Safety & Immunogenicity of Pneumococcal Vaccine 2189242A in Children Aged 12-23 Months at the Time of First Vaccination
- Full Text View
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Purpose
This study will assess the safety, reactogenicity and immunogenicity of different formulations of GSK Biologicals' pneumococcal vaccine 2189242A when administered alone or in combination with the 10-valent pneumococcal conjugate vaccine (GSK1024850A vaccine) as a 2-dose primary vaccination course followed by a booster dose in healthy children aged 12-23 months at the time of first vaccination. Considering that febrile reactions are frequently observed following pneumococcal vaccination, usually co-administered with other routine paediatric vaccines, the primary study objective will focus on evaluating the increase in grade 3 fever (i.e. rectal temperature >40.0°C).
| Condition | Intervention | Phase |
|---|---|---|
|
Pneumococcal Disease Haemophilus Influenzae Infections |
Biological: Pneumococcal vaccine GSK2189242A (formulation 1) Biological: Pneumococcal vaccine GSK2189242A (formulation 2) Biological: Pneumococcal vaccine GSK2189242A combined with pneumococcal vaccine GSK1024850A (formulation 3) Biological: Pneumococcal vaccine GSK2189242A combined with pneumococcal vaccine GSK1024850A (formulation 4) Biological: Pneumococcal vaccine GSK1024850A |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Prevention |
| Official Title: | Safety, Reactogenicity & Immunogenicity of GSK Biologicals' Pneumococcal Vaccine 2189242A in Children Aged 12-23 Months at the Time of First Vaccination |
- Occurrence of fever >40.0°C (rectal temperature) [ Time Frame: Within 7 days (Day 0-6) following at least one dose of the primary vaccinations. ] [ Designated as safety issue: No ]
- Occurrence of each solicited local and general adverse events [ Time Frame: Within 7 days (Day 0-6) after each vaccination ] [ Designated as safety issue: No ]
- Occurrence of unsolicited adverse events [ Time Frame: Within 31 days (Day 0-30) after each vaccination ] [ Designated as safety issue: No ]
- Occurrence of serious adverse events [ Time Frame: From the first vaccine dose up to study end ] [ Designated as safety issue: No ]
- Evaluation of the immune responses to components of the investigational vaccines [ Time Frame: One month post-dose 2, before booster dose and one month post-booster dose ] [ Designated as safety issue: No ]
| Enrollment: | 257 |
| Study Start Date: | November 2009 |
| Study Completion Date: | March 2011 |
| Primary Completion Date: | March 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Group 1 |
Biological: Pneumococcal vaccine GSK2189242A (formulation 1)
Three doses will be administered intramuscularly, at Month 0, 2 and 6.
|
| Experimental: Group 2 |
Biological: Pneumococcal vaccine GSK2189242A (formulation 2)
Three doses will be administered intramuscularly, at Month 0, 2 and 6
|
| Experimental: Group 3 |
Biological: Pneumococcal vaccine GSK2189242A combined with pneumococcal vaccine GSK1024850A (formulation 3)
Three doses will be administered intramuscularly, at Month 0, 2 and 6
|
| Experimental: Group 4 |
Biological: Pneumococcal vaccine GSK2189242A combined with pneumococcal vaccine GSK1024850A (formulation 4)
Three doses will be administered intramuscularly, at Month 0, 2 and 6
|
| Experimental: Control Group |
Biological: Pneumococcal vaccine GSK1024850A
Three doses will be administered intramuscularly, at Month 0, 2 and 6
|
Eligibility| Ages Eligible for Study: | 12 Months to 23 Months |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) (LAR) can and will comply with the requirements of the protocol
- Male or female between, and including, 12 and 23 months of age at the time of the first vaccination.
- Written informed consent obtained from the parents/LAR(s) of the subject.
- 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 other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
- Planned administration/administration of a vaccine not foreseen by the study protocol during the study period starting from 30 days before each dose and ending 30 days after each dose of vaccine(s).
- Previous vaccination against S. pneumoniae since birth.
- History of any hypersensitivity reaction following any previous vaccination.
- Eczema and any history of allergy
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required), including human immunodeficiency virus infection.
- A family history of congenital or hereditary immunodeficiency.
- Major congenital defects or any chronic illness.
- History of any neurologic disorders or seizures.
- Acute disease and/or fever at the time of enrolment.
- Fever is defined as temperature >= 37.5°C on oral or axillary setting, or >= 38.0°C on rectal setting.
- Subjects with a minor illness without fever may be enrolled at the discretion of the investigator.
- Administration of immunoglobulins and/ or any blood products within the 3 months preceding the first dose of study vaccine or planned use during the study period.
- Child in care.
Contacts and Locations| Czech Republic | |
| GSK Investigational Site | |
| Chomutov, Czech Republic, 43003 | |
| GSK Investigational Site | |
| Decin, Czech Republic, 405 01 | |
| GSK Investigational Site | |
| Nachod, Czech Republic, 547 01 | |
| GSK Investigational Site | |
| Odolena voda, Czech Republic, 25070 | |
| GSK Investigational Site | |
| Ostrava - Poruba, Czech Republic, 70868 | |
| GSK Investigational Site | |
| Pardubice, Czech Republic, 532 03 | |
| GSK Investigational Site | |
| Plzen, Czech Republic, 305 99 | |
| GSK Investigational Site | |
| Praha 4, Czech Republic, 140 00 | |
| GSK Investigational Site | |
| Praha 6, Czech Republic, 1600 | |
| GSK Investigational Site | |
| Znojmo, Czech Republic, 669 00 | |
| Study Director: | GSK Clinical Trials | GlaxoSmithKline |
More Information
No publications provided
| Responsible Party: | Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure |
| ClinicalTrials.gov Identifier: | NCT00985751 History of Changes |
| Other Study ID Numbers: | 113171 |
| Study First Received: | September 24, 2009 |
| Last Updated: | May 26, 2011 |
| Health Authority: | Czech: State Institute for Drug Control |
Keywords provided by GlaxoSmithKline:
|
immunogenicity toddlers Pneumococcal vaccine Haemophilus influenzae |
safety Streptococcus pneumoniae Streptococcus Pneumoniae Vaccines |
Additional relevant MeSH terms:
|
Influenza, Human Haemophilus Infections Orthomyxoviridae Infections RNA Virus Infections Virus Diseases |
Respiratory Tract Infections Respiratory Tract Diseases Pasteurellaceae Infections Gram-Negative Bacterial Infections Bacterial Infections |
ClinicalTrials.gov processed this record on May 21, 2013