Study of a Birth Dose of GlaxoSmithKline Biologicals' 251154 Vaccine

• ClinicalTrials.gov Identifier: NCT01110044
• Recruitment Status: Withdrawn
• First Posted: April 23, 2010
• Last Update Posted: March 27, 2015
• Sponsor: GlaxoSmithKline
• Information provided by (Responsible Party): GlaxoSmithKline

Tracking Information

• First Submitted Date: April 22, 2010
• First Posted Date: April 23, 2010
• Last Update Posted Date: March 27, 2015
• Study Start Date: April 2010
• Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current
• Change History: Complete list of historical versions of study NCT01110044 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Study of a Birth Dose of GlaxoSmithKline Biologicals' 251154 Vaccine
• Official Title: 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: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Prevention
• Condition: Infections, Rotavirus

Intervention

• Biological: 251154 vaccine
  Intramuscular, single dose
• Biological: Infanrix hexa™
  Intramuscular, four doses
• Biological: Synflorix™
  Intramuscular, four doses
• Biological: Rotarix™
  Oral, two doses

Study Arms

• 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

Recruitment Information

• Recruitment Status: Withdrawn
• Actual Enrollment (submitted: March 26, 2015): 0
• Original Estimated Enrollment (submitted: April 22, 2010): 300
• Estimated Study Completion Date: August 2012
• Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: up to 5 Days (Child)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT01110044
• Other Study ID Numbers: 112980
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: GlaxoSmithKline
• Study Sponsor: GlaxoSmithKline
• Collaborators: Not Provided

Investigators

• Study Director: GSK Clinical Trials; GlaxoSmithKline

• PRS Account: GlaxoSmithKline
• Verification Date: March 2015