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Study of DTaP-IPV-Hep B-PRP~T Combined Vaccine Compared With PENTAXIM™ and ENGERIX B® PEDIATRICO in Argentinean Infants

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ClinicalTrials.gov Identifier: NCT00831311
Recruitment Status : Completed
First Posted : January 28, 2009
Results First Posted : November 21, 2013
Last Update Posted : December 17, 2013
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

Study Description
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Brief Summary:

Primary Objective:

  • To demonstrate that the immune response of the DTaP-IPV-Hep B-PRP~T is non-inferior for all valences to those of the association of PENTAXIM™ and ENGERIX B® PEDIATRICO one month after a three-dose primary series.

Secondary Objectives:

  • To describe in each group the immunogenicity parameters one month after the three-dose primary series.
  • To describe safety profile after each vaccination in both groups.

Condition or disease Intervention/treatment Phase
Diphtheria Tetanus Pertussis Haemophilus Influenzae Type b Poliomyelitis Biological: DTaP-IPV-HB-PRP~T Biological: DTaP-IPV//PRP~T combined vaccine & Recombinant hep B vaccine Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 624 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Phase-II Immunogenicity Study of a DTaP-IPV-Hep B-PRP~T Combined Vaccine Compared With PENTAXIM™ and ENGERIX B® PEDIATRICO at 2, 4, and 6 Months of Age in Healthy Argentinean Infants
Study Start Date : October 2004
Actual Primary Completion Date : November 2005
Actual Study Completion Date : March 2007

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Arms and Interventions
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Arm Intervention/treatment
Experimental: 1
DTaP IPV HB-PRP~T vaccine group
 Biological: DTaP-IPV-HB-PRP~T
0.5 mL, Intramuscular
Active Comparator: 2
PENTAXIM™ and ENGERIX B® vaccines group
 Biological: DTaP-IPV//PRP~T combined vaccine & Recombinant hep B vaccine
0.5 mL, Intramuscular (right and left thighs, respectively)
Other Names:
  • PENTAXIM™
  • ENGERIX B® PEDIATRICO


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Participants With Seroconversion for Anti-pertussis Toxoid and Anti-filamentous Hemagglutinin Antibodies Post-vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B® [ Time Frame: 1 month post last vaccination ]
    Seroconversion was assessed by means of enzyme immunoassay (EIA) for anti-pertussis toxoid (PT) and anti-filamentous hemagglutinin (FHA) antibodies. Seroconversion was defined as ≥ 4 fold increase in antibody titers from Day 0 to 30 days after the third vaccination.

  2. Percentage of Participants With Seroprotection for Anti-Hepatitis B, Anti-Polyribosyl Ribitol Phosphate (PRP), Anti-Tetanus, Anti-Diphtheria, and Anti-Polio Antibodies After Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B® [ Time Frame: Day 150 (1 month post-vaccination 3) ]

    Immunogenicity was assessed by radioimmunoassay (RIA) for anti-hepatitis B (HBs) and anti-PRP antibodies, enzyme immunoassay (EIA) for anti-tetanus, serum neutralization (SN) for anti-diphtheria, and microneutralization for anti-polio type 1, 2, and 3 antibodies.

    Seroprotection was defined as titers ≥ 10 mIU/mL for anti-Hepatitis Bs, ≥ 0.15 μg/mL for anti-PRP, ≥ 0.01 IU/mL for anti-tetanus and anti-diphtheria, and ≥ 8 1/dil for anti-polio types 1, 2, and 3 at 30 days after the third vaccination.


  3. Geometric Mean Titers of Anti-Tetanus Before and Post-vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B® [ Time Frame: Day 150 (1 month post-vaccination 3) ]
    Geometric mean titers to Tetanus antigen was assessed by means of enzyme immunoassay (EIA) before the first vaccination (at Day 0) and 1 month after the third vaccination (Day 150).

  4. Geometric Mean Titers of Anti-Polio Types 1, 2, and 3 Antibodies Before and Post-vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B® [ Time Frame: Day 150 (1 month post-vaccination 3) ]
    Geometric mean titers to the Polio Antigens were assessed by means of microneutralization assay for anti-polio types 1, 2, and 3 before the first vaccination (at Day 0) and 1 month post-vaccination 3 (Day 150).


Secondary Outcome Measures :
  1. Number of Participants Reporting At Least One Solicited Injection Site Reaction Following Each Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ [ Time Frame: Day 0 up to Day 7 post-vaccination ]
    Solicited injection site reactions - erythema, edema, induration, and pain were assessed in each participant at the DTaP-IPV-Hep B-PRP~T and PENTAXIM™ injection sites

  2. Number of Participants Reporting At Least One Solicited Injection Site Reaction Following Each Vaccination With Either DTaP-IPV-Hep B-PRP~T or ENGERIX B® [ Time Frame: Day 0 up to Day 7 post-vaccination ]
    Solicited injection site reactions - erythema, edema, induration, and pain were assessed in each participant at the DTaP-IPV-Hep B-PRP~T and ENGERIX B® injection sites.

  3. Number of Participants Reporting At Least One Solicited Systemic Reaction Following Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B® [ Time Frame: Day 0 up to Day 7 post-vaccination ]

    Solicited systemic reactions: Pyrexia (temperature), Somnolence, Irritability, Anorexia, Vomiting not otherwise specified (NOS), Diarrhea NOS, and Crying were assessed in each participant following vaccination.

    Grade 3 reactions defined as: Pyrexia (temperature), ≥ 39.1°C; Somnolence, sleeping most of the time; Irritability, continuously irritable for ≥ 3 hours; Anorexia, refused most or all feeds; Vomiting NOS, frequent vomiting and inability to have any oral intake; Diarrhea NOS, multiple liquid stools without any solid material; and Crying, persistent, inconsolable cry ≥ 3 hours and/or high-pitched cry.



Eligibility Criteria
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Ages Eligible for Study:   50 Days to 70 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria :

  • Infant of either gender, aged 50 to 70 days inclusive
  • Mother is negative for HBsAg
  • Born at full term of pregnancy (≥37 weeks) and with a birth weight ≥2.5 kg
  • Written informed consent form signed by at least one parent or by another legal representative and an independent witness
  • Parent/legal representative able to attend scheduled visits and to comply with the trial procedures during the entire duration of the trial.

Exclusion Criteria :

  • Axillary temperature ≥37.1°C on the day of inclusion
  • Current or planned enrolment in another clinical trial during the clinical trial period
  • Known mother's history of Human Immunodeficiency Virus (HIV) infection
  • Known immunodeficiency (congenital or acquired) or induced by immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy since birth, or systemic corticosteroids in the last 4 weeks (≥0.5 mg per kilogram and per day equivalent prednisolone and lasting more than 7 days)
  • Receipt of blood-derived products since birth
  • Acute symptoms or severe chronic illness (e.g. cardiac, renal insufficiency, diabetes, auto immune disorders, congenital defect) that may interfere with conduct or completion of trial
  • Occurrence of seizures since birth
  • Hypersensitivity to any of the vaccine components
  • Coagulopathy contraindicating intramuscular injection
  • History of (documented) clinical or serological/microbiological confirmed infection due to pertussis, tetanus, diphtheria, polio, Haemophilus influenzae type b (Hib) or hepatitis B (HB) diseases
  • History of vaccination against pertussis, tetanus, diphtheria, polio, Hib or HB infections
  • Vaccination within the last 4 weeks.
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): NCT00831311


Locations
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Argentina
Córdoba, Argentina
Sponsors and Collaborators
Sanofi Pasteur, a Sanofi Company
Investigators
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Study Director: Medical Monitor Sanofi Pasteur Inc.
More Information
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Additional Information:

Publications of Results:

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Responsible Party: Sanofi Pasteur, a Sanofi Company
ClinicalTrials.gov Identifier: NCT00831311    
Other Study ID Numbers: A3L02
First Posted: January 28, 2009    Key Record Dates
Results First Posted: November 21, 2013
Last Update Posted: December 17, 2013
Last Verified: November 2013
Keywords provided by Sanofi ( Sanofi Pasteur, a Sanofi Company ):
Diphtheria
Tetanus
Pertussis
Whooping cough
 Hepatitis B
Poliomyelitis
Haemophilus influenzae type b
Additional relevant MeSH terms:
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Whooping Cough
Tetanus
Diphtheria
Poliomyelitis
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Bordetella Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Infection
Clostridium Infections
Gram-Positive Bacterial Infections
 Nervous System Diseases
Corynebacterium Infections
Actinomycetales Infections
Enterovirus Infections
Picornaviridae Infections
Myelitis
Central Nervous System Infections
Central Nervous System Diseases
Spinal Cord Diseases
Neuromuscular Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs