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

NCT00619502 | Completed Phase 3 Results DMC

• 1 other identifier: A3L22
• Study Type: interventional
• Target: 254
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diphtheria; Polio; Pertussis; Hepatitis B

Keywords

Hepatitis B; Polio; Diphtheria; Pertussis; H.influenzae type b

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Study Arms (2)

DTaP-IPV-Hep B-PRP~T Vaccine Group

EXPERIMENTAL

Participants received a primary series of 3 vaccinations with DTaP-IPV-Hep B-PRP\~T, with 1 dose each at 2, 3, and 4 months of age, in Study A3L10; they will receive a booster dose of DTaP-IPV-HepB-PRP\~T at 15 to 18 months of age in the present study

Biological: DTaP-IPV-HB-PRP~T vaccine

Pentaxim™ + Engerix B™ Vaccines Group

ACTIVE COMPARATOR

Participants received a primary series of 3 vaccinations with Pentaxim™ and Engerix B™ vaccines, with 1 dose each at 2, 3, and 4 months of age, in Study A3L10; they will receive a booster dose of DTaP-IPV-Hep B-PRP\~T at 15 to 18 months of age in the present study.

Biological: DTaP-IPV-HB-PRP~T vaccine

Interventions

DTaP-IPV-HB-PRP~T vaccine BIOLOGICAL

0.5 mL, intramuscular (IM)

DTaP-IPV-Hep B-PRP~T Vaccine Group; Pentaxim™ + Engerix B™ Vaccines Group

Eligibility Criteria

• Age: 15 Months - 18 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• Sanofi Pasteur, a Sanofi Company: lead

Study Sites (1)

Unknown Facility

Ankara, Turkey (Türkiye)

Location

Related Links

• Related Info

MeSH Terms

Conditions

Diphtheria; Poliomyelitis; Whooping Cough; Hepatitis B

Interventions

DTaP-IPV-HB-PRP-T vaccine

Condition Hierarchy (Ancestors)

Corynebacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Myelitis; Central Nervous System Infections; Enterovirus Infections; Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Central Nervous System Diseases; Nervous System Diseases; Spinal Cord Diseases; Neuroinflammatory Diseases; Neuromuscular Diseases; Bordetella Infections; Gram-Negative Bacterial Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Blood-Borne Infections; Communicable Diseases; Hepadnaviridae Infections; DNA Virus Infections; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases

Results Point of Contact

• Title: Medical Director
• Organization: Sanofi Pasteur Inc.

RegistryContactUs@sanofipasteur.com

Study Officials

• Medical Director

  Sanofi Pasteur Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2008
• First Posted: February 21, 2008
• Study Start: December 1, 2007
• Primary Completion: July 1, 2008
• Study Completion: July 1, 2008
• Last Updated: May 13, 2016
• Results First Posted: April 3, 2014

Record last verified: 2016-04

Locations

TU (1)