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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

Study Description
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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.


Condition or disease Intervention/treatment Phase
Diphtheria Tetanus Pertussis Poliomyelitis Hepatitis B Biological: DTaP-IPV//PRP~T combined vaccine Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 458 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: 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
Study Start Date : February 2006
Actual Primary Completion Date : April 2007
Actual Study Completion Date : September 2007

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Arms and Interventions
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Arm Intervention/treatment
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.
 Biological: DTaP-IPV//PRP~T combined vaccine
0.5 mL, Intramuscular
Other Name: PENTAXIM™
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)
 Biological: DTaP-IPV//PRP~T combined vaccine
0.5 mL, Intramuscular
Other Name: PENTAXIM™


Outcome Measures
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Primary Outcome Measures :
  1. 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).

  2. 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.

  3. 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.



Secondary Outcome Measures :
  1. 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.



Eligibility Criteria
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Ages Eligible for Study:   510 Days to 578 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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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): NCT00303316


Locations
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Argentina
Cordoba, Provincia de Córdoba, Argentina, 5000
Sponsors and Collaborators
Sanofi
Investigators
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Study Director: Clinical Trials Sanofi Pasteur, a Sanofi Company
More Information
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Additional Information:

Publications of Results:

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Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT00303316    
Other Study ID Numbers: A3L16
First Posted: March 16, 2006    Key Record Dates
Results First Posted: February 22, 2013
Last Update Posted: February 22, 2013
Last Verified: January 2013
Keywords provided by Sanofi:
Diphtheria
Tetanus
Pertussis
whooping cough
 Haemophilus influenzae type b
Hepatitis B
Poliomyelitis
Additional relevant MeSH terms:
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Whooping Cough
Tetanus
Diphtheria
Hepatitis B
Poliomyelitis
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
 Bordetella Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Respiratory Tract Infections
Infection
Respiratory Tract Diseases
Clostridium Infections
Gram-Positive Bacterial Infections
Nervous System Diseases
Corynebacterium Infections
Actinomycetales Infections
Myelitis
Central Nervous System Infections
Central Nervous System Diseases
Spinal Cord Diseases