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

Sponsored by:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00831311

Purpose

Primary Objective:

To demonstrate that the immune response of the DTaP-IPV-Hep B-PRP~T is comparable 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 II

MedlinePlus related topics: Diphtheria Flu Polio and Post-Polio Syndrome Tetanus Whooping Cough

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

Immunogenicity: To provide information concerning the immune response to DTaP IPV Hep B-PRP~T vaccine [ Time Frame: 30 days post vaccination 3 ] [ Designated as safety issue: No ]
Safety: To provide information concerning the safety of DTaP IPV Hep B-PRP~T vaccine [ Time Frame: 30 days after each vaccination and entire study duration ] [ Designated as safety issue: Yes ]

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
1: Experimental DTaP IPV HB-PRP~T vaccine group	Biological: DTaP-IPV-HB-PRP~T 0.5 mL, Intramuscular
2: Active Comparator 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)

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-Aventis

Investigators

Study Director:

Medical Monitor

Sanofi Pasteur Inc.

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Sanofi Pasteur Inc. ( Medical Monitor )
Study ID Numbers:	A3L02
Study First Received:	January 27, 2009
Last Updated:	January 27, 2009
ClinicalTrials.gov Identifier:	NCT00831311 History of Changes
Health Authority:	Argentina: Ministry of Health

Keywords provided by Sanofi-Aventis:

Diphtheria
Tetanus
Pertussis
Whooping cough

Hepatitis B
Poliomyelitis
Haemophilus influenzae type b

Study placed in the following topic categories:

Bacterial Infections
Spinal Cord Diseases
Whooping Cough
Orthomyxoviridae Infections
Healthy
Tetanus
Gram-Negative Bacterial Infections
Gram-Positive Bacterial Infections
Respiratory Tract Diseases
Respiratory Tract Infections
Neuromuscular Diseases
Hepatitis B
Degenerative Motor System Disease
Motor Neuron Disease

Haemophilus Influenzae
Cough
Picornaviridae Infections
Central Nervous System Diseases
Diphtheria
Hepatitis
Virus Diseases
Central Nervous System Infections
Poliomyelitis
Influenza, Human
Myelitis
Enterovirus Infections
Clostridium Infections

Additional relevant MeSH terms:

Bacterial Infections
Spinal Cord Diseases
Whooping Cough
Central Nervous System Viral Diseases
Orthomyxoviridae Infections
Infection
Tetanus
Gram-Negative Bacterial Infections
Gram-Positive Bacterial Infections
Neuromuscular Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Corynebacterium Infections
Motor Neuron Disease

RNA Virus Infections
Nervous System Diseases
Picornaviridae Infections
Central Nervous System Diseases
Diphtheria
Actinomycetales Infections
Bordetella Infections
Virus Diseases
Central Nervous System Infections
Poliomyelitis
Influenza, Human
Myelitis
Enterovirus Infections
Clostridium Infections

ClinicalTrials.gov processed this record on May 06, 2009