Primary Vaccination Course in Children Receiving Pneumococcal Conjugate Vaccine GSK 1024850A or Prevenar™ and Hiberix™

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00680914
First received: May 16, 2008
Last updated: January 12, 2012
Last verified: March 2011
  Purpose

The purposes of this study are:

To demonstrate the immunogenicity in terms of antibody response following primary vaccination of Korean infants with the pneumococcal conjugate vaccine GSK 1024850A compared to Prevenar™ when co-administered with a Haemophilus influenzae type b (Hib) vaccine in children during the first 6 months of life.

To evaluate the safety/reactogenicity in terms of solicited and unsolicited symptoms and serious adverse events following primary vaccination of Korean infants with the pneumococcal conjugate vaccine GSK 1024850A.


Condition Intervention Phase
Pneumococcal Disease
Streptococcus Pneumoniae Vaccines
Biological: Pneumococcal vaccine GSK1024850A (Synflorix)
Biological: Prevenar
Biological: GSK Biologicals' Hiberix™
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Primary Vaccination Course in Children Receiving the Pneumococcal Vaccine GSK 1024850A or Prevenar™ Co-administered With Hiberix™

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Number of Subjects With Vaccine Pneumococcal Serotypes Antibody Concentrations Above the Cut-Off Value [ Time Frame: One month after administration of 3rd dose of the pneumococcal conjugate vaccine ] [ Designated as safety issue: No ]

    Anti-pneumococcal antibody cut-off value assessed was 0.20 microgram per milliliter (ug/mL).

    The vaccine pneumococcal serotypes assessed include 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, and 23F.



Secondary Outcome Measures:
  • Number of Subjects With a Seropositivity Status Against Protein D and Defined Pneumococcal Serotypes [ Time Frame: One month after the administration of the 3rd vaccine dose of the pneumococcal conjugate vaccine ] [ Designated as safety issue: No ]

    Seropositivity status for protein D is defined as anti protein D (anti-PD) antibody concentrations >= 100 Enzyme-Linked Immuno Sorbent Assay (EL) units EL.U/mL.

    Seropositivity status for pneumococcal serotypes is defined as anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations >= 0.05 ug/mL.


  • Number of Subjects With Opsonophagocytic Activity Against Pneumococcal Serotypes Contained in the Vaccine Above the Cut-off Value [ Time Frame: One month after the administration of the 3rd vaccine dose of the pneumococcal conjugate vaccine ] [ Designated as safety issue: No ]

    The results were presented as the dilution of serum (opsonic titer) able to sustain 50% killing of live pneumococci under the assay conditions. In this assay the cut-off value for opsonophagocytic activity against pneumococcal antibody assessed was >= 8.

    The vaccine pneumococcal serotypes assessed include 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F.


  • Number of Subjects With Cross-reactive Pneumococcal Serotype Antibody Concentrations Above the Cut-Off Value [ Time Frame: One month after the administration of the 3rd vaccine dose of the pneumococcal conjugate vaccine ] [ Designated as safety issue: No ]

    Anti-pneumococcal antibody cut-off value assessed was 0.20 microgram per milliliter (ug/mL).

    Pneumococcal cross-reactive serotypes were 6A and 19A.


  • Antibody Concentrations Against Pneumococal Serotypes Contained in the Vaccine [ Time Frame: One month after the administration of the 3rd vaccine dose of the pneumococcal conjugate vaccine ] [ Designated as safety issue: No ]
    Concentrations are reported as Geometric Mean Concentrations in ug/mL. Pneumococcal serotypes assessed include 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, and 23F.

  • Anti-PD Antibody Concentration [ Time Frame: One month after administration of 3rd vaccine dose of the pneumococcal conjugate vaccine ] [ Designated as safety issue: No ]
    Concentration of anti-PD antibody given as GMC expressed in EL.U/mL.

  • Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes [ Time Frame: One month after the administration of the 3rd vaccine dose of the pneumococcal conjugate vaccine ] [ Designated as safety issue: No ]
    Concentration of cross-reactive pneumococcal serotypes 6A and 19A in ug/mL.

  • Number of Subjects With Opsonophagocytic Activity Against Pneumococcal Cross-reactive Serotypes [ Time Frame: One month after the administration of the 3rd vaccine dose of the pneumococcal conjugate vaccine ] [ Designated as safety issue: No ]
    The results were presented as the dilution of serum (opsonic titer) able to sustain 50% killing of live pneumococci under the assay conditions. In this assay the cut-off value for opsonophagocytic activity against pneumococcal cross-reactive serotypes 6A and 19A was defined as >= 8.

  • Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentrations [ Time Frame: One month after the administration of the 3rd vaccine dose of the pneumococcal conjugate vaccine ] [ Designated as safety issue: No ]
    Concentration of anti-PRP antibody given as GMC in ug/mL.

  • Number of Subjects With Seroprotection Status Against PRP [ Time Frame: One month after the administration of the 3rd vaccine dose of the pneumococcal conjugate vaccine ] [ Designated as safety issue: No ]
    Seroprotection status is defined as anti-PRP antibody concentrations above 0.15 ug/mL and above 1.0 ug/mL

  • Number of Subjects Reporting Solicited Local Symptoms [ Time Frame: Within 4 days after each vaccination ] [ Designated as safety issue: No ]
    Solicited local symptoms assessed include pain, redness and swelling.

  • Number of Subjects With Solicited General Symptoms [ Time Frame: Within 4 days after each vaccination ] [ Designated as safety issue: No ]

    Solicited general symptoms assessed include drowsiness, fever, irritability and loss of appetite.

    Fever was defined as axillary temperature >= 37.5 degrees Celsius.


  • Number of Subjects Reporting Unsolicited Adverse Events [ Time Frame: Within 31 days after each vaccination ] [ Designated as safety issue: No ]
  • Number of Subjects With Serious Adverse Events (SAE) [ Time Frame: Following the administration of the first dose of the study vaccines throughout the entire study period up to study month 5 ] [ 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.



Enrollment: 503
Study Start Date: June 2008
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Synflorix Group
Subjects received 3 doses of Synflorix vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4.
Biological: Pneumococcal vaccine GSK1024850A (Synflorix)
3 doses administered intramuscularly.
Biological: GSK Biologicals' Hiberix™
3 doses administered intramuscularly.
Other Name: Hib
Active Comparator: Prevenar Group
Subjects received 3 doses of Prevenar vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4.
Biological: Prevenar
3 doses administered intramuscularly.
Biological: GSK Biologicals' Hiberix™
3 doses administered intramuscularly.
Other Name: Hib

Detailed Description:

Vaccination course at 2, 4, 6 months of age.

  Eligibility

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

Inclusion Criteria:

  • Male or female subjects between, and including 6-12 weeks of age at the time of the first vaccination.
  • Subjects for whom the investigator believes that their parent(s)/guardian(s) can and will comply with the requirements of the protocol should be enrolled in the study.
  • Written and signed informed consent obtained from the parent(s)/guardian(s) of the child/ward.
  • Free of any known or suspected health problems as established by medical history and clinical examination before entering into the study.
  • Born after a gestation period of 36 to 42 weeks inclusive, with a birth weight of at least 2.5 kilogram.

Exclusion Criteria:

  • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the first dose of the study vaccines, or planned use 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 (pharmaceutical product or device).
  • Chronic administration of immunosuppressants or other immune-modifying drugs since birth.
  • Planned administration/administration of a vaccine not allowed by the study protocol during the study period. Vaccines included in the Korean routine immunization schedule can be administered at least one week before or at least one month after the administration of the study vaccines. Recommended live vaccines not included in the Korean routine immunization schedule can be given at least one month before or at least one month after the administration of the study vaccines.
  • A family history of congenital or hereditary immunodeficiency.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination.
  • Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period (Hepatitis B immunoglobulins at birth are allowed).
  • Previous vaccination against Streptococcus pneumoniae and/or Haemophilus influenzae type b.
  • History of, or intercurrent Streptococcus pneumoniae and/or Haemophilus influenzae type b disease.
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
  • History of any neurological disorders or seizures.
  • Major congenital defects or serious chronic illness.
  • Acute disease at the time of enrolment. Study entry should be delayed until the illness has improved.
  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: NCT00680914

Locations
Korea, Republic of
GSK Investigational Site
Ansan, Korea, Republic of, 425-707
GSK Investigational Site
Bucheon-si,, Korea, Republic of, 420-767
GSK Investigational Site
Daejeon, Korea, Republic of, 301-723
GSK Investigational Site
Gyeongnam, Korea, Republic of, 641-560
GSK Investigational Site
Iksan, Korea, Republic of, 570-711
GSK Investigational Site
Jeju, Korea, Republic of, 690-716
GSK Investigational Site
Jeonju Jeonbuk, Korea, Republic of, 561-712
GSK Investigational Site
Pusan, Korea, Republic of, 602-739
GSK Investigational Site
Seoul, Korea, Republic of, 411-706
GSK Investigational Site
Seoul, Korea, Republic of, 150-719
GSK Investigational Site
Seoul, Korea, Republic of, 158-710
GSK Investigational Site
Seoul, Korea, Republic of, 130-702
GSK Investigational Site
Suwon City, Korea, Republic of, 442-723
GSK Investigational Site
Wonju-si Kangwon-do, Korea, Republic of, 220-701
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Publications:
Schuerman L et al. Population variability of opsonophagocytic activity following 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate (PHiD-CV) vaccination more limited than antibody responses. Abstract presented at the 7th International Symposium on Pneumococci and Pneumococcal Diseases (ISPPD). Tel Aviv, Israel, 14-18 March 2010.
Kim KH et al. Immunogenicity of primary vaccination with the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) in Korean infants. Abstract presented at the 7th International Symposium on Pneumococci and Pneumococcal Diseases (ISPPD). Tel Aviv, Israel, 14-18 March 2010.
Kim JS et al. Safety and reactogenicity of primary vaccination with 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) in Korean infants. Abstract presented at the 7th International Symposium on Pneumococci and Pneumococcal Diseases (ISPPD). Tel Aviv, Israel, 14-18 March 2010.
Schuerman L et al. Population variability in antibody responses following pneumococcal conjugate vaccination: experience with the non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV). Abstract presented at the 7th International Symposium on Pneumococci and Pneumococcal Diseases (ISPPD). Tel Aviv, Israel, 14-18 March 2010.

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: NCT00680914     History of Changes
Other Study ID Numbers: 110808
Study First Received: May 16, 2008
Results First Received: May 13, 2010
Last Updated: January 12, 2012
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by GlaxoSmithKline:
Streptococcus pneumoniae
pneumococcal conjugate vaccine

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

ClinicalTrials.gov processed this record on August 28, 2014