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Pneumococcal Vaccine Booster Study in Healthy Children 12-18 Mths Old Previously Primed With the Same Vaccines

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00547248
First received: October 19, 2007
Last updated: March 10, 2011
Last verified: March 2011
History of Changes
  Purpose

The purpose of this observer blind study is to assess the safety in terms of fever >39°C (rectal temperature) and the immunogenicity in terms of antibody response following a booster vaccination with pneumococcal vaccine GSK 1024850A at 12 to 18 months of age in children previously primed with the same vaccines including a pneumococcal conjugate vaccine co-administered with a diphtheria, tetanus, whole cell pertussis (DTPw)-combined vaccine and OPV or IPV vaccines. Subjects participating in this study should have received three doses of pneumococcal conjugate vaccine in the primary study.

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 = NCT00344318)


Condition Intervention Phase
Pneumococcal Disease
Streptococcus Pneumoniae Vaccines
 Biological: Pneumococcal conjugate vaccine GSK1024850A
Biological: Tritanrix-HepB
Biological: Hiberix Hib vaccine
Biological: Polio Sabin
Biological: Poliorix
Biological: Prevenar (Wyeth)
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Caregiver, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Booster Vaccination Course With the Pneumococcal Vaccine GSK 1024850A, DTPw-HBV/Hib and OPV or IPV in Children Who Completed the Primary Vaccination Course in Study 107007

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Occurrence of fever with rectal temperature > 39°C [ Time Frame: Within 4 days after booster vaccination. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Occurrence of solicited local symptoms (any and grade 3) [ Time Frame: Within 4 days after booster vaccination. ] [ Designated as safety issue: Yes ]
  • Occurrence of solicited general symptoms (any and grade 3) [ Time Frame: Within 4 days after booster vaccination. ] [ Designated as safety issue: Yes ]
  • Occurrence of unsolicited adverse events [ Time Frame: Within 31 days after booster vaccination. ] [ Designated as safety issue: Yes ]
  • Occurrence of serious adverse events [ Time Frame: Throughout the active phase of the study ] [ Designated as safety issue: Yes ]
  • Occurrence of serious adverse events [ Time Frame: Throughout the entire study period from study start up to the end of the extended 6 months safety follow-up ] [ Designated as safety issue: Yes ]
  • In a subset of subjects: concentrations of antibodies against vaccine pneumococcal serotypes [ Time Frame: Prior to and one month after the booster vaccination ] [ Designated as safety issue: No ]
  • In a subset of subjects: opsonophagocytic activity against vaccine pneumococcal serotypes. [ Time Frame: Prior to and one month after the booster vaccination ] [ Designated as safety issue: No ]
  • In a subset of subjects: concentrations of antibodies against protein D. [ Time Frame: Prior to and one month after the booster vaccination ] [ Designated as safety issue: No ]
  • In a subset of subjects: concentrations of antibodies against cross-reactive pneumococcal serotypes. [ Time Frame: Prior to and one month after the booster vaccination ] [ Designated as safety issue: No ]
  • In a subset of subjects: opsonophagocytic activity against cross-reactive pneumococcal serotypes. [ Time Frame: Prior to and one month after the booster vaccination ] [ Designated as safety issue: No ]
  • In a subset of subjects: Anti-diphtheria and anti-tetanus toxoids, anti-PRP, anti- B. pertussis, anti-hepatitis B antibody concentrations, and anti-polio type 1, 2 and 3 antibody titers [ Time Frame: Prior to and one month after the administration of the booster dose of DTPw-HBV/Hib + OPV or IPV ] [ Designated as safety issue: No ]
  • Booster immune response to B. pertussis [ Time Frame: One month after the booster dose of DTPw-HBV/Hib + OPV or IPV ] [ Designated as safety issue: No ]

Enrollment: 756
Study Start Date: October 2007
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A
Receiving pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biological's DTPw-HBV/Hib vaccine (Tritanrix-HepB +Hiberix) and OPV (Polio Sabin) in the Philippines or IPV (Poliorix) in Poland.
 Biological: Pneumococcal conjugate vaccine GSK1024850A
Intramuscular injection, 1 dose
Biological: Tritanrix-HepB
Intramuscular injection, 1 dose
Other Name: DTPw-HBV vaccine
Biological: Hiberix Hib vaccine
Reconstituted with Tritanrix-Hep B before injection
Other Name: Hib vaccine
Biological: Polio Sabin
Oral, 1 dose
Other Name: OPV
Biological: Poliorix
Intramuscular injection, 1 dose
Other Name: IPV
Active Comparator: Group B
Receiving Prevenar (Wyeth) co-administered with GSK Biological's DTPw-HBV/Hib vaccine (Tritanrix-HepB +Hiberix) and OPV (Polio Sabin) in the Philippines or IPV (Poliorix) in Poland.
 Biological: Tritanrix-HepB
Intramuscular injection, 1 dose
Other Name: DTPw-HBV vaccine
Biological: Hiberix Hib vaccine
Reconstituted with Tritanrix-Hep B before injection
Other Name: Hib vaccine
Biological: Polio Sabin
Oral, 1 dose
Other Name: OPV
Biological: Poliorix
Intramuscular injection, 1 dose
Other Name: IPV
Biological: Prevenar (Wyeth)
Intramuscular injection, 1 dose
Other Name: Pneumococcal conjugate vaccine

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   12 Months to 18 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects for whom the investigator believes that their parents/guardians can and will comply with the requirements of the protocol.
  • A male or female between, and including, 12-18 months of age at the time of the booster vaccination and who previously participated in study 107007 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 (pharmaceutical product or device).
  • 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.
  • Administration of any pneumococcal, diphtheria, tetanus, pertussis, polio, hepatitis B, Haemophilus influenzae type b vaccine other than the study vaccines from study 107007.
  • History of, or intercurrent diphtheria, tetanus, pertussis, polio, hepatitis B, Haemophilus influenzae type b diseases.
  • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00547248

Locations
Philippines
GSK Investigational Site
Muntinlupa, Philippines, 1781
Poland
GSK Investigational Site
Gdansk, Poland, 80-394
GSK Investigational Site
Lodz, Poland, 91-347
GSK Investigational Site
Trzebnica, Poland, 55-100
GSK Investigational Site
Tuchola, Poland, 89-500
GSK Investigational Site
Wroclaw, Poland, 52-312
GSK Investigational Site
Wroclaw, Poland, 50345
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided by GlaxoSmithKline

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: NCT00547248     History of Changes
Other Study ID Numbers: 109509
Study First Received: October 19, 2007
Last Updated: March 10, 2011
Health Authority: Philippines: Bureau of Food and Drugs

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

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

ClinicalTrials.gov processed this record on May 16, 2013