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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT00831311
First received: January 27, 2009
Last updated: November 21, 2013
Last verified: November 2013
  Purpose

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 Intervention 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 Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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) ] [ Designated as safety issue: No ]

    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.


  • 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) ] [ Designated as safety issue: No ]
    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).

  • 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) ] [ Designated as safety issue: No ]
    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:
  • 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 ] [ Designated as safety issue: No ]
    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

  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]

    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.



Enrollment: 624
Study Start Date: October 2004
Study Completion Date: March 2007
Primary Completion Date: November 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   50 Days to 70 Days
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00831311

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

Additional Information:
Publications:
Responsible Party: Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT00831311     History of Changes
Other Study ID Numbers: A3L02
Study First Received: January 27, 2009
Results First Received: September 19, 2013
Last Updated: November 21, 2013
Health Authority: Argentina: Ministry of Health

Keywords provided by Sanofi:
Diphtheria
Tetanus
Pertussis
Whooping cough
Hepatitis B
Poliomyelitis
Haemophilus influenzae type b

Additional relevant MeSH terms:
Diphtheria
Influenza, Human
Whooping Cough
Poliomyelitis
Tetanus
Tetany
Corynebacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Bordetella Infections
Gram-Negative Bacterial Infections
Infection
Myelitis
Central Nervous System Viral Diseases
Enterovirus Infections
Picornaviridae Infections
Central Nervous System Infections
Central Nervous System Diseases
Nervous System Diseases
Spinal Cord Diseases
Neuromuscular Diseases
Clostridium Infections
Neuromuscular Manifestations
Neurologic Manifestations

ClinicalTrials.gov processed this record on April 15, 2014