Long-term Follow-up Study of Children Previously Primed With GSK Pneumococcal Vaccine (GSK1024850A) and of Unprimed Children
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Purpose
The objective of this study is to evaluate the immune memory through the administration of an additional dose of GSK Biologicals' pneumococcal conjugate vaccine GSK1024850A, the antibody persistence and long-term effect on nasopharyngeal carriage of S. pneumoniae and H. influenzae in subjects primed and boosted with GSK Biologicals' pneumococcal conjugate vaccine GSK1024850A in previous primary and booster studies. For subjects that did not receive the investigational vaccine during the primary and booster study, the objective is to evaluate immunogenicity, safety and reactogenicity of a 2-dose catch-up vaccination with GSK Biologicals' pneumococcal conjugate vaccine GSK1024850A.
This protocol posting deals with objectives & outcome measures of the extension phase. The objectives & outcome measures of the primary phase are presented in a separate protocol posting (NCT00370318). The objectives & outcome measures of the booster phase are presented in a separate protocol posting (NCT00496015).
| Condition | Intervention | Phase |
|---|---|---|
|
Streptococcus Pneumoniae Pneumococcal Disease |
Biological: Pneumococcal vaccine GSK1024850A |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Vaccination Course in Children Primed and Boosted With Pneumococcal Vaccine GSK 1024850A and in Age-matched Unprimed Children |
- Demonstration of immune memory through the evaluation of early immune responses in terms of concentration of antibodies against components of the investigational vaccine [ Time Frame: 7-10 days after the single/first dose of investigational vaccine ] [ Designated as safety issue: No ]
- Persistence of immune responses and evaluation of immune memory through the evaluation of early immune responses to components of the investigational vaccine for additional parameters [ Time Frame: prior to and 7-10 days after the single/first dose of investigational vaccine ] [ Designated as safety issue: No ]
- Evaluation of the immune responses to components of the investigational vaccine for additional parameters in the unprimed group [ Time Frame: one month post-dose II ] [ Designated as safety issue: No ]
- Persistence of immune responses in terms of antibody titres against components of the meningococcal conjugate vaccine in the unprimed group [ Time Frame: 25-36 months post-vaccination in previous study NCT00496015 ] [ Designated as safety issue: No ]
- Occurrence of each solicited adverse event [ Time Frame: within 4 days after each vaccination ] [ Designated as safety issue: No ]
- Occurrence of unsolicited adverse event [ Time Frame: within 31 days after each vaccination ] [ Designated as safety issue: No ]
- Occurrence of serious adverse events [ Time Frame: During the entire study period (day 0 - mth 10 for AP-AP group and NAP group and day 0- mth 12 for unprimed group) ] [ Designated as safety issue: No ]
- Occurrence of S. pneumoniae and H. influenzae in the nasopharynx [ Time Frame: at 31-44 months of age and prior to the single/first dose of investigational vaccine at 40-48 months of age ] [ Designated as safety issue: No ]
| Enrollment: | 467 |
| Study Start Date: | August 2009 |
| Study Completion Date: | October 2010 |
| Primary Completion Date: | October 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: AP-AP Group
subjects from the AP-AP group, previously vaccinated with pneumococcal conjugate vaccine GSK1024850A in study NCT00496015, receiving an additional dose of pneumococcal conjugate vaccine GSK1024850A for immune memory assessment
|
Biological: Pneumococcal vaccine GSK1024850A
1 or 2 intramuscular injections
|
|
Active Comparator: NAP-pre Group
subjects from the NAP-pre group, previously vaccinated with pneumococcal conjugate vaccine GSK1024850A in study NCT00496015 receiving an additional dose of pneumococcal conjugate vaccine GSK1024850A for immune memory assessment
|
Biological: Pneumococcal vaccine GSK1024850A
1 or 2 intramuscular injections
|
|
Active Comparator: Unprimed Group
Age-matched subjects from the unprimed group of the NCT00496015 study, not previously vaccinated with any pneumococcal vaccine, receiving two doses of pneumococcal conjugate vaccine GSK1024850A
|
Biological: Pneumococcal vaccine GSK1024850A
1 or 2 intramuscular injections
|
Detailed Description:
This protocol posting has been updated according to Protocol Amendment 1, July 2009
Eligibility| Ages Eligible for Study: | 31 Months to 44 Months |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Subjects who the investigator believes that their parents/ guardians can and will comply with the requirements of the protocol should be enrolled in the study.
- A male or female between, and including, 31 and 34 months of age at the time of the enrolment.
- Subjects who previously participated in study NCT00496015
- For the subjects in the primed AP-AP and NAP-pre groups: subjects who received a booster dose of the pneumococcal conjugate vaccine prior to the study amendment 3.
- For the subjects in the unprimed group: subjects who received a dose of the meningococcal vaccine GSK134612.
- 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 product (drug or vaccine) other than the study vaccine within 30 days preceding enrolment, or planned use during the entire study period.
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs during the entire study period.
- Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before each dose of study vaccine and ending 30 days after.
- Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
- History of seizures or progressive neurological disease.
- Acute disease at the time of enrolment, defined as the presence of a mild, moderate or severe illness with or without fever.
- Administration or planned use of immunoglobulins and/ or any blood products during the entire study period.
- A family history of congenital or hereditary immunodeficiency.
- Major congenital defects or serious chronic illness.
- Subjects of which both parents have a history of atopia (polinosis, asthma, atopic eczema).
- Administration of any pneumococcal vaccine since the end of study NCT00496015.
Contacts and Locations| Czech Republic | |
| GSK Investigational Site | |
| Brno, Czech Republic, 628 00 | |
| GSK Investigational Site | |
| Hradec Kralove, Czech Republic, 500 01 | |
| GSK Investigational Site | |
| Nachod, Czech Republic, 547 01 | |
| GSK Investigational Site | |
| Ostrava, Czech Republic, 70800 | |
| GSK Investigational Site | |
| Pardubice, Czech Republic, 532 03 | |
| GSK Investigational Site | |
| Praha 5, Czech Republic, 150 00 | |
| GSK Investigational Site | |
| Praha 6, Czech Republic, 160 00 | |
| GSK Investigational Site | |
| Praha 9, Czech Republic, 190 00 | |
| GSK Investigational Site | |
| Znojmo, Czech Republic, 669 00 | |
| 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: | NCT00950833 History of Changes |
| Other Study ID Numbers: | 112801 |
| Study First Received: | July 30, 2009 |
| Last Updated: | January 19, 2012 |
| Health Authority: | Czech: State Institute for Drug Control |
Keywords provided by GlaxoSmithKline:
|
Catch-up vaccination Pneumococcal vaccine Immune memory Nasopharyngeal carriage |
Immunogenicity Pneumococcal disease Safety |
Additional relevant MeSH terms:
|
Pneumonia Lung Diseases Respiratory Tract Diseases Respiratory Tract Infections |
ClinicalTrials.gov processed this record on May 19, 2013