NCT02040636

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
277

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jan 1999

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 1999

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2000

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2000

Completed
13.7 years until next milestone

First Submitted

Initial submission to the registry

January 16, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 20, 2014

Completed
Last Updated

March 25, 2015

Status Verified

March 1, 2015

Enrollment Period

1.3 years

First QC Date

January 16, 2014

Last Update Submit

March 24, 2015

Conditions

PertussisTetanusDiphtheriaPoliomyelitisHepatitis B

Keywords

PertussisTetanusDiphtheriaPoliomyelitisHepatitis BAcellular Pertussis Vaccines

Outcome Measures

Primary Outcomes (3)

  • 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.

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

  • 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

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

  • 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.

    Day 0 up to day 30 following each vaccination

Secondary Outcomes (1)

  • 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

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

Study Arms (2)

Study Group 1

EXPERIMENTAL

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.

Biological: Tetanus and Diphtheria Toxoids Adsorbed Combined with Component Pertussis Vaccine and IPVBiological: Hepatitis B vaccine

Study Group 2

ACTIVE COMPARATOR

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.

Biological: Tetanus and Diphtheria Toxoids Adsorbed Combined with Component Pertussis Vaccine and IPVBiological: Hepatitis B vaccine

Interventions

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

0.5 mL, Intramuscular

Also known as: TdcP-IPV
Study Group 1Study Group 2
Hepatitis B vaccineBIOLOGICAL

0.5 ml, Intramuscular

Also known as: Recombivax HB®
Study Group 1Study Group 2

Eligibility Criteria

Age11 Years - 14 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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).

You may not qualify if:

  • Pregnancy.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Winnipeg, Manitoba, R3E 3P4, Canada

Location

Related Publications (1)

  • 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.

    PMID: 25540274RESULT

Related Links

MeSH Terms

Conditions

Whooping CoughTetanusDiphtheriaPoliomyelitisHepatitis B

Interventions

Tetanus ToxoidPoliovirus Vaccine, InactivatedHepatitis B VaccinesRecombivax HB

Condition Hierarchy (Ancestors)

Bordetella InfectionsGram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsRespiratory Tract InfectionsRespiratory Tract DiseasesClostridium InfectionsGram-Positive Bacterial InfectionsCorynebacterium InfectionsActinomycetales InfectionsMyelitisCentral Nervous System InfectionsEnterovirus InfectionsPicornaviridae InfectionsRNA Virus InfectionsVirus DiseasesCentral Nervous System DiseasesNervous System DiseasesSpinal Cord DiseasesNeuroinflammatory DiseasesNeuromuscular DiseasesBlood-Borne InfectionsCommunicable DiseasesHepadnaviridae InfectionsDNA Virus InfectionsHepatitis, Viral, HumanHepatitisLiver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

ToxoidsVaccinesBiological ProductsComplex MixturesVaccines, InactivatedPoliovirus VaccinesViral VaccinesViral Hepatitis Vaccines

Study Officials

  • Medical Director

    Sanofi Pasteur Ltd.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 16, 2014

First Posted

January 20, 2014

Study Start

January 1, 1999

Primary Completion

May 1, 2000

Study Completion

May 1, 2000

Last Updated

March 25, 2015

Record last verified: 2015-03

Locations

CA(1)