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OpenTrials
Completed

NCT Number: NCT01248988

Post Marketing Surveillance of Synflorix Vaccine Safety Among Infants in Korea

The purpose of this study is to collect safety information following routine vaccination with Synflorix™ among infants in Korea.

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Key information

Conditions

Infections, Streptococcal Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections Pneumococcal Infections Streptococcal Infections

Age range

6 week–5 year

Sex eligibility

All sexes

Study type

Observational

Primary location

GSK Investigational Site

Suwon, Kyonggi-do, 443-721, South Korea

About this study

Rationale for the protocol amendment: The therapeutic indication for Synflorix in Korea has been updated. The protocol is being amended to reflect this update.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjects who the investigator believes that their parent(s)/Legally Acceptable Representatives can and will comply with the requirements of the protocol.
  • Korean male or female subjects whose age while receiving the first vaccination with Synflorix is 6 weeks - 5 years.
  • Written, signed or thumb-printed 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 a witness.

Exclusion criteria

  • At the time of Post Marketing Surveillance entry, the contraindications and precautions of use indicated in the local Prescribing Information should be checked and the infant must not be included in the Post Marketing Surveillance if there is any contraindication. Any changes in the locally approved Prescribing Information must be implemented immediately.
  • Subjects who receive any investigational or non-registered pneumococcal vaccine 30 days prior to the study start will not be enrolled. Subjects who had previous administration of a pneumococcal vaccine other than Synforix will not be enrolled into the study.
  • A male or female children >= 5 years of age at study entry.

Treatment and study plan

Synflorix™ Data collection

Other

Safety monitoring: recording of adverse events during using diary cards and recording of serious adverse events using the latest version of Korea's Post-Marketing Surveillance Serious Adverse Event Reporting Form.

Primary outcomes

  1. Occurrence of unexpected adverse events

    Time frame: During the 30-day (Day 0 - Day 29) follow-up period after each vaccine dose.

  2. Occurrence of expected adverse events

    Time frame: During the 30-day (Day 0 - Day 29) follow-up period after each vaccine dose.

  3. Occurrence of serious adverse events

    Time frame: From the first dose in the study up to 30 days (Day 0 - Day 29) after the last dose.

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

Safety of GlaxoSmithKline (GSK) Biologicals' 10-valent Pneumococcal-protein D-diphtheria Toxoid-tetanus Toxoid Conjugate (10PN-PD-DiT) Vaccine, Synflorix When Administered According to the Approved Prescribing Information in Korea

Important dates

Study start
2010
Primary completion
2015
Study completion
2015
First posted
Nov 25, 2010
Registry last updated
Jan 13, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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