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Assess Reacto- and Immunogenicity of Pneumococcal Conjugate Vaccine When Given as Booster or a 2 Dose Catch up Schedule

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ClinicalTrials.gov Identifier: NCT00513409
Recruitment Status : Completed
First Posted : August 8, 2007
Results First Posted : August 11, 2009
Last Update Posted : December 18, 2018
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Tracking Information
First Submitted Date  ICMJE August 7, 2007
First Posted Date  ICMJE August 8, 2007
Results First Submitted Date  ICMJE March 11, 2009
Results First Posted Date  ICMJE August 11, 2009
Last Update Posted Date December 18, 2018
Study Start Date  ICMJE August 22, 2007
Actual Primary Completion Date February 20, 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 4, 2010)
Number of Subjects Reporting Grade 3 Symptoms (Solicited and Unsolicited) [ Time Frame: Within 4 days after the administration of any study vaccine dose ]
Grade 3 symptoms are symptoms which prevent normal, everyday activities (e.g. in a young child such symptom would prevent attendance at school/ kindergarten/ a day-care center and would cause the parents/guardians to seek medical advice).
Original Primary Outcome Measures  ICMJE
 (submitted: August 7, 2007)
Occurrence of grade 3 adverse events after administration of any study vaccine dose
Change History Complete list of historical versions of study NCT00513409 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 4, 2010)
  • Number of Subjects Reporting Solicited Local Symptoms [ Time Frame: Within 4 days after the administration of any study vaccine dose ]
    Solicited local symptoms assessed include pain, redness and swelling.
  • Number of Subjects Reporting Solicited General Symptoms [ Time Frame: Within 4 days after the administration of any study vaccine dose ]
    Solicited general symptoms assessed include drowsiness, fever, irritability and loss of appetite. Fever was defined as rectal temperature ≥ 38 degrees Celsius.
  • Number of Subjects Reporting Unsolicited Adverse Events [ Time Frame: Within 31 days after the administration of any study vaccine dose ]
    An Adverse Event is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
  • Number of Subjects Reporting Serious Adverse Events During the Active Phase of the Study [ Time Frame: Throughout the active phase of the study ( from the beginning of the booster phase up to 1 month after the second booster dose) ]
    A serious adverse event (SAE) is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.
  • Number of Subjects Reporting Serious Adverse Events Throughout the Entire Study Period [ Time Frame: Throughout the entire study period (from the beginning of the booster phase up to the end of the 6-month extended safety follow-up) ]
    An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.
  • Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value [ Time Frame: Before (pre) and one month after (post) the administration of Dose 2 ]
    Anti-pneumococcal antibody cut-off value assessed was 0.20 microgram per milliliter (μg/mL). The vaccine pneumococcal serotypes assessed include 1, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F.
  • Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value [ Time Frame: Before (pre) and one month after (post) the administration of Dose 2 ]
    Cut-off value for opsonophagocytic activity against pneumococcal antibody assessed was ≥ 8 The vaccine pneumococcal serotypes assessed include 1, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F.
  • Number of Subjects With Anti-protein D Antibody Concentrations Above the Cut-off Value [ Time Frame: Before (pre) and one month after (post) the administration of Dose 2 ]
    Anti-protein D antibody cut-off value assessed was ≥ 100 Enzyme-Linked Immuno Sorbent Assay (ELISA) unit per milliliter (EL.U/mL).
  • Anti-hepatitis A Virus Antibodies Concentration [ Time Frame: Before (pre) and one month after (post) the administration of Dose 2 ]
    Concentration of anti-hepatitis A antibodies given as geometric mean concentration (GMC) in milli-international units per milliliter (mIU/mL).
  • Number of Subjects With Anti-hepatitis A Antibody Concentrations Above the Cut-off Value [ Time Frame: Before (pre) and one month after (post) the administration of Dose 2 ]
    Anti-hepatitis A antibodies cut-off value assessed was ≥ 15 mIU/mL.
Original Secondary Outcome Measures  ICMJE
 (submitted: August 7, 2007)
Occurrence of solicited local and general symptoms, Occurrence of unsolicited adverse events, Occurrence of serious adverse events during active phase of study, Assess vaccine immunogenicity
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Assess Reacto- and Immunogenicity of Pneumococcal Conjugate Vaccine When Given as Booster or a 2 Dose Catch up Schedule
Official Title  ICMJE Phase II, Observer-blind Follow-up Study to Assess reacto-and Immunogenicity of GSK Biologicals' Pneumococcal Conjugate Vaccine (GSK1024850A), When Given as Booster in Primed Children or as 2-dose Catch-up in Unprimed Children.
Brief Summary

This is a booster study in 2 groups of healthy children less than 3 years old to measure the reactogenicity, safety and immunogenicity of GSK Biologicals' pneumococcal conjugate vaccine, when given as a booster or as a two-dose catch-up vaccination.

This protocol posting deals with objectives and outcome measures of the booster phase. The objectives and outcome measures of the primary phase are presented in a separate protocol posting (NCT number = NCT00338351).

Detailed Description The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Investigator)
Primary Purpose: Prevention
Condition  ICMJE Infections, Streptococcal
Intervention  ICMJE
  • Biological: Synflorix
    Intramuscular injection, 1 or 2 doses
  • Biological: Infanrix Hexa
    1 Intramuscular injection
    Other Name: DTPa-HBV-IPV/Hib
  • Biological: Havrix
    1 Intramuscular injection
Study Arms  ICMJE
  • Experimental: Synflorix Booster Group
    Subjects previously primed with Synflorix™ and receiving in the current study Havrix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2).
    Interventions:
    • Biological: Synflorix
    • Biological: Infanrix Hexa
    • Biological: Havrix
  • Experimental: Synflorix Catch-up Group
    Subjects previously primed with Havrix™ co-administered with Infanrix™ hexa and receiving in the current study Synflorix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2).
    Interventions:
    • Biological: Synflorix
    • Biological: Infanrix Hexa
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 6, 2008)
163
Original Estimated Enrollment  ICMJE
 (submitted: August 7, 2007)
240
Actual Study Completion Date  ICMJE August 28, 2008
Actual Primary Completion Date February 20, 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male or female between, and including, 18-21 months of age at the time of vaccination.
  • Subjects who previously participated in the primary study and received 3 doses of study or control vaccines during the primary study.
  • Subjects for whom the investigator believes that their parents/guardians can and will comply with the requirements of the protocol.
  • Written informed consent obtained from the parent or guardian of the subject.
  • Free of obvious health problems as established by medical history and clinical examination before entering into the study.

Exclusion Criteria:

  • Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) within 30 days preceding the booster doses of study vaccines, or planned use during the study period (active phase and extended safety follow-up).
  • Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting one month (30 days) before the booster doses of vaccine(s) and during the active phase of the study (up to the follow-up visit (Visit 3)).
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
  • History of seizures (subjects who have had a single, uncomplicated febrile convulsion in the past can be included) or progressive neurological disease.
  • Acute disease at the time of enrolment.
  • Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within 6 months prior to the booster doses of study vaccines.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination.
  • A family history of congenital or hereditary immunodeficiency.
  • Major congenital defects or serious chronic illness.
  • Administration of immunoglobulins and/or any blood products within the last 3 months prior to booster or follow-up vaccination or planned administration during the active phase of the study.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Months to 21 Months   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Chile
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00513409
Other Study ID Numbers  ICMJE 110031
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Responsible Party GlaxoSmithKline
Study Sponsor  ICMJE GlaxoSmithKline
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: GSK Clinical Trials GlaxoSmithKline
PRS Account GlaxoSmithKline
Verification Date May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP