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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00158795

Enrollment

454

Registered

2005-09-12

Start date

2005-01-31

Completion date

2005-07-31

Last updated

2017-05-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Haemophilus Influenzae Type b Disease

Brief summary

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)

Detailed description

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.

Interventions

BIOLOGICALHaemophilus Influenza type b vaccine

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

3 Months to 4 Months

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
Occurrence of solicited symptoms of grade 3 intensity, during the specific follow-up period after vaccination.	—

Secondary

Measure	Time frame
- Occurrence of unsolicited symptoms during the specific follow up period after vaccination.	—
- Occurrence of serious adverse events during the study period.	—
- Occurrence of solicited symptoms during the specific follow up period after vaccination.	—

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026