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

NCT02040636 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 277

Last updated 2015-03-25

No results posted yet for this study

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.

Conditions

  • Pertussis
  • Tetanus
  • Diphtheria
  • Poliomyelitis
  • Hepatitis B

Interventions

BIOLOGICAL

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

0.5 mL, Intramuscular

BIOLOGICAL

Hepatitis B vaccine

0.5 ml, Intramuscular

Sponsors & Collaborators

  • Sanofi Pasteur, a Sanofi Company

    lead INDUSTRY

Principal Investigators

  • Medical Director · Sanofi Pasteur Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
11 Years
Max Age
14 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
1999-01-31
Primary Completion
2000-05-31
Completion
2000-05-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02040636 on ClinicalTrials.gov