Study to Evaluate the Immunogenicity and Reactogenicity of a Booster Dose of GSK2036874A Vaccine in Healthy Toddlers
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The purpose of the study is to assess the immunogenicity and safety of three formulations of GSK Biologicals' GSK2036874A vaccine compared to Zilbrix™/Hib and Poliorix™ vaccines administered concomitantly, when administered as a single booster dose to healthy poliovirus-primed toddlers aged 12-24 months.
Condition | Intervention | Phase |
---|---|---|
Haemophilus Influenzae Type b Poliomyelitis Hepatitis B Diphtheria Pertussis Tetanus |
Biological: GSK2036874A vaccine Biological: Zilbrix™/Hib vaccine Biological: Poliorix™ |
Phase 2 |
Study Type: | Interventional |
Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Prevention |
Official Title: | Immunogenicity and Reactogenicity of a Booster Dose of GlaxoSmithKline Biologicals' GSK2036874A Vaccine in Healthy Toddlers |
- Immunogenicity with respect to components of the study vaccines in terms of number of seroprotected/seropositive subjects [ Time Frame: One month after booster vaccination (At Month 1) ] [ Designated as safety issue: No ]
- Immunogenicity with respect to components of the study vaccine in terms of antibody titres [ Time Frame: Prior booster vaccination (At Month 0) ] [ Designated as safety issue: No ]
- Immunogenicity with respect to components of the study vaccine in terms of antibody titres [ Time Frame: One month after booster vaccination (At Month 1) ] [ Designated as safety issue: No ]
- Immunogenicity with respect to components of the study vaccines in terms of number of seroprotected/seropositive subjects [ Time Frame: Prior to and one month after booster vaccination (At Month 0 and Month 1) ] [ Designated as safety issue: No ]
- Immunogenicity with respect to components of the study vaccine in terms of antibody concentrations [ Time Frame: Prior to and one month after booster vaccination (At Month 0 and Month 1) ] [ Designated as safety issue: No ]
- Immunogenicity with respect to components of the study vaccine in terms of booster response to Bordetella pertussis [ Time Frame: One month after booster vaccination (At Month 1) ] [ Designated as safety issue: No ]
- Serious adverse events [ Time Frame: From the booster dose up to study end (From Day 0 to Month 1) ] [ Designated as safety issue: No ]
- Solicited local and general symptoms [ Time Frame: During the 8-day (Day 0-7) follow-up period after booster vaccination ] [ Designated as safety issue: No ]
- Unsolicited symptoms [ Time Frame: During the 31-day (Day 0-30) follow-up period after booster vaccination ] [ Designated as safety issue: No ]
Enrollment: | 312 |
Study Start Date: | May 2010 |
Study Completion Date: | September 2010 |
Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Experimental: Group A
Subjects will receive formulation 1 of GSK2036874A vaccine.
|
Biological: GSK2036874A vaccine
Intramuscular, single dose
|
Experimental: Group B
Subjects will receive formulation 2 of GSK2036874A vaccine.
|
Biological: GSK2036874A vaccine
Intramuscular, single dose
|
Experimental: Group C
Subjects will receive formulation 3 of GSK2036874A vaccine.
|
Biological: GSK2036874A vaccine
Intramuscular, single dose
|
Active Comparator: Control Group
Subjects will receive Zilbrix™/Hib and Poliorix™.
|
Biological: Zilbrix™/Hib vaccine
Intramuscular, single dose
Biological: Poliorix™
Intramuscular, single dose
|
Detailed Description:
The study will be conducted in a partially double-blinded manner. The study will be double-blinded with respect to the three GSK2036874A formulation groups and open-label with respect to the Control Group.
Ages Eligible for Study: | 12 Months to 24 Months |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- A male or female subject, between and including 12 and 24 months of age at the time of booster vaccination.
- Subjects who have received three doses of polio vaccine as primary vaccination along with the routine vaccinations indicated during the first year of life.
- Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative (s) can and will comply with the requirements of the protocol.
- Written informed consent obtained from the parent(s)/Legally Acceptable Representative (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 booster 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 booster dose.
- Administration of a vaccine not foreseen by the study protocol within 30 days prior to booster vaccination, or planned administration during the active study period (up to Visit 2).
- 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.
- History of diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and/or Haemophilus influenza type b diseases.
- Previous booster vaccination against diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B or H. influenzae diseases.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
- A family history of congenital or hereditary immunodeficiency.
- Major congenital defects or serious chronic illness.
- History of neurologic disorders or seizures.
- History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines.
- Administration of immunoglobulins and/or any blood products within the three months preceding the booster dose or planned administration during the study period.
- Occurrence of transient thrombocytopenia or neurological complications following an earlier immunisation against diphtheria and/or tetanus.
- Child in care.
Occurrence of any of the following adverse events after a previous administration of a diphtheria-tetanus-pertussis vaccine:
- encephalopathy of unknown aetiology occurring within seven days following previous vaccination with pertussis-containing vaccine,
- fever >= 40 °C within 48 hours of vaccination not due to another identifiable cause,
- collapse or shock-like state within 48 hours of vaccination,
- convulsions with or without fever, occurring within 3 days of vaccination.
Acute disease and/or fever at the time of enrolment.
- Fever is defined as temperature >= 37.5°C on oral, axillary or tympanic setting, or >= 38.0°C on rectal setting.
- Subjects with a minor illness without fever may, be enrolled at the discretion of the investigator.
- Other conditions which, in the opinion of the investigator, may potentially interfere with interpretation of study results.
No publications provided
Responsible Party: | Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure |
ClinicalTrials.gov Identifier: | NCT01106092 History of Changes |
Other Study ID Numbers: | 113264 |
Study First Received: | April 1, 2010 |
Last Updated: | December 8, 2011 |
Health Authority: | Philippines: Bureau of Food and Drugs |
Additional relevant MeSH terms:
Diphtheria Hepatitis Hepatitis A Hepatitis B Influenza, Human Whooping Cough Poliomyelitis Tetanus Corynebacterium Infections Actinomycetales Infections Gram-Positive Bacterial Infections Bacterial Infections Liver Diseases Digestive System Diseases Hepatitis, Viral, Human |
Virus Diseases Enterovirus Infections Picornaviridae Infections RNA Virus Infections Hepadnaviridae Infections DNA Virus Infections Orthomyxoviridae Infections Respiratory Tract Infections Respiratory Tract Diseases Bordetella Infections Gram-Negative Bacterial Infections Infection Myelitis Central Nervous System Viral Diseases Central Nervous System Infections |
ClinicalTrials.gov processed this record on October 17, 2012