Immunogenicity and Safety of Pentaxim as 3 Doses Primary Vaccination Followed by a Booster Dose at 18 Months

Tetanus Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00453570
• Other study ID #: E2I42
• Status: Completed
• Phase: Phase 3
• First received: March 28, 2007
• Last updated: April 13, 2012
• Start date: March 2007
• Est. completion date: January 2009

Study information

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

Clinical Trial Summary

As per request by the Heath Authorities, the present clinical study will assess the immunogenicity and safety of sanofi pasteur's DTacP-IPV// PRP~T combined vaccine (PENTAXIM™) as a three-dose primary vaccination at 2, 3, and 4 months of age or 3, 4 and 5 months of age followed by a booster dose at 18-20 months of age as compared to commercially available DTacP, Hib conjugate (Act-HIB™) and IPV (IMOVAX Polio™) monovalent vaccines in order to meet the requirements for registration of the product in People's Republic of China.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 792
• Est. completion date: January 2009
• Est. primary completion date: December 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 60 Days to 74 Days

Eligibility

Inclusion Criteria :

• Aged 2 months (60 to 74 days) inclusive on the day of inclusion

• Born at full term pregnancy (³36 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 trial inclusion

• 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 performed or planned in the 4 weeks preceding the first trial visit (except BCG and Hepatitis B, which can not be given within 8 days before the first study visit)

• Vaccination planned in the 4 weeks following any trial vaccination (except BCG and Hepatitis B, which can not be given within 8 days before or after the study vaccine(s) administration)

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

• Clinical or serological evidence of systemic illness including Hepatitis B, Hepatitis C and/or HIV infection

• 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 (axillary temperature = 37.1°C) or acute illness on the day of inclusion

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diphtheria
• Haemophilus Influenzae Type b
• Pertussis
• Poliomyelitis
• Tetanus

Intervention

Biological:
• Diphtheria, Tetanus, Polio, Acellular Pertussis and Hib
0.5 mL, IM
• Diphtheria, Tetanus, Polio, Acellular Pertussis and Hib
0.5 mL, IM
• Diphtheria, Tetanus, & Acellular Pertussis Combined, Absorbed
0.5 mL, IM

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

China, 

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-dose 3	No
Secondary	To provide information concerning the safety of DTacP-IPV//PRP~T combined vaccine		19 months post-dose 1	Yes

External Links

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