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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00513409
First received: August 7, 2007
Last updated: November 21, 2012
Last verified: November 2012
  Purpose

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).


Condition Intervention Phase
Streptococcus Pneumoniae and Nontypable Haemophilus Influenzae
Streptococcus Pneumoniae Vaccines
Biological: Synflorix
Biological: Infanrix Hexa
Biological: Havrix
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Caregiver, Investigator)
Primary Purpose: Prevention
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Number of Subjects Reporting Grade 3 Symptoms (Solicited and Unsolicited) [ Time Frame: Within 4 days after the administration of any study vaccine dose ] [ Designated as safety issue: No ]
    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).


Secondary Outcome Measures:
  • Number of Subjects Reporting Solicited Local Symptoms [ Time Frame: Within 4 days after the administration of any study vaccine dose ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]

    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) ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Anti-hepatitis A antibodies cut-off value assessed was ≥ 15 mIU/mL.


Enrollment: 163
Study Start Date: August 2007
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).
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
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).
Biological: Synflorix
Intramuscular injection, 1 or 2 doses
Biological: Infanrix Hexa
1 Intramuscular injection
Other Name: DTPa-HBV-IPV/Hib

Detailed Description:

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

  Eligibility

Ages Eligible for Study:   18 Months to 21 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  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: NCT00513409

Locations
Chile
GSK Investigational Site
Santiago, Región Metro De Santiago, Chile
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Publications:
Lagos R et al. (2011) Safety and immunogenicity of the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) in Chilean children. Hum Vaccin. 7(5):511-522.

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00513409     History of Changes
Other Study ID Numbers: 110031
Study First Received: August 7, 2007
Results First Received: March 11, 2009
Last Updated: November 21, 2012
Health Authority: Chile: Instituto de Salud Pública de Chile

Keywords provided by GlaxoSmithKline:
Immunogenicity
Pneumococcal disease
Safety
Booster vaccination
Pneumococcal vaccine

Additional relevant MeSH terms:
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections

ClinicalTrials.gov processed this record on November 24, 2014