Last updated: 11/20/2018 16:10:43
Study to compare immunogenicity and reactogenicity of GSK Bio’s DTPa-IPV vaccine, with GSK Bio’s DTPa (Infanrix) and Aventis MSDs IPV vaccine (Imovax Polio) administered separately to healthy children 4 to 6 years of age
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: Study to compare immunogenicity and reactogenicity of GSK Bio’s DTPa-IPV vaccine, with GSK Bio’s DTPa (Infanrix) and Aventis MSDs IPV vaccine (Imovax Polio) administered separately to healthy children 4 to 6 years of age
Trial description: Study to compare immunogenicity and reactogenicity of GSK Bio’s DTPa-IPV vaccine, with GSK Bio’s DTPa (Infanrix) and Aventis MSDs IPV vaccine (Imovax Polio) administered separately to healthy children 4 to 6 years 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:
Nillson L, et al. A fourth dose of DTPa-IPV vaccine given to 4-6 year old children in Italy and Sweden following primary vaccination at 3, 5 and 11-12 months of age. Scan J Inf Dis 2005; 37: 221-229
Nilsson L et al. Comparison of a Booster Dose of Combined DTPa-IPV With Separate Injections of DTPa and IPV in 4 6 Year Olds. Abstract presented at the 21st Annual Meeting ESPID, Taormina, Sicily, 9-11 April 2003.
Medical condition
Diphtheria, Tetanus, acellular pertussis
Product
Diphtheria, Tetanus, Acellular Pertussis Vaccine Adsorbed
Collaborators
Not applicable
Study date(s)
January 2002 to July 2002
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
2002-11-07
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
Not applicable
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