Last updated: 11/06/2018 23:51:55
Open, phase III clinical study to assess the immunogenicity and reactogenicity of GSK Biological's DTPa vaccine (Infanrix) in preterm infants (<37 weeks) in comparison with full-term infants, administered as a booster dose to children at four ages of age previously vaccinated with four doses of Infanrix Hexa at 2, 4, 6 and 18 months of age
Clinicaltrials.gov ID
Not applicable
EudraCT ID
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: Open, phase III clinical study to assess the immunogenicity and reactogenicity of GSK Biological's DTPa vaccine (Infanrix) in preterm infants (<37 weeks) in comparison with full-term infants, administered as a booster dose to children at four ages of age previously vaccinated with four doses of Infanrix Hexa at 2, 4, 6 and 18 months of age
Trial description: Open, phase III clinical study to assess the immunogenicity and reactogenicity of GSK Biological's DTPa vaccine (Infanrix) in preterm infants (<37 weeks) in comparison with full-term infants, administered as a booster dose to children at four ages of age previously vaccinated with four doses of Infanrix Hexa at 2, 4, 6 and 18 months of age
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Not applicable
Enrollment:
Not applicable
Primary completion date:
Not applicable
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Omenaca F et al. Four-year follow-up of vaccine response in a cohort of children who were born prematurely. Abstract presented at the 25th Annual Meeting ESPID, Porto, Portugal, 02-04 May 2007.
Omeñaca F et al. (2007) Antibody persistence and booster vaccination during the second and fifth years of life in a cohort of children who were born prematurely. Pediatr Infect Dis J. 26 (9):824-829.
Medical condition
Diphtheria-Tetanus-acellular Pertussis Vaccines
Product
SB208355
Collaborators
Not applicable
Study date(s)
September 2004 to February 2005
Type
Not applicable
Phase
3
Participation criteria
Sex
Not applicable
Age
Not applicable
Accepts healthy volunteers
Not applicable
Inclusion and exclusion criteria
Trial location(s)
This study does not involve prospective enrollment of participants.
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
Not applicable
Recruitment status
Study complete
Actual primary completion date
Not applicable
Actual study completion date
2005-22-02
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
Not applicable
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