PertussisPhase 1NCT01529645

Safety and Dose Ranging Study of Acellular Pertussis and Acellular Pertussis -Tetanus-Diphtheria Booster Vaccines in Healthy Adults Ages 18 to 40 Years

A Phase 1 study testing Acellular pertussis vaccine, Tetanus, reduced diphtheria, and acellular pertussis vaccine (adsorbed) and Licensed TdaP booster vaccine in people with Pertussis and Whooping Cough, run by Novartis Vaccines at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study will evaluate the safety and efficacy of 9 different vaccines containing aP (acellular pertussis) and TdaP (acellular pertussis, tetanus and diphtheria) in healthy subjects 18 to 40 years of age. Read more about this study

Who is it for?: Ages 18 to 40 yearsHealthy volunteers can take part
Conditions the study is for: Pertussis, Whooping Cough, Tetanus
What is being tested?: Acellular pertussis vaccine, Tetanus, reduced diphtheria, and acellular pertussis vaccine (adsorbed) and Licensed TdaP booster vaccine
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 420 participants
Where: 1 siteBelgium
Study dates: Mar 2012to Jul 2013
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 18 to 40 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Healthy male and female individuals between 18 and 40 years of age (inclusive) who had provided informed consent.
Individuals who were able to be contacted for the duration of the study.

Who cannot join

Individuals who had received vaccines containing T, D, or pertussis (aP or whole cell), been diagnosed with pertussis disease, or who have had a household exposure to pertussis within the past 8 years.
If female, "of childbearing potential", sexually active, and had not used any of the "acceptable contraceptive methods" for at least 2 months prior to study entry:
Of childbearing potential was defined as status post onset of menarche and not meeting any of the following conditions: menopausal for at least 2 years, status after bilateral tubal ligation for at least 1 year, status after bilateral oophorectomy, or status after hysterectomy.
Acceptable birth control methods were defined as one or more of the following:
Hormonal contraceptive (such as oral, injection, transdermal patch, implant, cervical ring);
Barrier (condom with spermicide or diaphragm with spermicide) each and every time during intercourse;

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Intrauterine device (IUD);
Monogamous relationship with vasectomized partner. Partner must have been vasectomized for at least six months prior to the subject's study entry.
If female of childbearing potential and sexually active, refusal to use an "acceptable contraceptive method" through to 3 weeks after last study vaccination.
Any positive or indeterminate pregnancy test.
Female individuals who were pregnant or breastfeeding.
Individuals with contraindications, warnings and/or precautions to vaccination with Boostrix or Td-pur as specified within the summary of product characteristics.
Individuals with a clinically significant active infection (as assessed by the investigator) or oral body temperature ≥38°C/100.4ºF within 3 days of the intended date of vaccination.
Known hypersensitivity or allergy to diphtheria, tetanus, or pertussis vaccine (including excipients of the investigational study vaccines, control or placebo as summarized in protocol section 5.0).
Individuals with behavioral or cognitive impairment or psychiatric disease that, in the opinion of the investigator, might have interfered with the subject's ability to participate in the study.
Individuals with any progressive or severe neurologic disorder, seizure disorder or Guillian-Barré syndrome.
Individuals with history or any illness that, in the opinion of the investigator, might have interfered with the results of the study or pose additional risk to the individuals due to participation in the study.
Known or suspected impairment/alteration of immune function, including:
Chronic use of oral steroids (≥15 days of use) within 60 days prior to visit 1 (day 1) (use of inhaled, intranasal, or topical corticosteroids was allowed);
Receipt of parenteral steroids within 60 days prior to visit 1 (day 1);
Receipt of immunostimulants within 60 days prior to visit 1 (day 1);
Receipt of parenteral immunoglobulin preparation, blood products, and/or plasma derivates within 3 months prior to visit 1 (day 1) or planned during the full length of the study;
HIV infection or HIV-related disease;
Heritable immunodeficiency.
Abnormalities of splenic or thymic function.
Individuals with a known bleeding diathesis, or any condition that might have been associated with a prolonged bleeding time.
Individuals with any serious chronic or progressive disease according to judgment of the investigator (neoplasm, insulin dependent diabetes, cardiac, renal or hepatic disease).
Individuals with body mass index (BMI) greater than or equal to 35 kg/m2 (= weight in kg / (height in meters x height in meters)).
Individuals participating in any clinical trial with another investigational product 30 days prior to first study visit or with intent to participate in another clinical study at any time during the conduct of this study.
Individuals who received any other vaccines within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to enrollment in this study or who were planning to receive any vaccine other than Td or placebo within 28 days from the study vaccines.
Individuals who were first degree relatives of subjects involved in trial conduct.
Individuals with history of substance or alcohol abuse within the past 2 years.

Trial locations and contacts

1 site in 1 country.

Belgium1 site

Center for Vaccinology (CEVAC), Ghent University Hospital
De Pintelaan, B-9000 Ghent, 185

Other trials in Belgium

About this study

Official title: Phase I, Randomized, Controlled, Observer-Blind, Dose-Ranging Study of Acellular Pertussis and Tetanus-Diptheria-Acellular Pertussis Booster Vaccine in Adults Ages 18 to 40 Years.

Conditions: Pertussis, Whooping Cough, Tetanus, Lockjaw, Diphtheria
Being tested: Acellular pertussis vaccine, Tetanus, reduced diphtheria, and acellular pertussis vaccine (adsorbed), Licensed TdaP booster vaccine, Diphtheria and tetanus vaccine (adsorbed, reduced antigen content, Germany), Saline solution
Keywords: pertussis, booster vaccine, tetanus, diphtheria in adults
Medical subject headings: Whooping Cough, Tetanus, Trismus, Diphtheria

What participants receive

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

Acellular pertussis vaccineBiological
Acellular pertussis (aP) vaccine was administered with different antigen doses intramuscularly in the upper deltoid region of the subject's non-dominant arm.
Tetanus, reduced diphtheria, and acellular pertussis vaccine (adsorbed)Biological
Tetanus, reduced diphtheria, and acellular pertussis (TdaP) vaccine was administered with different antigen doses intramuscularly in the upper deltoid region of the subject's non-dominant arm.
Licensed TdaP booster vaccineBiological
Licenced TdaP booster vaccine was administered intramuscularly in the upper deltoid region of the subject's non-dominant arm.
Diphtheria and tetanus vaccine (adsorbed, reduced antigen content, Germany)Biological
To ensure all subjects receive a tetanus and diphtheria booster vaccination, an injection was administered on Study Day 30, one month after the administration of the investigational vaccine.
Saline solutionOther
Subjects received one injection of saline solution at one month after vaccination.

Study groups in NCT01529645
Study group	Role	What they receive
Group 1: aP booster	Experimental	Subjects received acellular pertussis (aP) vaccine with different antigen dose formulations: low dose of PT, FHA, PRN, followed by one fixed dose of diphtheria and tetanus vaccine (adsorbed, reduced antigen content, Germany) administered one month apart. Receives: Biological: Acellular pertussis vaccine; Biological: Diphtheria and tetanus vaccine (adsorbed, reduced antigen content, Germany)
Group 2: aP booster	Experimental	Subjects received acellular pertussis (aP) vaccine with different antigen dose formulations: medium dose of PT, FHA, PRN, followed by one fixed dose of diphtheria and tetanus vaccine (adsorbed, reduced antigen content, Germany) administered one month apart. Receives: Biological: Acellular pertussis vaccine; Biological: Diphtheria and tetanus vaccine (adsorbed, reduced antigen content, Germany)
Group 3: aP booster	Experimental	Subjects received acellular pertussis (aP) vaccine with different antigen dose formulations: high dose of PT, FHA, PRN, followed by one fixed dose of diphtheria and tetanus vaccine (adsorbed, reduced antigen content, Germany) administered one month apart. Receives: Biological: Acellular pertussis vaccine; Biological: Diphtheria and tetanus vaccine (adsorbed, reduced antigen content, Germany)
Group 4: TdaP booster	Experimental	Subjects received tetanus, reduced diphtheria, and acellular pertussis vaccine (adsorbed) with different antigen dose formulations: low dose of PT, FHA, PRN, low dose of D (diphteria) toxoid, fixed dose of T (tetanus) toxoid, followed by one administration of saline solution one month apart. Receives: Biological: Tetanus, reduced diphtheria, and acellular pertussis vaccine (adsorbed); Other: Saline solution
Group 5: TdaP booster	Experimental	Subjects received tetanus, reduced diphtheria, and acellular pertussis vaccine (adsorbed) with different antigen dose formulations: medium dose of PT, FHA, PRN, low dose of D toxoid, fixed dose of T toxoid, followed by one administration of saline solution one month apart. Receives: Biological: Tetanus, reduced diphtheria, and acellular pertussis vaccine (adsorbed); Other: Saline solution
Group 6: TdaP booster	Experimental	Subjects received tetanus, reduced diphtheria, and acellular pertussis vaccine (adsorbed) with different antigen dose formulations: high dose of PT, FHA, PRN, low dose of D toxoid, fixed dose of T toxoid, followed by one administration of saline solution one month apart. Receives: Biological: Tetanus, reduced diphtheria, and acellular pertussis vaccine (adsorbed); Other: Saline solution
Group 7: TdaP booster	Experimental	Subjects received tetanus, reduced diphtheria, and acellular pertussis vaccine (adsorbed) with different antigen dose formulations: low dose of PT, FHA, PRN, double dose of D toxoid, fixed dose of T toxoid, followed by one administration of saline solution one month apart. Receives: Biological: Tetanus, reduced diphtheria, and acellular pertussis vaccine (adsorbed); Other: Saline solution
Group 8: TdaP booster	Experimental	Subjects received tetanus, reduced diphtheria, and acellular pertussis vaccine (adsorbed) with different antigen dose formulations: medium dose of PT, FHA, PRN, double dose of D toxoid, fixed dose of T toxoid, followed by one administration of saline solution one month apart. Receives: Biological: Tetanus, reduced diphtheria, and acellular pertussis vaccine (adsorbed); Other: Saline solution
Group 9: TDaP booster	Experimental	Subjects received tetanus, reduced diphtheria, and acellular pertussis vaccine (adsorbed) with different antigen dose formulations: high dose of PT, FHA, PRN, double dose of D toxoid, fixed dose of T toxoid, followed by one administration of saline solution one month apart. Receives: Biological: Tetanus, reduced diphtheria, and acellular pertussis vaccine (adsorbed); Other: Saline solution
Group 10: Licensed TdaP booster	Active comparator	Subject received one dose of a licensed TdaP booster vaccine (containing 8 μg each of PT, FHA and 2.5 μg of PRN antigens and 2.5 Lf of diphtheria toxoid and 5 Lf of tetanus toxoid) followed by one administration of saline solution one month apart. Receives: Biological: Licensed TdaP booster vaccine; Other: Saline solution

What is being measured

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

The Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine
The safety profiles of different antigenic formulations of the aP and TdaP booster vaccines were assessed and compared to that of licensed comparator in terms of the number of subjects reporting solicited local and systemic adverse events and other adverse events after vaccination.
Measured: Day 1 through 7 after vaccination
The Number of Subjects Reporting Unsolicited Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine
The safety profiles of different antigenic formulations of the aP and TdaP booster vaccines were assessed in terms of the number of subjects reporting any unsolicited adverse events (AEs) between day 1 to day 30 , serious adverse events (SAEs) and AEs leading to premature withdrawal between day 1 to day 365, after vaccination.
Measured: From day 1 to day 365
Geometric Mean Concentrations (GMCs) of Antibodies in aP1, aP2, aP4 Groups Against Pertussis Antigens Following Booster Vaccination
The GMCs of antibodies as measured by enzyme-linked immunosorbent assay (ELISA) on aP booster groups, against pertussis antigens pertussis toxoid (PT), filamentous hemagglutinin (FHA), pertactin (PRN), following vaccination with different antigenic formulations of aP versus the response to the commercially available comparator are reported.
Measured: Day 1 (baseline) and Day 30 post vaccination
GMCs of Antibodies in T5D2aP1, T5D2aP2 and T5D2aP4 Groups Against Pertussis Antigens Following Booster Vaccination
The GMCs of antibodies as measured by enzyme-linked immunosorbent assay (ELISA) in TdaP Booster Groups against pertussis antigens (PT, FHA and PRN), following vaccination with different antigenic formulations of TdaP booster versus the response to the commercially available comparator are reported.
Measured: Day 1 (baseline) and Day 30 post vaccination
GMCs of Antibodies in T5D4aP1, T5D4aP2 and T5D4aP4 Groups Against Pertussis Antigens Following Vaccination
The GMCs of antibodies as measured by enzyme-linked immunosorbent assay (ELISA) in TdaP booster groups, against pertussis antigens (PT, FHA and PRN), following vaccination with different antigenic formulations of TdaP booster versus the response to the commercially available comparator are reported.
Measured: Day 1 (baseline) and Day 30 post vaccination
Geometric Mean Ratios (GMRs) of Post Vaccination Versus Pre Vaccination GMCs of Antibodies in aP1, aP2, aP4 Booster Groups Against Pertussis Antigens
The GMRs of post-vaccination versus pre-vaccination GMCs of antibodies against pertussis antigens (PT, FHA and PRN) for different antigenic formulations of aP booster vaccines and for licensed comparator are reported.
Measured: Day 30 post vaccination/baseline (Day 1)
GMRs of Post Vaccination Versus Pre Vaccination GMCs of Antibodies in T5D2aP1, T5D2aP2 and T5D2aP4 Booster Groups Against Pertussis Antigens
The GMRs of post-vaccination versus pre-vaccination GMCs of antibodies against pertussis antigens (PT, FHA and PRN) for TdaP booster groups and for licensed comparator are reported.
Measured: Day 30 post vaccination/baseline (Day 1)
GMRs of Post Vaccination Versus Pre Vaccination GMCs of Antibodies for T5D4aP1, T5D4aP2 and T5D4aP4 Booster Groups Against Pertussis Antigens
The GMRs of post-vaccination versus pre-vaccination GMCs of antibodies against pertussis antigens (PT, FHA and PRN) for TdaP booster groups and for licensed comparator are reported.
Measured: Day 30 post vaccination/baseline (Day 1)
Percentages of Subjects With Diphtheria and Tetanus Antitoxin Units >= 0.1/mL After Vaccination
The percentages of subjects demonstrating diphtheria and tetanus antitoxin units >= 0.1/mL following vaccination with different antigenic formulations of TdaP booster vaccine, is compared to the response to commercially available comparator.
Measured: Day 1 (baseline) and Day 30 post vaccination

Secondary outcomes (3)

Percentages of Subjects With 2- and 4-fold Increase in GMCs Against Pertussis Antigens Following Vaccination.
Comparison of antibody responses against pertussis antigens (PT, FHA and PRN), following vaccination with different antigenic formulations of aP and TdaP booster vaccines and licensed comparator, are reported in terms of the percentages of subjects demonstrating 2- and 4-fold increase in GMCs from baseline.
Measured: Day 30 post vaccination
GMCs of Antibodies Against Diphtheria and Tetanus Antigens Following Vaccination
The GMCs of antibodies against diphtheria and tetanus antigens following vaccination with different formulations of TdaP booster are compared with the response to the commercially available comparator.
Measured: Day 1 (baseline) and Day 30 post vaccination
GMRs of Post Vaccination Versus Pre Vaccination GMCs of Antibodies Against Diphtheria and Tetanus Antigens
The GMRs of post vaccination versus pre vaccination GMCs of antibodies against diphtheria and tetanus antigens for different formulations of TdaP booster and commercially available comparator versus GMCs at baseline are reported.
Measured: Day 30 post vaccination/Day 1

Timeline

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

Mar 2012Jul 2013

First posted9 Feb 2012 (estimated)
Study startMar 2012
Primary completionJul 2012
Study completionJul 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for PertussisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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 1
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 420 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01529645
Sponsor's protocol ID: V113_01
Other IDs: 2011-000688-28
Status last verified: Mar 2016
First submitted: 6 Feb 2012
Last updated: 4 Apr 2016
Results posted: Yes, on ClinicalTrials.gov

Publications

Leroux-Roels G, Lattanzi M, Solis CD, Contorni M, Costantini M, Moraschini L, Bardelli M, Bertholet S, Borgogni E, Buricchi F, Cantisani R, Faenzi E, Finco O, Leuzzi R, Pizza M, Rosa D, Schiavetti F, Seubert A, Spensieri F, Volpini G, Zedda L, Giudice GD, Galgani I. A phase I, randomized, controlled, dose-ranging study of investigational acellular pertussis (aP) and reduced tetanus-diphtheria-acellular pertussis (TdaP) booster vaccines in adults. Hum Vaccin Immunother. 2018 Jan 2;14(1):45-58. doi: 10.1080/21645515.2017.1385686. Epub 2017 Nov 27.
PubMed 29172945

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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A Phase I/II Clinical Trial of the Diphtheria, Tetanus, Acellular Component Pertussis and Sabin Inactivated Poliomyelitis Vaccine Adsorbed
Diphtheria, Pertussis
RecruitingPhase 4
Concurrent Versus Sequential Administration of Tdap and RSV Vaccines in Pregnancy
RSV, Tdap - Tetanus, Diphtheria and Acellular Pertussis Vaccination
Not yet recruitingObservational study
Assessment of the Acceptability of, and Factors Associated With, Recommended Vaccinations During Pregnancy in Maternity Units in the Ile-de-France Region
Vaccination Coverage Among Pregnant Women
Not yet recruitingPhase 1/2
Safety and Immunogenicity of a Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Recombinant Poliomyelitis and Haemophilus Influenzae Type b (Hib) Vaccine (SIIPL DTwP-HepB-rPV-Hib)
Diptheria Immunization, Tetanus Immunization

All Pertussis trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase I, Randomized, Controlled, Observer-Blind, Dose-Ranging Study of Acellular Pertussis and Tetanus-Diptheria-Acellular Pertussis Booster Vaccine in Adults Ages 18 to 40 Years.
ClinicalTrials.gov ID: NCT01529645
Acronym / sponsor ID: V113_01
Conditions: Pertussis, Whooping Cough, Tetanus, Lockjaw, Diphtheria
Keywords: pertussis, booster vaccine, tetanus, diphtheria in adults
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 420 participants (actual)
Lead sponsor: Novartis VaccinesIndustry (pharma, biotech, devices)
Study start: Mar 2012
Primary completion: Jul 2012 (actual)
Study completion: Jul 2013 (actual)
First posted: 9 Feb 2012 (estimated)
Results: Posted 18 Sep 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 10

Arm	Type	Receives
Group 1: aP booster	Experimental	Biological: Acellular pertussis vaccine, Biological: Diphtheria and tetanus vaccine (adsorbed, reduced antigen content, Germany)Subjects received acellular pertussis (aP) vaccine with different antigen dose formulations: low dose of PT, FHA, PRN, followed by one fixed dose of diphtheria and tetanus vaccine (adsorbed, reduced antigen content, Germany) administered one month apart.
Group 2: aP booster	Experimental	Biological: Acellular pertussis vaccine, Biological: Diphtheria and tetanus vaccine (adsorbed, reduced antigen content, Germany)Subjects received acellular pertussis (aP) vaccine with different antigen dose formulations: medium dose of PT, FHA, PRN, followed by one fixed dose of diphtheria and tetanus vaccine (adsorbed, reduced antigen content, Germany) administered one month apart.
Group 3: aP booster	Experimental	Biological: Acellular pertussis vaccine, Biological: Diphtheria and tetanus vaccine (adsorbed, reduced antigen content, Germany)Subjects received acellular pertussis (aP) vaccine with different antigen dose formulations: high dose of PT, FHA, PRN, followed by one fixed dose of diphtheria and tetanus vaccine (adsorbed, reduced antigen content, Germany) administered one month apart.
Group 4: TdaP booster	Experimental	Biological: Tetanus, reduced diphtheria, and acellular pertussis vaccine (adsorbed), Other: Saline solutionSubjects received tetanus, reduced diphtheria, and acellular pertussis vaccine (adsorbed) with different antigen dose formulations: low dose of PT, FHA, PRN, low dose of D (diphteria) toxoid, fixed dose of T (tetanus) toxoid, followed by one administration of saline solution one month apart.
Group 5: TdaP booster	Experimental	Biological: Tetanus, reduced diphtheria, and acellular pertussis vaccine (adsorbed), Other: Saline solutionSubjects received tetanus, reduced diphtheria, and acellular pertussis vaccine (adsorbed) with different antigen dose formulations: medium dose of PT, FHA, PRN, low dose of D toxoid, fixed dose of T toxoid, followed by one administration of saline solution one month apart.
Group 6: TdaP booster	Experimental	Biological: Tetanus, reduced diphtheria, and acellular pertussis vaccine (adsorbed), Other: Saline solutionSubjects received tetanus, reduced diphtheria, and acellular pertussis vaccine (adsorbed) with different antigen dose formulations: high dose of PT, FHA, PRN, low dose of D toxoid, fixed dose of T toxoid, followed by one administration of saline solution one month apart.
Group 7: TdaP booster	Experimental	Biological: Tetanus, reduced diphtheria, and acellular pertussis vaccine (adsorbed), Other: Saline solutionSubjects received tetanus, reduced diphtheria, and acellular pertussis vaccine (adsorbed) with different antigen dose formulations: low dose of PT, FHA, PRN, double dose of D toxoid, fixed dose of T toxoid, followed by one administration of saline solution one month apart.
Group 8: TdaP booster	Experimental	Biological: Tetanus, reduced diphtheria, and acellular pertussis vaccine (adsorbed), Other: Saline solutionSubjects received tetanus, reduced diphtheria, and acellular pertussis vaccine (adsorbed) with different antigen dose formulations: medium dose of PT, FHA, PRN, double dose of D toxoid, fixed dose of T toxoid, followed by one administration of saline solution one month apart.
Group 9: TDaP booster	Experimental	Biological: Tetanus, reduced diphtheria, and acellular pertussis vaccine (adsorbed), Other: Saline solutionSubjects received tetanus, reduced diphtheria, and acellular pertussis vaccine (adsorbed) with different antigen dose formulations: high dose of PT, FHA, PRN, double dose of D toxoid, fixed dose of T toxoid, followed by one administration of saline solution one month apart.
Group 10: Licensed TdaP booster	Active comparator	Biological: Licensed TdaP booster vaccine, Other: Saline solutionSubject received one dose of a licensed TdaP booster vaccine (containing 8 μg each of PT, FHA and 2.5 μg of PRN antigens and 2.5 Lf of diphtheria toxoid and 5 Lf of tetanus toxoid) followed by one administration of saline solution one month apart.

Who may qualify

Ages: 18 to 40 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (2 listed)

Healthy male and female individuals between 18 and 40 years of age (inclusive) who had provided informed consent.
Individuals who were able to be contacted for the duration of the study.

Key exclusion criteria (32 listed)

Individuals who had received vaccines containing T, D, or pertussis (aP or whole cell), been diagnosed with pertussis disease, or who have had a household exposure to pertussis within the past 8 years.
If female, "of childbearing potential", sexually active, and had not used any of the "acceptable contraceptive methods" for at least 2 months prior to study entry:
If female of childbearing potential and sexually active, refusal to use an "acceptable contraceptive method" through to 3 weeks after last study vaccination.
Any positive or indeterminate pregnancy test.
Female individuals who were pregnant or breastfeeding.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Acellular pertussis vaccineAcellular pertussis (aP) vaccine was administered with different antigen doses intramuscularly in the upper deltoid region of the subject's non-dominant arm.	Biological	Group 1: aP booster, Group 2: aP booster, Group 3: aP booster
Tetanus, reduced diphtheria, and acellular pertussis vaccine (adsorbed)Tetanus, reduced diphtheria, and acellular pertussis (TdaP) vaccine was administered with different antigen doses intramuscularly in the upper deltoid region of the subject's non-dominant arm.	Biological	Group 4: TdaP booster, Group 5: TdaP booster, Group 6: TdaP booster, Group 7: TdaP booster, Group 8: TdaP booster, Group 9: TDaP booster
Licensed TdaP booster vaccineLicenced TdaP booster vaccine was administered intramuscularly in the upper deltoid region of the subject's non-dominant arm.	Biological	Group 10: Licensed TdaP booster
Diphtheria and tetanus vaccine (adsorbed, reduced antigen content, Germany)To ensure all subjects receive a tetanus and diphtheria booster vaccination, an injection was administered on Study Day 30, one month after the administration of the investigational vaccine.	Biological	Group 1: aP booster, Group 2: aP booster, Group 3: aP booster
Saline solutionSubjects received one injection of saline solution at one month after vaccination.	Other	Group 10: Licensed TdaP booster, Group 4: TdaP booster, Group 5: TdaP booster, Group 6: TdaP booster, Group 7: TdaP booster, Group 8: TdaP booster, Group 9: TDaP booster

Primary outcome

The Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine
Time frame: Day 1 through 7 after vaccination
The safety profiles of different antigenic formulations of the aP and TdaP booster vaccines were assessed and compared to that of licensed comparator in terms of the number of subjects reporting solicited local and systemic adverse events and other adverse events after vaccination.
The Number of Subjects Reporting Unsolicited Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine
Time frame: From day 1 to day 365
The safety profiles of different antigenic formulations of the aP and TdaP booster vaccines were assessed in terms of the number of subjects reporting any unsolicited adverse events (AEs) between day 1 to day 30 , serious adverse events (SAEs) and AEs leading to premature withdrawal between day 1 to day 365, after vaccination.
Geometric Mean Concentrations (GMCs) of Antibodies in aP1, aP2, aP4 Groups Against Pertussis Antigens Following Booster Vaccination
Time frame: Day 1 (baseline) and Day 30 post vaccination
The GMCs of antibodies as measured by enzyme-linked immunosorbent assay (ELISA) on aP booster groups, against pertussis antigens pertussis toxoid (PT), filamentous hemagglutinin (FHA), pertactin (PRN), following vaccination with different antigenic formulations of aP versus the response to the commercially available comparator are reported.
GMCs of Antibodies in T5D2aP1, T5D2aP2 and T5D2aP4 Groups Against Pertussis Antigens Following Booster Vaccination
Time frame: Day 1 (baseline) and Day 30 post vaccination
The GMCs of antibodies as measured by enzyme-linked immunosorbent assay (ELISA) in TdaP Booster Groups against pertussis antigens (PT, FHA and PRN), following vaccination with different antigenic formulations of TdaP booster versus the response to the commercially available comparator are reported.
GMCs of Antibodies in T5D4aP1, T5D4aP2 and T5D4aP4 Groups Against Pertussis Antigens Following Vaccination
Time frame: Day 1 (baseline) and Day 30 post vaccination
The GMCs of antibodies as measured by enzyme-linked immunosorbent assay (ELISA) in TdaP booster groups, against pertussis antigens (PT, FHA and PRN), following vaccination with different antigenic formulations of TdaP booster versus the response to the commercially available comparator are reported.
Geometric Mean Ratios (GMRs) of Post Vaccination Versus Pre Vaccination GMCs of Antibodies in aP1, aP2, aP4 Booster Groups Against Pertussis Antigens
Time frame: Day 30 post vaccination/baseline (Day 1)
The GMRs of post-vaccination versus pre-vaccination GMCs of antibodies against pertussis antigens (PT, FHA and PRN) for different antigenic formulations of aP booster vaccines and for licensed comparator are reported.
GMRs of Post Vaccination Versus Pre Vaccination GMCs of Antibodies in T5D2aP1, T5D2aP2 and T5D2aP4 Booster Groups Against Pertussis Antigens
Time frame: Day 30 post vaccination/baseline (Day 1)
The GMRs of post-vaccination versus pre-vaccination GMCs of antibodies against pertussis antigens (PT, FHA and PRN) for TdaP booster groups and for licensed comparator are reported.
GMRs of Post Vaccination Versus Pre Vaccination GMCs of Antibodies for T5D4aP1, T5D4aP2 and T5D4aP4 Booster Groups Against Pertussis Antigens
Time frame: Day 30 post vaccination/baseline (Day 1)
The GMRs of post-vaccination versus pre-vaccination GMCs of antibodies against pertussis antigens (PT, FHA and PRN) for TdaP booster groups and for licensed comparator are reported.
Percentages of Subjects With Diphtheria and Tetanus Antitoxin Units >= 0.1/mL After Vaccination
Time frame: Day 1 (baseline) and Day 30 post vaccination
The percentages of subjects demonstrating diphtheria and tetanus antitoxin units >= 0.1/mL following vaccination with different antigenic formulations of TdaP booster vaccine, is compared to the response to commercially available comparator.

3 secondary outcomes

Percentages of Subjects With 2- and 4-fold Increase in GMCs Against Pertussis Antigens Following Vaccination.
Time frame: Day 30 post vaccination
GMCs of Antibodies Against Diphtheria and Tetanus Antigens Following Vaccination
Time frame: Day 1 (baseline) and Day 30 post vaccination
GMRs of Post Vaccination Versus Pre Vaccination GMCs of Antibodies Against Diphtheria and Tetanus Antigens
Time frame: Day 30 post vaccination/Day 1

Results and safety

Results posted to the registry on 18 Sep 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Group aP1	42	40
Group aP2	42	41
Group aP4	42	40
Group T5D2aP1	42	40
Group T5D2aP2	42	40
Group T5D2aP4	42	41
Group T5D4aP1	42	40
Group T5D4aP2	42	42
Group T5D4aP4	42	41
Licensed TdaP	42	42

Primary outcome: The Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine

Time frame: Day 1 through 7 after vaccination. Number. Unit: participants

Measure	Group aP1 n = 42	Group aP2 n = 42	Group aP4 n = 41	Group T5D2aP1 n = 42	Group T5D2aP2 n = 42	Group T5D2aP4 n = 42	Group T5D4aP1 n = 41	Group T5D4aP2 n = 42	Group T5D4aP4 n = 42	Licensed TdaP n = 42
Any local	30	33	32	35	38	37	40	36	39	33
Injection site erythema	0	1	1	1	2	6	3	2	4	3
Injection site induration	3	3	1	6	1	7	9	4	4	6
Injection site pruritus	0	4	1	3	2	5	3	3	6	5
Injection site pain	30	32	31	35	38	36	40	35	39	31
Any Systemic	27	20	20	18	20	23	27	21	27	21
Nausea	3	6	2	1	2	5	4	6	7	1
Fatigue	19	14	13	13	15	18	20	15	16	12

Population analysed: Analysis was done on the safety set, ie, all subjects who received the study vaccination and provided post vaccination safety data.

Primary outcome: The Number of Subjects Reporting Unsolicited Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine

Time frame: From day 1 to day 365. Number. Unit: participants

Measure	Group aP1 n = 42	Group aP2 n = 42	Group aP4 n = 41	Group T5D2aP1 n = 42	Group T5D2aP2 n = 42	Group T5D2aP4 n = 42	Group T5D4aP1 n = 41	Group T5D4aP2 n = 42	Group T5D4aP4 n = 42	Licensed TdaP n = 42
Any AE (day 1 to 30)	20	28	12	21	13	17	16	14	18	18
At least possibly related unsolicited AEs	11	13	7	8	9	11	7	4	11	10
Any SAE (Day1 to Day 365)	4	1	1	1	0	1	1	2	2	1
At least possibly related SAEs	0	0	0	0	0	0	0	0	0	0
AEs leading to withdrawal (Day1 to Day 365)	0	0	0	0	0	0	0	0	0	0
Death	0	0	0	0	0	0	0	0	0	0

Population analysed: Analysis was done on the safety set.

Primary outcome: Geometric Mean Concentrations (GMCs) of Antibodies in aP1, aP2, aP4 Groups Against Pertussis Antigens Following Booster Vaccination

Time frame: Day 1 (baseline) and Day 30 post vaccination. Geometric mean (95% Confidence Interval). Unit: µg/mL

Measure	Group aP1 n = 42	Group aP2 n = 38	Group aP4 n = 39	Licensed TdaP n = 40
Day 1 (PT)	4.92 (3.22 to 7.53)	3.81 (2.43 to 5.95)	4.23 (2.72 to 6.57)	5.07 (3.28 to 7.84)
Day 30 (PT; N= 39,35,36,40)	91 (67 to 122)	145 (106 to 199)	182 (133 to 249)	87 (65 to 117)
Day 1 (FHA)	20 (15 to 27)	16 (11 to 22)	21 (15 to 29)	20 (15 to 28)
Day 30 (FHA; N= 39,35,36,40)	114 (93 to 140)	147 (119 to 182)	183 (148 to 226)	241 (198 to 294)
Day 1 (PRN)	20 (14 to 28)	16 (11 to 23)	17 (12 to 25)	21 (14 to 31)
Day 30 (PRN; N= 39,35,36,40)	589 (440 to 788)	936 (687 to 1273)	1384 (1020 to 1878)	475 (356 to 635)

Population analysed: Analysis was done on the per-protocol population, ie, all subjects who correctly received the vaccine, and provided evaluable serum samples at the relevant time points and had no major protocol violation as defined prior to unblinding.

Primary outcome: GMCs of Antibodies in T5D2aP1, T5D2aP2 and T5D2aP4 Groups Against Pertussis Antigens Following Booster Vaccination

Time frame: Day 1 (baseline) and Day 30 post vaccination. Geometric mean (95% Confidence Interval). Unit: µg/mL

Measure	Group T5D2aP1 n = 41	Group T5D2aP2 n = 38	Group T5D2aP4 n = 40	Licensed TdaP n = 40
Day 1 (PT)	4.35 (2.86 to 6.6)	4.97 (3.22 to 7.67)	4.8 (3.15 to 7.32)	5.07 (3.32 to 7.73)
Day 30 (PT; N= 41,38,38,40)	62 (49 to 80)	72 (56 to 93)	160 (124 to 206)	86 (68 to 110)
Day 1 (FHA)	20 (14 to 28)	16 (12 to 23)	23 (17 to 33)	20 (15 to 28)
Day 30 (FHA; N= 41,38,38,40)	83 (69 to 100)	90 (74 to 109)	118 (97 to 143)	241 (200 to 291)
Day 1 (PRN)	13 (8.72 to 21)	21 (13 to 32)	27 (17 to 41)	21 (14 to 32)
Day 30 (PRN; N= 41,38,38,40)	445 (317 to 626)	803 (567 to 1138)	1092 (766 to 1555)	496 (353 to 696)

Population analysed: Analysis was done on the per-protocol population.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Group aP1	4 of 42 (9.5%)	36 of 42 (85.7%)	Not reported
Group aP2	1 of 42 (2.4%)	39 of 42 (92.9%)	Not reported
Group aP4	1 of 41 (2.4%)	36 of 41 (87.8%)	Not reported
Group T5D2aP1	1 of 42 (2.4%)	38 of 42 (90.5%)	Not reported
Group T5D2aP2	0 of 42 (0%)	41 of 42 (97.6%)	Not reported
Group T5D2aP4	1 of 42 (2.4%)	42 of 42 (100%)	Not reported
Group T5D4aP1	1 of 41 (2.4%)	40 of 41 (97.6%)	Not reported
Group T5D4aP2	2 of 42 (4.8%)	39 of 42 (92.9%)	Not reported
Group T5D4aP4	2 of 42 (4.8%)	40 of 42 (95.2%)	Not reported
Licensed TdaP	1 of 42 (2.4%)	36 of 42 (85.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 29172945Leroux-Roels G, Lattanzi M, Solis CD, Contorni M, Costantini M, Moraschini L, Bardelli M, Bertholet S, Borgogni E, Buricchi F, Cantisani R, Faenzi E, Finco O, Leuzzi R, Pizza M, Rosa D, Schiavetti F, Seubert A, Spensieri F, Volpini G, Zedda L, Giudice GD, Galgani I. A phase I, randomized, controlled, dose-ranging study of investigational acellular pertussis (aP) and reduced tetanus-diphtheria-acellular pertussis (TdaP) booster vaccines in adults. Hum Vaccin Immunother. 2018 Jan 2;14(1):45-58. doi: 10.1080/21645515.2017.1385686. Epub 2017 Nov 27.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Novartis Vaccines study chair

Novartis Vaccines

Geert Leroux-Roels, Prof. Dr. principal investigator

Center for Vaccinology (CEVAC), Ghent University Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 2 inclusion and 32 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: finished, as of the sponsor's last update on 4 Apr 2016. 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 Belgium. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Sep 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

The Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine (time frame: Day 1 through 7 after vaccination). The study lists 9 primary outcomes in all. 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 NCT01529645, which also lists 1 linked publication.

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 4 Apr 2016.