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

• ClinicalTrials.gov Identifier: NCT00453570
• Recruitment Status: Completed
• First Posted: March 29, 2007
• Last Update Posted: April 17, 2012
• Sponsor: Sanofi
• Information provided by (Responsible Party): Sanofi

Study Description

Brief Summary:

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 or disease	Intervention/treatment	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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 792 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Study Start Date: March 2007
• Actual Primary Completion Date: December 2008
• Actual Study Completion Date: January 2009

Arms and Interventions

Arm	Intervention/treatment
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™

Outcome Measures

Primary Outcome Measures :

1. To provide information concerning the immunogenicity of DTacP-IPV//PRP~T combined vaccine [ Time Frame: 1 Month post-dose 3 ]

Secondary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 60 Days to 74 Days (Child)
• Sexes Eligible for Study: All
• 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

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 

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 approximately T vaccine compared to separate vaccines (DTaP, PRP approximately T and IPV) following primary vaccination of healthy infants in the People's Republic of China. Vaccine. 2011 Nov 21;29(50):9337-44. doi: 10.1016/j.vaccine.2011.09.131. 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. doi: 10.1016/j.vaccine.2010.12.103. Epub 2011 Jan 8.

• Responsible Party: Sanofi
• ClinicalTrials.gov Identifier: NCT00453570
• Other Study ID Numbers: E2I42
• First Posted: March 29, 2007
• Last Update Posted: April 17, 2012
• Last Verified: April 2012

Keywords provided by Sanofi:

Diphteria; Tetanus; Haemophilus influenzae type b; Poliomyelitis; Pertussis

Additional relevant MeSH terms:

Whooping Cough; Tetanus; Diphtheria; Poliomyelitis; Respiratory Tract Infections; Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Bordetella Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Clostridium Infections; Gram-Positive Bacterial Infections; Nervous System Diseases; Corynebacterium Infections; Actinomycetales Infections; Myelitis; Central Nervous System Infections; Enterovirus Infections; Picornaviridae Infections; Central Nervous System Diseases; Spinal Cord Diseases; Neuromuscular Diseases