NCT00254917

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
387

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Oct 2003

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2003

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

November 15, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 17, 2005

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2006

Completed
Last Updated

April 16, 2012

Status Verified

April 1, 2012

Enrollment Period

2.3 years

First QC Date

November 15, 2005

Last Update Submit

April 13, 2012

Conditions

DiphtheriaTetanusPolioPertussisHaemophilus Influenzae Type B

Keywords

Pentaxim

Outcome Measures

Primary Outcomes (1)

  • To provide information concerning the safety of PENTAXIM™ Vaccine.

    20 months

Study Arms (2)

1

EXPERIMENTAL

Concommitant recombinant hepatitis B vaccine at 0, 6 and 14 weeks of age

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

2

EXPERIMENTAL

Concommitant recombinant hepatitis B vaccine at 6, 10, and 14 weeks of age.

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

Interventions

Diphteria, Tetanus, Polio, Acellular Pertussis, Hib vaccineBIOLOGICAL

0.5 mL, IM

Also known as: PENTAXIM™
1

Eligibility Criteria

Age6 Weeks - 19 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Informed consent signed by one or both parent(s) and/or by a legally accepted representative prior to the first study intervention
  • Healthy male or female newborn
  • Age ranging from birth to 48 hours of life (included)
  • Birth weight \>2.5 kg and gestational age \>37 weeks
  • Born to HBs antigen-negative mother

You may not qualify if:

  • Known previous therapy of the mother with cadaveric pituitary derived human growth hormone
  • Infant presently enrolled or scheduled to be enrolled in another clinical trial
  • Infant with moderate or severe illness, mainly infectious diseases
  • Infant with fever (rectal temperature \> 38°C or axillary temperature \> 37.5°C)
  • Infant with severe congenital defects or abnormalities
  • Uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection.
  • Known immunological deficiency (including a known HIV seropositive mother)
  • Administration of vaccine since birth (other than BCG)
  • Previous or planned administration of immunosuppressive therapy, immunoglobulins and /or any blood-derived products (inhaled and topical corticoids are allowed)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Manila, Philippines

Location

Related Links

MeSH Terms

Conditions

DiphtheriaTetanusPoliomyelitisWhooping CoughHaemophilus Infections

Interventions

Tetanus ToxoidHibTITER protein, Haemophilus influenzaePentavac

Condition Hierarchy (Ancestors)

Corynebacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsClostridium InfectionsMyelitisCentral Nervous System InfectionsEnterovirus InfectionsPicornaviridae InfectionsRNA Virus InfectionsVirus DiseasesCentral Nervous System DiseasesNervous System DiseasesSpinal Cord DiseasesNeuroinflammatory DiseasesNeuromuscular DiseasesBordetella InfectionsGram-Negative Bacterial InfectionsRespiratory Tract InfectionsRespiratory Tract DiseasesPasteurellaceae Infections

Intervention Hierarchy (Ancestors)

ToxoidsVaccinesBiological ProductsComplex Mixtures

Study Officials

  • Clinical Trials

    Sanofi Pasteur, a Sanofi Company

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 15, 2005

First Posted

November 17, 2005

Study Start

October 1, 2003

Primary Completion

February 1, 2006

Study Completion

February 1, 2006

Last Updated

April 16, 2012

Record last verified: 2012-04

Locations

PH(1)