Immunogenicity and Safety of Sanofi Pasteur Pentaxim Combined Vaccine in Infants in Thailand

Tetanus Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00255021
• Other study ID #: E2I34
• Status: Completed
• Phase: Phase 4
• First received: November 15, 2005
• Last updated: April 13, 2012
• Start date: December 2005
• Est. completion date: January 2009

Study information

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

Clinical Trial Summary

The present clinical study will assess the immunogenicity and reactogenicity of Sanofi Pasteur's DTacP-IPV// PRP~T combined vaccine (Pentavac™ or Pentaxim™) as a three-dose primary vaccination at 2, 4, and 6 months of age followed by a booster dose during the second year of life and concomitant hepatitis B vaccine at 2 and 6 months of age in infants in Thailand.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 186
• Est. completion date: January 2009
• Est. primary completion date: September 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 2 Months to 2 Months

Eligibility

Inclusion Criteria:

• Aged 53 to 70 days inclusive on the day of inclusion

Exclusion Criteria:

• Participation in another clinical trial in the 4 weeks preceding the (first) trial vaccination

• Planned participation in another clinical trial during the present trial period

• Congenital or acquired immunodeficiency; immunosuppressive therapy such as long-term systemic corticosteroid 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.

• Mother known as seropositive to HIV or hepatitis B

• Any vaccination in the 5 weeks preceding the first trial vaccination (except Bacille Calmette-Guerin [BCG])

• History of diphtheria, tetanus, pertussis, poliomyelitis, Haemophilus influenzae type b infection or hepatitis B (confirmed either clinically, serologically or microbiologically).

• 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 seizures

• Febrile illness (rectal temperature = 38.0°C or axillary temperature = 37.4°C) or acute illness on the day of inclusion.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diphtheria
• Haemophilus Infections
• Pertussis
• Poliomyelitis
• Tetanus

Intervention

Biological:
• Diphtheria, Tetanus, Polio, Acellular Pertussis and Hib Vac
0.5 mL, IM

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Immunogenicity: To provide information concerning the immune response of the DTacP-IPV//PRP~T combined vaccine		1 month post-vaccination	No

External Links

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