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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2009 by Swedish Institute for Infectious Disease Control.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Sanofi Pasteur MSD
Statens Serum Institut
Information provided by:
Swedish Institute for Infectious Disease Control
ClinicalTrials.gov Identifier:
NCT00870350
First received: March 26, 2009
Last updated: June 4, 2010
Last verified: March 2009
  Purpose

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.


Condition Intervention Phase
Tetanus
Diphtheria
Pertussis
Biological: Td5ap
Biological: Td1aP
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
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

Resource links provided by NLM:


Further study details as provided by Swedish Institute for Infectious Disease Control:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • safety of a fith dose of DTP vaccines [ Time Frame: 42 days ] [ Designated as safety issue: Yes ]
  • pre-booster antibody levels [ Time Frame: 42 days ] [ Designated as safety issue: Yes ]
  • pre-booster and post-booster IgG and IgA levels [ Time Frame: 42 days ] [ Designated as safety issue: Yes ]
  • pre-booster and post-booster T cell immune responses [ Time Frame: 42 days ] [ Designated as safety issue: Yes ]
  • pre-booster and post-booster B cell immune responses [ Time Frame: 42 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 400
Study Start Date: April 2009
Estimated Study Completion Date: June 2010
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Td5ap
Group 1 receiving Td5ap as a single intramuscular injection.
Biological: Td5ap
Intramuscular injection of 0.5 mL Td5ap (COVAXiS) on day 1.
Other Name: COVAXiS
Active Comparator: Td1aP
Group 2 receiving Td1aP as a single intramuscular injection
Biological: Td1aP
Intramuscular injection of 0.5 mL Td1aP (diTekiBooster) on day 1.
Other Name: diTekiBooster

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.

  Eligibility

Ages Eligible for Study:   14 Years to 15 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00870350

Locations
Sweden
Swedish Institute for Infectious Disease Control
Lund, Sweden, 221 85
Sponsors and Collaborators
Swedish Institute for Infectious Disease Control
Sanofi Pasteur MSD
Statens Serum Institut
Investigators
Principal Investigator: Leif Gothefors, Prof. em. Swedish Institute for Infectious Disease Control
Study Director: Eva Netterlid Swedish Institute for Infectious Disease Control
  More Information

No publications provided

Responsible Party: Prof. em. Leif Gothefors, Swedish Institute for Infectious Disease Control
ClinicalTrials.gov Identifier: NCT00870350     History of Changes
Other Study ID Numbers: 2008-008195-13
Study First Received: March 26, 2009
Last Updated: June 4, 2010
Health Authority: Sweden: Medical Products Agency

Keywords provided by Swedish Institute for Infectious Disease Control:
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

Additional relevant MeSH terms:
Whooping Cough
Tetanus
Tetany
Diphtheria
Bordetella Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Respiratory Tract Infections
Infection
Respiratory Tract Diseases
Clostridium Infections
Gram-Positive Bacterial Infections
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Hypocalcemia
Calcium Metabolism Disorders
Metabolic Diseases
Signs and Symptoms
Corynebacterium Infections
Actinomycetales Infections

ClinicalTrials.gov processed this record on September 18, 2014