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TetanusPhase 4Tdap BoosterNCT00870350

An Immunogenicity and Safety Study of Tetanus, Diphtheria and Acellular Pertussis Vaccine Booster

A Phase 4 study testing Td5ap and Td1aP in people with Tetanus and Diphtheria, run by Swedish Institute for Infectious Disease Control at 1 site in Sweden.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Open-label, randomized, multi-centre study in which 400 subjects, divided into two groups, will receive Td5ap or Td1aP as a single injection. We will then describe the immune response and safety profile of the combined vaccine booster. Read more about this study

Who is it for?
Ages 14 to 15 yearsHealthy volunteers can take part
Conditions the study is for
Tetanus, Diphtheria, Pertussis
What is being tested?
Td5ap and Td1aP
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
400 participants
Where
1 siteSweden
Study dates
Apr 2009to Jun 2010
Phase
Phase 4
Are there results?
None posted in the registry

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 14 to 15 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • healthy subject
  • 14-15 years old
  • eligible for their school-leaving booster for DTP
  • received a complete primary vaccination with a 5-component acellular pertussis vaccine (DT5aP-IPV-Hib) at 3, 5 and 12 months of age and vaccinated with a 5-component acellular pertussis vaccine (Td5aP-IPV or Td5aP + IPV) as a booster at 5½ years of age
  • informed consent form signed by the subject and parent(s)/legal representative
  • subject understand and comply with the study procedures (i.e. able to read and write Swedish)
  • female must provide an agreement that they are either sexually continent or practice adequate contraceptive methods (intra-uterine contraceptive device (IUCD), hormonal contraceptives, condoms or other adequate barrier contraception).

Who cannot join

  • acute febrile illness or axillary temperature ≥38.0°C at the time of vaccination
  • receipt of immunoglobulin within the previous 3 months, immunosuppression (e g evidence of impaired cell mediated immunity, receipt of immunosuppressant drugs within the previous 3 months or receipt of systemic corticosteroids given daily or on alternate days at ≥20 mg/day prednisone equivalent during >14 days within the past 30 days)
  • receipt of a non-study vaccine in the past 30 days
  • evolving encephalopathy not attributable to another identifiable cause within 7 days of administration of a previous dose of any vaccine
  • booster vaccination with tetanus, low dose diphtheria and acellular pertussis vaccine since the booster vaccination at 5½ years of age
  • previous clinical or bacteriological diagnosis of diphtheria, tetanus or pertussis
Show all 13Show fewer
  • hypersensitivity to any component of any of the study vaccines
  • current participation in any other clinical trial or participation in any clinical trial in the previous month
  • inability to adhere to the protocol, including plans to move from the area
  • severe chronic disease
  • family history of congenital or hereditary immunodeficiency
  • any sever thrombocytopenia or any other coagulation disorder that would contraindicate intramuscular injection
  • any medical condition, which in the opinion of the investigator, might interfere with the evaluation of the study objectives.

Trial locations and contacts

1 site in 1 country.

Sweden1 site

  • Swedish Institute for Infectious Disease Control

    Lund, 221 85

Other trials in Sweden

About this study

Official title: An Immunogenicity and Safety Study of Combined Adsorbed Tetanus, Low Dose Diphtheria and Acellular Pertussis Vaccine (Td5ap and Td1aP) Given as a School-leaving Booster to 14-15-year-old Children Primed With a Five Component Acellular Pertussis Vaccine at 3, 5 and 12 Months of Age, and a Booster Dose at 5½ Years of Age

Open-label, randomized, multi-centre study in which 400 subjects, divided into two groups, will receive Td5ap or Td1aP as a single injection. We will then describe the immune response and safety profile of the combined vaccine booster.

Read the detailed description

The vaccines in the study are COVAXIS (Td5ap), Sanofi Pasteur Canada, and diTekiBooster (Td1aP), Statens Serum Institut, Denmark.

The primary objective of the study is to describe the immune response to diphtheria toxin, tetanus toxoid, pertussis toxin, filamentous haemagglutinin (FHA), fimbriae 2/3 and pertactin four weeks after immunization with Td1aP and Td5ap.

The secondary objectives include:

  • describing the safety of a fith dose of DTP vaccines in 14-15 year-old children by observing systemic and local adverse reactions
  • describing pre-booster antibody levels
  • describing pre-booster and post-booster IgG and IgA levels in saliva
  • describing in a subpopulation the pre-booster and post-booster T cell immune responses as determined by the production of cytokines
  • describing in a subpopulation the pre-booster and post-booster B cell immune responses as determined by the number of effector and memory B-cells

The sample size is 400 subjects (200 in group 1 and 200 in group 2). It will be an open-label, randomized, multi-centre study in which group 1 will receive Td5ap as a single injection and group 2 will receive Td1aP as a single injection. DTP antibodies will be measured before and 28 days (+ 14 days) after Td5ap and Td1aP vaccination. The proportion of children with positive IgG antibody response will be measured in each study arm. Sera will be tested blindly by established ELISA methods and saliva samples will be analyzed by exploratory assays. In a subpopulation cellmediated immunity will be analyzed. The safety evaluation criteria will be the percentage of subjects with adverse events describing injection-site adverse reactions, systemic adverse events, daily temperatures and serious adverse events.

Being tested
Td5ap, Td1aP
Keywords
immunogenicity, safety, tetanus, diphtheria, acellular, pertussis, vaccine, booster, adverse event, adverse reaction, DT1aP, DT5ap, FHA, fimbriae, pertactin, SMI, Smittskyddsinstitutet, Immune response and safety profile to a Tdap booster
Medical subject headings
Tetanus, Diphtheria, Whooping Cough

What participants receive

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

  • Td5apBiological

    Also called COVAXiS

    Intramuscular injection of 0.5 mL Td5ap (COVAXiS) on day 1.

  • Td1aPBiological

    Also called diTekiBooster

    Intramuscular injection of 0.5 mL Td1aP (diTekiBooster) on day 1.

Study groups in NCT00870350
Study groupRoleWhat they receive
Td5apActive comparatorGroup 1 receiving Td5ap as a single intramuscular injection.
Receives: Biological: Td5ap
Td1aPActive comparatorGroup 2 receiving Td1aP as a single intramuscular injection
Receives: Biological: Td1aP

What is being measured

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

  1. to describe in each arm the immune response to diptheria toxin, tetanus toxoid, pertussis toxin, FHA, fimbriae 2/3 and pertactin four weeks after immunization with Td1aP and Td5ap

    Measured: 42 days

Secondary outcomes (5)

  1. safety of a fith dose of DTP vaccines

    Measured: 42 days

  2. pre-booster antibody levels

    Measured: 42 days

  3. pre-booster and post-booster IgG and IgA levels

    Measured: 42 days

  4. pre-booster and post-booster T cell immune responses

    Measured: 42 days

  5. pre-booster and post-booster B cell immune responses

    Measured: 42 days

Timeline

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

  1. First posted27 Mar 2009 (estimated)
  2. Study startApr 2009
  3. Primary completionOct 2009
  4. Study completionJun 2010 (estimated)

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 4
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
400 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00870350
Sponsor's protocol ID
2008-008195-13
Other IDs
2008
Acronym
Tdap Booster
Status last verified
Mar 2009
First submitted
26 Mar 2009
Last updated
7 Jun 2010
Results posted
No
Data monitoring committee
Yes

Publications

  • Lin A, Apostolovic D, Jahnmatz M, Liang F, Ols S, Tecleab T, Wu C, van Hage M, Solovay K, Rubin K, Locht C, Thorstensson R, Thalen M, Lore K. Live attenuated pertussis vaccine BPZE1 induces a broad antibody response in humans. J Clin Invest. 2020 May 1;130(5):2332-2346. doi: 10.1172/JCI135020.

    PubMed 31945015

  • Carlsson RM, Gustafsson L, Hallander HO, Ljungman M, Olin P, Gothefors L, Nilsson L, Netterlid E. Two consecutive randomized controlled pertussis booster trials in children initially vaccinated in infancy with an acellular vaccine: The first with a five-component Tdap vaccine to 5-year olds and the second with five- or monocomponent Tdap vaccines at age 14-15 years. Vaccine. 2015 Jul 17;33(31):3717-25. doi: 10.1016/j.vaccine.2015.05.079. Epub 2015 Jun 7.

    PubMed 26057135

  • Jahnmatz M, Ljungman M, Netterlid E, Jenmalm MC, Nilsson L, Thorstensson R. Pertussis-specific memory B-cell and humoral IgG responses in adolescents after a fifth consecutive dose of acellular pertussis vaccine. Clin Vaccine Immunol. 2014 Sep;21(9):1301-8. doi: 10.1128/CVI.00280-14. Epub 2014 Jul 9.

    PubMed 25008903

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Td5ap and Td1aP in people with Tetanus and Diphtheria, run by Swedish Institute for Infectious Disease Control at 1 site in Sweden.

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 7 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 7 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in 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?

Results are not available in the source record.

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?

to describe in each arm the immune response to diptheria toxin, tetanus toxoid, pertussis toxin, FHA, fimbriae 2/3 and pertactin four weeks after immunization with Td1aP and Td5ap (time frame: 42 days). 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 NCT00870350, 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 7 Jun 2010.

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