Study to Evaluate GSK Biologicals' GSK2197870A Vaccine Given as Primary Course in Infants

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00871338
First received: March 26, 2009
Last updated: November 17, 2011
Last verified: June 2011
  Purpose

The purpose of this Phase II study is to evaluate the feasibility of GSK Biologicals' GSK2197870A vaccine co-administered with Wyeth-Lederle's Prevenar™ when given in healthy infants as a three-dose primary vaccination course at 2, 3 and 4 months of age followed by a booster dose of GSK Biologicals' Menitorix™ at 12 months of age.


Condition Intervention Phase
Poliomyelitis
Diphtheria
Whooping Cough
Meningococcal Serogroup C Infections
Haemophilus Influenzae Type b Infections
Tetanus
Biological: GSK2197870A vaccine
Biological: Prevenar™
Biological: Menitorix™
Biological: Sanofi-Pasteur's PediacelTM
Biological: Novartis' Menjugate TM
Biological: GSK Biologicals' Priorix TM
Biological: Prevenar™ or Prevenar 13™
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: Study in Healthy Children of GSK Biologicals' DTPa-IPV/Hib-MenC-TT Vaccine, GSK2197870A, Co-administered With Prevenar™ as a Three-dose Primary Vaccination Course in Infancy Followed by a Booster Dose of Menitorix™ at 12 Months of Age

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Immunogenicity to MenC and Hib components of vaccines [ Time Frame: 1 month post-dose 3 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Immunogenicity to diphtheria, tetanus, pertussis, polio and pneumococcal components of vaccines [ Time Frame: 1 month post-dose 3 ] [ Designated as safety issue: No ]
  • Immunogenicity to MenC component of vaccines [ Time Frame: 1 month post-dose 2 ] [ Designated as safety issue: No ]
  • Persistence of immunogenicity to MenC, Hib, diphtheria, tetanus, pertussis, polio components of vaccines [ Time Frame: Prior to the booster vaccination ] [ Designated as safety issue: No ]
  • Immunogenicity to booster dose with respect to MenC and Hib components of the vaccine [ Time Frame: 1 month post booster vaccination ] [ Designated as safety issue: No ]
  • Occurrence of solicited local/general symptoms [ Time Frame: Within 8 days of each vaccination ] [ Designated as safety issue: No ]
  • Occurrence of unsolicited symptoms [ Time Frame: Within 31 days of each vaccination ] [ Designated as safety issue: No ]
  • Occurrence of serious adverse events [ Time Frame: From day 1 to study end ] [ Designated as safety issue: No ]

Enrollment: 284
Study Start Date: June 2009
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MenC-Combo group Biological: GSK2197870A vaccine
3 doses given at 2, 3 and 4 months of age
Biological: Prevenar™
2 doses given at 2 and 4 months of age
Biological: Menitorix™
one booster dose at 12 months of age
Biological: GSK Biologicals' Priorix TM
1 dose given at 13 months of age
Biological: Prevenar™ or Prevenar 13™
1 booster dose given at 13 months of age.
Active Comparator: Control group Biological: Prevenar™
2 doses given at 2 and 4 months of age
Biological: Menitorix™
one booster dose at 12 months of age
Biological: Sanofi-Pasteur's PediacelTM
3 doses given at 2, 3 and 4 months of age
Biological: Novartis' Menjugate TM
2 doses given at 3 and 4 months of age
Biological: GSK Biologicals' Priorix TM
1 dose given at 13 months of age
Biological: Prevenar™ or Prevenar 13™
1 booster dose given at 13 months of age.

Detailed Description:

This protocol posting has been updated following Protocol amendment 1, 11-February-2010; The Study design section is impacted by this amendment.

  Eligibility

Ages Eligible for Study:   6 Weeks to 12 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

All subjects must satisfy the following criteria at study entry:

  • A male or female infant between, and including, 6 and 12 weeks of age at the time of the first vaccination.
  • Born after 36 to 42 weeks of gestation.
  • 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.
  • 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:

The following criteria should be checked at the time of study entry. If any apply, the subject must not be included in the study:

  • Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
  • Chronic administration of immunosuppressants or other immune-modifying drugs since birth. For corticosteroids, this will mean prednisone, or equivalent, >= 0.5 mg/kg/day. Inhaled and topical steroids are allowed.
  • Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
  • Administration of a vaccine not foreseen by the study protocol within 30 days prior to vaccination, or planned administration during the study period.
  • 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 .
  • Evidence of previous or intercurrent diphtheria, tetanus, pertussis, poliomyelitis, Hib, pneumococcal and/or group C meningococcal vaccination or disease.
  • History of seizures or progressive neurological disease (one episode of febrile convulsion does not constitute an exclusion criterion).
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccine(s).
  • Major congenital defects or serious chronic illness.

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

• Current febrile illness or axillary temperature ≥37.5ºC 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: NCT00871338

Locations
United Kingdom
GSK Investigational Site
Ely, Cambridgeshire, United Kingdom, CB7 4HF
GSK Investigational Site
Southampton, Hampshire, United Kingdom, SO16 6YD
GSK Investigational Site
Oxford, Oxfordshire, United Kingdom, OX3 7LJ
GSK Investigational Site
Bristol, United Kingdom, BS2 8AE
GSK Investigational Site
London, United Kingdom, SW17 0QT
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided by GlaxoSmithKline

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT00871338     History of Changes
Other Study ID Numbers: 111709
Study First Received: March 26, 2009
Last Updated: November 17, 2011
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by GlaxoSmithKline:
combined
Vaccines

Additional relevant MeSH terms:
Diphtheria
Influenza, Human
Poliomyelitis
Tetanus
Whooping Cough
Corynebacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Myelitis
Central Nervous System Viral Diseases
Enterovirus Infections
Picornaviridae Infections
Central Nervous System Infections
Central Nervous System Diseases
Nervous System Diseases
Spinal Cord Diseases
Neuromuscular Diseases
Clostridium Infections
Bordetella Infections
Gram-Negative Bacterial Infections
Infection

ClinicalTrials.gov processed this record on July 10, 2014