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Study of a Birth Dose of GlaxoSmithKline Biologicals' 251154 Vaccine

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ClinicalTrials.gov Identifier: NCT01110044
Recruitment Status : Withdrawn (Study was cancelled before enrolment for reasons not related to vaccine safety or efficacy.)
First Posted : April 23, 2010
Last Update Posted : March 27, 2015
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Tracking Information
First Submitted Date  ICMJE April 22, 2010
First Posted Date  ICMJE April 23, 2010
Last Update Posted Date March 27, 2015
Study Start Date  ICMJE April 2010
Estimated Primary Completion Date August 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 22, 2010)
  • Immunogenicity with respect to components of the study vaccines. [ Time Frame: One month after the first dose of primary vaccination. ]
  • Immunogenicity with respect to components of the study vaccines. [ Time Frame: One month after the third dose of primary vaccination. ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01110044 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 22, 2010)
  • Immunogenicity with respect to components of the study vaccines (on secondary readouts). [ Time Frame: One month after the second dose of primary vaccination. ]
  • Immunogenicity with respect to components of the study vaccines (on secondary readouts). [ Time Frame: One month after the third dose of primary vaccination. ]
  • Immunogenicity with respect to components of the study vaccines (on secondary readouts). [ Time Frame: One month after booster vaccination. ]
  • Occurrence of solicited local and general symptoms (on secondary readouts). [ Time Frame: On Day 0-Day 7 after neonatal vaccination. ]
  • Occurrence of solicited local and general symptoms (on secondary readouts). [ Time Frame: On Day 0-Day 3 after each dose of primary and booster vaccination. ]
  • Occurrence of unsolicited adverse events (on secondary readouts). [ Time Frame: On Day 0-Day 30 after each vaccination. ]
  • Occurrence of serious adverse events (on secondary readouts). [ Time Frame: From enrolment up to study end. ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of a Birth Dose of GlaxoSmithKline Biologicals' 251154 Vaccine
Official Title  ICMJE Immunogenicity and Safety of a Birth Dose of GlaxoSmithKline Biologicals' Reduced-antigen-content Tri-component Pertussis (251154) Vaccine
Brief Summary The purpose of the study is to evaluate the safety and immunogenicity of a birth dose of GSK Biologicals' reduced-antigen-content tri-component pertussis (251154) vaccine followed by routine paediatric vaccination.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Infections, Rotavirus
Intervention  ICMJE
  • Biological: 251154 vaccine
    Intramuscular, single dose
  • Biological: Infanrix hexa™
    Intramuscular, four doses
  • Biological: Synflorix™
    Intramuscular, four doses
  • Biological: Rotarix™
    Oral, two doses
Study Arms  ICMJE
  • Experimental: Group A
    Subjects will be administered 251154 vaccine at birth, Infanrix hexa™ at 2, 4, 6 and 12-18 months of age, Synflorix™ at 2, 4, 6 and 12-18 months of age, Rotarix™ at 2 and 4 months of age.
    Interventions:
    • Biological: 251154 vaccine
    • Biological: Infanrix hexa™
    • Biological: Synflorix™
    • Biological: Rotarix™
  • Active Comparator: Group B
    Subjects will be administered no vaccine at birth, Infanrix hexa™ at 2, 4, 6 and 12-18 months of age, Synflorix™ at 2, 4, 6 and 12-18 months of age, Rotarix™ at 2 and 4 months of age.
    Interventions:
    • Biological: Infanrix hexa™
    • Biological: Synflorix™
    • Biological: Rotarix™
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: March 26, 2015)
0
Original Estimated Enrollment  ICMJE
 (submitted: April 22, 2010)
300
Estimated Study Completion Date  ICMJE August 2012
Estimated Primary Completion Date August 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subjects who the investigator believes that their parent(s)/LAR(s) can and will comply with the requirements of the protocol.
  • Written informed consent obtained from the parent(s)/LAR(s) of the subject.
  • A male or female infant between, and including, 2 and 5 days of age at the time of randomisation.
  • Subjects who are born after an uncomplicated gestation period of 36 to 42 weeks inclusive.
  • Subjects born to a mother seronegative for hepatitis B surface antigen.
  • Subjects with a birth weight >= 2.5 kg.
  • Subjects with a 5-minute Apgar score >= 7.
  • Healthy subjects as established by medical history and clinical examination

Exclusion Criteria:

  • Use of any investigational or non-registered product other than the study vaccines since birth, or planned use during the study period.
  • Born to a mother known or suspected to be seropositive for HIV.
  • Family history of congenital or hereditary immunodeficiency.
  • Children in care..
  • Neonatal jaundice requiring systemic treatment.
  • Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
  • Administration of any vaccine since birth or planned administration during the study period with the exception of inactivated influenza vaccines.
  • Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product.
  • History of seizures or progressive neurological disease.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
  • History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines.
  • Major congenital defects or serious chronic illness, including perinatal brain damage.

The following condition is temporary or self-limiting, and a subject may be vaccinated once the condition has resolved if no other exclusion criteria is met:

• Current febrile illness or temperature >= 38.5°C on oral or axillary setting, or >= 39.0°C on rectal setting, or other moderate to severe illness within 24 hours of study vaccine administration.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 5 Days   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01110044
Other Study ID Numbers  ICMJE 112980
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party GlaxoSmithKline
Study Sponsor  ICMJE GlaxoSmithKline
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: GSK Clinical Trials GlaxoSmithKline
PRS Account GlaxoSmithKline
Verification Date March 2015

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