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Safety of DTaP-IPV-Hep B-PRP~T Combined Vaccine Compared to Tritanrix-HepB/Hib™ and OPV Given at Age 2, 4, and 6 Months.

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ClinicalTrials.gov Identifier: NCT00313911
Recruitment Status : Completed
First Posted : April 12, 2006
Results First Posted : November 19, 2012
Last Update Posted : April 21, 2014
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

Tracking Information
First Submitted Date  ICMJE April 11, 2006
First Posted Date  ICMJE April 12, 2006
Results First Submitted Date  ICMJE September 18, 2012
Results First Posted Date  ICMJE November 19, 2012
Last Update Posted Date April 21, 2014
Study Start Date  ICMJE July 2006
Actual Primary Completion Date January 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 18, 2012)
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. [ Time Frame: Day 0 up to Day 7 post-injection ]
High fever was defined as rectal temperature equivalent to ≥ 39.6ºC.
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00313911 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 18, 2012)
  • 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 [ Time Frame: Day 30 post-dose 3 ]
    Anti-hepatitis B (Hep B) antibodies were measured by automated enhanced chemiluminescence assay.
  • Percentage of Participants Reaching Seroprotection Threshold Following Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine + Placebo or Tritanrix-Hep B/Hib™ + Placebo [ Time Frame: Day 30 post-dose 3 ]
    Anti hepatitis B (Hep B) antibodies were measured by automated enhanced chemiluminescence assay. Two Seroprotection thresholds were defined: a titer ≥ 10 mIU/mL and ≥ 100 mIU/mL, respectively.
  • Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Each Vaccination [ Time Frame: Day 0 up to Day 7 Post-injection ]
    Solicited Injection Site Reactions: Pain, Erythema, Swelling. Solicited Systemic Reactions: Pyrexia (Temperature), Vomiting, Crying, Somnolence, Anorexia, Irritability. Severe solicited reactions were defined as follows: Pain, cries when injected limb is moved or the movement of the injected limb is reduced; Erythema and Swelling, ≥5 cm; Fever ≥39.6 ºC; Vomiting, ≥6 episodes per 24 hours or requiring parenteral hydration; Crying, >3 hours; Somnolence, sleeping most of the time or difficulty to wake up; Anorexia, refuses ≥3 feeds or refuses most feeds; Irritability, inconsolable.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety of DTaP-IPV-Hep B-PRP~T Combined Vaccine Compared to Tritanrix-HepB/Hib™ and OPV Given at Age 2, 4, and 6 Months.
Official Title  ICMJE Large Scale Safety Study of a DTaP-IPV-Hep B-PRP~T Combined Vaccine, in Comparison to Tritanrix-Hep B/Hib™ and OPV Administered at 2, 4, and 6 Months of Age in Latin American Infants
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Diphtheria
  • Tetanus
  • Pertussis
  • Haemophilus Influenzae Type b
  • Hepatitis B
Intervention  ICMJE
  • Biological: DTaP-IPV-HB-PRP~T
    0.5 mL, Intramuscular (IM)
  • Biological: Tritanrix-HepB/Hib
    0.5 mL, Intramuscular
Study Arms  ICMJE
  • Experimental: Group 1: DTaP-IPV-Hep B-PRP-T
    Intervention: Biological: DTaP-IPV-HB-PRP~T
  • Active Comparator: Group 2: Tritanrix-Hep B/Hib™+OPV
    Intervention: Biological: Tritanrix-HepB/Hib
Publications * Macías 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 19, 2006)
2133
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE February 2008
Actual Primary Completion Date January 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 2 months old infants on the day of inclusion
  • 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.

Exclusion Criteria:

  • 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
  • Febrile or acute illness on the day of inclusion.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Days to 71 Days   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Mexico,   Peru
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00313911
Other Study ID Numbers  ICMJE A3L04
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sanofi ( Sanofi Pasteur, a Sanofi Company )
Study Sponsor  ICMJE Sanofi Pasteur, a Sanofi Company
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Monitor Sanofi Pasteur Inc.
PRS Account Sanofi
Verification Date April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP