Immunogenicity and Reactogenicity of DTPa-HBV-IPV/Hib, Compared to DTPa-HBV-IPV and Hib Administered Separately
NCT ID: NCT01457508
Last Updated: 2017-06-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
440 participants
INTERVENTIONAL
1999-01-31
2000-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Group A
Subjects will receive one single injection of DTPa-HBV-IPV vaccine mixed with Hib vaccine.
DTPa-HBV-IPV/Hib (Infanrix hexa™)
Three doses administered intramuscularly
Group B
Subjects will receive two separate injections of DTPa-HBV-IPV and Hib vaccine.
DTPa-HBV-IPV (Infanrix penta™)
Three doses administered intramuscularly
Hib (Hiberix™)
Three doses administered intramuscularly
Interventions
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DTPa-HBV-IPV/Hib (Infanrix hexa™)
Three doses administered intramuscularly
DTPa-HBV-IPV (Infanrix penta™)
Three doses administered intramuscularly
Hib (Hiberix™)
Three doses administered intramuscularly
Eligibility Criteria
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Inclusion Criteria
* Free of obvious health problems as established by medical history and clinical examination before entering into the study.
* Written informed consent obtained from the parents or guardians of the subject after they have been advised of the risks and benefits of the study in a language which they clearly understood, and before performance of any study procedure.
Exclusion Criteria
* Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
* Administration of chronic immunosuppressants or other immune-modifying drugs within three months before vaccination.
* Administration of a vaccine not foreseen by the study within 30 days before each dose of the study vaccines and ending 30 days after.
* Previous vaccination against diphtheria, tetanus, pertussis, hepatitis B, polio and/or Hib disease.
* History of /or intercurrent diphtheria, tetanus, pertussis, hepatitis B, polio and/or Hib disease or infection.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
* History of allergic disease or reactions likely to be exacerbated by any component of the vaccine, including allergic reactions to neomycin and polymyxin B.
* Major congenital defects or serious chronic illness.
* History of seizures or of any neurological disease at study entry.
* Administration of immunoglobulins and/or any blood products since birth, or planned administration during the study period.
* Acute disease at time of enrolment
12 Weeks
16 Weeks
ALL
Yes
Sponsors
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GlaxoSmithKline
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
References
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Crovari P. et al. Immunogenicity and reactogenicity of combined DTPa-HBV-IPV/Hib vaccine compared to concomitant administered DTPa-HBV-IPV and Hib vaccines given at 3, 5 and 11 months of age. Abstract presented at the 19th Annual Meeting ESPID, Istanbul, Turkey, 26-28 March 2001.
Gabutti G, Zepp F, Schuerman L, Dentico P, Bamfi F, Soncini R, Habermehl P, Knuf M, Crovari P; Cooperative Italian Group for the Study of Combined Vaccines. Evaluation of the immunogenicity and reactogenicity of a DTPa-HBV-IPV Combination vaccine co-administered with a Hib conjugate vaccine either as a single injection of a hexavalent combination or as two separate injections at 3, 5 and 11 months of age. Scand J Infect Dis. 2004;36(8):585-92. doi: 10.1080/00365540410017572.
Van Der Meeren O, Kuriyakose S, Kolhe D, Hardt K. Immunogenicity of Infanrix hexa administered at 3, 5 and 11 months of age. Vaccine. 2012 Apr 5;30(17):2710-4. doi: 10.1016/j.vaccine.2012.02.024. Epub 2012 Feb 18.
Other Identifiers
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217744/054
Identifier Type: -
Identifier Source: org_study_id
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