Hepatitis B Clinical Trial
Official title:
Study to Assess the Immunogenicity and Reactogenicity of DTPa-HBV-IPV Vaccine Mixed With Hib Vaccine to Healthy Infants at 3, 5 and 11 Months of Age, Compared to Each Vaccine Administered Separately
Verified date | June 2017 |
Source | GlaxoSmithKline |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study will assess the immunogenicity and safety of GlaxoSmithKline (GSK) Biologicals' (formerly SB Biologicals') DTPa-HBV-IPV/Hib (Infanrix hexa™) vaccine compared with separate administration of DTPa-HBV-IPV (Infanrix penta™) and Hib (Hiberix™) vaccine administered at 3, 5 and 11 (or 12) months of age.
Status | Completed |
Enrollment | 440 |
Est. completion date | March 2000 |
Est. primary completion date | March 2000 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 12 Weeks to 16 Weeks |
Eligibility |
Inclusion Criteria: - A male or female 3 months of age at the time of the first vaccination. - 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: The following criteria should be checked at the time of study entry. If any apply at the time of study entry, the subject must not be included in the study: - 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 |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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GlaxoSmithKline |
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Immunogenicity with respect to the components of the study vaccine in terms of number of subjects with antibody titres greater than or equal to cut off value | One month after the 2nd dose of the primary vaccination course ( Month 3) | ||
Secondary | Immunogenicity with respect to the components of the study vaccines in terms of number of seroprotected subjects | One month after the 2nd dose ( Month 3), before and one month after the 3rd dose of the primary vaccination course ( Month 8 and 9) | ||
Secondary | Immunogenicity with respect to the components of the study vaccines in terms of number of seropositive subjects | One month after the 2nd dose ( Month 3), before and one month after the 3rd dose of the primary vaccination course ( Month 8 and 9) | ||
Secondary | Immunogenicity with respect to the components of the study vaccines in terms of antibody titres | One month after the 2nd dose ( Month 3), before and one month after the 3rd dose of the primary vaccination course ( Month 8 and 9) | ||
Secondary | Immunogenicity with respect to the components of the study vaccines in terms of vaccine response | One month after the 3rd dose ( Month 9), and one month after the 2nd dose of the primary vaccination course ( Month3) | ||
Secondary | Occurrence of solicited local symptoms | Within 4 days after each vaccination and overall | ||
Secondary | Occurrence of solicited general symptoms | Within 4 days after each vaccination and overall | ||
Secondary | Occurrence of unsolicited symptoms | Within 30 days after each vaccination and overall | ||
Secondary | Occurrence of serious adverse events | Throughout the entire study up to and including 30 days post-vaccination ( Month 0 to Month 9) |
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