Study to Evaluate Antibody Persistence in Children Previously Vaccinated With Infanrix Hexa™ or Infanrix-IPV/Hib™

Hepatitis B Clinical Trial

Official title:

Antibody Persistence in Children Previously Vaccinated With Three Doses of Infanrix Hexa™ or Infanrix-IPV/Hib™

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01358825
• Other study ID #: 115375
• Secondary ID: 2011-000943-26
• Status: Completed
• Phase: Phase 4
• Start date: May 30, 2011
• Est. completion date: July 15, 2011

Study information

• Verified date: January 2021
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to assess antibody persistence in infants who received three doses of Infanrix hexa™ (DTPa-HBV-IPV/Hib) or Infanrix-IPV/Hib™ (DTPa-IPV/Hib) at 3, 5 and 11 months of age in study NCT00307034.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: July 15, 2011
• Est. primary completion date: July 15, 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years to 6 Years

Eligibility

Inclusion Criteria:

• Subjects who had received 3 doses of Infanrix hexa™ or Infanrix-IPV/Hib™ in study NCT00307034.

• Subjects who the investigator believes that parent(s)/Legally Acceptable Representative(s) LAR(s) can and will comply with the requirements of the protocol.

• A male or female subject aged 5 years at the time of study entry.

• Written informed consent obtained from the parent(s)/LAR(s) of the subject.

• Healthy subjects as established by medical history and clinical examination before entering into the study.

Exclusion Criteria:

• Child in care.

• Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product.

• Use of any investigational or non-registered product within 30 days prior to blood sampling.

• Evidence of previous or intercurrent diphtheria, tetanus, pertussis, polio, hepatitis B, and Hib vaccination or disease since the study NCT00307034, with the exception of hepatitis B vaccination in the DTPa-IPV/Hib group.

• Administration of immunoglobulins and/or any blood products within the 3 months prior to blood sampling.

• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.

• Family history of congenital or hereditary immunodeficiency.

Related Conditions & MeSH terms

• Acellular Pertussis
• Diphtheria
• Diphtheria-Tetanus-aPertussis-Poliomyelitis-Haemophilus Influenzae Type b Vaccines
• Haemophilus Influenzae Type b
• Hepatitis B
• Influenza, Human
• Poliomyelitis
• Tetanus

Intervention

Procedure:
• Blood Sampling
A blood sample will be taken at 5 years of age, after vaccination in the primary study.

Locations

Country	Name	City	State
Norway	GSK Investigational Site	Morvik
Norway	GSK Investigational Site	Oslo
Sweden	GSK Investigational Site	Örebro
Sweden	GSK Investigational Site	Umeå

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

Norway,  Sweden, 

References & Publications (1)

Silfverdal SA, Assudani D, Kuriyakose S, Van Der Meeren O. Immunological persistence in 5 y olds previously vaccinated with hexavalent DTPa-HBV-IPV/Hib at 3, 5, and 11 months of age. Hum Vaccin Immunother. 2014;10(10):2795-8. doi: 10.4161/21645515.2014.970494. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Seroprotected Subjects Against Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T).	A seroprotected subject is a subject with anti-D/anti-T antibody concentrations greater than (=) or equal to 0.1 international units per milliliter (IU/mL)	At Day 0
Primary	Concentrations of Antibodies Against Anti-D and Anti-T	Concentrations are presented as geometric mean concentrations (GMCs), expressed in milliinternational units per millilitre (mIU/mL).	At Day 0
Primary	Number of Subjects With Anti-pertussis Toxoid (Anti-PT), Antifilamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations =5 ELISA Units Per Milliliter (EL.U/mL).	Cut-off values assessed were greater than or equal to 5 ELISA units per millilitre (EL.U/mL) in the sera of subjects seronegative before vaccination.	At Day 0
Primary	Concentrations of Antibodies Against Anti-PT, Anti-FHA and Anti-PRN.	Concentrations are presented as geometric mean concentrations (GMCs), expressed in ELISA units per millilitre (EL.U/mL).	At Day 0
Primary	Number of Seroprotected Subjects Against Anti-hepatitis B Surface Antigen (Anti-HBs).	Seroprotection = anti-HBs antibody concentration = 10 milli-international units per milliliter (mIU/mL).	At Day 0
Primary	Concentrations of Antibodies Against Anti-HBs.	Concentrations are presented as geometric mean concentrations (GMCs), expressed in milliinternational units per millilitre (mIU/mL).	At Day 0
Primary	Number of Seroprotected Subjects Against Anti-polyribosyl Ribitol Phosphate (Anti-PRP).	A seroprotected subject is a subject with anti-PRP antibody concentrations = 0.15 micrograms per milliliter (µg/mL)	At Day 0
Primary	Concentrations of Antibodies Against Anti-PRP.	Concentrations are presented as geometric mean concentrations (GMCs), expressed in micrograms per millilitre (µg/mL).	At Day 0
Primary	Number of Subjects With Serious Adverse Events (SAEs).	Assessed SAEs include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.	During the entire study period (up to Day 46)
Primary	Number of Subjects With Anti-HBs Antibody Concentrations = 6.2 mIU/mL	Cut-off values assessed were greater than or equal to 6.2 milliinternational units per millilitre ( mIU/mL) in the sera of subjects seronegative before vaccination.	At Day 0

External Links

•   Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.