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Trial registered on ANZCTR
Registration number
ACTRN12620000848909
Ethics application status
Approved
Date submitted
10/06/2020
Date registered
27/08/2020
Date last updated
13/07/2022
Date data sharing statement initially provided
27/08/2020
Date results information initially provided
13/07/2022
Type of registration
Retrospectively registered
Titles & IDs
Public title
A Clinical Trial to Assess the safety and immunogenicity of a combined Tetanus, Diphtheria, Acellular Pertussis and Poliomyelitis Vaccine (SIIPL Tdap-IPV) compared with Boostrix-IPV in Healthy Adults, Adolescents and Children
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Scientific title
A Phase I/II, Multicentre, Observer-blinded, Randomized, Active Controlled, Clinical Trial to Assess the Reactogenicity, Safety and Immunogenicity of a combined Tetanus, Diphtheria, Acellular Pertussis and Poliomyelitis Vaccine (SIIPL Tdap-IPV) in Comparison with Boostrix® -IPV in Healthy Adults, Adolescents and Children
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Secondary ID [1]
301399
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Nil
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Tetanus
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Diphtheria
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Pertussis
318005
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Polio
318006
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Condition category
Condition code
Infection
315742
315742
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0
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Other infectious diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Tetanus, diphtheria, acellular pertussis and poliomyelitis vaccine (SIIPL Tdap-IPV), single dose 0.5mL, intramuscular injection to be evaluated in Phase 1 (involving healthy adults only) and 2 (involving healthy adults, adolescents and children aged > 4 years)
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Intervention code [1]
317705
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Treatment: Drugs
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Comparator / control treatment
Tetanus, diphtheria, acellular pertussis and poliomyelitis vaccine (Boostrix-IPV) , single dose 0.5mL, intramuscular injection
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Control group
Active
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Outcomes
Primary outcome [1]
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Phase I: To assess the composite endpoints of reactogenicity and safety of a single dose of SIIPL Tdap-IPV vaccine in comparison with a single dose of Boostrix®-IPV vaccine in healthy adult participants aged 18-65 years as determined through participant reported local and systemic adverse events (i.e. injection site reaction, headaches, fever) and clinically identified local and systemic adverse events (physical examination, vital signs, serum assays)
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Assessment method [1]
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Timepoint [1]
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Participants will return to investigational sites on Day 7 and 30. During each visit, a symptom directed physical examination and vital signs assessment will be completed. During Phase 1, the day 30 visit will also include the collection of blood samples for safety assessments.
Adverse events (unsolicited/solicited) and body temperature will be recorded daily by participants in study specific diaries for 7 days post vaccination.
On Day 3 post-vaccination, participants will be contacted by phone to assess for the occurrence of any solicited or unsolicited adverse events.
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Primary outcome [2]
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Phase II: To assess the composite endpoints of reactogenicity and safety of a single dose of SIIPL Tdap-IPV vaccine in comparison with a single dose of Boostrix-IPV vaccine in healthy subjects of age 4-65 years as determined through participant/parent/guardian reported (i.e. injection site reaction, headaches, fever) and clinically identified local and systemic adverse events (physical examination, vital signs, serum assays).
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Assessment method [2]
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Timepoint [2]
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Participant/guardian/parent reported adverse events are assessed and recorded daily for 7 days post-vaccination using a study diary and then on occurrence up to 30 days post-vaccination. Body temperature will be measured daily for the 7 days post vaccination and recorded.
On Day 3 post-vaccination, participants will be contacted by phone to assess for the occurrence of any solicited or unsolicited adverse events.
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Secondary outcome [1]
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To demonstrate seroprotection against diphtheria, tetanus and poliomyelitis viruses (types 1 and 3) in Phase 2, as measured by antibody titres using blood samples of participants aged 4-65 years
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Assessment method [1]
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Timepoint [1]
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30 days after vaccination
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Secondary outcome [2]
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To assess percentage of seropositive subjects against pertussis antigens in Phase 2, as measured by the presence of a minimum antibody titres from blood samples of participants aged 4 to 65 years.
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Assessment method [2]
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Timepoint [2]
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30 days after vaccination
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Secondary outcome [3]
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To assess booster response rates to each vaccine, with respect to antibodies against diphtheria and tetanus toxoids and pertussis using blood samples in healthy subjects of age 4-65 years participating in Phase 2 of the study
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Assessment method [3]
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Timepoint [3]
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30 days after vaccination,
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Secondary outcome [4]
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To assess immune responses to vaccines through evaluation of antibody geometric mean concentrations (GMCs) using blood samples of participants aged 4-65 years participating in Phase 1 and Phase 2 of the study
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Assessment method [4]
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Timepoint [4]
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Prior to vaccination and 30 days after vaccination
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Eligibility
Key inclusion criteria
Phase 1:
1. Healthy male and female adults aged between 18 years and 65 years on the day of vaccination, who have received primary immunization series of the DTP vaccine.
2. Subjects willingness and ability to comply with the requirements of the protocol.
3. Women of childbearing potential (any female who has experienced menarche and who has not undergone surgical sterilization [including hysterectomy or bilateral oophorectomy]
or who is not postmenopausal) and their partners must agree to use a highly effective method of contraception for the duration of the study (from signing of the informed consent form), and for 30 days after the last dose of study drug, unless the subject has
undergone surgical sterilization or her partner has undergone vasectomy (both >6 months prior to study), or is a postmenopausal female (no menstrual period for 2 years prior
to study).
Males must agree to use a condom with the partner using a highly effective method of contraception.
Phase 2:
1. Healthy male and female adults, adolescents and children aged between 4 years and 65 years on the day of vaccination, who have received primary immunization series of the DTP vaccine.
2. Subjects/legal guardian’s willingness and ability to comply with the requirements of the protocol.
3. Women of childbearing potential (any female who has experienced menarche and who has not undergone surgical sterilization [including hysterectomy or bilateral oophorectomy]
or who is not postmenopausal) and their partners must agree to use a highly effective method of contraception for the duration of the study (from signing of the informed consent form), and for 30 days after the last dose of study drug, unless the subject has
undergone surgical sterilization or her partner has undergone vasectomy (both >6 months prior to study), or is a postmenopausal female (no menstrual period for 2 years prior
to study).
Males must agree to use a condom with the partner using a highly effective method of contraception.
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Minimum age
4
Years
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Maximum age
65
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
1. Children: History of previous vaccination against diphtheria, tetanus and pertussis with either the study vaccine or another vaccine in the past 2 years.
2. Adolescents and adults: History of previous vaccination against diphtheria, tetanus, pertussis or poliomyelitis (excluding tetanus- or Td-prone wound management for adults and/or for tetanus or Td vaccination in pregnant women) in the past 4 years.
3. History of tetanus, diphtheria, pertussis or poliomyelitis infection (confirmed either
clinically, serologically or microbiologically).
4. Administration of any investigational drug, or any vaccine within 30 days prior to vaccination.
5. History of a severe allergic reaction or hypersensitivity after a previous dose of any DT-, TT-, pertussis antigen or inactivated poliovirus types 1, 2 and 3 containing vaccine or to any component of the study vaccines.
7. History of adverse event known to have occurred in temporal relation to receipt of pertussis-containing vaccine.
8. History of Guillain-Barré syndrome or brachial neuritis that occurred within 6 weeks of receipt of a prior tetanus vaccine.
9. History of encephalopathy (e.g. coma, decreased level of consciousness, prolonged seizures) within 7 days of administration of a previous dose of a pertussis antigen-containing vaccine that is not attributable to another identifiable cause.
10. History of transient thrombocytopenia or a bleeding disorder following an intramuscular administration.
11. History of neurological complications following an earlier vaccination against diphtheria and/or tetanus.
12. History of any major pulmonary, cardiovascular, renal, neurological, metabolic, gastrointestinal, hepato-biliary, hematological functional abnormality, or mental disability.
13. History of surgery done within 30 days prior to the vaccination.
14. History of progressive or unstable neurologic conditions (e.g. cerebrovascular events).
15. Acute illness (moderate or severe) and/or fever (axillary temperature =38°C) at the time of vaccination or during the 72 hours prior to the vaccination.
16. History of receipt of a blood transfusion, other blood products, or immunoglobulins in 3 months prior to study vaccination, or planned administration during the active study period
17. Subjects with altered immunocompetence such as subjects with ongoing cancer treatment, human immunodeficiency virus (HIV) infection or any other active immune system disorder.
18. Subjects who have undergone organ transplant surgery.
19. Chronic administration of immunosuppressant or other immune modifying drugs during the period starting 6 months prior to the study vaccine dose, excluding inhaled or topical steroids.
20. Females who are pregnant or breastfeeding.
21. Subject has any plans to permanently relocate from the area prior to the completion of the study or to leave for an extended period of time when study visits would need to be scheduled.
22. Concurrent participation in another clinical study investigating a vaccine, drug, medical device, or medical procedure in the preceding 30 days from enrollment.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people assessing the outcomes
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 1 / Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Stopped early
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Data analysis
Data collected is being analysed
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Reason for early stopping/withdrawal
Participant recruitment difficulties
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Date of first participant enrolment
Anticipated
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Actual
7/07/2020
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Date of last participant enrolment
Anticipated
31/03/2021
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Actual
31/03/2021
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Date of last data collection
Anticipated
30/04/2021
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Actual
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Sample size
Target
204
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Accrual to date
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Final
107
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Recruitment in Australia
Recruitment state(s)
ACT,WA,VIC
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Funding & Sponsors
Funding source category [1]
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Commercial sector/Industry
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Name [1]
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Serum Institute of India Pvt Ltd
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Address [1]
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212/2, Off Soli Poonawalla Road, Hadapsar
Pune - 411028
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Country [1]
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India
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Primary sponsor type
Commercial sector/Industry
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Name
Serum Institute of India Pvt Ltd
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Address
212/2, Off Soli Poonawalla Road, Hadapsar
Pune - 411028
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Country
India
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Secondary sponsor category [1]
306283
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Commercial sector/Industry
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Name [1]
306283
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Accelagen Pty Ltd
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Address [1]
306283
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Suite 2.02, 785 Toorak Road Hawthorn East Victoria 3123
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Country [1]
306283
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
306103
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St Vincents Hospital Melbourne
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Ethics committee address [1]
306103
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27 Victoria Parade
Fitzroy VIC 3065
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Ethics committee country [1]
306103
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Australia
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Date submitted for ethics approval [1]
306103
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22/04/2020
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Approval date [1]
306103
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18/06/2020
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Ethics approval number [1]
306103
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Ethics committee name [2]
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Child and Adolescents Health Service HREC
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Ethics committee address [2]
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Perth Children’s Hospital
15 Hospital Avenue, Nedlands WA 6009
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Ethics committee country [2]
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Australia
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Date submitted for ethics approval [2]
306105
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16/06/2020
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Approval date [2]
306105
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Ethics approval number [2]
306105
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Summary
Brief summary
SIIPL Tdap-IPV, manufactured by Serum Institute of India Pvt. Ltd. (SIIPL), is a combined vaccine for active immunization against tetanus, diphtheria, pertussis and poliomyelitis. The formulation contains reduced amounts of the tetanus, diphtheria and acellular pertussis antigens in comparison to paediatric vaccines; it is indicated for booster immunization of children, adolescents and adults.
The study is aimed at comparing the reactogenicity and safety of SIIPL Tdap-IPV to comparator Boostrix®-IPV (GlaxoSmithKline). A comparison of immunogenicity in terms of seroprotection rates of tetanus, diphtheria and inactivated poliomyelitis components and the booster response rates to the acellular pertussis antigens will also be assessed.
The study will be conducted in two combined phases: phase I and phase II. Phase I will include healthy adults, whilst Phase II will also include adolescents and adults aged 4 years and above.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Louise Murdoch
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Address
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Emeritus Research Pty Ltd
Level 2/1180 Toorak Rd,
Camberwell VIC 3124
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Country
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Australia
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Phone
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+61 3 9509 6166
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Mr Greg Plunkett
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Address
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Accelagen Pty Ltd Suite 2.02, 785 Toorak Rd, Hawthorn East VIC 3123
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Country
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Australia
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Phone
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+61 3 9114 2270
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Mr Greg Plunkett
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Address
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Accelagen Pty Ltd Suite 2.02, 785 Toorak Rd, Hawthorn East VIC 3123
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Country
102720
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Australia
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Phone
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+61 3 9114 2270
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Fax
102720
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Email
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
Data from overall study population will be available within the clinical study report provided to participating sites, and scientific publications as prepared by Sponsor representatives or Study Investigators.
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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