Last updated: 11/29/2018 16:20:41
An open, multicentre, phase IV booster vaccination study to assess the immunogenicity and reactogenicity of a 4th dose of GSK Biologicals’ combined DTPa-HBV-IPV/Hib vaccine, co-administered with Wyeth's seven-valent Pneumococcal conjugate vaccine at a different injection site during the same visit in healthy children
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, multicentre, phase IV booster vaccination study to assess the immunogenicity and reactogenicity of a 4th dose of GSK Biologicals’ combined DTPa-HBV-IPV/Hib vaccine, co-administered with Wyeth's seven-valent Pneumococcal conjugate vaccine at a different injection site during the same visit in healthy children
Trial description: An open, multicentre, phase IV booster vaccination study to assess the immunogenicity and reactogenicity of a 4th dose of GSK Biologicals’ combined DTPa-HBV-IPV/Hib vaccine, co-administered with Wyeth's seven-valent Pneumococcal conjugate vaccine at a different injection site during the same visit in healthy children
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:
Alberto E. Tozzi et al. (2007) Hexavalent Vaccines Be Simultaneously Administered with Pneumococcal or Meningococcal Conjugate Vaccines? Hum Vaccin. 3 (6):252-259.
Schuerman et al. Immunogenicity and Reactogenicity of four doses (primary and booster) of Diphtheria-Tetanus-acellular Pertussis-Hepatitis B inactivated Poliovirus-Haemophilus influenzae Type b vaccine co administered with 7-Valent Pneumococcal conjugate vaccine. Abstract presented at the 24th ICP, Cancun, Mexico, 15-20 Aug 2004.
Sänger R et al. Safety and Immunogenicity of a Fourth (Booster) Dose of Diphtheria-Tetanus-Acellular Pertussis-HBV-IPV/Hib Vaccine Co-administered with 7-Valent Pneumococcal Conjugate Vaccine. Abstract presented at the 21st Annual Meeting ESPID, Taormina, Sicily, 9-11 April 2003.
Tichmann-Schumann I. et al. Immunogenicity and reactogenicity of four doses of diphtheria-tetanus-three component acellular pertussis-hepatitis B-inactivated polio virus-Haemophilus influenzae type b vaccine coadministered with 7-valent pneumococcal conjugate vaccine. Pediatr Infect Dis J. 2005; 24 (1): 70– 77.
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)
N/A 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
2002-15-07
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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