Assessment of Antibody Persistence in Children Previously Vaccinated With Pneumococcal Conjugate Vaccine - Full Text View

Purpose

This protocol posting deals with objectives & outcome measures of the extension phase up to 48-50 months post booster vaccination, to assess long-term antibody persistence in children at around 30, 42 and 66 months of age, who received previously 4 doses of pneumococcal conjugate vaccine. The objectives & outcome measures of the primary phase are presented in a separate protocol posting (NCT number = 00307554). This Protocol posting has been updated in order to comply with the FDA AA (Sep 2007).

Condition	Intervention	Phase
Diseases Caused by Streptococcus Pneumoniae and Haemophilus Influenzae	Biological: GSK1024805A Biological: Prevenar	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention
Official Title:	Long-term Follow-up Study to Assess Antibody Persistence in Children Previously Vaccinated With Four Doses of Pneumococcal Conjugate Vaccine in Primary Vaccination Study (105553) and Booster Vaccination Study (107046)

Resource links provided by NLM:

MedlinePlus related topics: Flu Pneumonia

Drug Information available for: Heptavalent pneumococcal conjugate vaccine Pneumococcal Vaccines

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Pneumococcal antibody concentrations against vaccine containing serotypes ≥ 0.05 µg/mL at around 1, 2 and 4 years post booster [ Time Frame: At 1, 2 and 4 years post booster vaccination ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Pneumococcal antibody concentrations against vaccine containing serotypes [ Time Frame: At 1, 2 and 4 years post booster vaccination ] [ Designated as safety issue: No ]
Opsonophagocytic activity against vaccine containing pneumococcal serotypes [ Time Frame: At 1, 2 and 4 years post-booster vaccination ] [ Designated as safety issue: No ]
Antibody concentrations against pneumococcal crossreactive serotypes 6A and 19A [ Time Frame: At 1, 2 and 4 years post-booster vaccination ] [ Designated as safety issue: No ]
Opsonophagocytic activity against pneumococcal cross-reactive serotypes 6A and 19A [ Time Frame: At 1, 2 and 4 years post-booster vaccination ] [ Designated as safety issue: No ]
Antibody concentrations against protein D [ Time Frame: At 1, 2 and 4 years post-booster vaccination ] [ Designated as safety issue: No ]
Seropositivity status [ Time Frame: At 1, 2 and 4 years post-booster vaccination ] [ Designated as safety issue: No ]
Occurrence of serious adverse event related to study procedures, previous study vaccination or non-participation at a defined visit [ Time Frame: Throughout the entire study period ] [ Designated as safety issue: No ]

Enrollment:	524
Study Start Date:	March 2008
Study Completion Date:	November 2011
Primary Completion Date:	November 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 10Pn-10Pn Group Subjects having received four doses of GlaxoSmithKline Biological's 10-valent pneumococcal conjugate vaccine (GSK1024850A) in primary vaccination study and in booster vaccination study	Biological: GSK1024805A No vaccination in this trial
Active Comparator: 7Pn-7Pn Group Subjects having received four doses of Prevenar vaccine in primary vaccination study and in booster vaccination study	Biological: Prevenar No vaccination in this trial
Experimental: 7Pn-10Pn Group Subjects having received three doses of Prevenar in primary vaccination study and one dose of GSK1024850A vaccine in booster vaccination study	Biological: GSK1024805A No vaccination in this trial Biological: Prevenar No vaccination in this trial

Detailed Description:

This study consists in a serological follow-up study to evaluate persistence 12, 24 and 48 months after the booster vaccination study (107046). No study vaccines will be administered within this study.

Eligibility

Ages Eligible for Study:	28 Months to 32 Months
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Male or female between, and including, 28-30 months of age at the time of first blood sampling.
Subjects who previously participated in the 105553 and 107046 studies and who received a full four dose regimen of pneumococcal conjugate vaccine during the primary and booster studies.
Subjects for whom the investigator believes that their parents/guardians can and will comply with the requirements of the protocol.
Written informed consent, covering visits 1, 2 and 3, 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:

Chronic administration of immunosuppressants or other immune-modifying drugs within 6 months prior to the blood sampling
Administration of any additional pneumococcal vaccine since end of 107046 study.
Use of any investigational or non-registered product (drug or vaccine) within 30 days preceding the blood sampling.
Administration of immunoglobulins and/or any blood products less than 6 months prior to blood sampling.
Any confirmed or suspected immunosuppressive or immunodeficient condition since the end of the 107046 study, based on medical history and physical examination.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00624819

Locations

Poland
GSK Investigational Site
Bydgoszcz, Poland, 85-021
GSK Investigational Site
Debica, Poland, 39-200
GSK Investigational Site
Krakow, Poland, 31-503
GSK Investigational Site
Olesnica, Poland, 56-400
GSK Investigational Site
Poznan, Poland, 6-709
GSK Investigational Site
Siemianowice Slaskie, Poland, 41-103

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00624819 History of Changes
Other Study ID Numbers:	111345 (Mth 12), 111346 (Mth 24), 111347 (Mth 48)
Study First Received:	February 15, 2008
Last Updated:	July 24, 2012
Health Authority:	Poland: Ministry of Health

Keywords provided by GlaxoSmithKline:

Streptococcus pneumoniae
Haemophilus influenzae
Pneumococcal conjugate vaccine
Antibody persistence

Additional relevant MeSH terms:

Influenza, Human
Pneumonia
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections

Respiratory Tract Diseases
Lung Diseases
Antibodies
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013