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
Completed
Completed
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:
Biological/vaccine: Study vaccines: IH+Hib-MenC/NVC; Control: IH+Meningitec
Enrollment:
480
Observational study model:
Not applicable
Primary completion date:
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)
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
Completed
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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