Immunogenicity and Safety of Pentaxim as 3 Doses Primary Vaccination Followed by a Booster Dose at 18 Months - Full Text View

Sponsored by:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00453570

Purpose

As per request by the Heath Authorities, the present clinical study will assess the immunogenicity and safety of sanofi pasteur's DTacP-IPV// PRP~T combined vaccine (PENTAXIM™) as a three-dose primary vaccination at 2, 3, and 4 months of age or 3, 4 and 5 months of age followed by a booster dose at 18-20 months of age as compared to commercially available DTacP, Hib conjugate (Act-HIB™) and IPV (IMOVAX Polio™) monovalent vaccines in order to meet the requirements for registration of the product in People's Republic of China.

Condition	Intervention	Phase
Diphtheria Tetanus Haemophilus Influenzae Type B Pertussis Poliomyelitis	Biological: Diphtheria, Tetanus, Polio, Acellular Pertussis and Hib Biological: Diphtheria, Tetanus, & Acellular Pertussis Combined, Absorbed	Phase III

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

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

To provide information concerning the immunogenicity of DTacP-IPV//PRP~T combined vaccine [ Time Frame: 1 Month post-dose 3 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To provide information concerning the safety of DTacP-IPV//PRP~T combined vaccine [ Time Frame: 19 months post-dose 1 ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	795
Study Start Date:	March 2007
Estimated Study Completion Date:	June 2009
Estimated Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental DTacP IPV// PRP~T combined vaccine at 2, 3 and 4 months of age, and a booster dose at 18-20 months of age.	Biological: Diphtheria, Tetanus, Polio, Acellular Pertussis and Hib 0.5 mL, IM
2: Experimental DTacP-IPV// PRP~T combined vaccine at 3, 4 and 5 months of age and a booster dose at 18-20 months of age.	Biological: Diphtheria, Tetanus, Polio, Acellular Pertussis and Hib 0.5 mL, IM
3: Active Comparator Control vaccines at 3, 4 and 5 months of age and a booster dose at 18-20 months of age	Biological: Diphtheria, Tetanus, & Acellular Pertussis Combined, Absorbed 0.5 mL, IM

Eligibility

Ages Eligible for Study:	60 Days to 74 Days
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria :

Aged 2 months (60 to 74 days) inclusive on the day of inclusion
Born at full term pregnancy (³36 weeks) with a birth weight ≥ 2.5 kg
Informed consent form signed by the parent(s) or other legal representative
Able to attend all scheduled visits and to comply with all trial procedures

Exclusion Criteria :

Participation in another clinical trial in the 4 weeks preceding the trial inclusion
Planned participation in another clinical trial during the present trial period
Congenital or acquired immunodeficiency, immunosuppressive therapy such as long-term systemic corticosteroids therapy
Systemic hypersensitivity to any of the vaccine components or history of a life threatening reaction to the trial vaccine or 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 past
Any vaccination performed or planned in the 4 weeks preceding the first trial visit (except BCG and Hepatitis B, which can not be given within 8 days before the first study visit)
Vaccination planned in the 4 weeks following any trial vaccination (except BCG and Hepatitis B, which can not be given within 8 days before or after the study vaccine(s) administration)
History of diphtheria, tetanus, pertussis, poliomyelitis, Haemophilus influenzae type b infection (confirmed either clinically, serologically or microbiologically)
Clinical or serological evidence of systemic illness including Hepatitis B, Hepatitis C and/or HIV infection
Previous vaccination against the diphtheria, tetanus, pertussis, poliomyelitis diseases or Haemophilus influenzae type b infection with the trial vaccine or another vaccine
Thrombocytopenia or a bleeding disorder contraindicating intramuscular vaccination
History of/current seizures
Febrile illness (axillary temperature ≥ 37.1°C) or acute illness on the day of inclusion

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00453570

Locations

China, Guangxi

Nanning, Guangxi, China, 530022

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Study Director:

Clinical Trials

sanofi pasteur

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Sanofi Pasteur Inc. ( Medical Director )
Study ID Numbers:	E2I42
Study First Received:	March 28, 2007
Last Updated:	May 12, 2008
ClinicalTrials.gov Identifier:	NCT00453570 History of Changes
Health Authority:	China: State Food and Drug Administration

Keywords provided by Sanofi-Aventis:

Diphteria
Tetanus
Haemophilus influenzae type b
Poliomyelitis
Pertussis

Study placed in the following topic categories:

Bacterial Infections
Spinal Cord Diseases
Haemophilus Influenzae
Central Nervous System Diseases
Picornaviridae Infections
Whooping Cough
Cough
Diphtheria
Orthomyxoviridae Infections
Tetanus
Gram-Negative Bacterial Infections
Virus Diseases

Gram-Positive Bacterial Infections
Neuromuscular Diseases
Central Nervous System Infections
Respiratory Tract Infections
Respiratory Tract Diseases
Poliomyelitis
Influenza, Human
Myelitis
Enterovirus Infections
Clostridium Infections
Degenerative Motor System Disease
Motor Neuron Disease

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 07, 2009