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

Phase 3

Completed

• Conditions: Diphtheria; Tetanus; Haemophilus Influenzae Type b; Pertussis; Poliomyelitis
• Interventions: Biological: Diphtheria, Tetanus, Polio, Acellular Pertussis and Hib; Biological: Diphtheria, Tetanus, & Acellular Pertussis Combined, Absorbed

• Registration Number: NCT00453570
• Lead Sponsor: Sanofi

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-03
• Study First Submitted: 2007-03-28
• Study First Submitted QC: 2007-03-28
• Study First Posted: 2007-03-29
• Primary Completion: 2008-12
• Study Completion: 2009-01
• Status Verified: 2012-04
• Last Update Submitted: 2012-04-13
• Last Update Posted: 2012-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 792

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Diphtheria, Tetanus, Polio, Acellular Pertussis and Hib	DTacP IPV// PRP\~T combined vaccine at 2, 3 and 4 months of age, and a booster dose at 18-20 months of age.
2	Diphtheria, Tetanus, Polio, Acellular Pertussis and Hib	DTacP-IPV// PRP\~T combined vaccine at 3, 4 and 5 months of age and a booster dose at 18-20 months of age.
3	Diphtheria, Tetanus, & Acellular Pertussis Combined, Absorbed	Control vaccines at 3, 4 and 5 months of age and a booster dose at 18-20 months of age

Primary Outcome Measures

Name	Time	Method
To provide information concerning the immunogenicity of DTacP-IPV//PRP~T combined vaccine	1 Month post-dose 3

Secondary Outcome Measures

Name	Time	Method
To provide information concerning the safety of DTacP-IPV//PRP~T combined vaccine	19 months post-dose 1