Safety and Immunogenicity Study of GlaxoSmithKline (GSK) Biologicals' Pneumococcal Vaccine 283093… (NCT01485406) | Clinical Trial Compass
CompletedPhase 1
Safety and Immunogenicity Study of GlaxoSmithKline (GSK) Biologicals' Pneumococcal Vaccine 2830930A Administered in Toddlers
Germany61 participantsStarted 2011-12-12
Plain-language summary
The purpose of this study is to assess the safety, reactogenicity and immunogenicity of the GSK Biologicals' pneumococcal vaccine 2830930A in toddlers aged 12 to 23 months at study entry.
Who can participate
Age range12 Months – 23 Months
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) (LARs) can and will comply with the requirements of the protocol.
* A male or female between, and including 12 to 23 months of age at the time of 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.
* Born after a gestation period of at least 36 weeks.
* Previously completed three-dose vaccination course with Synflorix.
Exclusion Criteria:
* Child in care.
* 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 since birth.
* Planned administration/administration of a vaccine containing diphtheria- or tetanus- toxoid or CRM197 and not foreseen by the study protocol during any time of the study period, or of any other vaccines not foreseen by the protocol in the period starting from 30 days before the vaccine dose and ending 30 days after, with the exception of licensed influenza vaccines.
* The licensed influenza vaccines are always allowed, even if concomitantly administered with the study vaccines but should be documented in the "Concomitant vaccination" of the electronic Case Report Form.
* Concurrently…
What they're measuring
1
Occurrence of each grade 3 solicited adverse event with relationship to vaccination
Timeframe: Within 7 days (Day 0-Day 6) after vaccination
2
Occurrence of grade 3 unsolicited adverse events with relationship to vaccination
Timeframe: Within 31 days (Day 0-Day 30) after vaccination
3
Occurrence of serious adverse events with relationship to vaccination
Timeframe: During the entire study (from Month 0 up to Month 1)