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Acellular PertussisPhase 3NCT01245049

Immunogenicity and Safety of GSK Biologicals' Boostrix Polio Vaccine in 3 and 4-year-old Children

A Phase 3 study testing Boostrix PolioTM, RepevaxTM and PriorixTM in people with Acellular Pertussis and Poliomyelitis, run by GlaxoSmithKline at 13 sites in United Kingdom.

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 purpose of the study is to compare the immunogenicity and safety of a booster dose of BoostrixTM Polio to that of Sanofi Pasteur MSD's RepevaxTM, when co-administered with a second dose of PriorixTM, in healthy 3 and 4-year-old children. Read more about this study

Who is it for?
Ages 3 to 4 yearsHealthy volunteers can take part
Conditions the study is for
Acellular Pertussis, Poliomyelitis, Tetanus
What is being tested?
Boostrix PolioTM, RepevaxTM and PriorixTM
Could I receive a placebo?
No, everyone receives an active treatment
How many people
387 participants
Where
13 sitesUnited Kingdom
Study dates
1 Apr 2011to 2 Apr 2012
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 4 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) (LAR) can and will comply with the requirements of the protocol should be enrolled in the study.
  • A male or female child of 3 or 4 years of age at the time of booster vaccination (up to, but excluding 5 years of age).
  • Subjects who have received a complete three-dose primary vaccination with diphtheria-tetanus-acellular pertussis (DTPa) vaccine and inactivated poliovirus (IPV) vaccine in the first six months of life, in line with recommendations in the United Kingdom (UK).
  • Subjects who received a first dose of a live attenuated measles-mumps-rubella vaccine within the second year of life, in line with recommendations in the UK.
  • Written informed consent obtained from the parent(s)/LAR(s) of the subject at the time of enrolment.
  • 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 vaccine(s) within 30 days preceding the booster 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, with the exception of inactivated influenza vaccine.
  • 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 diphtheria, tetanus, pertussis, poliomyelitis since primary vaccination in the first year of life.
Show all 20Show fewer
  • Previous measles, mumps and/or rubella second dose vaccination.
  • Evidence of previous or intercurrent diphtheria, tetanus, pertussis, poliomyelitis, measles, mumps and/or rubella disease.
  • Known exposure to measles, mumps and/or rubella within 30 days prior to study start.
  • Any confirmed or suspected immunosuppressive or immunodeficiency condition, based on medical history and physical examination.
  • History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine.
  • Administration of immunoglobulin and/or any blood products within the three months preceding the booster dose or planned administration during the study period.
  • Occurrence of transient thrombocytopenia or neurological complications following an earlier immunisation.
  • 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.
  • Acute disease and/or fever at the time of enrolment or within 24 hours of study vaccine administration.

Trial locations and contacts

13 sites in 1 country.

13 sites in 1 country

United Kingdom13 sites

  • GSK Investigational Site

    Atherstone, Warwickshire, CV9 1EU

  • GSK Investigational Site

    Axbridge, Somerset, BS26 2BJ

  • GSK Investigational Site

    Bangor, BT19 1PP

  • GSK Investigational Site

    Bolton, Nr Manchester, BL3 6TL

  • GSK Investigational Site

    Bristol, BS2 8AE

  • GSK Investigational Site

    Crumpsall, Manchester, M8 9JT

  • GSK Investigational Site

    Exeter, EX2 5DW

  • GSK Investigational Site

    Lancashire, BL1 6AP

  • GSK Investigational Site

    Oxford, OX3 7LJ

  • GSK Investigational Site

    Randalstown, BT41 3AE

  • GSK Investigational Site

    Southampton, Hampshire, SO16 6YD

  • GSK Investigational Site

    St Austell, Cornwall, PL26 7RL

  • GSK Investigational Site

    Taunton, Somerset, TA1 1XQ

Other trials in United Kingdom

About this study

Official title: Immunogenicity and Safety of GSK Biologicals' dTpa-IPV Vaccine (Boostrix Polio) as a Booster Dose in 3 and 4-year-old Children

The purpose of the study is to compare the immunogenicity and safety of a booster dose of BoostrixTM Polio to that of Sanofi Pasteur MSD's RepevaxTM, when co-administered with a second dose of PriorixTM, in healthy 3 and 4-year-old children.

Being tested
Boostrix PolioTM, RepevaxTM, PriorixTM
Keywords
MMR, dTpa-IPV, Boostrix Polio, Repevax, Priorix
Medical subject headings
Poliomyelitis, Tetanus, Diphtheria

What participants receive

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

  • Boostrix PolioTMBiological

    Single dose, intramuscular administration.

  • RepevaxTMBiological

    Single dose, intramuscular administration.

  • PriorixTMBiological

    Single dose, intramuscular or subcutaneous administration.

Study groups in NCT01245049
Study groupRoleWhat they receive
BOOSTRIX POLIO GROUPExperimentalHealthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Boostrix™ Polio vaccine co-administered with Priorix™ vaccine at Day 0. Boostrix™ Polio vaccine was administered intramuscularly in the deltoid muscle of the left arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arm or as an intramuscular injection into the deltoid muscle of the right arm.
Receives: Biological: Boostrix PolioTM; Biological: PriorixTM
REPEVAX GROUPActive comparatorHealthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Repevax™ vaccine co-administered with Priorix™ vaccine at Day 0. Repevax™ vaccine was administered intramuscularly in the deltoid muscle of the arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arn or as an intramuscular injection into the deltoid muscle of the right arm.
Receives: Biological: RepevaxTM; Biological: PriorixTM

What is being measured

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

  1. Number of Subjects With a Booster Response to Diphtheria (D) and Tetanus (T) Antigens

    Booster response was defined as: For initially seronegative subjects [i.e. pre-vaccination concentration below (<) cut-off value of 0.1 international units per milliliter (IU/mL)] antibody concentrations at least four times the assay cut-off [post vaccination concentration greater than or equal to (≥) 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 booster vaccination concentration.

    Measured: At Month 1, one month after the booster vaccination

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

    Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).

    Measured: At Month 1, one month after the booster vaccination

  3. Anti-Polio Virus Type 1, 2 and 3 Antibody Titers

    Antibody titers were presented as geometric mean titers (GMTs).

    Measured: At Month 1, one month after the booster vaccination

Secondary outcomes (20)

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

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

    Measured: Before (Month 0) and one month after (Month 1) the booster vaccination

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

    A seropositive subject for anti-PT, anti-FHA and anti-PRN was a subject whose antibody concentration was ≥ 5 EL.U/mL.

    Measured: Before (Month 0) and one month after (Month 1) the booster vaccination

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

    A seroprotected subject was defined as a subject with anti-polio type 1, 2 and 3 antibody titres ≥ the value of 8.

    Measured: Before (Month 0) and one month after (Month 1) the booster vaccination

  4. Number of Seropositive Subjects for Anti-measles Antibody

    A seropositive subject was defined as a subject with anti-measles antibody titers ≥ 150 mIU/mL.

    Measured: Before (Month 0) and one month after (Month 1) the booster vaccination

  5. Number of Seropositive Subjects for Anti-mumps Antibody

    A seropositive subject was defined as a subject with anti-mumps antibody titers ≥ 231 U/mL.

    Measured: Before (Month 0) and one month after (Month 1) the booster vaccination

  6. Number of Seropositive Subjects for Anti-rubella Antibody

    A seropositive subject was defined as a subject with anti-rubella antibody titers ≥ 4 IU/mL.

    Measured: Before (Month 0) and one month after (Month 1) the booster vaccination

  7. Anti-D and Anti-T Antibody Concentrations

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

    Measured: Before (Month 0) and one month after (Month 1) the booster vaccination

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

    Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in EL.U/mL.

    Measured: At Month 0, before the booster vaccination

  9. Anti-mumps Antibody Concentrations

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

    Measured: Before (Month 0) and one month after (Month 1) the booster vaccination

  10. Anti-measles Antibody Concentrations

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

    Measured: Before (Month 0) and one month after (Month 1) the booster vaccination

  11. Anti-rubella Antibody Concentrations

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

    Measured: Before (Month 0) and one month after (Month 1) the booster vaccination

  12. Anti-Polio Type 1, 2 and 3 Antibody Titers

    Antibody titers were presented as geometric mean titers (GMTs).

    Measured: At Month 0, before the booster vaccination

  13. Number of Subjects With a Booster Response to PT, FHA and PRN Antigens

    Booster response was defined as: For initially seronegative subjects (pre-vaccination concentration < 5 EL.U/mL), antibody concentrations at least four times the assay 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 booster 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 booster vaccination concentration.

    Measured: At Month 1, one month after the booster vaccination

  14. Number of Subjects With Booster Response for Polio Type 1, 2 and 3 Antigens

    Booster response defined as: For initially seronegative subjects, antibody titers at least four times the cut-off (post-vaccination titer ≥ 32); For initially seropositive subjects, an increase in antibody titers of at least four times the Pre booster vaccination titer.

    Measured: At Month 1, one month after the booster vaccination

  15. Number of Seroconverted Subjects for Anti-measles

    Seroconversion for anti-measles was defined as the appearance of antibodies after vaccination in subjects who were initially seronegative [with antibody concentrations ≥ 150 milli-international units per millilitre (mIU/mL)].

    Measured: Before (Month 0) and one month after (Month 1) the booster vaccination

  16. Number of Seroconverted Subjects for Anti-mumps

    Seroconversion for anti-mumps was defined as the appearance of antibodies after vaccination in subjects who were initially seronegative [with antibody concentrations ≥ 231 units per millilitre (U/mL)].

    Measured: Before (Month 0) and one month after (Month 1) the booster vaccination

  17. 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) follow-up period after booster vaccination

  18. Number of Subjects With Any Solicited General Symptoms

    Assessed solicited general symptoms were drowsiness, irritability, loss of appetite 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) follow-up period after booster vaccination

  19. 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) follow-up period after booster vaccination

  20. 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 entire study period (From Day 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 posted22 Nov 2010 (estimated)
  2. Study start1 Apr 2011
  3. Primary completion27 Mar 2012
  4. Study completion2 Apr 2012

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
387 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01245049
Sponsor's protocol ID
111763
Status last verified
Jun 2018
First submitted
18 Nov 2010
Last updated
17 Aug 2018
Individual data sharing
Yes: IPD for this study will be made available via the Clinical Study Data Request site.

Publications

  • Marlow R, Kuriyakose S, Mesaros N, Han HH, Tomlinson R, Faust SN, Snape MD, Pollard AJ, Finn A. A phase III, open-label, randomised multicentre study to evaluate the immunogenicity and safety of a booster dose of two different reduced antigen diphtheria-tetanus-acellular pertussis-polio vaccines, when co-administered with measles-mumps-rubella vaccine in 3 and 4-year-old healthy children in the UK. Vaccine. 2018 Apr 19;36(17):2300-2306. doi: 10.1016/j.vaccine.2018.03.021. Epub 2018 Mar 22.

    PubMed 29576304

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Boostrix PolioTM, RepevaxTM and PriorixTM in people with Acellular Pertussis and Poliomyelitis, run by GlaxoSmithKline at 13 sites in United Kingdom.

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 20 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 17 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in United Kingdom. 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 5 Jul 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 Subjects With a Booster Response to Diphtheria (D) and Tetanus (T) Antigens (time frame: At Month 1, one month after the booster vaccination). The study lists 3 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 NCT01245049, 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 17 Aug 2018.

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