Clinical trial NCT01358825: Study to Evaluate Antibody Persistence in Children Previously Vaccinated With Infanrix Hexa™ or Infanrix-IPV/Hib™
Official title: Antibody Persistence in Children Previously Vaccinated With Three Doses of Infanrix Hexa™ or Infanrix-IPV/Hib™
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Tetanus
Poliomyelitis
Haemophilus Influenzae Type b
Acellular Pertussis
Diphtheria
Hepatitis B
Diphtheria-Tetanus-aPertussis-Poliomyelitis-Haemophilus Influenzae Type b Vaccines
Keywords: Infanrix-IPV/Hib
Long-term follow up
Persistence
Infanrix hexa
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2011-05-24
Enrollment: 58
Sex: ALL
Minimum age (years): 5
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of Seroprotected Subjects Against Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T).
timeFrame: At Day 0
measure: Concentrations of Antibodies Against Anti-D and Anti-T
timeFrame: At Day 0
measure: 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).
timeFrame: At Day 0
measure: Concentrations of Antibodies Against Anti-PT, Anti-FHA and Anti-PRN.
timeFrame: At Day 0
measure: Number of Seroprotected Subjects Against Anti-hepatitis B Surface Antigen (Anti-HBs).
timeFrame: At Day 0
measure: Concentrations of Antibodies Against Anti-HBs.
timeFrame: At Day 0
measure: Number of Seroprotected Subjects Against Anti-polyribosyl Ribitol Phosphate (Anti-PRP).
timeFrame: At Day 0
measure: Concentrations of Antibodies Against Anti-PRP.
timeFrame: At Day 0
measure: Number of Subjects With Serious Adverse Events (SAEs).
timeFrame: During the entire study period (up to Day 46)
measure: Number of Subjects With Anti-HBs Antibody Concentrations ≥ 6.2 mIU/mL
timeFrame: At Day 0
Secondary outcomes:
Other outcomes:
Locations:
city: Morvik
country: Norway
facility: GSK Investigational Site
city: Oslo
country: Norway
facility: GSK Investigational Site
city: Umeå
country: Sweden
facility: GSK Investigational Site
city: Örebro
country: Sweden
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.