Assess the Safety & Reactogenicity of DTPa-IPV/Hib Vaccine Administered at 3, 4, 5 & 18 Mths of Age, in Healthy Infants

Phase 4

Completed

• Conditions: Diphtheria-Tetanus-aPertussis-Poliomyelitis Vaccines; Acellular Pertussis; Haemophilus Influenzae Type b; Poliomyelitis; Diphtheria; Tetanus
• Interventions: Biological: GSK Biologicals' combined DTPa-IPV/Hib vaccine

• Registration Number: NCT00325156
• Lead Sponsor: GlaxoSmithKline

Brief Summary

To assess the safety and reactogenicity of the DTPa-IPV/Hib vaccine as primary and booster vaccination. The DTPa-IPV/Hib vaccine given at 3 and 4 months of age is co-administered with GSK Biologicals' rotavirus vaccine or Placebo.

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Detailed Description

Single group study. Subjects in GSK Biologicals' rotavirus study (Rota-028) in Singapore will be enrolled in this study. 3-4-5 month schedule with a booster dose at 18 months

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2004-11-02
• Study First Submitted: 2006-02-08
• Study First Submitted QC: 2006-05-11
• Study First Posted: 2006-05-12
• Primary Completion: 2007-08-23
• Study Completion: 2007-08-23
• Results First Submitted: 2016-12-14
• Results First Submitted QC: 2016-12-14
• Results First Posted: 2017-02-07
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-26
• Last Update Posted: 2020-01-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2590

Inclusion Criteria

Not provided

Read More

Exclusion Criteria

Not provided

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Group A	GSK Biologicals' combined DTPa-IPV/Hib vaccine	-

Primary Outcome Measures

Name	Time	Method
Number of Subjects Reporting Any Solicited Local and General Symptoms	During the 4-day (Days 0-3) post-vaccination period, across doses	Assessed solicited local and general symptoms were pain, redness, swelling, drowsiness, fever \[defined as axillary temperature equal to or above 37.5 degrees Celsius (°C )\], irritability and loss of appetite. Any was defined as any report of the specified symptom irrespective of intensity grade and relationship to vaccination.

Secondary Outcome Measures

Name	Time	Method
Number of Subjects Reporting Any Unsolicited Adverse Events (AEs)	During the 30-day (Days 0-29) post-vaccination period	An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
Number of Subjects Reporting Large Injection Site Swelling	At Month 18, post-booster dose	A large swelling reaction was defined as swelling with a diameter greater than (\>) 50 millimeters (mm), noticeable diffuse swelling or noticeable increase of limb circumference.
Number of Subjects Reporting Any Serious Adverse Events (SAEs)	During the entire study period	Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

Trial Locations

Locations (1)

GSK Investigational Site; 🇸🇬 Singapore, Singapore