Study of Immunogenicity and Safety of a Booster Dose of DTaP-IPV-HB-PRP~T Combined Vaccine in Healthy Turkish Infants

Hepatitis B Clinical Trial

Official title:

Immunogenicity and Safety Study of a Booster Dose of DTaP-IPV-Hep B-PRP~T Combined Vaccine at 15 to 18 Months of Age Following a Primary Series at 2, 3 and 4 Months of Age in Healthy Turkish Infants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00619502
• Other study ID #: A3L22
• Status: Completed
• Phase: Phase 3
• First received: February 11, 2008
• Last updated: February 22, 2014
• Start date: December 2007
• Est. completion date: July 2008

Study information

• Verified date: February 2014
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

This is a follow-up of Study A3L10 (NCT00315055)

Immunogenicity

• To describe the antibody persistence following a primary series vaccination of either DTaP-IPV-HB-PRP~T or PENTAXIM™ and ENGERIX B®.

• To describe the immunogenicity of a booster dose of DTaP-IPV-HB-PRP~T.

Safety

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 254
• Est. completion date: July 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 15 Months to 18 Months

Eligibility

Inclusion Criteria:

• Toddler previously included in Study A3L10 who completed the three-dose primary series vaccination of either DTaP-IPV-HB-PRP~T or PENTAXIM™ and ENGERIX B® at 2, 3 and 4 months of age.

• Toddler of 15 to 18 months of age (range: 456 to 578 days of age inclusive).

• Informed Consent Form signed by the parent(s) or other legal representative(s) and an institution official other than an Investigator.

• 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 second Visit.

• History of documented pertussis, tetanus, diphtheria, polio, Haemophilus influenzae type b or hepatitis B infection(s) (confirmed either clinically, serologically or microbiologically).

• Previous booster vaccination against pertussis, tetanus, diphtheria, polio or Haemophilus influenzae type b, and hepatitis B infection(s).

• Coagulopathy, thrombocytopenia or a bleeding disorder contraindicating intramuscular vaccination.

• Any vaccine-related serious adverse event that occurred following the three-dose primary series administration of the investigational vaccine or of the reference vaccine in Study A3L10 (NCT00315055).

• 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: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diphtheria
• Hepatitis B
• Pertussis
• Polio

Intervention

Biological:
• DTaP-IPV-HB-PRP~T vaccine
0.5 mL, intramuscular (IM)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi Pasteur, a Sanofi Company

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Pre-booster Antibody Persistence and Booster Response to DTaP-IPV-Hep B-PRP~T After Primary Vaccination With Either DTaP-IPV-Hep B-PRP~T or Pentaxim™ + Engerix B Vaccine™	Antibody titers measured by chemiluminescence detection for Hepatitis B (Hep B); Farr type radioimmunoassay for Haemophilus influenza type b (PRP); toxin neutralization for Diphtheria (D); indirect enzyme-linked immunosorbent assay (ELISA) for Tetanus (T); neutralization assay for Poliovirus types 1, 2, and 3; and ELISA for Pertussis toxoid (PT) and Filamentous hemagglutinin (FHA). Persistence and response: = 10 mIU/mL for anti-Hep B, = 0.15 µg/mL for anti-PRP, = 0.01 IU/mL for anti-D and anti-T, = 8 (1/dil) for anti-Poliovirus; and = 4-fold increase from Day 0 for anti-PT and anti-FHA.	Day 0 before and Day 30 Post-booster vaccination	No
Primary	Geometric Mean Titers (GMTs) Before and After Booster Vaccination With DTaP-IPV-Hep B-PRP~T	Antibody titers were measured by chemiluminescence detection for Hepatitis B (Hep B); Farr type radioimmunoassay for Haemophilus influenza type b (PRP); toxin neutralization test for Diphtheria (D); indirect enzyme-linked immunosorbent assay (ELISA) for Tetanus (T); neutralization assay for Poliovirus types 1, 2, and 3; and ELISA for Pertussis toxoid (PT) and Filamentous hemagglutinin (FHA).	Day 0 before and Day 30 post-booster vaccination	No
Primary	Number of Participants With Solicited Injection Site and Systemic Reactions After Booster Vaccination With DTaP-IPV-Hep B-PRP~T	Solicited Injection Site Reactions: Pain, Erythema, Swelling, and Extensive Swelling of Vaccinated Limb. Solicited Systemic Reactions: Pyrexia (Temperature), Vomiting, Crying, Somnolence, Anorexia, and Irritability.; Grade 3 defined as: Pain, cries when injected limb is moved or movement of limb reduced; Erythema and Swelling, = 5 cm; Extensive Swelling of Vaccinated Limb, All; Pyrexia, = 39ºC; Vomiting, = 6 episodes/24 hours or requiring parenteral hydration; Crying > 3 hours; Somnolence, sleeping most of time or difficult to wake up; Anorexia, refuses = 3 feeds or most feeds; Irritability, inconsolable.	Day 0 up to Day 7 post-booster vaccination	No

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