Immunogenicity and Safety of Pentaxim™ in an Indian Population

Tetanus Clinical Trial

Official title:

Immunogenicity and Safety of the Sanofi Pasteur DTacP-IPV//PRP~T Combined Vaccine (PENTAXIM™) Given as a Three-Dose Primary Vaccination at 6, 10, and 14 Weeks of Age and Followed by a Booster Dose at 18-19 Months of Age in Healthy Infants in India.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00259337
• Other study ID #: E2I41
• Status: Completed
• Phase: Phase 3
• First received: November 24, 2005
• Last updated: April 13, 2012
• Start date: February 2006
• Est. completion date: December 2008

Study information

• Verified date: April 2012
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Indian Council of Medical Research
• Study type: Interventional

Clinical Trial Summary

The present clinical study will assess the immunogenicity as the primary objective and the reactogenicity as the secondary objective 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.

Safety:

This study will describe the safety after each dose of the primary series of the study's combined vaccine (Pentaxim™).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 226
• Est. completion date: December 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 42 Days to 56 Days

Eligibility

Inclusion Criteria:

• Aged 42 to 56 days inclusive on the day of inclusion

• Born at full term pregnancy (> 37 weeks) 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 (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 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.

• Any vaccination preceding the trial vaccination (except BCG and hepatitis B)

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

• Previous vaccination against the diphtheria, tetanus, pertussis, poliomyelitis diseases or Haemophilus influenza 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
• Polio
• Tetanus

Intervention

Biological:
• Diphteria/Tetanus/Polio/Acellular Pertussis/Hib vaccine
0.5 mL, IM

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To provide information concerning the safety of DTacP-IPV//PRP~T combined vaccine		19 months	Yes

External Links

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