Immunogenicity and Safety of Two Formulations of GSK Biologicals' Pneumococcal Vaccine (2830929A and 2830930A) When Administered in Healthy Infants

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01616459
First received: June 7, 2012
Last updated: March 6, 2014
Last verified: March 2014
  Purpose

The purpose of this study is to assess the immunogenicity, reactogenicity and safety of two formulations of GSK Biologicals' pneumococcal vaccine (2830929A and 2830930A) administered as 3-dose primary vaccination during the first 6 months of life followed by a booster dose in the second year of life. To comply with the routine infant immunisation program, the licensed GSK Biologicals DTPa-HBV-IPV/Hib (Infanrix hexa) vaccine will be co-administered in infants with the pneumococcal study vaccines.


Condition Intervention Phase
Infections, Streptococcal
Biological: Pneumococcal vaccine GSK2830929A
Biological: Pneumococcal vaccine GSK2830930A
Biological: Synflorix™
Biological: Prevenar 13™
Biological: Infanrix hexa™
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Immunogenicity and Safety Study of Two Formulations of GlaxoSmithKline (GSK) Biologicals' Pneumococcal Vaccine (2830929A and 2830930A) When Administered in Healthy Infants

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Evaluation of immune responses to components of the 2830929A and 2830930A vaccines in terms of antibody concentrations [ Time Frame: One month post-dose 3 (Month 3) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Evaluation of the immune responses to components of the 2830929A and 2830930A vaccines, for additional parameters [ Time Frame: One month post-dose 3 (Month 3) and one month post-booster vaccination (Month 11) ] [ Designated as safety issue: No ]
  • Evaluation of the immune responses to components of the 2830929A and 2830930A vaccines in terms of antibody concentrations [ Time Frame: Prior to booster vaccination (Month 10) ] [ Designated as safety issue: No ]
  • Occurrence of each solicited adverse event [ Time Frame: Within 4 days (Day 0-Day 3) after each vaccination ] [ Designated as safety issue: No ]
  • Occurrence of each unsolicited adverse event [ Time Frame: Within 31 days (Day 0-Day 30) after each vaccination ] [ Designated as safety issue: No ]
  • Occurrence of serious adverse event [ Time Frame: During the entire study (from Month 0 up to Month 11) ] [ Designated as safety issue: No ]

Enrollment: 953
Study Start Date: July 2012
Study Completion Date: January 2014
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A
Infants receiving GSK2830929A vaccine co-administered with Infanrix hexa.
Biological: Pneumococcal vaccine GSK2830929A
4 doses administered intramuscularly
Biological: Infanrix hexa™
4 doses administered intramuscularly
Experimental: Group B
Infants receiving GSK2830930A vaccine co-administered with Infanrix hexa.
Biological: Pneumococcal vaccine GSK2830930A
4 doses administered intramuscularly
Biological: Infanrix hexa™
4 doses administered intramuscularly
Active Comparator: Group C
Infants receiving Synflorix co-administered with Infanrix hexa.
Biological: Synflorix™
4 doses administered intramuscularly
Biological: Infanrix hexa™
4 doses administered intramuscularly
Active Comparator: Group D
Infants receiving Prevenar 13 co-administered with Infanrix hexa.
Biological: Prevenar 13™
4 doses administered intramuscularly
Biological: Infanrix hexa™
4 doses administered intramuscularly

  Eligibility

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

Inclusion Criteria:

  • Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) (LARs) can and will comply with the requirements of the protocol.
  • A male or female between, and including 6 to 12 weeks (42-90 days) of age at the time of the first vaccination. In addition, the first pneumococcal and DTPa-HBV-IPV/Hib vaccination should be given in accordance with the official national recommendations for the immunisation schedule of infants.
  • Written informed consent obtained from the parents/LAR(s) of the subject.
  • Healthy subjects as established by medical history and clinical examination before entering into the study.
  • Born after a gestation period of at least 36 weeks.

Exclusion Criteria:

  • Child in care.
  • 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.
  • Planned administration/administration of a vaccine containing diphtheria toxoid, tetanus toxoid (except MenC-TT in Spain) or CRM197 and not foreseen by the study protocol during any time of the study period, or of any other vaccines not foreseen by the protocol in the period starting from 30 days before each dose and ending 30 days after each dose of vaccine(s), with the following exceptions:

    • Licensed influenza vaccines are always allowed, even if concomitantly administered with the study vaccines.
    • Licensed rotavirus vaccines are allowed if administered at least 7 days before or after each dose of study of vaccines.
    • Licensed MenC-TT vaccine is allowed in Spain and should be concomitantly administered with the study vaccine at around 2, 4 and 12-15 months of age.
    • In case an emergency mass vaccination for an unforeseen public health threat (e.g. a pandemic) is organised by the public health authorities, outside the routine immunization program, that vaccine can be administered at any time during the study period provided it is licensed and used according to its Summary of Product Characteristics or Prescribing Information and according to the local governmental recommendations.
  • 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 .
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
  • Family history of congenital or hereditary immunodeficiency.
  • History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine(s).
  • Major congenital defects or serious chronic illness, including Kawasaki's syndrome.
  • History of any neurological disorders or seizures, including conditions such as hypotensive-hyporesponsive episodes, encephalopathy and any convulsions (afebrile and febrile).
  • Acute disease and/or fever at the time of enrolment.
  • Administration of immunoglobulins and/or any blood products since birth or planned administration during study period.
  • Previous vaccination against diphtheria, tetanus, pertussis, polio, H. influenzae type b.
  • Previous vaccination against S. pneumoniae.
  • History of or intercurrent diphtheria, tetanus, pertussis, hepatitis B, polio, H. influenzae type b disease.
  • Any medical condition which might interfere with the assessment of the study objectives in the opinion of the investigator.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01616459

  Show 43 Study Locations
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01616459     History of Changes
Other Study ID Numbers: 116485, 2011-005743-27
Study First Received: June 7, 2012
Last Updated: March 6, 2014
Health Authority: Czech Republic: State Institute for Drug Control

Keywords provided by GlaxoSmithKline:
Streptococcus pneumoniae
Haemophilus influenzae
Pneumococcal vaccine
Infants
Safety
Immunogenicity

Additional relevant MeSH terms:
Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on April 17, 2014