NCT00315055

Brief Summary

To demonstrate that the immune response to hepatitis B antigen of the DTaP-IPV-Hep B-PRP\~T is non-inferior to that of the association of PENTAXIM™ and ENGERIX B® one month after a three dose (2-3-4 month) primary series. Immunogenicity

  • To assess pre- and post-primary series
  • To assess pre- and post-booster series.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
310

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jul 2006

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

April 13, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 17, 2006

Completed
3 months until next milestone

Study Start

First participant enrolled

July 1, 2006

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2007

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2008

Completed
6 years until next milestone

Results Posted

Study results publicly available

February 4, 2014

Completed
Last Updated

September 12, 2014

Status Verified

September 1, 2014

Enrollment Period

1 year

First QC Date

April 13, 2006

Results QC Date

September 9, 2013

Last Update Submit

September 4, 2014

Conditions

Hepatitis BPolioDiphtheriaPertussis

Keywords

Hepatitis BPolioDiphtheriaPertussisH influenzae type b

Outcome Measures

Primary Outcomes (1)

  • Percentage of Participants With Anti HBs Seroprotection After the 3 Dose Primary Vaccination Series With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ + ENGERIX B® Vaccines

    Antibodies to hepatitis B surface antigen (HBs) were measured by means of automated enhanced chemoluminescence assay. Seroprotection was defined as a titer ≥ 10 mIU/mL.

    Day 90 post first dose

Secondary Outcomes (5)

  • Percentage of Participants With Seroprotection Against Hepatitis B Surface Antigen, Polyribosyl Ribitol Phosphate, Diptheria, and Tetanus After the 3 Dose Primary Series With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ + ENGERIX B®

    Day 90 post first dose

  • Percentage of Participants With Seroprotection Against Poliovirus Antigens After the 3 Dose Primary Series Vaccination With Either DTaP-IPV-HB-PRP~T or PENTAXIM™ + ENGERIX B®

    Day 90 post first dose

  • Percentage of Participants With Anti-Pertussis Seroconversion After the 3 Dose Primary Series Vaccination With Either DTaP-IPV-HB-PRP~T or PENTAXIM™ + ENGERIX B®

    Day 0 (pre-vaccination) and Day 30 post-dose 3

  • Geometric Mean Titers of Antibodies After the 3 Dose Primary Series With Either DTaP-IPV-HB-PRP~T or PENTAXIM™ + ENGERIX B®

    Day 90 (30 Days post-dose 3)

  • Number of Participants With at Least a Solicited Injection Site or Systemic Reaction After Vaccination With Either DTaP-IPV-HB-PRP~T or PENTAXIM™ + ENGERIX B®

    Day 0 to Day 7 post any dose

Study Arms (2)

Group 1: DTaP-IPV-Hep B-PRP-T

EXPERIMENTAL

Participants will receive 3 vaccinations with Diphtheria (D) and tetanus (T) toxoids, acellular pertussis (2-component) (aP), recombinant Hepatitis B surface antigen (HBsAg), inactivated poliomyelitis virus (IPV), and Hemophilus influenzae type b (Hib) polysaccharide conjugated to tetanus protein (DTaP-IPV-Hep B-PRP\~T); One dose each at 2, 3, and 4 months of age.

Biological: DTaP-IPV-HB-PRP~T vaccine

Group 2: PENTAXIM™ and ENGERIX B® PEDIATRIC

ACTIVE COMPARATOR

Participants will receive 3 vaccinations with DTaP-IPV-PRP\~T (PENTAXIM™ ) and recombinant Hepatitis B (ENGERIX® PEDIATRIC) vaccines. One dose each at 2, 3, and 4 months of age.

Biological: DTaP-IPV//PRP~T combinedBiological: Hepatitis B vaccine

Interventions

DTaP-IPV-HB-PRP~T vaccineBIOLOGICAL

0.5 mL, Intramuscular (IM)

Group 1: DTaP-IPV-Hep B-PRP-T
DTaP-IPV//PRP~T combinedBIOLOGICAL

0.5 mL, IM

Also known as: PENTAXIM™
Group 2: PENTAXIM™ and ENGERIX B® PEDIATRIC
Hepatitis B vaccineBIOLOGICAL

0.5 mL, IM

Also known as: ENGERIX B®
Group 2: PENTAXIM™ and ENGERIX B® PEDIATRIC

Eligibility Criteria

Age50 Days - 71 Days
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Born at full term of pregnancy (\>=37 weeks) with a birth weight \>=2.5 kg
  • Informed consent form signed by the parent(s) or other legal representative(s) and an institution official other than an investigator
  • 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 corticosteroid therapy
  • Systemic hypersensitivity to any of the vaccine components or history of a life threatening reaction to 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 since birth
  • Any vaccination (except BCG) in the 4 weeks preceding the first trial vaccination
  • Vaccination planned in the 4 weeks following trial vaccination
  • History of documented pertussis, tetanus, diphtheria, polio, Haemophilus influenzae type b or hepatitis B infection(s) (confirmed either clinically, serologically or microbiologically)
  • Known personal or maternal history of HIV, Hepatitis B or Hepatitis C seropositivity
  • Previous vaccination against pertussis, tetanus, diphtheria, polio or Hib, and HB infection(s)
  • Coagulopathy, thrombocytopenia or a bleeding disorder contraindicating intramuscular vaccination
  • History of seizures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Ankara, Turkey (Türkiye)

Location

Related Links

MeSH Terms

Conditions

Hepatitis BPoliomyelitisDiphtheriaWhooping CoughHaemophilus Infections

Interventions

DTaP-IPV-HB-PRP-T vaccinePentavacHepatitis B VaccinesEngerix-B

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitisLiver DiseasesDigestive System DiseasesMyelitisCentral Nervous System InfectionsEnterovirus InfectionsPicornaviridae InfectionsRNA Virus InfectionsCentral Nervous System DiseasesNervous System DiseasesSpinal Cord DiseasesNeuroinflammatory DiseasesNeuromuscular DiseasesCorynebacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesBordetella InfectionsGram-Negative Bacterial InfectionsRespiratory Tract InfectionsRespiratory Tract DiseasesPasteurellaceae Infections

Intervention Hierarchy (Ancestors)

Viral Hepatitis VaccinesViral VaccinesVaccinesBiological ProductsComplex Mixtures

Results Point of Contact

Title
Medical Director
Organization
Sanofi Pasteur Inc.
RegistryContactUs@sanofipasteur.com

Study Officials

  • Clinical Trials

    Sanofi Pasteur, a Sanofi Company

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

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

Study Record Dates

First Submitted

April 13, 2006

First Posted

April 17, 2006

Study Start

July 1, 2006

Primary Completion

July 1, 2007

Study Completion

February 1, 2008

Last Updated

September 12, 2014

Results First Posted

February 4, 2014

Record last verified: 2014-09

Locations

TU(1)