Last updated: 11/04/2018 01:13:47
Immunogenicity & safety study of combined/separate vaccine(s) against common diseases in infants (2,4,6 months of age).
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: Study to assess immunogenicity and reactogenicity of three doses of GSK Bio’s combined Hib-MenC vaccine co-admind with GSK Bio’s DTPa-HBV-IPV vaccine and of two doses of Baxters meningococcal C conjugate vaccine co-admind with GSK Bio’s DTPa-HBV-IPV/Hib vaccine
Trial description: This study will evaluate the immunogenicity of the co-administration of different combinations of DTPa, IPV, hepatitis B, Hib and Men C vaccines during the first year of life.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Enrollment:
480
Primary completion date:
Not applicable
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
J.C. Tejedor et al. (2006) Immunogenicity and reactogenicity of primary immunisation with a hexavalent diphtheria-tetanus-acellular pertussis-hepatitis B-inactivated polio-Haemophilus influenzae type b vaccine co-administered with two doses of a meningococcal C-tetanus toxoid conjugate vaccine. Pediatr Infect Dis J, 25 (8):713-720.
J.C. Tejedor et al. (2007) Immunogenicity and reactogenicity of primary immunization with a novel combined Haemophilus influenzae type b and Neisseria meningitidis serogroup C-tetanus toxoid conjugate vaccine co-administered with a diphtheria-tetanus-acellular pertussis-hepatitis B-inactivated poliovirus vaccine at 2, 4 and 6 months. Pediatr Infect Dis J 2007, 26(1): 1-7.
Jeanne Jaquet et al. Co-administration of DTPa-HBV-IPV/Hib with two doses of a MenC-TT conjugate vaccine in primary vaccination - 23rd Annual Meeting ESPID, Valencia, Spain, 18-20 May 2005.
Tejedor et al. Immunogenicity and reactogenicity of a novel combined Haemophilus influenzae type b and Neisseria meningitidis serogroup C-tetanus toxoid conjugate (Hib-MenC-TT) Vaccine co-administered with a pentavalent DTPa-HBV-IPV vaccine at 2, 4 and 6 months - 24th Annual Meeting ESPID, Basel, Switzerland, 03-05 May 2006.
Tozzi AE et al (2007) Can Hexavalent Vaccines Be Simultaneously Administered with Pneumococcal or Meningococcal Conjugate Vaccines. Hum Vaccin, 3 (6):252-259.
Medical condition
Poliomyelitis, Tetanus, acellular pertussis, Hepatitis B, Diphtheria
Product
SB217744
Collaborators
Not applicable
Study date(s)
September 2003 to July 2004
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
0 - 7 days
Accepts healthy volunteers
Yes
- Healthy male or female infant between, & including, 0 & 7 days of age at the time of the inclusion. Born after a normal gestation period (between 36 & 42 weeks).
- Written informed consent obtained from the parent/guardian of the subject.
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) or planned use during the study period.
- Administration of immunosuppressants or other immune-modifying drugs from birth.
Inclusion and exclusion criteria
Inclusion criteria:
- Healthy male or female infant between, & including, 0 & 7 days of age at the time of the inclusion. Born after a normal gestation period (between 36 & 42 weeks).
- Written informed consent obtained from the parent/guardian of the subject.
Exclusion criteria:
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) or planned use during the study period.
- Administration of immunosuppressants or other immune-modifying drugs from birth.
- Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
- Administration / planned administration of a vaccine not foreseen by the study protocol during the period starting from birth and ending 30 days after the last dose except BCG vaccination if given before the 30-day period preceding the administration of the 1st dose of Infanrix penta™ or Infanrix hexa™ in combination with a meningococcal C vaccine.
- Evidence of previous or intercurrent diphtheria, tetanus, pertussis, polio, hepatitis B, meningococcal C and Hib disease.
- Evidence of previous diphtheria, tetanus, pertussis, polio, hepatitis B, meningococcal C and Hib vaccination.
Trial location(s)
Showing 1 - 6 of 22 Results
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
Refer to study documents
Recruitment status
Study complete
Actual primary completion date
Not applicable
Actual study completion date
2004-16-07
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
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Additional information
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