Immunogenicity and Safety of Pentaxim in South African Infants

Tetanus Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00254969
• Other study ID #: E2I43
• Status: Completed
• Phase: Phase 3
• First received: November 15, 2005
• Last updated: April 16, 2012
• Start date: October 2005
• Est. completion date: January 2010

Study information

• Verified date: April 2012
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Africa: Medicines Control Council
• Study type: Interventional

Clinical Trial Summary

The present clinical study will assess the immunogenicity and reactogenicity of Aventis Pasteur's DTacP-IPV// PRP~T combined vaccine (Pentavac™ or Pentaxim™) as a three-dose primary vaccination at 6, 10 and 14 weeks of age followed by a booster dose during the second year of life in order to meet the requirements for application for the use of the product in the Expanded Program on Immunization (EPI) in South Africa.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 212
• Est. completion date: January 2010
• Est. primary completion date: May 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Aged < 24 hours on the day of inclusion

Exclusion Criteria:

• At visit 01 (screening)

• Illness at a stage that could interfere with trial conduct or completion.

• Any vaccination preceding the trial participation (except Bacille Calmette-Guerin [BCG])

• Acute illness on the day of screening. At visit 01 and visit 02 (screening and first study vaccination).

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

• Blood or blood-derived products received since birth.

• Mother known as seropositive to HIV or hepatitis B.

• Known thrombocytopenia or a bleeding disorder contraindicating intramuscular vaccination

• History of/current seizures at visit 02 (first study vaccination)

• Participation in another clinical trial preceding the first trial vaccination

• 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.

• Any vaccination preceding the first trial vaccination (except BCG)

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

• Previous vaccination against diphtheria, tetanus, pertussis, poliomyelitis, Haemophilus influenzae type b and hepatitis B infection with the trial vaccine or another vaccine.

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

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
0.5 mL, Im

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

South Africa, 

Outcome

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

External Links

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