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

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 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention

Resource links provided by NLM:

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

U.S. FDA Resources

Further study details as provided by Sanofi:

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 ]

Enrollment:	792
Study Start Date:	March 2007
Study Completion Date:	January 2009
Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 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 Other Name: PENTAXIM™
Experimental: 2 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 Other Name: PENTAXIM™
Active Comparator: 3 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 Other Name: DTacP, Act-HIB™ and IMOVAX Polio™

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

Investigators

Study Director:

Medical Director

Sanofi Pasteur Inc.

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided by Sanofi

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Li RC, Li FX, Li YP, Hou QM, Li CG, Li YN, Chen FS, Hu XZ, Su WB, Zhang SM, Fang HH, Ye Q, Zeng TD, Liu TX, Li XB, Huang YN, Deng ML, Zhang YP, Ortiz E. Antibody persistence at 18-20 months of age and safety and immunogenicity of a booster dose of a combined DTaP-IPV//PRP?T vaccine compared to separate vaccines (DTaP, PRP?T and IPV) following primary vaccination of healthy infants in the People's Republic of China. Vaccine. 2011 Nov 21;29(50):9337-44. Epub 2011 Oct 14.

Li RC, Li FX, Li YP, Hou QM, Li CG, Li YN, Chen FS, Hu XZ, Su WB, Zhang SM, Fang HH, Ye Q, Zeng TD, Liu TX, Li XB, Huang YN, Deng ML, Zhang YP, Ortiz E. Immunogenicity and safety of a pentavalent acellular pertussis combined vaccine including diphtheria, tetanus, inactivated poliovirus and conjugated Haemophilus Influenzae type b polysaccharide for primary vaccination at 2, 3, 4 or 3, 4, 5 months of age in infants in China. Vaccine. 2011 Feb 24;29(10):1913-20. Epub 2011 Jan 8.

Responsible Party:	Sanofi
ClinicalTrials.gov Identifier:	NCT00453570 History of Changes
Other Study ID Numbers:	E2I42
Study First Received:	March 28, 2007
Last Updated:	April 13, 2012
Health Authority:	China: Food and Drug Administration

Keywords provided by Sanofi:

Diphteria
Tetanus
Haemophilus influenzae type b
Poliomyelitis
Pertussis

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 June 18, 2013