyer N, Janssens W. Immunogenicity and safety of a combined DTPa-IPV/Hib vaccine administered as a three-dose primary vaccination course and a booster dose in healthy children in Russia: a phase III, non-randomized, open-label study. Hum Vaccin Immunother. 2020 Sep 1;16(9):2265-2273. doi: 10.1080/21645515.2020.1720437. Epub 2020 Feb 12.

Reference Type: DERIVED

PMID: 32048889 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2013-005577-43

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

116194

Identifier Type: -

Identifier Source: org_study_id