Study of DTaP-IPV-Hep B-PRP~T Combined Vaccine Compared to Infanrix®Hexa in Healthy Peruvian Infants - Full Text View

Sponsored by:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00831753

Purpose

The study aims to confirm that, in Peruvian infants, the investigational DTaP-IPV Hep B-PRP~T vaccine has immunological and safety profiles that are comparable to those of the control vaccine that is already marketed (Infanrix®Hexa)

Primary Objective:

To demonstrate that the hexavalent DTaP-IPV-Hep B-PRP~T combined vaccine induces an immune response that is at least as good as the response following Infanrix®Hexa in terms of seroprotection rates to HB, one month after a three-dose primary series (2, 4 and 6 months)

Secondary Objectives:

To describe in each group the immunogenicity to vaccine components (for DTaP-IPV-Hep B-PRP~T and Infanrix®Hexa) one month after the third dose of the primary series.
To assess the overall safety in each group one month after each dose of the primary series and through the entire study.

Condition	Intervention	Phase
Diphtheria Tetanus Pertussis Haemophilus Influenzae Type B Hepatitis B	Biological: DTaP IPV HB PRP~T vaccine Biological: DTaP-HB-IPV and Haemophilus influenzae type b	Phase III

MedlinePlus related topics: Diphtheria Flu Hepatitis Hepatitis B Tetanus Whooping Cough

Drug Information available for: Infanrix hexa

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Immunogenicity Study of DTaP-IPV-Hep B-PRP~T Combined Vaccine in Comparison to Infanrix®Hexa, at 2-4-6 Months of Age in Healthy Peruvian Infants

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

To provide information concerning the immunogenicity of DTaP-IPV-Hep B-PRP~T vaccine. [ Time Frame: 30 days post-vaccination 3 ] [ Designated as safety issue: No ]
To provide information concerning the safety of DTaP-IPV-Hep B-PRP~T vaccine. [ Time Frame: 30 days follwing each vaccination and entire study duration ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	266
Study Start Date:	May 2008
Estimated Study Completion Date:	November 2009
Estimated Primary Completion Date:	November 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental DTaP-IPV-Hep B-PRP~T vaccine group	Biological: DTaP IPV HB PRP~T vaccine 0.5 mL, Intramuscular
2: Active Comparator Infanrix® Hexa vaccine group	Biological: DTaP-HB-IPV and Haemophilus influenzae type b 0.5 mL, Intramuscular

Detailed Description:

The present trial will involve two-month old Peruvian infants, randomly assigned to receive three doses of either the investigational or the control vaccine at 2, 4, and 6 months of age.

Eligibility

Ages Eligible for Study:	50 Days to 71 Days
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria :

Two month old infant (50 to 71 days old) on the day of inclusion, of either gender
Born at full term of pregnancy (>=37 weeks) and with a birth weight >=2.5 kg
Mother negative for Hepatitis B surface Antigen (HBsAg) in approximately the last 30 days of pregnancy (>=36 weeks of amenorrhea) or in the 30 days post partum
Informed consent form signed by both parents. If one or both parent(s) are under 18 years of age, the subject's grandparent(s) should also sign. An independent witness should also sign if the parent(s)/grandparent(s) are illiterate
Able to attend all scheduled visits and to comply with all trial procedures
Received BCG vaccine between birth and one month of life in agreement with the national immunization calendar.

Exclusion Criteria :

Participation in another clinical trial in the 4 weeks preceding the first trial vaccination
Planned participation in another clinical trial during the present trial period
Known 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
Congenital or acquired immunodeficiency, or immunosuppressive therapy such as long-term (for more than 2 weeks) systemic corticosteroid therapy within the last four weeks
Chronic illness at a stage that could interfere with trial conduct or completion
Blood or blood-derived products received since birth
Any vaccination in the 4 weeks preceding the first trial vaccination
Any planned vaccination during the trial (until V06), except the study vaccines, rotavirus vaccine and pneumococcal conjugate vaccines
Documented history of pertussis, tetanus, diphtheria, poliomyelitis, hepatitis B or Haemophilus influenzae type b infection(s) (confirmed either clinically, serologically, or microbiologically)
Previous vaccination against pertussis, tetanus, diphtheria, poliomyelitis, hepatitis B or Haemophilus influenzae type b infection(s)
Known personal or maternal history of Human Immunodeficiency Virus, hepatitis B or hepatitis C seropositivity
Known thrombocytopenia or bleeding disorder contraindicating IM vaccination
History of seizures
Febrile (temperature >=38.0°C) or acute illness on the day of inclusion.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00831753

Locations

Peru

Lima, Peru

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Study Director:

Medical Monitor

Sanofi Pasteur Inc.

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Sanofi Pasteur Inc. ( Medical Monitor )
Study ID Numbers:	A3L17
Study First Received:	January 27, 2009
Last Updated:	January 27, 2009
ClinicalTrials.gov Identifier:	NCT00831753 History of Changes
Health Authority:	Peru: General Directorate of Pharmaceuticals, Devices, and Drugs

Keywords provided by Sanofi-Aventis:

Diphtheria
Tetanus
Pertussis
whooping cough

Haemophilus influenzae type b
Hepatitis B
Poliomyelitis

Study placed in the following topic categories:

Bacterial Infections
Liver Diseases
Haemophilus Influenzae
Hepatitis, Viral, Human
Whooping Cough
Cough
Healthy
Orthomyxoviridae Infections
Diphtheria
Tetanus
Gram-Negative Bacterial Infections

Virus Diseases
Hepatitis
Gram-Positive Bacterial Infections
Digestive System Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Poliomyelitis
Hepatitis B
Influenza, Human
DNA Virus Infections
Clostridium Infections

Additional relevant MeSH terms:

Bacterial Infections
RNA Virus Infections
Liver Diseases
Hepatitis, Viral, Human
Whooping Cough
Orthomyxoviridae Infections
Diphtheria
Tetanus
Infection
Hepadnaviridae Infections
Actinomycetales Infections
Gram-Negative Bacterial Infections

Virus Diseases
Hepatitis
Bordetella Infections
Gram-Positive Bacterial Infections
Digestive System Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Corynebacterium Infections
Hepatitis B
Influenza, Human
DNA Virus Infections
Clostridium Infections

ClinicalTrials.gov processed this record on May 06, 2009