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

Primary Purpose

Diphtheria, Tetanus, Haemophilus Influenzae Type b

Status

Completed

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

Diphtheria, Tetanus, Polio, Acellular Pertussis and Hib

Diphtheria, Tetanus, & Acellular Pertussis Combined, Absorbed

About this trial

This is an interventional prevention trial for Diphtheria focused on measuring Diphteria, Tetanus, Haemophilus influenzae type b, Poliomyelitis, Pertussis

Eligibility Criteria

60 Days - 74 Days (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

Arm Description

DTacP IPV// PRP~T combined vaccine at 2, 3 and 4 months of age, and a booster dose at 18-20 months of age.

DTacP-IPV// PRP~T combined vaccine at 3, 4 and 5 months of age and a booster dose at 18-20 months of age.

Control vaccines at 3, 4 and 5 months of age and a booster dose at 18-20 months of age

Outcomes

Primary Outcome Measures

To provide information concerning the immunogenicity of DTacP-IPV//PRP~T combined vaccine

Secondary Outcome Measures

To provide information concerning the safety of DTacP-IPV//PRP~T combined vaccine

Full Information

NCT ID

NCT00453570

First Posted

March 28, 2007

Last Updated

April 13, 2012

Sponsor

Sanofi

1. Study Identification

Unique Protocol Identification Number

NCT00453570

Brief Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2012

Overall Recruitment Status

Completed

Study Start Date

March 2007 (undefined)

Primary Completion Date

December 2008 (Actual)

Study Completion Date

January 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sanofi

4. Oversight

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diphtheria, Tetanus, Haemophilus Influenzae Type b, Pertussis, Poliomyelitis

Keywords

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

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

792 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

DTacP IPV// PRP~T combined vaccine at 2, 3 and 4 months of age, and a booster dose at 18-20 months of age.

Arm Title

Arm Type

Experimental

Arm Description

DTacP-IPV// PRP~T combined vaccine at 3, 4 and 5 months of age and a booster dose at 18-20 months of age.

Arm Title

Arm Type

Active Comparator

Arm Description

Control vaccines at 3, 4 and 5 months of age and a booster dose at 18-20 months of age

Intervention Type

Biological

Intervention Name(s)

Diphtheria, Tetanus, Polio, Acellular Pertussis and Hib

Other Intervention Name(s)

PENTAXIM™

Intervention Description

0.5 mL, IM

Intervention Type

Biological

Intervention Name(s)

Diphtheria, Tetanus, Polio, Acellular Pertussis and Hib

Other Intervention Name(s)

PENTAXIM™

Intervention Description

0.5 mL, IM

Intervention Type

Biological

Intervention Name(s)

Diphtheria, Tetanus, & Acellular Pertussis Combined, Absorbed

Other Intervention Name(s)

DTacP, Act-HIB™ and IMOVAX Polio™

Intervention Description

0.5 mL, IM

Primary Outcome Measure Information:

Title

To provide information concerning the immunogenicity of DTacP-IPV//PRP~T combined vaccine

Time Frame

1 Month post-dose 3

Secondary Outcome Measure Information:

Title

To provide information concerning the safety of DTacP-IPV//PRP~T combined vaccine

Time Frame

19 months post-dose 1

10. Eligibility

Sex

All

Minimum Age & Unit of Time

60 Days

Maximum Age & Unit of Time

74 Days

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Medical Director

Organizational Affiliation

Sanofi Pasteur Inc.

Official's Role

Study Director

Facility Information:

City

Nanning

State/Province

Guangxi

ZIP/Postal Code

530022

Country

China

12. IPD Sharing Statement

Citations:

PubMed Identifier

22001281

Citation

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.

Results Reference

derived

PubMed Identifier

21219984

Citation

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.

Results Reference

derived

Links:

URL

http://www.sanofipasteur.com

Description

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

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