TetanusPhase 4NCT01358825

Study to Evaluate Antibody Persistence in Children Previously Vaccinated With Infanrix Hexa™ or Infanrix-IPV/Hib™

A Phase 4 study testing Blood Sampling in people with Tetanus and Poliomyelitis, run by GlaxoSmithKline at 4 sites in 2 countries.

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 aim of this study is to assess antibody persistence in infants who received three doses of Infanrix hexa™ (DTPa-HBV-IPV/Hib) or Infanrix-IPV/Hib™ (DTPa-IPV/Hib) at 3, 5 and 11 months of age in study NCT00307034. Read more about this study

Who is it for?: Ages 5 to 6 yearsHealthy volunteers can take part
Conditions the study is for: Tetanus, Poliomyelitis, Haemophilus Influenzae Type b
What is being tested?: Blood Sampling
Type of treatment: Vaccines, Injection or infusion, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 58 participants
Where: 4 sitesin 2 countries
Study dates: 30 May 2011to 15 Jul 2011
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 5 to 6 years
All sexes
Healthy volunteers accepted
Child

Who may be able to join

Subjects who had received 3 doses of Infanrix hexa™ or Infanrix-IPV/Hib™ in study NCT00307034.
Subjects who the investigator believes that parent(s)/Legally Acceptable Representative(s) LAR(s) can and will comply with the requirements of the protocol.
A male or female subject aged 5 years at the time of study entry.
Written informed consent obtained from the parent(s)/LAR(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.
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.
Use of any investigational or non-registered product within 30 days prior to blood sampling.
Evidence of previous or intercurrent diphtheria, tetanus, pertussis, polio, hepatitis B, and Hib vaccination or disease since the study NCT00307034, with the exception of hepatitis B vaccination in the DTPa-IPV/Hib group.
Administration of immunoglobulins and/or any blood products within the 3 months prior to blood sampling.
Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
Family history of congenital or hereditary immunodeficiency.

Trial locations and contacts

4 sites in 2 countries.

Country

City, postcode or hospital

4 sites in 2 countries

Norway2 sites

GSK Investigational Site
Morvik, 5124
GSK Investigational Site
Oslo, 0130

Other trials in Norway

Sweden2 sites

GSK Investigational Site
Örebro, SE-702 11
GSK Investigational Site
Umeå, SE-901 85

Other trials in Sweden

About this study

Official title: Antibody Persistence in Children Previously Vaccinated With Three Doses of Infanrix Hexa™ or Infanrix-IPV/Hib™

Conditions: Tetanus, Poliomyelitis, Haemophilus Influenzae Type b, Acellular Pertussis, Diphtheria, Hepatitis B
Being tested: Blood Sampling
Keywords: Infanrix-IPV/Hib, Long-term follow up, Persistence, Infanrix hexa
Medical subject headings: Tetanus, Poliomyelitis, Haemophilus Infections, Diphtheria, Hepatitis B

What participants receive

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

Blood SamplingProcedure or surgery
A blood sample will be taken at 5 years of age, after vaccination in the primary study.

Study groups in NCT01358825
Study group	Role	What they receive
Infanrix hexa Group	Experimental	Subjects aged 5 years previously vaccinated at 3, 5 and 11 months of age with 3 doses of Infanrix hexa™ (DTPa-HBV-IPV/Hib) administered intramuscularly in study NCT00307034. Receives: Procedure: Blood Sampling
Infanrix-IPV/Hib Group	Experimental	Subjects aged 5 years previously vaccinated at 3, 5 and 11 months of age with 3 doses of Infanrix-IPV/Hib™ (DTPa-IPV/Hib) administered intramuscularly in study NCT00307034. Receives: Procedure: Blood Sampling

What is being measured

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

Number of Seroprotected Subjects Against Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T).
A seroprotected subject is a subject with anti-D/anti-T antibody concentrations greater than (≥) or equal to 0.1 international units per milliliter (IU/mL)
Measured: At Day 0
Concentrations of Antibodies Against Anti-D and Anti-T
Concentrations are presented as geometric mean concentrations (GMCs), expressed in milliinternational units per millilitre (mIU/mL).
Measured: At Day 0
Number of Subjects With Anti-pertussis Toxoid (Anti-PT), Antifilamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations ≥5 ELISA Units Per Milliliter (EL.U/mL).
Cut-off values assessed were greater than or equal to 5 ELISA units per millilitre (EL.U/mL) in the sera of subjects seronegative before vaccination.
Measured: At Day 0
Concentrations of Antibodies Against Anti-PT, Anti-FHA and Anti-PRN.
Concentrations are presented as geometric mean concentrations (GMCs), expressed in ELISA units per millilitre (EL.U/mL).
Measured: At Day 0
Number of Seroprotected Subjects Against Anti-hepatitis B Surface Antigen (Anti-HBs).
Seroprotection = anti-HBs antibody concentration ≥ 10 milli-international units per milliliter (mIU/mL).
Measured: At Day 0
Concentrations of Antibodies Against Anti-HBs.
Concentrations are presented as geometric mean concentrations (GMCs), expressed in milliinternational units per millilitre (mIU/mL).
Measured: At Day 0
Number of Seroprotected Subjects Against Anti-polyribosyl Ribitol Phosphate (Anti-PRP).
A seroprotected subject is a subject with anti-PRP antibody concentrations ≥ 0.15 micrograms per milliliter (μg/mL)
Measured: At Day 0
Concentrations of Antibodies Against Anti-PRP.
Concentrations are presented as geometric mean concentrations (GMCs), expressed in micrograms per millilitre (μg/mL).
Measured: At Day 0
Number of Subjects With Serious Adverse Events (SAEs).
Assessed SAEs 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 (up to Day 46)
Number of Subjects With Anti-HBs Antibody Concentrations ≥ 6.2 mIU/mL
Cut-off values assessed were greater than or equal to 6.2 milliinternational units per millilitre ( mIU/mL) in the sera of subjects seronegative before vaccination.
Measured: At Day 0

Timeline

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

30 May 201115 Jul 2011

First posted24 May 2011 (estimated)
Study start30 May 2011
Primary completion15 Jul 2011
Study completion15 Jul 2011

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 TetanusStudies 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: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 58 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01358825
Sponsor's protocol ID: 115375
Other IDs: 2011-000943-26
Status last verified: Jan 2021
First submitted: 20 May 2011
Last updated: 19 Jan 2021
Results posted: Yes, on ClinicalTrials.gov
Individual data sharing: Yes: IPD is available via the Clinical Study Data Request site (click on the link provided below)

Publications

Silfverdal SA, Assudani D, Kuriyakose S, Van Der Meeren O. Immunological persistence in 5 y olds previously vaccinated with hexavalent DTPa-HBV-IPV/Hib at 3, 5, and 11 months of age. Hum Vaccin Immunother. 2014;10(10):2795-8. doi: 10.4161/21645515.2014.970494.
PubMed 25483640

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Tetanus trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Antibody Persistence in Children Previously Vaccinated With Three Doses of Infanrix Hexa™ or Infanrix-IPV/Hib™
ClinicalTrials.gov ID: NCT01358825
Acronym / sponsor ID: 115375
Conditions: Tetanus, Poliomyelitis, Haemophilus Influenzae Type b, Acellular Pertussis, Diphtheria, Hepatitis B
Keywords: Infanrix-IPV/Hib, Long-term follow up, Persistence, Infanrix hexa
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 58 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 30 May 2011 (actual)
Primary completion: 15 Jul 2011 (actual)
Study completion: 15 Jul 2011 (actual)
First posted: 24 May 2011 (estimated)
Results: Posted 29 Dec 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Infanrix hexa Group	Experimental	Procedure: Blood SamplingSubjects aged 5 years previously vaccinated at 3, 5 and 11 months of age with 3 doses of Infanrix hexa™ (DTPa-HBV-IPV/Hib) administered intramuscularly in study NCT00307034.
Infanrix-IPV/Hib Group	Experimental	Procedure: Blood SamplingSubjects aged 5 years previously vaccinated at 3, 5 and 11 months of age with 3 doses of Infanrix-IPV/Hib™ (DTPa-IPV/Hib) administered intramuscularly in study NCT00307034.

Who may qualify

Ages: 5 to 6 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (5 listed)

Subjects who had received 3 doses of Infanrix hexa™ or Infanrix-IPV/Hib™ in study NCT00307034.
Subjects who the investigator believes that parent(s)/Legally Acceptable Representative(s) LAR(s) can and will comply with the requirements of the protocol.
A male or female subject aged 5 years at the time of study entry.
Written informed consent obtained from the parent(s)/LAR(s) of the subject.
Healthy subjects as established by medical history and clinical examination before entering into the study.

Key exclusion criteria (7 listed)

Child in care.
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.
Use of any investigational or non-registered product within 30 days prior to blood sampling.
Evidence of previous or intercurrent diphtheria, tetanus, pertussis, polio, hepatitis B, and Hib vaccination or disease since the study NCT00307034, with the exception of hepatitis B vaccination in the DTPa-IPV/Hib group.
Administration of immunoglobulins and/or any blood products within the 3 months prior to blood sampling.

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
Blood SamplingA blood sample will be taken at 5 years of age, after vaccination in the primary study.	Procedure or surgery	Infanrix hexa Group, Infanrix-IPV/Hib Group

Primary outcome

Number of Seroprotected Subjects Against Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T).
Time frame: At Day 0
A seroprotected subject is a subject with anti-D/anti-T antibody concentrations greater than (≥) or equal to 0.1 international units per milliliter (IU/mL)
Concentrations of Antibodies Against Anti-D and Anti-T
Time frame: At Day 0
Concentrations are presented as geometric mean concentrations (GMCs), expressed in milliinternational units per millilitre (mIU/mL).
Number of Subjects With Anti-pertussis Toxoid (Anti-PT), Antifilamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations ≥5 ELISA Units Per Milliliter (EL.U/mL).
Time frame: At Day 0
Cut-off values assessed were greater than or equal to 5 ELISA units per millilitre (EL.U/mL) in the sera of subjects seronegative before vaccination.
Concentrations of Antibodies Against Anti-PT, Anti-FHA and Anti-PRN.
Time frame: At Day 0
Concentrations are presented as geometric mean concentrations (GMCs), expressed in ELISA units per millilitre (EL.U/mL).
Number of Seroprotected Subjects Against Anti-hepatitis B Surface Antigen (Anti-HBs).
Time frame: At Day 0
Seroprotection = anti-HBs antibody concentration ≥ 10 milli-international units per milliliter (mIU/mL).
Concentrations of Antibodies Against Anti-HBs.
Time frame: At Day 0
Concentrations are presented as geometric mean concentrations (GMCs), expressed in milliinternational units per millilitre (mIU/mL).
Number of Seroprotected Subjects Against Anti-polyribosyl Ribitol Phosphate (Anti-PRP).
Time frame: At Day 0
A seroprotected subject is a subject with anti-PRP antibody concentrations ≥ 0.15 micrograms per milliliter (μg/mL)
Concentrations of Antibodies Against Anti-PRP.
Time frame: At Day 0
Concentrations are presented as geometric mean concentrations (GMCs), expressed in micrograms per millilitre (μg/mL).
Number of Subjects With Serious Adverse Events (SAEs).
Time frame: During the entire study period (up to Day 46)
Assessed SAEs include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Number of Subjects With Anti-HBs Antibody Concentrations ≥ 6.2 mIU/mL
Time frame: At Day 0
Cut-off values assessed were greater than or equal to 6.2 milliinternational units per millilitre ( mIU/mL) in the sera of subjects seronegative before vaccination.

Results and safety

Results posted to the registry on 29 Dec 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Infanrix Hexa Group	12	12
Infanrix-IPV/Hib Group	46	45

Primary outcome: Number of Seroprotected Subjects Against Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T).

Time frame: At Day 0. Count of participants. Unit: Participants

Measure	Infanrix Hexa Group n = 12	Infanrix-IPV/Hib Group n = 45
Anti-D	7	28
Anti-T	10	34

Population analysed: The analysis was performed on the According-To-Protocol (ATP) Cohort, which included all subjects with blood sample available and who met all the eligibility criteria, complying with the procedure defined in the protocol and with no elimination code assigned.

Primary outcome: Concentrations of Antibodies Against Anti-D and Anti-T

Time frame: At Day 0. Geometric mean (95% Confidence Interval). Unit: IU/mL

Measure	Infanrix Hexa Group n = 12	Infanrix-IPV/Hib Group n = 45
Anti-D	0.13 (0.072 to 0.235)	0.196 (0.114 to 0.338)
Anti-T	0.29 (0.135 to 0.624)	0.352 (0.207 to 0.599)

Primary outcome: Number of Subjects With Anti-pertussis Toxoid (Anti-PT), Antifilamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations ≥5 ELISA Units Per Milliliter (EL.U/mL).

Time frame: At Day 0. Count of participants. Unit: Participants

Measure	Infanrix Hexa Group n = 12	Infanrix-IPV/Hib Group n = 45
Anti-PT	0	9
Anti-FHA	12	41
Anti-PRN	8	34

Primary outcome: Concentrations of Antibodies Against Anti-PT, Anti-FHA and Anti-PRN.

Time frame: At Day 0. Geometric mean (95% Confidence Interval). Unit: EL.U/mL

Measure	Infanrix Hexa Group n = 12	Infanrix-IPV/Hib Group n = 45
Anti-PT	2.5 (2.5 to 2.5)	4.2 (2.9 to 6)
Anti-FHA	32.6 (11.5 to 92.5)	50.7 (30.6 to 84.1)
Anti-PRN	6.2 (3.9 to 9.9)	11.9 (8.4 to 16.8)

Adverse events

Time frame: SAEs: during the entire study period (Day 0 to Day 46). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Infanrix Hexa Group	0 of 12 (0%)	0 of 0	Not reported
Infanrix-IPV/Hib Group	0 of 46 (0%)	0 of 0	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 25483640Silfverdal SA, Assudani D, Kuriyakose S, Van Der Meeren O. Immunological persistence in 5 y olds previously vaccinated with hexavalent DTPa-HBV-IPV/Hib at 3, 5, and 11 months of age. Hum Vaccin Immunother. 2014;10(10):2795-8. doi: 10.4161/21645515.2014.970494.
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. IPD is available via the Clinical Study Data Request site (click on the link provided below)

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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

4 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 Blood Sampling in people with Tetanus and Poliomyelitis, run by GlaxoSmithKline at 4 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 5 inclusion and 7 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 19 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Norway, Sweden. 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 29 Dec 2016). 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 Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T). (time frame: At Day 0). The study lists 10 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 NCT01358825, 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 19 Jan 2021.