Study of the Safety, Immunogenicity and Lot Comparability of DAPTACEL When Administered With Other Recommended Vaccine

Sanofi

Status and phase: Completed; Phase 3

Conditions: Haemophilus Influenzae Type b; Diphtheria; Polio; Whooping Cough; Tetanus

Treatments: Biological: DAPTACEL® (Diphtheria and Tetanus Toxoids and Acellular Pertussis vaccine); Biological: Pentacel: DTaP-IPV/Hib

Study type: Interventional

Funder types: Industry

Identifiers

NCT00662870

P3T06

Details and patient eligibility

About

This study was designed to assess the lot comparability of DAPTACEL, as well as the safety and immunogenicity of DAPTACEL when co-administered with other recommended infant vaccines.

Stage I Primary Objectives:

1. To assess the lot-comparability of immunogenicity of DAPTACEL by when co-administered with other recommended vaccines.
2. To compare the immune response to DTaP-IPV/Hib (Pentacel) with those of three lots of DAPTACEL when co-administered with other recommended vaccines.
3. To compare the immune response of PRP-T antigen in Pentacel with that of ActHIB concurrently administered in a different injection site with DAPTACEL when these vaccines are co-administered with other recommended vaccines.

Stage II Primary Objectives:

1. To compare the immune response of DAPTACEL when the 4th dose is co-administered with Hib or other infant vaccines.
2. To compare the the immune response of Pentacel with those elicited by DAPTACEL when co-administered with ActHIB in toddlers.

Full description

This is a two-stage, randomized, multi-center study to assess the safety, immunogenicity and lot comparability of DAPTACEL

Enrollment: 1,941 patients

Sex: All

Ages: 42 to 84 days old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria :

• Healthy infants 2 months of age.
• Infants with at least 37 weeks of gestation at delivery.
• Signed informed consent from parent or guardian.
• Able to attend the scheduled visits and to comply with the study procedure.
• Subjects must have received the first dose of hepatitis B vaccine from birth to 28 days prior to the first dose of DAPTACEL or Pentacel.

Exclusion Criteria :

• Clinically significant findings on review of systems or physical examination (determined by investigator or sub-investigator to be sufficient for exclusion).
• Known or suspected hypersensitivity to any component of the study vaccine to be administered.
• Known or suspected impairment of immunologic function or receipt of immunosuppressive therapy or immunoglobulin since birth.
• Known HIV-positive mother.
• Personal or immediate family history of congenital immune deficiency.
• Developmental delay or neurologic disorders.
• Chronic medical, congenital, developmental or surgical disease.
• Participation in any other experimental vaccine trial.
• Any condition which, in the opinion of the investigator or sub-investigator, would interfere with the evaluation of the vaccine or pose a health risk to the subject.
• Prior history of having received more than one dose of hepatitis B vaccine, any diphtheria, tetanus and acellular pertussis combination vaccine (DTaP), diphtheria, tetanus and whole-cell pertussis combination vaccine (DTwP), Haemophilus influenzae type b (Hib)-conjugate vaccine, poliovirus vaccine or pneumococcal conjugate vaccine

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,941 participants in 4 patient groups

DAPTACEL Lot 1

Experimental group

Description:

Participants receiving Diphtheria and Tetanus Toxoids and Acellular Pertussis vaccine (DAPTACEL) Lot 1

Treatment:

Biological: DAPTACEL® (Diphtheria and Tetanus Toxoids and Acellular Pertussis vaccine)

DAPTACEL Lot 2

Experimental group

Description:

Participants receiving Diphtheria and Tetanus Toxoids and Acellular Pertussis vaccine (DAPTACEL) Lot 2

Treatment:

Biological: DAPTACEL® (Diphtheria and Tetanus Toxoids and Acellular Pertussis vaccine)

DAPTACEL Lot 3

Experimental group

Description:

Participants receiving Diphtheria and Tetanus Toxoids and Acellular Pertussis vaccine (DAPTACEL) Lot 3

Treatment:

Biological: DAPTACEL® (Diphtheria and Tetanus Toxoids and Acellular Pertussis vaccine)

Pentacel

Active Comparator group

Description:

Participants receiving Pentacel vaccine

Treatment:

Biological: Pentacel: DTaP-IPV/Hib