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

NCT00870350 | Unknown Phase 4 DMC

• 1 other identifier: 2008-008195-13
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Tetanus; Diphtheria; Pertussis

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

Outcome Measures

Primary Outcomes (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

  42 days

Secondary Outcomes (5)

• safety of a fith dose of DTP vaccines

  42 days

• pre-booster antibody levels

  42 days

• pre-booster and post-booster IgG and IgA levels

  42 days

• pre-booster and post-booster T cell immune responses

  42 days

• pre-booster and post-booster B cell immune responses

  42 days

Study Arms (2)

Td5ap

ACTIVE COMPARATOR

Group 1 receiving Td5ap as a single intramuscular injection.

Biological: Td5ap

Td1aP

ACTIVE COMPARATOR

Group 2 receiving Td1aP as a single intramuscular injection

Biological: Td1aP

Interventions

Td5ap BIOLOGICAL

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

Also known as: COVAXiS

Td5ap

Td1aP BIOLOGICAL

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

Also known as: diTekiBooster

Td1aP

Eligibility Criteria

• Age: 14 Years - 15 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• healthy subject
• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Swedish Institute for Infectious Disease Control: lead
• MCM Vaccines B.V.: collaborator
• Statens Serum Institut: collaborator

Study Sites (1)

Swedish Institute for Infectious Disease Control

Lund, 221 85, Sweden

Location

Related Publications (3)

• 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.

  PMID: 31945015 DERIVED

• 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.

  PMID: 26057135 DERIVED

• 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.

  PMID: 25008903 DERIVED

MeSH Terms

Conditions

Tetanus; Diphtheria; Whooping Cough

Interventions

adacel

Condition Hierarchy (Ancestors)

Clostridium Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Corynebacterium Infections; Actinomycetales Infections; Bordetella Infections; Gram-Negative Bacterial Infections; Respiratory Tract Infections; Respiratory Tract Diseases

Study Officials

• Leif Gothefors, Prof. em.

  Swedish Institute for Infectious Disease Control

  PRINCIPAL INVESTIGATOR

• Eva Netterlid

  Swedish Institute for Infectious Disease Control

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 26, 2009
• First Posted: March 27, 2009
• Study Start: April 1, 2009
• Primary Completion: October 1, 2009
• Study Completion: June 1, 2010
• Last Updated: June 7, 2010

Record last verified: 2009-03

Locations

SE (1)