Study of Immunogenicity and Safety of a Booster Dose of DTaP-IPV-HB-PRP~T Combined Vaccine 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.

Completed

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Key information

Conditions

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

Age range

15 month–18 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Ankara, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

DTaP-IPV-HB-PRP~T vaccine

Biological

0.5 mL, intramuscular (IM)

Primary outcomes

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.
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).
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.

Sponsors and collaborators

Lead sponsor

Sanofi Pasteur, a Sanofi Company

Industry

Registry information

Official study 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

Important dates

Study start: 2007
Primary completion: 2008
Study completion: 2008
First posted: Feb 21, 2008
Registry last updated: May 13, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed