AzTrials
AzTrials

DiphtheriaPhase 3NCT02858440

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

A Phase 3 study testing Infanrix-IPV/Hib in people with Diphtheria and Tetanus, run by GlaxoSmithKline at 5 sites in Russia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 3 to 19 monthsHealthy volunteers can take part
Conditions the study is for
Diphtheria, Tetanus, Pertussis
What is being tested?
Infanrix-IPV/Hib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
235 participants
Where
5 sitesRussia
Study dates
13 Sep 2016to 13 Nov 2018
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 3 to 19 months
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 19Show fewer
  • 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.

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

Russia5 sites

  • GSK Investigational Site

    Barnaul, 656056

  • GSK Investigational Site

    Murmansk, 183038

  • GSK Investigational Site

    Saint Petersburg, 191025

  • GSK Investigational Site

    Tomsk, 634 050

  • GSK Investigational Site

    Yekaterinburg, 620131

Other trials in Russia

About this study

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

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

Being tested
Infanrix-IPV/Hib
Keywords
Primary dose, Reactogenicity, Immunogenicity, Booster dose, Combined vaccine, Russian Infants, Infanrix®-IPV/Hib
Medical subject headings
Diphtheria, Tetanus, Whooping Cough, Hepatitis B, Haemophilus Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Infanrix-IPV/HibBiological

    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.

Study groups in NCT02858440
Study groupRoleWhat they receive
DTPa-IPV/Hib GroupExperimentalAll 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.
Receives: Biological: Infanrix-IPV/Hib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

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

  2. 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.

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

  3. 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).

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

  4. 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.

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

Secondary outcomes (19)

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

    A seroprotected subject is a subject whose anti-D and anti-T antibody concentration was ≥ 0.1 IU/mL.

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

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

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

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

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

    A seroprotected subject is a subject whose anti-PRP antibody concentration was ≥ 0.15 µg/mL.

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

  4. Number of Seropositive Subjects for Anti- PT, Anti-FHA and Anti-PRN, Post Booster 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.

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

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

    The antibody concentrations for anti-D and anti-T were presented as geometric mean concentrations (GMCs) and expressed as IU/mL.

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

  6. Antibody Concentrations for Anti-D and Anti-T, Post Booster Vaccination

    The antibody concentrations for anti-D and anti-T were presented as geometric mean concentrations (GMCs) and expressed as IU/mL.

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

  7. Antibody Titers for Anti-polio Types 1, 2 and 3, Post Primary Vaccination

    The antibody titers for anti-polio types 1, 2 and 3 were presented as geometric mean titres (GMTs).

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

  8. Antibody Titers for Anti-polio Types 1, 2 and 3, Post Booster Vaccination

    The antibody titers for anti-polio types 1, 2 and 3 were presented as geometric mean titres (GMTs).

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

  9. Antibody Concentration for Anti-PRP, Post Primary Vaccination

    The antibody concentrations for anti-PRP were presented as geometric mean concentrations (GMCs) and expressed as µg/mL.

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

  10. Antibody Concentration for Anti-PRP, Post Booster Vaccination

    The antibody concentrations for anti-PRP were presented as geometric mean concentrations (GMCs) and expressed as µg/mL.

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

  11. Antibody Concentrations for Anti-PT, Anti-FHA and Anti-PRN, Post Primary Vaccination

    The antibody concentrations for anti-PT, anti-FHA and anti-PRN were presented as GMCs and expressed as IU/mL.

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

  12. Antibody Concentrations for Anti-PT, Anti-FHA and Anti-PRN, Post Booster Vaccination

    The antibody concentrations for anti-PT, anti-FHA and anti-PRN were presented as GMCs and expressed as IU/mL.

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

  13. Number of Subjects With Any Solicited Local Adverse Events (AEs) Following Each Dose of Primary Vaccination

    The solicited local AEs assessed were pain, redness and swelling at injection site. Any = Occurrence of the AE regardless of the intensity grade.

    Measured: 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)

  14. Number of Subjects With Any Solicited Local AEs Following Booster Vaccination

    The solicited local AEs assessed were pain, redness and swelling at injection site. Any = Occurrence of the AE regardless of the intensity grade.

    Measured: During the 4-day (Days 0-3) follow-up period after booster vaccination dose (i.e. at Month 15)

  15. Number of Subjects With Any Solicited General AEs Following Each Dose of Primary Vaccination

    The solicited general AEs assessed were drowsiness, irritability/fussiness, loss of appetite and fever. Any = Occurrence of the AE regardless of the intensity grade. Any fever = Fever (axillary) ≥ 37.5°C.

    Measured: 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)

  16. Number of Subjects With Any Solicited General AEs Following Booster Vaccination

    The solicited general AEs assessed were drowsiness, irritability/fussiness, loss of appetite and fever. Any = Occurrence of the AE regardless of the intensity grade. Any fever = Fever (axillary) ≥ 37.5°C.

    Measured: During the 4-day (Days 0-3) follow-up period after booster vaccination dose (i.e. at Month 15)

  17. Number of Subjects With Unsolicited AEs Following Each Dose of Primary Vaccination

    An unsolicited AE was defined as any AE reported in addition to those solicited during the clinical study and any solicited AE with onset outside the specified period of follow-up for solicited AEs. Any = Occurrence of the AE regardless of the intensity grade.

    Measured: 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)

  18. Number of Subjects With Unsolicited AEs Following Booster Vaccination

    An unsolicited AE was defined as any AE reported in addition to those solicited during the clinical study and any solicited AE with onset outside the specified period of follow-up for solicited AEs. Any = Occurrence of the AE regardless of the intensity grade.

    Measured: During the 31-day (Days 0-30) follow-up period after booster vaccination dose (i.e. at Month 15)

  19. Number of Subjects With Serious Adverse Events (SAEs)

    The SAEs assessed included any untoward medical occurrences that resulted in death, were life threatening, required hospitalisation or prolongation of existing hospitalisation or resulted in disability/incapacity. Any = Occurrence of the AE regardless of the intensity grade.

    Measured: During the entire study period (i.e. from Day 0 until Month 16)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Aug 2016 (estimated)
  2. Study start13 Sep 2016
  3. Primary completion24 Oct 2017
  4. Study completion13 Nov 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
235 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02858440
Sponsor's protocol ID
116194
Other IDs
2013-005577-43
Status last verified
Sep 2019
First submitted
29 Jul 2016
Last updated
24 Sep 2019
Individual data sharing
Yes: IPD for this study will be made available via the Clinical Study Data Request site.

Publications

  • 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.

    PubMed 32048889

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Infanrix-IPV/Hib in people with Diphtheria and Tetanus, run by GlaxoSmithKline at 5 sites in Russia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Seroprotected Subjects for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T), Post Primary Vaccination (time frame: At Month 4 (i.e. one month after 3rd dose of primary vaccination)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02858440, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2019.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in