DiphtheriaPhase 4NCT01362322
Immunogenicity and Safety of BoostrixTM Using a New Syringe in 10 to 15-year Old Adolescents
A Phase 4 study testing Boostrix TM (new syringe presentation) and Boostrix TM (previous syringe presentation) in people with Diphtheria and Tetanus, run by GlaxoSmithKline at 3 sites in 2 countries.
Trial summary
The purpose of the study is to compare the immunogenicity and safety of a booster dose of BoostrixTM administered in a new syringe presentation to that of BoostrixTM administered in the previous syringe presentation in healthy adolescents aged 10-15 years. Read more about this study
- Who is it for?
- Ages 10 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Diphtheria, Tetanus, Acellular Pertussis
- What is being tested?
- Boostrix TM (new syringe presentation) and Boostrix TM (previous syringe presentation)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 671 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 1 Jul 2011to 3 Sep 2012
- Phase
- Phase 4
- 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 10 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Subject's parent(s)/Legally Acceptable Representative(s) and subjects who the investigator believes can and are willing to comply with the requirements of the protocol.
- A male or female between 10 and 15 years of age at the time of booster vaccination.
- Prior to protocol amendment 2, subjects who have previously received 5 doses of diphtheria-tetanus-pertussis vaccine (whole cell/acellular [w/a]) as part of primary and booster vaccination, in line with local recommendations.
- After protocol amendment 2, subjects who have previously received 6 doses of either DT(P) (w/a)/ dTpa vaccine as part of primary and booster vaccination, in line with local recommendations.
- Healthy subjects as determined by the investigator based on medical history and clinical examination before entering into the study.
- Written informed consent to be obtained before study entry from the parent(s)/ Legally Acceptable Representative(s) of the subject.
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- Written informed assent to be obtained from the subject in addition to the informed consent signed by the parent(s)/ Legally Acceptable Representative(s), if required by local regulations.
- Female subjects of non-childbearing potential may be enrolled in the study.
- Female subjects of childbearing potential may be enrolled in the study, if the subject:
- has a negative pregnancy test on the day of vaccination,
- if sexually active, has practiced adequate contraception for 30 days prior to vaccination, and has agreed to continue adequate contraception during the entire treatment period and for 2 months after booster vaccination.
Who cannot join
- Child in care.
- Use of any investigational or non-registered product other than the study vaccine 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 dose.
- Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days of the booster dose of vaccine - with the exception of influenza vaccine which is allowed up to 7 days before the study vaccine dose, or planned in the period ≥ 7 days after the study vaccine dose.
- 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.
- A history of previous or intercurrent diphtheria, tetanus or pertussis disease.
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- A history of vaccination against these diseases since the 5th or the 6th dose of DT(P)/dT(pa). For subjects who have received the 6th dose of the diphtheria, tetanus and/or pertussis containing vaccine, the interval between the last DT(P)/dT(pa) vaccination and the administration of the study vaccine should be at least 18 months.
- Occurrence of any of the following adverse event after a previous administration of a Boostrix vaccine :
- known hypersensitivity to any component of the vaccine, or have shown signs of hypersensitivity after previous administration of diphtheria, tetanus or pertussis vaccines,
- encephalopathy of unknown aetiology occurring within 7 days following previous vaccination with pertussis-containing vaccine,
- transient thrombocytopenia or neurological complications following an earlier immunisation against diphtheria and/or tetanus.
- 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 vaccine.
- Administration of immunoglobulins and/or any blood products within the 3 months preceding the first dose of study vaccine or planned administration during the study period.
- Acute disease and/or fever at the time of enrolment.
- Pregnant or lactating female.
- Female planning to become pregnant or planning to discontinue contraceptive precautions, if applicable.
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Mexico2 sites
GSK Investigational Site
Estado de México, 55075
GSK Investigational Site
Monterrey, Nuevo León, 64460
About this study
Official title: Immunogenicity and Safety Study of GSK Biologicals' Boostrix™ Vaccine Using a New Syringe Presentation in Healthy Adolescents Aged 10-15 Years
The purpose of the study is to compare the immunogenicity and safety of a booster dose of BoostrixTM administered in a new syringe presentation to that of BoostrixTM administered in the previous syringe presentation in healthy adolescents aged 10-15 years.
Read the detailed description
The protocol has been updated following Protocol amendment 1 date 03 August 2011 leading to the update of the exclusion criteria to allow subjects in Mexico to receive the flu vaccine in accordance with the local standard of care.
The protocol has been updated following Protocol amendment 2 dated 14 December 2011 due to the recruitment constraints as a result of the DT/dTpa vaccination campaign in the countries. The inclusion and exclusion criteria were amended to allow the participation of those who have already received the 6th dose of the diphtheria, tetanus and/or pertussis containing vaccine.
- Conditions
- Diphtheria, Tetanus, Acellular Pertussis
- Being tested
- Boostrix TM (new syringe presentation), Boostrix TM (previous syringe presentation)
- Keywords
- dTpa, Boostrix
- Medical subject headings
- Diphtheria, Tetanus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Boostrix TM (new syringe presentation)Biological
Single dose, intramuscular administration in a new syringe presentation
Boostrix TM (previous syringe presentation)Biological
Single dose, intramuscular administration in previous syringe presentation
| Study group | Role | What they receive |
|---|---|---|
| BOOSTRIX NEW GROUP | Experimental | Subjects, aged 10 to 15 years, received one dose of Boostrix™ vaccine administered using a new syringe presentation (prefilled syringes from a different manufacturer) in the deltoid of the non-dominant arm, at Day 0. Receives: Biological: Boostrix TM (new syringe presentation) |
| BOOSTRIX PREV GROUP | Active comparator | Subjects, aged 10 to 15 years, received one dose of Boostrix™ vaccine administered using a previous syringe presentation (single dose vial or a prefilled disposable syringe without a needle) in the deltoid of the non-dominant arm, at Day 0. Receives: Biological: Boostrix TM (previous syringe presentation) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) Antibody Concentrations
Concentrations are presented as geometric mean concentrations (GMCs), expressed in international units per milliliter (IU/mL).
Measured: At Month 1
Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA), Anti-pertactin (Anti-PRN) Antibody Concentrations
Concentrations are presented as geometric mean concentrations (GMCs), expressed in enzyme-linked immunosorbent assay (ELISA) units per milliliter(EL.U/mL)
Measured: At Month 1
Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) Antibody Concentrations
Concentrations are presented as geometric mean concentrations (GMCs), expressed in international units per milliliter (IU/mL).
Measured: At Day 0
Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA), Anti-pertactin (Anti-PRN) Antibody Concentrations
Concentrations are presented as geometric mean concentrations (GMCs), expressed in ELISA units per milliliter (EL.U/mL).
Measured: At Day 0
Secondary outcomes (9)
Number of Seropositive Subjects Against Diphtheria (D) and Tetanus (T) Antigens
A seroprotected subject was defined as a subject whose antibody concentration was greater than or equal to (≥) 0.1. international units per milliliter (IU/mL), as assessed by the Enzyme Linked Immunosorbent Assay (ELISA).
Measured: At Day 0 (PRE) and at Month 1 (POST)
Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T) Antigens
A seroprotected subject is defined as a vaccinated subject with anti-D and anti-T antibody concentration greater than or equal to ( ≥) 1 international units per milliliter (IU/mL).
Measured: At Day 0 (PRE) vaccine and at Month 1 (POST)
Number of Seropositive Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations)
A seroprotected subject was defined as a subject whose antibody concentration was greater than or equal to (≥) 5 Enzyme Linked Immunosorbent Assay (ELISA) units per milliliter (EL.U/mL).
Measured: At Day 0 (PRE) vaccine and at Month 1 (POST)
Number of Subjects With Booster Response to Diphtheria (D) and Tetanus (T) Antibodies
Booster response to the diphtheria and tetanus antigens, was defined as: for initially seronegative subjects (pre-vaccination concentration <0.1 IU/mL): antibody concentrations at least 4 times the 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 4 times the pre-vaccination concentration.
Measured: At Month 1
Number of Subjects With a Booster Response to Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA), Pertactin (PRN) Antigens.
Booster response to the PT, FHA and PRN antigens, was defined as: for initially seronegative subjects: antibody concentrations at least 4 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 4 times the pre-vaccination concentration; and for initially seropositive subjects with pre-vaccination concentration ≥ 20 EL.U/mL: an increase in antibody concentrations of at least 2 times the pre-vaccination concentration.
Measured: At Month 1
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: Within 4 days (Days 0-3) post vaccination period
Number of Subjects With 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: Within 31 days (Days 0-30) post
Number of Subjects With Any Solicited General Symptoms
Assessed solicited general symptoms were fatigue, temperature [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)], headache and gastrointestinal symptoms. Gastrointestinal symptoms included Nausea, Vomiting, Diarrhea and or Abdominal pain. Any = occurrence of the symptom regardless of intensity grade.
Measured: Within 4 days (Days 0-3) post vaccination period
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 (Day 0 - Month 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2011 (estimated)
- Study start1 Jul 2011
- Primary completion3 Sep 2012
- Study completion3 Sep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DiphtheriaStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 671 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01362322
- Sponsor's protocol ID
- 114778
- Status last verified
- May 2018
- First submitted
- 19 May 2011
- Last updated
- 10 Aug 2018
- Results posted
- Yes, on ClinicalTrials.gov
- 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
Pavia-Ruz N, Abarca K, Lepetic A, Cervantes-Apolinar MY, Hardt K, Jayadeva G, Kuriyakose S, Han HH, de la O M. Evaluation of a new syringe presentation of reduced-antigen content diphtheria, tetanus, and acellular pertussis vaccine in healthy adolescents--A single blind randomized trial. Hum Vaccin Immunother. 2015;11(7):1770-4. doi: 10.1080/21645515.2015.1041697.
PubMed 26075317
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunogenicity and Safety Study of GSK Biologicals' Boostrix™ Vaccine Using a New Syringe Presentation in Healthy Adolescents Aged 10-15 Years
- ClinicalTrials.gov ID
- NCT01362322
- Acronym / sponsor ID
- 114778
- Conditions
- Diphtheria, Tetanus, Acellular Pertussis
- Keywords
- dTpa, Boostrix
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 671 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 1 Jul 2011
- Primary completion
- 3 Sep 2012 (actual)
- Study completion
- 3 Sep 2012 (actual)
- First posted
- 30 May 2011 (estimated)
- Results
- Posted 10 Aug 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to compare the immunogenicity and safety of a booster dose of BoostrixTM administered in a new syringe presentation to that of BoostrixTM administered in the previous syringe presentation in healthy adolescents aged 10-15 years.
Detailed description
The protocol has been updated following Protocol amendment 1 date 03 August 2011 leading to the update of the exclusion criteria to allow subjects in Mexico to receive the flu vaccine in accordance with the local standard of care.
The protocol has been updated following Protocol amendment 2 dated 14 December 2011 due to the recruitment constraints as a result of the DT/dTpa vaccination campaign in the countries. The inclusion and exclusion criteria were amended to allow the participation of those who have already received the 6th dose of the diphtheria, tetanus and/or pertussis containing vaccine.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BOOSTRIX NEW GROUP | Experimental | Biological: Boostrix TM (new syringe presentation)Subjects, aged 10 to 15 years, received one dose of Boostrix™ vaccine administered using a new syringe presentation (prefilled syringes from a different manufacturer) in the deltoid of the non-dominant arm, at Day 0. |
| BOOSTRIX PREV GROUP | Active comparator | Biological: Boostrix TM (previous syringe presentation)Subjects, aged 10 to 15 years, received one dose of Boostrix™ vaccine administered using a previous syringe presentation (single dose vial or a prefilled disposable syringe without a needle) in the deltoid of the non-dominant arm, at Day 0. |
Who may qualify
- Ages
- 10 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (11 listed)
- Subject's parent(s)/Legally Acceptable Representative(s) and subjects who the investigator believes can and are willing to comply with the requirements of the protocol.
- A male or female between 10 and 15 years of age at the time of booster vaccination.
- Prior to protocol amendment 2, subjects who have previously received 5 doses of diphtheria-tetanus-pertussis vaccine (whole cell/acellular [w/a]) as part of primary and booster vaccination, in line with local recommendations.
- After protocol amendment 2, subjects who have previously received 6 doses of either DT(P) (w/a)/ dTpa vaccine as part of primary and booster vaccination, in line with local recommendations.
- Healthy subjects as determined by the investigator based on medical history and clinical examination before entering into the study.
Key exclusion criteria (17 listed)
- Child in care.
- Use of any investigational or non-registered product other than the study vaccine 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 dose.
- Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days of the booster dose of vaccine - with the exception of influenza vaccine which is allowed up to 7 days before the study vaccine dose, or planned in the period ≥ 7 days after the study vaccine dose.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Boostrix TM (new syringe presentation)Single dose, intramuscular administration in a new syringe presentation | Biological | BOOSTRIX NEW GROUP |
| Boostrix TM (previous syringe presentation)Single dose, intramuscular administration in previous syringe presentation | Biological | BOOSTRIX PREV GROUP |
Primary outcome
Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) Antibody Concentrations
Time frame: At Month 1
Concentrations are presented as geometric mean concentrations (GMCs), expressed in international units per milliliter (IU/mL).
Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA), Anti-pertactin (Anti-PRN) Antibody Concentrations
Time frame: At Month 1
Concentrations are presented as geometric mean concentrations (GMCs), expressed in enzyme-linked immunosorbent assay (ELISA) units per milliliter(EL.U/mL)
Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) Antibody Concentrations
Time frame: At Day 0
Concentrations are presented as geometric mean concentrations (GMCs), expressed in international units per milliliter (IU/mL).
Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA), Anti-pertactin (Anti-PRN) Antibody Concentrations
Time frame: At Day 0
Concentrations are presented as geometric mean concentrations (GMCs), expressed in ELISA units per milliliter (EL.U/mL).
9 secondary outcomes
Number of Seropositive Subjects Against Diphtheria (D) and Tetanus (T) Antigens
Time frame: At Day 0 (PRE) and at Month 1 (POST)
Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T) Antigens
Time frame: At Day 0 (PRE) vaccine and at Month 1 (POST)
Number of Seropositive Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations)
Time frame: At Day 0 (PRE) vaccine and at Month 1 (POST)
Number of Subjects With Booster Response to Diphtheria (D) and Tetanus (T) Antibodies
Time frame: At Month 1
Number of Subjects With a Booster Response to Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA), Pertactin (PRN) Antigens.
Time frame: At Month 1
Number of Subjects With Any Solicited Local Symptoms
Time frame: Within 4 days (Days 0-3) post vaccination period
Number of Subjects With Unsolicited Adverse Events (AEs)
Time frame: Within 31 days (Days 0-30) post
Number of Subjects With Any Solicited General Symptoms
Time frame: Within 4 days (Days 0-3) post vaccination period
Number of Subjects With Serious Adverse Events (SAEs)
Time frame: During the entire study period (Day 0 - Month 1)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 26075317Pavia-Ruz N, Abarca K, Lepetic A, Cervantes-Apolinar MY, Hardt K, Jayadeva G, Kuriyakose S, Han HH, de la O M. Evaluation of a new syringe presentation of reduced-antigen content diphtheria, tetanus, and acellular pertussis vaccine in healthy adolescents--A single blind randomized trial. Hum Vaccin Immunother. 2015;11(7):1770-4. doi: 10.1080/21645515.2015.1041697.
- Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Boostrix TM (new syringe presentation) and Boostrix TM (previous syringe presentation) in people with Diphtheria and Tetanus, run by GlaxoSmithKline at 3 sites in 2 countries.
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 11 inclusion and 17 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 10 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 3 sites in Mexico, Chile. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 10 Aug 2018). 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-diphteria (Anti-D) and Anti-tetanus (Anti-T) Antibody Concentrations (time frame: At Month 1). 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 NCT01362322, 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 10 Aug 2018.