Last updated: 07/17/2024 15:26:00
Primary vaccination study with GSK Biologicals’ pneumococcal vaccine in healthy infants in Vietnam
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: Primary vaccination course with the pneumococcal vaccine GSK 1024850A, in healthy infants in Vietnam when co-administered with GSK Biologicals’ Infanrix hexa™ (DTPa-HBV-IPV/Hib) vaccine
Trial description: The purpose of the study is to evaluate the safety and reactogenicity of Synflorix™ (GSK 1024850A) given as a 3-dose primary immunization course when co-administered with Infanrix hexa™ vaccine at 2, 3 and 4 months of age in infants in Vietnam.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
Number of subjects with Grade 3 symptoms (solicited and unsolicited)
Timeframe: Within the 31-day (Days 0-30) after each dose and across doses
Secondary outcomes:
Number of subjects reporting any and Grade 3 solicited local symptoms
Timeframe: During the 4-day (Days 0-3) post-vaccination period following each dose
Number of subjects reporting any, Grade 3 and related solicited general symptoms
Timeframe: During the 4-day (Days 0-3) post-vaccination period following each dose
Number of subjects with unsolicited adverse events (AEs)
Timeframe: During the 31-day (Days 0-30) follow-up period after each dose
Number of subjects with serious adverse events (SAEs)
Timeframe: After the first vaccination up to study end (From Month 0 to Month 3)
Interventions:
Biological/vaccine: Synflorix™( GSK1024850A)
Biological/vaccine: Infanrix hexa™
Enrollment:
300
Observational study model:
Not applicable
Primary completion date:
2011-26-07
Time perspective:
Not applicable
Clinical publications:
Huu TN et al. (2013) Safety and reactogenicity of primary vaccination with the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine in Vietnamese infants: a randomised, controlled trial. BMC Infect Dis. 21;13:95. doi: 10.1186/1471-2334-13-95.
Tran NH et al. Safety and reactogenicity of the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) co-administered with DTPa-HBV-IPV/Hib in Vietnamese infants. Abstract presented at the ICID, Bangkok, Thailand, June 13-16, 2012.
Medical condition
Infections, Streptococcal
Product
GSK1024850A
Collaborators
Not applicable
Study date(s)
February 2011 to July 2011
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
6 - 12 weeks
Accepts healthy volunteers
Yes
- Male or female subjects between, and including 6-12 weeks of age at the time of the first vaccination.
- Subjects for whom the investigator believes that their parents/guardians can and will comply with the requirements of the protocol.
- 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.
- 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.
Inclusion and exclusion criteria
Inclusion criteria:
- Subjects for whom the investigator believes that their parents/guardians can and will comply with the requirements of the protocol.
- Written and signed or thumb-printed informed consent obtained from the parent(s)/LAR of the child. Where parent(s)/guardian(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.
Male or female subjects between, and including 6-12 weeks of age at the time of the first vaccination.
Exclusion criteria:
- 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.
- Acute disease and/or fever at the time of enrolment.
- History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine(s).
- History of chronic condition(s) requiring treatment such as cancer or autoimmune disease.
- Hypersensitivity to latex.
- Previous vaccination against diphtheria, tetanus, pertussis, Hemophilus influenzae type b and/or Streptococcus pneumoniae. Locally recommended EPI vaccines to be given at birth are allowed, but should be administered at least one month before the first dose of the study vaccine is administered. Other locally recommended vaccines are allowed, even if concomitantly administered with the study vaccines, but should be documented in the eCRF.
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.
Trial location(s)
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2011-26-07
Actual study completion date
2011-26-07
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
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