Assess Reacto- & Immunogenicity of Pneumococcal Conjugate Vaccine When Given as Booster or a 2 Dose Catch up Schedule - Full Text View

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00513409

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 & outcome measures of the booster phase. The objectives & 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	Biological: Infanrix Hexa Biological: Pneumococcal conjugate vaccine GSK1024850A Biological: Havrix	Phase II

MedlinePlus related topics: Flu Pneumonia

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

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Non-Randomized, Double Blind (Caregiver, Investigator), Parallel Assignment, Safety/Efficacy Study
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.

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Occurrence of grade 3 adverse events (solicited and unsolicited) [ Time Frame: Within 4 days after the administration of any study vaccine dose ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Occurrence of solicited local symptoms [ Time Frame: Within 4 days after the administration of each of the study vaccine doses ] [ Designated as safety issue: Yes ]
Occurrence of solicited general symptoms [ Time Frame: Within 4 days after the administration of each of the study vaccine doses ] [ Designated as safety issue: Yes ]
Occurrence of unsolicited adverse events [ Time Frame: Within 31 days after the administration of each of the study vaccine doses ] [ Designated as safety issue: Yes ]
Occurrence of serious adverse events [ Time Frame: Throughout the active phase of the study ( from the first study dose up to Month 3). ] [ Designated as safety issue: Yes ]
Occurrence of serious adverse events [ Time Frame: Throughout the entire study period (from the first study dose up to the end of the extended safety follow-up) ] [ Designated as safety issue: Yes ]
Concentrations of antibodies against vaccine pneumococcal serotypes [ Time Frame: Prior to any vaccination and 1 month after administration of Dose 2 ] [ Designated as safety issue: No ]
Opsonophagocytic activity against vaccine pneumococcal serotypes [ Time Frame: Prior to any vaccination and 1 month after administration of Dose 2 ] [ Designated as safety issue: No ]
Concentrations of antibodies against protein D. [ Time Frame: Prior to any vaccination and 1 month after administration of Dose 2 ] [ Designated as safety issue: No ]
Anti-HAV antibody concentrations. [ Time Frame: Prior to any vaccination and 1 month after administration of Dose 2 ] [ Designated as safety issue: No ]

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
Primed 10V: Experimental Subjects primed with pneumococcal conjugate vaccine GSK1024850A, receiving hepatitis A (Havrix), co-administered with DTPa-HBV-IPV/Hib (infanrix hexa) as Dose 1, and receiving pneumococcal conjugate vaccine GSK1024850A, as Dose 2.	Biological: Infanrix Hexa 1 Intramuscular injection Biological: Pneumococcal conjugate vaccine GSK1024850A Intramuscular injection, 1 or 2 doses Biological: Havrix 1 Intramuscular injection
Unprimed 10V: Experimental Unprimed subjects receiving pneumococcal conjugate vaccine GSK1024850A, co-administered with DTPa-HBV-IPV/Hib (infanrix hexa) as catch-up Dose 1, and receiving pneumococcal conjugate vaccine GSK1024850A as catch-up Dose 2.	Biological: Infanrix Hexa 1 Intramuscular injection Biological: Pneumococcal conjugate vaccine GSK1024850A Intramuscular injection, 1 or 2 doses Biological: Havrix 1 Intramuscular injection

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00513409

Locations

Chile, Región Metro De Santiago
GSK Investigational Site
Santiago, Región Metro De Santiago, Chile

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	110031
Study First Received:	August 7, 2007
Last Updated:	January 8, 2009
ClinicalTrials.gov Identifier:	NCT00513409
Health Authority:	Chile: Instituto de Salud Publica de Chile

Keywords provided by GlaxoSmithKline:

Pneumococcal vaccine
Pneumococcal disease
Safety
Immunogenicity
Booster vaccination

Study placed in the following topic categories:

Virus Diseases
Haemophilus influenzae
Respiratory Tract Diseases
Respiratory Tract Infections

Lung Diseases
Influenza, Human
Orthomyxoviridae Infections
Pneumonia

Additional relevant MeSH terms:

RNA Virus Infections

ClinicalTrials.gov processed this record on January 15, 2009