Last updated: 11/27/2020 11:20:04
Study to evaluate antibody persistence in children previously vaccinated with Infanrix hexa™ or Infanrix-IPV/Hib™
EudraCT ID
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: Antibody persistence in children previously vaccinated with three doses of Infanrix hexa™ or Infanrix-IPV/Hib™
Trial description: 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.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:
Number of seroprotected subjects against anti-diphtheria (anti-D) and anti-tetanus (anti-T).
Timeframe: At Day 0
Concentrations of antibodies against anti-D and anti-T
Timeframe: At Day 0
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
Concentrations of antibodies against anti-PT, anti-FHA and anti-PRN.
Timeframe: At Day 0
Number of seroprotected subjects against anti-hepatitis B surface antigen (anti-HBs).
Timeframe: At Day 0
Concentrations of antibodies against anti-HBs.
Timeframe: At Day 0
Number of seroprotected subjects against anti-polyribosyl ribitol phosphate (anti-PRP).
Timeframe: At Day 0
Concentrations of antibodies against anti-PRP.
Timeframe: At Day 0
Number of subjects with serious adverse events (SAEs).
Timeframe: During the entire study period (up to Day 46)
Number of subjects with anti-HBs antibody concentrations ≥ 6.2 mIU/mL
Timeframe: At Day 0
Secondary outcomes:
Not applicable
Interventions:
Enrollment:
58
Primary completion date:
2011-15-07
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Silfverdal SA et al. (2014) 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. 10(10):2795-2798. doi: 10.4161/21645515.2014.970494.
Medical condition
Tetanus, Poliomyelitis, Haemophilus influenzae type b, acellular pertussis, Diphtheria, Hepatitis B, Diphtheria-Tetanus-aPertussis-Poliomyelitis-Haemophilus influenzae type b Vaccines
Product
SB213503, SB217744
Collaborators
Not applicable
Study date(s)
May 2011 to July 2011
Type
Interventional
Phase
4
Participation criteria
Sex
Female & Male
Age
5 - 6 years
Accepts healthy volunteers
Yes
- 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.
- 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.
Inclusion and exclusion criteria
Inclusion criteria:
- 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.
Subjects who had received 3 doses of Infanrix hexa™ or Infanrix-IPV/Hib™ in study NCT00307034.
Exclusion criteria:
- 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.
Child in care.
Trial location(s)
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Study complete
Actual primary completion date
2011-15-07
Actual study completion date
2011-15-07
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
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