Study Comparing a DTaP-HB-PRP~T Combined Vaccine With Tritanrix HepB/Hib™, Concomitantly With OPV in Healthy Infants

NCT ID: NCT00348881

Last Updated: 2013-10-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 2133 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-06-30
• Study Completion Date: 2008-06-30

Brief Summary

This is a study to compare the safety and immune response of a pentavalent DTaP-HB-PRP~T combined vaccine with Tritanrix-HepB/Hib™, when both are given concomitantly with OPV at 6, 10, and 14 weeks of age.

Conditions

Diphtheria; Tetanus; Pertussis; Hepatitis B; Influenza

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Group 1: DTaP-Hep B-PRP-T + OPV vaccine

Participants received 3 doses of the DTaP-Hep B-PRP-T concomitantly with OPV vaccine, 1 dose each at 6, 10, and 14 weeks of age.

Group Type: EXPERIMENTAL

DTaP-HB-PRP~T combined vaccine

Intervention Type: BIOLOGICAL

0.5 mL, Intramuscular

Oral poliomyelitis vaccine (OPV)

Intervention Type: BIOLOGICAL

Oral co-administered with study vaccine.

Group 2: Tritanrix-HepB/Hib™ + OPV vaccine

Participants received 3 doses of the Tritanrix-HepB/Hib™ concomitantly with OPV vaccine, 1 dose each at 6, 10, and 14 weeks of age.

Group Type: ACTIVE_COMPARATOR

Tritanrix-HepB/Hib™ vaccine

Intervention Type: BIOLOGICAL

0.5 mL, Intramuscular

Oral poliomyelitis vaccine (OPV)

Intervention Type: BIOLOGICAL

Oral co-administered with study vaccine.

Interventions

DTaP-HB-PRP~T combined vaccine

0.5 mL, Intramuscular

Intervention Type: BIOLOGICAL

Tritanrix-HepB/Hib™ vaccine

0.5 mL, Intramuscular

Intervention Type: BIOLOGICAL

Oral poliomyelitis vaccine (OPV)

Oral co-administered with study vaccine.

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

At Screening:

• 0 to 3 day old infants
• Born at full term of pregnancy (≥ 37 weeks) with a birth weight ≥ 2.5 kg
• Apgar score ≥ 7 at three minutes after birth
• Informed consent form signed by one parent or legal representative if appropriate (independent witness mandatory if parent is illiterate)

At Inclusion:

• Six weeks of age
• Received a dose of Hepatitis B (HB) in the first three days of life
• Able to attend all scheduled visits and to comply with all trial procedures.

Exclusion Criteria

At Screening:

• Illness at a stage that could interfere with trial conduct or completion
• Any vaccination before HB vaccination (except bacille Calmette-Guérin [BCG] given at birth)
• Vaccination planned in the 4 to 6 weeks following the first trial vaccination (except BCG if not given at birth)
• Acute illness on the day of screening.

At Screening and at Inclusion:

• Blood or blood-derived products received since birth
• Planned participation in another clinical trial during the present trial period
• Mother known as seropositive to Human immunodeficiency virus (HIV) or Hepatitis C, or as carrying the HB surface antigen (HBsAg)
• Known thrombocytopenia or bleeding disorder contraindicating intramuscular vaccination
• Known hypersensitivity to any component of any vaccine to be used in the trial (including neomycin and polymixin B)

At Inclusion:

• Non-trial vaccine administered since birth, except Bacille Calmette-Guérin (BCG)
• Participation in another clinical trial before 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
• Vaccination other than with the study vaccines planned in the 12 weeks following inclusion
• Documented history of pertussis, tetanus, diphtheria, polio, H. influenza type b, or HB infection (confirmed clinically, serologically, or microbiologically)
• History of seizures
• Febrile (rectal temperature ≥ 38.0°C) or acute illness on the day of inclusion.

• Minimum Eligible Age: 42 Days
• Maximum Eligible Age: 50 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sanofi Pasteur, a Sanofi Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Sanofi Pasteur Inc.

Locations

Alabang, Muntinlupa City, Philippines

Putatan, Muntinlupa City, Philippines

Tunasan, Muntinlupa City, Philippines

Filinvest

Corporate City, , Philippines

Countries

Philippines

Related Links

http://www.sanofipasteur.com

Related Info

Other Identifiers

AL201

Identifier Type: -

Identifier Source: org_study_id