Study of Tetanus and Diphtheria Toxoids Adsorbed Combined With Component Pertussis Vaccine and Inactivated Poliomyelitis

Sanofi

Status and phase: Completed; Phase 2

Conditions: Poliomyelitis; Diphtheria; Hepatitis B; Tetanus; Pertussis

Treatments: Biological: Hepatitis B vaccine; Biological: Tetanus and Diphtheria Toxoids Adsorbed Combined with Component Pertussis Vaccine and IPV

Study type: Interventional

Funder types: Industry

Identifiers

NCT02040636

TD9809

Details and patient eligibility

About

Primary objective:

• To determine the safety and immunogenicity of tetanus and diphtheria toxoids adsorbed combined with component pertussis and inactivated poliomyelitis vaccine grown on vero cells (TdcP-IPV) compared to tetanus and diphtheria toxoids adsorbed combined with component pertussis and inactivated poliomyelitis vaccine grown on vero cells (TdcP-IPV) and Hepatitis B vaccine administered concurrently in adolescents 11-14 years of age.

Secondary objective:

• To determine whether concurrent administration of TdcP-IPV and Hepatitis B vaccines at 11-14 years of age results in detectable immunologic interactions between components of the two vaccines.

Full description

Participants will be randomized into one of 2 groups to receive either a dose of the TdcP-IPV on Day 0 (visit 1) and Hepatitis B vaccine on subsequent visits 2, 3 and 4 (Group 1); or no vaccination on Day 0, concomitant administration of TdcP-IPV and Hepatitis B vaccine on Day 28 (Visit 2) and Hepatitis B vaccine on subsequent visits 3 and 4 (Group 2).

All participants will be followed up for immunogenicity and safety

Enrollment: 277 patients

Sex: All

Ages: 11 to 14 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age 11 years and < 14 years of age.
• Signed, witnessed and dated informed consent that is obtained prior to the first study intervention.
• Judged to be in good health on the basis of reported medical history.
• Plans to remain in the study area for the length of the trial.
• All minors have a parent or legal guardian who can read, write and understand English or French.
• Pregnancy test to be performed on all female participants at the time of enrollment into the study (prior to day of first immunization visit).

Exclusion criteria

• Pregnancy.
• Known or suspected primary disease of the immune system [conditions suspected of having an immunologic component such as autoimmune diseases (rheumatoid arthritis or inflammatory bowel disease) will not be excluded unless they meet exclusion criterion 3 or are sufficiently clinically active to meet exclusion criterion 5].
• Malignancy or is receiving immunosuppressive therapy (e.g., daily systemic prednisone ≥ 1 mg/kg would be excluded, participants who are taking topical and inhaled steroids could be included in the study as could participants on a "short course" of oral steroids, 5-7 days, as long as there are not two courses within the previous two week period).
• Prior receipt of any pertussis, diphtheria, tetanus or polio containing vaccines, including Hepatitis B vaccine, within the past 5 years.
• Any significant underlying chronic disease, including malignancy, cardiopulmonary disease, renal or hepatic dysfunction.
• Known impairment of neurologic function or seizure disorder of any etiology.
• Personal history of physician diagnosed or laboratory confirmed pertussis disease within the last 2 years.
• Receipt of blood products or immunoglobulin within the previous 3 months.
• Known or suspected allergy to any of the vaccines intended for use in the study or any of the vaccine components including neomycin, streptomycin and polymyxin B.
• Receipt of any vaccine within 2 weeks of receiving a study vaccine.
• Daily use of non-steroidal anti-inflammatory drugs.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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277 participants in 2 patient groups

Study Group 1

Experimental group

Description:

Participants randomized to receive Tetanus and Diphtheria Toxoids Adsorbed Combined with Component Pertussis Vaccine and Inactivated Poliomyelitis Vaccine (TdcP-IPV) at month 0, Hepatitis B at months 1, 2 and 7.

Treatment:

Biological: Tetanus and Diphtheria Toxoids Adsorbed Combined with Component Pertussis Vaccine and IPV

Biological: Hepatitis B vaccine

Study Group 2

Active Comparator group

Description:

Participants randomized to receive Tetanus and Diphtheria Toxoids Adsorbed Combined with Component Pertussis Vaccine and Inactivated Poliomyelitis Vaccine (TdcP-IPV) + Hepatitis B at month 0, Hepatitis B at months 1 and 6.

Treatment:

Biological: Tetanus and Diphtheria Toxoids Adsorbed Combined with Component Pertussis Vaccine and IPV

Biological: Hepatitis B vaccine