Immunization of Children Previously Primed With GSK Pneumococcal Vaccine GSK1024850A and of Unprimed Children in Mali
This study has been completed.
Sponsor:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00985465
First received: September 24, 2009
Last updated: November 16, 2012
Last verified: November 2012
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Purpose
The purpose of this trial is to assess the safety, reactogenicity and immunogenicity of GSK Biologicals' pneumococcal conjugate vaccine GSK1024850A when administered either as a booster dose or as a two dose catch-up vaccination in the second year of life to the Malian subjects previously enrolled in the primary vaccination study NCT00678301.
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 = NCT00678301).
| Condition | Intervention | Phase |
|---|---|---|
|
Pneumococcal Disease Streptococcus Pneumoniae Vaccines |
Biological: Pneumococcal vaccine GSK1024850A |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Safety, Reactogenicity and Immunogenicity Study of GSK Biologicals' Pneumococcal Vaccine GSK1024850A, Given Either as a Booster Dose or as a 2-dose Catch-up Immunization in Healthy Malian Children |
Resource links provided by NLM:
Further study details as provided by GlaxoSmithKline:
Primary Outcome Measures:
- Occurrence of grade 3 adverse events (solicited and unsolicited) [ Time Frame: within 31 days (Day 0 to Day 30) after booster vaccination ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Solicited local and general adverse events [ Time Frame: within 4 days (Day 0-Day 3) after each vaccine dose ] [ Designated as safety issue: No ]
- Unsolicited adverse events [ Time Frame: within 31 days (Day 0-Day 30) after each vaccine dose ] [ Designated as safety issue: No ]
- Serious adverse events [ Time Frame: At the first vaccination up to 31 Days after the last vaccination ] [ Designated as safety issue: No ]
- Evaluation of the immune responses to the components of the investigational vaccine in the primed group [ Time Frame: prior to and one month after the booster immunization ] [ Designated as safety issue: No ]
- Evaluation of the immune responses to the components of the investigational vaccine in the unprimed group [ Time Frame: prior to the first dose and one month after dose 2 ] [ Designated as safety issue: No ]
| Enrollment: | 210 |
| Study Start Date: | November 2009 |
| Study Completion Date: | July 2010 |
| Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Pn-Pn group
subjects from the Pn-Pn group, previously vaccinated with pneumococcal conjugate vaccine GSK1024850A in the Malian centre of study NCT00678301, receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A
|
Biological: Pneumococcal vaccine GSK1024850A
Intramuscular injection, 1 or 2 doses
|
|
Experimental: Zil-Pn group
subjects from the unprimed group of the NCT00678301 Malian study centre, not previously vaccinated with any pneumococcal vaccine, receiving two doses of pneumococcal conjugate vaccine GSK1024850A
|
Biological: Pneumococcal vaccine GSK1024850A
Intramuscular injection, 1 or 2 doses
|
Eligibility| Ages Eligible for Study: | 15 Months to 21 Months |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) (LAR(s)) can and will comply with the requirements of the protocol.
- A male or female, between and including 15-21 months of age at the time of visit 1.
- For the Pn-Pn group, subjects who completed the full vaccination course in study NCT00678301. For the Zil-Pn group, subjects who were previously enrolled in the control group of study NCT00678301.
- Written informed consent, signed or thumb printed, obtained from the parent(s)/LAR(s) of the subject. Where parent(s)/LAR(s) are illiterate, the consent form will be countersigned by a witness.
- Healthy subjects 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(s)/product(s) within 30 days preceding the first dose of vaccine, or planned use during the study period.
- Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to vaccination.
- 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. Locally recommended vaccines for example Oral Polio Vaccine or influenza vaccine are always allowed, even if concomitantly administered with the study vaccines, but should be documented in the CRF.
- 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).
- Administration of any pneumococcal vaccine since the end of study NCT00678301.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, since the end of study NCT00678301, based on medical history and physical examination.
- Major congenital defects or serious chronic illness.
- History of any progressive neurological disorders or seizures.
- Acute disease and/or fever at the time of enrolment.
- History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines.
- Administration of immunoglobulins and/or any blood products less than 3 months prior to visit 1 or planned use during the study.
- Child in care.
Contacts and Locations More Information
No publications provided
| Responsible Party: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT00985465 History of Changes |
| Other Study ID Numbers: | 113166 |
| Study First Received: | September 24, 2009 |
| Last Updated: | November 16, 2012 |
| Health Authority: | Mali: Health Ministry, General Secretary, Pharmacy and Drug Direction |
Keywords provided by GlaxoSmithKline:
|
Booster vaccination Pneumococcal vaccine Catch-up vaccination |
Pneumococcal disease Safety Immunogenicity |
Additional relevant MeSH terms:
|
Pneumonia Lung Diseases Respiratory Tract Diseases Respiratory Tract Infections |
ClinicalTrials.gov processed this record on May 23, 2013