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

April 8, 2016 updated by: Sanofi Pasteur, a Sanofi Company

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

254

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 1 year (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: DTaP-IPV-Hep B-PRP~T Vaccine Group
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
0.5 mL, intramuscular (IM)
Active Comparator: Pentaxim™ + Engerix B™ Vaccines Group
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
0.5 mL, intramuscular (IM)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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™
Time Frame: Day 0 before and Day 30 Post-booster vaccination
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
Time Frame: Day 0 before and Day 30 post-booster vaccination
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
Time Frame: Day 0 up to Day 7 post-booster vaccination

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi Pasteur, a Sanofi Company

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2007

Primary Completion (Actual)

July 1, 2008

Study Completion (Actual)

July 1, 2008

Study Registration Dates

First Submitted

February 11, 2008

First Submitted That Met QC Criteria

February 11, 2008

First Posted (Estimate)

February 21, 2008

Study Record Updates

Last Update Posted (Estimate)

May 13, 2016

Last Update Submitted That Met QC Criteria

April 8, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A3L22

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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