Study of PENTAXIM™ Vaccine Versus TETRAXIM™ Vaccine Given With ACTHIB™ Vaccine in South Korean Infants.

Tetanus Clinical Trial

Official title:

Immunogenicity and Safety of the Sanofi Pasteur's DTacP-IPV//PRP~T Combined Vaccine (PENTAXIM™) Versus Sanofi Pasteur's DTacP-IPV Combined Vaccine (TETRAXIM™) Given Simultaneously at Separate Sites With PRP~T Conjugate Vaccine (ACTHIB™) as a Three-dose Primary Vaccination at 2, 4 and 6 Months of Age in South Korean Infants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01214889
• Other study ID #: E2I49
• Secondary ID: U1111-1115-6381
• Status: Completed
• Phase: Phase 3
• First received: October 1, 2010
• Last updated: April 13, 2012
• Start date: September 2010
• Est. completion date: December 2011

Study information

• Verified date: April 2012
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This study is designed to assess the immunogenicity and safety of PENTAXIM™ combined vaccine versus TETRAXIM™ vaccine to support registration of PENTAXIM™ in South Korea.

Primary Objective:

To demonstrate the non-inferiority in terms of seroprotection rates (Diphtheria, Tetanus, Polio types 1, 2 and 3, Polyribosyl Ribitol Phosphate [PRP]) and vaccine response rates to acellular Pertussis antigens of sanofi pasteur's PENTAXIM™ vaccine versus sanofi pasteur's TETRAXIM™ and Act (Haemophilus influenzae type b) HIB™ vaccines, one month after the three-dose primary vaccination.

Description:

All participants will receive three primary doses of their assigned study the vaccine, on Days 0, 60, and 120. They will be assessed for immunogenicity on Day 0 before vaccination and Day 150 post-vaccination. Safety will be assessed for all participants throughout the study, up to Day 157.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 370
• Est. completion date: December 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 56 Days to 70 Days

Eligibility

Inclusion Criteria:

• Aged 2 months (56 to 70 days) inclusive on the day of inclusion

• Born at full term of pregnancy (= 37 weeks) and with a birth weight = 2.5 kg

• 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 3 weeks preceding the first trial vaccination.

• History of diphtheria, tetanus, pertussis, poliomyelitis, Haemophilus influenzae type b 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 or Haemophilus influenzae type b infection with the trial vaccine or another vaccine.

• Thrombocytopenia or a bleeding disorder contraindicating intramuscular vaccination

• History of/current major neurological diseases or seizures.

• Febrile illness (axillary temperature = 38ºC) or acute illness on the day of inclusion.

• Known family history of congenital or genetic immuno-deficiency.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diphtheria
• Haemophilus Influenzae Type B
• Pertussis
• Poliomyelitis
• Tetanus

Intervention

Biological:
• PENTAXIM™: DTacP IPV//PRP~T combined vaccine
0.5 mL, intramuscular
• TETRAXIM™: DTacP IPV combined vaccine and ActHIB™: PRP tetanus conjugate vaccine
0.5 mL of each vaccine; intramuscular

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Non-inferiority in terms of seroprotection rates (Diphtheria, Tetanus, Polio types 1, 2 and 3, Polyribosyl Ribitol Phosphate conjugated to Tetanus protein) of PENTAXIM™ Vaccine to the Tetraxim™ and PRP~T conjugate (Act-HIB™) vaccines.		1 month post-dose 3 vaccination	No
Secondary	Information regarding the safety (in terms of solicited injection site and systemic reactions) of PENTAXIM™ vaccine.		Day 0 up to Day 157	No

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