Booster and Catch-up Vaccination With Vaccine GSK1024850A
This study has been completed.
Sponsor:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01030822
First received: December 10, 2009
Last updated: April 11, 2013
Last verified: July 2012
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Purpose
The purpose of this study is to evaluate the immunogenicity, safety and reactogenicity of a booster dose of pneumococcal vaccine GSK1024850A administered either at 9-18 months or 15-18 months of age in children primed in primary study NCT00814710.
This study also aims to assess the persistence of antibodies induced following primary vaccination with pneumococcal vaccine GSK1024850A in primary study NCT00814710 prior to booster vaccination and following vaccination in the present study at approximately 24 months of age.
The study is also designed to evaluate the immunogenicity, safety and reactogenicity of pneumococcal vaccine GSK1024850A when administered as a catch-up vaccination (2+1) in the second year of life in children unprimed with vaccine GSK1024850A in study NCT00814710.
| Condition | Intervention | Phase |
|---|---|---|
|
Streptococcus Pneumoniae Pneumococcal Disease |
Biological: Pneumococcal vaccine GSK1024850A |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Booster Vaccination With Pneumococcal Vaccine GSK1024850A in Primed Children and Catch-up Vaccination in Unprimed Children |
Resource links provided by NLM:
Further study details as provided by GlaxoSmithKline:
Primary Outcome Measures:
- Evaluation of immune responses to components of the investigational vaccine in primed subjects [ Time Frame: One month after booster vaccination ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Evaluation of immune responses to components of the investigational vaccine in primed subjects [ Time Frame: Prior to booster vaccination, one month after booster vaccination and at approximately 24 months of age ] [ Designated as safety issue: No ]
- Evaluation of immune responses to components of the investigational vaccine in unprimed subjects [ Time Frame: Prior to vaccination, one month post-dose 2, prior to and one month after the third (booster) vaccine dose ] [ 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 events [ Time Frame: Within 31 days after each vaccination ] [ Designated as safety issue: No ]
- Occurrence of serious adverse events [ Time Frame: After the first vaccination up to 31 days after the last vaccination. ] [ Designated as safety issue: No ]
| Enrollment: | 282 |
| Study Start Date: | April 2010 |
| Study Completion Date: | September 2011 |
| Primary Completion Date: | September 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Group A
Subjects previously primed with pneumococcal vaccine GSK1024850A in the first year of life and receiving a booster dose of GSK1024850A at 9-18 months of age.
|
Biological: Pneumococcal vaccine GSK1024850A
Intramuscular injection, administered as a single dose
|
|
Experimental: Group B
Subjects previously primed with pneumococcal vaccine GSK1024850A in the first year of life and receiving a booster dose of GSK1024850A at 15-18 months of age.
|
Biological: Pneumococcal vaccine GSK1024850A
Intramuscular injection, administered as a single dose
|
|
Experimental: Group C
Unprimed subjects receiving a catch-up vaccination (2+1 schedule) in the second year of life.
|
Biological: Pneumococcal vaccine GSK1024850A
Intramuscular injection, 3 doses
|
Detailed Description:
The study is randomized for primed subjects and non-randomized for unprimed subjects.
The protocol posting has been updated according to the amendment of the protocol dated 16 April 2010. The age range at the time of randomization of subjects primed in study NCT00814710 and the age range for booster vaccination of one of the groups has been extended.
Eligibility| Ages Eligible for Study: | 9 Months to 18 Months |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Male or female subjects for whom the investigator believes that their parent(s)/ guardian(s) can and will comply with the requirements of the protocol.
- Written, signed or thumb-printed informed consent obtained from the parent(s)/guardian(s) of the child/ward. Where parent(s)/guardian(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.
For primed subjects:
- Completion of the full vaccination course in study NCT00814710.
- 9-18 months of age at the time of randomization.
- Group A: 9-18 months of age at the time of booster vaccination.
- Group B: 15-18 months of age at the time of booster vaccination.
For unprimed subjects (Group C):
- Enrolled in study NCT00814710.
- 12-18 months of age at the time of first vaccination.
Exclusion Criteria:
- Use of any investigational or non-registered product within 30 days preceding the vaccination, or planned use during the study period.
- 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.
- Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to vaccination.
- Administration of immunoglobulins and/or any blood products within three months preceding the vaccination or planned administration during the study period.
- Administration of any pneumococcal vaccine since the end of study NCT00814710.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- History of reactions or allergic disease likely to be exacerbated by any component of the vaccine.
- Major congenital defects or serious chronic illness.
- History of any neurologic disorders or seizures.
- Acute disease at the time of enrolment.
Contacts and Locations More Information
No publications provided
| Responsible Party: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT01030822 History of Changes |
| Other Study ID Numbers: | 112909 |
| Study First Received: | December 10, 2009 |
| Last Updated: | April 11, 2013 |
| Health Authority: | India: Drugs Controller General of India |
Keywords provided by GlaxoSmithKline:
|
Catch-up vaccination Safety Pneumococcal vaccine |
Pneumococcal disease Booster vaccination Immunogenicity |
Additional relevant MeSH terms:
|
Pneumonia Lung Diseases Respiratory Tract Diseases Respiratory Tract Infections |
ClinicalTrials.gov processed this record on May 23, 2013