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Assessment of the Immunogenicity and Safety of PENTAXIM™ in Philippines

NCT00254917 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 387

Last updated 2012-04-16

No results posted yet for this study

Summary

The present clinical study will assess the immunogenicity and reactogenicity of the subsequent administration of Aventis Pasteur's DTacP-IPV//PRP\~T combined vaccine (PENTAVAC™/PENTAXIM), as a three-dose primary vaccination in 6, 10 and 14 weeks of age schedule followed by a booster vaccination during the second year of life with the aim to cover the WHO EPI primary vaccination schedule at this age for diphtheria, tetanus, pertussis, poliomyelitis and Hib vaccines.

WHO EPI vaccination schedules for hepatitis B (either 0, 6 and 14 weeks or 6, 10 and 14 weeks of age) will be also assessed in infants born to HBsAg seronegative mothers.

To assess the safety of Pentaxim.

Conditions

  • Diphtheria
  • Tetanus
  • Polio
  • Pertussis
  • Haemophilus Influenzae Type B

Interventions

BIOLOGICAL

Diphteria, Tetanus, Polio, Acellular Pertussis, Hib vaccine

0.5 mL, IM

BIOLOGICAL

Diphteria, Tetanus, Polio, Acellular Pertussis, Hib vaccine

0.5 mL, IM

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Sanofi Pasteur, a Sanofi Company

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Weeks
Max Age
19 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2003-10-31
Primary Completion
2006-02-28
Completion
2006-02-28

Countries

  • Philippines

Study Locations

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Entities

Diseases
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 NCT00254917 on ClinicalTrials.gov