Last updated: 11/03/2018 14:57:29
Post-marketing surveillance study with GSK Biologicals’ pneumococcal vaccine in healthy infants in Philippines
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Other
Other
Trial overview
Official title: Post-marketing surveillance study of GSK Biologicals’ pneumococcal conjugate vaccine, Synflorix, when administered according to the local Prescribing Information in Philippines
Trial description: The purpose of this post-marketing surveillance study is to evaluate the safety of Synflorix™ when administered according to the local Prescribing Information to healthy Filipino infants.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Occurrence of grade 3 unsolicited adverse events.
Timeframe: Within 31 days (Day 0 - Day 30) after each vaccination.
Secondary outcomes:
Occurrence of unsolicited adverse events.
Timeframe: During 31 days (Day 0 - Day 30) follow-up period after each vaccination/vaccine dose.
Occurrence of serious adverse events.
Timeframe: From the Dose 1 up to study end.
Interventions:
Enrollment:
28
Primary completion date:
2013-03-07
Observational study model:
Other
Time perspective:
Prospective
Clinical publications:
Not applicable
Medical condition
Infections, Streptococcal
Product
GSK1024850A
Collaborators
Not applicable
Study date(s)
May 2010 to July 2013
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
6 weeks - 5 years
Accepts healthy volunteers
Yes
- Subjects who the investigator believes that their parents/Legally Acceptable Representative(s) (LAR(s)) can and will comply with the requirements of the protocol.
- Filipino male or female subjects whose age at the first vaccination with Synflorix™ in this PMS should not be less than 6 weeks of age.
- Acute disease and/or fever at the time of vaccine administration.
- Fever is defined as temperature ≥ 37.5°C (99.5°F) on axillary, infrared or tympanic setting.
Inclusion and exclusion criteria
Inclusion criteria:
- Subjects who the investigator believes that their parents/Legally Acceptable Representative(s) (LAR(s)) can and will comply with the requirements of the protocol.
- Filipino male or female subjects whose age at the first vaccination with Synflorix™ in this PMS should not be less than 6 weeks of age.
- Filipino male or female subjects who enter the PMS at the second dose should not be less than 10 weeks of age.
- Filipino male or female subjects who enter the PMS at the third dose should not be less than 14 weeks of age.
- Filipino male or female subjects who enter the PMS at the booster dose (i.e. if they have received Synflorix™ in the previous dose/s outside the PMS) should not be less than 10 months of age. The time interval between the primary vaccination and booster dose should be at least 6 months. For the booster dose, subjects who received PCV-7/-13 or Synflorix™ in their primary vaccination series will be allowed to take part in the PMS.
- Written and signed informed consent obtained from the parents/LAR(s) of the child. Where parents/LAR(s) are illiterate, the consent form will be countersigned by a witness.
- Free of obvious health problems as established by medical history and clinical examination before entering into the study.
Exclusion criteria:
- Acute disease and/or fever at the time of vaccine administration.
- Fever is defined as temperature ≥ 37.5°C (99.5°F) on axillary, infrared or tympanic setting.
- Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever may, be enrolled at the discretion of the investigator.
- History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine.
- History of chronic condition(s) requiring treatment such as cancer or autoimmune diseases.
- Hypersensitivity to latex (found in syringe-tip cap and plunger).
- Any contraindications as stated in the Prescribing Information.
Trial location(s)
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Other
Actual primary completion date
2013-03-07
Actual study completion date
2013-03-07
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
Participate in clinical trial
Access to clinical trial data by researchers
Visit website