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

Hepatitis B Clinical Trial

Official title:

Immunogenicity Study of the Antibody Persistence and Booster Effect of the DTaP-IPV-Hep B-PRP~T Combined Vaccine at 15 to 18 Months of Age Following a Primary Series of DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Administered at 2, 4, and 6 Months of Age in Healthy Mexican Infants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00654901
• Other study ID #: A3L21
• Status: Completed
• Phase: Phase 3
• First received: April 3, 2008
• Last updated: May 6, 2013
• Start date: March 2008
• Est. completion date: July 2009

Study information

• Verified date: May 2013
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 881
• Est. completion date: July 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 15 Months to 18 Months

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diphtheria
• Haemophilus Influenzae Type B Infection
• Hepatitis B
• Pertussis
• Poliomyelitis
• Tetanus

Intervention

Biological:
• DTaP-IPV-Hep B-PRP~T vaccine (Batch 1)
0.5 mL, Intramuscular
• DTaP-IPV-Hep B-PRP~T vaccine (Batch 2)
0.5 mL, Intramuscular
• DTaP-IPV-Hep B-PRP~T vaccine (Batch 3)
0.5 mL, Intramuscular
• Infanrix Hexa™
0.5 mL, Intramuscular

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi Pasteur, a Sanofi Company

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Geometric Mean Titers of Antibodies Before and After Booster Vaccination With DTaP-IPV-Hep B-PRP~T	Antibody titers were measured for hepatitis B (Hep B) by enhanced chemiluminescence detection, for Haemophilus influenzae type b (PRP) by Farr type radioimmunoassay, for diphtheria by toxin neutralization test, and for tetanus by enzyme linked immunosorbent assay (ELISA). Antibody titers were measured for poliovirus types 1, 2, and 3 by neutralization assay. Antibody titers were measured for pertussis toxoid (PT) and filamentous hemagglutinin (FHA) by ELISA.	Day 0 (pre-booster) and Day 30 (one month post-booster)	No
Primary	Number of Participants With Antibody Persistence Before and Immunogenicity Response After Booster Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine	Antibody persistence and immunogenicity response: Level 1: = 10 mIU/mL for hepatitis B (Hep B), = 0.15 µg/mL for Haemophilus influenzae type b (PRP), and = 0.01 IU/mL for diphtheria (D) and tetanus (T). Level 2: = 100 mIU/mL (Hep B), = 1.0 µg/mL (PRP), and = 0.1 IU/mL (D and T) Level 3, = 1.0 IU/mL (D and T). Anti-polio titers were defined as = 8 (1.dil), and pertussis toxoid (PT) and filamentous hemagglutinin (FHA) by a 4 fold increase from Day 0.	Day 0 (pre-booster) and Day 30 (one month post-booster)	No
Primary	Number of Participants With Solicited Injection Site or Systemic Reactions After Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine	Solicited Injection Site Reactions: Pain, Erythema, Swelling, Extensive Swelling of Vaccinated Limb. Solicited Systemic Reactions: Pyrexia (Temperature), Vomiting, Crying, Somnolence, Anorexia, Irritability.; Grade 3 reactions were defined as: Pain, cries when injected limb is moved or movement of injected limb reduced; Erythema and swelling, = 5cm; Extensive swelling of limb; Pyrexia, = 39.6ºC; Vomiting = 6 episodes/24 hours or requiring parenteral hydration; Somnolence, sleeping most of time or difficult to wake up; Anorexia, refuses = feeds or most feeds; Irritability, inconsolable.	Days 0 up to 7 after any injection	No

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