Last updated: 11/29/2018 16:20:26
An open, multicenter, phase IV clinical trial to assess the immunogenicity and reactogenicity of three doses of GSK Biologicals’ combined DTPa-HBV-IPV/Hib vaccine in healthy infants at 2, 4 and 6 months of age, when co-administered with Wyeth-Lederle’s meningococcal group C conjugate vaccine.
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: An open, multicenter, phase IV clinical trial to assess the immunogenicity and reactogenicity of three doses of GSK Biologicals’ combined DTPa-HBV-IPV/Hib vaccine in healthy infants at 2, 4 and 6 months of age, when co-administered with Wyeth-Lederle’s meningococcal group C conjugate vaccine.
Trial description: An open, multicenter, phase IV clinical trial to assess the immunogenicity and reactogenicity of three doses of GSK Biologicals’ combined DTPa-HBV-IPV/Hib vaccine in healthy infants at 2, 4 and 6 months of age, when co-administered with Wyeth-Lederle’s meningococcal group C conjugate 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:
Tejedor J. CO-ADMINISTRATION OF DTPa-HBV-IPV/Hib WITH MENINGOCOCCAL C CONJUGATE VACCINE. Abstract presented at the 21st Annual Meeting of the European Society of Paediatric Infectious Diseases (ESPID), Taormina, Sicily, 9-11 April 2003.
Tejedor JC. et al. (2004) Immunogenicity and reactogenicity of a three-dose primary vaccination course with a combined diphtheria-tetanus-acellular pertussis-hepatitis B-inactivated polio- Haemophilus influenzae type b vaccine coadministered with a meningococcal C conjugate vaccine. Pediatr Infect Dis J. 23(12): 1109–1115.
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
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)
June 2001 to July 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
2002-17-07
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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Access to clinical trial data by researchers
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