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

Sponsored by:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00303316

Purpose

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	Intervention	Phase
Diphtheria Tetanus Pertussis Poliomyelitis Hepatitis B	Biological: DTaP-IPV-HB-PRP~T combined vaccine Biological: DTaP-IPV//PRP~T combined vaccine	Phase III

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

Drug Information available for: Hepatitis B Vaccines Immunoglobulins Globulin, Immune

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

To provide information concerning the immune response of DTaP-IPV-HB-PRP~T vaccine. [ Time Frame: 30 days post-vaccination ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To provide information concerning the safety after administration of PENTAXIM™ Vaccine booster dose. [ Time Frame: 30 days post-vaccination ] [ Designated as safety issue: Yes ]

Enrollment:	459
Study Start Date:	February 2006
Study Completion Date:	September 2007
Primary Completion Date:	April 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Biological: DTaP-IPV-HB-PRP~T combined vaccine 0.5 mL, IM
2: Active Comparator Received ENGERIX B® PEDIATRICO in Study A3L02	Biological: DTaP-IPV//PRP~T combined vaccine 0.5 mL, IM

Eligibility

Ages Eligible for Study:	510 Days to 578 Days
Genders Eligible for Study:	Both
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 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00303316

Locations

Argentina, Provincia de Córdoba

Cordoba, Provincia de Córdoba, Argentina, 5000

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Study Director:

Clinical Trials

sanofi pasteur

More Information

Related Info This link exits the ClinicalTrials.gov site

Responsible Party:	Sanofi Pasteur Inc ( Medical Monitor )
Study ID Numbers:	A3L16
Study First Received:	March 13, 2006
Last Updated:	May 9, 2008
ClinicalTrials.gov Identifier:	NCT00303316
Health Authority:	Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica

Keywords provided by Sanofi-Aventis:

Diphtheria
Tetanus
Pertussis
whooping cough

Haemophilus influenzae type b
Hepatitis B
Poliomyelitis

Study placed in the following topic categories:

Bacterial Infections
Liver Diseases
Spinal Cord Diseases
Whooping Cough
Hepatitis, Viral, Human
Healthy
Tetanus
Whooping cough
Gram-Negative Bacterial Infections
Gram-Positive Bacterial Infections
Neuromuscular Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Hepatitis B
Motor Neuron Disease

Immunoglobulins
Haemophilus influenzae
Cough
Picornaviridae Infections
Central Nervous System Diseases
Degenerative motor system disease
Diphtheria
Motor neuron disease
Hepatitis
Virus Diseases
Antibodies
Digestive System Diseases
Central Nervous System Infections
Poliomyelitis
Influenza, Human

Additional relevant MeSH terms:

Bordetella Infections
RNA Virus Infections
Corynebacterium Infections
Nervous System Diseases

Central Nervous System Viral Diseases
Infection
Hepadnaviridae Infections
Actinomycetales Infections

ClinicalTrials.gov processed this record on January 16, 2009