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Study of Tetanus and Diphtheria Toxoids Adsorbed Combined With Component Pertussis Vaccine and Inactivated Poliomyelitis

Primary Purpose

Pertussis, Tetanus, Diphtheria

Status

Completed

Phase

Phase 2

Locations

Canada

Study Type

Interventional

Intervention

Tetanus and Diphtheria Toxoids Adsorbed Combined with Component Pertussis Vaccine and IPV

Hepatitis B vaccine

About this trial

This is an interventional prevention trial for Pertussis focused on measuring Pertussis, Tetanus, Diphtheria, Poliomyelitis, Hepatitis B, Acellular Pertussis Vaccines

Eligibility Criteria

11 Years - 14 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Age 11 years and < 14 years of age.
Signed, witnessed and dated informed consent that is obtained prior to the first study intervention.
Judged to be in good health on the basis of reported medical history.
Plans to remain in the study area for the length of the trial.
All minors have a parent or legal guardian who can read, write and understand English or French.
Pregnancy test to be performed on all female participants at the time of enrollment into the study (prior to day of first immunization visit).

Exclusion Criteria:

Pregnancy.
Known or suspected primary disease of the immune system [conditions suspected of having an immunologic component such as autoimmune diseases (rheumatoid arthritis or inflammatory bowel disease) will not be excluded unless they meet exclusion criterion 3 or are sufficiently clinically active to meet exclusion criterion 5].
Malignancy or is receiving immunosuppressive therapy (e.g., daily systemic prednisone ≥ 1 mg/kg would be excluded, participants who are taking topical and inhaled steroids could be included in the study as could participants on a "short course" of oral steroids, 5-7 days, as long as there are not two courses within the previous two week period).
Prior receipt of any pertussis, diphtheria, tetanus or polio containing vaccines, including Hepatitis B vaccine, within the past 5 years.
Any significant underlying chronic disease, including malignancy, cardiopulmonary disease, renal or hepatic dysfunction.
Known impairment of neurologic function or seizure disorder of any etiology.
Personal history of physician diagnosed or laboratory confirmed pertussis disease within the last 2 years.
Receipt of blood products or immunoglobulin within the previous 3 months.
Known or suspected allergy to any of the vaccines intended for use in the study or any of the vaccine components including neomycin, streptomycin and polymyxin B.
Receipt of any vaccine within 2 weeks of receiving a study vaccine.
Daily use of non-steroidal anti-inflammatory drugs.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Study Group 1

Study Group 2

Arm Description

Participants randomized to receive Tetanus and Diphtheria Toxoids Adsorbed Combined with Component Pertussis Vaccine and Inactivated Poliomyelitis Vaccine (TdcP-IPV) at month 0, Hepatitis B at months 1, 2 and 7.

Participants randomized to receive Tetanus and Diphtheria Toxoids Adsorbed Combined with Component Pertussis Vaccine and Inactivated Poliomyelitis Vaccine (TdcP-IPV) + Hepatitis B at month 0, Hepatitis B at months 1 and 6.

Outcomes

Primary Outcome Measures

Seroprotection against diphtheria and tetanus antigens after vaccination with either Tetanus and Diphtheria Toxoids Adsorbed Combined with Component Pertussis Vaccine and Inactivated Poliomyelitis (Tdcp-IPV) or concurrent Tdcp-IPV and Hepatitis B vaccine

Seroprotection defined as: Diphtheria levels ≥ 0.01 IU/mL and ≥ 0.1 IU/mL; Tetanus levels ≥ 0.01 EU/mL and ≥ 0.1 EU/mL.

Geometric Mean Titers for Diphtheria and Tetanus after vaccination with either Tetanus and Diphtheria Toxoids Adsorbed Combined with Component Pertussis Vaccine & Inactivated Poliomyelitis Vaccine (Tdcp-IPV) or concurrent Tdcp IPV and Hepatitis B vaccine

Diphtheria antibodies assayed using enzyme-linked immunoassay; Tetanus antibodies were assessed using microneutralization assay

Number of participants reporting solicited injection site reactions, solicited systemic reactions, unsolicited adverse events, and serious adverse events occurring during trial

Solicited local injection site reactions: Redness, Swelling, and Tenderness. Solicited systemic reactions: Altered Appetite, Headache, General Malaise, Nausea, Vomiting and Muscle aches.

Secondary Outcome Measures

Geometric Mean Titers for Pertussis antibodies after vaccination with either Tetanus and Diphtheria Toxoids Adsorbed Combined with Component Pertussis Vaccine and Inactivated Poliomyelitis Vaccine (TdcP IPV) or concurrent Tdcp IPV and Hepatitis B vaccine

Anti pertussis toxoid, anti filamentous hemagglutinin, anti fimbriae 2 + 3 and anti Pertactin antibodies were assayed by enzyme linked immunoassay; Polio types 1, 2, and 3 were assayed using neutralizing antibodies to poliovirus types1, 2 and 3.

Full Information

NCT ID

NCT02040636

First Posted

January 16, 2014

Last Updated

March 24, 2015

Sponsor

Sanofi Pasteur, a Sanofi Company

1. Study Identification

Unique Protocol Identification Number

NCT02040636

Brief Title

Study of Tetanus and Diphtheria Toxoids Adsorbed Combined With Component Pertussis Vaccine and Inactivated Poliomyelitis

Official Title

Safety and Immunogenicity of Tetanus and Diphtheria Toxoids Adsorbed Combined With Component Pertussis Vaccine and Inactivated Poliomyelitis Vaccine (TdcP-IPV) Compared to Tetanus and Diphtheria Toxoids Adsorbed Combined With Component Pertussis Vaccine and Inactivated Poliomyelitis Vaccine (TdcP-IPV) and Hepatitis B Vaccine Given Concurrently In Adolescents 11-14 Years of Age

Study Type

Interventional

2. Study Status

Record Verification Date

March 2015

Overall Recruitment Status

Completed

Study Start Date

January 1999 (undefined)

Primary Completion Date

May 2000 (Actual)

Study Completion Date

May 2000 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sanofi Pasteur, a Sanofi Company

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

Primary objective: To determine the safety and immunogenicity of tetanus and diphtheria toxoids adsorbed combined with component pertussis and inactivated poliomyelitis vaccine grown on vero cells (TdcP-IPV) compared to tetanus and diphtheria toxoids adsorbed combined with component pertussis and inactivated poliomyelitis vaccine grown on vero cells (TdcP-IPV) and Hepatitis B vaccine administered concurrently in adolescents 11-14 years of age. Secondary objective: To determine whether concurrent administration of TdcP-IPV and Hepatitis B vaccines at 11-14 years of age results in detectable immunologic interactions between components of the two vaccines.

Detailed Description

Participants will be randomized into one of 2 groups to receive either a dose of the TdcP-IPV on Day 0 (visit 1) and Hepatitis B vaccine on subsequent visits 2, 3 and 4 (Group 1); or no vaccination on Day 0, concomitant administration of TdcP-IPV and Hepatitis B vaccine on Day 28 (Visit 2) and Hepatitis B vaccine on subsequent visits 3 and 4 (Group 2). All participants will be followed up for immunogenicity and safety

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pertussis, Tetanus, Diphtheria, Poliomyelitis, Hepatitis B

Keywords

Pertussis, Tetanus, Diphtheria, Poliomyelitis, Hepatitis B, Acellular Pertussis Vaccines

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

277 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Study Group 1

Arm Type

Experimental

Arm Description

Arm Title

Study Group 2

Arm Type

Active Comparator

Arm Description

Intervention Type

Biological

Intervention Name(s)

Tetanus and Diphtheria Toxoids Adsorbed Combined with Component Pertussis Vaccine and IPV

Other Intervention Name(s)

TdcP-IPV

Intervention Description

0.5 mL, Intramuscular

Intervention Type

Biological

Intervention Name(s)

Hepatitis B vaccine

Other Intervention Name(s)

Recombivax HB®

Intervention Description

0.5 ml, Intramuscular

Primary Outcome Measure Information:

Title

Description

Seroprotection defined as: Diphtheria levels ≥ 0.01 IU/mL and ≥ 0.1 IU/mL; Tetanus levels ≥ 0.01 EU/mL and ≥ 0.1 EU/mL.

Time Frame

Day 0 (pre-vaccination) and 1 month, 3, 5 and 10 years post-vaccination

Title

Description

Diphtheria antibodies assayed using enzyme-linked immunoassay; Tetanus antibodies were assessed using microneutralization assay

Time Frame

Day 0 (pre-vaccination) and 1 month, 3, 5 and 10 years post-vaccination

Title

Number of participants reporting solicited injection site reactions, solicited systemic reactions, unsolicited adverse events, and serious adverse events occurring during trial

Description

Solicited local injection site reactions: Redness, Swelling, and Tenderness. Solicited systemic reactions: Altered Appetite, Headache, General Malaise, Nausea, Vomiting and Muscle aches.

Time Frame

Day 0 up to day 30 following each vaccination

Secondary Outcome Measure Information:

Title

Description

Time Frame

Day 0 (pre-vaccination) and 1 month, 3, 5 and 10 years post-vaccination

10. Eligibility

Sex

All

Minimum Age & Unit of Time

11 Years

Maximum Age & Unit of Time

14 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age 11 years and < 14 years of age. Signed, witnessed and dated informed consent that is obtained prior to the first study intervention. Judged to be in good health on the basis of reported medical history. Plans to remain in the study area for the length of the trial. All minors have a parent or legal guardian who can read, write and understand English or French. Pregnancy test to be performed on all female participants at the time of enrollment into the study (prior to day of first immunization visit). Exclusion Criteria: Pregnancy. Known or suspected primary disease of the immune system [conditions suspected of having an immunologic component such as autoimmune diseases (rheumatoid arthritis or inflammatory bowel disease) will not be excluded unless they meet exclusion criterion 3 or are sufficiently clinically active to meet exclusion criterion 5]. Malignancy or is receiving immunosuppressive therapy (e.g., daily systemic prednisone ≥ 1 mg/kg would be excluded, participants who are taking topical and inhaled steroids could be included in the study as could participants on a "short course" of oral steroids, 5-7 days, as long as there are not two courses within the previous two week period). Prior receipt of any pertussis, diphtheria, tetanus or polio containing vaccines, including Hepatitis B vaccine, within the past 5 years. Any significant underlying chronic disease, including malignancy, cardiopulmonary disease, renal or hepatic dysfunction. Known impairment of neurologic function or seizure disorder of any etiology. Personal history of physician diagnosed or laboratory confirmed pertussis disease within the last 2 years. Receipt of blood products or immunoglobulin within the previous 3 months. Known or suspected allergy to any of the vaccines intended for use in the study or any of the vaccine components including neomycin, streptomycin and polymyxin B. Receipt of any vaccine within 2 weeks of receiving a study vaccine. Daily use of non-steroidal anti-inflammatory drugs.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Medical Director

Organizational Affiliation

Sanofi Pasteur Ltd.

Official's Role

Study Director

Facility Information:

City

Winnipeg

State/Province

Manitoba

ZIP/Postal Code

R3E 3P4

Country

Canada

12. IPD Sharing Statement

Citations:

PubMed Identifier

25540274

Citation

Embree J, Law B, Voloshen T, Tomovici A. Immunogenicity, safety, and antibody persistence at 3, 5, and 10 years postvaccination in adolescents randomized to booster immunization with a combined tetanus, diphtheria, 5-component acellular pertussis, and inactivated poliomyelitis vaccine administered with a hepatitis B virus vaccine concurrently or 1 month apart. Clin Vaccine Immunol. 2015 Mar;22(3):282-90. doi: 10.1128/CVI.00682-14. Epub 2014 Dec 24.

Results Reference

result

Links:

URL

http://www.sanofipasteur.com

Description

Related Info

Learn more about this trial

Study of Tetanus and Diphtheria Toxoids Adsorbed Combined With Component Pertussis Vaccine and Inactivated Poliomyelitis

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