NCT00313911

Brief Summary

To demonstrate that DTaP-IPV-HB-PRP\~T combined vaccine does not induce a higher incidence rate of high fever than Tritanrix-HepB/Hib™ and Oral Polio Vaccine (OPV) after any of the three vaccinations at 2, 4, and 6 months of age for each subject. To evaluate the overall safety in terms of: Any solicited adverse reactions in the first 7 days after each injection, Any adverse events and reactions in the first 30 days after each injection, Any serious adverse events during the trial. Immunogenicity: To document the immune response to Hepatitis B antigen of the three batches of the investigational DTaP-IPV-HB-PRP\~T vaccine.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
2,133

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jul 2006

Geographic Reach
2 countries

2 active sites

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 11, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 12, 2006

Completed
3 months until next milestone

Study Start

First participant enrolled

July 1, 2006

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2008

Completed
4.8 years until next milestone

Results Posted

Study results publicly available

November 19, 2012

Completed
Last Updated

April 21, 2014

Status Verified

April 1, 2014

Enrollment Period

1.5 years

First QC Date

April 11, 2006

Results QC Date

September 18, 2012

Last Update Submit

April 2, 2014

Conditions

DiphtheriaTetanusPertussisHaemophilus Influenzae Type bHepatitis B

Keywords

DiphtheriaTetanusPertussisRecombinant Hepatitis BPoliomyelitisHaemophilus influenzae type bTetanus protein

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With High Fever Observed After Either DTaP-IPV-Hep B-PRP~T or Tritanrix Hep B/Hib™ + Placebo or Tritanrix-Hep B/Hib™ + Placebo Injection.

    High fever was defined as rectal temperature equivalent to ≥ 39.6ºC.

    Day 0 up to Day 7 post-injection

Secondary Outcomes (3)

  • Geometric Mean Titers of Anti Hepatitis B Antibodies Following Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine + Placebo or Tritanrix-Hep B/Hib™ + Placebo

    Day 30 post-dose 3

  • Percentage of Participants Reaching Seroprotection Threshold Following Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine + Placebo or Tritanrix-Hep B/Hib™ + Placebo

    Day 30 post-dose 3

  • Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Each Vaccination

    Day 0 up to Day 7 Post-injection

Study Arms (2)

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

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

Group 2: Tritanrix-Hep B/Hib™+OPV

ACTIVE COMPARATOR
Biological: Tritanrix-HepB/Hib

Interventions

DTaP-IPV-HB-PRP~TBIOLOGICAL

0.5 mL, Intramuscular (IM)

Group 1: DTaP-IPV-Hep B-PRP-T
Tritanrix-HepB/HibBIOLOGICAL

0.5 mL, Intramuscular

Group 2: Tritanrix-Hep B/Hib™+OPV

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 one or both parents or by the legally acceptable representative and 1 or 2 independent witnesses
  • Able to attend all scheduled visits and to comply with all trial procedures
  • Has complied with the national immunization calendar (BCG for both countries) for the first 2 months of life.

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
  • Subjects with congenital or acquired immunodeficiency in the child's surrounding
  • 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 since birth
  • Any vaccination in the 4 weeks preceding the first trial vaccination
  • Vaccination planned in the 4 weeks following the trial vaccination
  • Documented history of pertussis, tetanus, diphtheria, poliomyelitis, Haemophilus influenzae type b or hepatitis B infection(s) (confirmed either clinically, serologically or microbiologically)
  • Mother known as seropositive for HIV or Hepatitis C, or known carrier of Hepatitis B surface antigen
  • Previous vaccination against pertussis, tetanus, diphtheria, poliomyelitis, or Haemophilus influenzae type b infection(s)
  • Coagulopathy, thrombocytopenia or a bleeding disorder contraindicating IM vaccination
  • History of seizures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Unknown Facility

Mexico City, Mexico

Location

Unknown Facility

Lima, Peru

Location

Related Publications (1)

  • Macias M, Lanata CF, Zambrano B, Gil AI, Amemiya I, Mispireta M, Ecker L, Santos-Lima E. Safety and immunogenicity of an investigational fully liquid hexavalent DTaP-IPV-Hep B-PRP-T vaccine at two, four and six months of age compared with licensed vaccines in Latin America. Pediatr Infect Dis J. 2012 Aug;31(8):e126-32. doi: 10.1097/INF.0b013e318258400d.

    PMID: 22531237RESULT

Related Links

MeSH Terms

Conditions

DiphtheriaTetanusWhooping CoughHaemophilus InfectionsHepatitis BPoliomyelitis

Interventions

DTaP-IPV-HB-PRP-T vaccine

Condition Hierarchy (Ancestors)

Corynebacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsClostridium InfectionsBordetella InfectionsGram-Negative Bacterial InfectionsRespiratory Tract InfectionsRespiratory Tract DiseasesPasteurellaceae InfectionsBlood-Borne InfectionsCommunicable DiseasesHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitisLiver DiseasesDigestive System DiseasesMyelitisCentral Nervous System InfectionsEnterovirus InfectionsPicornaviridae InfectionsRNA Virus InfectionsCentral Nervous System DiseasesNervous System DiseasesSpinal Cord DiseasesNeuroinflammatory DiseasesNeuromuscular Diseases

Results Point of Contact

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

Study Officials

  • Medical Monitor

    Sanofi Pasteur Inc.

    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
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 11, 2006

First Posted

April 12, 2006

Study Start

July 1, 2006

Primary Completion

January 1, 2008

Study Completion

February 1, 2008

Last Updated

April 21, 2014

Results First Posted

November 19, 2012

Record last verified: 2014-04

Locations

ME(1)PE(1)