Immunogenicity and Safety of Pentaxim in South African In... | NCT00254969

Studies
Immunogenicity and Safety of Pentaxim in South African Infants

NCT00254969

Sponsor

Sanofi

Status

Completed

Last Update Posted

Apr 17, 2012Estimated

Enrollment

212Actual

Phase

Phase 3

Conditions

Diphtheria
Tetanus
Haemophilus Infections
Pertussis
Poliomyelitis

Interventions

Diphtheria, Tetanus, Polio, Acellular Pertussis and Hib

Countries

South Africa

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2005

Primary Completion Date

May 2008Actual

Completion Date

Jan 2010Actual

First Submitted Date

Nov 15, 2005

First Submission Date that Met QC Criteria

Nov 15, 2005

First Posted Date

Nov 17, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 16, 2012

Last Update Posted Date

Apr 17, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The present clinical study will assess the immunogenicity and reactogenicity of Aventis Pasteur's DTacP-IPV// PRP~T combined vaccine (Pentavac™ or Pentaxim™) as a three-dose primary vaccination at 6, 10 and 14 weeks of age followed by a booster dose during the second year of life in order to meet the requirements for application for the use of the product in the Expanded Program on Immunization (EPI) in South Africa.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

212Actual

Label	Type	Description	Intervention Names
1	Experimental		Biological: Diphtheria, Tetanus, Polio, Acellular Pertussis and Hib

Name	Type	Description	Arm Group Labels	Other Names
Diphtheria, Tetanus, Polio, Acellular Pertussis and Hib	Biological	0.5 mL, Im	1

Measure	Description	Time Frame
To provide information concerning the immunogenicity of DTacP-IPV//PRP~T combined vaccine.		1 month post-vaccination

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Aged < 24 hours on the day of inclusion

Exclusion Criteria:

At visit 01 (screening)
Illness at a stage that could interfere with trial conduct or completion.
Any vaccination preceding the trial participation (except Bacille Calmette-Guerin [BCG])
Acute illness on the day of screening. At visit 01 and visit 02 (screening and first study vaccination).
Planned participation in another clinical trial during the present trial period
Blood or blood-derived products received since birth.
Mother known as seropositive to HIV or hepatitis B.
Known thrombocytopenia or a bleeding disorder contraindicating intramuscular vaccination
History of/current seizures at visit 02 (first study vaccination)
Participation in another clinical trial preceding the first trial vaccination
Congenital or acquired immunodeficiency; immunosuppressive therapy such as long-term systemic corticosteroid 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.
Any vaccination preceding the first trial vaccination (except BCG)
History of diphtheria, tetanus, pertussis, poliomyelitis, Haemophilus influenzae type b and hepatitis B infection (confirmed either clinically, serologically or microbiologically).
Previous vaccination against diphtheria, tetanus, pertussis, poliomyelitis, Haemophilus influenzae type b and hepatitis B infection with the trial vaccine or another vaccine.
Febrile illness (rectal temperature ≥ 38.0°C or axillary temperature ≥ 37.4°C) or acute illness on the day of first vaccination

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

24 Hours

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Medical Director	Sanofi Pasteur Inc.	Study Director

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
22273029	Derived	Madhi SA, Cutland C, Jones S, Groome M, Ortiz E. One-year post-primary antibody persistence and booster immune response to a DTaP-IPV//PRP~T vaccine (Pentaxim) given at 18 - 19 months of age in South African children primed at 6, 10 and 14 weeks of age with the same vaccine. S Afr Med J. 2011 Nov 28;101(12):879-83.

ID	Term
D004165	Diphtheria
D013742	Tetanus
D006192	Haemophilus Infections
D014917	Whooping Cough
D011051	Poliomyelitis

ID	Term
D003354	Corynebacterium Infections
D000193	Actinomycetales Infections
D016908	Gram-Positive Bacterial Infections
D001424	Bacterial Infections

ID	Term
D013745	Tetanus Toxoid
C426945	Pentavac

ID	Term
D014121	Toxoids
D014612	Vaccines
D001688	Biological Products
D045424	Complex Mixtures