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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00259337
Other study ID # E2I41
Secondary ID
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


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
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