NCT01031303

Brief Summary

The purpose of this study is to provide further immunogenicity and safety information of sanofi pasteur's DTacP-IPV combined vaccine (TETRAXIM™) as a booster dose during the 4th and 6th year of life in children that previously received in Study E2I34 (NCT 00255021), sanofi pasteur DTacP-IPV// PRP\~T vaccine (PENTAXIM™) as a three-dose primary and booster vaccinations. Primary Objective :

  • To assess immunogenicity in terms of seroprotection rates (Diphtheria, Tetanus, Polio types 1, 2 and 3) and seroconversion/vaccine response rates to acellular Pertussis antigens (Pertussis toxoid \[PT\], Filamentous Haemagglutinin \[FHA\]) of sanofi pasteur's DTacP-IPV (Tetraxim™) vaccine, one month after the booster dose given at 4 to 6 years of age. Secondary Objectives :
  • To describe the antibody persistence in terms of anti-pertussis antibody levels (anti-PT, and -FHA) and in terms of seroprotection rates and GMTs for Diphtheria, Tetanus, and Poliovirus types 1, 2 and 3, just before administration of the booster dose (at Visit 1) in all subjects at 4-6 years of age.
  • To assess immunogenicity in terms of seroprotection rates (Diphtheria, Tetanus, Polio types 1, 2 and 3) and seroconversion/ vaccine response rates to acellular Pertussis antigens (PT, FHA) of sanofi pasteur's DTacP-IPV (Tetraxim™) vaccine, one month after administration of the booster dose given at 4 to 6 years of age.
  • To describe the safety after the booster dose of the study vaccine.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
123

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Dec 2009

Shorter than P25 for phase_4

Geographic Reach
1 country

2 active sites

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

December 1, 2009

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

December 10, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 14, 2009

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
Last Updated

October 5, 2011

Status Verified

October 1, 2011

Enrollment Period

9 months

First QC Date

December 10, 2009

Last Update Submit

October 4, 2011

Conditions

DiphtheriaTetanusPertussisPoliomyelitis

Keywords

DiphtheriaTetanusPertussisPoliomyelitisPENTAXIM™TETRAXIM™

Outcome Measures

Primary Outcomes (1)

  • To provide information concerning the immunogenicity of TETRAXIM™ after booster vaccination.

    30 days post-vaccination

Secondary Outcomes (1)

  • To provide information concerning the safety after booster administration of TETRAXIM™.

    30 days post-vaccination and entire study period

Study Arms (1)

Study Group

EXPERIMENTAL
Biological: DTacP-IPV combined vaccine (TETRAXIM™)

Interventions

DTacP-IPV combined vaccine (TETRAXIM™)BIOLOGICAL

0.5 mL, Intramuscular

Also known as: TETRAXIM™
Study Group

Eligibility Criteria

Age4 Years - 6 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Child having completed the three-dose vaccination and the booster vaccination with DTacP-IPV//PRP\~T combined vaccine (PENTAXIM™) of the study E2I34
  • Informed consent form signed by the parent(s) or other legal representative
  • Able to attend all scheduled visits and to comply with all trial procedures

You may not qualify if:

  • Planned participation in another clinical trial during the present trial period
  • Congenital or acquired immunodeficiency, immunosuppressive therapy such as long-term systemic corticosteroids therapy
  • Systemic hypersensitivity to any of the vaccine components or history of a life threatening reaction to the trial vaccine or a vaccine containing the same substances
  • Chronic illness at a stage that could interfere with trial conduct or completion
  • Blood or blood-derived products received in the past or current or planned administration during the trial (including immunoglobulins)
  • Any vaccination in the 4 weeks preceding the trial vaccination
  • History of diphtheria, tetanus, pertussis, poliomyelitis infection (confirmed either clinically, serologically or microbiologically)
  • Clinical or known serological evidence of systemic illness including Hepatitis B, Hepatitis C and/or Human immunodeficiency virus (HIV) infection
  • Previous vaccination against the diphtheria, tetanus, pertussis, poliomyelitis diseases infection with the trial vaccine or another vaccine after completion of previous study E2I34
  • Thrombocytopenia or a bleeding disorder contraindicating intramuscular vaccination
  • History of/current major neurological diseases or seizures
  • Serious or severe reaction after a previous dose of any vaccine containing pertussis antigen, such as
  • encephalopathy (with or without convulsions) in the 7days following previous administration of a pertussis containing vaccine,
  • temperature more than 39.5°C within 48 hours following vaccine injection, not due to another identifiable cause
  • inconsolable crying equal or more than 3 hours within 48 hours following vaccine injection,
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Unknown Facility

Bangkok, 10330, Thailand

Location

Unknown Facility

Bangkok, 10400, Thailand

Location

Related Publications (1)

  • Pancharoen C, Chotpitayasunondh T, Chuenkitmongkol S, Ortiz E. Long-term immunogenicity assessment of a DTaP-IPV//PRP-T vaccine given at 2, 4, 6 and 18-19 months of age, and immunogenicity and safety of a DTaP-IPV vaccine given as a booster dose at 4 to 6 years of age in Thai children. Southeast Asian J Trop Med Public Health. 2012 May;43(3):687-98.

    PMID: 23077849DERIVED

Related Links

MeSH Terms

Conditions

DiphtheriaTetanusWhooping CoughPoliomyelitis

Condition Hierarchy (Ancestors)

Corynebacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsClostridium InfectionsBordetella InfectionsGram-Negative Bacterial InfectionsRespiratory Tract InfectionsRespiratory Tract DiseasesMyelitisCentral Nervous System InfectionsEnterovirus InfectionsPicornaviridae InfectionsRNA Virus InfectionsVirus DiseasesCentral Nervous System DiseasesNervous System DiseasesSpinal Cord DiseasesNeuroinflammatory DiseasesNeuromuscular Diseases

Study Officials

  • Medical Director

    sanofi pasteur SA

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 10, 2009

First Posted

December 14, 2009

Study Start

December 1, 2009

Primary Completion

September 1, 2010

Study Completion

January 1, 2011

Last Updated

October 5, 2011

Record last verified: 2011-10

Locations

TH(2)