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Completed

NCT Number: NCT01546909

Antibody Persistence to REVAXIS or DT Polio and Immune Response to TETRAVAC-ACELLULAIRE

PRIMARY OBJECTIVES

* To describe in 11 to 13-year-old children previously vaccinated with either REVAXIS or DT Polio at 6 years of age the antibody persistence against diphtheria, tetanus, and poliovirus types 1, 2 and 3 * To describe one month after a booster dose of TETRAVAC-ACELLULAIRE the immune responses against diphtheria, tetanus, and poliovirus types 1, 2 and 3

SECONDARY OBJECTIVES

* To describe other parameters of the antibody persistence against diphtheria, tetanus and poliomyelitis antigens * To describe other parameters of the immune responses to diphtheria, tetanus and poliomyelitis antigens one month after a booster dose of TETRAVAC-ACELLULAIRE * To describe the safety profile of a booster dose of TETRAVAC-ACELLULAIRE

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Key information

Conditions

Diphtheria Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Central Nervous System Diseases Central Nervous System Infections Clostridium Infections Corynebacterium Infections Enterovirus Infections Gram-Positive Bacterial Infections Infections Myelitis Nervous System Diseases Neuroinflammatory Diseases Neuromuscular Diseases Picornaviridae Infections Poliomyelitis RNA Virus Infections Spinal Cord Diseases Tetanus Virus Diseases

Age range

11 year–13 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

SPMSD Investigational Site 120, Angers, France

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy child 11 to 13 years of age previously vaccinated in Study F05-TdI-301

Exclusion criteria

  • Immunization against diphtheria, tetanus, pertussis and/or poliomyelitis beyond Study F05-TdI-301
  • Previous clinical or bacteriological diagnosis of diphtheria, tetanus, pertussis or poliomyelitis
  • Known or suspected immune dysfunction
  • Receipt of medications / vaccination that may interfere with study assessments
  • Known true hypersensitivity to any of the vaccine components or to a vaccine containing the same substances
  • Known personal history of encephalopathy, seizure disorder or progressive, evolving or unstable neurological condition
  • Thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injection
  • Any medical condition that might interfere with the evaluation of the study objectives
  • Febrile illness

Treatment and study plan

Diphtheria, tetanus, polio and pertussis vaccination

Biological

1 dose of TETRAVAC-ACELLULAIRE (0.5 mL) at Day 0

Primary outcomes

  1. Proportion of subjects with an anti-diphtheria concentration ≥0.01 IU/mL

    Time frame: Pre-booster dose (Day 0)

  2. Proportion of subjects with an anti-tetanus concentration ≥0.01 IU/mL

    Time frame: Pre-booster dose (Day 0)

  3. Proportion of subjects with an anti-polio type 1 titer ≥ 8 (1/dilution)

    Time frame: Pre-booster dose (Day 0)

  4. Proportion of subjects with an anti-polio type 2 titer ≥ 8 (1/dilution)

    Time frame: Pre-booster dose (Day 0)

  5. Proportion of subjects with an anti-polio type 3 titer ≥ 8 (1/dilution)

    Time frame: Pre-booster dose (Day 0)

  6. Proportion of subjects with an anti-diphtheria concentration ≥0.1 IU/mL

    Time frame: 1 month post-booster dose

  7. Proportion of subjects with an anti-tetanus concentration ≥0.1 IU/mL

    Time frame: 1 month post-booster dose

  8. Proportion of subjects with an anti-polio type 1 titer ≥8 (1/dilution)

    Time frame: 1 month post-booster dose

  9. Proportion of subjects with an anti-polio type 2 titer ≥8 (1/dilution)

    Time frame: 1 month post-booster dose

  10. Proportion of subjects with an anti-polio type 3 titer ≥8 (1/dilution)

    Time frame: 1 month post-booster dose

Secondary outcomes

  1. Geometric mean titer for diphtheria

    Time frame: Pre-booster (Day 0) and 1 month post-booster dose

  2. Geometric mean titer for tetanus

    Time frame: Pre-booster (Day 0) and 1 month post-booster dose

  3. Geometric mean titer for polio type 1

    Time frame: Pre-booster (Day 0) and 1 month post-booster dose

  4. Geometric mean titer for polio type 2

    Time frame: Pre-booster (Day 0) and 1 month post-booster dose

  5. Geometric mean titer for polio type 3

    Time frame: Pre-booster (Day 0) and 1 month post-booster dose

  6. Solicited injection site and solicited systemic reactions

    Time frame: From Day 0 to Day 7 post vaccination

  7. Unsolicited injection site reactions and unsolicited systemic adverse events

    Time frame: From Day 0 to Day 28 days post vaccination

  8. Serious adverse events

    Time frame: From signature of informed consent up to last study visit of the subject

Sponsors and collaborators

Lead sponsor

Sanofi Pasteur, a Sanofi Company

Industry

Registry information

Official study title

Antibody Persistence in 11 to 13-year-old Children Previously Vaccinated at 6 Years Old With Either REVAXIS or DT Polio, and Immune Response to a Booster Dose of TETRAVAC-ACELLULAIRE

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Mar 7, 2012
Registry last updated
Sep 11, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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