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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 )

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.


Condition or disease Intervention/treatment Phase
Diphtheria Tetanus Pertussis Haemophilus Influenzae Type b Hepatitis B Biological: DTaP-IPV-HB-PRP~T Biological: Tritanrix-HepB/Hib Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2133 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: 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
Study Start Date : July 2006
Actual Primary Completion Date : January 2008
Actual Study Completion Date : February 2008


Arm Intervention/treatment
Experimental: Group 1: DTaP-IPV-Hep B-PRP-T Biological: DTaP-IPV-HB-PRP~T
0.5 mL, Intramuscular (IM)

Active Comparator: Group 2: Tritanrix-Hep B/Hib™+OPV Biological: Tritanrix-HepB/Hib
0.5 mL, Intramuscular




Primary Outcome Measures :
  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. [ Time Frame: Day 0 up to Day 7 post-injection ]
    High fever was defined as rectal temperature equivalent to ≥ 39.6ºC.


Secondary Outcome Measures :
  1. 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.

  2. 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.


  3. 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.




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Ages Eligible for Study:   50 Days to 71 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00313911


Locations
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Mexico
Mexico DF, Mexico
Peru
Lima, Peru
Sponsors and Collaborators
Sanofi Pasteur, a Sanofi Company
Investigators
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Study Director: Medical Monitor Sanofi Pasteur Inc.

Additional Information:
Publications of Results:
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Responsible Party: Sanofi Pasteur, a Sanofi Company
ClinicalTrials.gov Identifier: NCT00313911     History of Changes
Other Study ID Numbers: A3L04
First Posted: April 12, 2006    Key Record Dates
Results First Posted: November 19, 2012
Last Update Posted: April 21, 2014
Last Verified: April 2014
Keywords provided by Sanofi ( Sanofi Pasteur, a Sanofi Company ):
Diphtheria
Tetanus
Pertussis
Recombinant Hepatitis B
Poliomyelitis
Haemophilus influenzae type b
Tetanus protein
Additional relevant MeSH terms:
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Whooping Cough
Tetanus
Diphtheria
Hepatitis B
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Hepadnaviridae Infections
DNA Virus Infections
Bordetella Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Infection
Clostridium Infections
Gram-Positive Bacterial Infections
Corynebacterium Infections
Actinomycetales Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs