Immunogenicity and Safety of TETRAXIM™ Given as a Booster Dose at 4 to 6 Years of Age

• ClinicalTrials.gov Identifier: NCT01031303
• Recruitment Status: Completed
• First Posted: December 14, 2009
• Last Update Posted: October 5, 2011
• Sponsor: Sanofi
• Information provided by (Responsible Party): Sanofi

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Diphtheria; Tetanus; Pertussis; Poliomyelitis	Biological: DTacP-IPV combined vaccine (TETRAXIM™)	Phase 4

Detailed Description:

All participants that previously completed the three-dose primary and the booster vaccinations in the study E2I34 (NCT 00255021) will be contacted to enroll in this study to receive sanofi pasteur's DTacP IPV combined vaccine (Tetraxim™) at 4 to 6 years of age.

Participants will receive the study vaccine [sanofi pasteur's DTacP-IPV vaccine (TETRAXIM™)] at 4 to 6 years of age (at visit 1).

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 123 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Immunogenicity and Safety of the Sanofi Pasteur's DTacP-IPV Combined Vaccine (TETRAXIM™) Given as a Booster Dose at 4 to 6 Years of Life in Children Previously Vaccinated With PENTAXIM™ in the Study E2I34
• Study Start Date: December 2009
• Actual Primary Completion Date: September 2010
• Actual Study Completion Date: January 2011

Arms and Interventions

Arm	Intervention/treatment
Experimental: Study Group	Biological: DTacP-IPV combined vaccine (TETRAXIM™); 0.5 mL, Intramuscular; Other Name: TETRAXIM™

Outcome Measures

Primary Outcome Measures :

1. To provide information concerning the immunogenicity of TETRAXIM™ after booster vaccination. [ Time Frame: 30 days post-vaccination ]

Secondary Outcome Measures :

1. To provide information concerning the safety after booster administration of TETRAXIM™. [ Time Frame: 30 days post-vaccination and entire study period ]

Eligibility Criteria

• Ages Eligible for Study: 4 Years to 6 Years (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria :

• Aged 4-6 years inclusive on the day of inclusion
• 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

Exclusion Criteria :

• Participation in another clinical trial in the 4 weeks preceding the trial inclusion
• 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
• Febrile illness (temperature ≥ 38°C) or acute illness on the day of inclusion.
• 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,
• hypotonic hyporesponsive episode within 48 hours following vaccine injection,
• seizures with or without fever within 3 days following vaccine injection.

Contacts and Locations

Locations

Thailand

Bangkok, Thailand, 10330

Bangkok, Thailand, 10400

Sponsors and Collaborators

Sanofi

Investigators

• Study Director: Medical Director; sanofi pasteur SA

More Information

Additional Information:

Related Info 

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Sanofi
• ClinicalTrials.gov Identifier: NCT01031303
• Other Study ID Numbers: E2I57; UTN: U1111-1112-2680 ( Other Identifier: WHO )
• First Posted: December 14, 2009
• Last Update Posted: October 5, 2011
• Last Verified: October 2011

Keywords provided by Sanofi:

Diphtheria; Tetanus; Pertussis; Poliomyelitis; PENTAXIM™; TETRAXIM™

Additional relevant MeSH terms:

Whooping Cough; Tetanus; Diphtheria; Poliomyelitis; Bordetella Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Clostridium Infections; Gram-Positive Bacterial Infections; Nervous System Diseases; Corynebacterium Infections; Actinomycetales Infections; Myelitis; Central Nervous System Infections; Enterovirus Infections; Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Central Nervous System Diseases; Spinal Cord Diseases; Neuromuscular Diseases