Study of the DTaP-IPV-Hep B-PRP~T Combined Vaccine Following a Primary Series of DTacP IPV-HepB-PRP-T or Infanrix Hexa™

Sanofi

Status and phase: Completed; Phase 3

Conditions: Poliomyelitis; Diphtheria; Hepatitis B; Pertussis; Tetanus; Haemophilus Influenzae Type B Infection

Treatments: Biological: DTaP-IPV-Hep B-PRP~T vaccine (Batch 3); Biological: DTaP-IPV-Hep B-PRP~T vaccine (Batch 1); Biological: DTaP-IPV-Hep B-PRP~T vaccine (Batch 2); Biological: Infanrix Hexa™

Study type: Interventional

Funder types: Industry

Identifiers

NCT00654901

A3L21

Details and patient eligibility

About

This is a follow-up of Study A3L11 (NCT00404651).

Immunogenicity

• To describe the antibody persistence following a primary series vaccination of either DTaP-IPV-Hep B-PRP~T or Infanrix hexa™.
• To describe the immunogenicity of a booster dose of DTaP-IPV-HepB-PRP~T in a subset of subjects.

Safety

• To describe the safety profile after a booster dose of DTacP-IPV-HepB-PRP~T.

Enrollment: 881 patients

Sex: All

Ages: 15 to 18 months old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Toddlers previously included in Study A3L11 (NCT00404651) who completed the three-dose primary series vaccination of either DTaP-IPV-HepB-PRP-T or Infanrix hexa™ at 2, 4 and 6 months of age
• Toddlers of 15 to 18 months (456 to 578 days) of age, inclusive
• Informed Consent Form signed by at least one parent or legal representative and two mandatory witnesses
• Able to attend all scheduled visits and to comply with all trial procedures.

Exclusion criteria

• Participation in another clinical trial in the 4 weeks preceding the booster vaccination.
• Planned participation in another clinical trial during the present trial period.
• 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 a vaccine containing the same substances.
• Chronic illness at a stage that could interfere with trial conduct or completion.
• Blood or blood-derived products received in the last 3 months.
• Any vaccination in the 4 weeks preceding the booster vaccination.
• Any vaccination planned until the next visit.
• History of documented pertussis, tetanus, diphtheria, polio, Haemophilus influenzae type b or hepatitis B (HB) infection(s) (confirmed either clinically, serologically or microbiologically).
• Administration of a vaccine against pertussis, tetanus, diphtheria, polio, Hib, and/or hepatitis B infection(s) since the end of participation in Study A3L11.
• Coagulopathy, thrombocytopenia or a bleeding disorder contraindicating intramuscular vaccination.
• Known maternal history of human immunodeficiency virus (HIV), Hepatitis B surface antigen (HbsAg) or Hepatitis C seropositivity.
• Subjects with any related serious adverse event that occurred following the three-dose primary series administration of the investigational vaccine or of the reference vaccine in Study A3L11.
• History of seizures.
• Febrile (temperature ≥38.0°C) or acute illness on the day of inclusion
• Known contraindication to further vaccination with a pertussis vaccine, i.e.: Encephalopathy; Temperature >40.0°C within 48 hours following a vaccine injection, not due to another identifiable cause during the primary series; Inconsolable crying that occurred for >3 hours within 48 hours following vaccine injection during the primary series; Hypotonic hyporesponsive episode within 48 hours following vaccine injection during the primary series; Seizures with or without fever within 3 days following vaccine injection.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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881 participants in 4 patient groups

DTaP-IPV-Hep B-PRP~T Batch 1

Experimental group

Description:

Participants had received 3 primary doses of Batch 1 of Diphtheria (D), Tetanus (T), Pertussis (acellular, component \[aP\]), Hepatitis B (Hep B, \[recombinant DNA\]) and poliomyelitis (Inactivated \[IPV\]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP\~T) in Study A3L11 (NCT00404651); and will receive a booster dose of (DTaP-IPV-Hep B-PRP\~T) at Day 0 in the present study.

Treatment:

Biological: DTaP-IPV-Hep B-PRP~T vaccine (Batch 1)

DTaP-IPV-Hep B-PRP~T Batch 2

Experimental group

Description:

Participants had received 3 primary doses of Batch 1 of Diphtheria (D), Tetanus (T), Pertussis (acellular, component \[aP\]), Hepatitis B (Hep B, \[recombinant DNA\]) and poliomyelitis (Inactivated \[IPV\]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP\~T) in Study A3L11 (NCT00404651) and will receive a booster dose of (DTaP-IPV-Hep B-PRP\~T) at Day 0 in the present study.

Treatment:

Biological: DTaP-IPV-Hep B-PRP~T vaccine (Batch 2)

DTaP-IPV-Hep B-PRP~T Batch 3

Experimental group

Description:

Participants had received 3 primary doses of Batch 1 of Diphtheria (D), Tetanus (T), Pertussis (acellular, component \[aP\]), Hepatitis B (Hep B, \[recombinant DNA\]) and poliomyelitis (Inactivated \[IPV\]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP\~T) in Study A3L11 (NCT00404651) and will receive a booster dose of (DTaP-IPV-Hep B-PRP\~T) at Day 0 in the present study.

Treatment:

Biological: DTaP-IPV-Hep B-PRP~T vaccine (Batch 3)

Infanrix Hexa™

Active Comparator group

Description:

Participants had received 3 primary doses of Diphtheria (D), Tetanus (T), Pertussis (acellular, component \[aP\]), Hepatitis B (Hep B, \[recombinant DNA\]) and poliomyelitis (Inactivated \[IPV\]), (Infanrix Hexa™) plus Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed in Study A3L11 (NCT00404651) and received a booster dose of (DTaP-IPV-Hep B-PRP\~T) at Day 0 in the present study.

Treatment:

Biological: Infanrix Hexa™