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Study of a Birth Dose of GlaxoSmithKline Biologicals' 251154 Vaccine

This study has been withdrawn prior to enrollment.
(Study was cancelled before enrolment for reasons not related to vaccine safety or efficacy.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01110044
First Posted: April 23, 2010
Last Update Posted: March 27, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
GlaxoSmithKline
  Purpose
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.

Condition Intervention Phase
Infections, Rotavirus Biological: 251154 vaccine Biological: Infanrix hexa™ Biological: Synflorix™ Biological: Rotarix™ Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Immunogenicity and Safety of a Birth Dose of GlaxoSmithKline Biologicals' Reduced-antigen-content Tri-component Pertussis (251154) Vaccine

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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. ]

Secondary Outcome Measures:
  • 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. ]

Enrollment: 0
Study Start Date: April 2010
Estimated Study Completion Date: August 2012
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Biological: 251154 vaccine
Intramuscular, single dose
Biological: Infanrix hexa™
Intramuscular, four doses
Biological: Synflorix™
Intramuscular, four doses
Biological: Rotarix™
Oral, two doses
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.
Biological: Infanrix hexa™
Intramuscular, four doses
Biological: Synflorix™
Intramuscular, four doses
Biological: Rotarix™
Oral, two doses

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 5 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01110044


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

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01110044     History of Changes
Other Study ID Numbers: 112980
First Submitted: April 22, 2010
First Posted: April 23, 2010
Last Update Posted: March 27, 2015
Last Verified: March 2015

Keywords provided by GlaxoSmithKline:
Neonatal vaccination

Additional relevant MeSH terms:
Rotavirus Infections
Reoviridae Infections
RNA Virus Infections
Virus Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs