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Immunogenicity and Reactogenicity of DTPa-HBV-IPV/Hib Vaccine Followed by the Same Vaccine and Oral Polio Vaccine

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01457560
First received: October 20, 2011
Last updated: NA
Last verified: October 2011
History: No changes posted
  Purpose

This study will assess the immunogenicity and safety of the GlaxoSmithKline (GSK) Biologicals' (formerly SmithKline Beecham Biologicals') combined DTPa-HBV-IPV/Hib (Infanrix hexa™) vaccine administered in the 3rd, 5th, 11th month of life. The last dose of DTPa-HBV-IPV/Hib will be given simultaneously with one dose of OPV vaccine.


Condition Intervention Phase
Hepatitis B
Diphtheria
Haemophilus Influenzae Type b (Hib)
Poliomyelitis
Pertussis
Tetanus
 Biological: DTPa-HBV-IPV/Hib (Infanrix hexa™)
Biological: OPV
 Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Study to Assess the Immunogenicity and Reactogenicity of DTPa-HBV-IPV Mixed With Hib Vaccine in Healthy Infants, Followed by a Dose of the Same Vaccine Administered Simultaneously With One Dose of Oral Polio Vaccine (OPV)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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 values [ Time Frame: One month after the second dose and one month after the third dose of the primary vaccination course ( Month 3 and Month 9) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 values [ Time Frame: Before the first dose ( Month 0 ) ] [ Designated as safety issue: No ]
  • Immunogenicity with respect to the components of the study vaccine in terms of antibody titers [ Time Frame: Before the first dose (Month 0), one month after the second dose and one month after the third dose of the primary vaccination course ( Month 3 and Month 9). ] [ Designated as safety issue: No ]
  • Immunogenicity with respect to the components of the study vaccine in terms of number of subjects with vaccine response [ Time Frame: One month after the second dose, and one month after the third dose of the primary vaccination course (Month 3 and Month 9). ] [ Designated as safety issue: No ]
  • Immunogenicity with respect to the components of the study vaccine in terms of antibody titres greater than or equal to cut off values [ Time Frame: One month after the second dose, and one month after the third dose of the primary vaccination course (Month 3 and Month 9). ] [ Designated as safety issue: No ]
  • Number of subjects with solicited and unsolicited adverse events [ Time Frame: After each dose of the study vaccines (Month 0, Month 3 and Month 9) and overall ] [ Designated as safety issue: No ]
  • Number of subjects with serious adverse events [ Time Frame: During the study period (Month 0 to Month 9) ] [ Designated as safety issue: No ]

Enrollment: 80
Study Start Date: February 2000
Study Completion Date: April 2001
Primary Completion Date: April 2001 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A Biological: DTPa-HBV-IPV/Hib (Infanrix hexa™)
Three doses administered intramuscularly
Biological: OPV
One dose administered orally

  Eligibility

Ages Eligible for Study:   12 Weeks to 16 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

The inclusion criteria will be checked at study entry. If any of these criteria does not apply, the subject is not eligible for inclusion in the study.

  • Healthy male and female subjects in the ≥12 and <16 weeks of life 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/guardians of the infant 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 exclusion criteria will be checked at study entry and at each following visit. If any of these criteria applies at study entry, the subject is not eligible for inclusion in the study. If any of these criteria becomes applicable during the study, the subject should be withdrawn.

  • 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.
  • 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 the time of enrolment.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01457560

Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided by GlaxoSmithKline

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT01457560     History of Changes
Other Study ID Numbers: 217744/060
Study First Received: October 20, 2011
Last Updated: October 20, 2011
Health Authority: Italy: AIFA - Italian Ministry of Health

Keywords provided by GlaxoSmithKline:
Oral polio vaccine (OPV)
DTPa-HBV-IPV/Hib vaccine

Additional relevant MeSH terms:
Diphtheria
Hepatitis
Hepatitis A
Hepatitis B
Influenza, Human
Whooping Cough
Poliomyelitis
Tetanus
Corynebacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
 Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Orthomyxoviridae Infections
Respiratory Tract Infections
Respiratory Tract Diseases
Bordetella Infections
Gram-Negative Bacterial Infections
Infection
Myelitis
Central Nervous System Viral Diseases
Central Nervous System Infections

ClinicalTrials.gov processed this record on May 16, 2013