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TetanusPhase 2NCT01171989

Immunogenicity and Safety Study of GlaxoSmithKline Biologicals' GSK2202083A Vaccine Administered as a Booster Dose

A Phase 2 study testing GSK2202083A vaccine, Infanrix hexa™ and Menjugate™ in people with Tetanus and Diphtheria, run by GlaxoSmithKline at 9 sites in Poland.

Completed

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

Official record
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Trial summary

The current trial will evaluate the safety and immunogenicity of GSK Biologicals' GSK2202083A vaccine when administered as a booster dose following priming in the first year of life with the same vaccine. This protocol posting deals with objectives \& outcome measures of the booster phase. Read more about this study

Who is it for?
Ages 12 to 18 monthsHealthy volunteers can take part
Conditions the study is for
Tetanus, Diphtheria, Haemophilus Influenzae Type b
What is being tested?
GSK2202083A vaccine, Infanrix hexa™ and Menjugate™
Could I receive a placebo?
No, everyone receives an active treatment
How many people
391 participants
Where
9 sitesPoland
Study dates
18 Aug 2010to 3 Dec 2010
Phase
Phase 2
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 12 to 18 months
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Subjects who the investigator believes that parent(s)/ legally acceptable representative(s) can and will comply with the requirements of the protocol.
  • Subjects who have completed the full three-dose primary vaccination course according to their group allocation in the primary study DTPa-HBV-IPV=Hib-MenC-TT-002 (112157).
  • A male or female between, and including, 12 and 18 months of age at the time of booster vaccination.
  • Written informed consent obtained from the parent(s)/ legally acceptable representative(s) of the subject.
  • Healthy subjects as established by medical history and clinical examination before entering into the study.

Who cannot join

  • Child in care.
  • Use of any investigational or non-registered product other than the study vaccines within 30 days preceding the dose of study vaccine, or planned use during the study period.
  • Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the booster vaccination.
  • Planned administration/administration of immunoglobulins and/or any blood products within three months before the booster dose, or during the study period.
  • Planned administration/administration of any vaccine not foreseen by the study protocol during the period starting 30 days before and ending 30 days after the booster dose.
  • Participation in another clinical study since the primary study DTPa-HBV-IPV/Hib-MenC-TT-002 in which the subject has been or will be exposed to an investigational or a non-investigational product.
Show all 19Show fewer
  • Evidence of previous diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis, Hib, pneumococcal and MenC vaccination or disease since the conclusion visit of study DTPa-HBV-IPV/Hib-MenC-TT-002.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
  • History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines.
  • The following adverse event having occurred after previous administration of DTP vaccine:
  • Encephalopathy.
  • Temperature of >= 40.5°C (rectal temperature) within 48 hours of vaccination, not due to another identifiable cause.
  • Collapse or shock-like state within 48 hours of vaccination.
  • Persistent, inconsolable crying occurring within 48 hours of vaccination and lasting >= 3 hours.
  • Seizures with or without fever occurring within 3 days of vaccination.
  • The following condition is temporary or self-limiting, and a subject may be vaccinated once the condition has resolved if no other exclusion criteria is met:
  • Acute disease and/or fever at the time of enrolment.
  • Fever is defined as temperature ≥ 37.5°C on oral, axillary or tympanic setting, or ≥ 38.0°C on rectal setting.
  • Subjects with a minor illness without fever may be enrolled at the discretion of the investigator.

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

Poland9 sites

  • GSK Investigational Site

    Bydgoszcz, 85-021

  • GSK Investigational Site

    Dębica, 39-200

  • GSK Investigational Site

    Krakow, 31-422

  • GSK Investigational Site

    Krakow, 31-503

  • GSK Investigational Site

    Siemianowice Śląskie, 41-103

  • GSK Investigational Site

    Tarnów, 33-100

  • GSK Investigational Site

    Torun

  • GSK Investigational Site

    Trzebnica, 55-100

  • GSK Investigational Site

    Wroclaw, 50345

Other trials in Poland

About this study

Official title: Immunogenicity and Safety Study of GlaxoSmithKline Biologicals' GSK2202083A Vaccine Administered as a Booster Dose in 12-18 Months Old Healthy Children

The current trial will evaluate the safety and immunogenicity of GSK Biologicals' GSK2202083A vaccine when administered as a booster dose following priming in the first year of life with the same vaccine.

This protocol posting deals with objectives \& outcome measures of the booster phase. The objectives \& outcome measures of the primary phase are presented in a separate protocol posting (NCT number = NCT00970307).

Being tested
GSK2202083A vaccine, Infanrix hexa™, Menjugate™, NeisVac-C™, Synflorix™
Keywords
booster vaccination, combined vaccine
Medical subject headings
Tetanus, Diphtheria, Haemophilus Infections, Hepatitis B, Poliomyelitis

What participants receive

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

  • GSK2202083A vaccineBiological

    Intramuscular, one dose.

  • Infanrix hexa™Biological

    Intramuscular, one dose.

  • Menjugate™Biological

    Intramuscular, one dose.

  • NeisVac-C™Biological

    Intramuscular, one dose.

  • Synflorix™Biological

    Intramuscular, one dose.

Study groups in NCT01171989
Study groupRoleWhat they receive
GSK2202083A + SYNFLORIX GROUPExperimentalHealthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of GSK2202083A and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of GSK2202083A vaccine at Day 0 and of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
Receives: Biological: GSK2202083A vaccine; Biological: Synflorix™
INFANRIX HEXA/MENJUGATE GROUPActive comparatorHealthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and 2 doses of Menjugate® vaccine in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with Menjugate® vaccine at Day 0. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
Receives: Biological: Infanrix hexa™; Biological: Menjugate™
INFANRIX HEXA/NEISVAC-C + SYNFLORIX GROUPActive comparatorHealthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with NeisVac-C® vaccine at Day 0 and 1 dose of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
Receives: Biological: Infanrix hexa™; Biological: NeisVac-C™; Biological: Synflorix™

What is being measured

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

  1. Number of Seroprotected Subjects Against Polyribosyl-Ribitol-Phosphate (PRP)

    A seroprotected subject was defined as a subject with anti-PRP antibody concentrations greater than or equal to (≥) 0.15 micrograms per milliliter (μg/mL).

    Measured: At Month 1, post-booster dose

  2. Number of Seroprotected Subjects Against Neisseria Meningitidis Serogroup C Using Baby Rabbit Completent (rSBA-MenC)

    A seroprotected subject was defined as a subject with anti-rSBA-MenC titers greater than or equal to (≥) 1:8.

    Measured: At Month 1, post-booster dose

Secondary outcomes (20)

  1. Number of Seropositive Subjects for Anti-PRP

    A seropositive subject was defined as a subject with anti-PRP antibody concentrations ≥ 0.15 μg/mL.

    Measured: At Month 0, before the booster dose

  2. Number of Subjects With Anti-PRP Antibody Concentrations ≥ the Cut-off

    The cut-off value of the assay was an anti-PRP antibody concentration ≥ 1 μg/mL.

    Measured: At Month 0 and Month 1, before and one month after booster dose

  3. Anti-PRP Antibody Concentrations

    Concentrations were expressed as geometric mean concentrations (GMCs) for the cut-off value of ≥ 0.15 μg/mL.

    Measured: At Month 0 and Month 1, before and one month after booster dose

  4. Number of Seroprotected Subjects Against rSBA-MenC

    A seroprotected subject was defined as a subject with anti-rSBA-MenC antibody titers ≥ 1:8.

    Measured: At Month 0, before the booster dose

  5. Number of Seropositive Subjects for Anti-rSBA-MenC

    A seropositive subject for anti-rSBA-MenC was defined as a subject with antibody titers greater than or equal to (≥) 1:128.

    Measured: At Month 0 and Month 1, before and one month after booster dose

  6. Anti-rSBA-MenC Antibody Titres

    Antibody titers were expressed as geometric mean titers (GMTs) for the seroprotection cut-off value of ≥ 1:8.

    Measured: At Month 0 and Month 1, before and one month after booster dose

  7. Number of Subjects With Polysaccharide N. Meningitidis Serogroup C (PSC) Antibody Concentrations ≥ Cut-off Values

    The cut-off values assessed were ≥ 0.3 μg/mL and ≥ 2 μg/mL.

    Measured: At Month 0 and Month 1, before and one month after booster dose

  8. Anti-PSC Antibody Concentrations

    Concentrations were expressed as geometric mean concentrations (GMCs) for the seropositivity cut-off value of ≥ 0.3 μg/mL.

    Measured: At Month 0 and Month 1, before and one month after booster dose

  9. Number of Seropositive Subjects for Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T)

    A seropositive subject was defined as a subject with anti-D and anti-T antibody concentrations ≥ 0.1 international units per milliliter (IU/mL).

    Measured: At Month 0 and Month 1, before and one month after booster dose

  10. Anti-D and Anti-T Antibody Concentrations

    Concentrations were expressed as geometric mean concentrations (GMCs) for the seropositivity cut-off value of ≥ 0.1 IU/mL.

    Measured: At Month 0 and Month 1, before and one month after booster dose

  11. Number of Subjects With Anti-hepatitis B (Anti-HBs) Antibody Concentrations ≥ Cut-off Values

    The cut-off values assessed were 3.3 milli-international units per milliliter (mIU/mL), 10 mIU/mL and 100 mIU/mL.

    Measured: At Month 0 and Month 1, before and one month after booster dose

  12. Anti-HBs Antibody Concentrations

    Concentrations were presented as geometric mean concentrations (GMCs), expressed in mIU/mL.

    Measured: At Month 0 and Month 1, before and after booster dose

  13. Number of Seropositive Subjects for Anti-poliovirus Types 1, 2 and 3

    A seropositive subject was defined as a subject with anti-polio type 1, 2 or 3 ≥ 1:8.

    Measured: At Month 0 and Month 1, before and one month after booster dose

  14. Anti-poliovirus Types 1, 2 and 3 Antibody Titres

    Titers were expressed as geometric mean titters (GMTs) for the seropositivity cut-off value of ≥ 1:8.

    Measured: At Month 0 and Month 1, before and one month after booster dose

  15. Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN)

    A seropositive subject was defined as a subject with anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 5 enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).

    Measured: At Month 0 and Month 1, before and one month after booster dose

  16. Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations

    Concentrations were expressed as geometric mean concentrations (GMCs) for the seropositivity cut-off value ≥ 5 EL.U/mL.

    Measured: At Month 0 and Month 1, before and one month after booster dose

  17. Number of Subjects With Any Solicited Local Symptoms

    Solicited local symptoms assessed included pain, redness and swelling. Any= all reports of the speecified symptom irrespective of intensity grade.

    Measured: During the 8-day (Days 0-7) post-booster period

  18. Number of Subjects With Any Solicited General Symptoms

    Solicited general symptoms assessed included drowsiness, irritability, loss of appetite and fever (defined as axillary temperature ≥ 37.5º C). Any= all reports of the specified symptom irrespective of intensity grade and relationship to vaccination.

    Measured: During the 8-day (Days 0-7) post-booster period

  19. Number of Subjects With Unsolicited Adverse Events (AEs)

    An unsolicited AE was any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.

    Measured: During the 31-day (Days 0-30) post-booster period

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

    SAEs were defined as medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity.

    Measured: After the booster dose of the study vaccine up to the study end (from Month 0 to Month 1)

Timeline

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

  1. First posted29 Jul 2010 (estimated)
  2. Study start18 Aug 2010
  3. Primary completion3 Dec 2010
  4. Study completion3 Dec 2010

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 2
Primary purpose
Prevention
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
391 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01171989
Sponsor's protocol ID
113978
Other IDs
2010-019253-18
Status last verified
Jan 2020
First submitted
27 Jul 2010
Last updated
21 Jan 2020
Individual data sharing
Yes: IPD is available via the Clinical Study Data Request site (click on the link provided below)

Publications

  • Szenborn L, Czajka H, Brzostek J, Konior R, Caubet M, Ulianov L, Leyssen M. A randomized, controlled trial to assess the immunogenicity and safety of a heptavalent diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis, hib and meningococcal serogroup C combination vaccine administered at 2, 3, 4 and 12-18 months of age. Pediatr Infect Dis J. 2013 Jul;32(7):777-85. doi: 10.1097/INF.0b013e31828d6b20.

    PubMed 23838777

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing GSK2202083A vaccine, Infanrix hexa™ and Menjugate™ in people with Tetanus and Diphtheria, run by GlaxoSmithKline at 9 sites in Poland.

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 21 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in Poland. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 11 Apr 2017). 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 Against Polyribosyl-Ribitol-Phosphate (PRP) (time frame: At Month 1, post-booster dose). The study lists 2 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 NCT01171989, 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 21 Jan 2020.

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