Clinical Trials Register

Summary
EudraCT Number:	2015-003914-25
Sponsor's Protocol Code Number:	Td527
Clinical Trial Type:	Outside EU/EEA
Date on which this record was first entered in the EudraCT database:	2016-01-13
Trial results	View results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
H.4 THIRD COUNTRY IN WHICH THE TRIAL WAS FIRST AUTHORISED

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A. Protocol Information

A.2

EudraCT number

2015-003914-25

A.3

Full title of the trial

Clinical Safety Study of the Tdap Combined Vaccine (ADACEL) as a Booster Dose in Healthy Adults and Children in China

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

Study of Tdap Combined Vaccine (ADACEL) as a Booster Dose in Healthy Adults and Children in China.

A.4.1

Sponsor's protocol code number

Td527

A.5.2

US NCT (ClinicalTrials.gov registry) number

NCT01933776

A.5.3

WHO Universal Trial Reference Number (UTRN)

U1111-1127-7738

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	SANOFI PASTEUR
B.1.3.4	Country	France
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	SANOFI PASTEUR
B.4.2	Country	France
B.4.1	Name of organisation providing support	SANOFI PASTEUR
B.4.2	Country	China
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	SANOFI PASTEUR
B.5.2	Functional name of contact point	Oladayo OYELOLA
B.5.3	Address:
B.5.3.1	Street Address	1 Discovery Drive
B.5.3.2	Town/ city	SWIFTWATER, PA
B.5.3.3	Post code	18370
B.5.3.4	Country	United States
B.5.6	E-mail	oladayo.oyelola@sanofipasteur.com

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Adacel, Covaxis, Triaxis
D.2.1.1.2	Name of the Marketing Authorisation holder	SANOFI PASTEUR SA
D.2.1.2	Country which granted the Marketing Authorisation	Germany
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Adacel®)
D.3.4	Pharmaceutical form	Suspension for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intramuscular use
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	Yes
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Active immunization against tetanus, diphtheria and pertussis

E.1.1.1

Medical condition in easily understood language

Protection against tetanus, diphtheria and pertussis

E.1.1.2

Therapeutic area

Diseases [C] - Virus Diseases [C02]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	18.1
E.1.2	Level	PT
E.1.2	Classification code	10054129
E.1.2	Term	Diphtheria immunisation
E.1.2	System Organ Class	10042613 - Surgical and medical procedures

E.1.2 Medical condition or disease under investigation

E.1.2	Version	18.1
E.1.2	Level	PT
E.1.2	Classification code	10069577
E.1.2	Term	Pertussis immunisation
E.1.2	System Organ Class	10042613 - Surgical and medical procedures

E.1.2 Medical condition or disease under investigation

E.1.2	Version	18.1
E.1.2	Level	PT
E.1.2	Classification code	10054131
E.1.2	Term	Tetanus immunisation
E.1.2	System Organ Class	10042613 - Surgical and medical procedures

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

To describe the safety in terms of occurrence of serious adverse reactions and Grade 3 adverse
reactions after administration of Sanofi Pasteur’s Tdap vaccine (ADACEL) given as a single dose
in 20 adults and 20 children.

E.2.2

Secondary objectives of the trial

To describe the full reactogenicity profile after administration of Sanofi Pasteur’s Tdap vaccine
(ADACEL) given as a single dose in 20 adults and 20 children.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

An individual had to fulfill all of the following criteria in order to be eligible for trial
enrollment:
1) Group 1: Aged 18 through 64 years on the day of inclusion
Group 2: Aged 4 through 8 years on the day of inclusion
2) Informed consent form (ICF) signed by the subject (Group 1) or by the parent(s) or legal representative (Group 2)
3) Subject (Group 1 and 2) and parent/legal representative (Group 2 only) able to attend all scheduled visits and to comply with all trial procedures
4) Group 1 only: For a woman of child-bearing potential, avoid becoming pregnant (use of an effective method of contraception or abstinence) from at least 4 weeks prior to vaccination, until at least 4 weeks after vaccination
5) Group 2 only: Written documentation of complete primary series and fourth dose of DTP vaccine as per China National Immunization Recommendations.

E.4

Principal exclusion criteria

An individual fulfilling any of the following criteria had to be excluded from trial enrollment:

1) Group 1 only: For a woman of child-bearing potential, known pregnancy or positive serum or urine pregnancy test

2) Group 1 only: Currently breast-feeding a child

3) Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the trial vaccination

4) Planned participation in another clinical trial during the present trial period

5) Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months; or long-term systemic corticosteroids therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)

6) Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine or to a vaccine containing any of the same substances

7) Chronic illness that, in the opinion of the Investigator, is at a stage that could interfere with trial conduct or completion

8) Group 1 only: Current alcohol abuse or drug addiction that may interfere with the ability to comply with trial procedures

9) Receipt or planned receipt of any vaccine in the 4 weeks preceding or following trial vaccination, except for influenza vaccination, which may be received at least two weeks before the study vaccine

10) Self-reported seropositivity for Human Immunodeficiency Virus (HIV), Hepatitis B or Hepatitis C

11) History of diphtheria, tetanus, or pertussis infection (confirmed either clinically, serologically or microbiologically)

12) Previous fifth vaccination against pertussis disease and/or previous sixth vaccination against diphtheria and tetanus disease with either the trial vaccine or another vaccine (except Tetanus-prone wound management in Group 1)

13) Subject at high risk for diphtheria, tetanus, or pertussis infection during the trial, including persons who have exposure (e.g., member of a household with
another infected member, travelers to or residents of areas where one of this disease is hyperendemic or epidemic, or microbiologists routinely working with one of these pathogens)

14) Self-reported thrombocytopenia, bleeding disorder or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating IM vaccination

15) Group 1 only: Subjects deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily

16) History of contra-indication to vaccination with pertussis containing vaccine, including:
- Encephalopathy (eg, coma, decreased level of consciousness, prolonged seizures) within 7 days of a previous dose of a pertussis containing vaccine that was not attributable to another identifiable cause

17) Identified as employees of the Investigator or study center, with direct involvement in the proposed study or other studies under the direction of that Investigator or study center, as well as immediate family members (i.e. husband, wife and their children, adopted or natural) of the employees or the Investigator.

Temporary Contraindications:

A prospective subject had not to be included in the study until the following conditions
and/or symptoms were resolved:

18) Febrile illness (axillary temperature ≥37.1°C) or moderate or severe acute illness/infection on the day of vaccination, according to Investigator judgment.

E.5 End points

E.5.1

Primary end point(s)

The occurrence of any serious adverse reaction and Grade 3 adverse reaction occurring throughout the trial in each study group.

E.5.1.1

Timepoint(s) of evaluation of this end point

Vaccination:
Visit 1(Day 0): 1 dose of Adacel

Post-vaccination
Visit 2(Visit 1 + 8-10 days): staff reviewed the Day 0 to Day 7 safety data with subjects.
Visit 3 (Visit 1 + 28-35 days): staff reviewed the Day 8 to Day 28 safety datea with subjects.

E.5.2

Secondary end point(s)

The secondary endpoints for the safety evaluation in each study group were:

• The occurrence, intensity and relationship to vaccination of any unsolicited systemic adverse events (AEs) reported within 30 minutes after vaccination.

• The occurrence, time to onset, number of days of occurrence and intensity of solicited (terms pre-listed in the Case Report Form [CRF]) injection site and systemic reactions occurring from D0 through D7 after vaccination.

• The occurrence, nature (MedDRA preferred term), maximum intensity (for nonserious AEs only), and relationship to vaccination (for systemic AEs only) of unsolicited (spontaneously reported) AEs within 28 days after vaccination.

• The occurrence, nature (MedDRA preferred term), relationship to vaccination, outcome and seriousness of any serious AE (SAE) occurring throughout the trial period.

E.5.2.1

Timepoint(s) of evaluation of this end point

Vaccination:
Day 0: 30 minutes after vaccination.

Post-Vaccination:
Day 0 through Day7, Day 28 and throughout the trial period.

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

E.6.4

Safety

Yes

E.6.5

Efficacy

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

Yes

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

Yes

E.7.1.3.1

Other trial type description

Clinical safety study in healthy adults and children in China.

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

E.8.1.1

Randomised

E.8.1.2

Open

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

E.8.2.3

Other

E.8.3

Will this trial be conducted at a single site globally?

Yes

E.8.4

Will this trial be conducted at multiple sites globally?

E.8.6 Trial involving sites outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

Yes

E.8.6.3

Specify the countries outside of the EEA in which trial sites are planned

China

E.8.7

Trial has a data monitoring committee

Yes

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

LVLS

E.8.9 Initial estimate of the duration of the trial

E.8.9.2

In all countries concerned by the trial days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

Yes

F.1.1

Number of subjects for this age range:

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

Yes

F.1.1.5.1

Number of subjects for this age range:

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

F.1.3

Elderly (>=65 years)

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

Yes

F.3.2

Patients

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception