Last updated: 11/29/2018 16:30:26
Study to assess immunogenicity and reactogenicity of GSK Bio’s combined DTPa-HBV-IPV/Hib vaccine in pre-term infants in comparison with term infants, administered as a booster dose to children who previously were primed with 3 doses of GSK Biologicals combined DTPa-HBV-IPV/Hib vaccine
Clinicaltrials.gov ID
Not applicable
EudraCT ID
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: Study to assess immunogenicity and reactogenicity of GSK Bio’s combined DTPa-HBV-IPV/Hib vaccine in pre-term infants in comparison with term infants, administered as a booster dose to children who previously were primed with 3 doses of GSK Biologicals combined DTPa-HBV-IPV/Hib vaccine
Trial description: Study to assess immunogenicity and reactogenicity of GSK Bio’s combined DTPa-HBV-IPV/Hib vaccine in pre-term infants in comparison with term infants, administered as a booster dose to children who previously were primed with 3 doses of GSK Biologicals combined DTPa-HBV-IPV/Hib vaccine
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:
Omeñaca F et al (2007) DTPa-HBV-IPV-083 / DTPa-130: Antibody persistence and booster vaccination during the second and fifth years of life in a cohort of children who were born prematurelyPediatr Infect Dis J, 26 (9):824-829.
Omeñaca et al. (2007) Antipolyribosyl Ribitol Phosphate Response of Premature Infants to Primary and Booster Vaccination With a Combined Diphteria-Tetanus-Acellular Pertussis-Hepatitis B-Inactivated Polio Virus/Haemophilus influenzae Type b Vaccine. Pediatrics. 119: 179-185.
Medical condition
Diphtheria, Haemophilus influenzae type b, Hepatitis B, Poliomyelitis, Tetanus, acellular pertussis
Product
Combined Diphtheria, Tetanus, Acellular Pertussis, Hepatitis B, Inactivated Polio, Haemophilus influenzae Type b Vaccine
Collaborators
Not applicable
Study date(s)
September 2001 to August 2002
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
2002-06-08
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
Participate in clinical trial
Access to clinical trial data by researchers
Visit website