NCT00259337

Brief Summary

The present clinical study will assess the immunogenicity as the primary objective and the reactogenicity as the secondary objective of Aventis Pasteur's DTacP-IPV// PRP\~T combined vaccine (Pentavac™ or Pentaxim™) as a three-dose primary vaccination at 6, 10 and 14 weeks of age followed by a booster dose during the second year of life. Safety: This study will describe the safety after each dose of the primary series of the study's combined vaccine (Pentaxim™).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
226

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Feb 2006

Typical duration for phase_3

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

First Submitted

Initial submission to the registry

November 24, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 29, 2005

Completed
2 months until next milestone

Study Start

First participant enrolled

February 1, 2006

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

April 16, 2012

Status Verified

April 1, 2012

Enrollment Period

2.2 years

First QC Date

November 24, 2005

Last Update Submit

April 13, 2012

Conditions

DiphtheriaTetanusPolioPertussisHaemophilus Infections

Keywords

DiphteriaTetanusPolioAcellular PertussisHibHaemophilus influenzae type B

Outcome Measures

Primary Outcomes (1)

  • To provide information concerning the safety of DTacP-IPV//PRP~T combined vaccine

    19 months

Study Arms (1)

1

EXPERIMENTAL
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

Age42 Days - 56 Days
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Born at full term pregnancy (\> 37 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

You may not qualify if:

  • Participation in another clinical trial in the 4 weeks preceding the (first) trial vaccination
  • 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 preceding the trial vaccination (except BCG and hepatitis B)
  • History of diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B or Haemophilus influenza type b (confirmed either clinically, serologically or microbiologically).
  • Previous vaccination against the diphtheria, tetanus, pertussis, poliomyelitis diseases or Haemophilus influenza type b infection with the trial vaccine or another vaccine.
  • Thrombocytopenia or a bleeding disorder contraindicating intramuscular vaccination
  • History of/current seizures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

New Delhi, India

Location

Related Links

MeSH Terms

Conditions

DiphtheriaTetanusPoliomyelitisWhooping CoughHaemophilus Infections

Interventions

Pentavac

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

Study Officials

  • Medical Director

    Sanofi Pasteur Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 24, 2005

First Posted

November 29, 2005

Study Start

February 1, 2006

Primary Completion

April 1, 2008

Study Completion

December 1, 2008

Last Updated

April 16, 2012

Record last verified: 2012-04

Locations

IN(1)