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Acellular PertussisPhase 3NCT00871000

Immunogenicity and Safety of Boostrix Polio Vaccine as a Booster Dose in 5 to 6-year-old Children.

A Phase 3 study testing Boostrix Polio™ 711866, Priorix Tetra TM 208136 and Tetravac TM in people with Acellular Pertussis and Tetanus, run by GlaxoSmithKline at 8 sites in Italy.

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

This phase 3b study will compare the immunogenicity and reactogenicity of the dTpa-IPV vaccine to that of a DTPa-IPV vaccine when administered as a booster dose in healthy children 5-6 years of age who have received three primary vaccination doses of DTPa-based vaccine according to the "3-5-11" month schedule… Read more about this study

Who is it for?
Ages 5 to 6 yearsHealthy volunteers can take part
Conditions the study is for
Acellular Pertussis, Tetanus, Diphtheria
What is being tested?
Boostrix Polio™ 711866, Priorix Tetra TM 208136 and Tetravac TM
Could I receive a placebo?
No, everyone receives an active treatment
How many people
303 participants
Where
8 sitesItaly
Study dates
1 Apr 2009to 18 Nov 2009
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 5 to 6 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • A male or female child of 5 and 6 years of age at the time of vaccination.
  • Subjects who received a complete 3-dose vaccination with a DTPa-based combined vaccine according to a 3-5-11 month schedule in line with recommendations in Italy.
  • Subjects who received a first dose of a live attenuated measles-mumps-rubella vaccine in the second year of life, in line with recommendations in Italy.
  • Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study.
  • Written informed consent obtained from the parent or guardian of the subject.
  • Healthy subjects as established by medical history and clinical examination before entering into the study.

Who cannot join

  • Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the first 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 vaccine dose.
  • Administration of a vaccine not foreseen by the study protocol within 30 days prior to vaccination, or planned administration during the study period.
  • 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 product.
  • Previous booster vaccination against tetanus, diphtheria, pertussis and/or poliomyelitis since vaccination in the first two years of life.
  • Previous measles, mumps, rubella and/or varicella second dose vaccination.
Show all 21Show fewer
  • Known history of diphtheria, tetanus, pertussis, poliomyelitis, measles, mumps, rubella and/or varicella disease.
  • Known exposure to measles, mumps, rubella and/or varicella within 30 days prior to study start.
  • Any confirmed or suspected immunosuppressive or immunodeficiency condition, based on medical history and physical examination.
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
  • Administration of immunoglobulin and/or any blood products within the three months preceding vaccination or planned administration during the study period.
  • Occurrence of transient thrombocytopenia or neurological complications following an earlier immunisation against diphtheria and/or tetanus.
  • Occurrence of any of the following adverse events after a previous administration of a DTP vaccine:
  • Hypersensitivity reaction to any component of the vaccine;
  • Encephalopathy of unknown aetiology occurring within 7 days following previous vaccination with pertussis-containing vaccine;
  • Fever >= 40°C within 48 hours of vaccination, not due to another identifiable cause;
  • Collapse or shock-like state within 48 hours of vaccination;
  • Convulsions with or without fever, occurring within 3 days of vaccination.
  • Residence in the same household as a person high risk for varicella
  • 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:
  • Current febrile illness or axillary temperature ≥ 38.5 ºC or other moderate to severe illness within 24 hours of study vaccine administration.

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

Italy8 sites

  • GSK Investigational Site

    Cagliari, Sardinia, 09127

  • GSK Investigational Site

    Catania, Sicily, 95129

  • GSK Investigational Site

    Genoa, Liguria, 16132

  • GSK Investigational Site

    Milan, Lombardy, 20122

  • GSK Investigational Site

    Modica (RG), Sicily, 97100

  • GSK Investigational Site

    Novara, Piedmont, 28100

  • GSK Investigational Site

    Ragusa, Sicily, 97100

  • GSK Investigational Site

    Vittoria (RG)

Other trials in Italy

About this study

Official title: Immunogenicity and Safety of GSK Biologicals' dTpa-IPV Vaccine (Boostrix Polio) as a Booster Dose in 5 to 6-year-old Children.

This phase 3b study will compare the immunogenicity and reactogenicity of the dTpa-IPV vaccine to that of a DTPa-IPV vaccine when administered as a booster dose in healthy children 5-6 years of age who have received three primary vaccination doses of DTPa-based vaccine according to the "3-5-11" month schedule recommended in Italy.

In this study, MMRV vaccine will also be co-administered to all children.

Being tested
Boostrix Polio™ 711866, Priorix Tetra TM 208136, Tetravac TM
Keywords
Boostrix Polio, dTpa-IPV
Medical subject headings
Tetanus, Diphtheria, Poliomyelitis

What participants receive

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

  • Boostrix Polio™ 711866Biological

    Also called dTpa-IPV

    Single dose, intramuscular administration.

  • Priorix Tetra TM 208136Biological

    Also called MMRV

    Single dose, subcutaneously.

  • Tetravac TMBiological

    Also called DTPa-IPV

    Single dose, intramuscular administration.

Study groups in NCT00871000
Study groupRoleWhat they receive
BOOSTRIX POLIO GROUPExperimentalHealthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Boostrix Polio™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Boostrix Polio™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
Receives: Biological: Boostrix Polio™ 711866; Biological: Priorix Tetra TM 208136
TETRAVAC GROUPActive comparatorHealthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Tetravac™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Tetravac™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
Receives: Biological: Priorix Tetra TM 208136; Biological: Tetravac TM

What is being measured

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

  1. Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibody Concentrations

    Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in international units per milliliter (IU/mL). The reference cut-off value was greater than or equal to (≥) 0.1 IU/mL.

    Measured: At Month 1, one month post-vaccination

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

    Antibody titers were presented as geometric mean titers (GMTs) for the assay cut-off ≥ the value of 8.

    Measured: At Month 1, one month post-vaccination

  3. Number of Seroprotected Subjects Against Polio Types 1, 2 and 3

    A seroprotected subject was defined as a subject with anti-polio types 1, 2 and 3 titers ≥ the value of 8. Antibody titers have been assessed by neutralization assay.

    Measured: At Month 1, one month post-vaccination

  4. Number of Seropositive Subjects for Anti-D and Anti-T Antibodies

    A seropositive subject was defined as a subject with anti-D and anti-T concentrations ≥ 0.1 IU/mL. Antibody concentrations have been assessed by enzyme-linked immunosorbent assay (ELISA).

    Measured: At Month 1, one month post-vaccination

Secondary outcomes (15)

  1. Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Antigens

    A seroprotected subject was defined as a subject with anti-D and anti-T concentrations ≥ 1.0 IU/mL. Antibody concentrations have been assessed by ELISA.

    Measured: At Month 1, one month post-vaccination

  2. Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations

    Antibody concentrations were presented as geometric mean concentrations, expressed in ELISA units per milliliter (EL.U/mL). The reference cut-off value was ≥ 5 EL.U/mL.

    Measured: At Month 1, one month post-vaccination

  3. Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN Antibodies

    A seropositive subject was defined as a subject with anti-PT, anti-FHA and anti-PRN concentrations ≥ 5.0 IU/mL. Antibody concentrations have been assessed by ELISA.

    Measured: At Month 1, one month post-vaccination

  4. Number of Seropositive Subjects for Anti-measles, Anti-mumps, Anti-rubella and Anti-varicella

    Seropositivity was defined as: subjects with antibody concentrations ≥ 150 milli-international units per milliliter (mIU/mL), ≥ 231 units per milliliter (U/mL), ≥ 4 international units per milliliter (IU/mL) and ≥ 50 mIU/mL for anti-measles, anti-mumps, anti-rubella and anti-varicella antibodies, respectively.

    Measured: At Month 1, one month post-vaccination

  5. Anti-measles and Anti-varicella Antibody Concentrations

    Antibody concentrations were assessed by ELISA, presented as geometric mean concentrations (GMCs) and expressed in mIU/mL.

    Measured: At Month 1, one month post-vaccination

  6. Anti-mumps Antibody Concentrations

    Antibody concentrations were assessed by ELISA, presented as geometric mean concentrations (GMCs) and expressed in U/mL.

    Measured: At Month 1, one month post-vaccination

  7. Anti-rubella Antibody Concentrations

    Antibody concentrations were assessed by ELISA, presented as geometric mean concentrations (GMCs) and expressed in IU/mL.

    Measured: At Month 1, one month post-vaccination

  8. Number of Subjects With Booster Responses to Anti-D and Anti-T

    Booster responses to anti-D and anti-T were defined as: For initially seronegative subjects (pre-vaccination concentration < cut-off of 0.1 IU/mL), antibody concentrations at least four times the assay cut-off (post-vaccination concentration ≥ 0.4 IU/mL). For initially seropositive subjects (pre-vaccination concentration ≥ 0.1 IU/mL), an increase in antibody concentrations of at least four times the pre-vaccination concentration.

    Measured: At Month 1, one month post-vaccination

  9. Number of Subjects With Booster Responses to Anti-polio Type 1, 2 and 3

    Booster response to the poliovirus antigens was defined as: For initially seronegative subjects (pre-vaccination antibody titre < cut-off of 8), antibody titre ≥ 32. For initially seropositive subjects (pre-vaccination antibody titres ≥ 8), an increase in antibody titres of at least four times the pre-vaccination titre.

    Measured: At Month 1, one month post-vaccination

  10. Number of Subjects With Booster Responses to Anti-PT, Anti-FHA and Anti-PRN

    Booster response to the PT, FHA and PRN antigens was defined as: For initially seronegative subjects (pre-vaccination concentration < cut-off of 5 EL.U/mL), antibody concentrations at least four times the cut-off (post-vaccination concentration ≥ 20 EL.U/mL). For initially seropositive subjects with pre-vaccination concentration ≥ 5 EL.U/mL and < 20 EL.U/mL, an increase in antibody concentrations of at least four times the pre-vaccination concentration. For initially seropositive subjects with pre-vaccination concentration ≥ 20 EL.U/mL, an increase in antibody concentrations of at least two times the pre-vaccination concentration.

    Measured: At Month 1, one month post-vaccination

  11. Number of Seroconverted Subjects for Anti-measles, Anti-mumps, Anti-rubella and Anti-varicella

    Seroconversion for anti-measles, anti-mumps, anti-rubella and anti-varicella was defined as the appearance of antibodies after vaccination in subjects who were seronegative before vaccination. There were no seronegative subjects for anti-rubella antibodies, prior to vaccination.

    Measured: At Month 1, one month post-vaccination

  12. Number of Subjects With Any Solicited Local Symptoms

    Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade.

    Measured: During the 4-day (Days 0-3) post-vaccination period

  13. Number of Subjects With Any Solicited General Symptoms

    Assessed solicited general symptoms were fatigue, gastrointestinal, headache and temperature [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade.

    Measured: During the 4-day (Days 0-3) post-vaccination period

  14. Number of Subjects With Any Unsolicited Adverse Events (AEs)

    An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and 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. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.

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

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

    Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

    Measured: During the whole study period (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 posted30 Mar 2009 (estimated)
  2. Study start1 Apr 2009
  3. Primary completion18 Nov 2009
  4. Study completion18 Nov 2009

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
303 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00871000
Sponsor's protocol ID
111815
Status last verified
Apr 2017
First submitted
26 Mar 2009
Last updated
6 Jun 2018
Individual data sharing
Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Publications

  • Ferrera G, Cuccia M, Mereu G, Icardi G, Bona G, Esposito S, Marchetti F, Messier M, Kuriyakose S, Hardt K. Booster vaccination of pre-school children with reduced-antigen-content diphtheria-tetanus-acellular pertussis-inactivated poliovirus vaccine co-administered with measles-mumps-rubella-varicella vaccine: a randomized, controlled trial in children primed according to a 2 + 1 schedule in infancy. Hum Vaccin Immunother. 2012 Mar;8(3):355-62. doi: 10.4161/hv.18650. Epub 2012 Feb 13.

    PubMed 22327497

  • Ferrera G et al. A comparison of the immunogenicity and safety of a booster dose of reduced-antigen-content with full-strength DTPa-IPV vaccines administered with MMRV to children 5-6 years of age. Abstract presented at the 44th Congresso Nazionale Societa Italiana di Igiene, Medicina Preventiva e Sanita Pubblica (SITI). Venezia, Italia, 3-6 October, 2010.

  • Ferrera G et al. Immunogenicity and safety of Booster vaccination with reduced-antigen-content or full-strength Diphtheria-Tetanus-Acellular-Pertussis-IPV vaccines in pre-school children, primed with a 2+1 schedule. Abstract presented at the 29th Annual Meeting of the European Society for Paediatric Infectious Diseases (ESPID). The Hague, The Netherlands, 7-11 June 2011.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Boostrix Polio™ 711866, Priorix Tetra TM 208136 and Tetravac TM in people with Acellular Pertussis and Tetanus, run by GlaxoSmithKline at 8 sites in Italy.

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 6 inclusion and 21 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 6 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in Italy. 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 18 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?

Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibody Concentrations (time frame: At Month 1, one month post-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 NCT00871000, which also lists 3 linked publications.

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 6 Jun 2018.

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