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

NCT00453570 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 792

Last updated 2012-04-17

No results posted yet for this study

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.

Conditions

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

Interventions

BIOLOGICAL

Diphtheria, Tetanus, Polio, Acellular Pertussis and Hib

0.5 mL, IM

BIOLOGICAL

Diphtheria, Tetanus, Polio, Acellular Pertussis and Hib

0.5 mL, IM

BIOLOGICAL

Diphtheria, Tetanus, & Acellular Pertussis Combined, Absorbed

0.5 mL, IM

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Sanofi Pasteur Inc.

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
60 Days
Max Age
74 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-03-31
Primary Completion
2008-12-31
Completion
2009-01-31

Countries

  • China

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00453570 on ClinicalTrials.gov