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This study has been withdrawn prior to enrollment.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:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01110044
First received: April 22, 2010
Last updated: February 24, 2011
Last verified: February 2011
  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
Poliomyelitis
Haemophilus Influenzae Type b Disease
Hepatitis B
Diphtheria
Pertussis
Pneumococcal Diseases
Tetanus
Biological: 251154 vaccine
Biological: Infanrix hexa™
Biological: Synflorix™
Biological: Rotarix™
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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. ] [ Designated as safety issue: No ]
  • Immunogenicity with respect to components of the study vaccines. [ Time Frame: One month after the third dose of primary vaccination. ] [ Designated as safety issue: No ]

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. ] [ Designated as safety issue: No ]
  • Immunogenicity with respect to components of the study vaccines (on secondary readouts). [ Time Frame: One month after the third dose of primary vaccination. ] [ Designated as safety issue: No ]
  • Immunogenicity with respect to components of the study vaccines (on secondary readouts). [ Time Frame: One month after booster vaccination. ] [ Designated as safety issue: No ]
  • Occurrence of solicited local and general symptoms (on secondary readouts). [ Time Frame: On Day 0-Day 7 after neonatal vaccination. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • Occurrence of unsolicited adverse events (on secondary readouts). [ Time Frame: On Day 0-Day 30 after each vaccination. ] [ Designated as safety issue: No ]
  • Occurrence of serious adverse events (on secondary readouts). [ Time Frame: From enrolment up to study end. ] [ Designated as safety issue: No ]

Estimated Enrollment: 376
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

Ages Eligible for Study:   up to 5 Days
Genders Eligible for Study:   Both
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
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: NCT01110044

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

No publications provided

Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT01110044     History of Changes
Other Study ID Numbers: 112980
Study First Received: April 22, 2010
Last Updated: February 24, 2011
Health Authority: Belgium: Agence Fédérale des Médicaments et des Produits de la Santé
Canada: Biologics and Genetic Therapies Directorate (BGTD)
Germany: Paul-Ehrlich-Institut
Sweden: Medical Products Agency
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by GlaxoSmithKline:
Neonatal vaccination

Additional relevant MeSH terms:
Diphtheria
Hepatitis
Hepatitis A
Hepatitis B
Influenza, Human
Whooping Cough
Poliomyelitis
Tetanus
Corynebacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Orthomyxoviridae Infections
Respiratory Tract Infections
Respiratory Tract Diseases
Bordetella Infections
Gram-Negative Bacterial Infections
Infection
Myelitis
Central Nervous System Viral Diseases
Central Nervous System Infections

ClinicalTrials.gov processed this record on August 21, 2014