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

NCT02858440 | Completed Phase 3 Results

• 2 other identifiers: 1161942013-005577-43
• Study Type: interventional
• Target: 235
• Locations: 1 country
• Sites: 5

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

Keywords

Primary dose; Reactogenicity; Immunogenicity; Booster dose; Combined vaccine; Russian Infants; Infanrix®-IPV/Hib

Outcome Measures

Primary Outcomes (4)

• Number of Seroprotected Subjects for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T), Post Primary Vaccination

  A seroprotected subject is a subject whose anti-D and anti-T antibody concentration was greater than or equal to (≥) 0.1 International Units per milliliter (IU/mL).

  At Month 4 (i.e. one month after 3rd dose of primary vaccination)

• Number of Seroprotected Subjects for Anti-poliovirus Types 1, 2 and 3, Post Primary Vaccination

  A seroprotected subject is a subject whose anti-poliovirus types 1, 2 and 3 antibody titer was ≥ 8 ED50.

  At Month 4 (i.e. one month after 3rd dose of primary vaccination)

• Number of Seroprotected Subjects for Anti-polyribosyl Ribitol Phosphate (Anti-PRP), Post Primary Vaccination

  A seroprotected subject is a subject whose anti-PRP antibody concentration was ≥ 0.15 micrograms per milliliter (µg/mL).

  At Month 4 (i.e. one month after 3rd dose of primary vaccination)

• Number of Seropositive Subjects for Anti-pertussis (Anti- PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN), Post Primary Vaccination

  A seropositive subject is a subject whose antibody concentration was ≥ 2.046 IU/mL for anti-FHA, ≥ 2.187 IU/mL for anti-PRN and ≥ 2.693 IU/mL for anti-PT.

  At Month 4 (i.e. one month after 3rd dose of primary vaccination)

Secondary Outcomes (19)

• Number of Seroprotected Subjects for Anti-D and Anti-T, Post Booster Vaccination

  At Month 16 (i.e. one month after booster vaccination)

• Number of Seroprotected Subjects for Anti-poliovirus Types 1, 2 and 3, Post Booster Vaccination

  At Month 16 (i.e. one month after booster vaccination)

• Number of Seroprotected Subjects for Anti-PRP, Post Booster Vaccination

  At Month 16 (i.e. one month after booster vaccination)

• Number of Seropositive Subjects for Anti- PT, Anti-FHA and Anti-PRN, Post Booster Vaccination

  At Month 16 (i.e. one month after booster vaccination)

• Antibody Concentrations for Anti-D and Anti-T, Post Primary Vaccination

  At Month 4 (i.e. one month after 3rd dose of primary vaccination)

Study Arms (1)

DTPa-IPV/Hib Group

EXPERIMENTAL

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.

Biological: Infanrix-IPV/Hib

Interventions

Infanrix-IPV/Hib 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.

DTPa-IPV/Hib Group

Eligibility Criteria

• Age: 3 Months - 19 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (5)

GSK Investigational Site

Barnaul, 656056, Russia

Location

GSK Investigational Site

Murmansk, 183038, Russia

Location

GSK Investigational Site

Saint Petersburg, 191025, Russia

Location

GSK Investigational Site

Tomsk, 634 050, Russia

Location

GSK Investigational Site

Yekaterinburg, 620131, Russia

Location

Related Publications (1)

• 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.

  PMID: 32048889 DERIVED

MeSH Terms

Conditions

Diphtheria; Tetanus; Whooping Cough; Hepatitis B; Haemophilus Infections

Interventions

diphtheria-tetanus-acellular pertussis-inactivated poliovirus-Haemophilus influenzae b conjugate-hepatitis B vaccine

Condition Hierarchy (Ancestors)

Corynebacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Clostridium Infections; Bordetella Infections; Gram-Negative Bacterial Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Blood-Borne Infections; Communicable Diseases; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases; Pasteurellaceae Infections

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

lrs54533@gsk.com

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2016
• First Posted: August 8, 2016
• Study Start: September 13, 2016
• Primary Completion: October 24, 2017
• Study Completion: November 13, 2018
• Last Updated: September 24, 2019
• Results First Posted: July 19, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: IPD will be made available within 6 months of publishing the results of the primary endpoints of the study.
• Access Criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.

Locations

RU (5)