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Trial record 2 of 2 for:    A3L11

Lot Consistency Study of DTaP-IPV-HB-PRP~T Vaccine Administered at 2-4-6 Months of Age in Healthy Infants

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ClinicalTrials.gov Identifier: NCT00404651
Recruitment Status : Completed
First Posted : November 29, 2006
Results First Posted : May 9, 2014
Last Update Posted : May 9, 2014
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

Tracking Information
First Submitted Date  ICMJE November 28, 2006
First Posted Date  ICMJE November 29, 2006
Results First Submitted Date  ICMJE February 14, 2014
Results First Posted Date  ICMJE May 9, 2014
Last Update Posted Date May 9, 2014
Study Start Date  ICMJE November 2006
Actual Primary Completion Date April 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 11, 2014)
  • Equivalence of Seroprotection Against Vaccine Antigens in Study Participants After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T or Infanrix Hexa™ Vaccine [ Time Frame: Day 150 (one month post-dose 3) ]
    Antibody titers were measured for hepatitis B (Hep B) by enhanced chemiluminescence detection, for Haemophilus influenzae type b (PRP) by Farr type radioimmunoassay, for Diphtheria (D) by toxin neutralization test, and for Tetanus (T) by enzyme-linked immunosorbent assay (ELISA). Seroprotection was defined as a titer ≥ 0.10 mIU/mL for Hep B, ≥ 0.15 µg/mL for PRP, and ≥ 0.01 IU/mL for D and T antibodies.
  • Equivalence of Seroprotection Against Pertussis in Study Participants After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T or Infanrix Hexa™ Vaccine. [ Time Frame: Day 150 (one month post-dose 3) ]
    Antibody titers were measured for pertussis toxoid (PT) and filamentous hemagglutinin (FHA) by enzyme linked immunosorbent assay (ELISA). Seroconversion was defined as a ≥ 4 fold increase in titer from Day 0 (before dose 1) to Day 150, one month post-dose 3.
  • Equivalence of Seroprotection Against Poliovirus Types 1, 2, and 3 in Study Participants After Vaccination With Either One of the Batches of DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine [ Time Frame: Day 150 (one month post-dose 3) ]
    Antibody titers were measured for poliovirus types 1, 2, and 3 by Enzyme immuno assay. Seroprotection against Poliovirus Types 1, 2, and 3 was defined as a titer ≥ 8 (1/dilutions).
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00404651 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 11, 2014)
  • Geometric Mean Titers of Antibodies After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine [ Time Frame: Day 150 (one month post-dose 3) ]
    Antibody titers were measured for hepatitis B (Hep B) by enhanced chemiluminescence detection, for Haemophilus influenzae type b (PRP) by Farr type radioimmunoassay, for diphtheria (D) by toxin neutralization test, and for tetanus by enzyme linked immunosorbent assay. Antibody titers were measured for poliovirus types 1, 2, and 3 by neutralization assay. Antibody titers were measured for pertussis toxoid (PT) and filamentous hemagglutinin (FHA) by enzyme linked immunosorbent assay (ELISA).
  • Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine [ Time Frame: Day 0 (pre-each vaccination) up to 7 days post-each dose ]
    Solicited Injection Site Reactions: Pain, Erythema, and Swelling. Solicited Systemic Reactions: Fever ([pyrexia] - temperature), Vomiting, Crying, Somnolence, Anorexia, and Irritability
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 Lot Consistency Study of DTaP-IPV-HB-PRP~T Vaccine Administered at 2-4-6 Months of Age in Healthy Infants
Official Title  ICMJE Lot to Lot Consistency Study of DTaP-IPV-Hep B-PRP~T Vaccine Administered at 2-4-6 Months of Age in Healthy Mexican Infants
Brief Summary

The purpose of this trial is to clinically confirm that the manufacturing process of the final bulk products of the investigational DTaP-IPV-HB-PRP~T vaccine is consistent.

The primary objective is to demonstrate the equivalence of three batches of DTaP-IPV-HB-PRP~T vaccine, in terms of seroprotection and seroconversion rates for the vaccine antigens after the three-dose primary series.

The secondary objectives are:

  • To describe in each group, the immunogenicity parameters for all antigens one month after the third dose of the primary series
  • To assess the overall safety in each group one month after the third dose of the primary series.
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
  • Hepatitis B
  • Poliomyelitis
Intervention  ICMJE
  • Biological: DTaP-IPV-HB-PRP~T vaccine
    0.5 mL, intramuscular (IM)
  • Biological: DTaP-IPV-HB-PRP~T vaccine
    0.5 mL, IM
  • Biological: DTaP-HBV-IPV vaccine
    0.5 mL, IM
    Other Name: INFANRIX®HEXA
Study Arms  ICMJE
  • Experimental: Group 1
    Participants receive vaccine Batch A
    Intervention: Biological: DTaP-IPV-HB-PRP~T vaccine
  • Experimental: Group 2
    Participants receive vaccine Batch B
    Intervention: Biological: DTaP-IPV-HB-PRP~T vaccine
  • Experimental: Group 3
    Participants receive vaccine Batch C
    Intervention: Biological: DTaP-IPV-HB-PRP~T vaccine
  • Active Comparator: Group 4
    Participants receive Infanrix hexa™
    Intervention: Biological: DTaP-HBV-IPV vaccine
Publications * Not Provided

*   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: January 11, 2010)
1189
Original Enrollment  ICMJE
 (submitted: November 28, 2006)
1190
Actual Study Completion Date  ICMJE July 2008
Actual Primary Completion Date April 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria :

  • Two 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 guardian and two independent witnesses
  • Able to attend all scheduled visits and to comply with all trial procedures
  • Received Bacillus Calmette Guerin (BCG) vaccine between birth and one month of life in agreement with the national immunization calendar.

Exclusion Criteria :

  • Participation in another clinical trial in the four weeks preceding the (first) trial vaccination
  • Planned participation in another clinical trial during the present trial period
  • Congenital or acquired immunodeficiency
  • 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 four weeks preceding the first trial visit
  • Any planned vaccination (except BCG, rotavirus, and pneumococcal conjugated vaccines) during the study
  • Documented history of pertussis, tetanus, diphtheria, poliomyelitis, Haemophilus influenzae type b or hepatitis B infection(s) (confirmed either clinically, serologically or microbiologically)
  • Previous vaccination against hepatitis B, pertussis, tetanus, diphtheria, poliovirus, or Haemophilus influenzae type b infection(s)
  • Known personal or maternal history of HIV, Hepatitis B (HBsAg) or Hepatitis C seropositivity
  • Thrombocytopenia or a bleeding disorder contraindicating intramuscular vaccination
  • History of seizures
  • Febrile (rectal equivalent temperature ≥ 38.0°C) or acute illness on the day of inclusion.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 2 Months and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Mexico
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00404651
Other Study ID Numbers  ICMJE A3L11
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 Director 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