Immunogenicity and Reactogenicity of DTPa-HBV-IPV/Hib, Compared to DTPa-HBV-IPV and Hib Administered Separately

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01457508
• Other study ID #: 217744/054
• Status: Completed
• Phase: Phase 3
• First received: October 20, 2011
• Last updated: June 15, 2017
• Start date: January 1999
• Est. completion date: March 2000

Study information

• Verified date: June 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Diphtheria
• Haemophilus Influenzae Type b (Hib)
• Hepatitis B
• Pertussis
• Poliomyelitis
• Tetanus

Intervention

Biological:
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

References & Publications (2)

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

Outcome

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)