Pneumococcal Vaccine Booster Study in Healthy Children 11-18 Months Old Previously Primed With the Same Vaccines

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00463437
First received: April 19, 2007
Last updated: June 12, 2014
Last verified: August 2012
  Purpose

The purpose of this study is to assess the safety in terms of fever (rectal temperature) higher than 39 degree Celcius (°C) and the immunogenicity in terms of antibody response following a booster vaccination with pneumococcal vaccine GSK1024850A at 11 to 18 months of age in children previously primed with the same vaccines including a pneumococcal conjugate vaccine co-administered with a diphtheria, tetanus, acellular pertussis (DTPa)-combined and meningococcal serogroup C (MenC) or combined meningococcal serogroup C and Haemophilus influenzae type b (Hib-MenC) vaccine.

This protocol posting deals with objectives & outcome measures of the booster phase. The objectives & outcome measures of the primary phase are presented in a separate protocol posting (NCT number = NCT00334334).


Condition Intervention Phase
Hepatitis B
Acellular Pertussis
Tetanus
Poliomyelitis
Diphtheria
Biological: Pneumococcal conjugate vaccine GSK1024850A
Biological: Prevenar
Biological: Infanrix hexa
Biological: Infanrix IPV Hib
Biological: Infanrix penta
Biological: Infanrix IPV
Biological: Meningitec
Biological: NeisVac-C
Biological: Menitorix
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Booster Vaccination With Pneumococcal Vaccine GSK1024850A, a DTPa-Combined and MenC or Hib-MenC Vaccines

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Number of Subjects Reporting Fever Above 39.0 Degree Celsius (°C) [ Time Frame: During the 4-day (Day 0-3) period after the booster vaccination ] [ Designated as safety issue: No ]
    Fever was measured as rectal temperature.


Secondary Outcome Measures:
  • Number of Subjects Reporting Solicited Local Symptoms [ Time Frame: During the 4-day (Day 0-3) period after the booster vaccination ] [ Designated as safety issue: No ]
    Solicited local symptoms assessed include pain, redness and swelling.

  • Number of Subjects Reporting Solicited General Symptoms [ Time Frame: During the 4-day (Day 0-3) period after the booster vaccination ] [ Designated as safety issue: No ]
    Solicited general symptoms assessed include drowsiness, fever, irritability, and loss of appetite.

  • Number of Subjects Reporting Unsolicited Adverse Events (AE) [ Time Frame: During the 31-day (Day 0-30) period after the booster vaccination ] [ Designated as safety issue: No ]
    An AE 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 (SAE) [ Time Frame: During the 31-day (Day 0-30) period after the booster vaccination ] [ 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 Reporting Serious Adverse Events (SAE) [ Time Frame: From the beginning of the study up to the end of the extended 6-month safety follow-up period ] [ 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 booster administration ] [ Designated as safety issue: No ]

    Anti-pneumococcal antibody concentration cut-off value assessed was 0.05 microgram per milliliter (µg/mL).

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


  • Number of Subjects With Cross-reactive Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value [ Time Frame: Before (pre) and one month after (post) the booster administration ] [ Designated as safety issue: No ]

    Anti-pneumococcal antibody cut-off value assessed was 0.05 microgram per milliliter (µg/mL).

    The cross-reactive pneumococcal serotypes assessed include 6A and 19A.


  • Number of Subjects With Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes Above the Cut-off Value [ Time Frame: Before (pre) and one month after (post) the booster administration ] [ Designated as safety issue: No ]

    Anti-pneumococcal antibody cut-off value assessed was ≥ 8.

    The cross-reactive pneumococcal serotypes assessed include 6A and 19A.


  • Number of Subjects With Anti-protein D Antibody Concentrations Above the Cut-off Value [ Time Frame: Before (pre) and one month after (post) the booster administration ] [ 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).

  • Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Titer Above the Cut-off Value [ Time Frame: Before (pre) and one month after (post) the booster administration ] [ Designated as safety issue: No ]
    Meningococcal serogroup C serum bactericidal assay titer cut-off value assessed was ≥ 8.

  • Number of Subjects With Anti-meningococcal Polysaccharide C Antibody Concentrations Above the Cut-off Value [ Time Frame: Before (pre) and one month after (post) the booster administration ] [ Designated as safety issue: No ]
    Anti-meningococcal polysaccharide C antibody cut-off value assessed was ≥ 0.3 µg/mL.

  • Number of Subjects With Anti-polyribosyl-ribitol Phosphate Antibody Concentrations Above the Cut-off Value [ Time Frame: Before (pre) and one month after (post) the booster administration ] [ Designated as safety issue: No ]
    Anti-polyribosyl-ribitol phosphate antibody cut-off value assessed was ≥ 0.15 µg/mL.


Enrollment: 1437
Study Start Date: April 2007
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: GSK's 10-valent Pneumococcal Vaccine 1024850A + Meningitec™
Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals' DTPa-combined vaccine (Infanrix™ hexa in Germany & Poland and Infanrix™ IPV Hib in Spain) and Wyeth's Men-C conjugate vaccine (Meningitec™) at 11-18 months of age.
Biological: Pneumococcal conjugate vaccine GSK1024850A
Intramuscular injection, 1 dose.
Biological: Infanrix hexa
Intramuscular injection, 1 dose. In Germany and Poland.
Other Name: DTPa-HBV-IPV/Hib (GSK Biologicals).
Biological: Infanrix IPV Hib
Intramuscular injection, 1 dose. In Spain.
Other Name: DTPa-IPV/Hib (GSK Biologicals).
Biological: Meningitec
Intramuscular injection, 1 dose.
Other Name: Meningococcal C conjugate vaccine (Wyeth).
Experimental: GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™
Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals' DTPa-combined vaccine (Infanrix™ hexa in Germany & Poland and Infanrix™ IPV Hib in Spain) and Baxter's Men-C conjugate vaccine (NeisVac-C™) at 11-18 months of age.
Biological: Pneumococcal conjugate vaccine GSK1024850A
Intramuscular injection, 1 dose.
Biological: Infanrix hexa
Intramuscular injection, 1 dose. In Germany and Poland.
Other Name: DTPa-HBV-IPV/Hib (GSK Biologicals).
Biological: Infanrix IPV Hib
Intramuscular injection, 1 dose. In Spain.
Other Name: DTPa-IPV/Hib (GSK Biologicals).
Biological: NeisVac-C
Intramuscular injection, 1 dose.
Other Name: Meningococcal C conjugate vaccine (Baxter).
Experimental: GSK's 10-valent Pneumococcal Vaccine 1024850A + Menitorix™
Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany & Poland and Infanrix™ IPV in Spain) and GSK Biologicals' combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.
Biological: Pneumococcal conjugate vaccine GSK1024850A
Intramuscular injection, 1 dose.
Biological: Infanrix penta
Intramuscular injection, 1 dose. In Germany and Poland.
Other Name: DTPa-HBV-IPV (GSK Biologicals).
Biological: Infanrix IPV
Intramuscular injection, 1 dose. In Spain.
Other Name: DTPa-IPV (GSK Biologicals)
Biological: Menitorix
Intramuscular injection, 1 dose.
Other Name: Combined Hib-MenC vaccine (GSK Biologicals).
Active Comparator: Prevenar™ + Menitorix™
Subjects receiving a booster dose of Wyeth's pneumococcal conjugate vaccine (Prevenar™) co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany & Poland and Infanrix™ IPV in Spain) and GSK Biologicals' combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.
Biological: Prevenar
Intramuscular injection, 1 dose.
Other Name: Pneumococcal conjugate vaccine (Wyeth Lederle).
Biological: Infanrix penta
Intramuscular injection, 1 dose. In Germany and Poland.
Other Name: DTPa-HBV-IPV (GSK Biologicals).
Biological: Infanrix IPV
Intramuscular injection, 1 dose. In Spain.
Other Name: DTPa-IPV (GSK Biologicals)
Biological: Menitorix
Intramuscular injection, 1 dose.
Other Name: Combined Hib-MenC vaccine (GSK Biologicals).

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   11 Months to 18 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol.
  • A male or female between, and including, 11-18 months of age at the time of the booster vaccination.
  • A male or female who previously participated in study 107005 and received three doses of pneumococcal conjugate vaccine.
  • 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:

  • Concurrently participating in another clinical study, at any time during the study period (active phase and extended safety follow-up), in which the subject has been or will be exposed to an investigational or a non-investigational product.
  • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within one month preceding the booster dose of study vaccines, or planned use during the entire study period
  • Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within 6 months prior to the booster dose of study vaccines.
  • Planned administration/administration of a vaccine not foreseen by the study protocol, during the period starting one month before the booster dose of study vaccines and up to the follow-up visit (one month after the booster dose of study vaccines).
  • Administration of any pneumococcal, diphtheria, tetanus, pertussis, polio, hepatitis B, Haemophilus influenzae type b, MenC and/or Hib-MenC vaccines other than the study vaccines from study 107005.
  • History of, or intercurrent, diphtheria, tetanus, pertussis, polio, hepatitis B, Haemophilus influenzae type b, meningococcal serogroup C disease.
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
  • History of seizures (this criterion does not apply to subjects who have had a single, uncomplicated febrile convulsion in the past) or progressive neurological disease.
  • Acute disease at the time of enrolment.
  • 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 three months preceding the booster dose of study vaccines or planned administration during the active phase of the study (starting with the administration of the booster dose of study vaccines up to the follow-up visit one month after).
  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: NCT00463437

  Show 63 Study Locations
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Publications:
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00463437     History of Changes
Other Study ID Numbers: 109507
Study First Received: April 19, 2007
Results First Received: June 11, 2009
Last Updated: June 12, 2014
Health Authority: Germany: Paul-Ehrlich-Institut

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

Additional relevant MeSH terms:
Hepatitis B
Poliomyelitis
Central Nervous System Diseases
Central Nervous System Infections
Central Nervous System Viral Diseases
Digestive System Diseases
DNA Virus Infections
Enterovirus Infections
Hepadnaviridae Infections
Hepatitis
Hepatitis, Viral, Human
Liver Diseases
Myelitis
Nervous System Diseases
Neuromuscular Diseases
Picornaviridae Infections
RNA Virus Infections
Spinal Cord Diseases
Virus Diseases

ClinicalTrials.gov processed this record on October 21, 2014