Clinical trial NCT02858440: 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
Official title: Immunogenicity and Safety of GSK Biologicals' Combined Diphtheria-tetanus-acellular Pertussis-inactivated Poliovirus and Haemophilus Influenzae Type b (DTPa-IPV/Hib) Conjugate Vaccine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diphtheria
Tetanus
Pertussis
Hepatitis B
Haemophilus Influenzae Type b
Keywords: Primary dose
Reactogenicity
Immunogenicity
Booster dose
Combined vaccine
Russian Infants
Infanrix®-IPV/Hib
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2016-08-08
Enrollment: 235
Sex: ALL
Minimum age (years): 3
Maximum age (years): 19
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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


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.

Primary outcomes:
measure: Number of Seroprotected Subjects for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T), Post Primary Vaccination
timeFrame: At Month 4 (i.e. one month after 3rd dose of primary vaccination)
measure: Number of Seroprotected Subjects for Anti-poliovirus Types 1, 2 and 3, Post Primary Vaccination
timeFrame: At Month 4 (i.e. one month after 3rd dose of primary vaccination)
measure: Number of Seroprotected Subjects for Anti-polyribosyl Ribitol Phosphate (Anti-PRP), Post Primary Vaccination
timeFrame: At Month 4 (i.e. one month after 3rd dose of primary vaccination)
measure: Number of Seropositive Subjects for Anti-pertussis (Anti- PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN), Post Primary Vaccination
timeFrame: At Month 4 (i.e. one month after 3rd dose of primary vaccination)
Secondary outcomes:
measure: Number of Seroprotected Subjects for Anti-D and Anti-T, Post Booster Vaccination
timeFrame: At Month 16 (i.e. one month after booster vaccination)
measure: Number of Seroprotected Subjects for Anti-poliovirus Types 1, 2 and 3, Post Booster Vaccination
timeFrame: At Month 16 (i.e. one month after booster vaccination)
measure: Number of Seroprotected Subjects for Anti-PRP, Post Booster Vaccination
timeFrame: At Month 16 (i.e. one month after booster vaccination)
measure: Number of Seropositive Subjects for Anti- PT, Anti-FHA and Anti-PRN, Post Booster Vaccination
timeFrame: At Month 16 (i.e. one month after booster vaccination)
measure: Antibody Concentrations for Anti-D and Anti-T, Post Primary Vaccination
timeFrame: At Month 4 (i.e. one month after 3rd dose of primary vaccination)
measure: Antibody Concentrations for Anti-D and Anti-T, Post Booster Vaccination
timeFrame: At Month 16 (i.e. one month after booster vaccination)
measure: Antibody Titers for Anti-polio Types 1, 2 and 3, Post Primary Vaccination
timeFrame: At Month 4 (i.e. one month after 3rd dose of primary vaccination)
measure: Antibody Titers for Anti-polio Types 1, 2 and 3, Post Booster Vaccination
timeFrame: At Month 16 (i.e. one month after booster vaccination)
measure: Antibody Concentration for Anti-PRP, Post Primary Vaccination
timeFrame: At Month 4 (i.e. one month after 3rd dose of primary vaccination)
measure: Antibody Concentration for Anti-PRP, Post Booster Vaccination
timeFrame: At Month 16 (i.e. one month after booster vaccination)
measure: Antibody Concentrations for Anti-PT, Anti-FHA and Anti-PRN, Post Primary Vaccination
timeFrame: At Month 4 (i.e. one month after 3rd dose of primary vaccination)
measure: Antibody Concentrations for Anti-PT, Anti-FHA and Anti-PRN, Post Booster Vaccination
timeFrame: At Month 16 (i.e. one month after booster vaccination)
measure: Number of Subjects With Any Solicited Local Adverse Events (AEs) Following Each Dose of Primary Vaccination
timeFrame: During the 4-day (Days 0-3) follow-up period after each primary vaccination dose (i.e. at Day 0, at Month 1.5 and at Month 3)
measure: Number of Subjects With Any Solicited Local AEs Following Booster Vaccination
timeFrame: During the 4-day (Days 0-3) follow-up period after booster vaccination dose (i.e. at Month 15)
measure: Number of Subjects With Any Solicited General AEs Following Each Dose of Primary Vaccination
timeFrame: During the 4-day (Days 0-3) follow-up period after each primary vaccination dose (i.e. at Day 0, at Month 1.5 and at Month 3)
measure: Number of Subjects With Any Solicited General AEs Following Booster Vaccination
timeFrame: During the 4-day (Days 0-3) follow-up period after booster vaccination dose (i.e. at Month 15)
measure: Number of Subjects With Unsolicited AEs Following Each Dose of Primary Vaccination
timeFrame: During the 31-day (Days 0-30) follow-up period after each primary vaccination dose (i.e. at Day 0, at Month 1.5 and at Month 3)
measure: Number of Subjects With Unsolicited AEs Following Booster Vaccination
timeFrame: During the 31-day (Days 0-30) follow-up period after booster vaccination dose (i.e. at Month 15)
measure: Number of Subjects With Serious Adverse Events (SAEs)
timeFrame: During the entire study period (i.e. from Day 0 until Month 16)
Other outcomes:
Locations:
city: Barnaul
country: Russian Federation
facility: GSK Investigational Site
city: Ekaterinburg
country: Russian Federation
facility: GSK Investigational Site
city: Murmansk
country: Russian Federation
facility: GSK Investigational Site
city: St.Petersburg
country: Russian Federation
facility: GSK Investigational Site
city: Tomsk
country: Russian Federation
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.