Last updated: 11/06/2018 23:47:12

A phase IV, open, multicentre study to assess the immunogenicity and reactogenicity of GlaxoSmithKline Biologicals’ DTPa-HBV-IPV/Hib vaccine (Infanrixhexa) given as a booster at 18-24 months of age to pre-term children who have received a three-dose primary immunization course with the same vaccine in study 217744/090.

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GSK study ID
101518
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Clinicaltrials.gov ID
Not applicable
EudraCT ID
2011-004047-45
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: A phase IV, open, multicentre study to assess the immunogenicity and reactogenicity of GlaxoSmithKline Biologicals’ DTPa-HBV-IPV/Hib vaccine (Infanrixhexa) given as a booster at 18-24 months of age to pre-term children who have received a three-dose primary immunization course with the same vaccine in study 217744/090.
Trial description: A phase IV, open, multicentre study to assess the immunogenicity and reactogenicity of GlaxoSmithKline Biologicals’ DTPa-HBV-IPV/Hib vaccine (Infanrixhexa) given as a booster at 18-24 months of age to pre-term children who have received a three-dose primary immunization course with the same vaccine in study 217744/090.
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:
Vázquez L et al. (2008) Immunogenicity and reactogenicity of DTPa-HBV-IPV/Hib vaccine as primary and booster vaccination in low-birth-weight premature infants. Acta Paediatr. 97(9):1243-1249.
Medical condition
Diphtheria-Tetanus-aPertussis-Hepatitis B-Poliomyelitis Vaccines
Product
SB217744
Collaborators
Not applicable
Study date(s)
May 2004 to November 2004
Type
Not applicable
Phase
4

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
Download document(s)
Scientific result summary
Available language(s): English
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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
2004-18-11

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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