NCT00254969

Brief Summary

The present clinical study will assess the immunogenicity and reactogenicity 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 in order to meet the requirements for application for the use of the product in the Expanded Program on Immunization (EPI) in South Africa.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
212

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Oct 2005

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

Study Start

First participant enrolled

October 1, 2005

Completed
2 months 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
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
Last Updated

April 17, 2012

Status Verified

April 1, 2012

Enrollment Period

2.6 years

First QC Date

November 15, 2005

Last Update Submit

April 16, 2012

Conditions

DiphtheriaTetanusHaemophilus InfectionsPertussisPoliomyelitis

Keywords

Diphteriatetanushaemophilus influenzae type bpoliomyelitispertussis

Outcome Measures

Primary Outcomes (1)

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

    1 month post-vaccination

Study Arms (1)

1

EXPERIMENTAL
Biological: Diphtheria, Tetanus, Polio, Acellular Pertussis and Hib

Interventions

Diphtheria, Tetanus, Polio, Acellular Pertussis and HibBIOLOGICAL

0.5 mL, Im

Also known as: PENTAXIM™
1

Eligibility Criteria

Age24 Hours+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may not qualify if:

  • At visit 01 (screening)
  • Illness at a stage that could interfere with trial conduct or completion.
  • Any vaccination preceding the trial participation (except Bacille Calmette-Guerin \[BCG\])
  • Acute illness on the day of screening. At visit 01 and visit 02 (screening and first study vaccination).
  • Planned participation in another clinical trial during the present trial period
  • Blood or blood-derived products received since birth.
  • Mother known as seropositive to HIV or hepatitis B.
  • Known thrombocytopenia or a bleeding disorder contraindicating intramuscular vaccination
  • History of/current seizures at visit 02 (first study vaccination)
  • Participation in another clinical trial preceding the first trial vaccination
  • Congenital or acquired immunodeficiency; immunosuppressive therapy such as long-term systemic corticosteroid 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.
  • Any vaccination preceding the first trial vaccination (except BCG)
  • History of diphtheria, tetanus, pertussis, poliomyelitis, Haemophilus influenzae type b and hepatitis B infection (confirmed either clinically, serologically or microbiologically).
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Soweto, South Africa

Location

Related Publications (1)

  • Madhi SA, Cutland C, Jones S, Groome M, Ortiz E. One-year post-primary antibody persistence and booster immune response to a DTaP-IPV//PRP~T vaccine (Pentaxim) given at 18 - 19 months of age in South African children primed at 6, 10 and 14 weeks of age with the same vaccine. S Afr Med J. 2011 Nov 28;101(12):879-83.

    PMID: 22273029DERIVED

Related Links

MeSH Terms

Conditions

DiphtheriaTetanusHaemophilus InfectionsWhooping CoughPoliomyelitis

Interventions

Tetanus ToxoidPentavac

Condition Hierarchy (Ancestors)

Corynebacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsClostridium InfectionsPasteurellaceae InfectionsGram-Negative Bacterial InfectionsBordetella InfectionsRespiratory Tract InfectionsRespiratory Tract DiseasesMyelitisCentral Nervous System InfectionsEnterovirus InfectionsPicornaviridae InfectionsRNA Virus InfectionsVirus DiseasesCentral Nervous System DiseasesNervous System DiseasesSpinal Cord DiseasesNeuroinflammatory DiseasesNeuromuscular Diseases

Intervention Hierarchy (Ancestors)

ToxoidsVaccinesBiological ProductsComplex Mixtures

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 15, 2005

First Posted

November 17, 2005

Study Start

October 1, 2005

Primary Completion

May 1, 2008

Study Completion

January 1, 2010

Last Updated

April 17, 2012

Record last verified: 2012-04

Locations

ZA(1)