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Study of a New Formulation of DTPa-HBV-IPV/Hib Vaccine Administered as a Booster Dose to 18-23 Months Old Children

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00611559
First received: January 29, 2008
Last updated: October 15, 2009
Last verified: October 2009
  Purpose

The new formulation administered as a 4th consecutive dose will be compared to the current formulation of the vaccine in this partially double blind study.

The study will be double-blind with respect to the two DTPa-HBV-IPV/Hib groups. The study will be open with respect to the DTPa-HBV-IPV group.


Condition Intervention Phase
Diphtheria
Tetanus
Pertussis
Hepatitis B
Poliomyelitis
Haemophilus Influenzae Type b Disease
Biological: Infanrix™ penta
Biological: Infanrix™ hexa
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Immunogenicity and Reactogenicity Study of a New Formulation of GSK Biologicals' DTPa-HBV-IPV/Hib Vaccine Administered as a Booster Dose to 18-23 Months Old Children

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Number of Subjects With Anti-hepatitis B (HB) Antibody Concentrations Above the Cut-off One Month After the Booster Dose [ Time Frame: One month after the booster dose ] [ Designated as safety issue: No ]
  • Number of Subjects With Anti-polyribosyl-ribitol-phosphate (PRP) Antibodies Concentrations Above the Cut-off One Month After the Booster Dose [ Time Frame: One month after the booster dose ] [ Designated as safety issue: No ]
  • Number of Subjects With Anti-diphtheria and Anti-tetanus Antibodies Concentration Above the Cut-off One Month After the Booster Dose [ Time Frame: One month after the booster dose ] [ Designated as safety issue: No ]
  • Number of Subjects With Anti-poliovirus Antibodies Concentration Above the Cut-off One Month After the Booster Dose [ Time Frame: One month after the booster dose ] [ Designated as safety issue: No ]
  • Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN) Antibodies Concentration One Month After the Booster Dose [ Time Frame: One month after the booster dose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of Subjects With Anti-hepatitis B (HB) Antibody Concentrations Above the Cut-off Before and One Month After the Booster Dose [ Time Frame: Before (Pre) and one month after (Post) the booster dose ] [ Designated as safety issue: No ]
  • Anti-HB Antibodies Concentration [ Time Frame: Before (Pre) and one month after (Post) the booster dose ] [ Designated as safety issue: No ]
  • Number of Subjects With Anti-PRP Antibodies Concentrations Above the Cut-off Before and One Month After the Booster Dose [ Time Frame: Before (Pre) and one month after (Post) the booster dose ] [ Designated as safety issue: No ]
  • Anti-PRP Antibodies Concentration [ Time Frame: Before (Pre) and one month after (Post) the booster dose ] [ Designated as safety issue: No ]
  • Number of Subjects With Anti-diphtheria and Anti-tetanus Antibodies Concentration Above the Cut-off Before the Booster Dose [ Time Frame: Before the booster dose administration (at baseline) ] [ Designated as safety issue: No ]
  • Anti-diphtheria and Anti-tetanus Antibodies Concentration [ Time Frame: Before (Pre) and one month after (Post) the booster dose ] [ Designated as safety issue: No ]
  • Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibodies Concentration Above the Cut-off Before and One Month After the Booster Dose [ Time Frame: Before (Pre) and one month after (Post) the booster dose ] [ Designated as safety issue: No ]
  • Anti-PT, Anti-FHA, and Anti-PRN Antibodies Concentration Before the Booster Dose [ Time Frame: Before the booster dose administration (at baseline) ] [ Designated as safety issue: No ]
  • Number of Subjects With Anti-poliovirus Antibodies Concentration Above the Cut-off Before the Booster Dose [ Time Frame: Before the booster dose ] [ Designated as safety issue: No ]
  • Anti-poliovirus Antibodies Titer [ Time Frame: Before (Pre) and one month after (Post) the booster dose ] [ Designated as safety issue: No ]
  • Number of Subjects Reporting Solicited Symptoms [ Time Frame: Within the 4-day (Day 0-3) post-vaccination period ] [ Designated as safety issue: No ]
  • Number of Subjects Reporting Unsolicited Adverse Events (AE) [ Time Frame: Within the 31-day (Day 0-30) post-vaccination period ] [ Designated as safety issue: No ]
  • Number of Subjects Reporting Serious Adverse Events (SAE) [ Time Frame: Up to one month after the booster dose administration ] [ Designated as safety issue: No ]

Enrollment: 283
Study Start Date: February 2008
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Infanrix hexa Preservative-Containing Formulation Group
Subjects received a booster dose of the preservative-containing formulation of Infanrix™ hexa
Biological: Infanrix™ hexa
Subjects received a booster dose
Active Comparator: Infanrix penta Preservative-Free Formulation Group
Subjects received a booster dose of the preservative-free formulation of Infanrix™ penta.
Biological: Infanrix™ penta
Subjects received a booster dose
Other Name: Pediarix
Experimental: Infanrix hexa Preservative-Free Formulation Group
Subjects received a booster dose of the preservative-free formulation of Infanrix™ hexa
Biological: Infanrix™ hexa
Subjects received a booster dose

  Eligibility

Ages Eligible for Study:   18 Months to 23 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study.
  • Subjects must have completed full three-dose primary vaccination course with DTPa-HBV-IPV/Hib or DTPa-HBV-IPV in the primary study DTPa-HBV-IPV-109 (study NCT00320463).
  • A male or female between, and including 18 and 23 months of age at the time of the booster vaccination.
  • Written informed consent obtained from the parent or guardian of the subject.
  • Healthy subjects as established by medical history and clinical examination before entering into the study.

Exclusion Criteria:

  • Use of any investigational or non-registered product other than the study vaccines within 30 days preceding the booster dose of study vaccine, or planned use during the study period.
  • Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the booster dose.
  • Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days of the booster dose.
  • Participation in another clinical study, between the primary study NCT00320463 and the present booster study, or at any time during the study, in which the subject has been or will be exposed to an investigational or a non-investigational product.
  • Previous booster vaccination against diphtheria, tetanus, pertussis, poliomyelitis and hepatitis B since the conclusion visit of study NCT00320463.
  • Previous booster vaccination against Haemophilus influenzae diseases in the DTPa-HBV-IPV/Hib groups, since the conclusion visit of study NCT00320463.
  • History of exposure to diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B and/or Haemophilus influenzae disease since the conclusion visit of study NCT00320463.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on physical examination.
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
  • Acute disease at the time of enrolment.
  • Administration of immunoglobulins and/or any blood products within the three months preceding the booster dose or planned administration during the study period.
  • Any of the following adverse events having occurred after previous administration of DTP vaccine:
  • Hypersensitivity reaction due to the vaccine.
  • Encephalopathy defined as an acute, severe central nervous system disorder of unknown etiology occurring within 7 days following previous vaccination and generally consisting of major alterations in consciousness, unresponsiveness, generalized or focal seizures that persist more than a few hours, with failure to recover within 24 hours.
  • Any of the following adverse events having occurred after previous administration of DTP vaccine:
  • Temperature of >= 40.0 °C (axillary temperature), within 48 hours of vaccination.
  • Collapse or shock-like state within 48 hours of vaccination.
  • Persistent, inconsolable crying lasting >= 3 hours, occurring within 48 hours of vaccination.
  • Convulsions with or without fever, occurring within 3 days of vaccination
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00611559

Locations
Russian Federation
GSK Investigational Site
Murmansk, Russian Federation, 183046
GSK Investigational Site
Perm, Russian Federation, 614022
GSK Investigational Site
Syktyvkar, Russian Federation, 167000
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Study Director, GSK
ClinicalTrials.gov Identifier: NCT00611559     History of Changes
Other Study ID Numbers: 110478
Study First Received: January 29, 2008
Results First Received: June 22, 2009
Last Updated: October 15, 2009
Health Authority: Russia: Ministry of Health of the Russian Federation

Keywords provided by GlaxoSmithKline:
Infanrix hexa
combined vaccine

Additional relevant MeSH terms:
Hepatitis B
Poliomyelitis
Central Nervous System Diseases
Central Nervous System Infections
Central Nervous System Viral Diseases
DNA Virus Infections
Digestive System Diseases
Enterovirus Infections
Hepadnaviridae Infections
Hepatitis
Hepatitis, Viral, Human
Liver Diseases
Myelitis
Nervous System Diseases
Neuromuscular Diseases
Picornaviridae Infections
RNA Virus Infections
Spinal Cord Diseases
Virus Diseases

ClinicalTrials.gov processed this record on November 27, 2014