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OpenTrials
Completed

NCT Number: NCT00158795

Assess Safety & Reactogenicity of GSK Biologicals' Hib Vaccine Co-administered With or Without Chinese DTPw Vaccine

To assess safety and reactogenicity of GSK Biologicals' Haemophilus influenza type b vaccine co-administered with or without Chinese DTPw vaccine administered alone in healthy infants (3, 4 and 5 months of age)

Completed

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Key information

Conditions

Haemophilus Influenzae Type b Disease

Age range

3 month–4 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

GSK Investigational Site

Nanning, Guangxi, 530021, China

About this study

All subjects will be randomized into two groups. One group will receive DTPw vaccine co-administered with Hib and another group will receive DTPw vaccine alone. A specific follow-up of solicited local and general symptoms after each vaccination. A specific follow-up of unsolicited symptoms after each vaccination. Recording of serious adverse events reported during the study period.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • A male or female infant between, and including, 11 and 17 weeks of age at the time of the first vaccination.

Exclusion criteria

  • Planned administration of a vaccine not foreseen by the study protocol during the period starting 30 days before the administration of the first vaccine dose and ending 30 days after the last dose.
  • Chronic administration of immunosuppressants or other immune-modifying drugs from birth until administration of first dose of study vaccine.
  • Use of any investigational or non-registered product (drug or vaccine) within 30 days preceding the first dose of study vaccine, or planned use during the study period.

Treatment and study plan

Haemophilus Influenza type b vaccine

Biological

Primary outcomes

  1. Occurrence of solicited symptoms of grade 3 intensity, during the specific follow-up period after vaccination.

Secondary outcomes

  1. - Occurrence of solicited symptoms during the specific follow up period after vaccination.

  2. - Occurrence of unsolicited symptoms during the specific follow up period after vaccination.

  3. - Occurrence of serious adverse events during the study period.

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

Assess the Safety & Reactogenicity of GSK Biologicals Hib Vaccine Co-administered With Chinese Local DTPw Vaccine When Compared to Chinese Local DTPw Vaccine Administered Alone, in Healthy Infants at 3,4 & 5 Mths of Age

Important dates

Study start
2005
Primary completion
2005
Study completion
2005
First posted
Sep 12, 2005
Registry last updated
May 30, 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.