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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
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
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
Secondary ID [1] 301399 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Tetanus 317663 0
Diphtheria 318004 0
Pertussis 318005 0
Polio 318006 0
Condition category
Condition code
Infection 315742 315742 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
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)
Intervention code [1] 317705 0
Treatment: Drugs
Comparator / control treatment
Tetanus, diphtheria, acellular pertussis and poliomyelitis vaccine (Boostrix-IPV) , single dose 0.5mL, intramuscular injection
Control group
Active

Outcomes
Primary outcome [1] 323951 0
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)
Timepoint [1] 323951 0
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.
Primary outcome [2] 323952 0
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).
Timepoint [2] 323952 0
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.
Secondary outcome [1] 383413 0
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
Timepoint [1] 383413 0
30 days after vaccination
Secondary outcome [2] 383414 0
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.
Timepoint [2] 383414 0
30 days after vaccination
Secondary outcome [3] 383415 0
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
Timepoint [3] 383415 0
30 days after vaccination,
Secondary outcome [4] 383416 0
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
Timepoint [4] 383416 0
Prior to vaccination and 30 days after vaccination

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.
Minimum age
4 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 1 / Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
Actual
7/07/2020
Date of last participant enrolment
Anticipated
31/03/2021
Actual
31/03/2021
Date of last data collection
Anticipated
30/04/2021
Actual
Sample size
Target
204
Accrual to date
Final
107
Recruitment in Australia
Recruitment state(s)
ACT,WA,VIC

Funding & Sponsors
Funding source category [1] 305839 0
Commercial sector/Industry
Name [1] 305839 0
Serum Institute of India Pvt Ltd
Country [1] 305839 0
India
Primary sponsor type
Commercial sector/Industry
Name
Serum Institute of India Pvt Ltd
Address
212/2, Off Soli Poonawalla Road, Hadapsar
Pune - 411028
Country
India
Secondary sponsor category [1] 306283 0
Commercial sector/Industry
Name [1] 306283 0
Accelagen Pty Ltd
Address [1] 306283 0
Suite 2.02, 785 Toorak Road Hawthorn East Victoria 3123
Country [1] 306283 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306103 0
St Vincents Hospital Melbourne
Ethics committee address [1] 306103 0
Ethics committee country [1] 306103 0
Australia
Date submitted for ethics approval [1] 306103 0
22/04/2020
Approval date [1] 306103 0
18/06/2020
Ethics approval number [1] 306103 0
Ethics committee name [2] 306105 0
Child and Adolescents Health Service HREC
Ethics committee address [2] 306105 0
Ethics committee country [2] 306105 0
Australia
Date submitted for ethics approval [2] 306105 0
16/06/2020
Approval date [2] 306105 0
Ethics approval number [2] 306105 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 102718 0
Dr Louise Murdoch
Address 102718 0
Emeritus Research Pty Ltd
Level 2/1180 Toorak Rd,
Camberwell VIC 3124
Country 102718 0
Australia
Phone 102718 0
+61 3 9509 6166
Fax 102718 0
Email 102718 0
info@emeritusresearch.com
Contact person for public queries
Name 102719 0
Greg Plunkett
Address 102719 0
Accelagen Pty Ltd Suite 2.02, 785 Toorak Rd, Hawthorn East VIC 3123
Country 102719 0
Australia
Phone 102719 0
+61 3 9114 2270
Fax 102719 0
Email 102719 0
info@accelagen.com.au
Contact person for scientific queries
Name 102720 0
Greg Plunkett
Address 102720 0
Accelagen Pty Ltd Suite 2.02, 785 Toorak Rd, Hawthorn East VIC 3123
Country 102720 0
Australia
Phone 102720 0
+61 3 9114 2270
Fax 102720 0
Email 102720 0
info@accelagen.com.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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.


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.