Immunogenicity and Safety of Pentaxim™ in an Indian Population

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00259337
• Date of registration: 24/11/2005
• Prospective Registration: Yes
• Primary sponsor: Sanofi
• Public title: Immunogenicity and Safety of Pentaxim™ in an Indian Population
• Scientific 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.
• Date of first enrolment: February 2006
• Target sample size: 226
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00259337
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
• Phase: Phase 3

Countries of recruitment

India

Contacts

• Name: Medical Director
• Affiliation: Sanofi Pasteur Inc.

Key inclusion & exclusion criteria

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.



Age minimum: 42 Days
Age maximum: 56 Days
Gender: Both

Health Condition(s) or Problem(s) studied

Polio

Pertussis

Diphtheria

Haemophilus Infections

Tetanus

Intervention(s)

Biological: Diphteria/Tetanus/Polio/Acellular Pertussis/Hib vaccine

Primary Outcome(s)

To provide information concerning the safety of DTacP-IPV//PRP~T combined vaccine [Time Frame: 19 months]

Secondary ID(s)

E2I41

Source(s) of Monetary Support

Please refer to primary and secondary sponsors