Pneumococcal Vaccine Booster Study in Healthy Children 11-18 Mths Old Previously Primed With the Same Vaccines. - Full Text View

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00463437

Purpose

The purpose of this 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 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 MenC or 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
Pneumococcal Disease. Meningococcal Disease.	Biological: Pneumococcal conjugate vaccine GSK1024850A. Biological: Infanrix hexa Biological: Infanrix IPV Hib Biological: Infanrix penta. Biological: Prevenar Biological: Infanrix IPV. Biological: Meningitec. Biological: NeisVac-C. Biological: Menitorix.	Phase III

MedlinePlus related topics: Fever

Drug Information available for: Heptavalent pneumococcal conjugate vaccine Pneumococcal Vaccines Meningococcal Vaccines Infanrix hexa

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title:	Booster Vaccination With Pneumococcal Vaccine GSK1024850A, a DTPa-Combined and MenC or Hib-MenC Vaccines.

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Occurrence of fever > 39°C (rectal temperature). [ Time Frame: Within 4 days after the booster vaccination. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Occurrence of solicited local symptoms. [ Time Frame: Within 4 days after booster vaccination. ] [ Designated as safety issue: Yes ]
Occurrence of solicited general symptoms. [ 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 post-booster. ] [ Designated as safety issue: No ]
In a subset of subjects: opsonophagocytic activity against vaccine pneumococcal serotypes. [ Time Frame: Prior to and one month post-booster. ] [ 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 post-booster. ] [ Designated as safety issue: No ]
In a subset of subjects: opsonophagocytic activity against cross-reactive pneumococcal serotypes. [ Time Frame: Prior to and one month post-booster. ] [ Designated as safety issue: No ]
In a subset of subjects: concentrations of antibodies against protein D. [ Time Frame: Prior to and one month post-booster. ] [ Designated as safety issue: No ]
In a subset of subjects: meningococcal serogroup C serum bactericidal assay (rSBA) titres. [ Time Frame: Prior to and one month post-booster. ] [ Designated as safety issue: No ]
In a subset of subjects: anti-meningococcal polysaccharide C antibody concentrations. [ Time Frame: Prior to and one month post-booster. ] [ Designated as safety issue: No ]
In a subset of subjects: anti-PRP antibody concentrations. [ Time Frame: Prior to and one month post-booster. ] [ Designated as safety issue: No ]

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
Pn-HibC.: Experimental 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 & Poland Biological: Infanrix IPV. Intramuscular injection, 1 dose.In Spain. Biological: Menitorix. Intramuscular injection, 1 dose.
Pn-Men.: Experimental 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 & Poland. Biological: Infanrix IPV Hib Intramuscular injection, 1 dose.In Spain. Biological: Meningitec. Intramuscular injection, 1 dose.
Pr-HibC.: Active Comparator Subjects receiving a booster dose of Wyeth Lederle'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: Infanrix penta. Intramuscular injection, 1 dose.In Germany & Poland Biological: Prevenar Intramuscular injection, 1 dose. Biological: Infanrix IPV. Intramuscular injection, 1 dose.In Spain. Biological: Menitorix. Intramuscular injection, 1 dose.
Pn-Neis.: Experimental 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 & Poland. Biological: Infanrix IPV Hib Intramuscular injection, 1 dose.In Spain. Biological: NeisVac-C. Intramuscular injection, 1 dose.

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

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

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	109507
Study First Received:	April 19, 2007
Last Updated:	October 23, 2008
ClinicalTrials.gov Identifier:	NCT00463437
Health Authority:	Germany: Paul-Ehrlich-Institut

Keywords provided by GlaxoSmithKline:

Fever.
Pneumococcal vaccine.
Pneumococcal disease.
Meningococcal vaccine.

Meningococcal disease.
Safety.
Immunogenicity.
Booster vaccination.

Study placed in the following topic categories:

Bacterial Infections
Fever
Meningococcal Infections
Healthy

Meningococcal infection
Gram-Negative Bacterial Infections
Neisseriaceae Infections

ClinicalTrials.gov processed this record on January 16, 2009