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Immunogenicity Study of Antibody Persistence and Booster Effect of PENTAXIM™ at 18 Months in Healthy Argentinean Infants

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ClinicalTrials.gov Identifier: NCT00303316
Recruitment Status : Completed
First Posted : March 16, 2006
Results First Posted : February 22, 2013
Last Update Posted : February 22, 2013
Sponsor:
Information provided by (Responsible Party):
Sanofi

Tracking Information
First Submitted Date  ICMJE March 13, 2006
First Posted Date  ICMJE March 16, 2006
Results First Submitted Date  ICMJE December 11, 2012
Results First Posted Date  ICMJE February 22, 2013
Last Update Posted Date February 22, 2013
Study Start Date  ICMJE February 2006
Actual Primary Completion Date April 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 18, 2013)
  • Summary of Antibody Persistence at 18 Months of Age in Participants That Received Primary Series Vaccination of Either DTaP-IPV-HepB-PRP~T or PENTAXIM™ and ENGERIX B® PEDIATRICO at 2, 4, and 6 Months of Age. [ Time Frame: Day 0 (Before booster vaccination) ]
    Antibody persistence (pre-booster) were defined as titers ≥ 10 mIU/mL for hepatitis B (Hep B;); ≥ 0.15 µg/mL for Haemophilus influenzae type b (PRP); ≥ 0.01 IU/mL for Diphtheria and Tetanus; ≥ 8 (1/dil) for polio types 1, 2, and 3; and ≥ 4 EU/mL for Pertussis Toxoid (PT) and Filamentous Hemagglutinin (FHA).
  • Summary of Booster Response in Participants at 18 Months of Age Following Booster Vaccination With PENTAXIM™ Following a Primary Series Vaccination of Either DTaP-IPV-HepB-PRP~T or PENTAXIM™ and ENGERIX B® PEDIATRICO at 2, 4, and 6 Months of Age. [ Time Frame: Day 30 Post-booster Vaccination ]
    Booster response were defined as titers ≥ 1.0 µg/mL for Haemophilus influenzae type b (PRP); ≥ 0.1 IU/mL for Diphtheria and Tetanus; ≥ 8 (1/dil) for Polio types 1, 2, and 3; and for Pertussis Toxoid (PT) and Filamentous Hemagglutinin (FHA) ≥ 4 EU/mL and a ≥ 4 fold increase from pre-booster to post-booster value.
  • Geometric Mean Titers (GMTs) of Antibodies Before and After Booster Vaccination With PENTAXIM™ Following a Primary Series Vaccination of Either DTaP-IPV-HepB-PRP~T or PENTAXIM™ and ENGERIX B® PEDIATRICO at 2, 4, and 6 Months of Age. [ Time Frame: Day 0 (pre-booster) and Day 30 post-booster ]
    Antibody titers determination: Hepatitis B (Hep B) by enhanced chemiluminescence assay; Haemophilus influenzae type b (PRP), Tetanus, Pertussis toxoid (PT) and filamentous hemagglutinin (FHA) by enzyme linked immunosorbent assay (ELISA); Diphtheria by neutralization test; Poliovirus types 1,2, and 3 by microneutralization assay.
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00303316 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 18, 2013)
Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Post-booster Vaccination With PENTAXIM™ [ Time Frame: Day 0 up to Day 30 post-booster vaccination ]
Solicited Injection Site Reactions: Pain, Erythema, Swelling. Solicited Systemic Reactions: Pyrexia (Temperature), Vomiting, Crying, Somnolence, Anorexia, Irritability. Grade 3 was defined as: Pain, cries when injected limb is moved or movement of limb is reduced; Erythema and Swelling, ≥ 5 cm; Pyrexia, ≥ 39.6ºC; Vomiting, ≥ 6 episodes/24 hour or requiring parenteral hydration; Crying, > 3 hours; Somnolence, sleeping most of the time or difficulty to wake up; Anorexia, refuses ≥ 3 feeds/meals or refuses most feeds/meals; and 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 Immunogenicity Study of Antibody Persistence and Booster Effect of PENTAXIM™ at 18 Months in Healthy Argentinean Infants
Official Title  ICMJE Immunogenicity Study of the Antibody Persistence and Booster Effect of PENTAXIM™ at 18 Months of Age Following a Primary Series of DTaP-IPV-HB-PRP~T Combined Vaccine or of PENTAXIM™ and ENGERIX B® PEDIATRICO at 2, 4, and 6 Months of Age in Healthy Argentinean Infants
Brief Summary

This study will assess both the antibody persistence of the investigational vaccine and the immune response and safety of a booster dose of PENTAXIM™ vaccine in 18 months-old toddlers who participated in an earlier study in order to determine if they are still protected before they receive a booster dose of D, T, IPV, pertussis or Hib vaccines and also to assess the quality of the induced immune memory in response to a booster dose of the same vaccine as in the primary series.

Primary Objective:

To describe the antibody persistence at 18 months of age and the booster effect of a dose of PENTAXIM™ on immunogenicity.

Secondary objective:

To describe the safety profile of the booster dose PENTAXIM™ in each vaccine group defined by the vaccines received during the primary series.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Diphtheria
  • Tetanus
  • Pertussis
  • Poliomyelitis
  • Hepatitis B
Intervention  ICMJE Biological: DTaP-IPV//PRP~T combined vaccine
0.5 mL, Intramuscular
Other Name: PENTAXIM™
Study Arms  ICMJE
  • Experimental: DTacP IPV HepB PRP-T Combined Vaccine Group
    Participant will receive a booster dose of PENTAXIM™ having received DTacP-IPV-HepB-PRP-T (primary series) in Study A3L02.
    Intervention: Biological: DTaP-IPV//PRP~T combined vaccine
  • Active Comparator: PENTAXIM™ and ENGERIX B® Vaccine Group
    Participant will receive a booster dose of PENTAXIM™ having received ENGERIX B® and PEDIATRICO in Study A3L02 (Primary series)
    Intervention: Biological: DTaP-IPV//PRP~T combined vaccine
Publications * Tregnaghi M, Zambrano B, Santos-Lima E. Antibody persistence after a primary series of a new DTaP-IPV-Hep B-PRP-T combined vaccine or separate DTaP-IPV//PRP-T and hepatitis B vaccines at 2, 4, and 6 months of age and the effect of a subsequent DTaP-IPV//PRP-T booster vaccination at 18 months of age in healthy Argentinean infants. Pediatr Infect Dis J. 2012 Jan;31(1):e24-30. doi: 10.1097/INF.0b013e318242460a.

*   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 18, 2013)
458
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE September 2007
Actual Primary Completion Date April 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Toddler at 18 months of age (range: 510 days to 578 days of age inclusive)
  • Participated in study A3L02 (NCT00831311) and has completed the three-dose primary series with either diphtheria, tetanus, pertussis (2-component acellular), recombinant Hepatitis B Hansenula and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b vaccine, conjugated to tetanus protein (DTaP-IPV-HB-PRP~T) or PENTAXIM™ and ENGERIX B® PEDIATRICO at 2, 4, and 6 months of age
  • Written informed consent form signed by at least one parent or by a legal representative and an independent witness
  • Able to attend all scheduled visits and to comply with all trial procedures.

Exclusion Criteria:

  • Participation in another clinical trial in the four weeks preceding the trial vaccination
  • Planned participation in another clinical trial during the present trial period
  • Congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months or long-term systemic corticosteroids 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 in the last six months
  • Any vaccination in the four weeks preceding the trial
  • Vaccination with a vaccine containing diphtheria, tetanus, pertussis, Haemophilus influenzae type b, polio, or hepatitis B antigen, since the end of the primary series
  • History of documented diphtheria, tetanus, pertussis, Haemophilus influenzae type b, polio, or hepatitis B infection(s) (confirmed either clinically, serologically, or microbiologically)
  • Thrombocytopenia or bleeding disorder contraindicating intramuscular vaccination
  • History of seizures
  • Fever (axillary temperature ≥37.4°C or equivalent rectal temperature ≥38.0°C) or acute illness on the day of inclusion
  • Known contraindication to further vaccination with a pertussis vaccine such as:
  • Encephalopathy; Inconsolable crying for >3 hours within 48 hours following vaccine injection
  • Hypotonic hyporesponsive episode within 48 hours following vaccine injection
  • Seizures with or without fever within three days following vaccine injection
  • Axillary temperature >39.4°C or equivalent rectal temperature > 40.0°C within 48 hours following vaccine injection.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 510 Days to 578 Days   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00303316
Other Study ID Numbers  ICMJE A3L16
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sanofi
Study Sponsor  ICMJE Sanofi
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Trials Sanofi Pasteur, a Sanofi Company
PRS Account Sanofi
Verification Date January 2013

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