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CompletedNCT00379977Updated Oct 12, 2016

Study to Assess the Safety & Reactogenicity of GSK Biologicals' DTPa/Hib Vaccine When Given at 3, 4 and 5 Months of Age

A Phase 3 interventional study of diphtheria, tetanus, pertussis & Hib vaccine in Tetanus, Haemophilus Influenzae Type b and Acellular Pertussis, sponsored by GlaxoSmithKline. Completed at 1 site in China. Open to participants aged 90 Days to 120 Days, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-10-12.

Sponsored by GlaxoSmithKline · Phase 3, Interventional, and Prevention

Phase
Phase 3
Study type
Interventional
Enrollment
30
Allocation
Non-randomized
Ages
90 Days to 120 Days
Sex
All
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Study summary

This study will evaluate the safety and reactogenicity of GSK Biologicals' Diphtheria Tetanus acellular Pertussis/Haemophilus influenzae type b vaccine given to Chinese infants at 3, 4 and 5 months of age.

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Conditions studied

  • Tetanus
  • Haemophilus Influenzae Type b
  • Acellular Pertussis
  • Diphtheria

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03

In context

Diphtheria

265 studies on the registry are indexed under Diphtheria; 16 are open to participants now.

This study's enrollment of 30 is below the median of 440 across 239 interventional studies indexed under Diphtheria.

Browse Diphtheria studies →

Lead sponsor

GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.

Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
90 Days to 120 Days
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • A male or female between, and including, 90 and 120 days of age at the time of the first vaccination Written informed consent obtained from the parent or guardian of the subject

Exclusion criteria

Exclusion Criteria:

  • subjects with known exposure to diphtheria, tetanus, pertussis and/or Haemophilus influenzae disease can not participate, subjects who have received previous vaccination against diphtheria, tetanus, acellular pertussis and/or Haemophilus influenzae type b (Hib) diseases can not participate.
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Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants

Interventions

  • Biologicaldiphtheria, tetanus, pertussis & Hib vaccine

    Also known as: diphtheria, tetanus, pertussis & Hib vaccine

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What researchers measure

Primary outcomes

  1. Occurrence of solicited symptoms during the 4 days following vaccination, unsolicited symptoms during the 31 days following vaccination and serious adverse events

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Study locations

1 site
  • GSK Investigational Site
    Nanning, Guangxi 530021, China
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References and documents

Individual participant data

Plan to share: Yes — Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 12, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00379977
Lead sponsor
GlaxoSmithKline
Responsible party
Sponsor
First posted
Sep 25, 2006
Start date
Sep 2006
Completion
Dec 2006
Last update
Oct 12, 2016

Study contacts

GSK Clinical Trials
study director · GlaxoSmithKline
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.

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