Acellular Pertussis, Diphtheria, Diphtheria-Tetanus-acellular Pertussis Vaccines, Poliomyelitis, Tetanus
Conditions
Keywords
Safety, Infanrix-IPV, Post-marketing surveillance, Diphtheria, tetanus, pertussis and poliomyelitis
Brief summary
The purpose of this study is to collect safety information following routine vaccination with Infanrix-IPV among infants and children in Korea.
Interventions
OTHERInfanrix-IPV data collection
Safety monitoring: recording of adverse events using diary cards and recording of serious adverse events using the latest version of Korea's Post-Marketing Surveillance Serious Adverse Event Reporting Form.
Sponsors
GlaxoSmithKline
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
2 Months to 6 Years
Healthy volunteers
Yes
Inclusion criteria
* Subjects who the investigator believes that their parent(s)/legally acceptable representative(s) can and will comply with the requirements of the protocol. * Korean male or female subjects who are eligible for the primary and/or booster doses of Infanrix-IPV according to the Korean Prescribing Information. * Written or signed informed consent obtained from the parent(s)/ legally acceptable representative(s) of the child. Where parent(s)/ legally acceptable representatives are illiterate, the consent form will be countersigned by an impartial witness. Prior to enrollment of the subject into the post-marketing surveillance, the subject's parents/legally acceptable representatives will be requested to provide information regarding the enrollment of their child in a same/similar study previously. And prior to obtaining informed consent form, the investigator will check whether the subject is eligible for vaccination.
Exclusion criteria
* At the time of post-marketing surveillance (PMS) entry, the contraindications and precautions of use indicated in the local Prescribing Information should be checked and the subject must not be included in the PMS if there is any contraindication. Any changes in the locally approved Prescribing Information must be implemented immediately. * Subjects who receive any investigational or non-licensed DTPa-IPV vaccine within 30 days prior to study start will not be enrolled. * Child in care.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occurrence of adverse events | During the 30-day (Day 0 - Day 29) follow-up period after each vaccine dose. |
| Occurrence of serious adverse events | Starting at Visit 1 in the post-marketing surveillance (PMS) up to 30 days (Day 0 to Day 29) after the last dose is administered in the PMS |
Countries
South Korea
Outcome results
None listed