Last updated: 11/20/2018 16:20:27
An open, multicentre, phase IV booster vaccination study to assess the immunogenicity and reactogenicity of GSKBiologicals combined Infanrix-IPV+Hib (DTPa-IPV/Hib) vaccine in healthy children aged 17 to 20 months whocompleted a three-dose primary vaccination course
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: An open, multicentre, phase IV booster vaccination study to assess the immunogenicity and reactogenicity of GSKBiologicals combined Infanrix-IPV+Hib (DTPa-IPV/Hib) vaccine in healthy children aged 17 to 20 months whocompleted a three-dose primary vaccination course
Trial description: An open, multicentre, phase IV booster vaccination study to assess the immunogenicity and reactogenicity of GSKBiologicals combined Infanrix-IPV+Hib (DTPa-IPV/Hib) vaccine in healthy children aged 17 to 20 months whocompleted a three-dose primary vaccination course
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:
Tejedor JC, Omeñaca F, García-Sicilia J, Esporrín C, Molina V, Marés J, Muro M, Sanjuan P, Méndez M, Teixidor R, Enrubia M, García-Corbeira P, Boceta R, Jacquet JM, Schuerman L. Antibody persistence after primary vaccination with a hexavalent DTPa-HBV-IPV/Hib vaccine co-administered with a MenC-CRM197 vaccine and response to a DTPa-IPV/Hib booster at 18 months of age Ped Infect Dis J. 2006; 25(10):943-945
Tejedor et al. Diphtheria-tetanus acellular pertussis hepatitis B-inactivated polio virus-haemophilus influenze type B (DTPa-HBV-IPV/Hib) vaccine co-administered with meningococcal group C conjugate (Men C) antibody peristance at 18 months of age and response to a DTPa-IPV/ HIB booster. International Congress of Pediatrics (ICP) 15-20 August 2004, Cancun Mexico
Medical condition
Diphtheria, Haemophilus influenzae type b, Poliomyelitis, Tetanus, acellular pertussis
Product
Combined Diphtheria, Tetanus, Acellular Pertussis, Inactivated Polio, Haemophilus influenzae Type b Conjugate Vaccine
Collaborators
Not applicable
Study date(s)
October 2002 to June 2003
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
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
2003-09-06
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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Access to clinical trial data by researchers
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