Safety of DTPa-IPV/Hib & DTPa-HBV-IPV/Hib, Followed by DTPa-IPV/Hib Vaccine in Infants Who Received Hepatitis B Vaccine

Phase 3

Completed

• Conditions: Tetanus; Haemophilus Influenzae Type b; Diphtheria; Poliomyelitis; Acellular Pertussis
• Interventions: Biological: DTPa-HBV-IPV/Hib; Biological: DTPa-IPV/Hib vaccine

• Registration Number: NCT00325143
• Lead Sponsor: GlaxoSmithKline

Brief Summary

To assess the safety and reactogenicity of the DTPa-HBV-IPV/Hib vaccine and DTPa-IPV/Hib vaccine. This 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2003-12-01
• Study First Submitted: 2006-02-08
• Study First Submitted QC: 2006-05-11
• Study First Posted: 2006-05-12
• Primary Completion: 2007-02-01
• Study Completion: 2007-02-01
• Results First Submitted: 2016-12-13
• Results First Submitted QC: 2016-12-13
• Results First Posted: 2017-02-07
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-02
• Last Update Posted: 2018-06-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 702

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Infanrix Hexa Group	DTPa-IPV/Hib vaccine	Healthy male or female subjects between and including 11 to 17 weeks of age, who were previously vaccinated with Rotarix™ in study 444563/028 (NCT00197210), additionally received 2 doses of Infanrix™-IPV/Hib vaccine (at 3 and 4 months of age), 2 doses of Rotarix™ vaccine (at 2 and 4 months of age) and one dose of Infanrix Hexa™ vaccine (at 5 months of age) as a primary vaccination course, followed by administration of a booster dose of Infanrix™-IPV/Hib vaccine (at 18 months of age). The Infanrix™-IPV/Hib and Infanrix Hexa™ vaccines were administered intramuscularly into the right antero-lateral thigh, while the Rotarix™ vaccine was given orally.
Infanrix Hexa Group	DTPa-HBV-IPV/Hib	Healthy male or female subjects between and including 11 to 17 weeks of age, who were previously vaccinated with Rotarix™ in study 444563/028 (NCT00197210), additionally received 2 doses of Infanrix™-IPV/Hib vaccine (at 3 and 4 months of age), 2 doses of Rotarix™ vaccine (at 2 and 4 months of age) and one dose of Infanrix Hexa™ vaccine (at 5 months of age) as a primary vaccination course, followed by administration of a booster dose of Infanrix™-IPV/Hib vaccine (at 18 months of age). The Infanrix™-IPV/Hib and Infanrix Hexa™ vaccines were administered intramuscularly into the right antero-lateral thigh, while the Rotarix™ vaccine was given orally.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Number of Subjects Reporting Any Serious Adverse Events (SAEs)	During the entire study period (from Month 0 up to Month 21)	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.
Number of Subjects Reporting Any Unsolicited Adverse Events (AEs)	During the 31-day (Days 0-30) 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 Any Large Swelling Reactions	At Month 15, 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.

Trial Locations

Locations (1)

GSK Investigational Site; 🇸🇬 Singapore, Singapore