Immunogenicity and Safety of Pentaxim as 3 Doses Primary Vaccination Followed by a Booster Dose at 18 Months
1 other identifier
interventional
792
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Mar 2007
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2007
CompletedFirst Submitted
Initial submission to the registry
March 28, 2007
CompletedFirst Posted
Study publicly available on registry
March 29, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2009
CompletedApril 17, 2012
April 1, 2012
1.8 years
March 28, 2007
April 13, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To provide information concerning the immunogenicity of DTacP-IPV//PRP~T combined vaccine
1 Month post-dose 3
Secondary Outcomes (1)
To provide information concerning the safety of DTacP-IPV//PRP~T combined vaccine
19 months post-dose 1
Study Arms (3)
1
EXPERIMENTALDTacP IPV// PRP\~T combined vaccine at 2, 3 and 4 months of age, and a booster dose at 18-20 months of age.
2
EXPERIMENTALDTacP-IPV// PRP\~T combined vaccine at 3, 4 and 5 months of age and a booster dose at 18-20 months of age.
3
ACTIVE COMPARATORControl vaccines at 3, 4 and 5 months of age and a booster dose at 18-20 months of age
Interventions
0.5 mL, IM
0.5 mL, IM
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sanofilead
Study Sites (1)
Unknown Facility
Nanning, Guangxi, 530022, China
Related Publications (2)
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.
PMID: 22001281DERIVEDLi 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.
PMID: 21219984DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Director
Sanofi Pasteur Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 28, 2007
First Posted
March 29, 2007
Study Start
March 1, 2007
Primary Completion
December 1, 2008
Study Completion
January 1, 2009
Last Updated
April 17, 2012
Record last verified: 2012-04