Last updated: 11/29/2018 16:00:40
Open, clinical study to assess the safety and reactogenicity of GlaxoSmithKline (GSK) Biologicals’ combined diphtheria, tetanus, acellular pertussis, hepatitis B, inactivated poliovirus vaccine (DTPa-HBV-IPV) administered mixed in the same syringe with GSK Biologicals’ Haemophilus influenzae type b (Hib), tetanus conjugate vaccine in the 3rd and 5th month of life healthy infants, followed at the 11th month of life by a dose of the same GSK Biologicals’ DTPa-HBV-IPV and Hib vaccines mixed in the same syringe and administered simultaneously with one dose of oral poliovirus vaccine
Clinicaltrials.gov ID
Not applicable
EudraCT ID
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: Open, clinical study to assess the safety and reactogenicity of GlaxoSmithKline (GSK) Biologicals’ combined diphtheria, tetanus, acellular pertussis, hepatitis B, inactivated poliovirus vaccine (DTPa-HBV-IPV) administered mixed in the same syringe with GSK Biologicals’ Haemophilus influenzae type b (Hib), tetanus conjugate vaccine in the 3rd and 5th month of life healthy infants, followed at the 11th month of life by a dose of the same GSK Biologicals’ DTPa-HBV-IPV and Hib vaccines mixed in the same syringe and administered simultaneously with one dose of oral poliovirus vaccine
Trial description: Open, clinical study to assess the safety and reactogenicity of GlaxoSmithKline (GSK) Biologicals’ combined diphtheria, tetanus, acellular pertussis, hepatitis B, inactivated poliovirus vaccine (DTPa-HBV-IPV) administered mixed in the same syringe with GSK Biologicals’ Haemophilus influenzae type b (Hib), tetanus conjugate vaccine in the 3rd and 5th month of life healthy infants, followed at the 11th month of life by a dose of the same GSK Biologicals’ DTPa-HBV-IPV and Hib vaccines mixed in the same syringe and administered simultaneously with one dose of oral poliovirus 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:
Not applicable
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)
February 2000 to Invalid Date
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
Not applicable
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