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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

January 29, 2008
October 15, 2009
February 2008
June 2008   (final data collection date for primary outcome measure)
  • 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 ]
  • Anti-HBs antibody concentrations [ Time Frame: One month after the booster dose ]
  • Anti-PRP antibody concentrations [ Time Frame: One month after the booster dose ]
  • Anti-diphtheria antibody concentrations [ Time Frame: One month after the booster dose ]
  • Anti-poliovirus type 1, 2 and 3 titers [ Time Frame: One month after the booster dose ]
  • Anti-PT, anti-FHA and anti-PRN antibody concentrations [ Time Frame: One month after the booster dose ]
  • Anti-tetanus antibody concentrations [ Time Frame: One month after the booster dose ]
Complete list of historical versions of study NCT00611559 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Anti-HBs antibody concentrations [ Time Frame: One month after the booster dose ]
  • Anti-PRP antibody concentrations [ Time Frame: One month after the booster dose ]
  • Anti-PT, anti-FHA and anti-PRN seropositivity [ Time Frame: One month after the booster dose ]
  • Anti-HBs, anti-PRP, anti-diphtheria, anti-tetanus and anti-poliovirus types 1, 2 and 3 antibody concentrations or titres [ Time Frame: One month after the booster dose ]
  • Anti-HBs antibody concentrations [ Time Frame: Before the booster dose ]
  • Anti-PRP antibody concentrations [ Time Frame: Before the booster dose ]
  • Anti-diphtheria antibody concentrations [ Time Frame: Before the booster dose ]
  • Anti-tetanus antibody concentrations [ Time Frame: Before the booster dose ]
  • Anti-poliovirus type 1 titers [ Time Frame: Before the booster dose ]
  • Anti-poliovirus type 2 titers [ Time Frame: Before the booster dose ]
  • Anti-poliovirus type 3 titers [ Time Frame: Before the booster dose ]
  • Anti-PT, anti-FHA and anti-PRN seropositivity [ Time Frame: Before the booster dose ]
  • Anti-HBs, anti-PRP, anti-diphtheria, anti-tetanus and anti-poliovirus types 1, 2 and 3, anti-PT, anti-FHA and anti-PRN antibody concentrations or titres. [ Time Frame: Before the booster dose ]
  • Occurrence of solicited local and general symptoms [ Time Frame: During the 4-day follow-up period ]
  • Occurrence of unsolicited symptoms [ Time Frame: During the 31-day follow-up period ]
  • Occurrence of SAEs [ Time Frame: Following booster vaccination ]
Not Provided
Not Provided
 
Study of a New Formulation of DTPa-HBV-IPV/Hib Vaccine Administered as a Booster Dose to 18-23 Months Old Children
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

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • Diphtheria
  • Tetanus
  • Pertussis
  • Hepatitis B
  • Poliomyelitis
  • Haemophilus Influenzae Type b Disease
  • Biological: Infanrix™ penta
    Subjects received a booster dose
    Other Name: Pediarix
  • Biological: Infanrix™ hexa
    Subjects received a booster dose
  • Active Comparator: Infanrix hexa Preservative-Containing Formulation Group
    Subjects received a booster dose of the preservative-containing formulation of Infanrix™ hexa
    Intervention: Biological: Infanrix™ hexa
  • Active Comparator: Infanrix penta Preservative-Free Formulation Group
    Subjects received a booster dose of the preservative-free formulation of Infanrix™ penta.
    Intervention: Biological: Infanrix™ penta
  • Experimental: Infanrix hexa Preservative-Free Formulation Group
    Subjects received a booster dose of the preservative-free formulation of Infanrix™ hexa
    Intervention: Biological: Infanrix™ hexa
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
283
June 2008
June 2008   (final data collection date for primary outcome measure)

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
Both
18 Months to 23 Months
Yes
Contact information is only displayed when the study is recruiting subjects
Russian Federation
 
NCT00611559
110478
Not Provided
Study Director, GSK
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP